On 25 February 2022, the Spanish data protection authority (the AEPD) published its code of conduct (the CoC), regarding the processing of personal data in the context of clinical trials and pharmacovigilance.
Helpfully, the CoC provides detail on the responsibilities of each party to the clinical trial (such as the clinical trial sponsor and contract research organisation) and, amongst other things, addresses data protection impact assessments, codification of personal data, international data transfers, legal bases for processes, and data subject rights.
A mediation procedure is also established by the CoC to support swift resolution of disputes in this area. Promoted by Farmaindustria (the National Business Association of the pharmaceutical industry), this is the first sectorial CoC approved on this topic since the GDPR was introduced.
The press release is available here and the code of conduct (both in Spanish only).
