MEXICO Law and Practice Contributed by: Adriana Ibarra, Carla Calderón, Marina Hurtado Cruz and José Hoyos-Robles, Baker McKenzie
There is a comprehensive legal regime for pub- lic procurement in Mexico, which is overseen by the Ministry of Antibribery and Good Gov- ernment in co-ordination with the purchasing entity. On 22 December 2023 and 29 October 2024, a presidential decree was published that ordered BIRMEX to consolidate public procure- ment processes for the public health care sec- tor, which encompasses the Mexican Institute of Social Security ( Instituto Mexicano del Seg- uro Social ;IMSS), the Institute for Social Secu- rity and Services for State Workers ( Instituto de Seguridad y Servicios Sociales de los Tra- bajadores del Estado ISSSTE), IMSS-Bienestar, national health institutes and federal reference hospitals. Under this decree, the Vice Ministry of Health was tasked with preparing a diagnostic of necessities and plan the consolidated purchase of medical products. Thus, BIRMEX now con- ducts the public procurement process on behalf of the healthcare institutions, under the instruc- tions of the Vice Minister of Health. The first con- solidated public procurement process under this scheme began in December 2024 and was still on-going in February 2025, as challenges in its implementation arose. In general, public procurement operates through three mechanisms: • public bidding, with a national or international scope; • invitation to at least three persons; and • direct awards. Although public bidding is the general rule, pur- chasing by invitation or direct award is allowed under certain circumstances, which are listed in the Federal Law for Procurement, Leases and Services of the Public Sector. One of the exemp- tions refers to cases where there are no substi-
tute products, there is only one possible supplier or the required product is patent-protected. Accessing the public market for pharmaceu- ticals does not begin directly with public pro- curement. Other key regulatory steps must first be met, given that public procurement works through product codes included in the National Compendium for Medical Products. A product can only become part of a public procurement exercise once it has been allocated a code, which – in the case of medicines – is assigned per active ingredient. Note that on 8 November 2022, a national compendium of medical prod- ucts replaced the basic formulary and several institutional formularies. Regulations for the national compendium were issued on 22 November 2022, bringing several changes to the system – including one that has been a source of controversy and litigation, relat- ing to the introduction of a new requirement. The new rules now state that an application to add a product must first obtain and submit a sponsor- ing letter from one of the public payors, repre- senting an access barrier. 8.4 Cost-Benefit Analyses for Pharmaceuticals and Medical Devices Previously, the methodology for determining price was quite clear and included cost-benefit analyses. However, it is no longer clear, and it is also not currently clear whether the new admin- istration will be open to exploring value-based proposals. 8.5 Regulation of Prescriptions and Dispensing by Pharmacies The regulatory framework links the rules of pre- scription and dispensing with those of substitu- tion at the point of sale. There are two scenarios for the private and public markets.
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