MEXICO Law and Practice Contributed by: Adriana Ibarra, Carla Calderón, Marina Hurtado Cruz and José Hoyos-Robles, Baker McKenzie
For a whole decade following the creation of COFEPRIS in 2000, regulatory work was highly technical and was mainly handled by pharma- ceutical chemists, both in companies and in regulatory agencies. The health law and regu- lation did not evolve as quickly as the science and the market. The government’s regulatory decisions were frequently taken based not on existing legal rules but exclusively upon techni- cal criteria, which led to a highly discretionary system. Although decisions were always legally vulnerable, the concern of companies was that legally challenging a decision on one product would affect other decisions pending over other products. At the same time, public affairs actions were rather successful in achieving results with- out the need to litigate. Two COFEPRIS administrations (2010–18) then brought the legal framework up to date, bringing in lawyers to key positions and modernising the administrative system. This helped to trigger a trend for in-house lawyers and external counsel specialising in the field. At the same time, com- pliance controls tightened, forcing companies to evaluate, enforce and defend their rights and obligations on the one hand and to put pressure on the area of public affairs on the other. Finally, the actions of the two most recent COFE- PRIS administrations (2018–20 and 2020–23) deliberately isolated the agency from the indus- try by restricting contact with the regulated industries, replacing experienced examiners and reducing the number of available examin- ers, leading to a huge backlog that disrupted commercial operations. This created strong incentives for companies to litigate all kinds of pending approval applications. Taken together, the foregoing has resulted in a significant and sustained increase in litiga-
tion, year after year, for the past decade. This led to the creation of the Specialised Cham- ber for Regulatory Matters within the Federal Administrative Tribunal, which heard 300 cases against COFEPRIS in 2020. Currently, there is significant litigation against a lack of response on new authorisations, renewals, modifications, rejections and inspection procedures, in addition to the litigation of sanction decisions. In 2022, the total number of all types of litigation cases against COFEPRIS skyrocketed to 12,000. The previous administration (2023–24) partially restarted communication with the regulated industries via the Commissioner for Health Pro- motion, through technical sessions and goodwill meetings. Both schemes are confidential, non- binding and not regulated by applicable regu- lations. Nonetheless, these schemes represent an alternative means for the industry to under - stand COFEPRIS’ interpretation of regulations and requirements. How this new administration (2025–31) will tackle the regulated industries and the severe administrative backlog it has inherited remains to be seen. 1.3 Different Categories of Pharmaceuticals and Medical Devices The GHL contains many relevant classifications for medicines, including reference and generic/ biocomparable drugs, prescribed and non-pre- scribed drugs, standard and controlled drugs, and so on. Medical devices are divided into three classes according to the risk they pose to human health, as follows: • class I – devices that are recognised in medi- cal practice, have proven safety and efficacy, and are generally not introduced into the human body;
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