Ernesto Algaba
Partner of the Life Sciences Practice
Hogan Lovells BSTL
Cecilia Stahlhut
Cecilia Stahlhut
Senior Associate of the Life Sciences Practice
Hogan Lovells BSTL
View from the Top

TPP to Affect IP Regulation

Wed, 09/06/2017 - 10:20

Q: To what extent have regulations been homogenized with those of the FDA or EMA?

EA: Mexico has become an attractive investment destination for the pharmaceutical and health industry. Several factors have contributed to this interest in our country, including the successful harmonization and cooperation of COFEPRIS with other leading health agencies, such as the FDA. In 2011, the Ministry of Health implemented through COFEPRIS a special program known as the Agreement for the Promotion of Innovation, intended to expand the availability of innovative medicines to Mexican patients and strengthen the competitiveness of the market. Furthermore, it aimed to permit recognition of drug authorizations issued by other agencies for the marketing of new molecules. As a result of the implementation of the program, COFEPRIS has signed agreements with regulatory agencies from Australia, the US, Canada, the EU and Switzerland. Through these agreements, COFEPRIS can recognize and validate marketing authorizations of health inputs that are not yet marketed in Mexico and that have been issued in the partner countries, recognize GMP certificates of other countries and work with other agencies to evaluate new products before authorization is granted.

Q: What regulatory challenges do incoming foreign companies face?

EA: The main challenge facing companies is legal certainty that the government and the regulatory pathway provides guarantees and ensures certainty with respect to their submissions and assurance that authorizations are secure.

CS: They must also be reassured regarding time frames and requirements because there are many permits and authorizations needed. We need to be more focused on compliance with regulation rather than with paperwork and filings. Also, an important challenge is the difficulty of placing the new high-tech and innovative products within the regulatory framework. Our regulation is many steps behind new technology, which has resulted in certain companies and products facing adversity when complying with requirements.

EA: Companies are challenging and requesting that their patent rights are properly guaranteed by the law during the timeframes granted. On one side of the coin are the rights and warranties needed while on the flip side, those are precisely the challenges companies will face and they will request their rights and warranties are properly respected. A common desire is that the linkage system between COFEPRIS and the Mexican patent office turns into an efficient tool, providing the proper security for the exclusivity rights encompassing patent rights and product marketing authorizations.

Q: What will be the biggest regulatory issues in the next five years?

CS: Regulations improving biotechnology and high-tech and innovative products will be an issue. I would expect improvements to the legal framework for high technology in medical devices, which is difficult as the sector develops quickly. Personalized medicine is an important issue we will also see over the next few years. I think the cosmetic sector will see changes given rapid technological advances.

EA: Equivalence agreements and recognition of foreign product authorizations for faster pathways will provide the Mexican population with more alternatives. There should be homogenization through amendments to legal provisions, following the global trend of expanding markets. Product innovation will be a driver for regulatory change to ensure they are safe and efficient. Also important is the potential implementation of the TPP in Mexico, assuming that this treaty enters into force. The TPP proposes at least 10 years of protection from the date of marketing approval for undisclosed tests and other data concerning the safety and efficacy of chemical agricultural products. Biologics are granted an eight-year term of protection from the date of first marketing approval.