MEXICO Law and Practice Contributed by: Adriana Ibarra, Carla Calderón, Marina Hurtado Cruz and José Hoyos-Robles, Baker McKenzie
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 man- ufacturing 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 regulation, being subject to direct price competi- tion in the market. Newly launched products are initially exempted, as explained here. Public Market Until very recently, patented pharmaceuticals for the public market were subject to a differ- ent process of annual negotiation. For ten years, such negotiations were held with the Co-ordi- nating Commission for Negotiating the Price of Medicines and other Health Inputs ( Comisión Coordinadora para la Negociación de Preci- os de Medicamentos y otros Insumos para la Salud CCPNM), which was created in 2008 and encompassed all major public institutions buy- ing drugs in Mexico, as well as the Ministries of Public Administration, Finance, Economy and Health. However, the last federal administration, which took office on 1 December 2018, intro- duced two major changes. First, it eliminated the CCPNM, transferring the whole pricing process to the public procurement system. That change eliminated the prior distinc- tion between pricing and acquisition, which are now defined in the same process for patented medicines. The estimated price for generic and off-patent products was initially defined by those public institutions co-ordinating the public procure-
ment exercise, based on their market research. However, the price would also be influenced by the discounts offered by the participating bid- ders and would ultimately be determined in the acquisition award and contract. The administration then changed the rules again, by means of issuing a new version of the Second- ary 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 ver- sion 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 market are initially exempted from the maximum retail price (MRP) system – given that, in prin- ciple, 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 conducted to verify wheth- er the product exists in the international market. If this is confirmed, an MRP will be estimated, and the price of newly launched products will be influenced by prices for the same product in other countries but not based on a health tech- nology assessment. The price regulations for medicines do not apply to medical devices. 8.3 Pharmaceuticals and Medical Devices: Reimbursement From Public Funds The Mexican system operates not through a model of reimbursement, but through a model of public procurement of drugs and medical devices.
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