Constitutional reform initiative regarding pharmaceutical sovereignty and safety.

May 2, 2025

On April 22, 2025, a proposal was submitted to the Deputies Chamber proposing to reform articles 4, 25 and 28 of the Mexican Constitution, regarding pharmaceutical sovereignty and security.

The proposal appoints the modification of the legal framework at the constitutional level so that the State is required to guarantee pharmaceutical sovereignty and security, which in turn is intended to allow the subsequent adaptation of secondary laws, programs and budgets with a long-term vision.

This reform mainly states the following:

• The State will guarantee access to biological medicines, vaccines and medical devices by promoting the national production, storage and distribution of essential health products.
• Pharmaceutical sovereignty and security will be fundamental principles to ensure the timely supply of such products, especially those of public interest and high impact on health.
• The State will promote the development and strengthening of the national pharmaceutical industry, through public policies that encourage research, production and distribution of medicines recognized by law and that are strategic for the population, guaranteeing the reduction of external dependence in the acquisition of critical products for health.
• It defines as functions of strategic areas the production, storage and distribution of medicines, biologicals, vaccines and medical devices essential for public health and therefore exempts them from being considered as monopolies, with the objective of guaranteeing universal access to indispensable treatments.

If approved, this initiative would undoubtedly have an impact on Mexican health legislation and, of course, would imply the modification of processes for the evaluation and approval of health products, as well as the authorization of activities in establishments focused on the production, manufacture, storage and distribution of health products.

In other words, the effects of this proposal translate into drastic changes in the system of production of health products that are known today, so that if it is not analyzed harmoniously with the applicable legislation and the international treaties, in cooperation with the institutions and entities involved in the corresponding processes, as well as the subjects involved in the health system, it could complicate the due access to health products to the detriment of the patients.

At OLIVARES we remain aware of this constitutional reform initiative and its possible impact, we are available to advise our clients and ensure regulatory compliance in an increasingly rigorous environment.