MEXICO Law and Practice Contributed by: Adriana Ibarra, Carla Calderón, Marina Hurtado Cruz and José Hoyos-Robles, Baker McKenzie
1. Life Sciences Regulatory Framework 1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices The legal framework regulating pharmaceuticals and medical devices is largely federal in Mexico, and includes the following laws and regulations: the General Health Law (GHL); • the Health Supplies Secondary Regulations ( Reglamento de Insumos para la Salud , or RIS); • the Health Services Secondary Regulations; • the Health Advertisement Secondary Regula- tions; • the Clinical Research Secondary Regulations (CRSR); and • several official Mexican standards on specific technical aspects (eg, good manufacturing practices, labelling and stability). In Mexico, the legal and administrative nature of the Federal Commission for the Protection against Sanitary Risks ( Comisión Federal para la Protección contra Riesgos Sanitarios , or COFE- PRIS) is that of an autonomous agency, under the administrative structure of the Ministry of Health (MoH). The GHL created COFEPRIS and gave it administrative, technical and operational autonomy. 1.2 Challenging Decisions of Regulatory Bodies That Enforce Pharmaceuticals and Medical Devices Regulation Decisions of the regulatory bodies that apply and enforce pharmaceutical and medical device regulations may be challenged through the fol- lowing optional appeal proceedings:
• an initial administrative review, decided by the same authority that issued the appealed administrative decision; • an annulment trial, decided by the Federal Administrative Tribunal; and • an amparo trial, decided by a judicial body, a judge or a court (depending on the nature of the decision being challenged). The formal requirements for challenging a deci- sion vary depending on the nature of the deci- sion being challenged, but generally the appeal lawsuit will include: • identification of the affected party; • identification of the challenged decision; • identification of the authority that issued the decision; • a description of the facts; and • the available evidence. However, the most important element for suc- cessfully litigating regulatory decisions is in- depth understanding of life sciences regulations and public law, so that the science and the law can be properly understood, aligned and argued in each case. In the last couple of years, there has been a significant increase in litigation relating to deci- sions taken by health regulators. Litigation has always existed in this area – traditionally in rela- tion to sanctions. There is now a lot of litigation in relation to the system of authorisations and the interpretation of technical regulations. As the regulatory system has evolved into a more com- plete 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 increasingly confident in challenging regulatory decisions that affect their interests.
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