Julio Sánchez y Tépoz, Federal Commissioner, Federal Commission for the Protection against Sanitary Risk (COFEPRIS): Interview

Interview: Julio Sánchez y Tépoz

What recent advances have been made in Mexico regarding intellectual property (IP) rights?

JULIO SÁNCHEZ Y TEPOZ: Naturally, the lack of IP protection is a deterrent for any company entering a given market. Mexico is seen as a country that values and respects IP, especially when it comes to the pharmaceutical industry. As is the case in the US, pharma patents of 20 years are respected in Mexico, whereas this is not necessarily the case in China, India or Brazil. In recent years, Mexico has had a sound policy of medicinal regulation, combining access with a fundamental respect for IP rights and patents, as well as a policy based on the verification of products alongside tests of bioequivalence for generic products. Policies have been implemented over the past 20 years that correctly ensure generics are sold in the market in a fair and regulated way.

In 2005 the Mexican regulations changed, meaning all products in the market had to demonstrate bioequivalence from 2010 onward. All actors in the segment now have a very well-regulated market in which to operate. In just 10 years, the market value of generics has increased from 54% to 82%. Furthermore, while there were 36 registered generics providers three years ago, there are now 491. As well as providing assurances for customers, this has had a positive impact on the out-of-pocket expenses of the population.

What mechanisms can ensure continued investment in research and development (R&D)?

SÁNCHEZ: As the global pharmaceutical industry is principally driven by R&D, attracting clinical research has to be the number one priority for the government. There is currently work under way to map out the structural and dynamic relationship between Customs authorities, hospitals and the Federal Commission for the Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS). It is the responsibility of all the stakeholders involved to coordinate their efforts and ensure an “end-to-end” regulatory process, which will allow Mexico to compete on a global scale. Accreditation processes also need to be simplified so that approvals can be conducted by one committee rather than three, as is the case today. The processes should run concurrently so as to incentivise investment from firms, which can then know that their products will be not be delayed. In an ideal world, we would also like to cut the timeframe for completing procedures by 50%. The time taken to execute legal processes for COFEPRIS was 90 days, and we have already reduced this to 30 days. The challenge, however, is to match this period with those of other relevant entities, such as Customs authorities and hospitals.

In what ways do Mexican regulatory authorities interact with their international counterparts to harmonise cross-border regulation?

SÁNCHEZ: Mexico is a leader in health regulation in Latin America, as evidenced in 2014 when Cofepris was recognised as a functionary agency for vaccines from the World Trade Organisation, an honour awarded to just 28 countries. In the coming months, Mexico will also be admitted to the Pharmaceutical Inspection Cooperation Scheme – an arrangement between the regulatory authorities of 48 member nations to foster good manufacturing practice for medicinal products.

In addition, initiatives such as the Pan-American Network for Drug Regulatory Harmonisation, which supports regulatory harmonisation in the Americas, bring many immediate benefits to the Mexican pharmaceutical industry. For example, eight countries already recognise Mexican medicines as “preferential products”, meaning that these countries give priority to Mexican products. This benefits the industry, especially in terms of exports. However, the greatest challenge for regulatory agencies globally is to balance regulatory procedures with incentivising investment, producing high-quality goods, and exporting to other markets in a financially attractive and well-regulated marketplace.