Mexico Health Review 2020/21 by Mexico Business Publishing

2020/21

Introduction In 2020, Mexico’s health system went through intense reforms aligned to President Andrés Manuel López Obrador’s goals, which included the creation of the National Compendium of Health Supplies and the implementation of the Health Institute for Welfare, the latter being a key step toward achieving universal healthcare in the country. Already strained by these changes, Mexico’s health sector faced the unimaginable: a global pandemic that changed the way the world functions and that required the entire health system to come together like never before. The COVID-19 pandemic highlighted the deficiencies in the health system and the importance of preventive healthcare due to its impact on those suffering from chronic degenerative diseases. It also brought attention to long-neglected issues such as mental health and it accelerated the already powerful digital transformation, changing the way healthcare is provided. Digitalization trends were already transforming this sector by creating interoperability for care facilities and leveraging big data to create better solutions. During the pandemic, technology also ensured treatment continuity, medication supply and mental healthcare. It also kept hospitalizations in check and created learning and business opportunities. Throughout the year, the words “collaboration,” “unity” and “help” resonated among industry leaders. Joint work and multisectoral support helped the healthcare supply chain to move forward. It is also important to recognize that at the frontline of the pandemic were all the medical professionals, including doctors, nurses, administrative and technical staff at hospitals. Without their sacrifice and effort, the challenges brought by the pandemic would have been impossible to bear. Mexico Health Review 2020/2021 has gathered the insights of key industry leaders during the COVID-19 crisis, who share their efforts to thrive in the face of new trends and reforms and transform a challenging reality into a promising future.

Table of Contents

Introduction

State of the Industry

Care Providers

Innovative Medicines

Generics

Medical Devices

MedTech

102

Supply Chain

119

Logistics & Distribution

140

State of the Industry Reinvention is the current task of the healthcare industry. New alliances, investment and innovation are seen as the way forward after dealing with lacking care systems and distanced providers. A year into a global pandemic has set a new path for the industry and its leaders have been actively responding to the challenge. From the accelerated development of technology to the establishment of innovative, inclusive financing models to broaden access, this sector moves at a high speed to meet everyday needs with long-lasting sustainable solutions. Mexico has also been carrying a heavy burden of chronic diseases that it hopes to tackle with preventive and personalized approaches. Technology integration creates an opportunity for the sector to build an entire MedTech ecosystem that can later grow into a unified health system to end with Mexico’s highly fragmented nature in healthcare. Growing opportunities in R&D, multisectoral alliances and new market opportunities are being taken advantage by healthcare providers toward improving patients’ lives.

State of the Industry

Analysis Mexico’s Ongoing Healthcare Battle

Analysis Will the MedTech Industry Change Under a Biden Presidency?

Analysis Back and Forth With Innovation Rules

Analysis Cannabis Regulation Opens Fair Market Opportunities

Infographic The Road Toward Full COVID-19 Vaccination

HEALTH INSTITUTION AFFILIATES (millions)

Substantial reforms to the Mexican healthcare system began materializing in 2020. The first steps toward universal health were taken despite the sector’s highly fragmented entities and

Total:

the limited federal budget destined for such ambitious goals.

92.5

Mexico’s chronic disease epidemics continued to sponge most of the budget, representing a potential threat to the country’s

million

productivity and investment targets.

Total Mexican Population:

128.23 million

The healthcare sector, which is a large economic contributor, faced uncertainty to attract investment and foment growth as administrative decisions painted a foggy picture regarding fair financial and regulatory environments. Locally and internationally, Mexico’s attractiveness as an investment, manufacturing and research destination was put in question by multisectoral leaders

1.1

Other Other

1.1

SEDENA, SEMAR, PEMEX

2.6

8.2

ISSSTE ISSSTE

Privateinstitution institution Private

48.2 IMSS IMSS

Source: INEGI

SEDENA, SEMAR, PEMEX

32.8

of the health chain. Nevertheless, the country found innovative

INSABI INSABI

State of the Industry | 7

Mexico’s Ongoing Healthcare Battle

windows of opportunity to continue exploiting its potential and remain a relevant, enriching hub for both investment and research. An important achievement was the enforcement of USMCA, which Roberto Martínez, Director General of OECD for Mexico and Latin America, in an interview with MBN, described as “a window of opportunity for Mexico to attract more investment in the healthcare sector.” The agreement also highlighted opportunities in the medical devices sector, one of Mexico’s strongest areas in healthcare, especially due to the country’s

USMCA BENEFITS FOR MEXICO: + Timely and affordable access to pharmaceuticals and medical devices.

close ties with the US. Ana Riquelme, Executive President of AMID, explained to MBN that the association worked alongside the Ministry of Economy on the development of the medical devices chapters within the agreement.

+ Public health promotion. + Pharmaceutical products and medical devices R&D promotion. + Health care programs applied by the federal government remain unchanged. + Federal government drug purchases are protected through public procurement.

USMCA also includes a clause that reinforces the period during which generics manufacturers can study a product before its patent expires. This allows the industry to study these products for longer, facilitating their entrance to the Mexican market. This clause will not affect innovative companies as the patent remains fully protected. As a result, the country’s IP rules transformed into the Industrial Innovation Protection Law. Reforms to Mexican legislation also consider the introduction of cannabis regulation to allow its medical use. These long-awaited guidelines were finally released in January 2021. This will not only be an attractive market for the future but it will also open Mexico as a research hub for further scientific studies to reinforce cannabis’ therapeutic background. According to studies made by Grand View Research, the global marijuana market will exceed US$76 billion by the end of 2027 and Mexico has a US$2 billion earning potential with the creation of 70,000 formal jobs. With a freshly approved regulation, hopes for this looming industry are higher than ever. There is also a silver lining in the COVID-19 pandemic, which could spur opportunities in this industry to continue growing and to become independent and more digital. “(COVID-19) opens areas of opportunity to reduce imports of healing materials, medical devices and other supplies from China by having sustained local production at competitive prices,” Jaime López

More about this topic

de Silanes, President of the Mexican Pharmaceutical Council (CFM), told MBN.

State of the Industry | 8

Will the MedTech Industry Change Under a Biden Presidency? With US President Joe Biden now in office, his campaign promises are set to become policy. Some of those could prove to be contentious for the Mexico-US relationship, among them Biden’s plan to move production of medical equipment back to the US to boost its domestic supply chain. Related promises helped influence the polls during the election, with four of the Top 7 US medtech hubs – California, Massachusetts, Minnesota and Washington – turning blue in 2020. According to Biden’s website, “while medical supplies and equipment are our most pressing and urgent needs, US supply chain risks are not limited to these items. The US needs to close supply chain vulnerabilities across a range of critical products on which the US is dangerously dependent on foreign suppliers.” Despite the desired changes, Mexico has some protection in the form of the USMCA trade treaty. “Joe Biden’s promise is understandable but the agreements we have with the US are backed up by USMCA,” said Ana Riquelme, Executive Director of AMID, in an interview with MBN. Mexico, a manufacturing hub for medical devices, is the world’s eighth-largest exporter of such

Mexico’s medical devices market grew from US$4.9 billion in 2015 to US$6.5 billion by 2020

devices. The country is the top exporter in Latin America and the largest supplier to the US. In 2017, Mexico exported US$9.4 billion in medical devices, most of them to the US, followed by Italy, Germany and France. That same year, Mexico’s medical devices sector received US$161 million in direct foreign investment. The sector has been labeled a promoter of well-being and social progress by AMID. According to Riquelme, Mexico exports 80 percent of the medical

MEDICAL DEVICES AND EQUIPMENT MARKET SIZE IN MEXICO (US$ billions)

devices it manufactures to the US. Many commercial rules allow companies to manufacture in Mexico under the same terms that are applied in the US, which facilitates trade of the devices,

20 20

considering rules of origin, among other matters. Mexico’s highly qualified workforce is another great advantage for the

15 15

country. “We have experts on quality, regulation and conformity certificates and we are confident of remaining a competitive hub for medical devices for export to the US,” said Riquelme. Instead

10 10

of taking a step back, Riquelme explained that AMID is looking forward to working alongside the government to attract new

investment from the US. Moreover, she said that the country also is looking forward to obtaining raw materials to build components

0 0

2017” 2017

2018” 2018

— Total local production — Total exports — Total market size*

2019” 2020(Estimated)** 2019 2020

required by medical devices companies to strengthen their production capabilities.

(Estimated)

— Total imports — Imports from the US

USMCA negotiations presented a good opportunity to strengthen exports as Mexico’s competitiveness is founded on its manufacturing costs, which are around a 25 percent lower than in the US and smaller than those of BRIC (Brazil, Russia, India and

Source: Ministry of Economy’s Tariff Information System via Internet (SIAVI).

China) countries. Moreover, Mexico has many federal programs targeting the sector, including the Refund of Import Taxes to Exporters (Drawback), Sector Promotion Programs (PROSEC) and the Manufacturing Industry, Maquiladora and Export Services (IMMEX) program, as well as associations and chambers like

Read the complete article More about this topic

CANACINTRA, CANIFARMA, ANAFAM and AMIIF. Seven out of 10 exported medical devices are surgical, dental or veterinary instruments and devices.

State of the Industry | 9

Back and Forth With Innovation Rules With USMCA’s enforcement, Mexico developed a new Industrial Innovation Protection Law that complied with the agreed requirements. The expectation is that the new law will spur competition and speed the introduction of generics into the Mexican market. “Patents allow their owner to enjoy exclusivity for a given period. However, the day after the patent expires, we must have a generic medicine at a lower cost and with quality,” said Juan Lozano, Director General of the Mexican Institute of Industrial Property (IMPI), to El Financiero. The new framework around this law provides legal certainty, compliance with international commitments, support for Mexican creators, digital transformation and operational efficiency, he said. During the Senate’s approval meeting, the President of the Senate Health Commission Miguel Ángel Navarro assured that the new Industrial Innovation Protection Law approved during the plenary session eliminates industry concerns and limitations to competition of generic drugs. Navarro declared that IMPI authorities accepted three key aspects to advance the law: the barrier of three and eight years was removed for generics companies to do research on patented drugs, according to the so-called Bolar Clause; evergreen patents will no longer be allowed; and although the link between IMPI and COFEPRIS remains, “it will be more transparent and without the option for the institute to accept amparos to artificially extend patent protection.” Alejandro Luna, Partner Litigation and Life Sciences Co-Chair at Olivares, shared with MBN that this law will indeed bring positive effects to the industry and to innovation. However, there are elements that still need to be addressed, “like patentable matter, including the rules of the binding system mechanism in the law and the effective claim for damages derived from the violation of industrial property rights.” Agustin Azcatl, IP and Regulation Leader at Ortiz & Ramírez Abogados, qualified the new law as a positive measure to attract investment for both the generics industry and the innovation industry. Azcatl explained to MBN that the law is positive as it offers more information to companies, both manufacturers of innovative medicines and of generics. “Innovators are now certain that their rights are recognized. In the case of generics manufacturers, they will have information in a more accessible manner, while avoiding infringement of the rights of a third party.” AMIIF has publicly shared that this new law will establish incentives for the country to move toward a knowledge-based economy. However, support for innovation has been a concern in the industry. According to Rafael Gual, Director General of CANIFARMA, innovation suffered a significant setback last year. A committee for new molecules, which has the goal of authorizing new technologies and medicines, has not held any meetings for more than a year. “There are now 120 molecules waiting for approval and this heavily affects access to new technologies and, more alarmingly, to healthcare,” said Gual. According to Karel Fucikovsky, Director General of Pierre Fabre Mexico, the industry Read the complete article More about this topic

in Mexico is disappointed because it has worked for years to serve as a strategic innovation base for Latin America. Today, many R&D centers are even at risk of losing federal funding.

State of the Industry | 10

Cannabis Regulation Opens Fair Market Opportunities Regulation is key for medicinal cannabis use, from patient access to treatment outcomes. While cannabis has ancient uses, its inclusion in regulatory frameworks is recent. Canada was the first country to legalize medicinal cannabis with the purpose of treating terminally ill patients with chronic conditions to relieve their symptoms and their pain. Many other countries have followed suit, setting a template for Mexico to build its own regulatory framework. Which Way Forward for Mexico? In an MBN expert opinion, Pablo Ricaud Arriola, Co-Founder and Executive Chairman of Rising Farms, exposed the production and market concerns of the industry regarding regulations. “Usage can be legalized in various forms but what about production and distribution? The next question would be licensing. How many licenses will the government approve and how often?” Specialized academic sources broke down the main regulatory considerations for cannabis. The first is the need for education on the subject. In Mexico, companies like KHIRON have started to take this matter into their own hands so when regulations are ready, prescription can begin safely and quickly. According to Arboleda, KHIRON has decided to offer medical education programs to fill that gap, providing medical professionals with scientific support and understanding about cannabis use. The need for stronger scientific evidence on the benefits of cannabis is another must to encourage prescription. This information has scientific and policy-making value to improve regulation and prescription. Licensing has another interesting purpose. A study by Mexico Contra la Delicuencia (Mexico Against Crime) stresses the importance of licensing in maintaining other prohibitions, as is the case in Poland. The study also states that Latin American countries like Colombia and Peru issue individual licenses for each activity related to the supply of medicinal cannabis, from production to transportation and sale. According to the report, this has helped countries divide monitoring among different regulatory bodies. Karger’s report also describes the vital importance of transparency within the industry. The industry should be clear about the side effects or dangers from cannabis products. In Mexico, pre-packed food and beverages warn of potentially dangerous concentrations of certain substances. Demand, cost and insurance coverage are recurrent problem in the cases of Germany, Italy and Canada. This could block access to medicinal cannabis treatments, especially in countries with lower incomes like Mexico. While out-of-pocket expenditure in Mexico is the second-highest according to OECD figures, based on the Ministry of Health’s official figures, lowincome opportunities are a barrier for treatment access and followup in Mexico. Stigma and the role of social media are another important element in cannabis’ adoption. “Social stigma has created barriers around the prescription of cannabis, partly because of limitations on medical education on the subject,” says Arboleda. Avoiding

State of the Industry | 11

CANNABIS REGULATION OPENS FAIR MARKET OPPORTUNITIES

monopolistics practices that limit the market and dictate the economic welfare of cannabis treatments is also recommended. This includes guidelines that allow local production, as well

Population:

as imports, trying to integrate small-scale growers and equal

128.23 million

conditions for stakeholders. Streamlined sanitary processes would mean products reach the market faster with the highest quality standards. How To Introduce Cannabis to the Market?

Estimated consumers:

Introducing cannabis into a market requires a holistic point of view.

2.3 million

Society needs to be prepared for the paradigm shift that will result, according to Jaime Castro, Director General of BPF, part of QbD group, in an interview with MBN. Awareness and accountability campaigns regarding cannabis

Usage rate:

2.5%

use also are required, where the ethical limits that regulate the commercial activity of the product are clearly established. As for

from ages

medicinal cannabis, Castro says a fiscal and regulatory framework

15-65

must be established that favors the creation of companies that produce and import these products. This would also provide legal certainty and security for the handling of substances with

Annual consumption:

adequate controls to prevent theft and counterfeiting of products. It is a good opportunity to strengthen product serialization. “The

14.07

work on pharmacovigilance will also play an important role in this transition,” Castro says.

million oz.

Regulations must also take into account companies in charge of

Potential market:

the chemical analysis of this type of product as it is necessary to

US$3.2 billion

have the reference substances in time and form at adequate prices. Castro explains that it is necessary to adapt regulations on import and treatment of substances. It is also paramount to ensure the security and confidentiality of the information of those who require these products to guarantee they are not targets of extortion or

3rd country

corruption in other parts of the world. Intellectual property and patent management is the last subject that Castro highlights, according to his experience as President

to legalize cannabis

and Director of ISPE Mexico. “There will be a lot of work in the coming months before what I consider is the inevitable opening of Mexico for these types of products, both in their recreational and medicinal modalities.”

Source: New Frontier Data

Castro believes that the potential for Mexico to become an attractive investment and exploration actor in the medicinal cannabis field is huge. “Mexico, due to its geographical location and proximity to the US and Canada, is a strong and quite viable option to invest in this business,” he says. This is also complemented by Mexico’s strong pharmaceutical industry, which allows it to have the necessary infrastructure for production, evaluation, marketing and distribution. Ricaud mentions that the Mexican market has the potential to attract entrepreneurs. “Throughout 2019, the CBD market saw so many new participants that those earning less than US$1 million in annual revenues occupy over 97 percent of the market. The same is happening with players wanting to produce highquality, specialty biproducts for the pharmaceutical industry.” By legalizing cannabis, Mexico could take a slice of a US$2 billion Read the complete article More about this topic

market, according to New Frontier Data, a healthy sum even if the economic contribution of medicinal cannabis is still hard to predict because it differs widely from recreational use.

Infographic State of the Industry | 12

The Road Toward Full COVID-19 Vaccination After the Influenza AH1N1 pandemic, outbreaks around the world 95 95 91 70-90 79

were controlled locally or regionally before they were able to spread. In 2019, a novel coronavirus, which was later commonly known as COVID-19, was discovered in Wuhan, China. With the COVID-19 pandemic, the world has learned new lessons to consider should this scenario be repeated. The events that unfolded in the past year challenged humanity’s response at all levels. Science took center stage. Previously, innovative therapies and vaccines have solved serious threats but getting a new development to market could take several years of research and trials. The devastation of COVID-19 and its quick advancement defied R&D times to achieve a cure for the virus.

PEOPLE VACCINATED IN JANUARY 2021 (millions)

9.0

1.9

2.8 77

COVID-19 VACCINES’ STORAGE TEMPERATURES

2-8°C -18°C

-70°C

China

Israel

.087

35 64

MEXICO’S CONFIRMED DOSES (millions)

9.9

Sinopharm

CanSino Biologics

AstraZeneca

Gamaleya

Moderna

Pfizer/BioNTech

VACCINE EFFICIENCY (percentage)

Mexico

LEAD COMPANIES DEVELOPING A COVID-19 VACCINE Company

Vaccine Type

Doses

Moderna

Messenger RNA

AstraZenecaUniversity of Oxford

Non-replicating viral vector DNA sequence

CanSino Biologics

Non-replicating viral vector ad5

Sinopharm

Inactive virus

Gamaleya

Non-replicating viral vector ad26 ad5

Pfizer-BioNTech

Messenger RNA

State of the Industry | 13

Infographic CURRENT VACCINE DEVELOPMENTS

Phase 1

Safety and dosage tests Phase 2

Expanded safety trials Phase 3

Large-scale efficacy tests

APPROVED DEVELOPMENTS

For early, limited use

For full use

COVID-19 TIMELINE

2019 Dec. 31

The Municipal Health Commission of Wuhan, China reported several cases of pneumonia in the Chinese province, which were identified as a novel coronavirus.

2020 Jan. 5

WHO published the first Disease Outbreak News on the new virus, including a risk assessment. It also contained information regarding the status of patients and the province’s public health response.

Jan. 12

China publicly shared the genetic sequence of COVID-19 with further detailed information from the National Health Commission about the outbreak.

Jan. 13

The first recorded case outside China was announced in Thailand.

Jan. 30

WHO calls the novel coronavirus (COVID-19) outbreak a Public Health Emergency of International Concern (PHEIC). Worldwide, there were 7,818 cases, with the largest concentration happening in China and 18 other countries affected.

Feb. 27

Mexico detects its first COVID-19 case.

Mar. 7

WHO issued guidance regarding preparedness, readiness and response actions based on four different transmission scenarios: no cases, sporadic cases, clusters of cases and community transmission.

Apr. 4

Over 1 million cases of COVID-19 were confirmed worldwide, representing a 1,000 percent increase in less than a month.

June 17 July 6

WHO announced that the hydroxychloroquine arm of the Solidarity Trial to find an effective COVID-19 treatment was stopped. The US leaves WHO due to its disagreement over management of the pandemic.

July 22

Global COVID-19 cases surpass 15 million, with the US reporting the highest number of cases worldwide.

July 27

Pfizer and BioNTech announced the launch of a Phase 2/3 trial with 30,000 volunteers in the US and other countries including Argentina, Brazil and Germany.

Aug. 1

Mexico’s COVID-19 death toll becomes the third-highest in the world.

Nov. 8

Gamaleya Research Institute’s vaccine against COVID-19 is authorized by the Russian government.

Nov. 18

Pfizer announced that its COVID-19 vaccine is 95 percent effective and there are no safety concerns, according to the final analysis of its Phase 3 trial.

Nov. 23

AstraZeneca and University of Oxford’s vaccine reports 90 percent effectiveness.

Nov. 30

Clinical trials for Moderna Pharmaceutical’s vaccine demonstrate a 94 efficacy according to Phase 3 results.

Dec. 2

The UK gave an emergency authorization to the Pfizer/BioNTech’s vaccine. This was the first Western country to give such approval to a COVID-19 vaccine.

Dec. 8

The FDA released an independent analysis of the clinical trials. It determined that the Pfizer/BioNTech vaccine had an efficacy rate of 95 percent.

Dec. 14

COFEPRIS authorized the Pfizer/BioNTech vaccine for emergency use in Mexico.

Dec. 24

Mexico became the first Latin American country to have an authorized COVID-19 vaccine. With the Pfizer/BioNTech vaccine, the vaccination campaign against the virus began.

2021 Jan. 5 More about this topic

Mexico authorized the emergency use of the AstraZeneca/University of Oxford vaccine against COVID-19. This vaccine will be produced in Mexico and Argentina with the support of the Slim Foundation.

Care Providers A limited budget and a fragmented sector have challenged care providers to find innovative ways to approach patients and provide equal solutions to a population with unequal access to healthcare. The lack of a preventive healthcare culture among patients has pushed care providers to reformulate their offering and to communicate the dangers of poor health and unhealthy lifestyles through creative, yet functional methods. Technology is now key to creating a new approach to healthcare. From independent physicians to insurance companies, digital solutions for providers and patients are revolutionizing the sector. After the COVID-19 pandemic, patients will require flexible approaches that guarantee safe, continuous care provision as providers will face faster integration of digital tools, limited contact with patients and virtual learning. This chapter exposes the titanic efforts to provide health 24/7, while finding ways to cope with daily updates on COVID-19 and learning how to integrate digital solutions to connect with patients and colleagues to ensure that patients receive the promised solutions that the sector is moving toward.

2 17

Care Providers

Analysis

Misael Uribe | President of Médica Sur

The Road to Universal Healthcare

Analysis

View From the Top

Analysis

View From the Top

View From the Top Javier Potes | Director General of CMH

26 27

View From the Top Juan Luis Serrano | Partner-Life Sciences of Sánchez Devanny

View From the Top Fernando Becerril | Partner and President of BC&B

View From the Top Juan Galindo | Chief Medical Officer of CHRISTUS MUGUERZA

View From the Top Alejandro Luna | Partner Litigation and Life Sciences Co-Chair at OLIVARES

View From the Top Jorge E. Valdez | Dean of the TecSalud School of Medicine and Health Sciences

Spotlight Chiesi: Writing a Better Future for Patients With Rare Diseases

Juan Pablo González | CFO of Plan Seguro

View From the Top Héctor Martínez-Said | President of SMEO

View From the Top Salvador Arceo | Director General of Plan Seguro

Héctor Valle | Executive President of FunSalud

View From the Top Eduardo Lara | Vice President, Head of Health Latin America at RGA

UNOPS Medicine, Medical Supplies Purchasing Scheme for 2021

View From the Top Mario Sicilia | Director General of Laboratorio Médico Polanco

How Has the Centralized Purchasing Scheme Worked So Far?

View From the Top Rocío Bermudez | General Manager of Olarte y Akle Bacteriólogos

Patrick Devlyn | President of the Health Commission at CCE

View From the Top Juana Ramírez | CEO and Founder of Grupo SOHIN

Oliva López Arellano | Minister of Health of Mexico City

View From the Top Alberto Sanchez | Operations Director of Faro del Mayab

Long-Term Public-Private Collaboration to Fight COVID-19

View From the Top

View From the Top Miguel Prida | President of Grupo Consulmed

Roundtable What Can the Health Sector Learn From the COVID-19 Pandemic?

Care Providers | 17

The Road to Universal Healthcare In 2020, Mexico welcomed the new Health Institute for Welfare (INSABI), with the goal of achieving universal healthcare by offering social security to people outside IMSS and ISSSTE coverage, which is around 69 million Mexicans. INSABI offers primary and secondary levels of care and it is contemplating scaling up to tertiary care. Regarding primary care services, INSABI covers the following: + Preventive healthcare + Health promotion + Disease prevention + Outpatient care for the most common illnesses provided by general practitioners and nurses In the secondary level, the institute covers: + Basic specialties at general or specialty hospitals + Laboratory and imaging diagnostics + General surgery, gynecology, obstetrics, internal medicine and pediatrics At the beginning of 2020, the Institute explained that for tertiary coverage, INSABI would initially charge a modest fee, expecting that by December of this year it would no longer need to charge for its services. People affiliated with INSABI can go to public medical facilities, such as health centers, health centers with extended services (CESSA), IMSS Bienestar medical units, medical specialties units (UNEMES) and rural, community and general hospitals. The institute has faced many challenges since its introduction, the most obvious being medicine shortages for cancer patients. “(INSABI is) viable and necessary as a breaking point that breathes life into the healthcare system, which I think will be good for the population,” said Alejandro Sancen, Director General of MASZ, during an interview with MBN. “(However,) the way INSABI was implemented generated doubts and challenges, such as medicine shortages.” From a logistics point of view, Javier Calero, Commercial Vice President of GNK Logistics, told MBN that, “the arrival of INSABI created an operational gap that has hindered talks with the government as authorities themselves do not have the functioning rules to know which funds can support a project like ours.” For the pharmaceutical industry, the issue is clarity. “There has been a lack of clarity on who is responsible for medication purchases. INSABI has not really taken the reigns and there are still discussions on which dependency should be responsible for this,” Cecilia Bravo, President of ANAFAM, told MBN. How can the government put INSABI on track to achieve its goal of universal healthcare coverage? During an interview with MBN, Vinicio Orea. Deputy Director of Health and IT Business Unit at Grupo Altavista, reflected on the subject. “The current steps that the government is taking to improve healthcare with INSABI are Read the complete article More about this topic

good but very ambitious. When the government realizes that the burden cannot be tackled alone, it will start looking to the private sector.”

Care Providers | 18

Long-Term Public-Private Collaboration to Fight COVID-19 When asked by MBN about the greatest challenge to providing healthcare during the COVID-19 pandemic, Oliva López, Minister of Health of Mexico City, pointed to “the fragmented nature of the healthcare sector and how it complicates proper care provision.” Most industry observers agree with that assessment but COVID-19, for all its tragic consequences, is also highlighting what the sector could look like when the two sides that control healthcare in the country – the public and the private sectors – come together. Patrick Devlyn, President of the Health Commission at CCE, told MBN that “recognizing the fragmented nature of Mexico’s health system is key to be able to move to a simpler, more efficient one, where the private sector plays a relevant role in improving access for everyone.” COVID-19 is a great example of the private sector’s efforts to support the government through partnerships, he added. A unified healthcare sector was necessary to share the unprecedented burden brought about by COVID-19. The agreement reached between the two sides, called Juntos por la Salud (Together for Health), brought together hospitals, insurance companies, academic institutions, banks and communication groups, among others. Public and private hospitals shared their patient burden, related to both COVID-19 and non-COVID-19 patients, starting in April 2020. “Juntos por la Salud has a role in helping to close health access gaps and supporting the development of remote systems,” said Héctor Valle, Executive President of FunSalud, to MBN. Valle adds that this initiative has served to donate infrastructure to support hospitals with developments such as ventilators, diagnostic solutions, medicines and devices. In an interview with MBN, Javier Potes, Director General of CMH, recommended making this partnership a long-term solution for the sector. “Before COVID-19, the private sector would have around 40 percent bed availability. The unused space could perfectly be used to attend patients from the public sector at referenced prices.” According to Potes, the private sector could start investing in infrastructure to provide care for government beneficiaries, focusing on service provision rather than the building itself as in regular PPPs. Plans like Juntos por la Salud and the preventive measures encouraged by the government were linked to a decrease in hospitalizations in July and August. In September, hospitalizations bounced back but the response has been much smoother and with fewer shortages in supplies. The agreement with private hospitals allowed broader access to care for COVID-19 patients while giving public facilities the opportunity to open up other services. For the alliance between sectors to continue, Devlyn said the same level of engagement from both parties is required, especially after the economic crisis brought by the pandemic. “The challenges Read the complete article More about this topic

brought by COVID-19 require people, companies and governments to quickly adapt to this new normality to protect people’s lives, while helping our economy restart and grow sustainably.”

VIEW TOP Care Providers | 19

from the

Q: How is SEDESA promoting healthcare in the city? A: SEDESA employs an integral healthcare model, which was articulated on primary care attention. We have strengthened areas related to sanitary jurisdictions through health centers and ambulatory attention. The Ministry’s general program is Salud en tu Vida (Health in Your Life), and from that we derive Salud en tu Casa (Health at Home), Salud en tu Escuela (Health at School) and Barrios y Colonias Saludables (Healthy Boroughs and Neighborhoods). What we offer is integral territorial attention. Throughout 2019 and 2020, we have accomplished the opening of first-contact health units. We started with 10 units that worked on the weekends and by the end of 2019 we had 150. We are now up to 190. This substantially increases healthcare attention, providing much faster care to those who have no social security. Sanitary security for all people in the city, regardless of whether or not they have social security, is also very important for SEDESA. This implies providing safe conditions across neighborhoods and the monitoring of open spaces. Our brigades ensure water and food safety but also clean community areas to mitigate sanitary risks in crowded spaces, such as markets.

Oliva López Arellano

We are also working with the city’s Escuelas Saludables (Healthy Schools) program. We have 100 permanent brigades that work at those schools to implement sanitary and health measures. To

Minister of Health of Mexico City

date, we have 100 schools accredited as Escuela Saludable. Q: How did SEDESA react to the COVID-19 outbreak in Mexico City?

Pandemic Exposes Limitations of a Fragmented Healthcare System

A: SEDESA began taking action from the first signs of the pandemic in December 2019. When the first case arrived in Mexico, we were quick to alert the population and disseminate information and recommendations on the subject. We implemented a monitoring system and epidemiological vigilance to identify and analyze all data, because, as we have seen, the pandemic has acted differently depending on the particularities of the population. Thanks to this, we were able to implement sanitary protocols at the Mexico City International Airport. In the city, the Digital Public Innovation Agency contributed greatly by creating a text message option to filter patients with mild symptoms and encourage them to stay home, allowing SEDESA to offer telephone follows-ups and to provide general recommendations of isolation for suspicious cases. This also allowed us to register patients’ addresses to trace the cases and be able to approach them in case of complications. In Mexico, the serious cases are concentrated among people of 50-60 years of age with morbidities such as hypertension, diabetes or obesity. In the city, 12 out of 100 people suffer from diabetes, 20 out of 100 people over 20 years old suffer from

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hypertension and 75 percent of the population over 20 years old suffers from overweight or obesity. The text message method also allowed us to identify cases with morbidities to encourage them to go to the hospital or more carefully monitor their symptoms.

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Q: What measures has the Mexican healthcare industry implemented to address the challenges brought by COVID-19? A: The current situation is a great example of the private sector’s efforts to partner with the government to mitigate the impact of COVID-19. Private hospitals offered 50 percent of their beds to the public health sector, to be used for both non-COVID-19 and COVID-19 patients. The insurance industry almost immediately confirmed coverage of COVID-19 expenses for users and they also offered insurance coverage to healthcare workers on the frontline of the pandemic. Moreover, there is the initiative Juntos por la Salud (Together for Health), which brought together private sector companies, NGOs and academic institutions to donate medical supplies to hospitals treating COVID-19 patients. Q: How is CCE representing the interests of the healthcare industry in this difficult scenario? A: The private sector, including healthcare players in Mexico, share the same goals the president has defined, which are transparency, guaranteed availability of medications to the population, cost savings in the acquisition of medications and complete access to quality healthcare. However, profound change creates uncertainty and anxiety within the healthcare

Patrick Devlyn

industry. CCE’s Health Commission has been a platform to constructively communicate the industry’s concerns, as well as to share experiences and best practices that can support the government to implement these initiatives successfully.

President of the Health Commission at CCE

In the end, tension within the system can translate into a negative impact on patients and end-users, which we must avoid. Q: What are CCE’s main priorities

CCE: Private Sector Shares Government’s Goals

regarding the healthcare industry? A: CCE’s Health Commission, together with the 12 privatesector organizations that conform it, key allies like FunSalud, patient associations and academic institutions, agreed on a health agenda based on five main pillars. The first is the implementation of an integral public health policy on prevention to create and encourage a preventive healthcare culture. The second is to improve access to quality healthcare, which includes reinforcing first-level care and improving access to innovative medications. The third pillar is to increase investment in health and to use these resources more efficiently by improving transparency through public-private collaborations. The next pillar is recognizing the fragmented nature of Mexico’s health system. We need to move to a simpler, more efficient health system, where the private sector plays a relevant role in improving access for everyone. The last pillar is working toward national health coverage for all Mexicans, understanding our financial limitations and providing complementary access through private sector insurers.

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We need to put the patient at the center of what we do, both in the public and the private sectors. We must increase effective collaboration and redirect the country’s current health trends in ways that will help our people have prosperous levels of economic development.

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How Has the Centralized Purchasing Scheme Worked So Far? At the beginning of 2019, the Mexican government announced a new centralized purchasing scheme for medicines that aligned with President López Obrador’s general goal to fight corruption. According to an official release by the Ministry of Finance and Public Credit (SHCP), the new scheme sought to “achieve transparency, through the participation of the United Nations Office for Project Services (UNOPS), contracting procedures, as well as the establishment of competitive mechanisms that open the door to a greater number of suppliers in this industry, promoting at all times the best conditions for the State, in terms of price, quality and opportunity.” As described by the SHCP and the Ministry of Health, this scheme is based on an international public tender procedure for the purchase of medicines and healing materials required by the federal government and the federal entities. Minister of Health Jorge Alcocer expected that this change would allow savings of up to MX$608 million (US$26.8 million) in 2019. To date, this figure has not been confirmed. At the beginning of 2020, President López Obrador blamed laboratories for medicine shortages at public hospitals. To understand the context, MBN spoke with legal firms about the benefits and challenges of this purchasing scheme and also gathered the opinion of many pharma laboratories on the subject. Hogan Lovells Life Science’s experts Ernesto Algaba and Cecilia Stahlhut shared their opinions on how the scheme had been working for laboratories. “We are in a process of maturation, recomposing the structures and strengthening the supply of medicines for the public sector. In that sense, maybe the actions that have been taken were necessary an adequate strategy is still necessary to ensure that needs are properly satisfied. The government’s goal should be to ensure that new measures stick to the law and that they respect the industry’s rights. They should also comply with the legal framework and guarantee the interests of patients, including proper supply of products,” explained Algaba. Added Stahlhut: “Especially in this sector, fair competition is key. This goes beyond costs and prices. Medicines undergo a long and sometimes difficult process in Mexico to reach the market and competing with products that do not have to go through that process can distort the market and lead to shortages or unreliable distribution models that only endanger the consumer.” Director General of S&S IP LAW Agustin Azcatl said that the scheme could present both opportunities and challenges. “The new distribution scheme has opened the market, which will boost competition and lead to lower prices. Also, it enables SMEs to participate. A lack of legal protection would put these SMEs at a disadvantage against big players, however.” For his part, General Manager of Chiesi Marco Ruggiero said change is good, but that clarity was also necessary. “We all need to be open to change because this is how we evolve and make things better. What is missing is a clear plan for everyone to follow, as well as a timeline. In terms of communication, this year has not been Read the complete article More about this topic

the best because it has been difficult to follow all the changes that happened from one day to the other while trying to understand them with the little information that was provided.”

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UNOPS Medicine, Medical Supplies Purchasing Scheme for 2021 On July 2020, the Ministry of Heath announced it would start acquiring 80 percent of the medicine supply needed for public institutions through the United Nations Office for Project Services (UNOPS), following WHO and PAHO guidelines. The estimated investment will be between MX$60 billion (US$2.7 billion) and MX$70 billion (US$3.1 billion). The move required substantial modifications to Article 1 of the Public Sector Acquisitions, Leases and Services Law (LAASSP), related to the changes to the supply scheme of therapeutic goods and its implications. In addition, in August 2020, the Mexican regulatory agency COFEPRIS was attached to the Deputy Ministry of Health Promotion and Prevention. At the beginning of 2020, when the new centralized purchasing scheme came into effect, the government also announced an international tender to acquire medicine from abroad due to what President Andrés Manuel López Obrador called “corrupt acts on medicine acquisition during former presidential administrations.” The open tender raised concerns among players in the local pharmaceutical industry because they feared a lack of proper regulations and standards being managed by manufacturers entering the country. In an interview with MBN, Rafael Gual, Director General of CANIFARMA, described the action as “the exclusion of the acquisition of medicines and health supplies from public bids, which led the industry to file an appeal for protection and a large group of senators to submit an Action of Unconstitutionality to the Supreme Court.” The agreement between INSABI and UNOPS for the 2021 supply of medicines sets the ground for foreign companies to participate in an open international bid, with no regard for the commercial agreements Mexico has signed, Gual said. According to Gual: + The value of the pharmaceutical market in the Mexican public sector in 2019 was over MX$70 billion (US$3.2 billion). + During the same year, over 1.7 billion medicine units were required and/or consumed by the National Health System. Considering the total expense in pesos and consumption in units in Mexico in 2019, the medicines and vaccines that could be procured from international and intergovernmental agencies amount to just over MX$3.5 billion (US$178 million) and about 65 million units, which represent 5.09 percent and 3.82 percent of the national public demand, respectively. Impact on the Local Industry During an interview with MBN, President of the Mexican Association of Pharmaceutical Laboratories (AMELAF) Arturo Morales explained what an international tender for medicine

acquisition would involve for the industry. “Holding an open international tender was a step that could have been avoided because the purchase could be dangerous if not done under the same regulatory measures that COFEPRIS establishes, not to mention that it is unfair to national companies that do follow the national acquisition law.” Regarding the government decision to involve the UN in the process, Morales said that UNOPS allows the entrance of those medicines to underdeveloped countries or in cases of a crisis or emergency, which is not the case for Mexico. He also addressed one of the most vocal criticisms of the pharmaceutical industry. “We are not facing a shortage; the Mexican pharmaceutical industry has the capacity to cover those gaps but has no certainty from the government. We depend on what the public sector requires and if there is no clarity, the result is that medications cannot be manufactured on time, leading to shortages.” Cristóbal Thompson, Executive Director of AMIIF, agreed that Mexico’s industry was in position to deliver the necessary supply. “The Mexican pharmaceutical sector has the capacity to supply the local market. To date, medicinal supply has been covered. What caused most of the delays were tender discussions,” he told MBN. President of ANAFAM Cecilia Bravo also expressed her concerns about the international tender and said that “the openness to imported products from anywhere is adversely affecting national production. Products are being bought from countries that have lesser sanitary standards.” Bravo added that the matter is complex, pointing out that the measure endangers pharmacovigilance and could have implications in terms of tax revenue losses and, therefore, lost job opportunities. “Other countries could be subsidizing their industries, thus creating an unfair competitive advantage over Mexican companies,” said Bravo. What the country needs, these experts agree, are dialogue and cooperation between the private sector and the government. “We want to defend our national industry to help it grow and to maintain the level of high-quality jobs we offer,” said Morales. Not content to wait, the industry is also taking its cause to the courts. “(ANAFAM is) filing an amparo against a disposition proposed by the government that lowers the import requirements for many products, particularly in the oncological area. The government is opting for direct purchases without any bidding process,” said Bravo.

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Q: What are the main challenges in Mexico to start applying remote healthcare models? A: Some of these models are already under development. However, we still need quality internet access. In 2019, the first remote surgeries were performed in Asia. This happened in a 5G environment. If we tried to do that in Mexico, the signal could fail at any time. While doctors here have no problem providing remote consultations in the main cities of the country, there are still problems in more remote areas. The biggest challenge, without a doubt, is high-capacity connectivity. This is a joint effort between the telephone and internet companies, the Ministry of Communications and Transport (SCT) and the federal government. Q: How can society, government and the private sector use COVID-19 as a learning opportunity to improve overall health conditions in Mexico? A: Significant progress has been made by the Mexican Health Foundation, together with Juntos por la Salud, the federal government and the leadership of Marcelo Ebrard, Zoé Robledo and Jorge Alcocer. There are positive instances of the public and private sectors working together. The most relevant examples are public-private partnerships for hospitals. At the beginning of the pandemic, we were able to perform medical interventions together that had nothing to do with COVID-19. In that same way,

Héctor Valle

there is a great opportunity to treat chronic degenerative diseases. The private sector, for example, can help to monitor patients with diabetes, hypertension or high cholesterol.

Executive President of FunSalud

Q: You have said that the public-private project Juntos por la Salud should become permanent. How can this agreement evolve beyond COVID-19? A: Juntos por la Salud is a great initiative that came out of the

Public-Private Collaboration Key to Tackling the Pandemic

collaboration between the Mexican Health Foundation, the BBVA Foundation, TecSalud and the UNAM School of Medicine. It includes more than 580 companies. However, there is a health access gap that still needs to be addressed, which forces us to migrate to distance care models. Juntos por la Salud has a role in helping to close these gaps and supporting the development of remote systems. Regarding infrastructure, at Juntos por la Salud we work to realize donations of ventilators and even support their development. The same goes for diagnostics, medicines and devices. We have to support the government so medicine purchases are adequate to avoid crises like the lack of oncological medicines in the country. Q: What are the main challenges that the country faces with the arrival of the vaccine and its distribution? A: The Mexican Health Foundation is available and willing to work with the government. Together with Hugo López-Gatell, we have been discussing ways to collaborate. The government has already presented a strategy for the distribution of the vaccine and now we have to ensure that it is well-executed. Logistics will undoubtedly be one of the biggest challenges. This is where the private initiative

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can help to ensure that the vaccine reaches the right places. We will also have to find ways to ensure that vaccines that require two doses are applied correctly. We have to guarantee that people do not miss the second dose. This is a matter of communication and social awareness.

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Q: What is CMH doing to mitigate the impact of COVID-19 in Mexico? A: CMH established a partnership with the government to support patient care during the pandemic. Together with ANHP and other state hospital associations from Jalisco, Sonora, Mexicali, Queretaro and Nuevo Leon, we created a common front to approach the government and establish a bridge that would allow the creation of the needed structure for this project. We analyzed the capacity of the private sector to collaborate with the public sector. When the outbreak started spreading, private hospitals had wider capacity as already programmed surgeries were being postponed due to fear of contagion. This allowed us to negotiate with the government and to collaborate by offering our services to treat non-COVID-19 patients coming from public institutions. Q: How can this partnership improve healthcare access? A: The lack of structure and human resources to provide healthcare in Mexico is evident. Most of our indicators regarding healthcare fall behind compared to other OECD countries. Right now, we are working on a proposal to secure healthcare attention in Mexico beyond profit. In the near future, hospital building might be limited to take advantage of the already

Javier Potes

existing infrastructure within the private sector to ensure the best service offering. This dynamic could follow the same transparent scheme proposed during the COVID-19 crisis in which the government would pay for our services at the same

Director General of CMH

prices determined for the same procedure in the public sector. This opens a great opportunity for both sectors. Before COVID-19, the private sector would have around 40 percent bed availability, which could perfectly be used to attend

Democratizing Private Medicine Through Public-Private Agreements

patients from the public sector at those referenced prices. Under the right collaboration framework, the private sector could start investing in infrastructure to attend government beneficiaries, focusing on service provision rather than the building itself as in regular PPPs. Within this model, the private sector would charge for its services instead of rent for the building. This is a much more effective way to secure patient access in both sectors. The private sector has been promoting these initiatives knowing that it would involve more agreements, finding new financing models and creating more accessible insurance products to democratize medicine. Q: What challenges have CMH hospitals faced to maintain their regular activity and income during the COVID-19 crisis? A: One of the main challenges was economic. We had to convert our hospital spaces because, even though we agreed to take care of non-COVID-19 patient flows, we still needed to be prepared to treat other patients as we would not deny them service. Therefore, we established rigorous measures to protect staff, patients and families.

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As for our COVID-19 patients, we were in constant communication with AMIS to monitor service costs and determine which protocols would be useful to provide the most reasonable healthcare costs for both insured and out-of-pocket patients.

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Q: How has the pandemic impacted cancer treatment services in the country? A: People with cancer are at high risk with COVID-19, not just because of the cancer itself but also because of the condition of their immunosuppression. In addition, many cancers are associated with other major pandemics in this country, including obesity and metabolic syndrome, which in turn are linked to hypertension and cardiovascular disease. Our cancer patients have been affected in three ways. Firstly, in terms of care, both in the public and private sectors, we have had to reassess priorities. We have had to find a way to treat cancer, which cannot wait, and protect patients against COVID-19. We have had to prioritize patients at the National Institute of Cancerology according to their diagnosis, addressing the challenges this involves. The second way in which patients have been affected is through the reconversion of hospitals into COVID-19 clinics. This has led to displacements of patients to other centers. However, in many other hospitals around the country, assistance for cancer patients was postponed as the option of moving them to other COVID-19-free hospitals did not exist. The result is that people were not diagnosed and assisted at an early stage, which means they will have more advanced cancers by the time they

Héctor Martínez-Said

are treated. Mexico’s cancer-related deaths currently stand at 85,000 a year. The third impact has been on research. The pandemic has

President of SMEO

shifted CONACYT’s focus from cancer, as well as resources, to COVID-19. The council is looking into the impact of COVID-19 on subgroups, such as cardiac patients, children and pregnant women. In SMEO, through Cooperative Groups of Research, we have a national plan in which 103 researchers at 143 centers of

Cancer Treatments Must Continue Regardless of COVID-19

IMSS, ISSSTE, federal and state health institutions are reporting on the impact of COVID-19 on cancer patients. This will help us understand the risk and allow us to adjust our steps. Q: Regarding the government’s plan to create a more universal health system, what have been the main challenges in this area? A: There are many challenges. There is a need to harmonize the different perspectives of players in the sector to overcome these challenges. The system is still too fragmented. The government, civil societies like SMEO, pharmaceutical companies and medical distributors should join forces by focusing on one objective: better care for the patient regardless of background. I hope that by the end of this or next year we can return to this agenda, which will also be boosted by the social commitment of pharmaceutical companies. I am convinced that universal healthcare should not be limited to oncological drugs. The treatment of cancer is multidisciplinary, combining chemotherapy with surgery and radiotherapy. To limit access to just medication, you are dealing with only a third of the problem. All cancer

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treatment centers should be drawn into one vision. In the area of surgery, we need to ensure that anyone can have access to surgery performed by oncological specialists with the right experience. This harmonized approach is what the government and SMEO are moving toward.

SPOTLIGHT

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Chiesi: Writing a Better Future for Patients With Rare Diseases Driven by the belief that no patient should be left behind, Chiesi created a business unit in 2019 specifically dedicated to the development and commercialization of products for those with rare diseases. Patients with these diseases can encounter many difficulties, from receiving a timely and accurate diagnosis to accessing effective medical and social care. Chiesi believes this therapeutic area is of great importance, with equally significant impact. One of the key projects for Chiesi’s Rare Disease division is alpha-mannosidosis. This is a rare genetic disease caused by the impaired function of the lysosomal enzyme alphamannosidase. Due to this deficiency, oligosaccharides are only partially broken down and over time, they build up in the body, causing increasing damage to cells and leading to many medical problems. Alpha-mannosidosis is a heterogeneous disease, presenting a wide range of symptoms. The most frequent are recurrent chest infections and problems with hearing loss, distinctive facial features, cognitive impairment and progressive muscular weakness. Lack of voluntary coordination of muscle movements and skeletal and joint abnormalities can occur, as well. In adulthood, few patients manage to be completely independent socially, needing help with many activities and possibly requiring a wheelchair. High levels of oligosaccharides in urine can point to alpha-mannosidosis. Testing of the mannosidase enzyme’s residual activity and genetic analyses are used to confirm the diagnosis. Alpha-mannosidosis affects approximately one in 1 million babies born worldwide. Founded in 1935, Chiesi is an Italian company that specializes in the research, development and production of medicines Read the complete article More about this topic

for respiratory, neonatological and cardiovascular diseases. It distributes its products in more than 80 countries. Chiesi entered Mexico in 2006 with CUROSURF, a treatment for RDS.

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Q: How has TecSalud contributed to the fight against COVID-19? A: TecSalud created a COVID-Committee to analyze how the pandemic would affect Mexico, the healthcare sector and our institution. Thanks to these efforts, TecSalud and Tecnológico de Monterrey could support their decision-making and respond quickly to the upcoming challenges of COVID-19. As an educational institution, we were the first private education institutions in the country to cancel classes in campus and migrate to 100 percent online educational model. As for our medical academic centers, we assessed our bed and hospital capacity to optimize resources and expansion of our facilities, particularly in the ICU area. Based on the figures from other countries, we had a rough idea of what to expect in regards to hospitalized patient numbers and ventilator demand. All cases of COVD-19 that require hospitalization are assigned to our San José Hospital, which became the largest private COVID-19 hospital in the country. This has allowed us to standardize our attention as we have doctors fully dedicated to COVID-19 patients. We moved all postgraduate students doing their medical training specialty, to support our COVID-19 efforts. Our students in the mental health area are also joining our efforts to support families and medical professionals during these difficult times.

Jorge E. Valdez

After this, we started a training program for all our medical staff so we could have them ready to act but also to protect them from contagion. Finally, we have strongly driven our research capacities to contribute to find a cure or treatment

Dean of the TecSalud School of Medicine and Health Sciences

and also to generate scientific information to prevent and fight COVID-19. We are doing clinical trials on some drugs to test their effectiveness against COVID-19 and developing our own technology. This has led to many initiatives, including biomedical engineering projects such as the first Mexican

TecSalud’s Response Levels to Face COVID-19

ventilator VSZ-20-2. I think that our integral response has demonstrated the huge potential that healthcare systems such as TecSalud, which integrates public-private initiatives, have to continue supporting the country to increase its healthcare coverage and to start developing its own research and technology to be competitive against other countries. If initiatives like these were supported around the country, we would develop Mexican potential to its fullest and greatly contribute to foster adequate healthcare. Mexico City and Monterrey have this part covered; the capital hosts the most important institutes in the country, which have also demonstrated that they are what the country needs because of their academic and professional approaches to healthcare. Q: How are TecSalud’s students creating better opportunities for people who need it most? A: One of the main characteristics of the school is social accountability. We have alliances with local health authorities that allow us to reach around 2 million people and create an

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interaction between the nonprofit private sector and the public sector. This reinforces students’ involvement in social issues and makes them more aware. Through these agreements, we contribute to providing care to the disadvantaged population with top-notch attention and equipment.

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Q: How has CHRISTUS MUGUERZA responded to the COVID-19 pandemic? A: CHRISTUS MUGUERZA’s plan considered three aspects. The first was the safety of our associates and physicians who were to treat COVID-19 patients. Secondly, to ensure the best care for people suffering from COVID-19. The last factor was to educate the community on the disease and ways to prevent contagion. We organized response teams at all of our hospitals in the country to ensure a coordinated response. These are formed by the medical director of each hospital and another three to five specialists, ideally a pneumologist, an infectologist and/ or an intensivist. Our response has resulted in a 7.4 percent mortality rate and at our best performing hospital, the number falls to 4 percent. These are low rates. Despite facing an overflow of patients at one point, we were able to balance the workload and ensure our associates’ safety and our patients’ prosperity. From the emergency room to the intensive care unit, we defined protocols that detailed the actions of everyone involved in the process, from the physicians to the cleaning services team. Furthermore, it was very important for us to provide

Juan Galindo

continuity for our regular medical appointments. Emergency situations do not stop and nor do treatments for patients with chronic diseases, so all our hospitals followed a hybrid modality to ensure continuity of attention for non-COVID-19

Chief Medical Officer of CHRISTUS MUGUERZA

patients. Q: How is CHRISTUS MUGUERZA participating in the digital transformation of the CHRISTUS network?

Undisrupted Operation Through Effective Planning, Safety Measures

A: One of our hospitals in Saltillo, Coahuila has been fully digitalized. We were aware of the need to integrate our system to an interconnected digital world that could improve our personalized attention. We began by integrating an electronic medical record (EMR) at our facilities to encourage full digitalization. The EMR we use covers the complete care of a patient and every member of the staff has learned to use it. The implementation process took years and so did the training. However, we have had positive results from its implementation. The EMR allowed us to interconnect all areas of the hospital and provides higher levels of safety for the staff. It can help avoid mistakes in everything from medications to room availability. Q: How does the network ensure that more patients have the access to your integral service offering? A: CHRISTUS MUGUERZA is a nonprofit organization. All the earnings we generate go to taxes, reinvestment to strengthen our performance and to social community service. Our social responsibility has enabled us to provide expensive care to children in different parts of the country. We have attention

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centers that range from primary care to higher levels of care and we take our services to zones that lack access to healthcare. Moreover, we invest MX$50 million (US$2.4 million) in our residency training program that is directed at 150 medical students.

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Q: What makes Médica Sur one of the best private highspecialty hospitals in Mexico and the best in Mexico City? A: This is thanks to our social scope and objectives that have shaped Médica Sur from its origins 40 years ago. The hospital was founded by a group of doctors and academics who perceived the difficulties of providing good healthcare and of finding a hospital with good practices and values. These factors, alongside rules and obligations, have shaped the quality of services found at Médica Sur. Innovation and education have also been differentiators for our patients. Q: What does you association with Mayo Clinic on neurology mean in terms of services? A: This important association speaks of quality and education. Médica Sur is open to partner with international and national institutes in all specialties because we know there is a lot to learn. Médica Sur also has a great deal to teach. In Mexico, we have an alliance with Médica Santa Carmen to attend renal insufficiency by creating a hemodialysis unit. We have also partnered with technology groups that allow us to develop our own software and robots that help diminish risks for patients and doctors at Médica Sur. The digital part of the hospital is very important and we focus on always developing

Misael Uribe

and introducing tools that are going to benefit patients and doctors. We are consolidating a super safe hospital where you can go for treatment without fear of any kind. This is especially important now that we are facing a pandemic and safety inside

President of Médica Sur

the hospital is key to avoid further contagion. Q: How does Médica Sur promote medical education and research?

Knowledge Needs to Be Generated

A: From the beginning, Médica Sur has been a university hospital. To date, we offer 17 graduate courses and we have from 120 to 170 doctors who work and study at the hospital. Aside from institutional hospitals in Mexico, we are the ones that dedicate the most to research. Knowledge, beyond learned, must be generated and we have the mindset and tools to do it. Médica Sur believes in innovation and we encourage the use of technology, such as robots. Q: How is Médica Sur facing the pandemic caused by COVID-19? A: Médica Sur has created a document about the protocol and steps to follow for other hospitals which follows the Ministry of Health guidelines. This operating manual was created out of our experience attending COVID-19 cases and also the situation inside the hospital, guidelines and protection for our staff and the patients at Médica Sur. We have dedicated a separate area of the hospital to attend COVID-19 cases. We took this decision based on the patients we already have at the hospital and to also provide the proper

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attention to COVID-19 patients during the crisis. We knew we needed clear guidelines to approach this epidemic, which is why we developed an operational manual based n the official guidelines of the Ministry of Health and decided to share it with the facilities that need it.

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Q: What makes Faro del Mayab one of the best hospitals in Mexico’s southern region? A: In December 2020, we celebrated our first-year anniversary. We have been able to offer an innovative approach to health through the use of technology and state-of-the-art equipment. We are a top choice among the C+ to B population in the Mexican southeast in a developing and growing region of the country. Due to its prosperity, Merida is experiencing an influx of many people to the city and this has enabled us to recruit doctors from different parts of Mexico. This has distinguished Faro del Mayab as a highly inclusive hospital with high-quality standards of attention. Moreover, as part of the CHRISTUS MUGUERZA Health System, we guarantee international quality standards for patient attention and safety. At the hospital, we perform thoracic surgery, cardiac catheterization, highly specialized orthopedics and neurosurgery. I can confidently say that we are the best highly specialized hospital in the southeast of Mexico. Our social responsibility program is another advantage. We work with Global Spine Outreach to provide free scoliosis surgeries to children. Moreover, alongside Operation Smile, we perform around 250-300 free cleft lip and palate surgeries per year. At a local level, Faro del Mayab works with local health authorities and public entities like DIF to treat these ailments, which is also

Alberto Sanchez

enriching for medical professionals as we work with foreign institutes and state-of-the-art technology. Before implementing any new social program, Faro del Mayab

Operations Director of Faro del Mayab

solicits the local support of doctors and authorities. This ensures we can expand the programs so they reach the people who need them the most. Q: How has Faro del Mayab integrated new technology

Innovation, Social Responsibility Define Faro del Mayab in Mexico’s Southeast

to improve its offering and performance? A: Our imaging department is well-equipped, with 1.5T resonance equipment for traumatology and orthopedics’ studies. Faro del Mayab offers angioresonance studies and high-resolution equipment for diagnostic studies. Moreover, we have X-ray machines and the best and newest mammography equipment in the region. Faro del Mayab’s hemodynamic equipment is also the most advanced in the region. In addition, we have a strong department for clinical analysis and a blood bank. All of these are complemented by highly competitive medical professionals who work in our five ORs. Our doctors’ input has been a watershed for our growth as their generational differences have complemented each other and enriched the way we approach and treat patients. Q: What potential does Faro del Mayab have to become a reference for medical tourism in Mexico? A: Faro del Mayab is working with three companies that focus

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on medical tourism. They work as intermediaries for foreigners living in Mexico or who have a foreign medical insurance policy and are seeking medical attention with us. Faro del Mayab works with recognized physicians and intermediaries to be able to grow as an international care center.

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Q: How effective have personalized healthcare services been, beyond personalized medicine? A: For more than 11 years, Grupo SOHIN has dedicated its different service areas to patients living with a chronic or degenerative noncommunicable disease or highly complex infectious disease. We are talking about 1 percent of all the patients with a public or private insurer. We are also talking about those who represent more than 60 percent of healthcare spending. In this sense, what we have shown throughout this time is that a patient who is correctly cared for and assisted is a patient who has better therapeutic response to treatment. They are patients who obtain better results and who benefit the health system financially. We stress the need to treat the patient as a person, as a social being, rather than just a page number with a diagnosis. Q: How has Grupo SOHIN’s integration of technology and innovation improved your health treatments? A: Grupo SOHIN has been working on telemedicine for 10 years. Long before the start of the pandemic, we were already advocating for this model. For a long time, we have stated firmly that patients with immune deficiencies should only go to hospitals when necessary.

Juana Ramírez

Q: During the COVID-19 pandemic, how has Grupo SOHIN ensured continuous care provision? A: At Grupo SOHIN, we have a team of 150 people working full

CEO and Founder of Grupo SOHIN

time and 400 professionals who we hire on demand. This allowed us to be very flexible toward the needs of our patients in 25 cities in Mexico. Likewise, the alliances that we have generated during all these years allow us to coordinate medical care in different hospitals very quickly. We know the processes of each one of

Connected Health Ecosystem a Lesson and a Challenge From the Pandemic

them in depth and we can support our patient in every part of the process. A couple of weeks before the pandemic hit, we launched the Cuidarte clinics. This is an integrated outpatient care model focused on complex autoimmune and onco-hematological diseases. The first Cuidarte clinic was opened in Mexico City but we have opened mobile units in Guadalajara, Veracruz and Queretaro. What we seek with this model is to bring medical services closer to patients and to optimize the costs associated with these diseases. Q: Grupo SOHIN is a pioneer in genomic diagnostics for cancer patients, especially for breast cancer patients. How can this become available to more people? A: We continue to urge public institutions to provide patients with molecular diagnostic tools that optimize resources and improve the response to treatment. We have also made progress in implementing genetic prevention tests. Today, we not only work in that area but also genetic diagnostic tools for cardiometabolic diseases and rare diseases. We do this with partners around

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the world, such as major diagnostic laboratories. We have also successfully included genetic prevention testing. This means understanding the potential for cancer, heart attack or metabolic diseases from genetic information. Having this information allows people to develop personalized care and prevention plans.

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Q: What are the benefits of offering simple home tests? A: Before the COVID-19 pandemic, Olarte y Akle’s crown jewel was its home tests. We have provided this service for years and while it may seem unimportant, we are aware of the challenge of welcoming our staff at home. Patients at any laboratory facility already feel uncomfortable because of why they are there and how invasive tests can be. However, we have been able to break this barrier and make them feel comfortable at our facilities and at home. It has been gratifying to see them trusting our services and welcoming our collaborators comfortably into their homes. Q: How did Olarte y Akle become one of the first labs authorized to perform COVID-19 tests? A: We were the first private laboratory to receive authorization for COVID-19 tests in Mexico. Olarte y Akle is highly committed to supporting early diagnosis of the virus, so we had to quickly understand the methodology and protocol for taking samples. We have a lab for molecular biology, an expert chemist, a pathologist medical director and a committed staff that allowed us to start validating tests. We based our process on the Berlin protocol for swabbing samples, developing a technique that allows us to be gentle with the patient. Despite working with half of our staff during

Rocío Bermudez

the highest peak of the pandemic, we were able to cover our demand while maintaining all safety measures for our collaborators in and out of our facilities.

General Manager of Olarte y Akle Bacteriólogos

Q: How is Olarte y Akle contributing to fostering prevention and decreasing Mexico’s disease burden? A: There are special cases that require more investment or specialized services and our laboratory has found ways to

Precise Clinical Diagnosis to Strengthen Portfolio

respond to this without charging an additional cost to our patients or physicians. This has been of great help to the medical community because it saves them time and cost and provides them a clear view from which to act. Q: What alliances have been key to your success? A: We have alliances with global laboratories, as well as the Mayo Clinic and the College of American Pathologists (CAP) to provide better information to our patients and to remain up to date on new technologies or platforms. Through these alliances, Olarte y Akle adopts new diagnostic practices or ways to approach a disease to add further value to our services. Q: What are the company’s near-term goals? A: We are focusing on the institutionalization of the company to continue growing. This is part of our 10-year strategy to achieve organic growth and be present in more states with our own facilities and home services. We are working on new home tests such as ultrasounds or X-rays. Olarte y Akle is looking to invest in state-of-the-art portable equipment for such studies. We are

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also waiting to introduce more COVID-19 tests, as well as tests for food sensitivities and allergies. To tie all of this together, we are strengthening our efforts on creating more personalized diagnostic approaches based on the patient’s profile, age, gender and genetics.

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from the

Q: How has Laboratorio Médico Polanco adapted and responded to the needs brought by the pandemic? A: Our laboratory in Puebla, Laboratorios Clínicos de Puebla, has more than 70 years of experience and performs molecular diagnostics. Thus, we have vast knowledge of polymerase chain reaction (PCR) tests. While this technology already existed, we developed a test to detect the COVID-19 strand using worldwide accepted protocols. In March 2020, Laboratorio Médico Polanco became the first to develop this test in Mexico. Thanks to this proprietary technology and an agnostic platform that allows different reagents, we had the flexibility to switch brands while the country faced reagent shortages. This resulted in business continuity and an important competitive advantage. Laboratorio Médico Polanco’s initial capacity was of 250 tests per day. We decisively invested in technology and human resources. Allowing us to scale to more than 1,000 tests per day in four months and eventually 4,500 test per day. We believe that this capacity makes us the largest national laboratory for PCR testing in Mexico. Cumulatively, we have applied close to 810,000 tests to date and we are convinced that testing is key to control and overcome the pandemic. Other than PCR testing, we have developed antibody tests to detect immunity against the SARS-CoV-2 virus, as well as

Mario Sicilia

home service, telemedicine, online payment and IT solutions to interact with our patients. We are convinced that these abilities will play a key role in the new normality.

Director General of Laboratorio Médico Polanco

Our hope is that this pandemic will force people to realize the importance of prevention and early diagnosis. The pandemic has demonstrated how dangerous it is for people to be unhealthy or to suffer from other chronic diseases that could be easily prevented. Unfortunately, Mexico is among

Developing World‑Class Technology Solutions for Mexico

the top countries regarding diabetes and obesity. Eighty percent of the health budget is destined to treat four chronical degenerative diseases. These resources could be better used to early detect high-risk individuals. Q: Aside from COVID-19 testing, what else is Laboratorio Médico Polanco introducing to its services portfolio? A: We are working on a D-dimer test that detects inflammation and can help predict how a patient will evolve during an infection. For COVID-19, this is very valuable. We are also working on early detection of cancer and diabetes tests and we have a new promising test to measure vitamin D, which should be ready soon. Regarding the pandemic, we have been given the opportunity to operate the laboratory at the temporary hospital at Centro Citibanamex. This is a world-class hospital that was built to create additional capacity to face the pandemic. It is an extraordinary project with top medical staff. This experience has been very gratifying; we are seeing the impact of this initiative on families, since the service is free of charge and it

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has already saved thousands of lives. While this center has had outstanding results, it has not been used as much as we had initially anticipated. Its capacity has been only partially used because of the criteria to take patients and the difficulty to transfer patients through the healthcare system.

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Q: How has RGA used its global experience to focus on the Mexican health insurance context? A: Each year, we do a retreat in which we analyze ways to strengthen collaboration among regions more effectively and in line with our customers’ needs. Digitalization is the new normal and RGA is embracing this because it is also in the best interest of our customers. In Mexico, we need to try, to fail and to learn. I believe we are still in this stage in the country of launching new products and seeing how they fare. If they fail, we can fine-tune all different variables involved. For instance, we are conducting a global study on COVID-19 and its potential financial impact. Given our reinsurance schemes, if we need to deal with a pandemic, we will be required to pay a lot of money. Latin America, especially Mexico, is at the forefront of one of the newest products RGA is about to launch. A special insurance product that provides coverage for people who live with a chronic disease. Traditionally, insurance covers the potential risk of being ill but not a pre-existent illness. We designed a product that will be completely digital. After more than a year in development, we are combining artificial intelligence and Big Data to embrace the digital revolution. Q: How is technology transforming insurance companies?

Eduardo Lara

A: The digital revolution has impacted the healthcare industry greatly, as well as insurance companies. In particular, health insurance companies are suffering a double impact. On the one hand, you have genomics, personalized healthcare and smart

Vice President, Head of Health Latin America at RGA

medicine, among other technological advances that are being integrated into patient treatment. On the other hand, insurance companies are trying to expand their distribution channels and are adopting blockchain technologies and smart coverage, among other features, to make the client’s journey as smooth as

Digitalization to Make New Market Segments Financially Sound

possible. Thanks to technology, we have an extraordinary opportunity to make processes smoother for our customers. Most importantly, technology will enable us to participate in different market segments. Today, private insurance companies have been focused on the upper and upper middle-class segments, where a broker or agent model usually works well. When thinking about mass products, we need to think about other distribution channels. Smartphones and other technological features will enable us to participate in other segments while reducing our costs. For instance, we can employ a chat box where patients can talk to a doctor before going to the hospital. Telemedicine provides filters that will provide the user with a better service while greatly reducing costs. Q: How will RGA help insurance companies to take this next step? A: We are creating these products and solutions so direct insurance companies can distribute them. At the end of the day, we will absorb the financial risk. Insurance companies need more

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focus on satisfying the needs of individuals and companies. RGA has been supporting them directly, understanding end customers’ current and changing needs so we can truly serve them. We have all the infrastructure to design a product that actually satisfies those needs.

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from the

Q: How successful is your preventive healthcare approach in improving user outcomes? SA: The model has been a total success because all of our plans are specifically targeted to provide users with easy access to health, while bringing them closer to preventive healthcare opportunities and encouraging them to maintain a healthy lifestyle. We offer both basic and more complex, complete plans. Our flexibility and variety allow users to choose the policy that best meets their needs, without having to pay for extra services that are not going to be required. Plan Seguro also offers traditional coverage, including major medical expenses given the demand for these products.

Salvador Arceo

Q: How do you measure the impact of your products on people’s lives?

Director General of Plan Seguro

SA: We track this through the use of our policies. Through providers, we can also measure the impact of our plans and follow up on patients. So, through providers and the use of facilities, we measure how our policies benefit patients. Q: How has technology changed Plan Seguro’s operations and products? SA: Plan Seguro’s digital transformation began years ago. Looking ahead gave us an advantage to face the challenges that emerged with COVID-19. While the whole world had to accelerate its digital transformation, we had already adopted the technology. The more we dabble into digital tools, the more efficient the company gets. For over a year, we have worked on creating more personalized plans, which we have now launched. We offer four plans that can be customized according

Juan Pablo González

to the user’s needs. A digital tool is available to the broker to sell the plan. JG: Four years ago, the company started to digitalize its

CFO of Plan Seguro

process to have a robust system that would allow constant product innovation. We had to digitalize the foundations of the company: policy administration and claim management. Once this was done, we could start transforming our service offer and practices. To date, more than half of our new policies are

Digitalized Company Delivers Effective Insurance Plans

offered digitally. Moreover, we moved to digital paperwork 24 hours after the COVID-19 contingency began to ensure a safe service and to fully work digitally. Any user can now request a quote for their ideal policy digitally. This ensures functionality for our users and our own employees. Furthermore, Plan Seguro offers an app that allows users to follow up on their benefits and explore our network of hospitals and doctors. This helps them make the most of their plan. Technology is the basis for our growth. Q: What other measures should be implemented to increase insurance penetration in Mexico? SA: It is the industry’s task to offer creative policies and health coverage plans. With a wider offer, people would find a solution that fits them best and really be able to pay for something they will use. I think that education should be highly encouraged and

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the authorities should take action to promote the importance of health and its prevention. Today, people prefer to insure their car rather than themselves.

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from the

Q: How can Mexico improve the enforcement of IP law regarding pharmaceutical products? A: For many years, new uses of known products, including primary and secondary medical uses, have been patented by the Mexican Patent and Trademark Office (IMPI). The express recognition that new uses are patentable would provide the required legal certainty for these products. Better definitions and clear standards for novelty, inventive step and utility, along with the preparation and issuance of an Examiner’s Manual would benefit the patent law with particular impact on the pharmaceutical sector. Q: With the ratification of USMCA, what would you identify as the main concern the pharmaceutical industry has regarding IP protection? A: The concern would be proper implementation of some obligations established in USMCA. Important areas for implementation relate to patentability, including new uses, although this is not a USMCA obligation. It is necessary to review IMPI’s current practice and the integrity of patent linkage, including the eventual amendments to notices in the Mexican patent linkage process. Also, there is need for the proper establishment of patent term compensation for unjustified delays in the patent process.

Alejandro Luna

Regarding enforcement, there are very important opportunities for improvement, such as direct civil remedies available in case of any violation of IP rights, including trade

Partner Litigation and Life Sciences Co-Chair at OLIVARES

secrets. The current system in which the titleholder is required to exhaust two different proceedings, administrative and civil, in order to get as compensation an award of damages derived from the violation of an IP right is inefficient, absurd and only encourages illegal activities due to the long period of time

Mexico’s Weak Health Regulations Threaten Well-Being

before there is a real sanction. Q: How will the recently approved labels for food and non-alcoholic beverages hurt or benefit the goal to reduce obesity and overweight in Mexico? A: I do not believe in the rationale behind the Official Standard recently enacted. In my opinion, the NOM is illegal. One of the main concerns refers to provision 4.1.5, which states that pre-packaged food and non-alcoholic beverage products that include one or more warning seals or a sweetener inscription shall not include on the label children’s characters, animations, animated cartoons, celebrities, athletes or mascots, interactive elements such as visual-spatial games or digital downloads (all of them addressed to children) that encourage or promote consumption, purchase or selection of products that have an excess of critical nutrients or sweeteners and shall make reference on the label to unrelated elements of the product. It must be stated that this NOM violates the human rights protected by our Constitution, such as freedom of profession, industry, commerce or work, information rights, freedom of speech, property rights,

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economic rights and copyrights. It also contravenes provisions that preserve the use of intellectual property contained in our IP Law, Federal Copyright Law and Federal Law for Protection of the Consumer. It also violates several international treaties to which Mexico is a party.

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from the

Q: What is the scope of Sánchez Devanny’s work in the healthcare sector? A: We work with all industries regulated by COFEPRIS so our clients include pharmaceutical companies (both innovators and generics), medical device manufacturers, technology companies venturing into the healthcare sector, for example through telemedicine, CROs, hospitals and companies that provide laboratory analyses. We also offer consulting regarding government procurement processes, as the main provider of health services in Mexico is the government – both federal and state level. Many legal issues often arise when selling medications or medical devices to the government and we advise manufacturers when purchasing problems arise. While we do not do regulatory submissions, we advise on the process. We also deal with import issues and with crossover IP and regulatory matters, such as approval of brands for life sciences companies. We work with the tobacco and vaping industries, advising them on local regulatory issues, for example in challenging COFEPRIS’ recent position against vaping devices. We also have important clients in the cosmetics sector, which we support on labeling and consumer protection issues. Q: What opportunities do you see in the recent regulations regarding cannabis products?

Juan Luis Serrano

A: Cannabis finally moving forward in Mexico, in great part thanks to the litigation process, but a significant threshold was reached this month with the issuance of the Regulations

Partner-Life Sciences of Sánchez Devanny

associated to health products containing cannabis derivatives. We are also waiting to see the final version of the law, which will regulate adult use. The Senate already passed it but we are still waiting for Congress to approve it. Once cannabis is legalized, there will be significant opportunities for local and international

Opportunities Abound in Mexico’s Life Sciences Sector

companies in this market. There are many different potential players in the cannabis market, from large multinational companies’ small stores and farmers. The main challenge for local companies is to fully understand the law, its implications and the possibilities it brings. As long as the rules are clear, there is an opportunity for everyone to participate. Q: How are the recent changes in government procurement processes affecting the Mexican healthcare sector? A: I do not believe this is the best policy, to be honest, as the government must ensure that all companies participating in the Mexican market adhere to the same regulatory standards and policies. These regulatory changes are forcing Mexican companies to work extra hard to compete. Q: What measures should be taken to strengthen the role of local regulators? A: It is necessary to pay greater attention to COFEPRIS, which has been underfunded for the past year, and to clarify and strengthen

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its role as an independent regulator. COFEPRIS should be at the same level as the regulatory agencies of major powers in the world such as Europe, the US, Australia and Canada. A strong regulatory framework and regulator can ensure the industry has a good combination of multinationals and strong national companies.

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from the

Q: What tools does BC&B offer entrepreneurs in the area of intellectual property? A: BC&B supports entrepreneurs by guiding them to find the right corporate purpose for their company so they can be legally protected. We also help them in making their business plan, seeking profitability, finding the DNA of what they intend to undertake, looking for investors and building a commercialization model. In Mexico, consulting services are perceived as an expense and not as an investment. Q: Is the lack of knowledge regarding IP an exclusive problem of startups? A: Every company should be clear about IP. Some very large companies like Carso, Grupo Modelo, Bimbo and Televisa have IP departments in-house and are self-sufficient. But in general, companies do not have these capabilities and then believe that their general practice lawyer or even their accountant, who is dedicated to 10,000 different things, should also be aware of branding issues. Q: What is the biggest risk that a company takes when not paying attention to IP matters? A: Companies could be jeopardizing the profitability of the

Fernando Becerril

business and even its existence. Many businesses now depend on a valuable brand to represent them, which may contribute more than 50 percent to the company’s sales. But if its brand IP right is not properly protected and is challenged, it puts the company in a

Partner and President of BC&B

crisis situation because they can no longer market or advertise its products. Q: How do you think the new IP law presented to the Senate will benefit the health industry?

IP: Life or Death Situation for Branding

A: Promotion of a healthy ecosystem to innovate and protect IP will generate benefits for all, not only in the pharmaceutical industry. This initiative to reform the law is intended to promote and encourage innovation and technological development and thereby boost the economy and our competitiveness globally. Q: Have you detected a lack of investment in Mexico from pharmaceutical companies? A: There has been a lack of investment. We are fortunate to manage a good portfolio of pharmaceutical laboratories that file patent applications in Mexico. Many main players have submitted their applications through us and some of the leading laboratories submitting an average of 100 patent applications some years ago. Today, those same laboratories are submitting around 25 applications a year. This implies a decrease in investment. Q: What factors drive drug counterfeiting in the country? A: Definitely it is mostly cost. People are not normally aware of the impact that a fake product could have on their system and on their

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health; they just want to get a better health condition and may not have the resources to acquire an original product, which leads people to purchase products of questionable quality and origin. Shortages within the public health system also influence that people try to get their medicines by any means available.

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from the

Q: How did Grupo Consulmed face the COVID-19 pandemic? A: The first two months of the pandemic were difficult because a large number of our health personnel who were at the front line and could not continue working as they were among the vulnerable groups to COVID-19, either by age or by suffering from a chronic degenerative disease. They were sent home for indications and government orders, however, we made sure that none of those doctors or nurses lost their jobs. This was a challenge from a financial perspective that Grupo Consulmed had to continue paying salaries at 100 percent. Another problem was also that our clients had fewer staff in their facilities, which forced them to suspend operations. In addition to our occupational health service, Grupo Consulmed has other business units that helped us face the pandemic, such as the supply of medicines, healing materials and medical equipment and that was strengthened during the pandemic, since we incorporated products that were essential to combat COVID-19. As a long-standing trusted provider of medical supplies, we faced little competition from companies that sporadically started offering these products. Our sales in this division grew by 500 percent, which helped us balance our occupational health and pharmaceutical divisions that had been experiencing financial difficulties.

Miguel Prida

To date, our balance is recovering as we have experienced even greater demand for our services as companies expanded the number of doctors or nurses in their facilities to ensure the safety of their staff. We also have an IMSS certification

President of Grupo Consulmed

that ensures we understand the official guidelines for the new normal. Q: How has Grupo Consulmed innovated in its business divisions?

Varied Healthcare Portfolio Helps Brave Pandemic

A: Our membership division grew but instead of offering presential visits, we migrated to phone and digital consultations. To this service we added psychological and thanatology attention and medical orientation in case of a suspected COVID-19 case. Our occupational health service works with clinical laboratories and has been supporting them with COVID-19 diagnostic tests or other specialized services to respond to the pandemic, such as ambulance services. Due to our service continuity, expertise and reputation, Grupo Consulmed stood its ground during the pandemic. We never sought to abuse prices on supplies or to offer services that we had no experience with. Grupo Consulmed also allied with MAG Medical Group, which has a strong healthcare offer. Through this strategy, our collaborators are getting healthcare services at preferential prices. Q: What infrastructure plans does Grupo Consulmed have? A: We have a project for infusion clinics that will resume after the pandemic comes under control. Together with

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pharmaceutical companies, we also developed mobile clinics to ensure treatment provision during COVID-19 as fear of contagion kept patients away from hospitals. Moreover, we are betting on medical tourism and we are interested in developing infusion clinics in the country’s main beach destinations.

Fragmentation of the Mexican health system and the existent barrier between the public and private sectors represent a broad

Care Providers | 41

What Can the Health Sector Learn From the COVID-19 Pandemic?

area of opportunity to build a united system based on personalized health responses for patients, regardless of the entity they reach out to. The COVID-19 pandemic opened up long overdue communication channels with the government, resulting the organization of multisectoral efforts with potential to last beyond the duration of the pandemic. How can the sector take advantage of this tragic event to improve healthcare in the long term?

A: We faced many scenarios that will impact the hospital environment. For instance, patients with mild COVID-19 symptoms were sent home to recover because they did not need to be hospitalized. However, this raised the potential of sending a message of abandonment to the patient, even though this was not the intention. This scenario opened up the spectrum for telemedicine and digital consultations and checkups but it has also brought to light the many needs and deficiencies of this practice in Mexico, such as payment methods, clinical records or medicine prescriptions. We are well aware that all of these solutions exist

Javier Potes Director General of Consorcio Mexicano de Hospitales (CMH)

but their implementation is still not a reality in the country. By implementing the right telehealth tools, hospital care could be delivered at the patient’s home with all the necessary equipment.

A: There are positive instances of the public and private sectors working together. The most relevant examples are publicprivate partnerships for hospitals and the Juntos por la Salud initiative. At the beginning of the pandemic, we were able to perform medical interventions together that had nothing to do with COVID-19. In that same way, there is a great opportunity to treat chronic degenerative diseases. The private sector, for example, can help to monitor patients with diabetes, hypertension or high cholesterol.

Héctor Valle Executive President of FunSalud

A: There is no amount of money that can structurally resolve the extreme needs of our country’s health system. The best and most effective way to have a positive impact on people most in need is clearly through increased public-private alliances. Infrastructure, technologies and human resources from the public and private sectors are required to close the access gap to quality healthcare services. The sector is here to help provide critical services to the population and give people the opportunity to grow and to pursue and achieve their dreams. We can find many more ways to use our strengths and complement each other. CCE wants Mexico to become a country that truly provides quality of life and

Patrick Devlyn President of the Health Commission at CCE

opportunities for economic development.

Innovative Medicines Science and innovation received special attention in 2020. Aside from their already crucial role in boosting the national economy, boundaries were pushed to the limit in an effort to solve the COVID-19 pandemic crisis. From the very first findings regarding the virus’ effects to developing a vaccine in record time, R&D and collaboration proved to be the only way to fight the pandemic. Innovation in Mexico seems to be walking a tightrope, however. Despite being a strong player in the pharmaceutical industry, the country’s desire to move from manufacturing to technology development fell further down the government’s priority list. The lack of public support for research institutions and the delays of the New Molecules Committee have discouraged the industry. Nevertheless, private entities continue to look forward to finding a solution and exploiting this fertile soil. In this chapter, leaders of the Big Pharma industry share their efforts on the titanic task of developing a COVID-19 vaccine or treatment. They also share their opinions on the country’s R&D landscape, the new medicine purchasing scheme and changes to the way healthcare is delivered.

3 45

Innovative Medicines

Analysis

Moving Toward Sustainable Healthcare Models

View From the Top Rafael Gual | Director General of CANIFARMA

Yolanda Cervantes | Vaccine Medical Director at GSK Mexico

View From the Top José Arnaud Coelho | Director General of Merck Group México

View From the Top Omar Lugo | C. Lead, nPVU and Market Access, Op. Head at UCB Mexico and Latin America

View From the Top Juan Silanes | CEO of Inosan Biopharma

Expert Contributor Melissa Rosales | Director General of RM Pharma

View From the Top Arturo de la Rosa | General Manager of AbbVie Mexico

View From the Top Karel Fucikovsky | Pharma Director of Pierre Fabre Mexico

View From the Top

View From the Top Marco Ruggiero | General Manager of Chiesi Mexico

Fernando Sampaio | General Manager at Sanofi Pasteur

View From the Top Augusto Muench | CEO of Boehringer Ingelheim Mexico, Central America and Caribbean

View From the Top Constanza Losada | President and Country Manager of Pfizer

Analysis Mexico’s Opportunities, Challenges as a Research Hub

Fernando Cruz | C. President and Head of Corp. Affairs and Comms at Novartis Group Mexico

View From the Top Cristóbal Thompson | Executive Director of AMIIF

View From the Top

View From the Top Sergio Filho | CEO of INTRIALS

Innovative Medicines | 45

Moving Toward Sustainable Healthcare Models As science and medicine move toward a more holistic and integrated health approaches, new health models arise. This shift is reflected in trends like Value-Based Health, a care model in which providers, including hospitals and physicians, are paid based on patient health outcomes. Value-Based Healthcare focuses on the patient outcome and how their health improves while reducing complications from chronic diseases. Professor Michael Porter, who introduced the Value-Based Healthcare concept, outlines three metrics to base an assessment for the implementation of this model: diagnosis, treatment and recovery. The basic unit of measurement should be the patient and outcomes what dictates financing. Porter also established a three-level outcome hierarchy to determine the effectiveness of the treatment. The first refers to the recovery process, which can be survival or the return to a previous health status. The second is the state of recovered health, meaning a return to normal activity, as well as complications that may appear following the therapeutic process. Finally, Porter refers to a state of sustainable well-being, which can also consider long-term affectations following the therapeutic process. Financially, the Value-Based Health model is intended to be more beneficial for health systems and patients. Patients are able to achieve better health outcomes with a lower expenditure, which is especially valuable for patients suffering from chronic degenerative diseases predominant in Mexico, like cancer, diabetes and hypertension. These diseases represent a large burden for both patient and for care systems. In Mexico, for instance, according to Mario Sicilia, Director General of Laboratorio Médico Polanco, “80 percent of the health budget is destined to chronic degenerative diseases.” MBN asked leaders of the pharmaceutical industry in Mexico about the benefits of this model. Their points of view help to understand how the model works and how Mexico could adapt to it. “The patient is able to receive an effective treatment, while the government reduces its costs. At a macro scale, these savings allow the sector to reallocate resources. This new payment method is also an effective way to measure the impact of our treatments on patients,” said Fernando Cruz, Country Manager of Novartis. While there is still a long way to go before this model can be fully applied in Mexico, Novartis is looking to use it for specific ailments such as multiple sclerosis or blindness caused by diabetic retinopathy. Director General of Merck Group Mexico José Arnaud Coelho spoke about the main barrier holding back the model of payment for results adoption in Mexico. “The problem is that even with the right products, authorities always look for discounts instead of looking for better outcomes or an innovative integral solution. Moreover, without the appropriate follow-up or adherence to treatment, products will not have the desired outcome for the patient. The sector’s authorities are not yet addressing that.” Although the implementation of Value-Based Health would be a big step for pharma, UCB’s Country Lead Omar Lugo agrees with

Innovative Medicines | 46

Coelho, saying that, “to date there is no regulatory framework that allows these kinds of dynamics. There is not a tender process that allows this.” Even for less prevalent diseases, BioMarin’s Country Manager David López said that there are many benefits to the model. “BioMarin has worked through this model in different countries that have clear and regulated frameworks. This patient-centric scheme is beneficial for the government because it allows it to see the value history of each therapy,” said López. He highlighted that AMIIF is already encouraging these innovative models but also highlighted regulatory barriers. “AMIIF has been actively working with different institutions to establish this scheme but in the country, it is hard to establish standardization on medicine effectiveness as the system is very fragmented and each institution has different KPIs.” According to López, this model is the future for innovative medicines because the rise in treatment costs is unsustainable. “As the largest provider of health in Mexico, the government will sooner or later need to change its investment model to something more thoughtful and personalized.” One factor that could hasten the adoption of Value-Based Healthcare is COVID-19. Mexico’s desire to replicate the Value-Based Health model has already been brought to the table. “Mexico could benefit from the globally discussed Read the complete article More about this topic

Value-Based Healthcare model to reduce expenses while achieving efficiency,” said Executive President of AMIIF Cristóbal Thompson.

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from the

Q: Has the industry embraced the new centralized purchasing scheme and what could be done to improve this model and ensure seamless logistics? A: CANIFARMA is looking for a much better tender process for medications in 2021. In 2020, just 30 percent of medicine demand was consolidated; the other 70 percent is being purchased through direct adjudication. The latter mechanism does not allow for fair market competition and transparency. It is also inefficient because the industry is not preparing its stock for the long run but just adding a patch to address what comes up. The industry is very concerned because it can no longer foresee the demand in order to plan production. Companies cannot prepare the right API orders and materials to produce medications because demand is neither clear nor visible. The government’s international tender for acquiring medicine was another concern for the industry. Attempting to cover the demand externally, the government organized an international tender but the response was poor. Additionally, the president recently announced that the government will acquire medicines under WHO guidelines, which is an even more concerning statement because of what this implies. Purchasing through WHO, which is expressly focused on covering medicine supply for poor countries afflicted by tropical or regional conditions, is not good news for a developing country like Mexico that has

Rafael Gual

a well-established pharmaceutical industry and that produces according to strict global quality standards. A governmental action of this sort would hurt the national

Director General of CANIFARMA

medicine supply greatly in terms of competition, quality and safety of the medication. Moreover, it is not likely that the government will find the right medications to respond to national therapeutic needs in WHO’s inventory because it mainly focuses on diseases prevalent in poor countries.

National Pharma Industry Open to Dialogue

Right now, CANIFARMA is working to create a framework that will allow for fair competition, attempting to promote an open dialogue with the government and offer support in securing medicine supply. CANIFARMA is seeking to positively impact the availability of medicines for the patients, as well as meeting the government needs and foster the development of the industry. Q: How has CANIFARMA adapted its goals to the general changes in Mexico’s political environment? A: CANIFARMA is actively seeking to build communication channels with the authorities in Mexico to create a smooth and favorable environment for pharmaceutical companies to work and develop operations in Mexico. Sadly, the current COVID-19 context has delayed the growth of our project to boost research in the country has not been able to grow much despite having around 14 agreements with different hospitals in Mexico. Moreover, regulatory processes have slowed down significantly, which also affects research. Clinical research in Mexico is very limited, which is discouraging for those looking

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to undertake research projects in Mexico. A significant setback is the committee for new molecules, for example, has come to a virtual standstill in the authorization of new technologies and medicines.

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Q: How did AMIIF help to increase access to innovative medicines in 2019-2020? A: In the past, only pharmaceutical research companies were members of AMIIF. Now, companies involved in healthcare research, such as medical devices manufacturers, are joining the association. This makes AMIIF a better representative of healthcare innovation leaders. In 2020, AMIIF established three strategic axes. The first is related to the value of innovation and its impact on improving the patient’s health. The second is focused on improving access to innovative treatments for more patients. Our third goal is to consolidate AMIIF as an ethical actor that contributes to the national economy through a social agenda. Q: How is AMIIF incorporating social issues to its agenda? A: We participate in programs with the Red Cross, such as the promotion of healthy habits to institute a preventive healthcare culture starting at a very young age. AMIIF has also worked with Save the Children on a study to follow the first 1,000 days of children after birth, because this period is crucial for the future development of a person’s health. In 2019, AMIIF joined the government’s initiative Jóvenes

Cristóbal Thompson

Construyendo el Futuro (Youth Building the Future). At first we were hesitant but after working with five people, we were convinced of the benefits and effectiveness in incorporating youngsters to the workforce.

Executive Director of AMIIF

Additionally, AMIIF gave support to Clínica Esquipulas, which is a project that brings healthcare services to indigenous people in Chiapas. AMIIF created a strategic plan to donate 300 healthy nutritious meals to the evening shift of the INCMNSZ

Social Agenda Demonstrates Leadership

from April 20 to May 30. This represents around 15,000 meals for hospital staff. To help SMEs, we ordered the meals from local companies that have around 50 employees, meaning that 50 families could also benefit. Moreover, on May 12, we signed an agreement with a group of psychiatrists who wanted to support the medical community, as the crisis has also impacted mental health. These specialists offered to donate their time to support fellow medical professionals and with the help of UNAM, we were able to create an online platform to offer consultations. Q: The pharmaceutical industry is key during the COVID-19 fight. What is it doing to support the sector? A: The current efforts are unprecedented. The industry has been speaking of the importance of innovation and clinical research and we wanted to increase our investment in this area. For the first time in history, companies have opened their libraries of pharmaceutical assets to start combining all that information and previous experience related to R&D

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treatments. This is incredibly beneficial as it reduces times for approval because there are previous advancements. This action has incredibly accelerated the vaccine development process and has put the world in a much more advantageous position than before.

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Mexico’s Opportunities, Challenges as a Research Hub Clinical research is a US$140 billion industry globally. In Mexico, which ranks 21 st in clinical research, according to AMIIF, every peso invested generates an economic benefit of 1.64 pesos. However, Latin America only receives 6 percent of the global investment, demonstrating the open opportunity to boost market share. Given its population and patient demographics, and the availability of skilled talent, Mexico has high potential to become a true research hub, according to leaders interviewed by MBN. “The country has favorable conditions to become a regional hub for clinical research. Mexico has an important number of patients treated by IMSS and in total, the public sector tends to more than 70 million patients,” said Fernando Cruz, Country President of Novartis. There are two additional facts that play in favor of Mexico as a research hub. “There is a great deal of talent among healthcare professionals and enough infrastructure to make this investment a smart choice. Additionally, COFEPRIS is a reference in regulatory processes in the region, which allows clinical studies done in Mexico to gain faster approval in many countries of the region that have COFEPRIS as a reference.” José Luis Torres, Associate Director of Clinical Operations at Syneos Health, shared a similar opinion. “Mexico, given the type and size of its population, is very attractive to multinational companies, especially for Phase II and Phase III clinical research.” Torres mentioned that Mexico’s strong epidemiological profile makes the country an attractive hub for research, although that also speaks negatively about the country’s healthcare habits. To capitalize on its potential, a stable regulatory framework should be a priority, said Melissa Rosales from RM Pharma. “Regulations are just stabilizing after the change in administration but I do hope to see more research protocols. If COFEPRIS maintains its three-month approval period, we can call it a win.” Mauricio Mendieta, Managing Director of Gedeon Richter México, contextualized research processes in Mexico by using the company’s own experience. “R&D is not our immediate priority due to bureaucratic hurdles. There are other institutes that are dedicating efforts to development but approval processes are slow. We certainly see potential in Mexico as a research and innovation location for us but industrywide, there needs to be more support.” Another barrier is volunteer recruitment. “In Mexico, we would run the risk of receiving more volunteers than could be accepted and they probably would not meet the necessary criteria to participate,” said Rosales. IMSS offered its beneficiaries the option to participate in clinical studies but the regulatory situation was brought to light once more. “IMSS’ initiative would really boost participation and R&D in Mexico. IMSS, INCar and INCAN have all the ingredients

to fuel research but regulation stops them because of the long processes and times needed to approve initiatives like that.” According to Rosales, a suitable solution would be education. “Volunteering for a clinical research study gives patients options to treat their illness and helps eliminate from society the stigma that volunteers are guinea pigs.” CEO of Infinite Arturo Rodriguez also addressed the benefits of research. “Clinical research gives patients access to new treatments for free; yet, Mexico only contributes 1 percent of the world’s clinical research projects. If the country were to attract another 1 percent of the available world market, that could represent up to US$200 million in added clinical research investment.” COVID-19 has also played a role in growing the importance of research. During an MBN interview, President of ACROM Fabiola Encinas explained that while challenging, the pandemic helped to focus the interest of important actors in the industry on expanding clinical research in Mexico and exploiting the opportunities to become a research hub. “Clinical research is the core of healthcare so having an active participation as a country can translate into many health benefits,” she said. Strong Capabilities Recognized During Crisis Mexico has also been active in clinical trials for the COVID-19 vaccine. Currently, CanSino Biologics is running its Phase 3 trials in Mexico. Others in development include Novavax, Curevac and the Russian vaccine Sputnik V. Chinese company CanSino Biologics has explained that its trials are being monitored by Mexican company EPIC Research CRO, after the company oversaw the designing of the protocols to properly tackle the trials in Mexico. CanSino Biologics’ decision to work through an intermediary in Mexico took into consideration that the investigation of any clinical protocol needs to go through at least three rigorous committees: ethics, research and biosafety. According to AMIIF, to minimize potential risks, a series of ethical principles have been established that research protocols must comply with: respect for autonomy, non-maleficence, beneficence and justice, all reflected in national and international guidelines. These principles, of course, are not exclusive and it is necessary to complement them with other ethical criteria typical of clinical research, including scientific integrity, confidentiality in handling sensitive information and the social value of research.

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Q: How does Pfizer demonstrate its commitment to patient health in Mexico? A: We always have worked in favor of the patient and is what makes us a global leader in the pharmaceutical sector. We continuously work to generate significant innovation and proof of this is Pfizer’s effort in developing a vaccine for COVID-19 in collaboration with BioNTech. The vaccine is based on Messenger RNA, an innovative technology that allows a quicker evaluation process and faster mass production. We are expanding our manufacturing network so we can produce the vaccine quickly if our studies are successful. This is a clear example of our commitment to patients globally and, of course, my own commitment with Mexico. Q: What were Pfizer Mexico’s biggest contributions in the past year? A: We measure our success based on patients. I am very proud to say that in 2019 we reached more than 5 million patients in Mexico, meaning that they were treated with our products. We made a significant investment of US$8.5 million in our manufacturing plant in Toluca to make it a state-of-the-art production plant. Additionally, we invested US$15 million in R&D and we launched 12 new products related to women’s health, antibiotics and oncological medicine.

Constanza Losada

This year, we are investing US$25 million in R&D and in our manufacturing plant, while pushing for a launch of 13 new products in a two-year period. We will present oncological

President and Country Manager of Pfizer

and inflammation therapies. One of these products is the first oncological biosimilar offered by Pfizer Mexico. This launch and our other upcoming biosimilars products are a priority to have more options of treatment and broader access for patients.

Pfizer: COVID-19 Vaccine Trials Demonstrate Leadership

Q: As the new head of Pfizer Mexico, what are your expectations for the company? A: Our purpose is breakthroughs to change patients’ lives. Innovation in healthcare is synonymous with a better quality of life and the opportunity to save lives. To achieve this, we need to invest in R&D and to create global platforms to accompany the patient. The company invests 15 percent of its global budget in R&D and in Mexico, investment in this area continues to be a priority, in fact eleven percent of Pfizer’s global studies are done in the country. Our goal is to continue bringing innovative medicines to our portfolio in Mexico, broader our impact in patients in the country, while continue our leadership in reputation and transparency. Another expectation is to contribute to Mexico’s productive and economic growth. We have 1,660 collaborators and generate 19,000 indirect jobs in the country. Q: In your opinion, what are Pfizer Mexico’s coming challenges and opportunities?

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A: The biggest challenge is the COVID-19 pandemic and the “new normal” that will follow. We are convinced that now, more than ever, with the help of the industry, society and government, we can join together to protect people’s lives, safeguard employment, maintain financial stability and support businesses and families.

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Q: How is Sanofi contributing to the global fight against COVID-19? A: Sanofi aims to transform the lives of patients. We employ a preventive health approach with vaccines, treatments to control chronic diseases, highly specialized solutions for specific conditions and promotion of self-care through freely accessible medicines. We are one of the leading companies in the search for a vaccine against COVID-19. Sanofi is investing in two projects simultaneously to fight this unprecedented pandemic. As part of this effort, we have created alliances with other entities, including our competitors, with the goal of achieving an effective and accessible vaccine in the shortest possible time. Q: What led Sanofi to open a new vaccine plant in Mexico? A: We have been committed to Mexico for more than 90 years. Our investment in the country is proof of that commitment. The new vaccine production plant is Sanofi’s third in Latin America. We are investing €129 million (US$152 million) in this project and we are also collaborating with the public sector so that Mexico can have its own manufacturing plant for seasonal influenza vaccines in the near future.

Fernando Sampaio

Q: What are the highlights of Sanofi’s recent global R&D projects? A: Today, Sanofi is an innovation leader in several therapeutic

General Manager at Sanofi Pasteur

areas. We are the world’s leading producer of the influenza vaccine, hexavalent vaccines for children and a total of 14 vaccines for all ages, which allow us to ensure that no one suffers or dies from an affliction that can be prevented.

Investment, Research a Reflection of Strong Commitment

Regarding general medicine, we are leaders in solutions for patients with Type I and II diabetes, in addition to having a broad portfolio of medicines that have been on the market for decades, changing the lives of patients with conditions ranging from disease to infertility. In areas of high specialty, we were the first company to bring a monoclonal antibody to Mexico to treat patients with severe atopic dermatitis, a therapy that has the potential to target other diseases caused by Type II inflammation. Q: What is Mexico’s role in Sanofi’s overall strategy? A: Mexico is one of the 10 most important countries for Sanofi worldwide. We have the opportunity to collaborate with the health sector in all areas: prevention, treatment and self-care, so we have a long way to go. In addition to investing in the construction of the new vaccine plant, we will continue working to introduce influenza vaccines, pediatric combos to protect children and medications that are in high demanded from Mexican patients.

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Diabetes is the main public health problem in Mexico and our portfolio includes a variety of alternatives adaptable to each type of patient. In addition, our monoclonal antibody will revolutionize the clinical approach to atopic dermatitis and that will undoubtedly transform the lives of patients.

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Q: What are GSK’s biggest contributions to the Mexican healthcare sector? A: GSK has participated in universal vaccine campaigns in Mexico. Moreover, the company’s rotavirus vaccine ended its development cycle in the country, allowing the vaccine to arrive during the last stage of its trials. This meant Mexico received the vaccine in three years, whereas normally, vaccines can take 15 years to arrive to the country. As a result, Mexico was among the first countries to implement a universal vaccination campaign against rotavirus, reducing mortality rates by 50 percent. The human papilloma virus vaccine is another example. GSK was able to introduce the vaccine and start a campaign in Mexico in 2011. Alongside the Ministry of Health and the Ministry of Education, we were able to take doses to schools in Mexico, protecting children against the virus, which is the No. 1 cause of uterine cancer. Additionally, in 2009 when Mexico faced the AH1N1 influenza outbreak, GSK quickly responded and introduced the first vaccine for the virus. Q: Aside from COVID-19, what are GSK’s current vaccine developments in the country? A: Vaccine development related to respiratory syncytial virus is a

Yolanda Cervantes

priority for GSK. This virus is especially dangerous for newborns, the elderly or people with serious respiratory problems. There is still further research needed on the meningococcus vaccine. Although this disease is not very common, it has a high mortality

Vaccine Medical Director at GSK Mexico

rate and many complications. GSK is focusing on developing a combination of vaccines against meningococcus variations. GSK’s vaccine on herpes zoster was also developed in Mexico but it is not currently available here. Its efficiency is higher than

Education on Vaccination Key for Effective Results

97 percent; we are waiting for its arrival to the country due to the benefits it will provide patients as it also prevents other ailments or disabilities that can develop as a result of the pain herpes zoster causes. Q: What are GSK’s current efforts regarding the COVID-19 vaccine? A: GSK is contributing with the development of many vaccines using its A S03 adjuvant system, which was previously used for the development of the AH1N1 vaccine. This adjuvant system favors a positive immune response and defenses among those who get the vaccine. Furthermore, the system allows more vaccine production because less antigen goes into the vaccine, enabling this resource to last for more doses. GSK is in phase 1-2 trials of a vaccine with Sanofi and Curevac, which provided the antigen component of the vaccine while we provided the A S03 adjuvant system. Other advanced collaborations are with Innovax, which are also in pre-clinical trials, and with Clover Biopharmaceuticals in China, Medicago and Dinavax which is in Phase 1. Additionally, GSK is part of

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the Coalition for Innovation in Epidemic Preparedness (CEPI) based in Norway, which includes many industry entities such as the WHO, governments and private companies. As part of CEPI, countries have the opportunity to start planning their vaccine supply.

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Q: In which areas is AbbVie focused in terms of its R&D goals? A: We are pioneers and leaders in the field of autoimmune diseases, which have a wide range of symptomatology and can manifest differently depending on the patient. Most of our R&D investment targets new therapies for these chronic degenerative diseases. We are always looking to discover promising new immunology pathways and targets that is inspired and guided by those whose lives are touched by immune-mediated diseases. Oncology is another priority area. We have grown our oncology and hematology portfolio, focusing on blood cancers, such as lymphomas, leukemias and solid tumors. AbbVie is also investing strongly in neurology. We have developed many solutions for Parkinson’s disease, for example. The acquisition of Allergan and its therapeutic botulin toxin solutions also has strengthened our neurology area considerably, making it much more relevant to the company. The fourth investment area we focus on is virology. We are pioneers in HIV and hepatitis C. In fact, we have a cure for hepatitis C. Our R&D area continues to invest in finding a functional cure for hepatitis C and a functional cure for HIV. Q: How does AbbVie Mexico ensure quick access to AbbVie’s most recent global launches?

Arturo de la Rosa

A: Due to the type of critical diseases that AbbVie focuses on, treatments can involve a considerable investment and the likelihood of people being able to spend out of pocket is

General Manager of AbbVie Mexico

limited. AbbVie has understood this reality, which is why, parallel to our clinical trials on a drug, we invest time and money in understanding the pharmaco-economics and the economic benefits that this drug can bring to the population.

Strong Commitment in the Face of Crisis

In Mexico, when a company submits a product for inclusion in the country’s basic table of medicines, it has to demonstrate that the inclusion of this innovative medicine, because of its safety and effectiveness, can compensate the cost of the drug through its direct effects and through a reduction in further costs related to hospitalization, mortality or adverse effects. As a company, we are interested in establishing a close relationship with the government to offer a solution that will overcome the actual challenges of the healthcare sector. We go beyond the economic savings to also presenting our expertise on the management of difficult diseases to offer an improvement and add value to the government’s approach to health. Half of the effectiveness of a treatment depends on the patient’s adherence to it. Otherwise, the therapies are useless. Because of this, AbbVie supports the government’s preventive healthcare campaigns, raising awareness regarding adherence to treatment and promoting healthy lifestyles. Q: What releases are AbbVie global and AbbVie Mexico working on?

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A: In Mexico, we are working on two revolutionary treatments for autoimmune diseases: one is for rheumatoid arthritis and the other is for psoriasis. Globally, we are developing a treatment for the autoimmune disease atopic dermatitis.

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Q: How is Merck Group increasing access to its medicines? A: INSABI is in an implementation process and our project is cooperating with it. With IMSS and ISSSTE, we already are working with the clear goal of providing the best medical attention for Mexican patients. The country invests very little in healthcare, so one of our tasks is to work with public institutions on diverse programs related to our diabetes, thyroid, oncology and multiple sclerosis products. We have ongoing clinical trials in the country, a continuous medical education program and we hold constant talks with decision-makers to work together and achieve real access to healthcare. Q: What are your views on the pay-by-results model that some pharmaceutical companies are promoting? A: What this model attempts to achieve is something that the industry is always looking for: to find the right patient for the right products. The problem is that even with the right products, the authorities always look for discounts instead of looking for better outcomes or an innovative integral solution. Moreover, without the appropriate follow-up or adherence to treatment, products will not have the desired outcome for the patient.

José Arnaud Coelho

Q: What have been Merck’s most recent product introductions?

Director General of Merck Group México

A: We are the oldest pharmaceutical company in the world. We have more than 350 years of history in the sector and we have focused on being a leader in the specialty areas of oncology, multiple sclerosis and immunology. In the area of personalized medicine, we released a product that introduces

Innovation to Optimize Years of Treatments

high innovation into the country in the area of multiple sclerosis. The treatment is administered for 10 days in the first year and then another 10 days in the second year, replacing four years of traditional treatments. This substitutes yearslong inventories of tablets and injections and it also facilitates the monitoring of the patient. Also, it is safer because it has been tested for years. Merck in Mexico also has an upcoming product for Merkel cell carcinoma, which is a rare and aggressive type of cancer. Out treatment is effective up to 40 percent and can be used to treat kidney disease or the urogenital system. Alongside COFEPRIS, we are working on the approval of the products in those three specialties. Q: What are Merck’s short-term goals in Mexico? A: Merck has three divisions: healthcare, life sciences and high-performance materials. The latter created liquid crystal and also develops products like pigments for human use. We are working toward double-digit growth as we are releasing many products and bringing to market others that address the

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dermatology, oncology and obesity areas. We are investing in more multiple sclerosis findings that can contribute to our growth. Mexico hosts Merck’s most important distribution center in Latin America and is a very strategic country for the company.

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Q: What is Novartis current investment in Mexico and which areas are priorities? A: Last year, Novartis made a US$20 million investment for 2019-2020 in the country. Most of this investment is allocated to clinical R&D because we think the country has favorable conditions to become a regional hub for clinical research. Mexico has an important number of patients under IMSS coverage and in total, the public sector tends to more than 70 million patients. Also, there is a great deal of talent among healthcare professionals and enough infrastructure to make this investment a smart choice. Additionally, COFEPRIS is a reference in regulatory processes in the region, which allows clinical studies done in Mexico to gain faster approval in many countries of the region that have COFEPRIS as a reference. As a result of our latest investment, Novartis’ footprint in Mexico is around US$500 million, including our investment in talent and in our Shared Services Center that caters to all our operations in America, even in the US. Q: How does Novartis promote access to innovative medicines in Mexico? A: To date, purchasing models are based on traditional methods of making an order and paying for the product. However, a new

Fernando Cruz

business model that pays based on results instead of doses can lead to better outcomes. The patient is able to receive an effective treatment, while the government reduces its costs. There is still a long way to go but in Mexico, talks for applying

C. President and Head of Corp. Affairs and Comms at Novartis Group Mexico

this payment scheme for ailments such as multiple sclerosis or blindness caused by diabetic retinopathy have already started. Novartis also has a very strong production line of generics that also enables accessibility of innovative medicine for the public and helps support the financial sustainability of the healthcare

Leadership Translates to Disruptive Innovative Solutions

sector in Mexico. Q: What has been Novartis’ response to the COVID-19 pandemic? A: Our internal capacity and well-being come first, so one of our priorities was to reduce risk of exposure for our team members that needed to be working, as we are an essential activity and cannot stop operating. Meanwhile, we intensified preventive measures at laboratories that require presential activities. Regarding patients, through our program Contacto (Contact) they are able to access their medicine with a discount and have it sent home. We had to be very careful with our medicine distribution and intensify sanitary protocols to reduce exposure of vulnerable groups to the pandemic, such as older people who need Novartis treatments. The company has also put many digital tools for mental health at our associates’ disposal, as well as educational tools and training sessions that can help them adapt to the new normal that is coming and that we are living. Novartis made a US$250,000 donation to FunSalud to contribute to its digital hospital retraining platform, which is an

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initiative that monitors available clinical infrastructure to receive patients and it also helps manage patients and follow up on their treatment. Mexico’s Minister of Foreign Affairs Marcelo Ebrard announced Novartis’ second contribution to the fight against the pandemic, which was the donation of hydroxychloroquine.

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Q: How does the company’s approach to innovation benefit Mexican patients? A: We have two important manufacturing plants in the country, one in Mexico City and the other one in Guadalajara, Jalisco. This installed production and exporting capacity has led our country to be classified as one of the strategic locations for the company. Boehringer Ingelheim has two main business lines in Mexico: human and animal health. Our cardiometabolic division is significantly relevant in the country due to the high prevalence of diabetes, arterial hypertension, thrombosis and heart failure. Our products, beyond focusing on the generality of a disease, are meant to benefit patients with unsolved health needs. Over the past 10 years, the company has launched three groups of compounds to treat cardiovascular diseases. We have recently received the results of our product SGLT2 inhibitor, which showed potential to reduce deaths related to heart failure on patients with and without diabetes. This allows the product to reach many more patients as it will have a positive effect regardless of the patient’s pre-existing condition. We are pursuing the medical indication and approval in Mexico because it is highly relevant for the local population. Q: What does Mexico represent to Boehringer

Augusto Muench

Ingelheim’s global operations? A: Mexico’s manufacturing center is one of our most important globally. The country’s proximity to the US offers an advantage

CEO of Boehringer Ingelheim Mexico, Central America and Caribbean

as 60 percent of production is exported there. Last year, Boehringer Ingelheim approved a MX$1.6 billion (US$76.1 million) investment in our human health plant and MX$100 million (US$4.7 million) in our animal health plant. This demonstrates the commitment of the company to Mexico as

Boehringer Ingelheim’s Bet on Innovation Drives Mexican Efforts

a long-term strategic manufacturing hub. We centralize in our lines more than 50 percent of the cardio-metabolic products needed in Mexico. In the future, we hope that the Mexican population’s demand for these products can be fully met by the country’s local production capacity. Mexico’s role has been specifically relevant during the COVID-19 pandemic. Boehringer Ingelheim never stopped its production plants as we are an essential industry. We worked along our collaborators to avoid any disruption to the supply chain. Q: How important is Mexico for Boehringer Ingelheim’s R&D efforts? A: Last year, 18 percent of our net sales were directed to this area. In Mexico, we collaborated with 51 clinical research centers focused on Phase 3 developments. These centers, aside from focusing on cardiometabolic diseases, also targeted their efforts in respiratory therapy to strengthen our compounds for chronic obstructive pulmonary disease, asthma and idiopathic pulmonary fibrosis. For this type of research, we established close relations with Mexican health institutes like

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INER. In Germany, Boehringer Ingelheim has been evaluating a new type of PCR test, which is based in recollecting samples for COVID-19 using a chewable element that may be used in existing diagnostic machines which detect the virus and skip the common swabbing method that is being currently used.

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Q: How was your product performance in the Mexican market impacted by the pandemic? A: Besides difficulties in terms of logistics, planning and acquiring products that we import from Italy, we performed successfully in 2020, achieving a record 36 percent growth against 2019. Q: How have changes to the public medication acquisition scheme impacted Chiesi? A: There are a few points to highlight. First, there was an enormous delay in product acquisition. Normally, government tenders take place around March and April. Last year, this was delayed until August-September. The result is that the market suffered a shortage of products. The second issue is related to the collection of due payments. Unfortunately, we are still awaiting payment from the government for 2H19 and the entirety of 2020. This is a serious problem. It is okay to wait for a while and payment terms may be negotiated but waiting a whole year or even a year and a half to get your money is absolutely unacceptable. Q: What is your view on the government’s intention to acquire medications through UNOPS? A: UNOPS is an additional change. We have seen changes to the

Marco Ruggiero

tender process every year. Personally, I think change is good. It forces people to look for new business models that are sometimes more efficient. UNOPS has a globally recognized reputation in terms of acquisition of pharmaceutical products. The only thing

General Manager of Chiesi Mexico

that I am wondering about is the planning. Today, we are already seeing a delay with the tender processes. Patented products were discussed last December. The time to deliver the products will end up being around May, optimistically speaking. This is five months into the year. We do expect some trouble in 2021.

Dialogue is Essential to Ensure Quality Treatments: Chiesi

Q: Do you think the government’s product decisions are too focused on price? A: Yes, this is the wrong approach. If you want an innovative product, you need to pay for the innovation. It is much better to take into account the total cost of treatment. A costlier product will have a lower total cost of treatment, if it treats the patient better. A cheaper product means you will need to spend on longer hospitalization and additional products. The total cost of treatment ends up being higher. Q: In which product areas do you expect the most growth? A: COPD and respiratory disease treatments will see increased demand. I assume that the COPD segment, and later also asthma, will contribute to the growth of the company because people need treatments for respiratory diseases. We found that many people have had respiratory issues that were wrongly treated. There is still a great deal of potential in this area. The key is to create awareness. We have seen awareness rising,

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not just because of our own campaigns but also because of other organizations. Moreover, we need to create access to treatments. This means making the product available in the private and public sectors. We need to work together to overcome the obstacles.

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Q: How has Pierre Fabre ensured business continuity during COVID-19 ? A: During the outbreak, Pierre Fabre had two priorities. The first was to secure the health and safety of our collaborators to ensure continuity of our pharmaceutical and cosmetic lines. Commercially, we implemented preventive measures to ensure distribution. However, changes in this area were dramatic following the pandemic. Q: What were Pierre Fabre’s goals during 2019 and 2020? A: The company began a transformation plan in 2020 to optimize our financial and commercial operations. Our CEO is looking to build the company as a whole, considering that in the past we had two separate business units, medical care and dermo-cosmetics, which sometimes implied two general directions in some countries. By unifying the company, we make it easier for Pierre Fabre to contribute to making the world better and healthier. The unified unit is called Medical Care and it still maintains many of our previous goals, such as organic market growth for our brands. Oncology is one of our recently strengthened verticals. Globally, we are investing and launching many treatments to treat skin cancer, melanoma and colorectal cancer. Mexico

Karel Fucikovsky

will be a priority country for our oncological products in the future. To date, we are focusing on a geographic rationalization of our portfolios. Pierre Fabre is changing and focusing on the products that have penetrated the market the

Pharma Director of Pierre Fabre Mexico

most and that have generated the most benefits. The pharmaceutical market in Mexico changed a great deal in 2019 and 2020 and this has driven many companies to focus on the private retail market. The public sector has yet to

Unified Innovation to Explore Nontraditional Pharma Markets

define some rules and that uncertainty has driven away many companies. We are also exploring e-commerce for our dermocosmetics line. Joining this digital transformation is important for the company because the market will keep expanding, especially after the pandemic. We are looking forward to consolidating our transformation and continuing our organic growth. We are also exploring new nontraditional distribution markets. The traditional distribution model based on wholesalers is changing. There are regional distributors emerging that have a different operational capacity, creating a virtuous circle due to their controlled operations. Q: What is the value of innovation in healthcare and why should Mexico prioritize it? A: Innovation is fundamental for emerging and developing economies. Mexican health authorities are addressing other priorities and overall, the administration is seeing innovation as an expenditure rather than an investment tool that will spur development. Pierre Fabre, our representatives, AMIIF and

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CANIFARMA are concerned about Mexico setting innovation aside. This is disappointing because the Mexican industry has worked for years to serve as a strategic innovation base for Latin America. Today, many R&D centers are even at risk of losing federal funding.

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Q: What are UCB’s main contributions to Mexico’s healthcare system and its patients? A: We have a relevant participation in solutions for patients who live with chronic degenerative diseases like epilepsy, Parkinson’s, rheumatoid arthritis, anxiety and vertigo. Our goal is to enable the patient to recover control over their lives. Q: How is UCB helping to improve access to medicine in the country? A: This year, we started working with INSABI and have introduced our solutions for rheumatoid arthritis. Originally, we participated with our products for epilepsy and Parkinson’s. We work alongside all other public entities like IMSS, ISSSTE and SEDENA with our products. With the government’s new centralized purchasing scheme, medicine supply would be easier as all public institutions can access the same database, instead of each company having to reach institutions separately. This is a very positive step toward universal health coverage. Additionally, to try to improve access to our medications, UCB offers support programs for patients through the private sector. For example, one program is called Affordability, which focuses on a person’s payment capability according to their treatment. Through a socioeconomic study,

Omar Lugo

we can offer individual discounts on therapies. Q: How is UCB encouraging innovation in the country?

C. Lead, nPVU and Market Access, Op. Head at UCB Mexico and Latin America

A: We are developing a new concept called “Beyond the Pill” that offers added value to our solutions through digital tools, such as wearables or apps. For example, patients with epilepsy can suffer fatal episodes, so we are trying to develop technological tools that can anticipate those seizures and warn

Innovative Care Concepts to Ensure Patient Well-Being

the patient through their phones or wearables. This is also intended to alert their caregivers or people around them about the situation, enabling a support network. Q: What new products will UCB launch in the Mexican market? A: UCB is among the companies with the largest reinvestment rates, investing around 26 percent of its revenue in R&D. In 2019, we acquired Ra Pharma, significantly increasing our product portfolio for neurodegenerative diseases. UCB is now focusing our R&D on neurodegenerative diseases, immunology, osteoporosis and bone innovation. Regarding new products, Mexico plays a very relevant role in trials. Q: How has COVID-19 impacted demand and production for UCB? A: Since the beginning of the year, we have focused on four areas. The first was our employees’ physical and mental health and safety. Second, we ensured medicine supply for patients by performing an analysis of our value chain to avoid disruptions, which allows us to secure supply for Mexico with

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no further complications. Third, we are cooperating with the authorities by following their indications and protecting our staff. Lastly, UCB would like to support the economic dynamics of the country, recognizing that the pandemic is having a negative effect.

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Q: Why is Inosan Biopharma a unique player in the healthcare sector? A: Inosan Biopharma has focused on developing a technological platform related to antibodies. We began developing antibodies such as antivenoms for Africa and the Middle East. To date, we export almost all our production to countries in those regions. Inosan Biopharma’s antibodies have been tested and proven to work as antivenoms, antitoxins and antivirals. This has paved the way for our R&D pipelines, especially for antiviral solutions. Q: Antivenoms are complex and costly to produce and develop. How has Inosan Biopharma tackled these challenges to offer cost-effective solutions? A: For antivenom development, we created a technological platform that allows us to simplify the antibody. We took our original development for antivenom and we divided it into three stages: venom selection, horse immunization, purification and lyophilization. Working with each individual stage and through the use of technology, we were able to reach a purifying stage that guarantees its safe use. For Inosan Biopharma, safety was the priority because our products tend to be used in precarious healthcare systems. Alongside the purifying stage, we were able to develop complex products that are multipurpose, having the ability to neutralize the venom from multiple snakes or scorpions. This

Juan Silanes

expanded the regionalization of our products in these parts of the world. Increasing the efficiency of our products has enabled us to do more with less, despite the volume of the primary investment. Inosan Biopharma develops its products to FDA and EMA

CEO of Inosan Biopharma

standards to guarantee the highest quality. Q: Inosan products are sold to NATO, the US Army and other military bodies going to Asia and Africa. How have Inosan Biopharma’s products reached these entities?

Antibody-Based Solutions Address Rare Health Issues

A: We are very proud of this work because it is recognition of the quality and effectiveness of our products. The US Army was the first to reach out to us during its research to find the best antivenom solutions in the market. We began working with the primary armed forces of the world. We take our solutions to their military bases or they receive it through their local embassy. This is the result of years of having a quality product in the market. Q: How does Inosan Biopharma uses its expertise to combat the COVID-19 pandemic? A: Years ago, Inosan Biopharma was invited by the FDA to participate in a treatment development project for Ebola. From this work, we recognized the effectiveness of our antibodies as antivirals. This experience gave us the background to work on a COVID-19 solution as soon as we found the right immune response to develop a treatment. Inosan Biopharma began working with horses to find this immune response. We developed two research lines and we selected the one that delivered the best antibody efficiency. We then began preclinical trials and to date, the results have been very positive. We have noticed a neutralization of the

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virus while keeping a safe profile in terms of other reactions. Inosan Biopharma has allied with TecSalud to scale this project and begin other trials and for this stage, CINVESTAV has recently joined us. We are already in talks with the FDA and COFEPRIS to begin human trials in the upcoming weeks.

atient recruitment is widely recognized as a key determinant for success in clinical trials. Yet, a substantial number of trials fail to reach their recruitment goals, a situation that has important scientific, financial and ethical implications. Despite

efforts over multiple decades to identify and address barriers, recruitment challenges persist. Most people being treated for a disease or condition are not aware that they might be eligible for a clinical trial or that trials are conducted where they are receiving treatment. Education and communication are paramount. There are factors that potentially contribute to the recruitment success. These include trial design, study staff, recruitment strategies, patient care, targets and timelines. The scope of factors that affect recruitment to clinical trials suggests a fundamental need for more inclusive and proactive approaches that extend beyond

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common study-specific strategies.

Improving Recruitment and Retention in Clinical Trials Melissa Rosales Director General of RM Pharma

Other factors also play a role, including: + Access or proximity of clinical trials to minority communities; + Readability and length of informed consent forms; + Provider bias in offering clinical trials or assumptions made about interest and how people are approached; + Eligibility criteria and other aspects of the trial design; + Patients not wanting to participate because they do not understand the protocol, do not want to receive a placebo, cannot take time off work to attend follow-up visits or just because of the fear of the unknown; + Challenges to effectively communicate the purpose, technical aspects and implications of trials to patients and to assist them in decision-making, providing full and unbiased information about options, benefits and risks, while considering the participants’ cultural traditions, personal preferences and values, family situations, social circumstances and lifestyles; and + Quality health education. In November 2019, RM Pharma organized a workshop for our patients called “Designing a Full Life,” in which we also invited health ambassadors to be part of our program to encourage patients to be involved in clinical trials, sharing their experiences participating in studies and how trials can improve quality of life, sharing the importance of clinical research, the work done by our institution in providing cutting-edge care, the possibilities of having additional options for care by choosing to get care within the context of a clinical trial and the extra monitoring and attention participants receive during a clinical trial. In some trials, the sponsor made agreements with clinical trial patient recruitment companies that use a range of methods, from digital advertising to community partnerships, to find the right patients for the trial. Those are helpful but, in the end, the researchers and site staff made the difference. When the recruitment goal has been reached and one our

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participants leaves a trial before it is completed, it means that the site and sponsor resources, such as staff time, materials and medical research, are wasted because the data is incomplete. Therefore, it is critical to find ways to promote appointment adherence, treatment compliance and patient safety.

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Q: Why is INTRIALS the best CRO partner for the healthcare industry? A: INTRIALS has a local understanding of the region and each country’s differences, unlike other companies that see the region as a uniform entity. Even within the same country, there are regional differences. Moreover, to understand budgets and service coverage, it is important to have knowledge of Latin American society. There is a huge gap in clinical research in the region regarding the quality of doctors and the quantity of medical trials that are happening in the area. Latin America is a strong economy and has a very representative population. Yet, healthcare access is precarious. Clinical trials can contribute to closing this gap so it was very important to take our regional knowledge and expertise to the global stage to improve access to treatments and technology, while complementing the high quality of medical doctors and infrastructure in the region. Q: What main advantages has the company gained by operating in Mexico? A: Mexico is the one of the most important markets for INTRIALS. We have some of our strongest partnerships here and some of our largest clinical trials are running in the country.

Sergio Filho

We see more opportunities in the future and we are hoping to become more competitive on a global scale. Mexico offers a mature market that is likely to develop quickly and we are prepared to capitalize on this.

CEO of INTRIALS

Q: What have been INTRIALS’ main focus areas in Mexico? A: Oncology, cardiovascular diseases and diabetes are enormous fields in the country. However, we have a strong focus on rare

Shining a Light on Latin America for Initial Stages of Clinical Trials

diseases and we are running clinical trials for these in Mexico. There are already many large pharmaceutical companies tackling research in those diseases and INTRIALS works with them. Q: What challenges has INTRIALS faced in recruiting local patients? A: Mexico has an interesting dynamic in this sense. Depending on the part of the country where we want to focus, there can be a lack of proper infrastructure (laboratories or research centers) to provide the right diagnosis for a specific disease. To recruit patients, they also must have a strong relationship of trust with physicians. We have patients who are willing to participate but the infrastructure barriers makes it difficult. In Mexico, many people depend on the government for access to healthcare, which provides a more fruitful environment for recruiting and eventually improving the coverage of their services. The COVID-19 vaccine development has definitely focused attention on clinical trials and its stages. This has, in a way, been useful in that we’ve been able to provide more

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information to the population about the importance of trials and also to push COFEPRIS to improve its regulatory framework for clinical trials. Having a strong regulatory authority is key because it enables us to be at the same level of worldwide developments and products.

Generics Whether treating simple ailments or chronic degenerative diseases, generics companies are a significant contributor to Mexico’s healthcare industry and economy, while providing an accessible solution for patients paying out of pocket. In 2020, the generics industry experienced favorable changes regarding production. COFEPRIS eliminated criteria that limited generics manufacturing once the corresponding patent expired. Meanwhile, the new Industrial Innovation Protection Law derived from USMCA sought to speed up the entry of generics to the market by helping producers to prepare for when the patents expire. However, changes to the centralized medicine purchasing scheme and the federal medicine supply coming from UNOPS present a challenge for this industry. Overall, generics sales experienced 19.1 percent growth last year, according to ANADIM’s figures. Looking ahead, industry players are focusing on biosimilar production, opening dialogue with Mexican authorities, expansion and an overall strengthening of the industry in terms of quality and production capacity. Large multinational players are even taking a positive look at Mexico’s chemical pharmaceutical industry to exploit its manufacturing capabilities for API production. This chapter explores an important industry for the country’s micro and macro economy, with hopes for a thriving 2021.

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Generics

Analysis

Mexico’s API Manufacturing Potential Boosted by COVID-19

View From the Top

Américo García | Director General of Mexico and Latin America at Apotex

Arturo Morales | President of AMELAF

View From the Top Cecilia Bravo | President of ANAFAM

View From the Top Rafael Quintanilla | Pharma and Biologics Director of Laboratorios Silanes

View From the Top Esteban Abad | Vice President and Head of Upper Latin America at Glenmark

View From the Top Lourdes López | Executive Director of ANADIM

View From the Top Ignacio Merino | Director General of Farmacia París

View From the Top Gabriel Zavala | Commercial Executive Director of Farmacias del Ahorro

View From the Top Benjamín Vega | Commercial Director of Allen Laboratorios

View From the Top Efrén Ocampo | President of Grupo Neolpharma

View From the Top Vincenzo D’Elia | General Manager of Laboratorios Alfasigma

View From the Top Rodrigo Hernández | Director General of Quimpharma

View From the Top Juan José Aguirre | Commercial Director of Grupo Bruluart

View From the Top MS Nagendra | Director General of Zydus Pharmaceuticals

View From the Top Jaime López de Silanes | Executive Director of CFM

View From the Top

View From the Top Santiago González | Operations Director Mexico of Farmacias YZA

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Mexico’s API Manufacturing Potential Boosted by COVID-19 COVID-19 demonstrated the world’s dependence on certain markets. In the healthcare industry, this was clearly evident in the logistics and supply chain disruptions related to API production, which mainly happens in Asia, specifically in India and China. The resulting calls for nearshoring production put Mexico in a good position to capitalize on its strengths. WHO describes Active Pharmaceutical Ingredients (API) as “any substance used in a finished pharmaceutical product, intended to furnish pharmacological activity, to otherwise have direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease or to have direct effect in restoring, correcting or modifying physiological functions in human beings.” According to MDTV Alliance, depending on the complexity of the molecule required, synthesis of APIs might require multistep complex chemistry using a range of processing technologies. API manufacturers are highly specialized and globally, Teva, with headquarters in Israel, and Dr.Reddy’s, located in India, are two of the largest API manufacturers. Manufacturing APIs involves a regulated process that requires strict safety and quality standards. While these are determined by each country, the final API product is inspected and licensed by the regulatory entity of each country where it arrives; for example, the FDA in the US and COFEPRIS in Mexico. However, MDTV Alliance warns that “regular inspection outside the country of use can prove difficult with counterfeiting and contamination being high on the list of various agencies’ concerns.” During the COVID-19 pandemic, API distribution was disrupted when India and China limited logistics operations to secure internal supply. This caused global concerns and production delays but it also raised a question: Could this be an opportunity for Mexico? In an interview with MBN, President of the Mexican Pharmaceutical Council (CFM) Jaime López de Silanes explained that China and India represent around 80 percent of the global API market. “Mexico needs strategic mechanisms between the government and the pharmaceutical industry to promote national API production and reduce this dependence,” said Silanes. This is an opportunity for the country, especially now with USMCA’s enforcement. “Even the US is actively promoting this route, which makes this an ideal time for Mexico, the US and Canada to promote medium and long-term commitments between companies and governments to create certainty for investments.” Esteban Abad, Vice President and Head of Upper Latin America at Glenmark, told MBN that Mexico has potential as an API manufacturer but that it might not be quite ready for it. “It has been said that Mexico could become an API producer but it is not that simple. While we might have manufacturing capabilities, there needs to be a specific demand to fully develop them as the Read the complete article More about this topic

infrastructure required for a single API is not cheap.” Abad added that for the goal to become a reality, Mexico would need global demand to ensure profitability.

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Q: How is AMELAF helping to shape and grow the Mexican pharmaceutical industry? A: AMELAF represents 44 national laboratories with 100 percent Mexican investment, having 63 plants that comply with COFEPRIS’ standards and working to the highest international pharmaceutical standards. We encourage COFEPRIS to visit those plants to ensure the quality work of our laboratories. This sector is a direct employer of at least 90,000 people and generates 400,000 indirect jobs in Mexico. AMELAF’s focus is to boost competition among national laboratories. We are in charge of distributing almost threefourths of the medicine that the public sector requires, charging only a third of what these medicines really cost. We are interested in defending and representing the national pharmaceutical industry before the government, which is our main client and regulator. AMELAF builds communication bridges between companies and the government. We promote dialogue and participation so both parties can fulfil their interests while generating a positive impact on society. At the end on the day, companies and the government have the same interest to contribute to the Mexican healthcare sector and to promote well-being. Q: How is AMELAF connecting to public institutions and

Arturo Morales

supporting its members during this complex period? A: AMELAF’s main focus is on the centralized purchasing system, which was recently implemented to address the areas

President of AMELAF

of opportunity in the old purchasing system. The main flaw I saw with the old system was the distribution of the budget rather than of the medicine itself. The new system combats the misuse of resources, which is a very assertive measure and will benefit the healthcare sector. However, the way it was implemented was

Pushing for Cooperation Between the Public, Private Sectors

abrupt and generated issues that could have been avoided with proper timing. It is worth mentioning that there was no such thing as a monopolistic sale. Seventy laboratories sold to three distributors, which generated the receipt for the government. That ended up looking like a monopolistic practice. Laboratories had the option of working directly with the government but it was less complicated to work through a distributor. What the pharmaceutical industry wants is clarity regarding demand and work hours. Mexico and its current national contractors have the capacity to fully supply the government’s requirements. Holding an open international tender was a step that could have been avoided because, aside from all the legal procedures, the purchase could be dangerous if not done under the same regulatory measures that COFEPRIS establishes, not to mention that it is unfair to national companies that do follow the national acquisition law. The government backed up its decision by saying WHO validated those medicines, which is not entirely true. WHO allows the entrance of those medicines to underdeveloped countries or in cases of a crisis or emergency, which is not the case for Mexico.

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We are not facing a shortage; the Mexican pharmaceutical industry has the capacity to cover those gaps but has no certainty from the government. We depend on what the public sector requires and if there is no clarity, the result is that medications cannot be manufactured on time, leading to shortages.

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from the

Q: What steps has ANAFAM taken to guarantee manufacturing and supply during the pandemic? A: Our sector did not halt activities. However, in the area of raw materials, we did have a few issues in a number of cases. Some countries restricted the export of certain supplies. This was a problem when the supplier was bound to a specific SKU here in Mexico. In these cases, we asked the sanitary authority to authorize imports from a different supplier. COFEPRIS provided some support on the issue but only to a certain extent. There were about 20 cases where imported supplies were at risk. Q: Do you expect greater flexibility in adapting imports in the future? A: We have a problem with the current regulatory situation, which is very complex and does not benefit the industry. During the COVID-19 crisis, the authorities have actually been introducing new regulations that place an even greater burden on companies in Mexico. These regulations do not have to do with COVID-19. Companies that have been waiting for procedures to be completed now have to meet new requirements that set back their plans. Instead of simplifying, the government is making things more and more complicated. Q: Where does medication development

Cecilia Bravo

in Mexico stand at the moment? A: We have some labs that have their raw material manufacturing here. One of our members specifically

President of ANAFAM

manufactures only raw materials. For Mexican manufacturers, it is better to focus on a specialized medical product that can be marketed in a smaller volume market at a higher price. This can provide a return without a major investment up front. If we wanted to compete with China or India in the large volume

Inconsistent Medication Purchases Hurting National Sector

markets, we would need a great deal of capital. Q: What impact is the government’s approach to buying medication having on the sector? A: Under previous FTA conditions, the Mexican government would set more requirements for public sector purchasing that would give preference to products that were more strongly integrated in the national productive chain. This was lost with the new free trade negotiations. We support getting medications from elsewhere if there is no provider in the country. However, with many imports, this is not the case. I believe the government could still handle a not-socostly mechanism where, in the case of two available providers, the government gives preference to the one with the larger national presence. I do not see this happening, however. Q: What actions are you taking to improve this situation? A: We are filing an amparo against a disposition proposed by the government that lowers the import requirements for many

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products, particularly in the oncological area. The government is opting for direct purchases without any bidding process. Formerly, things happened according to structured bidding processes. Manufacturers would be informed of the demand from the public sector, which would allow them to plan their production.

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from the

Q: How much has CFM’s work been reshaped by the general changes in the sector and overall political climate in the country? A: From our perspective and that of our pharmaceutical laboratory members, we have a firm commitment to the country. This refers to the long-term focus on R&D to contribute with more therapeutic innovations for the medical community and for the benefit of the population’s health. Along the way, we evaluate and adapt the necessary changes to provide continuity to the constructive relationship with the government. Q: How does the promotion of R&D initiatives contribute to retaining Mexican talent? A: Encouraging talent is a path we have taken to strengthen the scope and installed capacity of companies with the knowledge that the academy offers. This is also supported by close collaboration with institutions and the impetus of talent seeking more opportunities to contribute to health solutions and improve the quality of life of the population. It should be noted that the national pharmaceutical sector, in addition to creating thousands of jobs annually, continuously implements programs to ensure talent is better prepared in their respective areas. Q: What can Mexico do to start developing more

Jaime López de Silanes

technology and science on healthcare? A: Globally, the incentives that governments create and offer to pharmaceutical companies are the key to growing technological

Executive Director of CFM

platforms, R&D and speeding up the process for new medicine development. This is a virtuous cycle that requires the modernization of regulatory processes in institutions to benefit more patients. In this sense, Mexico and its regulatory bodies must be in tune with their global peers.

Can COVID-19 Translate to Opportunities for Mexican Healthcare?

Q: What measures has CFM taken to address the COVID-19 crisis? A: Several CFM companies are conducting clinical trials of new products to combat COVID-19, which we hope are successful. On May 17, 88 intensive care Shangrila 510s ventilators arrived to Mexico from Shanghai, which were jointly acquired by the Mexican pharmaceutical laboratories Silanes, Carnot, Liomont, Sanfer and Chinoin, in alliance with the Carlos Slim and Grupo México foundations. These were donated to the benefit of 11 hospitals and health and charitable institutions that combat the COVID-19 pandemic. This group of companies and foundations was coordinated by CFM, with the support of the INCIDE (Innovation and Science for Business Development) Foundation and following an agreement reached with the IMSS Foundation. Q: How could API production help Mexico position in the pharmaceutical production market? A: The country needs strategic mechanisms between the government and the pharmaceutical industry to promote national API production and reduce the dependence on China

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or India, which together cover around 80 percent of the global API market. Even the US is actively promoting this route, which makes this an ideal time for Mexico, the US and Canada to promote medium and long-term commitments between companies and governments to create certainty for investments.

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from the

Q: What is the reach of your distribution services for independent pharmacies? A: We have distribution centers, called Medicine Depot, that work like a wholesale shop. Independent pharmacies can supply customers after proper registration and following our authentication process. These shops allow us to cover the entire country. Q: What other market niches has Grupo Bruluart identified in 2020? A: Hypertension is a growing trend in Mexico. We only have a few products directed to that ailment but we are starting to address it. Sexual health is another growing trend. Contraceptive use has increased a great deal as a result of the change in societal mindset. Grupo Bruluart has been working on campaigns to prevent unwanted pregnancies and we are working on a stronger communication strategy to announce our products. Instead of being a medicine provider, we are a health provider. Our efforts our focused on seeing medicine as preventive rather than corrective. Through digital platforms and physical magazines, we distribute information and advise patients on living healthy lifestyles.

Juan José Aguirre

Q: How has the use of technology in logistics helped the company to face the COVID-19 crisis?

Commercial Director of Grupo Bruluart

A: Our mindset shifted to a digital vision, which has led us to integrate more technological tools to help make our logistics more agile. We created a business intelligence department a year ago. Through it, we had been able to use data in our favor. The initiative is still pretty new so there is little historical record

Strong Portfolio Helps Deal With Disruption

to base on, but we are already working on creating a robust database to, in the future, be able to make better predictions and build intelligent business strategies to be more purposeful. Q: What has been the reception of Bruluart’s multivitamins given the fact that Mexicans are not very health-focused? A: Our advantage is that Grupo Bruluart’s products are almost a reference in Mexico. Products are known by name, not as a “supplement” or a “multivitamin.” Such is the case of Tribedoce. This has become a referent for different ailments or discomforts and this is the result of our work in the market. We have one of the strongest facilities for injectable product manufacturing in the country and this has secured product supply at all times and helped with promotion. For Tribedoce we did not have to create a massive promotional campaign since the product is wellknown and always available. We have started to receive requests from the US to test Tribedoce. Q: What are the company’s strategies in terms of growth? A: Because of the uncertainty regarding the public sector, we

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have been focusing on the private sector, betting on a new growth strategy for our pharmacy chain because it has been growing organically. Investing more in it will strengthen its development. We are also interested in supporting independent pharmacies through or distribution services.

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from the

Q: How has Quimpharma’s business evolved throughout the years? A: We have three business lines in the medications area: oral liquids, non-oral liquids and pills. We have also ventured into traditional capsules. In the supplements and cosmetics area, we offer capsules, pills, creams and solutions. We are gradually shifting toward solids in the area of medications. Our production capacity will be further expanded with our intention to build a new plant next year. The idea is to open this facility in Mexico City. We are focusing most of our investment there, with the rest allocated to developing the best active ingredients for our products. Q: What is your perspective on the government’s agenda? A: The government is attempting to change the rules in different ways. I understand there is a need to guarantee medicinal supplies and I believe the Mexican industry is capable of supplying high-quality medications at the required volume and at competitive prices. The more complex part is distribution. The government is now going directly to laboratories to purchase medications. There is a risk involved in this, as laboratories need to learn how to conduct sales procedures. Eliminating the middleman introduces other challenges too. We have high standards for medication transport and distributors

Rodrigo Hernández

ensure these standards are always met. We are also used to including distribution in our price calculation. Nonetheless, we will adapt to the condition established by the market. Generally, changes in government purchases do not affect

Director General of Quimpharma

us that much because 85 percent of our clients are from the private sector. Currently, you see more laboratories trying to expand their portfolio in the private sector to safeguard their business. We have the benefit of knowing how to operate in this sector already.

Despite Regulatory Changes, Communication Channels Must Remain Open

Q: What is the state of generics manufacturing in Mexico? A: Many laboratories are working hard to meet COFEPRIS’ new demands. A lot of pressure is being applied to eliminate any form of corruption. We are all for that. However, at times it has led to delays, from authorities, which paralyzes the industry. There should be strong cooperation between the sanitary and health authorities and the laboratories to ensure that innovation and new developments can continue. This is foremost dependent on transparent communication channels. The desire to rectify things is understandable, but those channels between the manufacturers and COFEPRIS have to exist. Q: How has the epidemic affected your supply and distribution lines? A: This is a major problem. Derived from border closures in several countries, the supply chain has been disrupted. At the same time, the public sector has been unable to handle the pressure of the pandemic which has resulted in increased waiting times regarding regulatory procedures. Communication

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is key to face this situation. Public medicine purchases have also been greatly delayed and given the difficulty of importing raw materials, along with challenges regarding distribution, it becomes vital to accelerate regulations to not jeopardize the timely supply of medicines.

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Q: Grupo Neolpharma recently inaugurated its distribution center and production plant for plastic vials in Vallejo. How does this reflect the company’s commitment to the sector? A: Grupo Neolpharma’s high production rates, coupled with the new centralized purchasing schemes from INSABI that gathers supply from different states and institutions, meant we needed to have more efficient orders and deliveries. Last year, we began the construction of a production plant for plastic vials from 1mL to 50mL. We realized the offering for this product was lacking despite its low production and packaging costs, not to mention the advantage derived from eliminating the dependency on glass. To date, glass vials are a barrier as the melting processes can endanger the condition of injectable solutions. Grupo Neolpharma now has a plant for injectable oncological products, one for specialty analgesics and one large-volume plant for injectables focused on distribution to the US, plus our distribution center. We know that the US has a fragmented offer. However, we are familiar with its market from the experience we have with our plant in Puerto Rico. Our injectables plant in División del Norte has the capacity to produce around 50 million vials per quarter, 16.6 million vials

Efrén Ocampo

each month. This enables us to serve large orders when needed and be a strong competitor for vaccine production. Moreover, our level of distribution has increased with the distribution center, which allows us to take advantage of quick delivery

President of Grupo Neolpharma

opportunities. Q: What is the status of Grupo Neolpharma’s initiative to introduce pain medications for conditions like terminal cancer?

Investment Responds to Patient, Market and Industry Needs

A: These products will be manufactured at our specialties’ plant, where we produce analgesics for intense pain. Our plant for oncological injectables also responds to these needs and it will start operating by the end of 2020. Mexico has a large demand for oncological products and we are proud to contribute to reducing the negative impact of this disease. Q: Why is Grupo Neoplharma the right partner for UNAM and its COVID-19 development? A: We have worked with UNAM research centers for years now. We have two patents that began at UNAM’s facilities. This institution, along with CINVESTAV, has been working on vaccine development for a while. From our side, as part of the objectives for our production plants, we wanted to introduce biotechnology and APIs from bacteria and cells. Putting this together, we created a link with these institutions to help them accelerate their development processes to manufacture vaccines. We are also working on the development of the correspondent APIs for production. Q: What are Grupo Neolpharma’s near-term plans?

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A: We want to grow internationally and to increase our API production for Mexico by collaborating with institutes that are developing petrochemicals, which are an important base for API production.

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Q: How has Allen Laboratorios positioned itself as a key player in the Mexican healthcare market? A: To provide the best quality generics, we follow the strict regulations Mexico applies to the pharmaceutical industry. Moreover, from 2018 to today, we have invested more than MX$200 million (US$9.9 million) to strengthen our production plant, which has allowed us to diversify our market from the public to the private sector. For the latter, we have looked for commercial partners among retailers, self-service stores and pharmacy chains to strengthen our presence and grow. In addition to expanding our market options, with this investment we went from manufacturing 3 million units per month to now having the capacity to produce 8 million units per month. Q: In which areas are Allen Laboratorios’ strongest market niches? A: Retail and self-service stores have become our strongest market niches through our proprietary brands. Pharmacy chains also represent a large share of our sales as we work with the largest companies in the country. Moreover, we are present at Farmacias Similares, which is a big reference in volume consumption. These three channels complement our supply to the government.

Benjamín Vega

Q: How is Allen Laboratorios able to provide quality, accessible generics that respond to specialty treatments? A: When growing our production plant, we took some risks

Commercial Director of Allen Laboratorios

regarding long-term negotiations for raw material supply to guarantee competitive prices and affordable costs. Moreover, we targeted the products that were having the most impact and best performance in the market regarding volume sales and focused solely on those.

Strong Product Mix Allows for Competitive Quality, Price

Q: What new market niches have you identified in the past year? A: We want to focus on regional or local chains to target consumers directly, instead of through larger distributors. Allen Laboratorios is also looking forward to dabbling into the Central American market. We offer basic products that would perform just as well there as they do in Mexico and we are already finding ways to enter that market. Moreover, regulations from Mexico are a reference for the region, meaning that we would not struggle on that subject at all. The products we are looking to strengthen are our analgesics, supplements and cough suppressants. One of our best-selling products is Gerial B, which is constantly undergoing a brand renewal process and continues to have the same success. Q: What has been the impact of changes in the public sector on the Mexican industry? A: Government changes have brought uncertainty to the environment to the point of impacting the nation’s healthcare

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due to shortages. However, the intention is good and we are more than ready to keep doing things correctly. Allen Laboratorios decided to strengthen its internal processes to understand our capacity and profitability to supply the government in a timely manner and in full.

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Q: How is the company transforming the healthcare reality of the population regarding diabetes? A: Laboratorios Silanes is celebrating its 77th anniversary this year. Throughout our history, we have focused on innovation that is aligned with the healthcare needs of Mexico and with our capacity as a company. Diabetes and metabolic diseases are the most relevant and represent around 40 percent of our revenues. To date, the most remarkable achievement of our participation in the market is our patented pharmaceutical development of glimepiride and metformin, which we licensed to companies like Sanofi. This product has not been matched in its effectiveness, making it our flagship solution. We are developing a similar combination and a new molecule is already in the registration process. Unlike other companies, Laboratorios Silanes is focused on constant innovation. We are global leaders in metabolic disease treatments and preventive treatments for diabetic complications. We measure success not by profit but by the true impact products have on changing people’s lives. We often look for commercial partners like Sanofi that have a global presence and can help us reach more patients. Q: What other examples can you offer regarding Laboratorios Silanes’ innovative contributions to healthcare?

Rafael Quintanilla

A: We have a business unit dedicated to antivenoms. Labratorios Silanes is a global leader in the subject and the only Mexican company with two FDA-registered products. One of them is an anti-scorpion bite serum and the other is an anti-rattlesnake bite

Pharma and Biologics Director of Laboratorios Silanes

serum. Both products are being commercialized in the US, which is a unique step for our company. Last year, we also developed an antivenom for violin spider bite and it already has gone through basic approval processes.

Innovation is Only Worth It When Giving Back to the Patient

We are working with WHO to tackle snake bites, which cause the death of 120,000 people and 400,000 amputations around the world every year. WHO started a project 18 months ago to reduce the number of fatalities to at least half. The organization started looking for allies to supply 3 million doses of the serum. Laboratorios Silanes is among the three companies participating in this project, which we are very proud of because it is an example of our efforts on innovation and our true commitment to contribute to healthcare. We dedicate 10 percent of our earnings to R&D because innovation has been key to the sustainability of the company. Laboratorios Silanes has 147 registered patents and 18 months ago, we decided to invest MX$100 million (US$4.398 million) in our research center in Toluca. This allows us to have a pipeline of 18 products for the coming year. They are all at different stages but they are the engine for our growth and expansion. Q: What are Laboratorios Silanes’ priorities and growth expectations for 2020? A: We are launching a product to lower cholesterol. This product

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is the most effective on the market, which is why, despite the contingency, we decided to release it. The benefits are significant. Additionally, we are still expecting double-digit growth because we have been working at the same pace, with the same effort and also launching this new product.

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Q: How is Apotex innovating to attend the growing prevalence of chronic diseases in Mexico? A: At Apotex, we have a portfolio with a wide variety of products for several chronic diseases, including diabetes, arterial hypertension, high cholesterol and triglycerides and metabolic syndrome. We are committed to raising patients’ quality of life by offering affordable products that meet the highest quality standards. This is precisely why we are constantly striving for innovation, not only in our product portfolio but also in our communication channels. Entering the digital world to reach more patients means providing better solutions for their health problems, as well as creating a support network that ensures proper treatment completion. Q: How would you describe the reception to Apotex’s cardio-analgesic portfolio? A: Given that Apotex meets internationally recognized quality standards, specialists are highly welcoming of our cardio-analgesic portfolio. Apopharma (Apotex’s prescription division), is now highly recognized by traumatologists, internal medicine specialists and general physicians, who are the main prescribers of these kinds of treatments. Along with our central nervous system portfolio, cardio-analgesics will be an important business segment for Apotex in the foreseeable future given the epidemiological trends

Américo García

affecting the Mexican population. Q: What other therapeutic areas is Apotex targeting and why were they chosen?

Director General of Mexico and Latin America at Apotex

A: Other therapeutic areas that are being analyzed are gastroenterology, metabolic syndrome and oncology. There continues to be a high incidence of metabolic diseases such as diabetes, hypertension and hypercholesterolemia in Latin

Proper Treatment Completion Through Digitalized Practices

America, which is why we will be introducing several high-quality therapeutic options at affordable prices in the region. Cancer is also prevalent in Latin America, which has led to a rise in the demand for oncological drugs. In the next five years, our goal is to introduce a variety of oncological generics. Q: What new market niches have you identified? A: Over the past three years, we have explored branded market segments such as OTC and prescription medication. The Apopharma division is an excellent example of our effort to introduce prescription alternatives that can efficiently support specialists and physicians in general. Regarding the OTC segment, Espadiva is consolidating as the leading treatment option for menstrual cramps. Q: What is the status for production of biosimilars in Mexico? What challenges has the company faced to introduce this division to the country? A: Undoubtedly, biosimilars are a business opportunity and one of our major priorities. Apotex has created Apobiologix, a specific

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division to enhance our worldwide presence in this market. As a result, we have launched two biosimilars in Canada: Filgrastrim and Pegfilgrastim, indicated for patients with cancer receiving myelosuppressive chemotherapy. Similarly, we are looking forward to launching important biosimilar products in Latin America.

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Q: What are Zydus’ most recent introductions to the Mexican market? A: We conducted phase 3 of clinical trials in Mexico for Lipaglyn (saroglitazar Magnesium) to treat Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH). NASH is a progressive disease of the liver caused by metabolic disorders and a significant unmet medical needs. During clinical trials, we recognized the potential this product had as the only drug developed to treat such an ailment. We completed phase 3 of clinical trials and Mexico took part in the process. Zydus has already got DCGI approval for this one-of-a-kind drug in India and we are also looking to gain its approval in the US and Mexico. Once we get the NASH approval in Mexico, we will introduce it to the country as soon as we can. Q: How is Zydus capitalizing on the biosimilar market opportunity in Mexico? A: We are in the process of registering biosimilar products in Mexico. However, in the last couple of years, COFERIS has a long gestation period for its approvals and this has delayed our process of introducing such a portfolio to the country. Q: How has Zydus advanced on its plans to introduce vaccines to Mexico?

MS Nagendra

A: Vaccine introduction is one of our most import global goals. The global vaccine market is around US$60 billion and Zydus has positioned itself as an emerging global player in

Director General of Zydus Pharmaceuticals

this market. We have a unique distinction already: we are the first Indian company to launch a tetravalent vaccine in India. We are the second company to launch a TD vaccine. Now, we are among the few companies in the world working on a COVID-19 vaccine development. Zydus’ development is called

Market Strategies to Capitalize on Pharmaceutical Opportunities

“ZyCoV-D” and it has already entered Phase 2 clinical trials. If Phase 3 is completed by 2021, we have the ability to launch it fairly quickly. Mexico is an important participant in Zydus’ research and we have established a very positive relationship with the country. We are running two trials for COVID-19 in the country, both representing a substantial investment in terms of R&D. Q: You have recently allied with the government of Hidalgo to be part of a pharmaceutical cluster. Why was this project of interest to Zydus? A: We try to be meaningful players in the countries where we are present, which is why we are interested in collaborating through positive actions that boost the industry. Zydus tries to leverage its strengths in areas of market needs. For instance, Mexico has gaps to develop complex technological solutions for things such as injectable devices, so Zydus plan to fill in those gaps and improves access to those solutions. In CNS, Zydus has successfully introduced many products that could be very beneficial to the Mexican population. For complex generics, Mexico’s regulatory framework involves long

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approval times regardless of the good history of the product in the recognized reference countries. Regulatory barriers can sometimes hold us back from introducing products to Mexico and this is discouraging, considering the investment and technology solutions we can bring to the country.

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Q: What is Alfasigma’s focus for the Mexican market? A: We have set a budget to strengthen our R&D capabilities at our facilities near Rome. Having said that, Mexico can be involved in many of those projects. We shifted our focus toward specialty products and rare diseases because it is a highly profitable segment and there still many unmet medical needs. Thus, these segments could provide interesting ROIs and play an important role in needed new medical weapons to treat these diseases. In addition, this approach allows Alfasigma to focus more on specialists, such as cardiologists or gastroenterologists. Mexico plays a relevant role as we represent one of the most important subsidiaries within our organization. Whenever a new product or license is released, Mexico is among our priority countries. There are many opportunities in the country, particularly in the health sector where there is fertile soil for new products. Q: How has Alfasigma’s approach to the public sector changed since 2019? A: We are not actively involved with the government as a supplier. However, we have been paying close attention to certain public institutions specialized in specific treatments,

Vincenzo D’Elia

given the role they play in the education of specialists. Having said that, after almost two years in office, I cannot say innovation is a priority for the federal government. I believe its approach is more focused on providing medicines for all rather

General Manager of Laboratorios Alfasigma

than have the latest innovation to the general population. The federal government has not shown any signs of giving R&D the importance it deserves. Q: What has Alfasigma done to cope with

A New World Ushers in New Trends

the effects of the pandemic? A: At Alfasigma, our No. 1 priority is our collaborators’ health. From the beginning of March, we started to implement all necessary measures to protect them. As a socially responsible company, we have supported many nonprofit initiatives to acquire the necessary equipment to protect patients. We have also focused on medical personnel’s mental health because they are being subjected to a high level of stress. Q: What role are digitalization and data-related solutions playing in Alfasigma’s strategies? A: The world will never be the same. The pandemic is accelerating existing trends, particularly the use of digital platforms, home office, state-of-the-art technologies and customer interaction. A key area where we will see greater developments is in automation. We are just getting started. As part of our local initiative, we are aware that the world is moving in a greater technological direction. At Alfasigma, we are using data tools to conduct internal

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audits and spot trends. We have yet to see the results of this initiative, but I can tell you that management is the art of anticipating. If we can understand how the future might look, we can develop the right approach. I am confident of the steps we are taking.

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Q: How has the demand for your products behaved during 2019-2020? A: We have a global best-case in Mexico with one of our respiratory products, which is a combination of our topselling antihistamine and our top-selling antileukotriene. This combination is unique in Mexico and has enjoyed a solid performance in the country because it tackles both root causes of allergic rhinitis. This is a prescription-only product, so the role of doctors is key here. However, the results are evident and doctors are confident in prescribing it. As a respiratory product powerhouse, we are constantly innovating to keep building the company. Glenmark is focused on creating new formulas that can be a watershed for patient treatment, such as that previously mentioned. We are expecting to introduce a differentiated product for allergic rhinitis that is already awaiting COFEPRIS approval. We are investing in digital tools that will allow us to have direct contact with doctors and be able to communicate and launch this product in the market. Q: How does Glenmark take advantage of the highly competitive and fast-growing market for generics in Mexico? A: Our strategy is to create a differentiator for each product

Esteban Abad

we launch. Many companies can participate in the market but not all of them have a strong scientific team to dabble in new formulas or combinations. Mexico could become an important player like India. However, the US, the biggest market for

Vice President and Head of Upper Latin America at Glenmark

the country, is not interested in reformulated combinations because the FDA does not take a positive view of these. Their market is strictly ruled by new molecules, which could be a reason why Mexico has not fully developed in the area.

Innovation Key to Remaining Competitive in the Generics Industry

Q: What is Mexico’s potential as an API manufacturer? A: It has been said that Mexico could become an API producer but it is not that simple. While we might have manufacturing capabilities, there needs to be a specific demand to fully develop them as the infrastructure required for a single API is not cheap. It ends up being easier to import from already expert countries. For Mexico to become an API producer, demand would need to be global, such as India’s. Only then would it be a profitable business. Q: What has been the impact of the pandemic on your product demand in Latin America and Mexico? A: In Mexico, we have been facing a drop in sales. Around March, most therapeutic products, especially for respiratory conditions, grew in demand and companies started to build inventory to prepare for when COVID-19 arrived to Mexico. Our stronger business lines are respiratory and dermatology. Especially in the latter segment, these are not critical illnesses that people tend to prioritize. However, I think we have

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already seen the worst of it and we expect sales in Mexico to recover soon, but not quickly enough to put us back at pre-COVID-19 levels. The branded generic industry is better placed in terms of recovery because of the more accessible prices it manages.

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Q: What has been the most significant benefit for patients from pharmacy-adjacent medical offices (PAMOs)? A: We have 4,500 PAMOs across the country, which deliver more than 130,000 consultations per day. The biggest benefit is the convenience the population derives from them. PAMOs provide quality and affordable healthcare access through welltrained, qualified doctors. ANADIM’s PAMOs cover significant patient needs, especially now, given the workload that hospitals are facing due to the COVID-19 pandemic. We work closely with the General Health Council and one of our main objectives is to continuously improve the quality of PAMOs. We are doing this through certification of quality processes. We are also interested in working alongside the Ministry of Health to collaborate on the provision of healthcare. PAMOs are an important contributor to the sector due to their capacity and how they support the industry’s workload. We would like to work alongside the government as a medicine distribution center and to have our facilities provide greater coverage and expand capacity. PAMOs are also an option as vaccinating points due to the large number of facilities available. We are approaching the government in this regard to create a positive health environment that generates added value for the industry.

Lourdes López

Q: Why was it important for ANADIM to establish an ethics code for PAMOs?

Executive Director of ANADIM

A: The ethics code is a way to homologate how PAMO doctors behave with different entities, including patients, the pharmacy employer and pharmaceutical laboratories. This code serves as a guideline that allows service to be transparent and clear. It was drafted alongside ANTAD and the General Health Council to

PharmacyAdjacent Medical Offices Can Expand Health Coverage

demonstrate our joint objective to improve service quality. Q: What are the main benefits doctors receive from working in PAMOs? A: Among the main benefits is that they have a space for business and a guaranteed salary. PAMO doctors are employees of the pharmacy, meaning that regardless of the workload, they receive a salary. Q: How can PAMOs help expand health coverage in Mexico? A: PAMOs are oriented to primary care; however, we understand the need for Mexico to expand medical care for chronic diseases. In this sense, we are looking forward to fomenting preventive healthcare to avoid developing ailments that represent a burden on the public health system. Q: What are your experiences as a female leader in the healthcare industry? A: I think this sector is very open to equal gender participation.

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I have never felt gender inequality regarding opportunity and development and my voice in the sector has always been heard. I have been able to work with many women who are also in leadership positions, so I see this sector as a place where women have the opportunity to grow.

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Q: Why should people consider Farmacia París as their first and best option? A: Farmacia París is known as the pharmacy of the people. We are not a pharmacy that offers non-trademarked medicines at a discount. We sell brand-name, quality products, at the best price. We offer the widest range of products sourced directly from top laboratories and manufacturers. We work hard to offer unique services, like compounded formulas or shipping across the country. Ultimately, we care about the wellbeing of our customers. That is why we honor with fidelity the prescriptions written by physicians. We strive to be an ethical business enterprise. Today we are the only pharmacy in the country that offers Ayurvedic medicine. Q: What are Farmacia París’ strongest areas and what other areas does the company want to strengthen in the near future? A: Our biggest strength is the relationship we have with our partners and customers, such as laboratories, suppliers and manufacturers. Some relationships go back many decades and in some cases many generations. Our second most important differentiator is our beauty and personal care

Ignacio Merino

offering, because we believe in helping our customers cater to their own well-being. Thirdly, I can highlight our range of surgical and hospital products to support both public and private medicine practices. Our diabetes division will also

Director General of Farmacia París

remain as one of our most important divisions for the next 20 years, as Mexico’s diabetes crisis continues to balloon. Q: What is Farmacia París’ growth strategy?

Evolution Needed to Strengthen Pharmacy Business Practices

A: The sector is evolving from being a traditional retailer to a business focused on customer experience. Farmacia París is transforming according to that trend. We are working on alliances with Laboratorio Medico Polanco, to offer on-premises clinical tests and lab-work. We are partnering with Óptica Devlyn to offer audiology and ophthalmology services. In the near future, we are also looking to incorporate general medicine offices through a partnership with a select group of doctors. We are excited to announce that in the second half of 2020, we will launch Farmacia Paris’ e-commerce website offering 5,200 products from our catalog. We aim to reach every corner of Mexico City serving about 10 million people. Moreover, through Farmacia Paris’ e-commerce platform, we will be able to reach customers in the whole country. Q: How would you describe the general state of the pharmaceutical sector in Mexico? A: The pharmaceutical sector is changing its business model and so are the laboratories. In time, pharmacies as we know them will disappear and will be replaced by points of sale of

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mostly OTC products. Specialized products will be managed differently, which is why I do not think that opening more brick-and-mortar branches is the best option. Also, from a regulatory perspective, COFEPRIS will require an even more regulated point-of-sale.

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Q: How do you balance price with quality to remain one of the most competitive pharmacies in Mexico? A: Farmacias del Ahorro (FAhorro) is committed to offering fair prices for services and products. Our services go beyond selling medicines. One of our top achievements has been our leadership in supplying complete prescriptions due to our large and homogenous offer. We have the most complete portfolio in the medicine retail market. Moreover, we offer free medical consultations and an electronic wallet where clients can accumulate money. FAhorro’s home delivery service is also free of charge and our broad coverage makes our health service widely available. This integral offering has made us a leader among pharmacies and a success story in Mexico. We have an effective reorder system that customizes our supply for each pharmacy according to its needs and trends. Our clients build our catalog, which means we are responding to patients’ needs based on demand. We are looking forward to expanding our presence where there is opportunity to grow and position FAhorro as the best-known and relevant pharmacy chain in Mexico. Q: How does FAhorro contribute to increasing prevention and decreasing the disease burden in Mexico?

Gabriel Zavala

A: Our pharmacies are based on four main pillars. The first is correction, which focuses on medicines. The second pillar is drive, which includes our hygiene, beauty, dental care and drinks. The third is the emotive pillar, which includes

Commercial Executive Director of Farmacias del Ahorro

dermatological care. The last pillar is prevention, which promotes preventive healthcare. Three years ago, we launched a project to introduce healthier products, such as snacks, organic vitamins, dietary products and

Client-Centric Portfolio Strengthens Leadership Position

supplements, as well as other products that go beyond being sugar-free and that are organic and healthy options for the client. Q: How are FAhorro’s pharmacies transforming to meet technological and digital demands? A: We started with home deliveries and our digital platform before COVID-19. We have a department working on this service, instead of depending on another company for it. Thanks to this experience, we have been able to improve our service offering. We can ensure deliveries within 30-60 minutes and we are working to improve those times. FAhorro has also launched its own app because we understand that the digital transformation accelerated with COVID-19 and is here to stay. Q: What is the most significant challenge that FAhorro faced during the COVID-19 pandemic and how did you overcome it? A: We faced increasing demand for a group of products. Manufacturers of such products would significantly increase the prices on those supplies and due to the high demand and

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prices we created strategies to keep our offering affordable. Over time, we established strategies be independent of third parties and continue supplying to our clients. We continue to reduce the price for this product, despite increases in the cost of raw materials.

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Q: What are the benefits and disadvantages of having a doctor’s office adjacent to a pharmacy against traditional offices? A: Pharmacy offices offer three advantages to users. The most obvious is convenience, since they offer proximity, long hours and short waiting times. The second advantage is the low cost. The fee of a single visit is low and prescriptions usually refer to active ingredients instead of brands, which benefits the user economically. The third advantage is their level of service. Independent and serious surveys give pharmacyadjacent offices the highest level of customer satisfaction, at the same level as traditional private offices. The main pending that is necessary to work on with pharmacy offices is to improve their reputation as they offer hundreds of thousands of daily consultations and they are normally the first point of contact with the patient thanks to their wide coverage. Pharmacy offices can also do more in terms of prevention and timely detection of chronic diseases. The easiest thing is to train doctors and establish protocols. However, the challenge is for the user to see these places as an option for prevention and care.

Santiago González

Q: What is your opinion regarding doctors’ wages in these establishments? A: As president of ANADIM, I collaborated in developing and

Operations Director Mexico of Farmacias YZA

promoting a code of ethics that was endorsed by the General Health Council, CCE and ANTAD. The document specifies that doctors’ wages must be calculated according to their time and effort, never to the prescription, which I believe is met in most cases.

Pharmacies Grow Their Role as Health Providers

Q: What have you observed following the COVID-19 emergency regarding growth in telemedicine alternatives and access? A: Telemedicine has grown significantly. Many doctors at the beginning of the health emergency canceled their medical consultations and only worked remotely. There is evidence of the great boost resulting from telemedicine, regardless of the age or profile of the doctor using this technology. Unfortunately, consultations are offered with tools not designed for this work, with the most popular channel being WhatsApp. Today, there are many tools that save the clinical history or that help the doctor with the diagnosis. Regulatory changes are required to foster their use and to create awareness. Telemedicine is undoubtedly appreciated by a patient who cannot visit a doctor. Q: What impact has the COVID-19 pandemic had on drive-through care and home service options?

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A: During the worst months of the pandemic, these services doubled in demand. However, as people returned to their regular activities, growth has been limited. Many operational changes were required to support the increase in demand for these solutions.

Medical Devices The medical devices industry is one of the most important contributors to the national economy. Not only does it provide specialized jobs but it also strengthens Mexico’s strategic position in the North American region and globally. The sustained growth of this industry has pushed the country to integrate new technologies and to look toward further integration and a more complex specialization in device manufacturing. Globally, Mexico ranks eighth as a medical devices exporter, with strong local hubs with potential to grow. The country’s strict, yet favorable, regulations make it an attractive destiny for mass production and according to AMID, Mexico’s ambitions include sourcing significant raw materials to strengthen our production capabilities, including the production of disposables, metal devices and plastic components. The country’s main commercial partner in this sector is the US, which has a new government administration that has promised to “bring back” manufacturing jobs to the US. However, associations like AMID are confident that USMCA will protect and strengthen Mexico’s position in the medical devices field. This chapter analyses the challenges of meeting high and urgent demand for devices during the COVID-19 pandemic, the integration of homecare trends and future industry plans to boost local consumption of state-of-the-art devices that could potentially be a watershed for preventive healthcare in Mexico.

Medical Devices

Analysis Reducing Foreign Expenditure on Medical Devices

View From the Top Ana Riquelme | Executive Director of AMID

View From the Top Héctor Barillas | Director General of bioMérieux

View From the Top Pablo Bufano | Managing Director of Dräger México

View From the Top Carlos Jiménez | Director General of B. Braun Mexico

View From the Top Jordi Fernández | General Manager Mexico of Roche Diagnostics

View From the Top Paul Barber | Managing Director of Getinge Mexico

View From the Top Carlos Hernández | Director General of Beckman Coulter

View From the Top Enrique Giraud | Managing Director of Fujifilm Mexico Javier Giraud | Medical Systems Vice President of Fujifilm Mexico

View From the Top Carlos Franyutii | Sales and Marketing Manager of Healthcare Solutions at Canon Mexicana

View From the Top Raúl Jacobo | Health Manager of CHG Meridian Mexico

View From the Top Alejandro Von Mohr | Director General of Atramat

100 View From the Top Carlos Pardo | Marketing and Sales Vice President of Levbeth Group

101 Analysis A Mexican Ventilator to Stand Against COVID-19

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Reducing Foreign Expenditure on Medical Devices Despite Mexico’s role in the production of medical devices, the country imports around 90 percent of such devices. “Mexico spends US$25 per capita on medical devices whereas countries like the US spend around $500,” explains Ramses Galaz, CEO of GSE Biomedical, in an interview with MBN. The medical devices market represents around US$5 billion in Mexico, which means the country imports close to US$4.5 billion. According to Galaz, Mexico’s potential on technology development and quality in manufacturing could save the country around 70 percent of that US$4.5 billion expenditure if investment begins soon. GSE Biomedical was part of the successfully developed Mexican ventilator to combat COVID-19, VSZ-20-2. Galaz explained that the pandemic exposed Mexico’s great dependency on foreign technology. Yet, despite the barriers, there are around eight ventilator developments. “However, from my experience, I know that taking a Class 2 development to our regulatory authorities takes a great deal of effort, indepth knowledge and investment,” he said. MBN also spoke with Josué Garza, Director of Business Development and Operations at Insumos para la Salud, about the barriers to making medical devices development a reality in Mexico. “We are still missing resources and support for educational and talent activities, which is a big barrier for the country to accelerate and boost its abilities.” Discussing the opportunity in the sector with MBN, María Luisa Gutiérrez, CEO of Medisi, explained that Mexican companies developing their own technology are normally participating with Class 1 devices, not 2 or 3, which are the most sophisticated. “The regulatory process has a lot to do with this because we really do not have the guidelines to develop a Class 3 medical device.” These regulatory gaps can represent a setback on investment and prevent the industry from generating a true economic spillover. How could the country exploit this opportunity? “Mexico would have to begin with Class 1 devices, which require an investment of around US$200,000 to US$2 million. Class 2 developments require an US$8 million investment and Class 3 needs US$10 million or more,” said Galaz. While the return on investment for Class 3 development takes years to materialize, this is the only way to ensure a sustainable healthcare sector in the long term. “Mexico has all the facilities and infrastructure needed to perform clinical trials and to grant approvals for medical devices,” explained Fernanda Villareal, Country Manager of Kiyeon Law, in an interview with MBN. Villareal highlighted Mexico’s leading profile for clinical trials due to the diversity of its population and COFEPRIS’ Rank 4 as a regulatory Read the complete article More about this topic

agency, which is the highest. “This enables the country to homologate certifications to grant equivalence for imported products.”

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Q: What is your reaction to US President-elect Joe Biden’s promise to “return” jobs in the medical devices sector and reduce US dependence on foreign countries in this area? A: Joe Biden’s promise is understandable but the agreements we have with the US are backed up by USMCA. Mexico exports 80 percent of the medical devices it manufactures to the US. Many commercial rules allow companies to manufacture in Mexico under the same terms that are applied in the US, which facilitates trade, considering rules of origin and other matters. We have experts on quality, regulation and conformity certificates and we are confident of remaining a competitive hub for medical devices for export to the US. Mexico also is looking forward to obtaining significant raw materials to build components required by medical devices to strengthen our production capabilities, including the production of disposables, metal devices and plastic components. Q: How far along is AMID’s proposal to introduce better regulatory standards for medical devices? A: AMID is part of the Inter-American Coalition for Regulatory Convergence for the Medical Technology Sector and we have been pushing regulation in Mexico and the Americas. One challenge we have faced is the presidential and Ministry of Health mandates regarding equivalence agreements. This has changed supply paradigm, with UNOPS now joining the party. But we are confident

Ana Riquelme

of a positive outcome once doubts have been cleared away. This measure goes against promoting local manufacturing and, therefore, is not beneficial to the sector and its future.

Executive Director of AMID

Q: What is required for Mexico to achieve more final production of medical devices in the country? A: We will begin to manufacture final products in the country when the Mexican government recognizes how important this sector

USMCA, Other Advantages Propel Medical Devices Sector: AMID

is as a generator of health and starts to support the industry, alongside prioritizing local consumption over foreign consumption. It also implies a commitment to device and technology adoption within the public sector. Furthermore, Mexico would have to create protocols that standardize the use of medical devices, which would ensure the availability of and access to homogeneous equipment and technology regardless of location. Q: How did the sector respond to the needs of the COVID-19 pandemic? A: The manufacturing of all devices used during COVID-19, from personal protection supplies to ventilators, multiplied by 10. This has been the largest growth we have experienced; however, we remain committed to non-COVID-19 patients who are experiencing other ailments. To this end, AMID and the pharmaceutical industry generated a care protocol within hospitals to ensure doctors could continue practicing safely. Q: What has been your experience as a female leader in the healthcare industry ?

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A: The medical devices sector is highly innovative and dynamic and this has helped open the doors to women. Our leadership in the industry is still limited but I am happy to see that each day there are more women heading important companies and being properly recognized.

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Q: bioMérieux had an active response to the COVID-19 pandemic and developed a diagnostic test, how did the company develop the test in such a short timeline? A: Numerous teams, such as Regulatory Affairs, Quality, Product Labelling and Documentation, Industrialization and Production, Quality Control and Clinical Affairs, were mobilized to support the availability of the new test as quickly as possible. This project succeeded so quickly because everyone was aware of their responsibility and helped on top of their routine activities. It is an example of our spirit of collaboration and exceptional efficiency. In fact, we currently have not only one but five tests available. In less than two months, bioMérieux was able to develop and brought to market its first PCR diagnostic test for the new coronavirus. This challenge was met thanks to the expertise and exemplary mobilization of multidisciplinary teams that were set up to support the availability of the new test as quickly as possible. Q: What are the unique benefits of the diagnostic test? How does it compare to others in the market in terms of cost, accuracy, time to get results, scalability and ease of use? A: All of our tests comply many international accreditations

Héctor Barillas

thanks to their excellent performance. In particular, our PCR Multiplex solution has great advantages thanks to its capacity to simultaneously detect several pathogens than can cause respiratory infections including SARS-CoV-2, Influenza and other

Director General of bioMérieux

viruses and bacteria in only 45 minutes, which will be highly relevant during winter period. Our solution is highly accurate, cost-efficient, does not requires complex infrastructure or specialized personnel on molecular biology, and it is scalable with the capability of processing up to 264 tests per day.

Saving Lives With Faster, Better Diagnostics

Q: What is bioMérieux’s formula to provide high value diagnostics and pioneering diagnostic innovation? A: We offer complete solutions that focus on patients from the moment they enter the hospital to when they leave. In the field of microbiology, we are leaders not only in the area of bacteria, but also viruses and parasites. Our state-of-the-art diagnostic equipment allows a diagnosis to be done in under an hour, which means a patient can get help faster and more effectively. Our diagnosis solutions reduce the amount of human error that can lead to a misdiagnosis and decreases the application of inappropriate treatments. It also helps hospitals reduce the time allotted to patients. Q: With respect to antibiotic resistance, what else can be done to mitigate this issue in Mexico? A: We are already working with several institutions, including a number of associations that are focused on antibiotic resistance. Here in Mexico, there is a network for epidemiological vigilance, with its main base in Monterrey.

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They gather data from hospitals to map the development of resistance. This can be done with a software that allows data to processed immediately. Lastly, public awareness is also important. People need to know that they should not just take antibiotics without a proper study of their problem.

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Q: How has Dräger improved its market share in the private sector? A: Dräger has grown its sales in the private sector in medical equipment and consumables. We are reaching more private hospitals around the country and offer financing programs to access equipment and consumable consumption. Q: Dräger created a protocol to digitalize data and enable communication between devices. What is the status of this project? A: Dräger devices are now following this protocol, which fully guarantees process digitalization. Even our older equipment has the capacity to interconnect and achieve information digitalization. The protocol is already available worldwide but we expect Europe to be the first to adopt it as its hospital networks favor digitalization and technology. With this protocol, Dräger intends to gather as much information as possible to support doctors during their decision-making process. The protocol provides information on patients and their actual status, helping doctors, anesthesiologists and nurses. Mexico lacks the hospital infrastructure and equipment necessary to build a communication network for devices. The country does have public and private hospitals that have digitalized their

Pablo Bufano

practices and many others are working toward this goal, but COVID-19 has highlighted that Mexico’s hospital capacity still has concerning deficiencies.

Managing Director of Dräger México

Q: What new products or solutions is Dräger planning to introduce to the Mexican market? A: We are about to introduce a new anesthesia machine called Atlan. We hope to introduce a new ventilator technology that

An Integral Provider is the Best Ally During a Crisis

is already in other countries. It is going through the regulatory process in Mexico. Q: Amid the global pandemic, how has demand for your services and solutions grown? A: We are seeing a significant increase in global demand, especially for ventilators, and increased demand for ventilation accessories and light respiratory protection. Usually, hospitals are our customers but up to date, health authorities or government agencies are increasing asking for our products. Despite all efforts, the demand for ventilators and protective masks is well above the capabilities of the entire industry. In Mexico, we have incoming orders for ventilators but this year we will not deliver more than what was already arranged. However, we are selling more monitors, which is new and positive for hospitals expanding their ICU capacity. While the pandemic is a terrible situation, hospitals will end up being properly equipped. Q: How is Dräger contributing to helping Mexico overcome the pandemic?

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A: Dräger has been intensively working on the service part of its offering. We hold service contracts with IMSS and INSABI to check on their existing equipment, so we have been quick to react and provide the proper maintenance. We have prioritized ventilator equipment calls, which are coming at a very high speed.

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Q: How has the company’s commitment to the company grown? A: Depending on third parties is not our strategy as there are many factors that can impact our operations. Having our processes centralized – logistics, accounting and staff – allows us to maintain control but most importantly, to provide many benefits to our employees. Our new distribution center (CEDIS) will boost our growth in the next six to eight years, according to our projections, and we also have the option of expanding it because it is was built according to a modular infrastructure concept. The main goal of the CEDIS is to have more capacity to serve the large volume orders that we receive from the government. B. Braun participated in the last tender under the government’s new centralized purchasing scheme and winning that tender meant a lot of growth. On-time delivery is key for the government, so B. Braun has to tackle all challenges related to logistics, which is why CEDIS was key for our development. Additionally, we have exclusive transportation and drivers. As for CEDIS, it is an infrastructure that will serve us for our current operation and our growth for the next six to eight years, with the possibility of expanding the building under a modular concept, which allows us to directly serve businesses high-volume government sector. For example, in the most recent consolidated tender E5, B. Braun was the company that participated with the highest number of codes, being assigned in an important way, and

Carlos Jiménez

that we are already executing directly from our CEDIS. For the metropolitan area, we have our own transport and delivery service and, with the support of logistical third parties, we complete the distribution network in foreign areas.

Director General of B. Braun Mexico

CEDIS has been a project that has brought an important benefit with this option of participating in large volume projects directly and we still have many more products that we want to bring to Mexico to participate with even more presence and with more

Learning Tool Helps Companies Become Integral Providers

impact on the system of health in Mexico. Q: What makes B. Braun an integral provider for healthcare in Mexico? A: We are making all the necessary investments to bring and distribute more innovative products for the health system. For example, our investment in 2020 in Mexico exceeds MX$120 million (US$5,347.91) only in equipment, such as hemodialysis pumps, infusion pumps, equipment for orthopedic implants, intercranial precision monitoring for head injuries and products that can promote technological development in the hospitals. As a way to contribute to the Mexican health sector, B. Braun has presented one of our most successful models, which is the rental of equipment. This reduces the impact of capital requirements, in both the public and private sectors, and optimizes the operating costs of institutions. Apart from this, we are very interested in introducing more pharmaceutical products in Mexico. We have a strong line of medical devices, but we also have a pharmaceutical line focused on injectable solutions. Additionally, we work closely with associations

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such as CANIFARMA and AMID to ensure that our products can be delivered to Mexican patients and to ensure a good relationship with the government to resolve any complications in documentation or processes, especially during the COVID-19 when all deliveries must be made in a timely manner.

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Q: How does Roche Diagnostics address the needs of patients? A: A fundamental pillar of how Roche Diagnostics meets the needs of the sector with its diverse solutions is through the positive impact that it can deliver to patients, with methods supported by innovation and development. The company has a clear commitment to invest in R&D. Last year, Roche Diagnostics spent some CHF 11.6 billion (approximately US$13.503 billion) on R&D at the global level. This is one of the reasons we are a global leader in the healthcare industry. Q: How has Roche Diagnostics demonstrated its quality during the pandemic? A: One of the key demonstrations during the pandemic has been the effort and speed at which we have delivered highquality diagnostic solutions. Quality is extremely important because not all diagnostic solutions available today have the sensitivity and specificity that is required for COVID-19 patients. We have almost 10 COVID-19 tests in global markets, though these are not yet available in the Mexican market because they must first go through the country’s regulatory process. Q: How does Roche Diagnostics identify

Jordi Fernández

solutions suited for the future? A: The company is very decentralized. It is also very close to the market, the main stakeholders and patients. We also have

General Manager Mexico of Roche Diagnostics

almost 125 years of experience improving people’s lives. All of this puts us in a favorable position to meet future needs and deliver personalized healthcare. The most important stage of the process is direct testing with patients. This enables us to develop preventive solutions that can help with

Comprehensive Diagnosis Solutions for Today and Tomorrow

early diagnosis of any disease so patients find appropriate treatments sooner. Q: How do the company’s software support solutions complement its clinical diagnostics solutions? A: Digital solutions have grown rapidly over the past few years, diversifying the ways in which we can provide value to patients who we value the most. The value of digital solutions can be viewed from connectivity between our solutions and its integration to the electronic healthcare records (EHR). We have solutions to help healthcare professionals treat patients more effectively across several therapeutic areas such as diabetes, oncology, infectious diseases, among others. Q: Does the company have any other solutions that will soon reach Mexico? A: We continue to focus on diseases that represent heavy burdens across the globe. We are developing specific tests in the oncology field, which will give results far more quickly and will help increase survival rates for patients. Similar

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developments are ongoing in the cardiovascular area, as well as for diabetes. We have not stopped any of these developments due to COVID-19 and we are aiming to expand the access our solutions into other pathologies like infectious diseases, metabolism illnesses and other chronic diseases.

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Q: Which would you identify as Getinge’s largest contribution to Mexico’s healthcare system? A: Our largest contribution to Mexico’s healthcare system is our wide range of products. Mexico, especially in the public sector, has problems investing as there are not always enough capital resources available to buy new equipment, which can be quite expensive. So, many procedures are made possible in Mexico by the use of integrated service providers, which rent services to hospitals. We have seen this with anesthesia, endoscopic and cardio procedures, which are offered on a rental or procedure basis. Getinge has a wide portfolio of equipment and consumables that are ideal for this business model, including our anesthesia machines, ventilators, sterilizers and life-support systems. Q: How is Getinge incorporating digitalization and what benefits does this bring to doctors? A: We are aunching a new software called Torin for the optimization of operating rooms. It is a surgical procedure programming software that is already being used in some countries where it has shown to increase OR efficiency by 30 percent. We now have our first demo unit for this software in Mexico. Our OR offering includes the T-Doc software for instrument traceability and the Tegris digital integration software; there is a growing interest in OR digital integration but so far it is

Paul Barber

only implemented in very high-end hospitals or in certain OR’s. Q: What benefits do your customers get from connecting their devices to Getinge Online?

Managing Director of Getinge Mexico

A: We have two product lines that can be connected to our online service Getinge Online: one focuses on acute care products, including ventilators and anesthesia machines, and the other deals with sterilizers. These products are becoming increasingly

Operating Room Digitalization a Priority for Swedish Tech Giant

popular as a growing number of hospitals understand the benefits of connecting their equipment to Getinge Online, which includes instant access to data, remote diagnosis to optimize the devices’ performance, maintenance and remote diagnostics to ensure that technicians arrive with a full set of tools and parts and are able to fix the equipment on their first visit. Q: What are the main lessons Getinge learned from the COVID-19 outbreak? A: This crisis has shown us that the most sophisticated device is not necessarily the most effective one for optimal patient outcomes. Ventilators have been a priority. Our factory has increased production by 160 percent. Our goal is to produce 26,000 devices this year, of which we expect to install over 400 units in Mexico, Central America and Caribbean region this year. Our other priority is our new product Stericool: a low temperature sterilizer. During this crisis, low temperature sterilizers have been highly convenient as their working cycles are very fast and they are delicate with instruments. Q: What products will Getinge introduce to Mexico this year

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and what difference will they make in the local market? A: In Mexico, we are introducing a series of next-generation operating tables and by the end of this year, we will introduce two new devices for extracorporeal oxygenation life support.

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Q: How has Beckman Coulter boosted its presence in the Mexican market? A: Over the past two years, we were able to dabble in the public sector. We have had an important number of product releases and our unique technology has opened new opportunities for Beckman Coulter. We have launched the new hematology platform DxH 900 which includes an innovative early indicator for sepsis, which is one of the most aggressive and dangerous ailments during hospital stays. Beckman Coulter is focused on patient-centric solutions and these kinds of tools have increased our presence in the market. Q: What has been the reception for Beckman Coulter’s diagnostic test for prostate cancer? A: The product has attracted interest from the public sector, mainly from Hospital General de Mexico, Hospital DR. Manuel Gea Gonzalez, INCMNSZ and Centro Medico Naval. Using this test might reduce the number of patients that require invasive prostate biopsies. Although the benefit of the product is clear, we still have a major opportunity to generalize adoption of this novel test at public and private institutions. Chronic degenerative diseases worsen with age, meaning the patient will require follow-up and attention. For these groups,

Carlos Hernández

going into a biopsy is already a risky decision. With diagnostic tools such as our test for prostate cancer, the hospital reduces operation room occupation. Due to its increased specificity phi (Prostate Health Index) has potential to reduce unnecessary

Director General of Beckman Coulter

biopsies by 30 percent. The test also reduces diagnostic wait times as the results are returned in just a few days. Q: Based on your work in Mexico, what trends are shaping clinical diagnostics?

Innovative Diagnostic Test Reduces Overall Costs

A: Sepsis is an important trend shaping clinical diagnostics, which is why we developed the Early Sepsis Indicator for our hematology platform DxH 900. This endemic problem for hospitals has recently worsened because patients are arriving in more critical condition. Sepsis is an often-difficult condition to be detected early and sepsis shock is one of the most expensive and dangerous conditions for hospitals to treat. COVID-19 is and will be the major clinical diagnostic trend for the market. We are developing and will soon launch serology tests to determine if the person shows antibodies and could have developed immunological response to COVID-19. Beckman Coulter has worked on an assay that detects antibodies against the virus spike protein that may be more likely to confer immunity, delivering higher sensibility and specificity in the early days of infection and also not impacting on laboratory regular workflow. Q: How is Beckman Coulter improving access to its solutions and bringing its technology closer to Mexican patients?

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A: It is very important to gather clinical and pharmacoeconomic evidence generated at the hospitals where we are present. This allows us to prove to clients that the investment they are making is actually contributing to their practices and saving them further costs, increasing patient’s quality of life and safety.

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Q: What are the company’s strengths in home care and device interoperability trends? EG: The market in Japan is driven toward constant innovation, which is reflected globally at Fujifilm. Home care and device interoperability to facilitate diagnosis and treatment is pushing innovative changes to make our equipment smaller and lighter, meaning they are easier to transport. Fujifilm is consolidating different studies generated by a wide variety of medical devices to provide an integral treatment to the patient. Our technological platform allows us to combine different data coming from the diverse equipment we have for

Enrique Giraud

various specialties, such as imaging and endoscopy. JG: When developing new technologies, our goal is to provide better image resolution and this has led us to develop devices

Managing Director of Fujifilm Mexico

that provide high-resolution images with considerably less direct radiation in a much more compact, portable device. The creation of portable devices makes home care a reality. Fujifilm is also moving toward more interoperability. Today, all our devices are interconnected and we have been implementing AI for years on many devices for mammograms, radiographies, X-rays, magnetic resonance and, more recently, ultrasounds and endoscopy. With our interoperable open platform called REiLI, we are allowing new technology developments even from other companies or developers to deliver the best solutions for healthcare. Fujifilm’s innovative technologies are making it easier for doctors to identify the damage to the respiratory system of patients suffering from COVID-19. The company has been

Javier Giraud Medical Systems Vice President of Fujifilm Mexico

exploiting AI for some time; however, the ReiLI platform has allowed us to prove its functionality in an open-source way. Q: How has Fujifilm Mexico positioned itself in the booming market of digital technologies? JG: While the benefits of these developments are obvious, there is still a great deal to do to fully adapt interoperability to benefit different areas. Many medical units tend to be

Device Innovation Delivers Long‑Term Benefits

isolated, which is why Fujifilm Mexico is introducing our developments to the medical environment so companies can start incorporating them more naturally into their work. We are working with the Ministry of Health of Veracruz where Fujifilm has installed an interconnected environment between the area of ultrasound, endoscopy and radiology that allows them to communicate across areas, hospitals and the whole ministry. This means that patients’ clinical records can be stored in one place. Q: What new development is Fujifilm introducing to Mexico in the near term? JG: We have been working on a C-arc development, which is intended to be introduced in Mexico by the end of 2020. This has the same characteristics as our compact and Nano

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developments. It is built to be smaller and with a lower radiation dose. We developed this device alongside our imaging and endoscopy areas.

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Q: How is Canon Medical Systems shaping the future of medical imaging and diagnostics in Mexico? A: Technology has changed a great deal throughout the years and its impact has been beneficial for medical practices. The images that Canon Medical Systems generate provide more information to doctors to support their diagnosis and allow them to write very precise prescriptions. The company believes that the future is promising for medical image digitalization. Q: How is digitalization changing healthcare practices and how can it be implemented in Mexico’s fractured system? A: Canon provides solutions that optimize costs, which range from the introduction of a medical system to its maintenance and operation. Canon Medical Systems focuses on workflows that can lead to a better and more efficient image, which also impacts a doctor’s daily practice as it provides an opportunity for early detection of a possible medical condition or issue. Our products are user-friendly in terms of process, use and diagnostics. Our goal is to reduce burden on both the healthcare systems and the patient. Q: How do your services incorporate technologies and digitalization models such as electronic clinical records?

Carlos Franyutii

A: The introduction and use of electronic clinical records has been in the works for both the private and public healthcare sectors, but the progress so far has fallen short of expectations. Also, the current conditions of the Mexican healthcare system

Sales and Marketing Manager of Healthcare Solutions at Canon Mexicana

do not allow the smooth and correct functioning of a cohesive electronic record. The Mexican public sector incorporates a variety of entities such as IMSS, ISSSTE, SEDENA, SEMAR and PEMEX. Between them, there is no in-depth coordination, which is necessary for the correct use of an electronic clinical

Universal Healthcare Demands Refurbishment of Obsolete Equipment

record. Having a universal healthcare system can create the right conditions to accomplish a unique health record. Canon Medical Systems is the first link in the imaging process. Our products and services help to integrate a digital image that allows high portability. Canon Medical Systems’ software for digital solutions allows a more efficient handling of images, while complying with the industry’s standards and current healthcare needs. Q: How does Canon Medical Systems improve the health and quality of people’s lives through its diagnostic products? A: Canon Medical Systems values its products based on their added benefits, the high quality of the image, high productivity and lower operational costs. All these benefits can translate to the patient’s treatment and to a doctor’s daily practice. By using our imaging products and services, a doctor will be operating with the best images, the most efficient workflows and the knowledge that the information generated by the equipment can be managed on different systems. Q: What new products and services will Canon Medical

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Systems introduce to Mexico’s healthcare sector this year? A: We are launching a new optical coherence tomography especially for angiography. Right now, we are focusing mostly on products for ophthalmology and digital radiology.

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Q: How did the pandemic impact your operations and how did you adapt? A: CHG Meridian did not stop any operations during the pandemic. We attended our clients and acquired a few more. We are a highly digital company, therefore switching to a fully remote working model was an easy transition for us. We have been very active in the market throughout this time. Furthermore, we are supporting our global clients with their digital transition. One of our biggest verticals worldwide is technology equipment. The demand for mobile technology equipment has picked up a lot during this time. We believe that this is going to further grow our business in 2021. Q: What are the latest upgrades you have made to TESMA, your digital platform for asset management? A: TESMA is one of the pillars of CHG Meridian. Approximately every two years we do a new release with improved capacities. The platform, which is web-based, is very user friendly and one of the latest upgrades made it mobile-friendly. Being web-based means that clients do not need to download a software program to use it, regardless of the device. We have the philosophy to simplify asset management to our customers, therefore we constantly increase the capabilities of TESMA.

Raúl Jacobo

Q: What are the considerations for hospitals when adopting more technology?

Health Manager of CHG Meridian Mexico

A: Science and technology are always evolving, and it is important that hospitals promote new trends among their doctors and patients. With new technology and innovative equipment, the hospital can build competitive advantages such as better doctors, shorter and less invasive procedures, new treatments and a

Heavy IT Integration Proves Beneficial in ‘Odd Times’

better branding. However, there are important cost deliberations. Sometimes, a hospital only conducts five procedures for a specific treatment a year. For any new equipment, the hospital needs to justify a minimum number of procedures to make it costefficient and do affect the income statement. Q: How would more public-private sector collaboration impact the penetration of new technologies? A: I think the public sector is overburdened. Collaboration between the two sectors would benefit everyone. If a private hospital can negotiate the provision of a certain procedure for the public sector, it would greatly help public hospitals and patients. On the other hand, this would also serve as strong branding for private hospitals and will bring income to finance other projects. Q: What should the sector learn from the pandemic? A: During the pandemic the sector experienced an increase in technology and digital demand between doctors and patients. All hospitals should have a solid technology base to respond quickly to new trends. Those that did well adopted WHO’s recommendations

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very early. Some hospitals created separate COVID-19 and nonCOVID-19 areas. These hospitals are not necessarily the vanguard of technology and equipment but they were at the forefront when implementing safety measures. Using smart financial options, like leasing, can save cash to act fast in situations like this.

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Q: How has Internacional Farmacéutica’s new plant supported Atramat’s operations? A: The plant, called S&Mohr America, is a co-investment between Atramat and our Turkish partners that have 25 years of expertise in anesthesia and ventilation circuits. The regulatory process for this plant began in 2020, meaning that in just a couple of months, we obtained all the necessary regulatory certificates, including Good Manufacturing Practices, ISO 13485 and CE Mark. We have been commercializing these circuits for about two months in Mexico and we will soon start exporting them to five Latin American countries. Q: How is Atramat innovating in the sutures market and what are some of your recent contributions to the sector? A: Right now, due to the pandemic, the market is ruled by respiratory products. Hospitals have reduced considerably the number of regular surgeries, as a result our strongest business line which are surgical supplies have decreased in demand. However, we have already started to experience growth in demand and we hope to start seeing a recovery by the end of the year regarding surgical supplies. Regardless of the pandemic, the company has not stopped

Alejandro Von Mohr

innovating. In the end of 2019, we acquired a company in Germany called Santec Medical GmbH, which is dedicated to innovate in the field of cardiac surgery. They developed a new product that allows a less invasive and safer procedure for the

Director General of Atramat

repair or replacement of mitral valves. While Atramat does have experience in this field this is the first time that we are growing significantly in this market. This is a strategic step for these types of applications that are

Infrastructure and Innovation Investment to Lead the Market

an essential life support for patients. This acquisition allows us to continue innovating through that company and to be able to commercialize such products in all markets where we are present. Q: As one of the world’s largest supplier of surgical sutures, how did Atramat respond to the COVID-19 outbreak in Mexico? A: We have a very strong distribution network that covers all private and public entities which was especially useful during the pandemic and enabled us to keep our distribution undisrupted for the continuity of the surgeries in Hospitals in Mexico and Worldwide. Q: How will the government’s decision to create a new distribution center for medical devices impact Atramat’s operations? A: We continue participating in regular government tenders to keep offering our top-quality devices at a very competitive price. It is not yet clear if essential or primary-need products

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will also be subject to the new purchasing and distribution management that the government is undertaking. However, we are one of the main distributors for UNICEF in surgical sutures, so we can use this experience to the UN acquisitions purchases with the Mexican government.

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Q: How has the group’s presence developed in Mexico? A: Our group consists of a number of companies that work together. BMC Medical develops and manufactures medical devices; Angio Medical sells and distributes medical equipment, devices and medical products; Endovascular Health Services, or EHS, installs medical equipment in hospitals and clinics; CETE trains doctors, technicians and nurses in using our devices and the latest technology; CONRAZON, a nonprofit association, provides medical care to people with limited resources; BMA develops and commercializes natural diet supplements; and lastly, LABTAM distributes pharmacogenetic tests or DNA tests. Additionally, Levbeth Medical distributes medical devices for endovascular therapy on seven specialties Our developer and manufacturer BMC has two factories in Mexico, both located in Nuevo Leon. Of the devices we sell, 85 percent go to the public health sector and 15 percent to the private sector. Q: What new products have you added to your lineup? A: In 2019, we launched and distributed a special stimulation device for Parkinson’s and another one to treat pain. This is a unique device because it can be operated by a doctor from an iPad, allowing the doctor to program the stimulation

Carlos Pardo

according to the particular condition of the patient. The patient can monitor their own parameters with an iTouch device. This system already existed but we brought the latest technology to the market.

Marketing and Sales Vice President of Levbeth Group

CP: This year, various BMC products will receive the registration from COFEPRIS. One of these is a device called WEB that is used to treat brain aneurisms. We expect this device, for which we have distribution rights in Mexico, to be registered by May.

Tech Innovation for Less-Invasive Endovascular Solutions

Q: How do your different companies come together to strengthen the group’s capabilities? A: For many years, we have been investing in developing our manufacturing capabilities here in Mexico. BMC’s plants are the first in Mexico to manufacture many of what we know as Class 3 devices. In the US border region, there are many plants with an export calling. Instead, we manufacture for the Mexican market, although we are also targeting the rest of Latin America. We want to make high-quality devices at a better cost in order to increase access to these devices. Q: What improvements would you like to see the regulatory framework? A: This is a very regulated industry. The registry process with COFEPRIS takes between two to three years. Before getting to the registry phase, we have several phases of development and production. Some of the products we have developed originated from the ideas of local doctors who approach us. In other cases, we buy the technology, conducting the legal

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acquisition of intellectual property, and then develop products from this. At BMC, we have an engineering department with six biomedical engineers. They develop a prototype, search for the material, build the product and test its performance and biocompatibility.

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A Mexican Ventilator to Stand Against COVID-19 Ventilator availability was among the main concerns at the beginning of the COVID-19 pandemic. The necessity drove Mexico to draft quick acquisition plans and prodded entrepreneurs to start developing or to at least contribute to the development of these technologies. In August, INCMNSZ announced the creation of the ventilator VSZ-20-2, developed alongside Metalsa, Proeza, FEMSA, Torrey, Bocar Group, GSE Biomedical, Coppel, Lodi Automotríz, TLM, Tecnológico de Monterrey, Lanix Med, Steris, Universidad de Monterrey, Ternium, Nemak and TINC with the technical and regulatory evaluation of COFEPRIS, CONACYT and CENETEC. To learn more about this development, MBN spoke with Guillermo Domínguez Cherit, Deputy Director of the Critical Medicine Area at INCMNSZ, who took part in the ventilator’s creation. “Years ago, the institute developed a ventilator that mimics the workings of a syringe. We took this prototype and designed an engine that would move a cam to drive a piston and push the air,” he said. Dominguez Cherit clarified that the device is intended to be used only during the pandemic; VSZ-20-2 will not become the standard ventilator for ICUs. Development began in March after the institute, together with the Ministry of Foreign Affairs, made a public announcement inviting companies to join the project. Metalsa was in charge of assembly at its manufacturing plant in Apodaca, Nuevo Leon, where a space was certified by COFEPRIS for medical equipment manufacturing. The first 20 ventilators were acquired by Fundación Carlos Slim to be donated and distributed to four hospitals in San Luis Potosi, Yucatan, Coahuila and Guerrero. The titanic effort brought together many well-intentioned actors and stands as an example of the alliances and cooperation that have resulted from the COVID-19 pandemic. During the device’s presentation, Ramsés Galaz, Director General at GSE Biomedical, highlighted that the “the VSZ-20-2 emergency ventilator is further proof that collaboration between the government, academic institutions and the private sector can lead to successful projects for the benefit of all Mexicans.” Developers also drafted an open manual of the device’s operating functionality and made all guidelines necessary for its correct use open source. Moreover, the coalition also offered training for professionals who were to use the device. Biomedical professionals involved in the VSZ-20-2 project, such as Luis Fernández, Founder and CEO of TINC, have been vocal about the importance of their profession to the healthcare system and the seriousness of an entrepreneurial development to solve the crisis. “It is time for our national industry to start revamping itself to produce national solutions for national needs. We need to set things into motion by supporting national Read the complete article More about this topic

entrepreneurship and intrapreneurship and enhancing our current regulation to facilitate growth in the coming years,” said Fernández in an interview with MBN.

MedTech The importance of technology in care provision took a giant leap in 2020. Medical platforms enabled doctors and patients to connect by creating a healthcare environment that was quick to respond to the needs of physicians and patients, while respecting the limitations introduced by the pandemic. Digital tools and technological solutions, including big data, IoT, AI, the cloud, augmented and virtual reality, were already emerging trends for the healthcare industry in Mexico. However, their integration accelerated threefold as a result of COVID-19 limitations. From the daily use of wearables to track habits to complete interoperability at hospitals, medtech helped the industry to face the crisis. Now, the challenge for medtech is to become a standard approach in care provision. In this chapter, leaders of the industry explain how technology broke the boundaries of medical performance, offering innovative ways to operate businesses, offer treatments, perform surgeries and create assertive solutions. Interviewees also address regulatory requirements for players in this segment, cybersecurity standards, further interconnectivity between entities and ways to empower patients to take control of their health through digital tools.

MedTech

105 Analysis COVID-19 Accelerates Healthcare Technology Transformation

106 Analysis Technology Eases Hospital Burden, Enhances Health Access

107 View From the Top Mario Muniz | Regional General Manager for North Latin America at IQVIA

108 View From the Top Antonio Carrasco | CEO of PLM Latina

109 View From the Top Guillaume Corpart | Managing Director of Global Health Intelligence

110 View From the Top Ricardo Rentería | Director of AWS Mexico

111 Analysis Redefining Preventive Health Through Technology

112 View From the Top Juan Manuel Cáceres | CEO of Aidicare

113 View From the Top Jorge Camargo | Co-Founder and Co-CEO of Ecaresoft

114 View From the Top Tomás Iglesias | Founder and CEO of Osiris Healthtech Systems

115 View From the Top Ricardo Moguel | Country Manager of Doctoralia for Mexico, Colombia and Argentina Adrián Alcántara | COO of Doctoralia for Mexico, Colombia and Argentina

116 View From the Top Charles Nader | CEO and Co-Founder of Doc.com

117 View From the Top Juan Camilo Garay | Country Manager of 1DOC3

118 View From the Top Gino Scarangella | Vice President Life Sciences LATAM of Dassault Systèmes

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COVID-19 Accelerates Healthcare Technology Transformation Even before COVID-19, companies were embracing the digital transformation but full digitalization remained a faraway reality. The pandemic is helping to change that. Today, companies are adopting technology into their practices at an accelerated pace to ensure business continuity following global lockdowns. The same is true in the healthcare sector, where technology trends are having an impact on care provision. “Technologies that increase patient security are among the strongest trends as they provide clinical excellence and facilitate communication with providers and consumers,” said Roberto Aguilera, Health Sciences and Wellness Consulting Partner at EY, in an interview with MBN. Telemedicine is one of the tools that quickly accelerated its market penetration. “Before the pandemic, 64 percent of doctors were not planning, in the near future, to introduce virtual consultations or digital check-ups nor to use voicecontrolled digital assistants. Our survey indicated that around 60 to 80 percent of doctors were now very open or willing to incorporate new technologies into their practices,” said Aguilera. In addition to incorporating a telemedicine platform, Aguilera recommends hospitals to digitalize their practices, too. “Hospital staff experiences an improvement in their productivity and in the long run, patients also experience the benefits because they are able to receive more personalized and appropriate attention.” To make digitalization a reality, a broad alliance of players is required, explains Enrique Remezal, CEO of icon Group. “This involves the creation of a whole network of people: patients, medical professionals and providers. Creating a digital environment involves a great deal of management to allow the whole community to coexist and ensure the efficiency and safety of the hospital’s services.” In Mexico, Médica Sur is among those diving into the digital transformation experience. “We have partnered with technology groups that allow us to develop our own software and robots that help diminish risks for patients and doctors at Médica Sur,” Misael Uribe, President of Médica Sur, told MBN. “We are consolidating a super safe hospital where you can go for treatment without fear of any kind. This is especially important now that we are facing a pandemic and safety inside the hospital is key to avoid further contagion.” Improving performance throughout the whole healthcare chain with the help of technology is becoming increasingly important. “What we are seeing now is that many companies are interested in combining their service offering with digital tools that will add value to their offering,” said Andrés Gavenda, North Latin America Health Sciences and Wellness Industry Leader at EY. “They all have to hyper automate their process and start thinking Read the complete article More about this topic

about solutions that use artificial intelligence. With the use of robots, we can improve productivity in all industries, save time and focus on other matters that require specific attention.”

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Technology Eases Hospital Burden, Enhances Health Access The demonstrated benefits of technology and digitalization have driven countries to develop their own apps to trace COVID-19 contagion or to try to keep people at home when presenting slight health discomfort or mild COVID-19 symptoms. And for good reason: Amid the pandemic and given the number of people who live in the Mexico City metropolitan area, hospital capacity could be severely threatened if people throng to the emergency room. As one of the world’s biggest cities, size alone presented a daunting hurdle for Mexico City in terms of its response to the crisis, according to Oliva López, Minister of Health of Mexico City, in an interview with MBN. Here, too, technology has come into play, although López explained that while technology is almost all around the capital, a single app was not enough to reach all citizens. As a result, the ministry created an additional tool that could complement the existing apps that the federal government launched with information on COVID-19 symptoms. “The Digital Public Innovation Agency contributed greatly by creating a text message option to filter patients with mild symptoms and encourage them to stay home, allowing SEDESA to offer telephone follow-ups and to provide general recommendations regarding isolation for suspicious cases,” she said. López added that the text message method also allowed the ministry to identify delicate cases linked to other morbidities to encourage patients to go to the hospital or more carefully monitor their symptoms. Chile has also taken advantage of technology to better face the pandemic. Alongside EY, the government developed a digital solution that allows remote guidance through an app. In an interview with MBN, Roberto Aguilera, Health and Life Sciences Advisory Leader at EY Latam North, explained how it works. “Through artificial intelligence, the app detects possible COVID-19 cases as Chilean users are asked to fill in a survey about their current health status. When detecting a case, the app is able to provide digital consultations with a doctor to confirm if the person is COVID-19-positive.” According to Aguilera, the app has elevated COVID-19 testing in Chile and has also resulted in more manageable flows of patients, who cannot visit a medical facility without previous digital approval to do so. For a more in-depth understanding of the impact and helpfulness of technology during the COVID-19 crisis, Ricardo Renteria, Sales Management Enterprise Lead Amazon Web Services, told MBN that the company developed a service called AWS Diagnostic Development Initiative, which is a supporting tool for companies. “This program supports customers working on better, more accurate diagnostic solutions and promotes better collaboration across organizations solving similar problems.” In Mexico, the company developed a project alongside a client company called Roomie IT Services. “This is the first and only 100 percent Mexican organization to develop, produce and sell Read the complete article More about this topic

humanoid robotics in Mexico which, in collaboration with infectious disease experts, designed a prototype robot whose purpose is to identify suspicious cases of COVID-19.”

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Q: What role has IQVIA played in the pandemic? A: IQVia has provided valuable information to CEOs in Mexico. During the pandemic, we did more than 20 webinars divided into two groups. One was called The Thought Leadership, where our experts addressed some of the topics of greatest interest and impact at the time, such as digitalization in the pharmaceutical industry, what will happen with the use of technology and projections for market growth. We are a unique company in the sector due to our size and our wide range of solutions for the pharmaceutical industry, from clinical to commercial. Q: What were IQVia’s most in-demand solutions in 2020? A: There are three groups of solutions that grew considerably in 2020: everything that has to do with digitalization and the implementation of technology platforms and the deployment of virtual campaigns and consulting together with market research. Our clients want to know what doctors are thinking, what the position of the laboratories is during the pandemic and who is perceived as the most ethical or the most helpful player, for example. Q: What obstacles does the health sector in the

Mario Muniz

country face regarding new technologies? A: Regulation is the first hurdle. We are completely lagging behind in establishing regulation that is transparent but at the

Regional General Manager for North Latin America at IQVIA

same time contemplates all the necessary aspects involved. There is little technology promotion in the country for the health sector. If we compare ourselves to other Latin American countries like Brazil, we are at a great disadvantage.

Standardized Data System First Step To Digitalizing Health System

Meanwhile, in Mexico, everyone in the industry has to fend for themselves. Even though there are already telemedicine companies operating in the country, there is a need for standardization to allow the general market to benefit during this crisis. We are losing a lot of time because we do not have the appropriate regulation. Q: What possibilities does AI open up in the health sector? A: AI and machine learning do not exist without solid databases. The big barrier in the country is developing homogeneous databases that communicate with each other, allowing for data analysis. In Mexico, the health system is fragmented and it is difficult to connect the databases in the public and private sectors. One day a patient may go to one place, the next day they might go to another and their medical record is traceable, nor uniform. Without a standardized database, however, we are limited to take full advantage of these tools for the benefit of patients. At the moment, the government is busy with keeping the health sector operating and providing medicine at the lowest cost. When we meet with members of the government and show them our data

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and analysis, they are amazed but they should already have the information because they are the ones who are purchasing all the medicines. The government’s approach in Mexico is not designed to analyze but to only provide healthcare, at the lowest cost possible.

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Q: Last year, PLM Latina (PLM) talked about starting a project with the Amazon virtual assistant Alexa called Salud PLM. Where do you stand with this project? A: The project is gradually advancing and we expect its use will explode soon. We have been working to improve the digitals tools in our applications and on the web, as well as APIs for third parties. We make improvements according to the demands of our clients, who want to be able to place messages about their products in very specific places. We help them by collecting intent data, which tells us what doctors do when they search for medications and prescribe them. This allows us to place product messages at the moment when the doctor is going to make the decision. Q: What is your perspective on health marketing? A: High-level professional audiences search and find information for their decision-making process. In the journey to fulfill their inquiries, physicians, for example, investigate and respond their prescription doubts with the content provided by databases, web services and digital media. Just in 2019, PLM’s digital media reached over 700,000 health professionals with more than 90 million views. This amount of data, bounded by a particular content domain and specific audience, has been demonstrated the correlation between drug sales and inquiries in PLM’s services, as all searches are brand correlated.

Antonio Carrasco

Concretely, PLM’s intent data brings market knowledge of brand awareness, market share and, most importantly, who is the critical audience to look for to change the market share composition.

CEO of PLM Latina

Furthermore, in the patient’s market, for example, PLM holds real-time intent data of organic searches on the web by millions of patients looking for a more precise understanding of their prescription. That set of intent data, for marketing purposes, is the real-time description of the pharmaceutical market distribution by

The Goal Is to Read the Doctor’s Mind

the brand that allows effective and efficient marketing campaigns over the frequent use of data whispering in social media. Q: As the infrastructure of technology expands, will company’s like pharmaceuticals develop their own software for intent data? A: Yes, technologies such as cloud computing are very democratic and there are essentially no limits. Companies will develop their own technology. For this reason, we need to be attentive to what services can disappear and always be attentive of new innovations. What matters is creating the capacity to integrate the largest amount of information. You then need to bring this to clients in a manner in which they can see how they can benefit. We break up the information we collect according to target groups. Generally speaking, we see that this industry, unlike others, is generally slow in adopting technology. There is a high level of regulation that is dampening the spirit of innovation and risk-taking. The transfer of technology greatly depends on the number of people who know about natural language processing. In Mexico, there are about three people who know this very well. However, this represents growth because five years ago

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there were none. One of the ways in which large businesses can attain a technological footprint is by acquiring smaller digital platforms. Mergers can also effectively accelerate the adoption of technology in Mexico. Ultimately, intent data is highly useful and its potential is great.

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Q: How have you advanced in developing products to support your clients based on their size and market participation? A: We have two unique products. The first is HospiScope, which contains information about hospital infrastructure, and the second is SurgiScope, which analyzes hospital procedures. HospiScope lets users understand the capacity of each hospital as it permits to know the number beds, operating rooms, delivery rooms, X-ray machines, MRI-scanners, etc. SurgiScope, meanwhile, collects data on the number of procedures for every hospital, such as appendix removals or knee surgeries. In 2017, we redesigned both platforms to make them more robust and streamlined. We also launched tools, including HospiCheck and HospiVista, to allow clients to search these databases in an accessible and tailored way. Our information related to medical devices and medical supplies remains our core business. Q: What is the advantage clients gain from using Global Health Intelligence’s systems? A: A large part of what we do is to give companies the confidence to make better decisions. They want to increase their understanding of the market, identify opportunities and target specific clients. To guarantee good solutions for our clients takes a lot of work. We partner with our clients to

Guillaume Corpart

achieve this. Q: How would you describe the state of the health sector in Mexico in terms of infrastructure and equipment?

Managing Director of Global Health Intelligence

A: There are approximately 22,000 hospitals across Latin America with almost a million beds region-wide, resulting on a region average of 45 beds per hospital. While this average holds true in Mexico, private Mexican hospitals only have 13

Data Necessary to Make Better Decisions

beds. Hospitals of a small size, very common in Mexico, are less likely to invest in equipment that is capital intensive, such as surgical robots, CT-scanners or MRI-scanners that can cost US$1 million or more. If you sell capital-intensive equipment, which is usually sold to hospitals with over 200 beds, there are about 185 hospitals in Mexico that are potential clients. This is a big issue. Many manufacturers also have been questioning the public sector direction under the current government. Sales have seen a rapid contraction over the last year and a half, between 25 and 50 percent. Some clients have seen their sales for specific business units go from US$5 million to US$4 million almost overnight. This is terrible. Q: What competitive advantage do Mexican hospitals offer? A: Many public hospitals are renowned. However, they are oversaturated. Mexico needs to have a more efficient healthcare system in order to improve the quality of care. In the private sector, there are very good hospitals. One of the achievements in Mexico is that we have been able to

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make expensive procedures more accessible to lower socioeconomic classes through short-stay surgery and better use of infrastructure. However, the distribution of resources available per capita still remains low, even compared to the Latin American average.

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Q: What actions is AWS taking with healthcare providers, public health agencies, government corporations and life sciences companies to support their efforts to control COVID-19? A: We launched the AWS Diagnostic Development Initiative, a program to support customers working on better, more accurate diagnostic solutions and promote better collaboration across organizations solving similar problems. As part of this, we are committing an initial investment of US$20 million to accelerate diagnostic research, innovation and development to speed our collective understanding and detection of COVID-19. The AWS Diagnostic Development Initiative begins with participation from 35 global research institutions, startups and businesses focused on tackling this challenge. In Mexico, Roomie IT Services is one of our customers using AWS tools: the first and only 100 percent Mexican organization to develop, produce and sell humanoid robotics in Mexico which, in collaboration with infectious disease experts, designed a prototype robot whose purpose is to identify suspicious cases of COVID-19. With AWS software, the main objective of the robot is to protect medical staff and patients and prevent the spread of infection. It strengthens the health system at the height of the pandemic, acting as a first point of contact in hospitals. It is important to point out that the robot identifies suspicious cases but does not diagnose them, so it does not replace doctors.

Ricardo Rentería

Another great case is NEORIS, a digital accelerator that creates disruptive solutions for businesses with digital aspirations to boost their connections with customers, employees and

Director of AWS Mexico

stakeholders. In response to the COVID-19 pandemic, it has expanded the capabilities of its HealthCheck platform to support the efforts of businesses and governments to reopen operations in multiple countries and slowly become productive again.

A Digital Partner Able to Transform the Sector

Q: What added value does AWS’ solutions deliver to the healthcare sector? A: The AWS cloud plays a significant role in how this sector innovates. Without AWS, there might be fewer prescription drug breakthroughs widely available, for instance. Today, the American Heart Association is building a precision medicine platform on AWS to aggregate and analyze data that will help researchers uncover cardiovascular disease insights. Similarly, the Cancer Genome Atlas dataset has made its data available on the AWS cloud, lowering entry barriers for researchers working on developing new treatments for cancer. Using AWS, AstraZeneca is enabling scientists to identify more patients with actionable cancer types, to develop medicines faster and to treat more patients sooner. GRAIL, Inc. is combining high-intensity genomic sequencing with modern data science techniques to transform the way cancer is diagnosed. SkinVision offers affordable detection of skin cancer, one of the fastestgrowing diseases in the world. AWS also has a direct impact on improvements in patient care.

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Arterys is revolutionizing medical imaging and healthcare through ultra-fast cloud computing, advanced visualization and deep learning. Qventus is using AWS for machine learning and analytics to help hospitals to identify bottlenecks and improve efficiencies in the emergency room, operating room and pharmacies.

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Redefining Preventive Health Through Technology Mexico’s health system faces numerous hurdles, including rising costs and a fractured structure, but the lack of a culture of prevention is among its biggest drawbacks, according to Graciela Teruel, Director of EQUIDE. “Mexico’s lack of sufficient emphasis on preventive healthcare might be the largest one,” she told MBN when asked what was the industry’s major deficiency. While COVID-19 has had tragic consequences, the pandemic also has helped redefine preventive healthcare. Experts such as Patrick Devlyn, President of the Health Commission at CCE, have urged the country to move from a curative to a preventive model in the wake of the virus. “The first pillar for transforming the sector after COVID-19 is the implementation of an integral public health policy on prevention to create and encourage a preventive healthcare culture,” Devlyn told MBN. To this end, technology can play a significant role. Both startups and multinational giants in the industry have developed technological tools to encourage and track healthy habits, while at the same time developing personalized solutions that can help people adopt a healthier lifestyle. “Health, disease and disability are dynamic processes in an individual’s lifespan and therefore preventive healthcare must be equally dynamic,” says an APPT study that highlights three concerns regarding healthcare complications and developing a healthy lifestyle: 1. Preventive healthcare promotes individual well-being and happiness because it raises self-awareness regarding people’s bodies and enhances all capabilities for them to function in the best way possible. Individuals live longer with less ailments, which prevents them from experiencing physical pain. 2. It boosts the economy as healthy people are more productive. A healthier population means more people employed and working productively. 3. Reduces the pressure on healthcare services. Mexico is a prime example; the country has an obesity epidemic that cost MX$240 billion (US$12.43 billion) just in 2017 and is now linked to the three main mortality causes: heart disease, diabetes mellitus and malignant tumors. Today, technological developments allow people have greater control of their health habits and track their lifestyle regarding exercise, meals, moods and emotional health. MBN interviewed companies that have developed apps that help the user to be aware of their habits through smartphones. Among them, KALMY, a digital broker for health insurance, has developed an interesting dynamic to promote health and incentivize people to keep healthy lifestyles. According to CEO Emmanuelle Brunet, “given that the whole purpose of the app is to promote a healthier lifestyle, we have a section that automatically registers habits and lifestyle characteristics and displays a progress bar that indicates improvements, which will also unlock benefits that could include discounts at healthy restaurants or movie tickets.” Habits.ai is a corporate health-management app that, according to CEO José Antonio Torres, is “a combination of artificial intelligence, Read the complete article More about this topic

behavioral change and gamification. For companies, the gamify component is key because company employees are constantly competing and thus changing their habits.”

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Q: Why is Aidicare’s technological approach to healthcare the best solution for patients and hospitals? A: Aidicare wants to improve people’s quality of life but also ensure safety during their hospital visits, which is why we offer one service for the individual user and another for hospitals. Aidicare transforms technological innovation into a useful and beneficial service for the patient. The company started four years ago and we are now present in Miami, London and Mexico. Our goal is to respect the hospital’s structure while smoothly digitalizing its practices, not to disrupt its way of working. Our first service, Aidicare Life, is designed to help patients care for their health outside the hospital through a wearable and an app that track the person’s vital signs, including sleep patterns, physical activity, daily steps, weight control, glucose control, heart rate, blood pressure, oximetry and temperature. The wearable allows us to keep track of certain aspects, while elements such as temperature or weight can be submitted through other devices that can connect to the app, which also are available for purchase through Aidicare. To connect this information with a doctor and offer a complete healthcare service, Aidicare also provides a digital board where doctors can keep track of the patient’s health. The objective is to

Juan Manuel Cáceres

provide doctors with a clear view of the patient’s lifestyle, habits and health status, which also trims around 35 minutes from the consult. This customized solution using AI algorithms allows for a precise diagnosis and better advice for a healthier lifestyle.

CEO of Aidicare

The Aidicare Hospital solution targets patients who are in the ICU or have just come out surgery. It uses a tablet to track vital signs and alert medical staff of any changes in the patient’s condition. Through the use of AI, Aidicare offers facial

Creating a Technological Environment at Medical Facilities

recognition of the patient before entering the ICU or before surgery, which is possible through a partnership with Amazon. The objective of this development is to avoid any misdiagnosis or use of a wrong clinical record. Aidicare can also complete necessary forms used by nurses with the information gathered through the patient’s wearable. At Medica Sur, around 60 percent of doctors use this digitalized concept, which has also diminished their use of paper due to the digital connection to the patient electronic clinical record. Aidicare has also received guidance at technology competitions organized by Endeavor and Prosible that have helped the company to perfect its products. Q: How has COVID-19 impacted the way your company works? A: Our services have been boosted because technology is driving the healthcare sector right now. With the pandemic, Aidicare was able to develop and run the hospital service for insurers and we have also created a product called Torre Medica Virtual to enable hospitals to correctly use telemedicine. This product is a platform for hospitals to provide the same services they usually offer but digitally.

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This is a personalized solution that maintains the hospital’s institutionalized concepts. The platform adapts to their concept, themed colors, options and services, and it includes a scheduling system to book consultations and offer teleconferences.

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Q: How will the Cirrus platform transform as a result of the COVID-19 pandemic? A: Cirrus is a horizontal solution that takes care of every process in a hospital. It helps to manage patient admission, medical records, patient notes and process and prescriptions. It is also involved in inventory management, purchases, accounts receivable and stocks. The main differentiator of this solution is how it integrates clinical processes and their administrative and financial counterparts into a single platform. The system brings together all patient information during their stay, from prescriptions to their bill. As a result, hospitals can have a complete follow-up of each case. The platform works in seven levels, each gathering more information. Once in level seven, hospitals will be fully automated, with interconnected areas. With the pandemic, non-urgent surgeries were being canceled, as were regular consultations with a doctor. This significant decrease pushed us toward the telemedicine idea we had already been dabbling into with our product Nimbo but that was not fully introduced in Cirrus, yet. Q: How does Cirrus adapt to each hospital’s particularities? A: We first start with an analysis of the hospital to detect how it works and what is effective about its practices. Next, we work

Jorge Camargo

alongside management to create a solution. Not all hospitals have the same ability to adapt to a cookie-cutter product. While the software works the same for all of them, hospitals will not always have or share the same processes.

Co-Founder and Co-CEO of Ecaresoft

Q: How are you positioning Nimbo among smaller clinics and private practices? A: Nimbo has developed from its initial purpose of helping

Buildable, Flexible Products Escalate Business

primary care clinics more easily manage their operations. It was a scheduling solution with electronic clinical records. Now, it is a platform with different products that helps build a clinic’s online reputation, from website to brand. Once the patient finds the doctor, we support them with a digital appointment, which offers the option of telemedicine. Through Nimbo, a clinical electronic record of the patient is created to also allow for a proper follow-up. Through Nimbo, primary care clinics can have the option of a fully digital service. This platform has been very successful, experiencing growth of around 130 percent every year. To date, the platform is being used in 25 countries, with around 500 to 1,000 clients. It offers the opportunity to grow its platform constantly, whereas Cirrus takes longer to mature as the solution is based on levels and connection on information. However, this has pushed us to look for more markets in Latin America to introduce Cirrus. Q: What is your marketing strategy as a company? A: We have understood that to grow and succeed as a business, the products and the company itself need to be

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flexible. All products that we offer need to be buildable and able to adapt to different contexts. They are not fully personalized because that would not make them scalable. However, they can build up, instead of changing the whole basis of the core product.

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Q: How is Osiris Healthtech Systems’ responding to the needs of care providers in the emerging digital healthcare environment? A: In early 2019, we launched OMI statistics. This tool is basically an electronic clinical record that can translate information into a visual report for decision-makers. At the end of last year, by studying the market’s response and listening to feedback from end-users, there were three main points brought to our attention. The first was charging for queries sent through instant messaging services, like WhatsApp or Messenger. Most people do not understand that having the ability to answer a medical query, even with a text message, requires many years of study, which comes at a cost. The second area of concern for doctors was the cancellation of medical appointments. Before the digital acceleration, it was normal for 40 to 50 percent of patients to miss their medical appointments. With these digital tools, doctors wanted to measure the level of cancellations. Now, our platform has a system that allows them to see who canceled and their cancellation rate. Third, doctors want to attract more patients. To address this, we analyzed the market to create a tool that a person would use every day like Uber or Rappi. Through agreements, we will also offer additional benefits to our clients. Q: How did you develop a functional platform? A: Before the pandemic hit, we were creating a platform for

Tomás Iglesias

confirming and canceling appointments. However, when the COVID-19 crisis began, we saw that many hospitals, clinics and doctors were making an effort to develop their own software to close the patient connection gap. Most of our clients had to

Founder and CEO of Osiris Healthtech Systems

close their offices temporarily or permanently. We decided to create a platform together with a group of doctors from Colegio de Medicina Interna del Noreste. We concluded that the best approach was to create a tool that

Technology a Major Ally in Addressing COVID-19 Crisis

would prevent patients from going to the hospital to see if they had COVID-19. After six days from starting, we took the prototype to friends and family. However, eight days after we began the development and had the platform ready to launch the government announced and launched its COVID-19 digital platform. We monitored their launch and noticed that many people resisted it because it asked for too much personal data. We decided to make adjustments to let people use our platform anonymously and then launched some hours after. One day after its launch, we had more than 200,000 users in 15 countries. Q: What were the main challenges in launching this platform? A: It was no longer just an app for checking if people were infected but one where patients were seeking medical advice as well. Realizing this, we formed an alliance with various telemedicine platforms, such as Wellmedic to offer the option of telemedicine through the platform. It was such a success that telemedicine allies were able to conduct 2,500 remote consultations a day and we reached a million users a week after the app’s launch. The tool quickly became an international hub for COVID-19 patients. Within three weeks of its launch, we

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were present in more than 100 countries. As of today, our digital platform has been used by 3.3 million people in 192 countries, and we were awarded with a state award for creating a digital tool with global impact. For this development we received Premio Tecnos 4.0 Nuevo León.

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Q: How did Doctoralia become the largest healthcare platform in the market? RM: Doctoralia began as a marketplace that links doctors with patients. Our goal was to help doctors make more efficient use of their time by generating online demand managed through a digital schedule. To date, we have developed other technological solutions for the healthcare chain to build an entire healthcare ecosystem within the same platform. What enabled us to become the largest healthcare platform in the world is our extensive network of doctors in every country where we are present. Doctoralia Mexico has around 180,000

Ricardo Moguel

doctors registered on the platform and, at least in Mexico, we arrange more than 1 million medical consultations per month and have around 4-5 million people looking for a doctor per month.

Country Manager of Doctoralia for Mexico, Colombia and Argentina

AA: Doctoralia’s goal is to make healthcare more human. In the past, technology was seen as a detachment between doctors and patients. After the pandemic, this scenario changed when people realized that technology could get patients closer to a doctor despite mobility limitations. Q: How has Doctoralia grown its doctor userbase in Mexico? AA: Doctoralia took advantage of the fact that people always go to the internet to look up their heath symptoms. We took this and transformed it into a tool that provided answers to healthcare questions from a doctor’s perspective. Q: How do clinics and hospitals participate in Doctoralia? RM: We created a solution for clinics that digitally supports

Adrián Alcántara COO of Doctoralia for Mexico, Colombia and Argentina

scheduling to make the most of their collaborators’ time and infrastructure. The approach with hospitals was different because they already invest in technology to improve their performance in all senses. To offer a true value proposition, Doctoralia acquired an Italian company called Tuo-Tempo, which allows us to manage and customize patient files, from the moment the patient arrives in the hospital to the end of their treatment. Moreover, we build white label apps for each hospital so they can complement their digital offering.

A Healthcare Ecosystem at Your Fingertips

AA: We created a solution for laboratories that originated from patients’ needs. Lab Doctoralia offers a quick glance at the services and requirements of each laboratory. To date, we have allied with large and local laboratories. Q: What impact has telemedicine had on your platform? RM: COVID-19 accelerated the development of a tool that we had already pictured for the near future. Telemedicine cannot be an option for all medical specialties, however. For some, it can only act as the first point of contact but for others it can be a recurrent attention method. Doctoralia has arranged more than 250,000 medical consultations since its launch date in March and through this experience we have seen how this method breaks geographic

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barriers. We are complementing our telemedicine offer with a digital prescription service. To date, through Doctoralia, doctors have issued more than 3,200 digital prescriptions.

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Q: How have you optimized the Doc.com platform to make it more user-friendly? A: We consolidated our two services in the same app, which increases the functionality of both. Now, patients have the option to speak to a doctor or psychologist directly via chat, with fewer restrictions and using only half the bandwidth, which makes the platform a faster download. In the US, we have a contract with TracFone Wireless, which is integrating our services to its telephone plans for half of its users. We also optimized our classification system for epidemiological disease information, which is the core of what Doc.com does and what makes it possible for us to offer cheaper services. We classify scientific data based on relevance, according to international standards. In terms of price, we are the cheapest healthcare service in the US, even considering our first version of the platform. Q: How has Doc.com’s client base evolved? A: Doc.com is available for free to those who cannot afford it. However, the premium version is the most complete. More than 50 percent of our users are from Mexico and the rest are from Latin America.

Charles Nader

In terms of doctors, we have 53 users in the US, although not all of them are active at the same time; it depends on the number of patients using the platform. We measure platform use by time: half an hour approximately, which is the usual time that

CEO and Co-Founder of Doc.com

a doctor’s consultation takes. This allows us to have an idea of the number of users and to foresee when we might need more doctors according to periods of peak demand. Q: What benefits do doctors get from allying with Doc.com?

Technology Can Help Provide Universal Healthcare

A: They become part of the company, which means they receive a competitive salary. We have also come up with an innovative benefit in which we pay people for their data in cryptocurrency, whether they have the free or premium plan. This is one way we are using technology in our favor and collaborating to achieve universal healthcare coverage and accessibility. In 2021, we hope to reach out to the other half of TracFone’s users, which will help us end 2021 with 1 million users. This would make Doc.com the largest telemedicine company of its kind. Q: How will Doc.com’s work contribute to improving healthcare? A: Doc.com has treated thousands of cases, from mental crises to dengue. Mexico’s government, for example, delivered millions of pesos to eradicate dengue but it is hard to identify each case. Because of this, having data from nontraditional sources is fundamental. The epidemiological data we generate with Doc.com creates

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a real-time epidemiological map of at least one part of the population, which opens the door for many studies and findings that can transform the healthcare system. This is globally important and useful. It is what we do and want to continue doing to transform difficult realities around the world.

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Q: What added value does 1DOC3 bring to Mexican patients and doctors? A: The platform went from being a B2C free healthcare forum to a paid interaction with medical professionals with a teleconsulting option within the platform. We are focusing on teleconsultations and medical orientation. In the case of Mexico, we work closely with insurance companies like MAPFRE. Its telemedicine service is provided by 1DOC3 through a white label service. In other countries, such as Colombia, we work alongside the government. In Mexico, our approach is to work with multinational institutions such as the Inter-American Development Bank, which supports us with the financing of some telemedicine projects that are executed by 1DOC3 alongside different health ministries. Q: How has COVID-19 impacted 1DOC3? A: 1DOC3 offered clients the chance to see how their employees were doing despite working from home, even in different states. Mental health is another subject that has received a great deal of attention. 1DOC3 already offered consultations for stress or anxiety. However, the increase in these services has been exponential. Q: What challenges has 1DOC3 faced in Mexico to grow its presence?

Juan Camilo Garay

A: 1DOC3 offers basic primary attention so most of our doctors are general practitioners. They are open and used to technology, very flexible and have successfully adapted to the digital

Country Manager of 1DOC3

offering. The challenge is that we have many doctors wanting to participate. However, it would not be efficient to have a surplus. Q: How has 1DOC3 used the information gathered in Mexico to generate a positive impact?

Digital Health Must Be as Trusted as Traditional Healthcare Provision

A: In 2018, we supported IMCO with its yearly diabetes report on understanding how patients behaved and how this compared to other countries with less diabetes incidence. We found that Mexican patients learn about the disease only after presenting symptoms, leading to severe healthcare complications. Q: How does 1DOC3 protect itself from cybersecurity threats? A: 1DOC3 has high cybersecurity standards and we use the HIPAA quality model to protect our data. This helps us guarantee that user data is safe and protected. This is an obligation for any telemedicine provider. However, the norms in Latin America are not there yet, which is why we are following other models used in different countries. Q: What are the near-term plans for 1DOC3? A: We want to strengthen our market position in Mexico as this is still a very attractive market for us. Mexico’s population is among the leading out-of-pocket spenders in healthcare, which means our services can be adapted easily. We want to

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continue investing in our data. Thanks to our tools, we are able to visualize what is affecting the population. We can also know what medicines they take and other information that enable us to build AI that better understands symptoms to then offer improved care.

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Q: How does the company bring technology and innovation to pharma and biotechnology companies? A: Dassault Systèmes views life sciences in three significant sectors: pharma and biotechnology, medical devices, and patient care. With our recent acquisition of Medidata in October of 2019 we really expanded our capacity, which allowed us to focus on this new market. Dassault Systèmes has the capacity to break down barriers currently blocking companies because of the siloed solutions that have been deployed for so many years, by leveraging a platform architecture that connects applications so they may share data across the spectrum of the different work cycles within life sciences. This allows companies to take advantage of data flow across the entire business to increase productivity and reduce the time from ideation to actual production. This eventually leads to a drop in R&D costs and a much faster delivery of therapies to patients. With pharmaceutical companies, it is common to have sufficient data collected throughout the years across many projects, and yet companies find themselves redoing many of the experiments they have done because they cannot access all the information gathered and stored. Our task here is to enable them to access that data and show them how,

Gino Scarangella

through technology, they can continuously improve their processes and performance through better data access and collaboration.

Vice President Life Sciences LATAM of Dassault Systèmes

Q: How is your 3DExperience solution a differentiator for Dassault Systèmes? A: 3DEXPERIENCE connects the company’s different work streams, across business operations and transforms them

Business Solutions Through the Smart Use of Data

into a unified engine, focused on reaching the company’s goals. It enables the sharing of all relevant information, whether it relates to the manufacturing process or R&D data, and increases its value by being accessible and useful to the people that leverage it. Q: How are Dassault Systèmes digital tools helping to grow healthcare access? A: We have a very successful example in our Living Heart project. Through this solution, companies can create a simulation of an individual’s heart and then look for positive treatments. Medical devices companies use this to make sure their products work as designed. For the medical professional that is actually performing the work, this solution may enable them to take the data collected from the patient and project it into the Living Heart system. This could allow Surgeons to use a heart model driven by the data from their patient to practice before the actual surgery. Dassault Systèmes also has a Living Brain project that delivers a simulation of the brain and also allows surgical simulations

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for medical professionals, or even determining the efficacy a drug has getting past the blood brain barrier. With the participation of more companies, we could even develop full body projects to ensure a safer performance for the medical professional and the patient.

Supply Chain An efficient and cost-effective supply chain translates to immediate benefits for all industry players. In a sector with quick shifts and constant emergencies, stable stock and operating capabilities ensure correct care provision and the opportunity to focus on patient-centric solutions. The health sector is moving toward Value-Based Healthcare models that are likely to reshape supply chain operations to better respond to an evolved care system with greater cost-effectiveness. Windows of opportunity opened up in the supply chain during the critical months of the COVID-19 pandemic. Normally, supply chain continuity is rarely a problem. However, amid mobility restrictions, the world’s supply chain was disrupted. API provision during the first months of the pandemic was severely affected, which demonstrated that building resilient supply chains though collaboration and technology is key to supporting the health sector in becoming a key pillar for economic recovery in 2021. This chapter explores Mexico’s chances to transform last year’s challenges into opportunities. “This is the right opportunity for Mexico to take on one valuable pillar of the supply chain, API production. This could reactivate the pharmacochemical industry in the country and it would mean more opportunities for Mexico and for the region, even,” Rafael Gual, Director General of CANIFARMA, told MBN.

Supply Chain

122 Analysis Opportunity in Supply Chain Dependency, Disruption

123 View From the Top Deyanira Chávez | Director of T5DC

124 Expert Contributor Jaime Castro | Director General of BPF, part of QbD group

125 Insight Cecilia Padierna | Director of New Business Development at LEI

126 View From the Top Salvador Berrios | Managing Director of Qually

127 Expert Contributor Philippe Fournet-Fayard | CEO of Eolis América Latina

128 View From the Top Antonio Martínez | Sales Manager of Sefar

129 View From the Top Fernando Infante | Service Manager of Waters Corporation Latin America

130 View From the Top Daniel Abril | Mexico Country Director of STERIS

131 View From the Top Mario Ochoa | CEO of GRUPO SINOTEK

132 View From the Top José Luis Jacques | Director General of Lavartex

133 View From the Top Leticia Zermeño | Commercial Director at Grupo CPQ

134 View From the Top Alonzo Autrey | Managing Director of DVA Mexicana

135 View From the Top Rafael Mendez | Regional Director of Croda

136 View From the Top Luis Gabriel García | General Manager of DIBICO

137 View From the Top Anil Andrade | Director General of ACG Group

138 View From the Top Enrique Hernández | Founder and General Manager of Capsutec

139 View From the Top Ernesto Hernández | Director General of Zebra Technologies Mexico

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Opportunity in Supply Chain Dependency, Disruption Uncertainty and disruption within global supply chains at the height of the pandemic, combined with a high increase in demand for simple things like face masks, sanitizers and cleaners to ventilators and medicines, led to shortages that concerned the healthcare industry and world governments. But the crisis also opened a door of opportunity for Mexico. Healthcare manufacturing and supply chains are challenging. In China, the rapid expansion of the virus led to mass lockdowns and isolation measures, leading to stoppages in API production that complicated the operations of supply chains around the world, especially among heavily dependent generics companies. India imports 70 percent of its APIs from China and delivers around 45 percent of the generic products used in the US. According to the US Trade Department, China produces 95 percent of US imports of ibuprofen, 70 percent of acetaminophen and about 45 percent of its imports of penicillin. As China’s supply chain faced the challenge of having to comply with orders received when factories closed, as well as with ongoing high demand for specific products, it highlighted the opportunity for Mexico, a key commercial partner to the US, to take advantage of the gaps in the pharmaceutical sector and with medical devices. Tijuana is a large manufacturer of medical devices in Mexico, exporting 91 percent of its medical equipment to the US and hosting around 48 medical devices companies. Furthermore, the country is a large producer of generics and has API production capabilities, which M.S. Nagendra, Director General of Zydus Pharmaceuticals highlighted in an interview with MBN. Both international and local players already meet strict regulatory requirements, he said, but there are still opportunities and gaps in terms of technology and innovation. “API production is one of those gaps as there are just a few local companies dedicated to API production.” The opportunity for Mexico is bolstered by its shared continental boarders that are less likely to suffer disruption due to events like the pandemic. Moreover, the crisis could see the whole pharmaceutical sector diversify its production processes across different markets to avoid future mass disruptions. In the medical devices sector, Mexico is the eighth-most important producer in the world and the leading manufacturer in Latin America. From the beginning of the pandemic, US demand for ventilators from Tijuana increased around 1,000 percent, according to AMID. Manufacturers in Mexico complied with the demand for ventilators as best they could, while also attracting criticism for continuing to export to other countries while Mexico had its own needs regarding medical equipment. Many of the manufacturing companies in Mexico are foreign and supplied their clients first. The Mexican government turned to these companies to support local shortages but they faced issues producing the needed equipment Read the complete article More about this topic

as their supply chain had been disrupted in terms of materials, costs, production and transportation – another argument for regionalizing the chain.

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Q: What are the main advances T5DC has made over its 25-year history? A: Pharmaceutical companies must wash, clean and sanitize all the equipment involved in production of medicines to ensure their safety, purity and effectiveness. Our challenge for the past 25 years has been to change the culture that washing or cleaning has to be done by hand. Plant operators and managers often believe that it is less expensive to hire people to wash the equipment in eight-hour shifts than buying a washing or drying equipment. The equipment we offer allow users to control all inputs, such as water flow, total water use, detergent and neutralizing volume, times, temperatures and drying times using twice- HEPA filtered, heated air. This cleaning process is much more efficient than washing by hand in terms of time, water and cleaning products consumes. Q: What products does T5DC offer in Mexico and how do they benefit the pharmaceutical industry? A: We offer Steelco’s automated washing equipment, Borer Chemie’s chemical cleaning agents and neutralizers and Suez’s Total Organic Carbon (TOC) analyzers. This last brand, which are now our highest-selling products, are used to analyze and

Deyanira Chávez

control all water used at pharmaceutical plants to determine the amount of organic and inorganic impurities present as residuals. We are also a supplier of Comecer isolators, which are inert

Director of T5DC

atmosphere glove boxes used to handle products that are sterile, sensitive to ambient moisture and other air particles or high-risk products that are dangerous for the user due to their high pharmacological activity and cytotoxicity.

New Technology Facilitates Sanitation, Validation

Q: How are you increasing awareness of the benefits these products offer to the pharmaceutical industry? A: We participate in several Pharma forums, Symposia and UNAM’s Post-graduate School of Chemistry courses related to cleaning validation. Our most significant work, is with the financial areas of our potential clients. Pharmaceutical companies must validate the trustworthiness and reproducibility of all processes and all products they will release to the market. Mexico is increasingly embracing these technologies. Some national pharmaceutical companies, such as Pisa Farmaceutica, Silanes, Senosiain, Liomont, Ultra and Chinoin, are now spearheading the adoption of these state-of-the-art technologies. Q: Which new technology trends are you seeing in pharmaceutical manufacturing? A: Track-and-trace technology is critical to the pharmaceutical industry. As the pharmaceutical industry grows, so does counterfeiting. The industry has invested significantly to stay ahead of pirates by modifying labels, dosages systems

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and packages, but what is increasingly more popular is the incorporation of traceability measures. Another growing trend are isolator systems. Medicines in Mexico and the world, are becoming more specialized as personalized and genomic medicines gain strength.

ne of the most recurrent concerns among managers, directors and business owners has to do with the results obtained in the various areas of a company and how these impact on regulatory compliance, business and the satisfaction of

customers and users of our products. Effort, time and money are usually invested in correcting procedures, remedies, re-work process changes, personnel turnover, fines, customer complaints and many other situations of which we are not always sure of the cause but which are part of the daily happenings in the company. In the health industries, most of the work in the operational and quality areas of the company has to do with knowledge, information management, measurement and scientific evaluation and implementation of processes and their related controls. Likewise, failures and errors are usually related to these

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same aspects.

Critical Thinking: The Basis for New Regulatory Compliance Jaime Castro Director General of BPF, part of QbD group

During the documentary review of quality systems and Good Practices, as well as the evidence of their compliance, one of the most valued attributes is that of robustness.

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The adoption of critical thinking within the culture of the company and especially in the processes related to quality, production and regulatory compliance ... (allows for) better decisions that increase the efficiency, effectiveness and quality of the results in processes” Robust results and evidence imply the fulfilment of some key attributes: complete, orderly, congruent and consistent information and data with the context and its background, with solid arguments that support the conclusions and results, coupled with sufficient evidence and proof. But how do we achieve robustness in our processes, their results, documentation and regulatory compliance? Normally, the answer we give to this question has to do with “ordering it to staff” or in other cases we try many isolated actions (purchase of equipment, changes in processes, change controls, deviations, hiring new staff, etc.) that, in the best of situations, and with some luck, many attempts and money wasted, can result in the desired compliance. This is where I integrate the concept of critical thinking. Critical thinking is defined as the systematic, rational and disciplined process of evaluating information from multiple perspectives to produce balanced and adequately reasoned responses.

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The adoption of critical thinking within the culture of the company and especially in the processes related to quality, production and regulatory compliance allows the people involved to make, in a conscious and rational way, better decisions that increase the efficiency, effectiveness and quality of the results in processes.

LEI: Authorized Third Party that Responds to The Pandemic

mid the COVID-19 global pandemic, the healthcare sector faces an urgent challenge that demands all actors in the industry join efforts to successfully conquer the health emergency. “COVID-19 quickly became a problem for healthcare systems around

the world. Once it became a pandemic, it was clear that the whole healthcare industry had to cooperate and contribute, including both public and private entities,” says Cecilia Padierna, Director of the New Business Development at LEI. Laboratorios de Especialidades Inmunológicas (LEI), a third party authorized by COFEPRIS, is developing a portfolio of services in response to the pandemic. “Our integral portfolio offers

Cecilia Padierna

high-quality services with the scientific support of high-level professionals and state-of-the-art technology,” says Padierna. LEI is characterized by its innovative

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catalog of research tools and solutions for the pharmaceutical, human and veterinary segments. Building on its good reputation and complete portfolio, LEI decided to adapt its tools to offer polymerase chain reaction (PCR) tests for detecting COVID-19. PCR tests have been highly recommended by WHO because they detect the actual activity of the virus, determining if the person is infected. Padierna highlights LEI’s collaboration with the Institute of Epidemiological Diagnosis and Reference (InDRE), which allowed the company to offer these tests after the institute recognized LEI’s previous work on positive controls and solutions. LEI also runs verification on diagnosis kits, which serves as a way to verify the specificity and sensitivity of antigen and antibody detection kits. These services complement the company’s biocompatibility tests of medical devices, which provide results related to the biocompatibility analysis panel of medical devices used to treat seriously ill patients infected with SARS-CoV-2. LEI carries out the tests in 3D in vitro systems that

Director of New Business Development at LEI

reduce the time of analysis. Regarding sanitizers, LEI studies the viricidal activity of products. Padierna says that the reception of these products has been good and that the company is happy to have been actively able to help the Mexican population and the authorities through LEI’s knowledge and experience. She adds that “the current context will lead to developments in the field of pharmaceutics and biotechnology, which presents an opportunity for LEI in its future work as an authorized third party for COFEPRIS.” Innovation and technology are banners for LEI. Its technological management model, supported by consolidated tools for the development and quality control of advanced therapies, allows to actively participate in the battle to control the pandemic. “This puts us one step ahead by offering the SARS-CoV-2 and viricidal activity tests, which are of the utmost importance in providing quality and scientific certainty for the benefit of tomorrow,” says Padierna.

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LEI is focusing all its efforts on the COVID-19 fight. “COFEPRIS’ workload is saturated with medical supplies and medical devices, which are urgently needed to prevent an overburdening of the Mexican healthcare system. Being an ally will help avoid delays in regulatory process regarding SARS- CoV-2,” Padierna says.

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Q: What new products are emerging on the Mexican health market? A: One new service we could start providing is testing cannabidiol (CBD). We have been waiting for two years for the legislative approval for legal production in Mexico. We have about 50 percent of the necessary technology already in place. Our total investment in tech for this is about MX$10 million (US$434,000). Our tests verify whether CBD oil has absolutely no trace or less than 0.5 percent of THC and therefore no psychoactive effect on the central nervous system. We are working with Canadian companies that have formed a cluster of high-level producers. A part of this cluster is dedicated to genetically modifying seeds to ensure the plant has no narcotic substance. For Mexico, the production potential of CBD is enormous. We are among of the largest global producers, which means the opportunity to transform this into a proper industry is big. Another area in which we have been very active over the last two years is antiretrovirals. We are collaborating with Gilead Sciences on 12 different types of antiretrovirals. In the last year, we have also been testing a lot of OTC and consumer products. These are products you can buy at OXXO, like naproxeno or caffeine combined with aspirin. Q: What is your perspective on the government’s

Salvador Berrios

current approach to medication purchases? A: I think that this is the worst decision for the country. We must fix the politics of purchases together. Right now, companies and

Managing Director of Qually

associations are in negotiations with the government. Some are saying there will be an agreement but If there is none, the national industry could be badly affected. By opening public purchases to international suppliers, which is what the Mexican government is doing, you are displacing Mexican producers. Lower revenues, in

Testing the Quality of Alcohol Gels

turn, mean less available resources for research and development. There can be no economy of scale without profits. If you are a company that has already invested in a biosimilar, for example, you are going to be in troubled waters. I think both the government and producers are to blame. If there is transparency, medication prices will favor the final patient. The national industry will not be lost as a result of the government’s direction but it will certainly contract. The industry represents over 1 percent of GDP and over 600,000 direct jobs. It is an important sector for the country. Q: What determines the cost of a medication? A: What makes a medication expensive is all the different steps in the distribution chain, which can be as much as 50 percent of the final price. The problem in Mexico is that the producer is one party and the distributor another. Government purchasing volumes are enormous, which means that if it buys 50 million units of one product, these cannot be produced by just one lab. Distributors get the product from different laboratories to create a complete package. This means, however, that laboratories

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cannot sell directly to the government, which would reduce the middleman costs. Having said that, if everything was managed by direct purchasing through producers, the big players would squeeze out the smaller producers. The government has not created a new scheme to create a more economical distribution.

very business leader or salesperson has been faced with this unbelievable customer decision regarding industrial investment: Take the cheapest offer despite evident differences in technology and its operational costs. The total cost of ownership (TCO) is used to

calculate the total cost of purchasing and operating a technology product or service over its useful life. These three underlined phrases are the basis of the analysis necessary to support the right decision. When an industrial company decides to invest, there are normally three basic possible reasons for it: + Growing the business + Answering customer concerns + Regulation compliance Despite the motivation, the pharmaceutical industry acts as a

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long-term investor. Any industrial project is based on 20-plus years

Total Cost of Ownership: Cost Versus Value Philippe Fournet-Fayard CEO of Eolis América Latina

of operating the facility. As a result, it makes a great deal of sense to take special care regarding the costs linked to these 20-plus years of operation. We are all used to handling operating costs. Most are identified and direct; some are not always considered. For example, in our health industry, to intervene in a critical system requires requalifying and validating the system, to the extent required by the facility documents. Any additional intervention for maintenance on the systems would cost time and effort, on top of costs related to the lack of production and spare parts.

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Industries that invest for a long period of time in operations (like biopharma) gain a huge benefit by focusing on total cost” The investment cost in the biopharma industry is treated as a fixed asset and typically depreciates over a long period of time (several decades). As a result, the impact of a 10 percent higher price on a purchasing decision has very little impact on the cost of the product itself. On the contrary, the operational expenses have a direct and immediate impact on the production costs, and consequently on the cost of the product and its sales price on the market, or the margin the market will allow you to get. This is key to understanding where to put extra money. The TCO is important for evaluating technology costs that are not always reflected in upfront pricing. Industries that invest for a long period of time in operations (like biopharma) gain a huge benefit by focusing on total cost, including purchasing and operation. Yes, this is more complicated to calculate than just the acquisition price, but it may make the difference on the indirect part of the product manufacturing cost.

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Motivating the organization to adapt the TCO analysis before deciding is the key. And it may begin with changing the bonus calculation of the purchasing department: no more reward only for the savings on the acquisition price. This approach is still a cultural challenge in many companies.

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Q: How do Sefar’s products support Mexico’s healthcare sector? A: Sefar is a Swiss company with more than 190 years of history. Sefar’s core business is the production of high-specialty fabrics, which represents a significant share of our earnings. The pharmaceutical industry is an important segment for the company. We began operations in Mexico in 2007 and we are one of the few companies that offers products with FDA certifications. Such products are also designed following GMP certifications, which guarantees safe use for powders and medicines for human consumption. Sefar has very limited competition due to the market we target, the high-quality product we offer and the technical maintenance we provide. Q: What are the main advantages SEFAR MEDIFAB and SEFAR MEDITEX provide to clients? A: These divisions offer fabrics for specialized technical use that comply with FDA and GMP certifications. These allow us to manufacture all types of filters. SEFAR MEDIFAB is exclusively focused on the life sciences area but can also target for implants, blood filters and infusion sets. We have also FDA materials to produce filters for powders and medicines for human consumption. Q: How is your multinational experience reflected in

Antonio Martínez

the portfolio of services you offer in Mexico? A: At our headquarters in Switzerland, Sefar has a global market management team in charge of gathering all success

Sales Manager of Sefar

cases around the world from our work with multinational pharmaceutical companies. This allows us to detect successes and replicate them in similar cases we face in different countries. In Mexico, we have a specialist for the Mexican pharmaceutical

High-Specialty Fabrics for Safe Pharmaceutical Production

industry who shares the experience in the country and the dynamics of this industry. The specialist will look to both Swiss knowledge and Mexican experience when creating tailored solutions that meet high-quality standards and share this valuable knowledge with the 10 sales people in Mexico. Q: How does Sefar help customers comply with safety requirements? A: Sefar offers traceability on all its products, from the reception of our raw materials coming from Switzerland. We even offer a quality certification, which is highly valuable for companies to prove their safe processes to COFEPRIS. Our engineering and design department detects when we need to adapt our solutions to improve our client’s performance. Each week, we analyze if there is any specific case where the team has spotted an area of opportunity to deliver a fast, innovative solution. Q: How does Sefar position its products in the Mexican market? A: Sefar products talk for us and we also participate in congresses and events like Expofarma where we can showcase

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our works and newest services. Our field work is one of our strengths; we have 10 sales people around the country, all of them with a high technical capacity to demonstrate Sefar’s expertise through our products. We mainly work with the private sector in Mexico.

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from the

Q: How do your solutions adapt to the different needs of the life sciences sector? A: Our strongest market in life sciences is the pharmaceutical sector, mainly laboratories that develop drugs and those that focus on quality control. We also work on research projects, which in Mexico are mostly basic research projects done mainly at research centers. Brazil and Mexico are just behind the US, Canada and China on the company’s priority list because of the size and growth in R&D in these markets. Mexico has always been important for our growth on the continent. Q: How involved is the country in Waters Corporation’s new developments and products? A: In Mexico, we have around 70 collaborators who have been working with us for close to 25 years. These experts have a lot of say when developing new products or innovating in our portfolio because of their vast knowledge in the field. Waters maintains close communication with clients to receive and apply their feedback. We are interested in being part of their operations, to improve our services and always offer them the best solutions. We have had clients that trust us with their first product models, meaning that we work alongside them from the design of the product to the trials.

Fernando Infante

Q: What added value does Waters Corporation offer to complement its solutions portfolio?

Service Manager of Waters Corporation Latin America

A: In the niche of laboratory instrumentation, support service is one of the strongest differentiators. Waters Corporation significantly invests in the development of protocols and processes, in staff training and keeping our members up to date.

Expert Feedback Influences Innovation, Product Development

Q: What has been your most successful product or service in Mexico? A: Bioaccord is one of the products that we designed especially for the pharmaceutical area, which is intended to support the development and trials of a product. We also have high resolution products that focus on mass spectrometry at hospitals and research centers such as the INCMNSZ, INMEGEN, CINVESTAV or the UANL, as well as pharmaceuticals like Probiomed and the National School for Biological Sciences. Q: What are the near-term goals for Waters Corporation in Mexico? A: Our priority is the safety of our collaborators and our clients. We have been actively tracing any possible case to avoid contagion. Another priority is to ensure business continuity. This pandemic has put us all in an unknown place but we have accepted the challenge and responded to the new reality. It is key to maintain financial strength and flexibility for payments to keep moving. Waters Corporation is committed to fighting COVID-19. Our

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global research centers in Europe and the US are actively participating in vaccine development and drug trials. We have a special collaboration with AstraZeneca, which is one of the main contenders for a COVID-19 vaccine, and we are very proud of this effort.

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Q: What are the benefits of the company’s Going Green line? A: Washing and sterilization are two key processes at hospitals. A considerable amount of clean water and energy are needed to guarantee proper decontamination. Steris uses technology to reduce consumption of these two resources through the safe recirculation of water and taking advantage of the thermal energy contained in the existent steam system to heat the water that is entering through heat exchangers. Q: What added value do you offer with your state-of-the-art products? A: STERIS has a certified field service network that includes our employees but also the technicians from our distribution network, all trained at our facilities. We conduct all maintenance operations in-house. We also have technicians at strategic locations to provide quick access to hospitals if needed. Q: What makes STERIS the global leader in decontamination and infection control? A: One of STERIS’ advantages is the introduction of a sterilization method for material that cannot withstand high temperatures, such as endoscopes, thermoplastics and robotic tools. Our technology differentiates us from other companies that use

Daniel Abril

hydrogen peroxide plasma sterilization. STERIS Vaporized Hydrogen Peroxide process has several benefits. STERIS strands out for its adaptability to the costumer demands.

Mexico Country Director of STERIS

From costumers that do not consider sterile processing core to their business to the ones that consider it critical within their operation, we have a solution for every need and approach. Q: How does STERIS decide what to

Smart Resource Management in Sterilization Processes

incorporate into its service portfolio? A: STERIS awareness of new trends drives the innovation within the current business units or expansion of new business models, most commonly, through incorporations of new companies. On the last decade or so, Steris has been acquiring several smaller companies that specializes on specific service offerings that fits STERIS vision. Q: What are your priorities for STERIS Mexico in the short term? A: We see great potential in Mexico. in spite of having a manufacturing footprint in Monterrey for more than a decade, our commercial presence was supported solely by distributors. However, after a recent acquisition, we now have a direct commercial operation of more than 40 people. STERIS is really looking forward to seeing our presence in Mexico grow significantly. We are exploring how to adapt the new business models implemented elsewhere within STERIS in Mexico, moving away from the view of being a manufacturer towards a complete

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service provider. It is very important for us to be close to our customers, understand their processes, generate diagnostics of the current state and then offer something that adds value, rather than offering a cookie-cutter solution. Our diagnostic process is based on international norms, which results in real improvements.

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Q: How representative are the pharmaceutical and medical divisions for GRUPO SINOTEK’s operations? A: When GRUPO SINOTEK started, we were solely dedicated to the purchase, revamping and sale of used equipment for the pharmaceutical industry. The amount of used equipment in the US made us dabble in this market to meet the needs of Mexican buyers, with GRUPO SINOTEK taking care of the transportation and maintenance of the equipment. From this experience, we began building a team of experts on pharmaceutical equipment companies in line with mechanical, electrical, software and validation requirements. With a strong team – high-quality programmers have differentiated GRUPO SINOTEK from other companies – and after realizing the opportunity that Asian machinery manufacturers trying to enter the Mexican market, we began to team up to promote, sell and service their equipment. GRUPO SINOTEK represents, among others, the Chinese International Machinery Association (CIMA) to standardize purchases of spare parts and build a stable equipment offering and local maintenance for such parts. This was a necessary step to secure our market penetration and growth. We have worked with more than 450 pharmaceutical companies, sold 3,500 pieces of equipment and machinery representing sales of US$250 million. Moreover, GRUPO SINOTEK has allied with

Mario Ochoa

engineering companies to put together larger projects for our clients, including pharmaceutical companies in Mexico, Venezuela and Argentina and we are now expanding to Latin America. Despite working with other sectors, the pharmaceutical industry

CEO of GRUPO SINOTEK

represents around 70 percent of our revenue. The projects we put together for our customers take around 12 to 24 months so the capital turnover is slow. However, multisectoral and regional work has made our business model sustainable over

Project Management Solutions for Pharmaceutical Developments

time. Additionally, GRUPO SINOTEK has offices in China in charge of the quality management services we offer in the Americas. This has enabled us to understand complex scenarios, such as the isolation and containment systems for highly toxic products or biotechnological developments of monoclonal antibodies. This international experience has pushed us to search for customers in the Americas interested in bringing new technologies to their side of the world. In fact, we are working with a Chinese pharmaceutical company to transfer technology for COVID-19 vaccines that is interested in finding Latin American partners. Q: What are GRUPO SINOTEK’s short-term plans? A: Local drug manufacturers are being challenged due to the open medicine purchasing scheme. We have seen two sides of the story: manufacturers that are betting everything to remain competitive and win the tenders and others that have lost hope of filling an order. Within this scenario, we want to encourage the former and work with the industry to realize the benefits of being a company that knows the industry and that manufactures locally. We can identify many plants in need of equipment maintenance or replacement and we can prove advice for

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better performance or specialization depending on a company’s capacities or market opportunities. This industry has a great deal of potential and we see it reflected in laboratories such as Liomont and Landsteiner, both of which are working on different COVID-19 developments.

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Q: What is the main value derived from Lavartex’s products and services? A: Lavartex is a company backed by 98 years of history and continuous innovation. We constantly analyze best international practices and adopt them. We are also generators of ideas and proposals for the industry. We want to be recognized for the value of our services and not be seen as a commodity. The company is not just an industrial laundry. We consider ourselves as a hospital and surgery clothing supplier. We now make uniforms for doctors and nurses. We provide a comprehensive solution for everything that has to do with textiles in hospitals. All our textiles are reusable and are ours, which means that the hospital does not buy clothes or need to have a laundry. We offer a comprehensive service and that benefits the hospital because it can focus its CAPEX on its core business and not on buying clothes. We have smart clothes, like an operating room uniform that repels liquids and protects the medical staff and the patient. It also has active carbon fibers to dissipate the conductivity within operating rooms. Soldering irons are used to heal wounds in operating rooms and we provide the doctor with uniforms that help to prevent the static generation. Another added value of Lavartex is that we pack and sterilize

José Luis Jacques

surgical clothing at our plants, where we have confined and specialized spaces equal to Sterilization and Equipment Centers (CEYE). This saves the hospital time and we ensure quality thanks to our more than 15 years of expertise in

Director General of Lavartex

this area. Q: Is Lavartex technology created in in-house laboratories or in partnership with someone else?

Reusable Medical Clothes in a NonDisposable World

A: We work following both schemes. We do not have scientists; we have process engineers. We have an engineering department that is constantly looking for improvements. We have a continuous management and improvement system, which is why we are ISO 9001 and ISO 14001 certified. In addition, our marketing department is constantly looking for new products. We not only seek to ensure cleanliness and quality but also the comfort of doctors. Our reusable uniforms with natural fibers like cotton are not as heavy as disposable uniforms. We care about comfort and protection and that is why we care about design and manufacture products with smart textiles. Q: How relevant is Lavartex’s presence in the pharmaceutical sector? A: We serve more than 1,000 public and private hospitals. Pharmaceutical is our third division. In this area, we focus on textile rentals and washing solutions. Lavartex is a leasing model with maintenance and a logistics and control system that guarantees that what our customers use is hygienic. Last year, we certified in NMX-040, which is the first standard in the

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sector that specifies the maximum number of microorganisms that a garment can have. For example, a cloth napkin that comes in contact with people’s mouths, if not processed correctly, will have a high number of microorganisms. The same thing applies to a gown in a pharmaceutical laboratory.

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Q: What differentiates Grupo CPQ from other distributors in Mexico? A: Originally, we started as suppliers of veterinary APIs. Later on, and thanks to the acquisition of several distributions in Mexico we expanded the scope to pharmaceuticals delivery systems as nutrients and health ingredients. We currently have five national distributions from global leaders and more than 135 international partners whom we regularly audit to ensure the quality of their supplies. This allows us to have a portfolio of comprehensive solutions that amounts around 900 products in the last year. Our primary role is to connect the supply chain, complying with Mexican regulations and at the same time strengthen our extensive storage capacity to provide fast and competitive response to our customers. We have recently opened a Personal Care Applications laboratory, which allows us to support our business partners in their formulation and performance challenges, seeking to generate new business opportunities. Regarding human pharma business unit, we walk together with our customers on their development process, from the selection of reliable sources until the obtention of registration. International logistics and different schemes of importations add an additional dimension of complexity to our service, as most of our products come from India, China, the US as well as some European

Leticia Zermeño

countries. We manage our own logistics up to a radius of 500 km and cover 22 states actively through a network of logistics partners throughout the country that organize the transfer of goods. For reference last year we managed 4,200 tons.

Commercial Director at Grupo CPQ

Q: How do you choose the companies you partner with? A: Since we are focused on understanding the needs of our customers, we are looking for strong and reliable business

Strong 900-Product Portfolio for a Connected Supply Chain

partners, with whom we share business philosophy, market vision and who have innovative and high-quality products and technology. Our strength is in the ability to anticipate situations and calculate risks, as well as foreseen market trends. Q: What new products are you planning to introduce to the market? A: At the beginning of 2020, we signed a contract with a global leader to be their specialty excipient distributor for pharmaceutical segment. In terms of other products, we must consider that Mexican pharmaceutical industry is dominated by generics and depends heavily on patents to expire in the upcoming years, so we work on making partnerships with manufacturers who can provide the documentary and technical support required to comply with Mexican regulation. On average, we attend about 750 project evaluations each year. We will also seek to expand our Human Nutrition portfolio including a variety of natural extracts and custom formulations (Premix), as well as boost our portfolio of sustainable skin and Hair Care Bio actives, solar filters and surfactants.

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Currently the industries in which we participate face different challenges, from optimization of inventories and logistics of goods to create differentiated value propositions. Our challenge, to continuously renew ourselves and innovate to constantly more efficient and specific mechanisms.

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Q: How has DVA Mexicana addressed COVID-19 challenges as a provider of APIs, excipients and coating solutions? A: To avoid disruptions, DVA Mexicana has strategically planned long-term inventory orders. In the past, we would begin planning three to four months prior, whereas now we plan five to six months ahead because delivery times are uncertain. In Latin America, this logistics challenge had a positive impact on our API demand. DVA Mexicana received large orders to supply APIs that we would usually sell in limited amounts for analgesic products. We have been vigilant regarding market behavior to respond to our clients’ needs and requests. Q: How has the government’s purchasing scheme impacted DVA Mexicana and its clients? A: We see this directly reflected in two areas. The first was the considerable reduction in excipients going to special government orders. Since 2018, many medicines in the government’s basic scheme have faced cuts. We started to resent these changes when our clients began asking for lower prices on APIs after the tender of that same year was paused when the new government entered office. Pausing the tender resulted in medicine shortages.

Alonzo Autrey

In 2019, the government released another tender but many key drugs were not covered and others were asked to be covered at 80-120 percent. Another impact for the industry was the elimination of distributors from the purchasing

Managing Director of DVA Mexicana

process, which led to a reconfiguration of suppliers. Q: How has your patent plan for DVA Mexicana’s production plant in Mexico developed?

Market Analysis Spurs Successful Portfolio Offering

A: This project in Hidalgo has been developing favorably. Patent processes are long but we are already halfway through a development called Easycoat SP that helps protect products in an oily medium or co-process active in an oily medium, such as capsules that contain oily mediums. Q: What is the differentiator for DVA Mexicana’s excipients line? A: The strategic partners we work with help us stand out. We have been able to create strong partnerships with the manufacturers we work with, which even allowed us to communicate their innovations to our clients. We have chosen high-level partners from Asia that work to high standards. Q: How active is Mexico in the development of new molecules for treatments? A: In Mexico, we have not seen the development of new molecules, only their production once the patent expires. To successfully participate in this process, DVA Mexicana studies trends in larger markets and looks at the patents soon

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to expire in the US or Europe. As a result, we know which products will successfully enter Mexico using our excipients. We have one of the largest specialized excipient portfolios in the Mexican market and that helps us to reach more clients and offer a complete service.

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Q: Why is Croda the ideal provider of specialty ingredients for the healthcare sector? A: Croda has been labeled one of the most sustainable companies globally due to the natural origin of around 65 percent of our raw materials. We have a strong sustainable chemical base and our investments today are 100 percent focused on sustainability and green chemistry. At a global level, Croda has three core divisions: personal care; life sciences; and performance technologies and industrial chemicals. Our personal care division follows a B2B approach for the cosmetics and personal care Industry. Our life sciences division include three business units: Health Care, Crop Care & Seed Enhancement. Lastly our performance technologies and industrial chemicals division responds to the needs of diverse sectors, such as Coatings & Polymers, Polymer Additives, Home-care, Energy Technologies and Mining. Recently, Croda defined its goals for 2030 and we are determined to become the most sustainable partner & supplier of specialty chemicals globally and to become Climate, Land & People Positive. In the last 2 years we have made important global acquisitions to expand our knowledge and expertise in the Excipients,

Rafael Mendez

Adjuvants & Lipids technologies, and our expectation in to become a very important world leader in these areas in the following years.

Regional Director of Croda

Q: How is Croda expanding in the pharmaceutical market? A: We want to position Croda as a strategic & key partner for drug delivery, excipients & adjuvants systems for the entire pharmaceutical market. Our expertise in the area has driven

Sustainable Chemical Ingredients to Lead the Market

us to perfect and evolve our offering for these segments. In the last years, Croda has been focused in high-purity excipients solutions for complex pharmaceutical formulations and in the last two years we have made significant new acquisitions that has strongly complemented our portfolio. The first one, Biosector (Denmark), was an acquisition made in 2018 focused on vaccine adjuvants, and at the beginning of 2020 we acquired Avanti Lipids (US), that is a company specialized in lipid-based drug delivery technologies. As a dynamic global company, our complete product portfolio is available in Mexico and the Americas to ensure equal access to our solutions. Q: How representative is Mexico for the company globally and what are the strengths that Croda sees in the country? A: Mexico is one of the priorities countries for Croda globally. This is a very interesting market that has a fructiferous synergy with the US market and economy and has a very important internal demand. Croda has built a competitive advantage with our strong local operation, supported by a local commercial team and a local supply structure. Our

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products are imported from our manufacturing sites from all the world (US, EU, Asia and LATAM), but our offer in Mexico is highly concentrated in products coming from our sites in the US and Brazil, that allow us to offer a high level of competitiveness.

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Q: Why are DIBICO’s solutions the best option for the clinical diagnostics and pharma industries? A: DIBICO is a family business with 40 years of experience providing products for the clinical diagnostics, pharmaceutical, food and beverages, cosmetics, water treatment and research industries. DIBICO began building its name by providing high quality products that allowed us to compete in niche markets with multinational companies. DIBICO has strong manufacturing capabilities and a guaranteed quality that is not easy to replicate in other markets. This has been key to our success outside Mexico. We have established a good synergy with other products in the microbiology segment in Central America and have successfully built our presence alongside our distribution partners. Q: How representative is the life sciences sector for DIBICO? A: About 50 percent of our sales are within the clinical diagnostics market to clients such as SSA, IMSS, ISSSTE or private laboratories. In the pharmaceutical market, our clients are quality control areas of local and international pharmaceutical manufacturers, which they use to make sure their products or processes comply with quality and sanitary regulations. On the industrial side, we supply companies like Kimberly Clark de

Luis Gabriel García

Mexico, FEMSA and P&G. As a supplier, complying with the regulatory and technical requirements of local authorities as well as of large multinationals

General Manager of DIBICO

has been a challenging, but rewarding journey that never seems to end. Their strict and high standard requirements become our advantage against competitors. Q: What are DIBICO’s flagship products?

Clinical Diagnosis, Flexible Pharma Solutions From Mexican SME

A: Our prepared culture media for clinical diagnostics has been among our most successful products this year. We have over 100 products and solutions in microbiological diagnostics. This area has experienced solid growth this year, coupled with products known as transport mediums. When COVID-19 began in Mexico, demand for viral transport medium used for samples of COVID-19 tests increased quickly. As an SME, we have been able to respond and adapt to demand because of our flexibility and fast product development. We shifted our production lines and thanks to our good manufacturing practices, we could even invest in this new production. In the long term, this is a market we can keep exploiting. Moreover, our strategy and vision to move quickly into this market allowed us to compensate other areas that were hit as a result of the pandemic. Therefore, we remained strong in the market. In the near term, DIBICO will work to consolidate these new products. Q: How has DIBICO positioned itself in the life sciences market? A: DIBICO has achieved a high-quality product consistency, which

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delivers the satisfactory results for our clients when using our products. Quality and efficiency are highly valued in culture media market that works with short expiration dates. We have built smart product mix and inventory that allows a quick response to our clients’ immediate needs.

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Q: Which segments have performed best this year and where does ACG Group (ACG) see the most growth in the coming years? A: In recent years, ACG has been on a growth trajectory, and, partnered with a variety of new customers. We have had a sizable footprint in Mexico for quite some time, and understand that products are put through a lengthy approval process with COFEPRIS. In 2019, we positioned ourselves as the preferred supplier of integrated manufacturing solutions in the market – a strategy that resulted in impressive year over year growth. We are pleased with our current standing in the Mexico market, and expect a similar level of growth in the coming years, including an increased customer base. Many more capsulebased product manufacturers in Mexico now view ACG as a premium supplier, and we are in the process of integrating those accounts, many of which are multinational companies. Many customers, especially in the pharmaceutical sector, are looking for supply chain risk mitigation, which means they are considering new suppliers that can meet the same requirements as their current supplier. We are the only capsule company that consistently increase capacity, build new plants and acquire new companies across the world. This persistent infrastructure investment is noticed by existing and potential customers alike.

Anil Andrade

Traditionally, our manufacturing base was in India, meaning we exported most of our capsules to Mexico from India. In 2020, we started using Brazil as a closer alternative, and look

Director General of ACG Group

forward to this site becoming a major supplier to Mexico. We are already importing material from there and, once COVID-19 restrictions ease, we will arrange site tours of our plants for current and prospective customers in Mexico and across Central and South America, so they can see our processes for

Regionalization Key to Avoiding Disruption

themselves. We do not rule out the possibility of opening a manufacturing plant in Mexico in the coming years. Q: What is your perspective on stimulating national production versus importing products? A: For many countries, stimulating domestic production would be a wise move once the COVID-19 crisis subsides. This has, of course, transitionally been a challenge in the pharmaceutical industry, as many APIs are either from India or China, and that has led to disruption in the supply chain. We are also concerned about this issue since we are based in the US and rely on supplies from India and Brazil. We are working on a solution to overcome this issue through a local facility. At present, we have a facility in Brazil. In the coming years, we will plan another facility. Manufacturing capsules requires a great deal of capital investment. It is also an art form of sorts, so people with the right skills are needed to manufacture superior product. As soon as USMCA is enforced, trade between the US, Canada

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and Mexico will become for more expedient. Globally, there are 50 to 60 capsule manufacturers, and the top 3 are in the US. The gap between the leading players and all other companies is still huge in terms of technology, expertise, manufacturing capabilities, quality and buying capacity.

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Q: What business opportunity has Capsutec found in the Mexican market? A: As a group, we have been working for over 20 years in the nutraceutical and biopharmaceutical industries and even in cosmetics due to the large amount of companies focused on the “beauty from within,” concept, which combines capsules with typical dosage forms. We are not in the soft gelatin capsule market, but we do participate in hard gelatin capsules as well as polymer capsules. Q: How did the idea to manufacture capsules in Mexico emerge? A: Lefan, a large capsule manufacturer, approached me with the idea of installing a capsule manufacturing facility. After exploring opportunities in Brazil and Argentina, they decided on Mexico. We began as a distributor of their products. After a successful commercial partnership they decided to manufacture in the country due to its privileged location that allows easier export to North and South America. The brand so far has performed really well in the market due to its several Asian, European and North American certifications. We have been in the Mexican market for two years, with 70 percent of our sales based in the nutraceutical sector and 30 percent in the pharma segment.

Enrique Hernández

Q: What challenges does a capsule manufacturer face? A: In capsule manufacturing, there is a profit margin of at

Founder and General Manager of Capsutec

least 40 percent. Naturally, we face fierce competition, but it remains a good business given its main focus is on the US and Canada markets. In addition, it is a market with a great deal of potential in many areas, from dermatological to nutraceutical applications. However, growth remained low in 2019 in Mexico,

Capsules: A Business with Great Potential

at around 5 percent given the changes that took place at the federal level. Several public bids have been canceled or suspended. If our customers cannot participate in these bids, it will affect the double-digit growth rate we enjoyed in other years. Q: What strengths have made Capsutec stand out in the market? A: Our main strength is quality. We manufacture our product using high-quality materials. There are just a few companies in the world that supply pharmaceutical grade gelatin to the pharmaceutical industry. A second element is hypromellose, where there are also just a few companies that produce this for the health sector. The suppliers we choose must use these kinds of components. Another major strength is our process. We have automated a great part of the process already and our landmark is speed. Our main advantage is that for product development, we have direct access to the decision-makers of the companies we work with, making our process much faster. In addition, customer service,

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delivery times and product quality make us more efficient. What can be a liability for us, but that is outside our control, is the import licensing from COFEPRIS, which can take from one week up to a month to receive.

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Q: Why are Zebra Technologies’ solutions the best for the healthcare industry? A: Zebra offers a variety of solutions and products for different stages of healthcare. We work with hospitals, clinics, pharmaceutical laboratories and clinical laboratories, from raw material processing to product delivery to the end consumer. Our solutions in the pharmaceutical market cover raw materials supply, processing, packaging and shipment to the warehouse. We also offer tracking services throughout the entire processing and distribution stages. We work with the most recognized laboratories to track boxes and pallets in warehouses and shipments from laboratories to wholesalers. Our work with wholesalers, on the other hand, is based on logistics, classification and sorting of products. Zebra also offers mobile computing solutions to help wholesalers deliver their products to pharmacies. As for pharmacies, we also offer them mobile computing solutions for when they distribute to the general public. We also have a wide portfolio of scanner solutions to track supplies. The added value we offer to mobile computing is the security shield we provide with our operating systems to guard the information generated by our clients. Zebra is also present in hospitals, where we offer identification bracelets for patients to ensure a controlled supply of medicine.

Ernesto Hernández

There are frequent mistakes in hospitals regarding prescriptions, from wrong doses to adherence to treatment. The use of technology can provide solutions to reduce these incidences. We offer a similar solution to laboratories for tagging samples. When

Director General of Zebra Technologies Mexico

these are sent for analysis, our labels offer tracking, providing information regarding location, programmed date of return and the temperature needed to keep the sample safe. We also offer identification through radio frequency for high-value medical equipment. This solution allows us to track the assets owned by

Technology-Based Solutions for Effective Results

a medical facility. We provide training in the use of our products to ensure productivity and the correct use of the tools. It is important to mention that all our devices have an auto diagnostic system that determines the state of its components. We also have an agreement with Google to support clients. This agreement guarantees at least two updates to our software to include security patches as our system evolves. Q: How does Zebra promote investment in innovative technologies? A: I see a lot of potential in the Mexican market as demand for new solutions will grow. However, regulatory measures and government mandates are necessary to ensure that Mexico properly improves its general healthcare practices. Right now, the country is only demanding basic management systems, which cannot compare to the standards of international healthcare systems. Q: What are Zebra’s growth expectations for the near term? A: Our goal is to achieve double-digit growth by the end of

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2022, with a focus on the healthcare sector. While coverage can improve, medical attention standards in Mexico are competitive. That being said, we hope to see government action to improve the overall state of the sector to provide patients the most effective solution for their situation.

Logistics & Distribution Probably the most important step toward integral health provision is last-mile delivery. Safe delivery of active ingredients to disposable supplies and efficient strategies in logistics operations are what ties health provision together. Storage, distribution, workforce and time efficiency are essential for this. However, security and mobility challenges demand better responses and quick reformulations. During 2020, there were three major disruptors to healthcare logistics and this chapter explores them all: a new medicine distribution scheme, mobility disruptions caused by the COVID-19 pandemic and the necessity to build a cold chain network to support the demanding requisites of the COVID-19 vaccines. Industry leaders conclude that Mexico and the Latin American region need to optimize distribution channels to best respond to uncertainty, taking into consideration terminal automation, smart ports and security. 2021 challenges logistics with larger port deliveries, fewer arrivals and faster last-mile demands. Moreover, this sector will need to meet demands from federal medicine purchases and the COVID-19 vaccine distribution to remote areas in the country.

Logistics & Distribution

143 Analysis Securing the Cold Chain for a COVID-19 Vaccine

144 Insight Mario Alberto Aguilar | President of Mexico’s Association of Logistics Operators (AOLM)

145 View From the Top Agustín Croche | President of DHL Supply Chain México

146 View From the Top Javier Calero | Vice President Commercial of GNK Logística

147 View From the Top Rolando Marín | Country Manager Mexico at World Courier

148 View From the Top José Luis Ortiz | Managing Director of Medistik

149 View From the Top Eric Delgado | Director General of Grupo SICAMSA

150 View From the Top Alesio Bereciartu | Commercial Director of the Healthcare Business Unit Latin America at OCASA

151 View From the Top Rodolfo Camargo | Director General of El Crisol

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Securing the Cold Chain for a COVID-19 Vaccine Recent vaccine approvals have given hope to a world that continues to suffer the devastation of the COVID-19 pandemic. Developments from Pfizer/BioNTech, Moderna, Gamaleya Institute, AstraZeneca and CanSino Biologics lead the race, but as distribution ramps up, they are running into another high hurdle: logistics. Minister of Foreign Affairs Marcelo Ebrard had already stated that securing the cold chain for the correct distribution of the vaccine would be a challenge in Mexico, which in late December launched its campaign to distribute the Pfizer/BioNTech vaccine. The logistics challenge related to the transportation and safety of vaccines like that of Pfizer/BioNTech is a result of the uncommonly low temperatures that are required to store the doses. This vaccine must be stored between -70°C and -80°C, allowing them to last for up to six months, or in specially designed shipping containers, called dry ice packs, for a maximum of 10 days. Once removed from the containers, the vaccine can be kept unfrozen for one day at 2°C to 8°C, or for a maximum of 2 hours at room temperature. Pfizer offered a solution to help transport and store its vaccine for Mexico. The company proposed storing the vaccine doses at distribution points of Mexico’s choosing, from which they could be transported using the country’s cold chain systems. Ebrard said the Ministry of Health had already evaluated Mexico’s logistics capacity, and found it was sufficient and qualified to handle the task. Otherwise, “Mexico would not have signed the contract with Pfizer,” he said. DHL, a multinational, was selected for the distribution. The German company has developed a strategy for the transportation and handling of Pfizer’s vaccine. Antonio Arranz, CEO of DHL Express in Mexico, explained to media outlets the holistic solution that the company planned to use in Mexico, which includes its Global Forwarding, Supply Chain and Express services to fully meet the transportation, storage and followup needs of different vaccines, such as ultra-freezing or regular cold storage. Arranz said that DHL Express would make use of 9,000 employees, more than 4,300 vehicles, five intercontinental flights and 16 national flights to complete the monumental task. Globally, securing the vaccine’s delivery will not be easy. Two-thirds of the global population are unlikely to have access to any COVID-19 vaccine that requires similarly low storage temperatures, according to DHL. Consultancy firm McKinsey reportedly found insufficient last-mile cooling facilities for the successful delivery of a vaccine in several countries. According to its findings, Africa, Asia and South America would be the most affected regions. Despite the challenges, Mexico’s distribution campaign was fully underway by midJanuary 2021. Ebrard said that between Dec. 23 and Jan. 31, Read the complete article More about this topic

Mexico was expected to receive 1,417,659 vaccine doses. The Mexican government has signed shipment orders for over 198 million doses from various developers.

Embracing Disruption Key to Logistics Operator’s Future

hroughout its history, AOLM has worked on strategic issues that fall under the jurisdiction of 3PLs and has supported various initiatives through its working groups and committees. There has been no exception with the health crisis that the world is experiencing.

The active participation of its members in a cooperative and cordial environment is one of the characteristics that distinguishes AOLM the most. Faced with this pandemic, we have shared good practices to benefit our logistics operations and also the environment with our customers and suppliers. The suspension of temporary activities and the confinement

Mario Alberto Aguilar

of employees caused a shortage of goods and raw materials in most sectors, as well as serious customs problems around the world, because strict sanitary measures

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had to be put in place to prevent COVID-19 from spreading. WHAT AWAITS US POST COVID-19? The coronavirus crisis is going to pass but it will undoubtedly cause the traditional supply chains to change. In many instances, due to the lack of contingency plans, the major impacts of this crisis have shown a supply chain that is not very resistant to disruption. Thinking about the next 100 years, all companies, not only those in logistics, should integrate prevention plans for future crises, as well as improve communication channels with our suppliers and adopt new technologies to monitor the performance of the entire supply chain. There is a great need, while maintaining economies of scale, for a more distributed, coordinated and traceable supply of components across multiple geographies and suppliers. This would require the creation of global platforms that use sophisticated

President of Mexico’s Association of Logistics Operators (AOLM)

technologies such as 5G, robotics, IoT and blockchain to help reliably link multiple buyers through a “mesh” of supply chains with multiple suppliers. In our new normality, change is definitely one of the constants we have to consider in our planning. The decisions that were taken without solid grounding as was done before will be remembered without a doubt as a great success or a great learning experience, depending on the result that we obtained before a changing world and being little prepared for an accelerated evolution. The B2B platform’s usual suspects, such as Amazon and Alibaba, are likely to move forward and compete for ownership of this more advanced supply chain ecosystem, while logistics operators will continue to be key players in globalization’s future. In this and other matters, AOLM will continue to work with

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other associations, organizations and chambers, both private and public, to benefit members and to allow a change in the development of logistics throughout Mexico. the Mexican republic. Similarly, work will continue on strategic issues that will keep it a pioneer in the logistics sector at the national level.

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Q: What are the challenges of having a vast network that can cater to the needs of different industries? A: DHL is a logistics company for the world and has become a global leader in the logistics arena. Thanks to its specialized solutions for growing industries such as technology, biological sciences and health services, energy, the automotive sector, consumption and retail, in addition to the company’s corporate responsibility and its presence in development markets, DHL has positioned as the best logistics company with an offering for the entire world. Each industry and each client has its own challenges, which may vary by geographical region. In this scenario, the global experience of DHL Supply Chain, as well as the solutions it has developed for each sector and the local knowledge it possesses, make it an ally to overcome any challenge and difficulty the company might face. Which is why is important to signal the emergence of new technologies that play an important role in optimizing operations, reducing costs and improving customer service, which are among the most important challenges that we currently face. Q: What are the strategies that DHL is implementing in Mexico to ensure that its operations are as sustainable as possible?

Agustín Croche

A: We know that our clients, regardless of their size, are looking for new ways to becoming more ecologic and sustainable and we know that if we want the planet to be habitable for future generations, we need to work together to identify and reduce

President of DHL Supply Chain México

emissions, improve business sustainability and achieve a circular economy. Q: How advanced is the digitalization of logistics services in Mexico and how can the country speed up this process?

Global Logistics Leader Bets on Digitalization and Innovation

A: Digitalization represents the largest logistics opportunity since globalization. Tools like the Logistics Trend Radar, published by DHL, allows to capture the development of trends for businesses, society and technology and has become a reference point for designing supply chain strategies. In past years, the adoption of these trends has transformed supply chains, making them 100 percent technological, increasing their response capability in a faster way. Q: What are the challenges that logistic providers face to maintain their operations uninterrupted in emergencies like the COVID-19 outbreak? A: Against the backdrop of the global COVID-19 outbreak, Deutsche Post DHL Group’s business operations are continuously adapting to mitigate potential impacts. As a global company, epidemic and pandemic risk scenarios are an integral part of the Group’s continuous risk planning. The Group follows a holistic management process that enables our business units to ensure the best possible operations for our customers with the help of so-called business continuity planning, even in an

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emergency. The safety of our employees and customers is paramount. The Group’s task force monitors the situation daily, coordinates with international organizations such as WHO, CDC, ECDC and the Robert Koch Institute and provides the necessary information to all employees.

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Q: How has the government’s new purchasing scheme impacted the pharmaceutical supply chain? A: The old Mexican model of distribution was based on states selecting what and where to get their medical supplies for the next fiscal year. State governments would release a tender in which manufacturing companies would participate. The winning companies would directly, or through distributors, deliver their products to public institutions. This has been strongly criticized as it makes the distributor an intermediary between the government and the supplier. Whatever the distribution option was, deliveries arrived to state warehouses and they were later distributed to end consumers. Q: What is the role of logistics companies in this process? A: Logistics companies need to negotiate with the manufacturer. Usually, logistic companies will finance manufacturers for the distribution of products and assume any added costs that are later recovered by the government’s payment. The new scheme takes logistics companies out of the equation, with everything now managed directly with the manufacturer. The main goal of the scheme is to provide timely payments to ensure the manufacturer has enough capital to produce. The government first tried to absorb the distribution costs by

Javier Calero

itself but then realized the challenge that entailed because it did not have experience and therefore the knowledge to handle this properly. The second option was to manage this through IMSS and ISSSTE services, but their capacity was not going to cover

Vice President Commercial of GNK Logística

it. This led the government, specifically SAT, to seek logistics operators specialized in pharma. That is how they found GNK. When we started working on plans for distribution, we realized that manufacturers were not ready for the complexity of direct

Exact Storage Control Systems To Prevent Product Loss

purchases and this caused delivery delays. It took four months for manufacturers, the government and us to learn from the new scheme. Q: How has the centralized purchasing scheme impacted GNKL’s use of technology and innovation? A: GNKL has developed a software system called Administration and Logistics System for the Health Sector (SIALSS). This system has been in development for 15 years. SIALSS is installed at hospital warehouses, regardless of whether they are located in large cities or rural communities. It allows us to measure the real consumption of the facility. This has given the authorities real-time information that allows them to create accurate consumption plans for future purchases. SIALSS also allows the possibility to measure expiration dates, oversupply, stock with relation to consumption behaviors and also the profile of the patient consuming the supplies. The system works through very basic infrastructure systems. We wanted to make it easy to implement at different facilities, independently of their technological capacity. SIALSS data is

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stored on the cloud, which allows us to generate reports that can be easily accessed through a smart device. SIALSS is the perfect tool to measure consumption rates and red flags related to the generation of fake consumption needs, which would create additional costs.

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Q: What role does World Courier play in clinical trials and research? A: Clinical trials are the starting point for APIs to become patented, commercialized and distributed. They are usually performed by large laboratories that need to meet strict global standards. At a laboratory warehouse, pharmaceuticals and placebos, derivatives and other materials are all part of a trial. Our depots have specialized storage and distribution facilities designed to transport specialty logistics products while meeting global compliance standards. For clinical trials in Latin America, we help pharmaceutical companies and central labs with the administration of the necessary supplies and APIs. We receive everything, catalog it and maintain the necessary temperature range required through our packaging solutions. We prepare orders and distribute them to clinics, hospitals, clinical trial sites and even directly to patients through our DTP service. Q: How does World Courier’s Cocoon service help clients to improve their logistics processes? A: International demand is increasingly growing for technologically advanced packaging solutions. Cocoon is a patented and exclusive product from World Courier used for international shipments. When a client needs to transport an asset, be it a medicine or a vaccine, Cocoon’s specific combination of gels alongside its

Rolando Marín

proprietary technology guarantees temperature-control for a certain period without the need for a power source. Power failures due to errors can lead to temperature variations that can spoil an API. Millions of dollars behind a research protocol can go to

Country Manager Mexico at World Courier

waste if a client does not have a container that meets today’s international standards. Cocoon’s predecessors sometimes also used a gel system but our containers are more advanced, last longer, weigh less and are made of carbon fiber. We offer different packaging sizes that can range from one European or American

Cold Chain Specialization for Clinical Trial Success

pallet to two EU pallets. Q: What actions is World Courier taking to strengthen its operations and solutions? A: Customers are frantically looking for faster and reliable options at a lower cost. With this in mind, we showcase Cocoon’s benefits and we do trial runs to demonstrate the quality we manage, delivering specialty logistics products in the shortest time possible while maintaining the correct temperature range. Globally, World Courier is recognized as the most trusted company for supply chain solutions. We are now using all international contracts to touch base with our clients here in Mexico. The strategy is to focus on the client and on our competitive advantage: clinical trial storage and distribution that meet global compliance standards. Q: What factors do you consider key to grow the company? A: World Courier was acquired in 2012 by AmerisourceBergen. We turn 50 in 2019 and we are now partnered with the 10th-largest Fortune 500 company. This drug distribution company is also governed by many agencies that regulate everything in terms of

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anti-corruption practices. This year, our goal is to develop and promote Cocoon and advise our clients, both CROs and large laboratories, on the subject of clinical trials. World Courier is the most reliable worldwide company in cold chain logistics at an international level.

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Q: What new services did Medistik develop to improve hospital logistics and inventories? A: We have worked on a specialized supply chain for hospitals and clinics to reach even the operating room. We deliver equipment for operating rooms, as well as supplies that are going to be used during the surgery. We have also developed a tool called Consigna to administrate, within hospitals, laboratory supplies according to a continuous replacement process, which consists of having a backup inventory and ordering supplies based on a demand forecast. Q: How are you participating in the growing home care trend? A: We deliver dialysis equipment directly to our clients’ patients. We deliver to around 700-800 patients, many of them connected to their medical devices and with limited mobility or just too far from cities with hospitals or clinics. This is part of a global trend called “medicine that follows the patient” that impacts both public and private hospitals and that also addresses hospital overcapacity. Our Healink service has also helped us to improve care and our clients’ relationship with their patients. Its goal is to avoid “switching,” which occurs when a patient receives a prescription for a certain medicine although due to out-of-

José Luis Ortiz

stock or other similar issues, the pharmacy ends up giving something similar to the patient instead of the recommended treatment. Healink registers the prescription and directly delivers the specific medicine to the patient to avoid

Managing Director of Medistik

switching issues. Q: How has Medistik innovated in its services to tackle new business opportunities?

Excellence Through Technology

A: We started working with the federal government, so our challenge now is to distribute large quantities of medicine. We need our technology to support the requirements that come from transporting such volumes and for that reason, we have worked with Logística de México to implement a warehouse management system (WMS) and we also want to connect with a transportation management system (TMS). We have also established an alliance with a Mexican organization, which is the current representative of JDA in Mexico, to help us develop a TMS. On the transport side, we have an alliance with trailer companies that have around 500 units to deliver the large volumes demanded by the government. We are investing to improve our storage capacity, order processing and on hiring more people for transportation operations. Q: How successful do you think the government’s new purchasing scheme will be? A: It will take time for all actors to adapt. But overall, I see this as a positive change that has a lot of vision and will bring

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savings for the government in terms of time and money. There are fewer losses with this scheme and the government can have more control over the process. My only recommendation would be to change things gradually so the impact is not drastic.

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Q: What challenges did SICAMSA face due to changes in the government’s centralized purchasing scheme? A: We received requests from institutions asking us to modify our contract to avoid affecting medicine supply because suppliers were struggling to deliver the minimum of services. The disorganization of public tenders was further affected by the pandemic, alongside scarcity in sanitary products due to increasing demand from other countries. Shortages and elevated prices opened the door to a black market that endangered the population due to the unknown precedence of such products. SICAMSA and the formal industry had to find ways to supply quality products to fill those gaps but COFERIS was slow with approvals and permits, which was also a barrier. We are facing unknown terms for medicine tenders and distribution while there is also uncertainty regarding the distribution of the COVID-19 vaccine when it arrives. The private sector has tried to reach out to the government to fix this but we have not obtained a clear response on how things will be managed or if the private sector will be economically supported due to the financial crisis that COVID-19 generated. I am concerned about future medicine supply. We have oncological treatments for children being stolen, counterfeit influenza vaccines and a restricted supply of this same product.

Eric Delgado

In the past, the public and private sectors would offer this vaccine. However, this year, its distribution has been limited to the public sector. Aside from this being a hit to the private sector, it means fewer access options for the population that

Director General of Grupo SICAMSA

would normally acquire this privately because they felt more comfortable going to their family doctor. All these decisions and uncertainty have pushed the private sector to find new ways to sustain companies. Even before

Health Industry Logistics Challenges Exposed

COVID-19, Mexico’s health system was already faltering. Q: What are your expectations regarding the Santa Lucia airport? A: This is another delicate subject that has been highly questioned by the logistics industry. It has become a politicized subject where public opinion is the only one that matters, despite the lack of viability or logic of the project. NAIM was closer to the city, which would make transportation and connection with AICM easier. The Santa Lucia airport will bring growth to that area. For the user, however, it will only generate more complications. I see more opportunity and less expenditure in investing in airports nearer the city instead of building a dubiously functional one. Experts on the subject predict the aerospace industry will recover in 10 years. But even if the forecast were better, this industry is slowing down, meaning that investing in more airports might not be the best bet. Instead, using Toluca, Puebla or Cuernavaca could have the same functionality or even be more efficient. Improving airline services could result in greater efficiency.

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I see a very difficult transition for logistics companies to using Santa Lucia. Operating in Mexico City is expensive. Operating in Santa Lucia will be expensive and the airport will be far from the city.

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Q: What is OCASA looking forward to implementing in its services? A: To date, real time information for logistic services is one of most requested added values from our clients. Reliable and accurate information for our shipments of medications and recollection of biological samples are critical for the healthcare logistics sector. We must provide the correct transit time, a controlled temperature through the entire supply chain and offer specific process in order to guarantee the most challenging requirements from the Pharmaceutical Industry. The traditional logistics have become a commodity, but the accurate real time information we can offer is what differentiate us. The efficiency of information and its effective use by companies is outstanding in the logistics sector. OCASA integrated that into its services. Traceability makes the difference for our clients and for our company. Our challenge is adding to our offer a first-class service in terms of quality and information technology, with best cost and benefit rate. OCASA brings to the Latin American market the service of excellence we provide in the US and Europe with an adjusted price to this market. Q: What makes you the top choice for CROs?

Alesio Bereciartu

A: OCASA knows what the market expects from a healthcare logistic provider mainly because our key staff comes from CROs and international pharmaceutical companies. We

Commercial Director of the Healthcare Business Unit Latin America at OCASA

understand their critical times, processes, dynamics between sponsors, hospitals, research sites, local authorities, custom authorities, etc., because we work with all of them in different stages of a clinical trial.

Information Database a Key Differentiator

In the clinical research field, there is no room for errors. Our prices are very competitive in the Latin-American market and our services comply with the highest standards. Q: How can OCASA contribute to the government’s plan to increase access to medicine and healthcare services? A: With the pandemic context, we implemented special services for the clinical research area where we deliver medications to patient’s home and we also collect samples from patient’s home. These services are called Direct to patient and Direct from patient services (DTP/DFP). The goal it is to reduce the exposure of the patients going to the hospital and to minimize the workload of hospitals by decreasing the number of patients looking for attention. This is an example of our Patient Centric Approach. Moreover, our contribution reflects through competitive prices and coverage. We have vast coverage and our cold chain and temperature control is very well-monitored, with a clear registration and proof of the process so clients can be confident that the

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product is safe to use and in good condition. The database we generate with the information is also statistically valuable as it shows patterns, stability, growth or losses. It also helps clients detect common problems or tendencies that they can address.

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Q: What results have emerged from your recently launched e-commerce platform? A: The platform started working this year. In the beginning, it was challenge to understand all the metrics because it is a whole new market involving new policies and regulations. Also, response times and logistics are very different, which led to many challenges at an operational level. We were very lucky to have it available before the COVID-19 outbreak. Q: How has El Crisol transformed its logistics operations. How have these changes strengthened your domestic and export operations? A: We have started to expand our distribution center and construction will begin in 4Q20. This has driven us to reformulate our logistics, involving more technology, data collection and tracing our new distribution routes. We are adding another logistics area to have control over all distribution units and warehouse activities to improve our times and reduce costs and risks related to temperatures. El Crisol has started making significant investments in technology, first by incorporating a SAP system and IP telephone services and later implementing barcode systems, automation warehouse systems, robots and reorganizational systems. This investment has allowed us to keep our operations flowing at a normal pace, even amid the pandemic.

Rodolfo Camargo

Q: What new trends are shaping the industry? A: Derived from the pandemic, the emerging trend is the change

Director General of El Crisol

to traditional business models that relied on presential visits. This will push digitalization on companies that were still resisting. As soon as the closures began, everything had to go digital or else you were left behind.

Strategic Planning Secures Successful Growth

Q: How has the pandemic impacted your logistics operations? A: We experienced panic purchases from laboratories and chemists and we were able to supply them before the emergence of this new “black market” for products such as alcohol and sanitizers. This subject is sensitive as COFEPRIS has control over those products and these new people in the market do not comply with regulations. I understand this is a business survival thing and that many people in Mexico adapted their sales to something profitable but from the regulatory side, it might not be the safest solution. Q: What are your growth expectations for El Crisol this year and the priorities of the company for 2021? A: We want to grow our monetary and time investment in our e-commerce platform. We have 3,000 products available and the goal is to have 13,000. Another goal is to finish our distribution center and therefore strengthen our technological investment and logistics operations. For the pharmaceutical sector itself, I expect double-digit growth due to the high peaks in demand following the tender results. As a supplier, we have realized this

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repetitive behavior and we are prepared to address the demand spikes following tender approvals. Lastly, we want to achieve the double-digit growth we have experienced each year, which will come thanks to our stable demand during the crisis and the big stock of laboratory products that El Crisol has.

Acronyms 3PLs

Third Party Logistics

CPTPP

ACROM

Comprehensive and Progressive Trans-Pacific Partnership Agreement

Clinical Research Organization Alliance of Mexico

CRO

Clinical Research Organization

AMELAF

Mexican Association of Pharmaceutical Laboratories

DCGI

Drugs Controller General of India

AMID

DRP

Direct From Patient

Mexican Association of Innovative Industries of Medical Devices

DTP

Direct to Patient

AMIIF

Mexican Association of Pharmaceutical Research Industries

ECDC

European Centre for Disease Prevention and Control

AMIS

Mexican Association of Insurance Institutes

EMA

European Medicines Agency

ANADIM

EMR

Electronic Medical Record

National Association of Drug Distributors

ENSANUT

ANAFAM

National Survey of Health and Nutrition

National Association of Drug Manufacturers

European Union

ANTAD

National Association of Supermarket and Department Stores

FDA

Food and Drug Administration

AOLM

Mexico’s Association of Logistics Operators

FIFARMA

Latin American Federation of the Pharmaceutical Industry

API

Active Pharmaceutical Ingredient

FPGC

Protection Fund Against Catastrophic Expenditures

AWS

Amazon Web Services

FTA

Free-Trade Agreement

CANACINTRA

National Chamber of the Transformation Industry

GMP

Good Manufacturing Practices

CANIFARMA

HIV

Human Immunodeficiency Virus

National Chamber of the Pharmaceutical Industry

ICU

Intensive Care Unit

CBD

Cannabidiol

IFPMA

CDC

US Centers for Disease Control and Prevention

International Federation of Pharmaceutical Manufacturers & Associations

CEDIS

Distribution Center

IMMEX

The Manufacturing Industry, Maquiladora and Export Services

CEPI

Coalition for Innovation in Epidemic Preparedness

IMPI

Mexican Institute of Industrial Property

CESSA

Health Centers With Extended Services

IMSS

Mexican Institute of Social Security

CEYE

Sterilization and Equipment Centers

INCIDE

Innovation and Science for Business Development

CFM

Mexican Pharmaceutical Council

INCMNSZ

CIMA

The Chinese International Machinery Association

The National Institute of Medical Sciences and Nutrition Salvador Zubirán

CINVESTAV

Center for Research and Advanced Studies of the National Polytechnic Institute

INDRE

Epidemiologic Diagnostics and Reference Institute

INEGI

National Institute of Statistic and Geography

INSABI

Health Institute for Welfare

Intellectual Property

CNS

Central Nervous System

COFECE

Federal Commission of Economic Competition

COFEPRIS

Federal Commission for Protection Against Sanitary Risks

ISSSTE

Institute of Safety and Social Services for Federal Workers

CONACYT

National Council for Science and Technology

JCI

Joint Commission International

Acronyms LAASSP

The Public Sector Acquisitions, Leases and Services Law

Prescription Drugs

LEI

Laboratorios de Especialidades Inmunológicas

SCT

Ministry of Communications and Transportation

M&A

Merger and Acquisition

SEDENA

Ministry of National Defense

MBN

Mexico Business News

SEDESA

Ministry of Health of Mexico City

NAFTA

North American Free Trade Agreement

SEMAR

Ministry of the Navy

SINGREM

National System of Medicines and Bottle Residue Management

NCD

Non-Communicable Disease

NOM

Mexican Official Norms

SME

Small-Medium Enterprise

NSF

National Safety in Food

SMEO

Mexican Society of Oncology

OECD

Organization for Economic Cooperation and Development

SSA

Ministry of Health

Tetanus and Diphtheria

OMC

The Office for Medical Cannabis

TMS

Transportation Management System

Operating Room

UNAM

OTC

National Autonomous University of Mexico

Over the Counter

PAHO

UNEMES

Medical Specialties Units

Pan-American Health Organization

PAMO

UNICEF

United Nations Children’s Fund

Pharmacy-Adjacent Medical Offices

PCR

Polymerase Chain Reaction

UNOPS

The United Nations Office for Project Services

PEMEX

Petróleos Mexicanos

USMCA

PHEIC

United States-MexicoCanada Agreement

Public Health Emergency of International Concern

VAT

Value Added Tax

PPP

Public-Private Partnership

WHO

World Health Organization

PROSEC

Sector Promotion Programs

WIPO

RGA

World Intellectual Property Organization

Reinsurance Group of America

WMS

Warehouse Management System

Advertising Index 1 Atramat

65 LEI

69 Quimpharma

Mexico Health Summit 2021

15 bioMérieux

86 Atramat

23 CHG-Meridian

103 eUnicare

43 Chiesi

120 BPF part of QbD Group

46 OLIVARES

141 Sánchez Devanny

50 Eolis

Index 1DOC3 117

DHL 142, 143, 145, 156

AbbVie 44, 54, 156

DIBICO 121, 136, 156

ACG Group 121, 137, 156

DIF 31

ACROM 50, 152

Digital Public Innovation Agency 19, 106

Aidicare 104, 112, 156

Dinavax 53

Allen Laboratorios 66, 75, 156

Doc.com 104, 116

Allergan 54

Doctoralia 104, 115, 156

Amazon 106, 108, 112, 144, 152, 156

Dräger 87, 91, 156

AMELAF 22, 66, 68, 152, 156

DVA Mexicana 121, 134, 156

AmerisourceBergen 147

Ecaresoft 104, 113, 156

AMID , 7, 8, 85, 87, 89, 92, 7, 122, 8

ECDC 145, 152

AMIIF , 8, 9, 23, 44, 46, 48, 49, 50, 59, 8, 9

El Crisol 142, 151

AMIS 25, 152

EMA 61, 152

ANADIM 64, 66, 81, 84, 152, 156

EMR 29, 152

ANAFAM , 8, 17, 23, 66, 70, 152, 8

Eolis 121, 127, 153

ANHP 25

EY 105, 106

ANTAD 81, 84, 152

Farmacia París 66, 82, 156

AOLM 142, 144, 152, 156

Farmacias del Ahorro 66, 83, 156

Apopharma 77

Farmacias YZA 66, 84, 156

Apotex 66, 77, 156

Faro del Mayab 16, 31, 156

AstraZeneca , 12, 13, 110, 12, 13

FDA , 13, 61, 67, 76, 80, 128, 152, 13

Atramat 87, 99, 153

FEMSA 101, 136

AWS 104, 106, 110, 152

FIFARMA 152

B. Braun 87, 92, 156

Fujifilm 87, 96, 156

BBVA Foundation 24

Fundación Carlos Slim 101

BC&B 16, 39

FunSalud 16, 18, 20, 24, 41, 56, 156

Beckman Coulter 87, 95, 156

Gedeon Richter 49

Bimbo 39

Getinge 87, 94, 156

bioMérieux 87, 90, 153, 156

Gilead Sciences 126

BioNTech , 12, 13, 12, 51, 12, 13

Glenmark 66, 67, 80

Boehringer Ingelheim 44, 57, 156

Global Health Intelligence 104, 109, 156

BPF, part of QbD group 11, 121, 124

Global Spine Outreach 31

CANIFARMA , 8, 9, 22, 44, 47, 59, 92, 119, 152, 8, 9

GNK Logistics 17, 146

Canon Medical 97

Grupo Altavista 17

CanSino Biologics , 12, 50, 12

Grupo Bruluart 66, 72, 156

CAP 33

Grupo Consulmed 16, 40

Capsutec 121, 138, 156

Grupo CPQ 121, 133, 156

CCE 16, 18, 20, 41, 84, 111

Grupo Modelo 39

CDC 145, 152

Grupo SICAMSA 142, 149

CENETEC 101

GRUPO SINOTEK 121, 131, 156

Centro Citibanamex 34

Grupo SOHIN 16, 32, 156

CESSA 17, 152

GSK 44, 53, 156

CFM , 7, 66, 67, 71, 152, 7

Habits.ai 111

CHG Meridian 87, 98

Hogan Lovells 21

Chiesi 16, 21, 27, 44, 58, 153, 156

Hogan Lovells Life Science 21

Chinoin 71, 123

icon Group 105

CHRISTUS MUGUERZA 16, 29, 31, 156

IFPMA 152

CINVESTAV 61, 74, 129, 152

IMPI , 9, 9, 37, 9

Clínica Esquipulas 48

IMSS 7, 17, 26, 40, 49, 55, 56, 60,

Clover Biopharmaceuticals 53

71, 91, 97, 136, 146, 152

CMH 16, 18, 25, 41, 156

INCAN 49

Coalition for Innovation in Epidemic

INCMNSZ 48, 95, 101, 129, 152

Preparedness 53, 152

INDRE 152

COFEPRIS , 9, 13, 22, 23, 38, 49, 55,

INER 57

56, 61, 63, 64, 67, 68, 70, 73, 80, 82, 88,

Innovation and Science for Business

100, 101, 125, 128, 137, 138, 151, 9, 13

Development 71, 152

College of American Pathologists 33

Innovax 53

CONACYT 26, 101, 152

Inosan Biopharma 44, 61, 156

Croda 121, 135, 156

INSABI 7, 17, 22, 55, 60, 74, 91, 152

Curevac 50, 53

Insumos para la Salud 88

Dassault Systèmes 104, 118, 156

INTRIALS 44, 63, 156

Deutsche Post DHL Group 145

IQVIA 104, 107, 156

Index ISSSTE 7, 17, 26, 55, 60, 97, 136, 146, 152

Pierre Fabre , 9, 44, 9, 59

KALMY 111

Plan Seguro 16, 36, 156

Kiyeon Law 88

PLM Latina 104, 108

LAASSP 22, 153

Qually 121, 126

Laboratorio Médico Polanco 16, 34, 45

Quimpharma 66, 73, 153

Laboratorios Alfasigma 66, 79

Ra Pharma 60

Laboratorios Clínicos de Puebla 34

Red Cross 48

Laboratorios de Especialidades

Reinsurance Group of America 153

Inmunológicas 125, 153

RGA 16, 35, 153, 156

Laboratorios Silanes 66, 76, 156

RM Pharma 44, 49, 62, 156

Lanix Med 101

Roche Diagnostics 87, 93, 156

Lavartex 121, 132

Sánchez Devanny 16, 38, 153, 156

LEI 121, 125, 153, 156

San José Hospital 28

Levbeth Group 87, 100

Sanofi 44, 52, 53, 76, 156

Liomont 71, 123, 131

Sanofi Pasteur 44, 52

MAG Medical Group 40

Save the Children 48

MASZ 17

SCT 24, 153

Mayo Clinic 30, 33

SEDENA 7, 60, 97, 153

Medicago 53

SEDESA 19, 106, 153

Médica Santa Carmen 30

Sefar 121, 128, 156

Médica Sur 16, 30, 105, 156

SEMAR 7, 97, 153

Medisi 88

Senosiain 123

Medistik 142, 148, 156

SHCP 21

Merck Group 44, 45, 55, 156

SMEO 16, 26, 153, 156

Metalsa 101

S&S IP LAW Agustin Azcatl 21

Mexican Patent and Trademark Office 37

Steris 101, 130

Minister of Health 16, 18, 19, 21, 106

Syneos Health 49

Minister of Health of Mexico City 16, 18, 19, 106

T5DC 121, 123, 156

Ministry of Communications and Transport 24

Tecnológico de Monterrey 28, 101

Ministry of Economy , 7

TecSalud 16, 24, 28, 61, 156

Ministry of Education 53

Televisa 39

Ministry of Health , 10, 21, 22, 30,

Ternium 101

53, 81, 89, 96, 143, 153, 10

The Mexican Health Foundation 24

Ministry of Health of Mexico City 153

the Robert Koch Institute 145

Ministry of Heath 22

TINC 101

NATO 61

UCB 44, 45, 60, 156

Nemak 101

UNAM 24, 48, 74, 123, 153

Neolpharma 66, 74, 156

UNEMES 17, 153

Novartis 44, 45, 49, 56, 156

University of Oxford , 12, 13

OCASA 142, 150, 156

UNOPS 16, 21, 22, 23, 58, 64, 89, 153

Olarte y Akle 16, 33, 156

USMCA , 7, 8, 9, 37, 7, 67, 7, 8, 8, 9

Olarte y Akle Bacteriólogos 16, 33, 156

Waters 121, 129, 156

OLIVARES 9, 16, 37, 153

WHO , 13, 22, 47, 53, 67, 68, 76, 98, 125, 13, 13, 13

Operation Smile 31

World Courier 142, 147

Osiris Healthtech Systems 104, 114

World Health Organization 153

PAHO 22, 153

Zebra Technologies 121, 139, 156

PEMEX 7, 97, 153

Zydus Pharmaceuticals 66, 78, 122, 156

Pfizer , 12, 13, 44, 51, 143, 12, 13, 13

Photo Credits Cover EnvatoElements

83 Farmacias del Ahorro

84 Farmacias YZA

CHRISTUS MUGUERZA

14 Getinge

85 Boehringer Ingelheim

19 MBN

89 AMID

20 MBN

90 bioMérieux

24 FunSalud

91 Dräger

25 CMH

92 MBN

26 SMEO

93 Roche Diagnostics

27 Chiesi

94 Getinge

28 TecSalud School of Medicine and Health Sciences

95 Beckman Coulter

29 CHRISTUS MUGUERZA

96 Fujifilm, Fujifilm

30 Médica Sur

97 Canon Mexicana

31 Faro del Mayab

98 MBN

32 Grupo SOHIN

99 MBN

33 Olarte y Akle Bacteriólogos

100 MBN

34 MBN

102 Beckman Coulter

35 RGA

107 IQVIA

36 Plan Seguro, MBN

108 MBN

37 MBN

109 Global Health Intelligence

38 Sánchez Devanny

110 Amazon Web Services

39 MBN

112 Aidicare

40 MBN

113 Ecaresoft

41 CMH, FunSalud, MBN

114 Osiris Health Tech

42 Grupo Bruluart

115 Doctoralia, Doctoralia

47 CANIFARMA

116 MBN

48 MBN

117 1DOC3

51 Pfizer

118 Dassault Systèmes

52 Sanofi

119 Grupo CPQ

53 GSK

123 T5DC

54 AbbVie

124 MBN

55 Merck Group

125 LEI

56 Novartis

126 MBN

57 Boehringer Ingelheim

127 MBN

58 MBN

128 Sefar

59 MBN

129 Waters

60 UCB

130 STERIS

61 Inosan Biopharma

131 GRUPO SINOTEK

62 RM Pharma

132 MBN

63 INTRIALS

133 Grupo CPQ

64 Liomont

134 DVA Mexicana

68 AMELAF

135 Croda

70 ANAFAM

136 DIBICO

71 CFM

137 ACG Group

72 MBN

138 Capsutec

73 QUIMPHARMA

139 Zebra Technologies

74 Grupo Neolpharma

140 B. Braun

75 Allen Laboratorios

144 AOLM

76 Laboratorios Silanes

145 DHL

77 Apotex

146 GNK Logística

78 Zydus Pharmaceuticals

147 MBN

79 MBN

148 Medistik

80 MBN

149 MBN

81 ANADIM

150 OCASA

82 Farmacia París

151 MBN

Credits Journalist & Industry Analyst: Miriam Bello Journalist & Industry Analyst: Jan Hogewoning Senior Editor: Mario Di Simine Senior Writer: Alicia Arizpe Senior Editorial Manager: Alejandro Salas Publication Coordinator: Alan Rueda Publication Coordinator: Samantha Bonomo Commercial Manager: Jorge Naupari Commercial Manager: Bruna Brandão Graphic Designer: Tania Aguiñiga Graphic Designer: Marcela Muñoz Senior Graphic Designer: Mónica López Design Director: Marcos González Web Development: Omar Sánchez Collaborator: Alessa Flores Collaborator: Andrea Villar Circulation Manager: Constanza Blanco Director General: Jeroen Posma

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Mexico Health Review 2020/21

Articles inside

MedTech

Medical Devices

Generics

Care Providers

Introduction