Q: As an advocate of pharmaceutical innovation, how would you harness Mexico’s innovative strengths and what needs to be done to create an optimal environment for innovation promotion?
A: The low level of access to pharmaceutical innovation is a concern. According to a 2014 IMS Health report, patients in the public system have access to less than 10% of the innovation approved by COFEPRIS. Mexican approval of innovative products is the slowest compared to global key markets, taking as long as five years. With non-commutable diseases on the rise, it is essential to give the patients the opportunity to access the available treatment options at the earliest stage of their disease. We believe that a higher efficiency in health spending (current spending of 6.2% is the lowest in all OECD countries) is the first critical step. There is then a need to increase the spending to levels similar to the average of OECD countries.
Another area of great interest is Clinical Research, in which innovation industry currently invests US$160 million a year. Despite COFEPRIS’ improvement of protocol approval, further acceleration in the next two to three years in line with benchmark countries means investment levels could reach over US$500 million a year. Yet another factor that would contribute to an increase in this type of investment is tax benefits.
Q: Is the Mexican based big pharmaceutical industry satisfied with the current patent protection environment in the country?
A: The national legal framework has evolved but there are still some issues that need to be addressed. Firstly, it is necessary to guarantee effective enforcement of formulation and use of patents in order to mitigate the risk of product infringement. Secondly, there is a huge concern regarding the require protocol for removing products found violating patents from the market. Thirdly, linkage systems must include patent use in accordance with the Court precedents. Furthermore, the statutory reform of implementation of regulatory data protection is still pending, as the guidelines in force could be questioned or revoked at any time. Finally, it is necessary to establish clear criteria for the importation of raw material or finished product for those importers that are seeking a marketing authorization, due to the possible abuse of the Bolar exemption by some importers.
Q: The regulatory agency is now more efficient – nonetheless, what key areas need to be addressed in order to bring more investment to Mexico?
A: The current officials in COFEPRIS have offered the pharmaceutical industry an open communication channel as the main mechanism of interaction between authorities and industry. This environment allows us to have a platform to promote the use of international standards from clinical research to marketing authorization. With the adoption of these international standards by COFEPRIS, we have the recognition from PAHO and the WHO of the Mexican regulatory authorities as a reference agency for drugs and vaccines.
There are currently two main challenges: firstly, to find out how to harness the potential of Clinical Research in Mexico as the main opportunity to attract investments from pharmaceutical companies. In order to do so, we must implement a clear pathway for the clinical protocols authorization process. Secondly, in terms of the initial steps for introducing new products into the national market, it is critical to ensure the transparency and efficiency of the New Molecule Committee and its subcommittees to avoid unnecessary delays when a new product submission has been filed. We are currently working with COFEPRIS on both issues and we expect to have made developments by the end of the year.
Q: How can multinational companies collaborate with the government in order to further improve access to pharmaceuticals?
A: There are common priorities for pharmaceutical companies and the government when it comes to health. Having a healthy population and reducing recovery time increases productivity in the workforce. Under this scope we understand that innovation and technology are strategically crucial to reaching our target. That is why we are developing new collaboration frameworks aimed at improving processes and generating data. One of our most ambitious government proposals relates to innovation access models.
Q: How will the Clinical Data Protection initiative benefit the local pharmaceutical industry? Do you believe the innovative and generics industries can reach agreement on their varied positions on the matter?
A: Clinical Data Protection refers to the process of obtaining protection against unfair commercial use and reliance on the information enclosed in the product dossier. As a matter of principle, clinical data protection gives peace of mind to those who invest millions of dollars in the development of new medicines or in the research of new uses. Furthermore, this legislation extends to all national and transnational companies who invest in clinical research; anyone can be the subject of protection. Regarding the TPP negotiation, AMIIF has presented its position to the Mexican government and we are following the negotiation. I would say that companies cannot be clasified as exclusively innovative or generic. On one hand, almost all of the big pharmaceutical companies have a generic company or division within the corporation and some of them are working to develop biosimilar products. On the other hand, there are generic companies investing in research and development. In this way their positions are not completely divergent.
Q: What are AMIIF’s goals over the coming year?
A: We aim to continue working to accelerate patient access to innovation and to work in alliance with the public sector to pave the way for attracting increased investment in the field of Clinical Research. We want to become a strong actor in supporting the transformation of the health system in order to achieve superior outcomes by increasing the expenditure and spending more efficiently. We advocate the premise that we are all patients, so we will adhere to our commitment of contributing to better healthcare in Mexico.