Pharma: A Mexican tradeoff
Free trade between countries dates from the first industrial revolution at the end of the 18th century. On the basis of free trade, several of the current theories of international trade and world trade policies have been built.
The World Trade Organization has registered nearly 400 existing regional agreements or treaties and in all of them the purpose is to release commercial exchanges. The vast majority refer to agreements between neighbouring countries or those belonging to the same geographical region; a few, about a quarter, exist between developed and undeveloped countries.
Free trade agreements are important to end economic protectionism as they constitute an effective means to guarantee access to products to foreign markets, in an easier and barrier-free way.
On November 30, 2018, the US, Mexico and Canada signed the USMCA agreement, an update of the North American Free Trade Agreement (NAFTA) created in 1994. This agreement contains significant trade changes among the three nations in industries such as automotive, farming, manufacturing, and pharma. This last sector will be affected thanks to the amendments made to the IP fields of this trade deal.
Data and more
USMCA includes a detailed section about data protection and in this case, the Mexican Industrial Property Law (MIPL) does not contemplate data exclusivity. Nevertheless, it is worth noting that in 2012 the Federal Commission for Protection against Sanitary Risk (COFEPRIS, its acronym in Spanish) published an internal decree providing a five-year term of data protection for new chemical entities only. Thus, Mexico is now granting five-year protection periods for new chemicals.
In connection with data protection terms, under the USMCA, Mexico has agreed to extend the term for data protection of new agricultural chemical products, new pharmaceutical products, new indications and biologics. In this regard, USMCA has a specific section establishing that parties should not permit generic manufacturers referencing undisclosed test or other data concerning safety and efficacy of new pharmaceutical products that contain a “biologic” for at least ten years from the date marketing approval was first granted.
