Cristóbal Thompson
Executive Director
Mexican Association of the Pharmaceutical Research Industry
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View from the Top

Healthcare Drives Productivity

Wed, 09/07/2016 - 09:57

Q: In light of industry trends, what has been the main focus of AMIIF over the course of the last year?

A: Our main priority has always been to ensure effective access to pharmaceutical innovation and we are doing this through an extensive approval rate with public institutions mainly IMSS, ISSSTE and Seguro Popular. Only 10 percent of innovative medicines are approved for use in public healthcare institutions and this must change, both in terms of the number of approved medicines and speed of access. Nowadays, these drugs take an average of 4 1/2 years to be introduced into public healthcare institutions, affecting patients with non communicable diseases who are unable to receive adequate treatment. Our second priority is to guarantee the highest quality standards, especially for biotechnological medicines and biosimilars. We are pleased that NOM 257 has been enforced but we still have to ensure the requirement standards for biosimilars are sufficient to provide patient safety. In addition, we are focusing on bringing more clinical research to Mexico, for which it is necessary to update all internal processes. At AMIIF, we greatly support all regulatory modifications COFEPRIS has implemented in recent years but there are still opportunities for improvement including the acceleration of clinical studies at IMSS and the implementation of a clinical research program at ISSSTE. We are working alongside COFEPRIS to improve the regulatory environment in the country.

Q: What other strategic alliances have you developed to position healthcare as key to improving productivity in Mexico?

A: This was among the largest shifts in our strategy. There is a strong link between health and productivity and we are discussing this connection within several associations, including COPARMEX and CONCAMIN. We want healthcare to become a priority for the Mexican government, which will allow the country to improve patient outcome and fully understand the impact of health on productivity. Mexico’s working population will increase in the next 10 years from 70 million to 88 million and our goal is to ensure these individuals have solid education and healthcare systems in place. We believe that a healthy Mexico is a productive Mexico and this will also have a strong impact on the country’s development abroad. We are working closely with other associations such as AMID, the Health and Wellness Council, ACROM, FUNSALUD and 25 patient associations. Last year, we established four possible scenarios for Mexico ranked on attractiveness, and today the country places in the third segment. The optimum scenario includes access to innovation and all activities we are implementing at this point target that goal.

Q: In the face of an ever-changing healthcare system, what are the main challenges you have experienced?

A: COFEPRIS and the General Health Council (CSG) have made significant developments in the matter of regulations for biotechnological products and the CSG has approved 65 percent of them. The low healthcare budget is among the main problems the sector is facing since only 6.2 percent of the GDP is invested in healthcare in Mexico, while the OECD average is 8.9 percent. Pedro Aspe, CEO of Evercore, compiled a comprehensive report of the healthcare system and discovered that 8.8 percent of the budget was spent on administrative expenses, while the OECD average for administrative expenses is 3.4 percent. We believe that Mexico can analyze these expenditures and save expenditures by using that money to invest in healthcare services directly. Our first recommendation would be for the healthcare system to identify the areas in which it is overspending and redirect this money to increase efficiency, hence, the healthcare budget should be increased. The OECD estimates that in the next 30 years, the resource allocation must increase by between 7-11 percent to satisfy growing demand.

Q: To what extent does the healthcare system in Mexico adopt a patient-centered approach and what can be done to improve this?
A: The healthcare system as a whole must undergo a reform. There are several discussions regarding the next steps the system must undertake. Recently, Dr. Mercedes Juan, the director of the National Council for the Inclusion and Development of the Disabled (CONADIS) mentioned that the government is open to discussing the Health Reform, thus all the actors in the system will have to develop a proposal to place the patient at the center of the conversation. This has not been done so far but it is a highly necessary step to improve the system. Among the problems that damage the efficiency of the healthcare system is its fragmentation, so to increase efficiency it will be necessary to align the entire organization with the regulatory authority. Another topic to discuss is portability, which will allow the system to capitalize on its current infrastructure.

Q: Are you engaged in conversation with IMSS and ISSSTE to reduce the speed with which these institutions incorporate new medicines into their basic formularies?

A: We have continuous talks with IMSS regarding basic formulary registrations and one of the topics being reviewed is the implementation of new models to incorporate innovation, a priority for both the government and the industry. These models can be diverse and are generally implemented after discussions between all interested parties. One successful example is the case of Hepatitis B, despite the fact the details of each process are confidential between IMSS and each pharmaceutical company. Distribution models are also evolving mainly for specialty products as companies are identifying new ways to reach their patients more efficiently.

Q: Mexico has the potential to triple clinical research investment from US$200 million to US$600 million in five years. What is the best way to achieve this?

A: Clinical research funds are assigned to a country based on the needs of the multicenter study and the regulatory authority’s approval speed. COFEPRIS’ approval speed has greatly increased as approval times were reduced by 60-70 percent in the last year. It is necessary to ensure the proper authorization for these studies is received and that researchers are properly compensated. At this point, we are in the process of bringing all stakeholders together. This year, we signed an agreement with the Autonomous University of Nuevo Leon (UANL) because it has a large capacity for clinical trials. Our role in this negotiation was to ensure innovative companies were fully aware of all the services the university has to offer. UANL already has 250 protocols with several innovative companies and in April 2016 will host our Innovation Week where we will gather all service providers for clinical trials in Mexico. This includes hospitals, academia and research centers and all companies that might require these services. One of our goals is to support investment in Mexico and contribute to research in the country, which will eventually lead to its development. To do so, we are collaborating with CONACYT, ProMéxico and several healthcare institutions.

Q: Given the volatility of the market in the last year, what should we expect from the industry in terms of new products and M&A activities in 2016?

A: Regarding products, it is clear that innovation is at the forefront of the industry and we will have the opportunity to see many new products in Mexico, including one for hepatitis C that can cure approximately 90 percent of patients. We also hope to have an approved medicine for dengue that is undergoing registration. Several companies have a strong pipeline so we will provide a forum for all of them to present their latest developments within our Innovation Week. These pipelines are expected to include many biotechnology products. In terms of M&A, we saw several in the final months of 2015 and we expect this trend to continue throughout 2016. AMIIF’s first priority is to work with major employer associations. The second is to ensure that health becomes a significant priority for the government, which will allow increased efficiency and eventually raise the healthcare budget. We expect that this surge will translate into reinvestments in infrastructure and human resources, including recruiting more nurses and doctors. Finally, we plan to work on further increasing access to medicines.