MEXICO Law and Practice Contributed by: Adriana Ibarra, Carla Calderón, Marina Hurtado Cruz and José Hoyos-Robles, Baker McKenzie
The administration then changed the rules again, by means of issuing a new version of the Secondary Regulations for the National Compendium, creating a national formulary from which public health institutions must – in principle – acquire the medical products they need. The new version incorporated new provisions under which a company must provide a maximum price as part of the process to add products; if the addition is approved, that maximum price will become the basis for any public acquisition mechanism. 8.2 Price Levels of Pharmaceuticals or Medical Devices Newly launched pharmaceuticals for the private mar- ket are initially exempted from the maximum retail price (MRP) system – given that, in principle, they would not have a comparator. The manufacturer can set the initial price, subject to a re-evaluation three months after the product launch. The review is con- ducted to verify whether the product exists in the international market. If this is confirmed, an MRP will be estimated, and the price of newly launched prod- ucts will be influenced by prices for the same product in other countries but not based on a health technol- ogy assessment. The price regulations for medicines do not apply to medical devices. 8.3 Reimbursement From Public Funds The Mexican system operates not through a model of reimbursement, but through a model of public pro- curement of drugs and medical devices. There is a comprehensive legal regime for public pro- curement in Mexico, which is overseen by the Ministry of Antibribery and Good Government 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 sector, which encompasses the Mexican Institute of Social Security ( Instituto Mexicano del Seguro Social IMSS), the Institute for Social Security and Services for State Workers ( Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado ISSSTE), IMSS-Bie- nestar, national health institutes and federal refer - ence hospitals. Under this decree, the Vice Ministry of Health was tasked with preparing a diagnostic of necessities and planning the consolidated purchase
of medical products. Thus, BIRMEX now conducts the public procurement process on behalf of healthcare institutions, under the instructions of the Vice Minister of Health. The first consolidated public procurement process under this scheme began in December 2024 and was still ongoing in February 2025, as challenges to 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, purchasing 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 Sec- tor. One of the exemptions refers to cases where there are no substitute products, there is only one possible supplier or the required product is patent-protected. Accessing the public market for pharmaceuticals does not begin directly with public procurement. Other key regulatory steps must first be completed, given that public procurement works through product codes included in the National Compendium for Medical Products. A product can only become part of a pub- lic 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 products replaced the basic formulary and several institutional formular- ies. 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, relating to the introduc- tion of a new requirement. The new rules now state that an application to add a product must first obtain and submit a sponsoring letter from one of the public payors, representing an access barrier.
203 CHAMBERS.COM
Powered by FlippingBook