MEXICO Law and Practice Contributed by: Adriana Ibarra, Carla Calderón, Marina Hurtado Cruz and José Hoyos-Robles, Baker McKenzie
• The creation of third authorised parties for clinical research: COFEPRIS has authorised 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 COFEPRIS are reduced significantly. The same rules regulate medical devices and phar- maceuticals. 2.2 Securing Authorisation to Undertake a Clinical Trial The procedure for securing authorisation to undertake a clinical trial of a pharmaceutical or a medical device comprises the following three basic steps, which are sequential and cannot be applied for in parallel: • favourable opinion of the research protocol granted by the ethics committee of the health institution where the trial is to be conducted, which – accord- ing to the Decree for the Operation of Ethics Com- mittees – 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 COFEPRIS, which – according to the Federal Law on Adminis- trative 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 COFE- PRIS, most trials are recorded in the National Reg- istry of Clinical Trials ( Registro Nacional de Ensayos Clínicos , or RNEC). The information contained in the RNEC is collected 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 available. Confidential information is not included in the RNEC, and nor is the health infor- mation 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 dis- close or publish the results of clinical trials, although the Code of Ethics of the Council of Ethics and Trans- parency of the Pharmaceutical Industry ( Consejo de Ética y Transparencia de la Industria Farmacéutica , or CETIFARMA) does contain a specific obligation for sponsors to disseminate the positive and negative results of trials, particularly the adverse events. 2.4 Use of Online Tools to Support Clinical Trials There are no specific restrictions regarding online clin- ical 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 advertising of medical products, services and privacy protection, so it is important that platform content be reviewed on a case-by-case basis. The data resulting from a clinical trial would be con- sidered personal if the patients enrolled therein are identified. If the results of a clinical trial are presented without providing information or images that could lead to the identification of the patients, such results It is permissible to transfer the data resulting from a clinical trial to a third party or an affiliate, if the privacy notice states that a transfer will occur and identifies a justifiable purpose for that transfer. When sensitive personal data is involved, the data controller must obtain express written consent for its processing through a signature, an electronic signature or any authentication mechanism established for that pur- pose. 2.6 Personal or Sensitive Data The creation of databases that contain sensitive per- sonal data must be justified, and must follow legiti- mate and concrete purposes that correspond to the activities and explicit objectives of the data controller. would not be considered personal data. 2.5 Use of Data From Clinical Trials
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