MEXICO Law and Practice Contributed by: Adriana Ibarra, Carla Calderón, Marina Hurtado Cruz and José Hoyos-Robles, Baker McKenzie
7.5 Trade Blocs and Free Trade Agreements Mexico has entered into 14 free trade agreements with more than 50 different countries. Mexico is an active party to the Pacific Alliance (along with Chile, Colom- bia and Peru). The Pacific Alliance and its framework agreement have specific provisions on regulatory co- operation and product-specific annexes, covering cosmetics, medical devices, dietary supplements and cleaning products. This has started a very promising regulatory harmonisation/convergence process in the region. Mexico is also party to the Comprehensive and Pro- gressive Agreement for Trans-Pacific Partnership (the revised Trans-Pacific Partnership Agreement), which contains promising provisions on the regulatory co- operation side, as well as product-specific annexes. The United States–Mexico–Canada Agreement (USM- CA) entered into force in July 2020 and contains sev- eral regulatory annexes for pharmaceuticals, medical devices, chemical substances, cosmetic products and food products. 8. Pharmaceutical and Medical Device Pricing and Reimbursement 8.1 Price Control for Pharmaceuticals and Medical Devices In Mexico, the private and public markets for medical products have separate rules depending on wheth- er the products are patented. However, this mainly applies to pharmaceuticals and has changed during the new federal administration. The very general legislative bases of the dual system are contained in two laws: the GHL (Article 31) and the Federal Economic Competition Law (Article 9). However, the rest of the rules are largely contained in separate regulatory instruments of lower hierarchy, including the Addendum to the Agreement for Drug Pricing Co-ordination signed in 2004 between the Ministry of Economy and the National Chamber of the Pharmaceutical Industry, and the technical standard for the labelling of drugs (NOM-072-SSA1-2012).
Private Market Patented drugs for the private market are subject to a hybrid system that is largely self-regulated and vol- untary. Under this system, companies compile their own information about their prices in other jurisdic- tions and submit that to the authority, which monitors the accuracy of the data. The manufacturer is required to stamp the price on the label of the product at the end of the manufacturing process. PROFECO verifies that the prices at the point of sale (ie, at pharmacies) do not exceed that price. Generic drugs, off-patent products and medical devices in general are not part of this pricing regula- tion, being subject to direct price competition in the market. Newly launched products are initially exempt- ed, as explained here. Public Market Until very recently, patented pharmaceuticals for the public market were subject to a different process of annual negotiation. For ten years, such negotiations were held with the Co-ordinating Commission for Negotiating the Price of Medicines and other Health Inputs ( Comisión Coordinadora para la Negociación de Precios de Medicamentos y otros Insumos para la Salud CCPNM), which was created in 2008 and encompassed all major public institutions buying drugs in Mexico, as well as the Ministries of Public Administration, Finance, Economy and Health. How- ever, the last federal administration, which took office on 1 December 2018, introduced two major changes. First, it eliminated the CCPNM, transferring the whole pricing process to the public procurement system. That change eliminated the prior distinction between pricing and acquisition, which are now defined in the same process for patented medicines. The estimated price for generic and off-patent prod- ucts was initially defined by those public institutions co-ordinating the public procurement exercise, based on their market research. However, the price would also be influenced by the discounts offered by the par- ticipating bidders and would ultimately be determined in the acquisition award and contract.
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