MEXICO Law and Practice Contributed by: Adriana Ibarra, Carla Calderón, Marina Hurtado Cruz and José Hoyos-Robles, Baker McKenzie
• identification of the authority that issued the deci- sion; • a description of the facts; and • the available evidence. However, the most important element for successfully litigating regulatory decisions is in-depth understand- ing of life sciences regulations and public law, so that the science and the law can be properly aligned and argued in each case. In the last couple of years, there has been a signifi- cant increase in litigation relating to decisions taken by health regulators. Litigation has always existed in this area – traditionally in relation to sanctions. There is now a large amount of litigation related to the system of authorisations and the interpretation of technical regulations. As the regulatory system has evolved into a more complete set of legal rules, and as regulatory work is now being undertaken not only by pharmaceu- tical chemists but also by lawyers, companies have better understood their rights and have felt increas- ingly confident in challenging regulatory decisions that affect their interests. For a whole decade following the creation of COFE- PRIS in 2000, regulatory work was highly technical and was mainly handled by pharmaceutical chemists, both in companies and in regulatory agencies. The health law and regulation 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 technical criteria, which led to a highly discretionary system. Although decisions were always legally vulnerable, the concern of companies was that legally challeng- ing a decision on one product would affect decisions pending over other products. At the same time, pub- lic affairs actions were rather successful in achieving results without 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 adminis- trative system. This contributed to a trend for in-house lawyers and external counsel specialising in the field. At the same time, compliance controls tightened, forc- ing companies to evaluate, enforce and defend their
rights and obligations on the one hand and exert pres- sure in the area of public affairs on the other. The actions of the 2018–20 and 2020–23 COFEPRIS administrations deliberately isolated the agency from the industry by restricting contact with the regulat- ed industries, replacing experienced examiners and reducing the number of available examiners, leading to a huge backlog that disrupted commercial opera- tions. This created strong incentives for companies to litigate all kinds of pending approval applications. Finally, the prohibition to interact with the industry, in combination with the pandemic, led to an enor- mous regulatory backlog, which still has not been fully resolved. Jointly, these events resulted in a significant and sus- tained increase in litigation, year after year, for the past decade. This led to the creation of the Special- ised Chamber for Regulatory Matters within the Fed- eral Administrative Tribunal, which heard 300 cases against COFEPRIS in 2020. Currently, there is sig- nificant litigation against a lack of response on new authorisations, renewals, modifications, rejections and inspection procedures, in addition to the litiga- tion of sanction decisions. In 2022, the total number of all types of litigation cases against COFEPRIS sky- rocketed to 12,000. The 2023–24 administration partially restarted com- munication with the regulated industries via the Commissioner for Health Promotion, through techni- cal sessions and goodwill meetings. Both schemes were confidential, non-binding and not regulated by applicable regulations. Nonetheless, these schemes represented an alternative means for the industry to understand COFEPRIS’ interpretation of regulations and requirements. The 2025–26 administration tack- led the regulated industries and the severe administra- tive backlog it inherited by reinstating a line of com- munication between the regulator and the regulated subjects, taking note of up to three key submissions from companies to provide close follow-up on their resolution. A significant number of pending applica- tions were resolved but in some cases the resolution times remain uncertain. In 2026, there is a new admin- istration under Dr Victor Hugo Borja, though no poli- cies have been implemented yet.
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