With key speakers on the most pressing matters of the healthcare sector to this day, Mexico Health Summit 2015 became a unique platform for the exchange of vital information between the country’s main players in the healthcare sector. The event provided excellent networking opportunities for more than 200 industry leaders, and marked the launch of Mexico Health Review 2015, an annual publication that provides the most comprehensive overview of the sector’s trends, achievements, and challenges.
Opening Speech: The right Regulation for the New Life Sciences Era
Opening Mexico Health Summit, Patricio Caso Prado, Director General of Strategic Affairs at COFEPRIS, began the forum with a speech regarding the Right Regulation for the New Life Sciences Era. After his initial greetings to the guests, Caso started his presentation asking if there is a causal relation between an efficient sanitary agency and a better access to the pharmaceutical market. According to him, COFEPRIS is a regulatory agency that affects several industries, representing close to 10% of the GDP. “Out of every peso spent by Mexicans, 44 cents correspond to products regulated by COFEPRIS.”
Caso states that one of COFEPRIS’ main goals was to improve its whole process including paperwork and standardization. The institution had a limited capacity, which restricted its organic growth, but its maturing process allowed it to reduce its response time. “We now have more than 5,000 procedures following our new standard, with 105 regulators that represent 88% of our total work capacity,” said Caso.
COFEPRIS has also worked to eliminate entry barriers for new products, especially generics. The institution has located substances with proper patents, communicating new treatments and price reductions in the country. “We now have 32 substances and more than 350 new medication options, representing 1,715,495 more people that can be attended as proper patients. Generics’ prices have dropped by 61%, and IMSS has disclosed that it has seen price reductions of up to 60%. Compared to Central America, prices are 70% lower, and 55% less compared with South America,” claimed Caso.
Regarding the promotion of innovation, Caso stated that the government launched an agreement to attract new medications with equivalence agreements, substituting free-trade certificates with new clinical analyses. Mexico has now 150 new innovative medicine registrations, representing a 4,900% increase compared to 2011. By 2013, COFEPRIS finished its regulation for biopharmaceuticals, which the association identified as a huge area or opportunity. The country has a really low consumption per capita of biotechnology drugs, and one of COFEPRIS’ objectives is to promote them as a viable option in the market. “This innovation strategy has also followed a strict intellectual property measures, and during 2013, Mexico was ranked as one of the most protective countries in this matter,” states Caso. Additionally, the agency has established equivalence agreements and good manufacturing practices certifications for the FDA, ANVISA, and other international organizations. This has led to a more open market, attracting more investment to the pharmaceutical sector. Furthermore, COFEPRIS has now been recognized by the WHO as a functional agency in terms of vaccines, entering an elite group of 38 countries.
Caso concluded with two main statements. The first is that there is in fact a causal regulation between an efficient sanitary agency and a better access to the pharmaceutical market. The second is that this also has an impact in the growth and development of the industry. This has reflected on a greater penetration of generics into the market, and Mexico’s ranking as one of the main global markets in the health sector, and the second in Latin America.
Mexico’s Health Climate Today and the effect of “El Médico en tu Casa” (House Call Doctor)
Dr. Armando Ahued, Secretary of Health of Mexico City, started his presentation on the House Call Doctor program. The background of the program was based on the rising maternal and infant mortality rate in Mexico City and efforts of the local government to stop this issue. He explained that originally, the program was to be called “Looking out for pregnant women”, however the city mayor changed the name and decided to enlarge its coverage for every the household habitant. “The program started in September 2014 and it is innovative and necessary. The program looks for mature adults, people with disabilities, and every person that might need any kind of health aid,” Ahued explained.
Ahued said that the program started in the Iztapalapa borough, then moved on to the Gustavo A. Madero until it finally it covered the complete city. The House Call Doctor program has 3,000 people working in its brigades, including 600 physicians and 600 nurses, as well as mobile laboratories for blood tests.
“We discovered that 33.2% of the pregnant women we found through the program had no prenatal follow up and 38.5% of them were high risk pregnancies, so we created a nutritional basket to aid a good fetus development. We have managed to raise prenatal consultations from four to seven,” the Secretary explained.
The program visits 10 households daily, and Dr. Ahued says that the program has identified more than 140,000 elders in need, 290 persons in state of abandonment and 60 terminal patients.
According to the National Institute of Statistics and Geography (INEGI), Mexico City has 2.4 million households and the Secretariat of Health has reached 75% of them. The main illness afflicting Mexico City citizens are diabetes, cancer, medical depression, and senile dementia. Dr. Ahued explained that the program is closely working with Center of Economic Research and Teaching (CIDE) and the Harvard Public Health School to evaluate the program’s success.
“There are other entities that want to reply the House Call Doctor program, as it is aiding the sick with the necessary treatments while educating them in health matters,” Dr. Ahued mentioned.
The Secretary concluded his speech by informing the audience that there is still much to do, but Mexico City is looking forward for a complete and universal healthcare system.
Pharmaceuticals, Life Sciences, and Mexico’s New Health Economy for 2020
The first panel’s moderator, Xavier Valdez, General Manager of Mexico and North Latin America of IMS Health, began the panel on Pharmaceuticals, Life Sciences, and Mexico’s New Health Economy for 2020 presenting the predicted global industry growth of 3-6%, much of which will come from emerging economies. He explained the main tendencies in legislature, drawing attention to the Orphan Drugs Act and 21st Century Cures Act, and also collaborations between pharmaceutical companies and ONGs. Genomics and patient-led efforts are increasing in popularity, according to Xavier Valdez, leading to new players in the industry.
As patients gain more access to their treatment information, and companies are under more pressure to make products more cost effective, biological products, and biocomparables are rising in number and are overtaking small molecules, continued Valdez. He opened the discussion asking panelists about the industry vision for the next 5 years. Dr. Dagoberto Cortés Cervantes, Director General of Hormona and President of ANAFAM’s first contribution was his description of the pharmaceutical industry as one of the few that depends on continued innovation. In the past pharmaceutical companies created drugs aimed at young adults and children, specifically for infectious diseases, but this has changed. “Molecular innovators have had to develop new technologies to combat new diseases and refocus on obesity and diabetes to reflect the changes in the most common diseases,” he mentioned.
Félix Scott, Director General of Sanofi Mexico began by congratulating COFEPRIS on the advancements made in the health industry. He pointed out that the focus on degenerative diseases is a major focus, but considers that the consequences following diseases of this type are much greater than the price of the medicine required to treat them. “The health system must reflect this, and move toward a system that provides solutions and patient control.
Astovastatina, for example, has dropped its price considerably to become more accessible, but patients cannot depend solely on this, he expounded. “Pathological and therapeutic technology must help doctors to monitor patients and ensure they follow through with their treatment.”
Sandra Sanchez y Oldenhage, Deputy CEO of PROBIOMED, commented on the different players in the market catering to the 9 million diabetics in Mexico and the country’s first position in child obesity. COFEPRIS’s first presentation stated that 6.2% of GDP is dedicated to health and medicine, considerably lower than the global average of 9%, said Sanchéz y Oldenhage. This has left a gap in the industry requiring the expansion of big data and clinical trials, lower priced treatment, and the creation of biosimilars and biocomparables according to Sanchéz. “The generation of coexistence of the health institutions with generics, biocomparables, and R&D is crucial for the future of the industry.”
José Alberto Peña, Vice President and General Manager of GlaxoSmithKline, recognized that “health is not the government’s priority.” He demands the change of mentality from health being an expense to being an investment, and suggests that innovation is the way to make the system work more effectively. The low level of spending in public health has not been changed since the pharmaceutical industry began. The commercial side also needs to evolve to reflect how companies interact with doctors, and promote diversification into more coordinated contact and the involvement of technology.
Sanchéz commented that the highest ever average age of the Mexican demographic will be much greater than the global average, which will test the health industry more than ever. Valdéz reopened the topic of difficulties faced with acquiring products with very high prices in the public sector. Cortés Cervantes expanded on the fact that the government cannot solve the problem alone, and that collaboration and shared responsibility, including suppliers, is the only way forward. He pointed out that the industry used to do a lot to expand disease prevention, having health insurance is positive on paper, but it does not mean that the health industry is able to help everyone covered if government spending is cut further.
Scott affirms that this type of transformation takes time. The reinvestment of savings must be guaranteed to the health system, he said, “and the tax specifically on foods with high fat content, must also be invested in the health sector, to aid the tax’s aim to reduce obesity in Mexico.” Sanchéz added that as an industry, fragmentation is more of a challenge than added value for the nation. The existence of so many different institutions creates confusion and bureaucracy limits access to medications. Peña agreed that access is important, but that education is also extremely important. “The whole population must understand that health is not when someone gets sick, but rather preventing illnesses in the first place.”
Valdéz continued by asking about accessible products, and Peña answered that the profitable model of products having a limited life cycle is not being reinvested in innovation, which means that generics will not be created. He finished his point saying that quality monitoring takes a back position as soon as a medicine has been released, but that there should be more control even on existing medicine.
Sanchez added that biotechnologicals and biocomparables are a topic that will be an import trend in the industry. Scott also said that as more patents expire, generics will grow in number, “however, companies must begin to contribute to the development of innovative products, not just copying existing drugs.” Cortés Cervantes suggested that in order to see new drugs being created in Mexico, government incentives as well as the guarantee of IP rights for companies carrying out R&D. He reiterated that Mexico is already very advanced in terms of legislature, and that COFEPRIS has done an excellent job of creating a market that will allow the industry to remain robust enough to compete with other countries, and become a regulatory agency of international acclaim.
Continuing on the topic of international growth, Cortes Cervantes said that in collaboration with COFEPRIS, CANIFARMA was able to establish a strong an efficient regulatory agency. This is directly linked to the competitiveness of the industry, the success of the economy, and access to medication.
“It’s important to search for options for developing Latin American countries,” continued Scott. Sanchéz also said that 97% of APIs are imported, “high quality at low costs will be our best chance at offering international standards.” According to Peña, the country must branch out of manufacturing drugs to be exported, into clinical trials as well to establish Mexico as an investigation center. Mexico invests approximately 35% the amount that Argentina invests in investigation, a country less prepared in terms of capacity.
Convergence of Technology, Data, and Healthcare: What the Future Holds
After presenting the panelists, Paola Abril Campos, Operations Manager at Carlos Slim Institute of Health, opened the second panel of Mexico Health Summit related to the Convergence of Technology, Data, and Healthcare: What the Future Holds. According to Campos, information, health, and technology are three words that are always together nowadays and there is a lot of potential and high expectations regarding reaching new heights to satisfy the demand for innovation in the country. “Our goal is for our patients to achieve the results they want, and for doctors to have the necessary equipment to make the right decisions at the right time,” said Campos.
The moderator began the discussion by asking the panelists how the data, health, and technology environment has evolved in Mexico. The first panelist to answer was Antonio Carrasco Ruiz, CEO of PLM, who stated that technology is a great way to achieve a better healthcare. He claimed that a multilateral relationship exists, including patients, doctors, pharmaceuticals, and all other aspects of the healthcare system, with patients at the center of all other factors. “We can see that the technology already exists, but we still need standardization and a common practice in the entire health ecosystem,” said Marianela Santos, Director General of Orben Communications and Health Angel Monitor Systems. “We still need to increase investment, but right now the most important action will be incorporating technology in the existing process.”
Campos continued by asking the panelists how ready the Mexican infrastructure was to receive these technologies and what could make the integration process easier. To do this, Eduardo Verges, General Manager of Boston Scientific, replied that in general, patients do not yet have access to telehealth or similar technological systems. “We do not have an emergency number or an emergency system that cares for the general public. If we compare ourselves to more developed countries we may find out infrastructure lacking, but we have also underutilized the assets that we do have with state of the art technology.”
According to Santos, telehealth and telemedicine are not new. These services have been available in Europe since 1940, although there is greater access nowadays. “However, without the proper health programs to promote these alternatives, they cannot be a viable option.”
Carrasco elaborated on the importance of showing the public the advantages of these services, while Edna Álvarez, Latin America Manager at Malvern Instruments, stated that Mexico is currently facing a great challenge in terms of scientific education. Finally, Verges gave an example of an IMSS’ initiative called “Project Heart Attack,” in which the institution found out that it had the necessary infrastructure to respond to these situations, but it still had to update its processes to support its technology.
“We need to understand the reality we are living, as well as the integration the sector needs between all its players,” claimed Campos, before asking the other participants how they planned to achieve this kind of synergy.
Verges replied that the country needs more communication between companies, suppliers, and distributors, as well as a better access for the patients. According to him, institutions are creating more transparency, but companies need to seize those opportunities considering the patient as their top priority.
“Even though there is information about every patient, that data is not centralized. Standardization allows companies and pharmaceuticals to offer a better and more transparent service, which is leading us to a future where machines are now starting to make science, taking data directly from the patients,” stated Carrasco.
Santos added that in the US, health institutions have as much information and data management as any bank. “Mexico needs to adopt this vision and adapt its strategies to educate doctors from a business and investment perspective,” she concluded.
Innovations in the Supply Chain, Transforming Manufacturing and Distribution
Moderator José Antonio García, Vice President at DHL Supply Chain Mexico started the panel by stating that innovation is a must in the pharmaceutical industry, so he asked his fellow panelists to share their company’s innovations briefly after presenting the audience with a drone ambulance project from Holland.
Panelist Fernando Pacheco, Head of Procurement at Bayer Mexico, said that his company has a very innovative product that offers radioactive therapy for bone cancer patients with a new approach.“This innovation attacks cancer cells and seeks to give a focalized therapy that would not affect the patient’s body,” Pacheco explained. Bayer’s product has a 28-day expiration and, according Pacheco the biggest challenge for this medication is the logistics since it has to get the patient before day 15 from the product’s creation.
Carlos Gutiérrez, Corporate Director of Material Resources at ABC Medical Center, intervened and stated that ABC Medical Center’s main innovation is the outsourcing of logistics and inventory. “Our focus is the recovery and attention of patients. For many years the hospital was limited to grow, so we reached out to the world to see what they were doing,” ABC’s manager described. Yet, the panelist mentioned that there’s room for improvement in the private sector to streamline products, services and processes.
The fourth panelist, Miguel Ángel Ricchiuti, from laboratory Apotex, said that in order to achieve innovation, companies should start breaking their paradigms. He explained that the first step to do this would be to break the traditional business model and, as Apotex did, directly approach clients and learn about their demand. Ricchiuti proposed an integrated business solution (IBS) for each pharmaceutical player to offer medications in faster way.
Moderator García, moved on and presented the DHL parcel drone, an innovative tool now used in Germany that is, actually, providing medical supplies for a little unconnected island in the North.
Fernando Pacheco’s point of view consisted in further explaining Bayer’s product and challenges, however he pointed out that in Mexico, there are little radioactive distributors and more competence is needed to excel and offer a better service for patients.
For panelist Gutiérrez the three main guidelines for ABC are to offer better devices, and meditation at a more competitive cost. “Private medicine is getting more expensive and we need more participation from the industry players to deliver the expected quality and to stay focused on the industry objectives,” he mentioned.
Finally, Miguel Ricchiuti said that the generic sector might need better forecasting to deliver efficiently and keep bio similar medications at low cost. He argued that the best way for Mexico to innovate at the moment is to find new ways to lower operational costs.
Attracting Clinical Trials to Mexico: Current Demands and Capabilities
Dr José Luis Viramontes, Director of Remote Site Management and Monitoring at PPD, gave a short presentation after which he invited Gabriela Dávila, Director de Compliance and Oversight in Mexico, Puerto Rico, Caribeean and Central America at Pfizer, to discuss competitive advantages. Dávila discussed clinical investigation, mainly in topics regarding quality and the improvement of processing speed. Regulatory authorities want Mexico to become a more competitive country in investigation, as well as clinical infrastructure. Karen Hahn, Director of Clinical Trial Management at ICON, agreed with Dávila but focused her presentation on the need for more qualified personnel. She discussed that clinical investigations were not even mentioned as an area of investigation within Mexico, but that now the number of courses, diplomas, and R&D centers for which students do not have to leave the country to take is impressive.
Rafael Bravo, Chief Scientific Officer at Novartis touched on the topic of Mexico’s geographical competitive advantages close to the US, and having relatively low costs of operations. “Mexico could be the first country for R&D,” he said. “Six months ago only 3 innovative drugs had been approved by the regulatory authorities, but as this grows Mexico will become more competitive.” Sergio Guerrero, President and CEO of Accelerium spoke on the role of the academia all over the world, and mentioned that foreign academic institutions have invited Mexico to participate in trials and investigations. To promote internationalization, last year COFEPRIS visited Europe and will subsequently visit Asia and Africa.
Dr. Viramontes complemented the advances in human capital, infrastructure, fast-tracking processes in Mexico, before asking why investigation is not advancing as we expected, in spite of the long list of competitive advantages. Sergio Guerrero suggested that this is because the country has not yet had the opportunity to show off its benefits. “We know that opportunities exist here, and now is the time to take advantage and begin to compete with the biggest countries in innovation and investigation.” Bravo candidly added that offering is increasing globally, whereas the number of clinical trials carried out in Mexico is dropping. “We are in 30th place globally, and it is extremely difficult to catch up from so far behind.” Hahn joined the discussion by recommending the creation of a Master course in innovations, “we must not always assume we have to tropicalize existing university courses, why not create our own, focused on the competencies we need to develop in Mexico?”
Dr. Viramontes mentioned initiatives with ANIF and CANIFARMA among others, hope to take advantage of the enormous quantity of patients in Mexico who are willing to participate in trials, ending the discussion on one of the country’s most important competitive advantages. Guerrero warned that in order to improve project quality in research and innovation, 35 of which were authorized by COFEPRIS, R&D centers need continued investment.
Commercializing Research to Drive Innovation: Mexico’s Transition
Before starting the discussion, Dr. Xavier Soberón, Director General of INMEGEN, presented the implications of the human genome in life sciences, and the importance of genomics in the biotechnological industry. According to Soberón, Mexico is truly behind in innovation and patent generation in comparison to other countries. However, Mexico does have strong institutions and enough human talent to compete in these segments at an international level. The problem is that there are few economic activities directed to innovation, which means the government and academic institutions have to promote this participation. “The INMEGEN is the only institution that has a Technological Transfer Office, which shows the opportunity to increase the level of transparency throughout the entire industry,” says Soberón.
The first question he addressed as the panel moderator was related to the main factors regarding innovation in the health sector. Dr. Gustavo Cabrera, CEO of Global Biotherapeutics, was the first to answer, claiming that this is a slow process that requires a total compliance of the regulations and standards that rule the sector. Cabrera states that there are few CROs in Mexico, and they still need to develop to intermediate species to be more competitive in the market. According to Dr. Sonia Mayra Pérez Tapia, Executive Director of UDIBI, the academia has the advantage that part of its vision is to generate knowledge. However, she explains a disadvantage of professional research; people who do research cannot normally commercialize their products, but recent changes in regulations might change this for the better. Another obstacle is that research in Mexico is much more expensive than in many other global locations. “These changes in regulations could further promote innovation in our country, and even work as employment generators in the national industry,” claims Pérez. Sergio Valentinotti, Director Life Sciences at Laboratorios Liomont, says that Mexican research is more directed to publications, instead of patents and prototypes that could benefit the sector. Nevertheless, the generation of appropriate patents is another factor that should be analyzed to engage in better innovation activities.
The next question presented by Soberón was related to the needs of researchers from the private and the public sector, and the most promising innovation areas in Mexico. Valentinotti explained that the private sector has not been so quick in innovation processes, since most new projects require a high return on investment in short periods. “Companies and academic institutions need to develop proper relationships to create effective solutions. While corporations need to look for innovation, the academia needs to keep generating knowledge,” he concluded. Pérez added that there is a miscommunication between the private and the education sector. “There needs to be a proper link that understands technology and commercialization.” In terms of areas of opportunity, Pérez mentions quality in generics, veterinary biotechnology drugs, and molecules that have not been exploited to their full potential. On the other hand, Cabrera states that the relationship between companies and his company has been really effective, and has led to extraordinary innovations thanks to the support of CONACYT. The problem he has found is that there are no clinic Phase I analyses, but he expects to reach critical mass for these developments by 2017.
As a final question presented by the public, Soberón asks if there are any successful relationships between educational institutions and private companies that have led to new and effective pharmaceuticals. There were some discrepancies in the answers of all three panelists, since Valentinotti claims there have not been many national examples, while Pérez and Cabrera state the opposite, supported by a member of the audience from CINVESTAV.
The Rise of Generics and Market Access Trends
The final panel was welcomed by Rafael Maciel, President of AMEGI, acting as moderator for a debate on the topic of Generics and Market Access Trends. Maciel informed us about the importance of generic drugs in the Mexican market. “The largest part of the world’s illnesses can be cured with medicine, 80% of which are generic drugs.” The generics market represented US$194 billion in 2014. The savings for the general population is clear, saving EU$100 billion last year in Europe. He asked what the future of generics will be, and predicted that they will continue to grow and dominate the market for many years to go. Mexico currently exports U$2 billion worth of generics per year, considerably lower than many European countries that export over US$30 billion in the same timeframe. Maciel predicts that pharmacies that are not parts of chains will continue to drop in number in coming years.
The first input was offered by Cecilia Bravo, Vice President of ANAFAM, who told us that efficiency is an important milestone, something that must be improved to generate a better generics market. In terms of the government, she explained that uniform rules at a national level have helped increase trust in the industry, and therefore increase demand for generics.
Juvenal Becerra Orozco, President of UNEFARM, expanded on this topic by explaining that it is a problem of culture, but that the monetary savings were clear, encouraging the population to recognize the homogeneity of these alternatives. He admitted that there is still plenty of ground to gain to convince every patient that generics respect the original formula, but that pharmacies have helped considerably to encourage market penetration of generics.
“Why have generics grown at such speed?” asked Maciel, and Cristina Viruega Aranda, Director General of TAPVS, answered that there is a need for therapeutic options as an effective treatment. “Bioequivalence studies are attended by a limited amount of third party authorization centers.” She explained that this still requires more investment but that fortunately 357 new drug registrations were processed this year, 91% of which were processed successfully. Becerra Orozco reiterated how pleasing it was to see such a huge backlog of registries being released and processed to date. “We want to be extremely precise and unambiguous in order to generate trust, to create solidarity and confidence in products processed by TAPVS,” added Viruega Aranda.
The moderator drew the discussion toward the importance of Mexico’s regulatory environment being comparable with international regulations. He touches on the Trans Pacific Partnership (TPP) and the issues surrounding data protection and the difficulties of launching a new product. Bravo states that “it is inacceptable for an authority to takes such a long time to allow the generation of generics, should patents be extended the population would suffer from an administrative piece of red tape.” The TPP needs to take into account different socioeconomic purchasing power in Mexico before making any decisions that would limit access. A potential move is to increase protection rights from 5 to 8 years, which would be dangerous for the distribution of existing chemical molecular formulas. Bravo mentioned that in the area of biotechnologies, she believes that Mexico has been very slow in catching up on the distribution of this new type of treatment. Bravo emphasized the importance of the whole population having access to this new type of generic product in Mexico. Maciel concluded by commenting that drug policing is the responsibility of all authorities and companies in the industry.
Dr. Dagoberto Cortés Cervantes, Director General of Hormona and President of ANAFAM, started his speech by informing the audience on the wealth generated by the pharmaceutical industry. He then moved forward to the progress that COFEPRIS has done in the last few years.
“This agency is efficient, protects the patient with safe medicines and helps the pharmaceutical industry competitiveness,” Cortés mentioned. According to him, the agency contributes by opening new markets for Mexico and pushes local standards to compete with the most innovative and advanced countries, bringing new and larger investments.
The president of ANAFAM explained that the industry needs to collaborate with public policies to endorse growth and specialization in order to improve the medicines quality. He stated that Mexico has lots of research potential, backed up by trustworthy institutions and with main asset for the pharmaceutical sector: patients.
“The country needs to adapt to international standards, there are several high technology processes that no not require large investments but will and resource efficiency,” Cortés said.
He concluded that the industry needs tighter participation between academia, the public sector and the companies to achieve a transcendent industry.
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