On February 23, 2026, the Rules of the Pharmaceutical Investment Promotion Committee were published, following the Decree of June 2, 2025, which aims to promote investment and strengthen the development of the pharmaceutical industry and the production of health supplies in Mexico.
The Rules formally establish the operation of the Committee and define its role in promoting investment projects and industrial development within the pharmaceutical sector.
The new rules link participation in certain public procurement procedures (direct awards and restricted tenders) to the fulfillment of investment commitments and related criteria.
This new framework may give rise to several legal and operational implications, including:
- International considerations: The introduction of requirements related to investment and technology transfer should be assessed in light of Mexico’s obligations under international trade and government procurement agreements, particularly regarding principles such as national treatment and non-discrimination.
- Public procurement dynamics: The potential exclusion of suppliers that do not meet the investment criteria could affect market participation in certain segments, particularly where there are limited suppliers or patent-protected medicines. This may create artificial barriers to supply, impact consolidated procurement processes, increase costs, and lead to reliance on therapeutically inferior alternatives.
- Industrial property and innovation: Conditioning access to the public market on criteria other than strictly technical or economic considerations may raise questions regarding its interaction with the industrial property framework and incentives for research and development. In practice, this could weaken the effective exercise of exclusive rights.
- Access to medicines: In cases where a product represents a relevant or sole therapeutic option, it will be important to assess the practical effects of these requirements on availability and continuity of supply. Conditioning the procurement of medicines, particularly when they constitute the only therapeutic option, on investment-related criteria unrelated to safety, efficacy, or quality may affect the availability and accessibility standards required under Mexico’s constitutional and international framework.
In this context, pharmaceutical companies, both domestic and foreign, should carefully review the scope of the new Rules, assess their potential impact on investment and public procurement strategies, as well as the possibility of challenging the new Rules either upon their entry into force or at the time of their first act of application and monitor regulatory and practical developments in their implementation.
Further contributions to this article by Ingrid Ortiz, Jorge Juaréz, Karla Olvera, Luz Elena Elias
