STORY INLINE POST
During the transition period toward the consolidation of the obligations contracted with the signing of the United States-Mexico-Canada Agreement (USMCA), a period set to expire in 2025, it is worth putting on the table the preponderant role that international treaties have had in facilitating patients’ timely access to innovative treatments that contribute to better health and quality of life.
The entry into force of this free trade agreement represents a juncture conducive to the Mexican government in incorporating measures into our legal regime that, in addition to complying with international obligations, favor the improvement of health conditions in Mexico and the promotion of the dynamics of innovation in health.
Annex 12-F of the USMCA focuses on the regulation of pharmaceutical products. It is based on standards for the protection of innovation and intellectual property that were already part of other trade agreements, such as the Trans-Pacific Partnership (TPP), now known as the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP).
In addition to intellectual property in the pharmaceutical sector, this Annex to the USMCA ties the observance of these provisions to the human right to health protection enshrined in Article 4of the Mexican Constitution.
What measures will the USMCA implement to enhance the availability of innovative medications to patients and the National Health System?
In the first place, the Annex establishes that when developing regulatory requirements for pharmaceutical products, each party must ensure that the authority minimizes the likelihood of implementing requirements that would lead to substantial delays in making pharmaceutical products available within its market. The Annex also states that the parties are bound to provide applicants requesting marketing authorization for a pharmaceutical product with their determination within a reasonable period of time.
The key point is that the international obligation to approve marketing authorizations for medications in a timely manner also benefits patients. When the health authority (Federal Commission for the Protection against Sanitary Risks (COFEPRIS)) in Mexico adheres to the legal deadlines for issuing marketing authorizations, this generates an advantage for patients by providing them with the possibility to access the innovative medicines they need to treat their conditions.
The Annex on Pharmaceuticals also establishes the bases whereby Mexico, the US and Canada may collaborate by aligning their respective regulations for pharmaceutical products through initiatives aimed at harmonization. This opens up the possibility that another country could accept a prior marketing authorization issued by the regulatory authority of one country as evidence that a pharmaceutical product meets its requirements. With these measures, the procedure to issue marketing authorizations allowing for the commercialization of medications in Mexico could be facilitated in both the public and private sectors, reducing the time patients must wait before gaining access to their required medications.
Obligations during the USMCA transition period also include compensating holders of pharmaceutical patents for delays attributable to the health authority granting the marketing authorization. To provide restitution to holders, the USMCA states that they must be compensated with an adjustment to the patent term for the medication whose marketing authorization has been delayed.
Another obligation of crucial importance during the transition period that must be fulfilled by 2025 is protecting the clinical data of medications, including biotechnology products. It provides a period of exclusivity of at least five years in favor of the person or entity that conducted the research to demonstrate the medication’s safety, effectiveness and quality. During this period, only that person or entity may obtain marketing authorization from the health authority on the basis of that data. At the end of the protection period, third parties may apply for authorization to produce generic medications referencing the data generated by the initial applicant.
Despite being required to guarantee the protection of clinical data since 1994 under NAFTA, the Mexican government has not implemented this measure in its legislation. By virtue of the decisions of the competent courts, COFEPRIS has had to recognize this right in favor of those producing the clinical data, but the lack of specific regulations has generated uncertainty.
The USMCA provides the opportunity to establish a special regulation on the protection of clinical data in our country, which, in addition to complying with an international obligation, will encourage the research and development of new medications.
In short, compliance with the provisions mentioned above will continue to position our country as a regional benchmark in protecting intellectual property. The pharmaceutical innovation sector is ready to contribute and promote a constructive dialogue that will allow our country to implement the regulatory updates it needs to adopt these international commitments.