This Decree, published in the Official Gazette of the Federation on June 2, 2025, establishes a regulatory framework aimed at promoting investment within Mexico to strengthen the pharmaceutical industry, the production of medicines, health inputs, and medical devices, as well as fostering scientific research. Its main objective is to reduce import dependency and ensure the availability of these essential products, using consolidated public procurement as a lever for economic development.
UPDATE
This Decree introduces a series of provisions aimed at incentivizing local investment and production in the health sector. The key measures include:
Points and Percentages Evaluation Criteria in Bidding Processes: In consolidated procurement processes for generic medicines, health inputs, and medical devices, the evaluation will be based on a points and percentages system. Additional points will be awarded to proposals submitted by companies that demonstrate investment within the national territory along the production chain (e.g., manufacturing plants, laboratories, warehouses) or that engage in scientific research or the development of innovative products in Mexico.
Administrative Simplification by COFEPRIS: The Federal Commission for Protection against Health Risks (COFEPRIS) will implement measures to simplify and expedite the issuance of sanitary registrations (for medicines and medical devices), scientific research protocols approvals, export certificates, and raw material import permits, to promote national manufacturing.
Committee for the Promotion of Pharmaceutical Investment: For consolidated procurement processes involving single-source and patented medicines, health supplies, and medical devices, a Committee will be established, composed of representatives from the Ministries of Health, Economy, and Anti-Corruption and Good Governance. This Committee will facilitate dialogue with the industry to evaluate national investment proposals, taking into account the estimated procurement volume, investment level, installed production capacity, and research activities conducted in Mexico. The outcomes of these discussions will be formalized through concertation agreements.
REGULATORY FRAMEWORK
This Decree is based on various laws and regulations, and primarily impacts the following areas:
Political Constitution of the United Mexican States: Article 4, fourth paragraph (right to health protection) and Article 134 (public procurement).
General Health Law (LGS): Articles 3, 27, 32, and 96, related to medical care, availability of essential inputs, and health research.
Law on Acquisitions, Leases, and Services of the Public Sector: Especially Article 9 (public procurement policy) and provisions on evaluation criteria.
Organic Law of the Federal Public Administration (LOAPF): Attributions of the Ministry of Economy (Art. 34), Ministry of Health (Art. 39), and the Ministry of Anti-Corruption and Good Governance (Art. 37) regarding health, industry, investments, and public procurement, respectively.
National Development Plan 2025-2030 (PND): General axes on "Healthy Republic" and "Moral Economy and Work," which promote health sovereignty and national industrial policy.
Effects from RA Update
This Decree will have significant implications for stakeholders across the sector:
National Manufacturers and Importers with Investment in Mexico:
Competitive Advantage in Bidding: Companies that already have investments in productive infrastructure (such as factories, laboratories, or warehouses) or engage in scientific research in Mexico will be given preferential consideration in consolidated public tenders for generic medicines, as their proposals will receive additional points.
Investment Incentive: This creates a strong incentive for importers and distributors to consider investing in local manufacturing or R&D activities in order to enhance their competitiveness.
New Investors and Foreign Companies:
Capital Attraction: The Decree seeks to attract new investments in the pharmaceutical and medical device sectors by facilitating the establishment of manufacturing facilities and the transfer of technology.
Business Opportunities: New business opportunities are emerging for companies that choose to establish operations in Mexico, particularly those focused on local production and innovation.
COFEPRIS:
Increased Workload and Operational Challenge: COFEPRIS will need to optimize its internal processes to comply with the mandated simplification and acceleration of procedures. This will require institutional re-engineering and potentially the strengthening of operational and human resources.
Greater Dynamism in Registrations: An increase is expected in the number of requests for sanitary registrations and import/export permits associated with national manufacturing activities.
Public Sector (Ministry of Health, Ministry of Economy, Ministry of Anti-Corruption and Good Governance):
Interinstitutional Coordination: Close inter-institutional collaboration is essential for the establishment and effective operation of the Committee for the Promotion of Pharmaceutical Investment, as well as for the development and issuance of complementary guidelines.
Public Procurement Management: The entities responsible for consolidated procurement must adapt their procedures to incorporate the new points-and-percentages evaluation criterion and to ensure fair and open competition.
In summary, the Decree aims to transform the public health procurement landscape in Mexico, leveraging it as a strategic tool to promote productive self-sufficiency, job creation, and national scientific development, while ensuring access to quality medicines and health supplies for the population.
The provisions of this Decree shall enter into force on the day following its publication.
Written By:
Mariel Antonio
About ips
Given the imminent effective date of these provisions, it's crucial for your company to assess its current standing and the opportunities that arise. At IPS, we have a team of experts in regulatory and business affairs within Mexico's health sector, ready to provide you with personalized advice on how this Decree will impact your operations.
Contact us to analyze the implications for your organization in detail and to develop a strategy for compliance and leveraging these new guidelines. info@insumosparasalud.com