Viviana Linares
Executive President
The Mexican Pharmaceutical Council
View from the Top

How to Protect the Interests of Mexican Pharmaceuticals

Wed, 09/05/2018 - 09:22

Q: What spurred the founding of the Mexican Pharmaceutical Council (CFM) and what are the group’s main priorities?

A: CFM was created in 2009 to represent the common interests of Liomont, Sanfer, Silanes, Carnot, Chinoin and Senosiain, all of them mainly Mexican pharma companies with a broad range of products, including innovative medicines, generics and OTCs. All members focus mainly on the prescription private market, but the competition between them has not prevented a concerted effort on common interests with respect to the policies regarding the pharmaceutical industry in Mexico. Their common goal is to promote the growth of Mexico’s pharmaceutical industry.

The council holds monthly meetings to address the many issues of concern, including legal framework, pharmaceutical and social responsibility. It does not compete with other industry groups such as CANIFARMA, ANAFAM or AMIIF.

Q: How can regulations achieve the ideal balance between patented medicines and generics?

A: Mexican regulations should include strong IP protections and transparent processes that all interested parties can easily follow. The link between COFEPRIS and the Mexican Institute of Industrial Property (IMPI) must also be improved to ensure the effective launching of products in the Mexican market.

Access to medications must be improved by creating mechanisms that ensure the availability of many options for each API. Patients should have access to a full range of available products so they can make informed decisions about their health. To achieve this, a transparent and balanced regulatory framework that protects IP is necessary.

Q: Considering the interest of its members in R&D, how is the council supporting Mexican research?

A: The council has partnered with Fundación UNAM and many universities to promote Mexican R&D. The council has also launched the CFM-Fundación UNAM Award for pharmaceutical innovation. This award targets bachelor’s, master’s and Ph.D. thesis projects that focus on research and which can be easily translated to the market. In the past two years, winners have already patented their products. The council is working with universities, the Ministry of Health, the Ministry of Economy and CONACYT to support local R&D. There is a large accumulation of investment in technology that should be addressed as soon as possible. In addition, Mexico does not have clear financial mechanisms that allow companies to deduct research incentives.

Q: In what other areas of opportunity does CFM focus?

A: Exports are a great area of opportunity since Mexican products have excellent quality and provide innovation to patients at reasonable prices. The pharmaceutical industry everywhere protects its local manufacturers, so entering other markets is usually a challenge. Now, we are focusing mainly on Latin America and Europe and our members have expanded their markets to 17 countries in those regions. In addition, they have played an important role in explaining to COFEPRIS the challenges faced by the local pharmaceutical industry to export its products, including certifications, suppliers, audits and import permits.

Q: What role should regulators, manufacturers and organizations take to ensure the safety of medications?

A: For patients to be sure that the medication they take is correct and effective, a strong regulator is needed to ensure that local medicines meet national and international standards. We are convinced that Mexico has strong regulators that prioritize quality and the efficacy of medicines and all our members have invested strongly to have their plants certified also by EMA and FDA, among others. To achieve this, CFM has promoted a strong and internationally recognized pharmaceutical regulator through participation in the PAHO-CFM league.