EFFECTS OF THE USMCA (US-MEXICO-CANADA AGREEMENT) IN THE MEXICAN PHARMACEUTICAL INDUSTRY
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 refers to agreements between neighboring countries or those belonging to the same geographical region, and there are few, about a quarter, those that exist between developed and undeveloped countries.
Free trade agreements are important to end economic protectionism as they constitute in an effective means to guarantee access to products to foreign markets, in an easier and barrier-free way.
On November 30, 2018, United States, 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 in the intellectual property field of this new trade deal.
UMCA 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, for its acronym in Spanish Language) published an internal decree providing a 5 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.
Going deeper for this kind of definitions, a biologic is defined at the USMCA as a product that, at minimum, is “produced using biotechnology processes and that is, or, alternatively, contains, a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein, or analogous product, for use in human beings for the prevention, treatment, or cure of a disease or condition.”
For the case of data protection exclusivity for new and previously approved pharmaceutical products under the USMCA – Non-biologics, please bear in mind that USMCA prohibits generic manufacturers from referencing undisclosed test or other data concerning safety and efficacy of “new pharmaceutical products” for at least five years from the date marketing approval was first granted. And now, returning again to definitions, a “new pharmaceutical product” is defined at the USMCA as “a pharmaceutical product that does not contain a chemical entity that has been previously approved for that party.”
In addition, USMCA also establishes at least three years of data protection for new clinical information submitted for a previously approved pharmaceutical product covering a new indication, formulation, or method of administration.
This new change of the USCMA deal in the biologics products have advantages and disadvantages for the Mexican pharmaceutical industry. It is beneficial for this sector to now have the legal tools to protect the clinical data of this specific type of products, nevertheless, the tradeoff of this positive consequence may be the high costs Mexican population will have to pay in order to access biologics products. With this in mind, positive and negative effects can be seen in the next years in the Mexican pharmaceutical industry; if there are more positive than negative ones will depend in if the Mexican innovation investments and advances can outsmart the biologics products of foreign industry.
On the other hand, it is important to consider also that the above mentioned new provisions limit the access of the Mexican population to these products because it was agreed that this exclusivity will be given as from the register of these products in Mexico instead of since the first register in the world, meaning that if a company decides to delay the register of its product in Mexico 15 years, for example, Mexican population will not have access with cheaper prices to this biologics product for 25 years, if we add the 15 years of the register delay plus the 10 years agreed in the USCMA. Regarding this, the Mexican Ministry of Economy stated that the deal has clear limits to avoid artificial delays of the entry of generic medicines to the Mexican market.
Nevertheless, not all the experts and analysts consider that these changes will negatively affect the Mexican pharmaceutical industry. According to the Mexican Association for Industries of Pharmaceutic Innovation (AMIIF, for its acronym in Spanish Language), this agreement will bring juridical certainty to the protection of clinical data promoting more investments in the pharmaceutical industry. Under this provision, laboratories of biologics medicines will have to present their own studies and clinical data in order to receive their sanitary register and be able to sell these products. These modifications, will enable the Mexican pharmaceutical industry to count in the legal aspect with the figure of clinical data protection, situation that will promote more investments in the pharmaceutical industry, mainly in its innovation sector.
Finally, the USMCA has provisions impacting a number of many sectors, healthcare being just one of many. The key issues of the impact the trilateral agreement has for healthcare are mainly:
- New protections for biologics including a minimum of ten year’s data protection from the date of first marketing approval of the product. The commented ten-year period of exclusivity represents a requirement which surpasses the current periods in effect in Mexico and Canada, but which is shorter than the current period in the United States.
- Enforced digital trade guidelines in connection with privacy and cross-border data transfer laws and specifically the restrictions on data localization requirements may not extend to “sensitive government information,” which may include patient and other medical data.
by Margarita Guerrero