MEXICO Law and Practice Contributed by: Adriana Ibarra, Carla Calderón, Marina Hurtado Cruz and José Hoyos-Robles, Baker McKenzie
of registration. In 2012, however, this rule was changed to make it possible to submit a clinical trial report instead, provided that the Mexican population was included in the trial. • The creation of third authorised parties for clinical research – COFEPRIS has author- ised several public hospitals with extensive experience in clinical research to conduct a pre-evaluation of research protocols. If their report is positive, approval times at COFE- PRIS are reduced significantly. The same rules regulate medical devices and pharmaceuticals. 2.2 Procedure for Securing Authorisation to Undertake a Clinical Trial The procedure for securing authorisation to undertake a clinical trial of a pharmaceutical or a medical device is comprised of three basic steps, which are sequential and cannot be applied for in parallel, as follows: • favourable opinion of the research protocol by the ethics committee of the health institu- tion where the trial is to be conducted, which – according to the Decree for the Operation of Ethics Committees – must take place within 30 business days of filing; • authorisation of the research protocol by the director of the health institution where the trial is to be conducted, which must take place under its relevant internal rules; and • approval of the research protocol from COFE- PRIS, which – according to the Federal Law on Administrative Proceedings – must take place within three months of filing. 2.3 Public Availability of the Conduct of a Clinical Trial After their protocols have been authorised by COFEPRIS, most trials are currently recorded
in the National Registry of Clinical Trials ( Reg- istro Nacional de Ensayos Clínicos , or RNEC). The information contained in the RNEC is col- lected by COFEPRIS in collaboration with those responsible for conducting the clinical trial (ie, a sponsor, CRO or healthcare institution). The RNEC publishes an electronic database that includes only general information about clinical trials. Although limited, this database has seen significant progress; until very recently, almost no local information was made publicly avail- able. Confidential information is not included in the RNEC, and nor is the health information of patients, which will be regarded as sensitive personal information under data protection laws and will be protected accordingly. On the other hand, there is no binding provision to disclose or publish the results of clinical trials, although the Code of Ethics of the Council of Ethics and Transparency of the Pharmaceutical Industry (CETIFARMA) does contain a specific obligation for sponsors to disseminate the posi- tive and negative results of trials, particularly the adverse events. 2.4 Restriction on Using Online Tools to Support Clinical Trials There are no specific restrictions regarding online clinical trial platforms. However, it would be important for a platform to comply with the regulations regarding the recruitment of and interaction with patients enrolled in a clinical trial if those functionalities are included in that platform. There could also be other regulatory implications, such as in relation to the advertis- ing of health inputs, services and privacy protec- tion, so it is important that platform content be reviewed on a case-by-case basis. The data resulting from a clinical trial would be considered personal if the patients enrolled
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