Interview with Cristóbal Thompson, Executive Director of AMIIF
Q: What are AMIIF’s main priorities for 2016?
A: Our primary 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. Currently, only 10% of innovative medicines are approved for use in the public healthcare institutions, and this must change, both in number of approved medicines and in speed of access as these drugs take an average of 4.5 years to be introduced into public healthcare institutions. This affects patients with non-communicable diseases since they are unable to receive opportune treatment. Our second priority is to guarantee the highest quality standards for medicines, especially for biotechnological medicines and biosimilars. We are pleased that the NOM 257 has made some progress, but we still have to ensure that the requirement standards for biosimilars, including ensuring that the sample size of clinical studies, are sufficient to ensure the safety of patients. Other areas we are focusing on include bringing more clinical research into Mexico, for which it is necessary to update all internal processes. There are still opportunities for improvement, including accelerating the introduction of clinical studies at IMSS and to begin implementing clinical research at ISSSTE.
Q: How are you working to promote healthcare as a key driver of economic productivity in Mexico?
A: This has been among the largest shifts in our strategy. There is a strong link between health and productivity and we are discussing this link within several associations, including COPARMEX and CONCAMIN. Among the topics we are discussing, we want health to become a priority for the Mexican government, which will allow the country to improve patient outcomes and to fully analyze the impact of health in productivity. Mexico’s working population will increase in the next ten years from 70 million to 88 million and our goal is to ensure that these individuals have solid education and a healthcare system in place. We believe that a healthy Mexico is a productive Mexico, and this will also have a strong impact in the country’s development abroad. As our goal is for health to become a top priority, we are working closely with other associations, such as AMID, the Health and Wellness Council, ACROM, and Funsalud, and at this point we are also collaborating with 25 patient associations.
Q: What are the main challenges being faced in the introduction of innovative medicines into the country, for example biotechnological medications?
A: COFEPRIS and the General Health Council (GHC) have made significant developments in the matter of regulations for biotechnological products, and the GHC has approved 65% of them. Among the main problems that this sector is facing is the low health budget as, at 6.2% of the GDP, Mexico’s health budget is among the lowest in the OECD, whose countries invest an average of 8.9% of their respective GDPs. The health budget must increase and it must also be spent more efficiently. The OECD estimates that in the next 30 years, this budget must increase by between 7% and 11%, depending on the country, thus it is necessary to augment expenses. A comprehensive report of the healthcare system showed that 8.8% of the budget was spent on administrative expenses, while the OECD average for administrative expenses is 3.4%.
Q: Are you also engaged 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 on that regard, and one of the topics currently discussed is the implementation of new models to incorporate innovation. Both the industry and the government agree that new models are necessary to improve access to innovative medicines. These models can be diverse and they are generally agreed on after discussions between all interested parties, but they are based on the outcome of medications. One successful example is the case of Hepatitis B. The exact details of each process are confidential between IMSS and each pharmaceutical implementing these models. Distribution models are also evolving, mainly for specialty products, as companies are identifying new ways to reach their patients more efficiently.
Q: You recently mentioned that Mexico has the potential to triplicate the investment in clinical research from US$200 million to US$600 million in five years. What are the best ways to achieve this?
A: Clinical research funds are assigned to the country on the basis of the needs of the multicenter study and the regulatory authority’s approval speed. COFEPRIS’ approval speed has greatly increased, as approval times have reduced by 60% to 70% last year. It is necessary to ensure that the authorization for these studies is obtained in a timely manner and that researchers are properly compensated for these studies. 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), as it has a large capacity for clinical trials. Our role on this negotiation was to ensure that innovative companies were fully aware of all the services the university had to offer. UANL already has 250 protocols with several innovative companies. Next year, in April we will host our Innovation Week, where we will gather all service providers for clinical trials in Mexico, including hospitals, academia, and research centers, and all companies that might require these services.
Q: What should we expect from the industry in terms of M&A activities and new products?
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 about 90% of patients. Next year, we hope to have an approved medicine for dengue that is currently undergoing registration. Several companies have a strong pipeline, so we will provide a forum for all companies to present their latest developments within our Innovation Week. These pipelines are expected to include many biotechnology products. On the matter of M&As, we have seen several in the finals months of 2015, and we expect this trend to continue throughout 2016.
This is an excerpt of an interview to be featured in Mexico Health Review 2016. For more information please visit http://mexicohealthreview.com and http://mexicohealthsummit.com
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