The United States Trade Representative Office has been engaging with a number of countries, including Mexico, to address concerns related to IP protection and enforcement and market access barriers for pharmaceuticals and medical devices. Mexico remained on USTR’s Watch List in 2019 because there has not been a significant change in the level of intellectual property (IP) protection and enforcement since last year. However, Mexico agreed to important IP provisions in the United States-Mexico-Canada Agreement (USMCA) and remains among the most attractive markets in the region.
Inefficiency in Mexico’s drug approval process has been a significant barrier to market access. The cumbersome process, which is initiated through the national health regulatory agency (the Federal National Commission for Protection Against Health Risks or COFEPRIS), delays pharmaceutical companies from putting their products on the market, and some innovative drugs are prevented from reaching the market at all. Recent statistics reported by PhRMA’s local sister association (AMIIF) show that on average it takes 1,500 days for Mexican patients to access innovative medicines. These delays are largely due to COFEPRIS’s unpredictable and opaque reimbursement procedures, tacking on an average of two years to the process. Once marketing authorization is granted, several other public agencies become involved in coordinating patents, pricing, procurement and negotiation, requiring large amounts of clinical and financial data.
In addition to lengthy bureaucratic procedures, Mexico’s reputation for protecting intellectual property is weak despite efforts to reform. Generic and biosimilar companies report difficulty in obtaining timely or correct information from COFEPRIS about the products they are working on, leading to these drugmakers putting potentially patent-infringing products on the market. The problem of weak patent enforcement leads to a wider distrust of Mexico’s IP system and undermines companies’ ability to do business properly. Furthermore, Mexico may be too lenient when allowing generics manufacturers to import active pharmaceutical ingredients and raw materials by not imposing restrictions on volume, which may be leading to the stockpiling of materials or the selling of substandard medicines.
Concern has been raised over the way Mexico provides regulatory data protection. While COFEPRIS and the Institute of Industrial Property (IPI) have clearly agreed to provide such protection for all products, it has become known that the authorities may have given different protections to small molecule drugs versus biologic drugs. Mexico is a member of Trade-Related Aspects of Intellectual Property Rights (TRIPS), and therefore regulatory data protection should be provided regardless of the way medicines are synthesised.
Despite the plethora of issues still to be resolved, Mexico remains among the most attractive markets in the Latin America region. According to Fitch Solutions’ Innovative Pharmaceuticals Risk/Reward Index, Mexico ranks 6th out of the 18 Latin American markets assessed, and 33rd out of the 110 markets assessed globally. Such rewards and risks include market size (industry reward), population growth (country reward), pricing regime (industry risk) and economic risk indices (country risk).
The pharma industry hopes that the 2018 United States-Mexico-Canada agreement will enhance Mexico’s commitment to protecting intellectual property. The three nations have reached an agreement on a modernized, high-standard Intellectual Property (IP) chapter that provides strong and effective protection and enforcement of IP rights critical to driving innovation, creating economic growth. (Source)