The strongest point is directed at the patent enforcement mechanism. PhRMA, which brings together global companies such as AstraZeneca, Bayer, Biogen, Pfizer, Sanofi, Novartisamong others, states that Mexico does not notify holders when a third party requests approval of a drug that could infringe a patent.
It also states that it does not offer sufficient information to demonstrate a possible violation and that the precautionary measures are ineffective because they are lifted without a final resolution. The organization adds that the Federal Commission for the Protection against Sanitary Risks (Cofepris) and the Mexican Institute of Industrial Property (IMPI) operate with partial rules, without a clear obligation to include all patents related to a drug and with criteria that exclude use patents due to a judicial decision issued this year.
Access delay
Criticism increases when analyzing real access to new therapies. PhRMA assures that Mexico maintains a structure that delays the entry of cutting-edge treatments and that only 23% of the medicines launched worldwide since 2014 arrive in the country, with waits that are around 30 months.
The document maintains that Cofepris faces delays in approving health records and that the General Health Council adds more time to the process, which limits patient access and reduces incentives to introduce innovations.
Cofepris recognizes that it inherited a structural lag in procedures and authorizations that slowed the arrival of medications, medical devices and research protocols. But this year a restructuring began to overcome the historical delay.
It deployed a three-axis strategy: digitalization, regulatory simplification and special attention days.
The Commission published new guidelines that allow the use of a fast track to grant health registrations to supplies approved by internationally recognized authorities. Mexico will accept evaluations from agencies that make up the International Council for Harmonization (ICH), a group where the world’s strictest drug regulators participate.
Measures to remedy
It will also recognize decisions by authorities from the International Medical Device Regulators Forum (IMDRF), which brings together the main medical device regulators, and the Medical Device Single Audit Program (MDSAP), which validates the quality systems accepted by several countries with a single audit.
The measure will facilitate access to new molecules, generics, biotechnological, biocomparable, biological, vaccines and medical devices.
In August, Cofepris also published an agreement in the Official Gazette of the Federation (DOF) that establishes a transformation that seeks to break with the bureaucracy accumulated for years and align the health authority with the national simplification mandate.
The document details the elimination of physical requirements for 29 procedures. The measure includes import permits for medicines, raw materials, medical devices, herbal remedies, tobacco products, cells and tissues. In some cases, forms, licenses, additional invoices, explanatory letters and duplicate documents disappear.
Another key action is the fusion of procedures that were previously atomized into multiple homoclaves. For example, nine different permits to import medicines without registration now form a single procedure.
Investment potential
For Larry Rubin, president of the American Society of Mexico, Mexico faces a decisive opportunity in clinical research. The pharmaceutical industry invests close to 200 million dollars a year in studies carried out in Mexico, but estimates that the figure can grow to 4,000 million if Cofepris’ regulatory process is more efficient.
Mexico has the conditions to become a hub of pharmaceutical innovation. He points out that investment in clinical research generates recurring flows every year, unlike an investment in infrastructure, which occurs only once.
The business representative says that a more agile regulatory environment would allow the population to access medical innovations in less time and would prevent patients from waiting years to receive new treatments.
More signs
PhRMA’s analysis extends to the test data protection system. The industry points out that Mexico only grants protection to new chemical entities and leaves out biological therapies, new indications and innovative formulations.
Remember that the USMCA sets a minimum standard of five years and requires legal clarity, something that Mexico has not guaranteed through a specific law.
The pressure increases when evaluating the recent changes in the General Health Law. PhRMA questions the proposals that reserve preferential treatment for medicines manufactured in Mexico, interpreting this measure as a barrier that affects US products and contradicts the commitments of the agreement. It also points out practices in public procurement that, according to the organization, favor tenders with little transparency and requirements that privilege local investment.
“On September 26, 2025, amendments to the General Health Law of Mexico were proposed, published in the Parliamentary Gazette, in order to grant preferential and expeditious marketing authorization to locally manufactured pharmaceutical products, thus discriminating against US manufacturers.”
Canada is not saved
The organization directs the same criticism at Canada. The text states that Ottawa fails to meet commitments on patent term adjustments and maintains a scheme that limits compensation for regulatory delays.
It also questions the health technology evaluation system and pricing policy, which the industry says reduces the value of innovative medicines and delays patient access. PhRMA maintains that Canada benefits from American innovation, without assuming a proportional cost, and calls for binding commitments to increase its spending on new therapies.
The industry urges the US government to use the review of the T-MEC as a platform to restore intellectual property standards that were eliminated in internal negotiations in 2019. He says those changes limited the agreement’s potential and that the 2026 review must correct course to strengthen the innovation ecosystem in North America.
The pressure intensifies at a time when the three countries refine their strategy towards a review that will define the next decade of regional trade. For the United States, the window represents the opportunity to push Mexico and Canada toward clearer regulatory ground.
