Spain: AEPD approves regulatory code of conduct for processing of personal data in field of clinical trials
The Spanish data protection authority ('AEPD') approved, on 25 February 2022, the regulatory code of conduct for processing of personal data in the field of clinical trials and other clinical research and pharmacovigilance. In particular, the AEPD noted that the code of conduct was promoted by Farmaindustria, which is the National Business Association of the Pharmaceutical Industry.
Moreover, the AEPD highlighted that the code of conduct regulates how the sponsors of clinical studies of medicine and the Contact Research Organisations that decide to adhere to it must apply the General Data Protection Regulation (Regulation (EU) 2016/679) ('GDPR'). In addition, the AEPD provided that the objective scope of application of the code of the conduct is the activities of treatment of personal data in the framework of clinical investigations in general, and clinical trials in particular, as well as those related to compliance with the obligations imposed by current regulations on pharmacovigilance for the detection and prevention of adverse effects of medicinal products already marketed.
Furthermore, the AEPD emphasised, among other things, that the code of conduct's scope of application is national, although it aspires to be a benchmark at the European level, as it is the first sectoral code of conduct that has been approved in Europe.