On December 28, 2022, the Spanish Data Protection Authority (“AEPD”) published a statement on the interplay between its recently approved Spanish code of conduct for the pharmaceutical industry and the European Federation of Pharmaceutical Industries and Associations’ (“EFPIA”) proposal for an EU code of conduct on clinical trials and pharmacovigilance.  The statement relates specifically to the legal basis for processing personal data in the context of clinical trials.

The AEPD adopted the Spanish code of conduct for the pharmaceutical industry on February 25, 2022.  The code aims to help Spanish pharmaceutical companies to comply with the GDPR when conducting clinical trials, other clinical investigations and pharmacovigilance.  Among other things, the Spanish code lists a number of legal bases that can be relied upon for processing this data and defines sponsors and investigators as independent controllers.  The AEPD states that the legal bases set out in the code are aligned with the criteria set out in the EDPB’s opinion 3/2019 (regarding the interplay between the Clinical Trials Regulation and the GDPR).

Separately, in the past few years, EFPIA has been working on an EU code of conduct on clinical trials and pharmacovigilance, which is currently under review by the Supervisory Authorities and the European Data Protection Board (“EDPB”).  The code would apply EU-wide, meaning that pharmaceutical companies active in any EU member state could adhere to the code.

The AEPD’s statement concerns the future relationship between the Spanish code and EU code specifically in relation to the legal basis for processing personal data.

The AEPD reassures companies that want to adhere to the Spanish code that it is committed to defend the legal bases identified in the Spanish code in the debate held with the other Supervisory Authorities and EDPB regarding the EU code.  In addition, it clarified that if the EU code contains legal bases other than those identified in the Spanish code, the Spanish rules on health research in Spain contain a “wide and flexible range of legal bases” that would allow for the adaptation of the Spanish code to reflect novel interpretations by the EDPB.

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Covington & Burling regularly advises companies on all aspects of scientific research and has assisted EFPIA on the development of the EU code of conduct.  Our Data Privacy & Cybersecurity Team, alongside our Life Sciences team, is happy to assist you with any inquiries related to clinical trials and pharmacovigilance in the EU.

Tags: clinical trials, Code of Conduct, EFPIA, EU Code of Conduct on Clinical Trials, Pharmaceutical Industry, Spanish Data Protection Authority
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Photo of Kristof Van Quathem Kristof Van Quathem

Kristof Van Quathem advises clients on information technology matters and policy, with a focus on data protection, cybercrime and various EU data-related initiatives, such as the Data Act, the AI Act and EHDS.

Kristof has been specializing in this area for over twenty…

Kristof Van Quathem advises clients on information technology matters and policy, with a focus on data protection, cybercrime and various EU data-related initiatives, such as the Data Act, the AI Act and EHDS.

Kristof has been specializing in this area for over twenty years and developed particular experience in the life science and information technology sectors. He counsels clients on government affairs strategies concerning EU lawmaking and their compliance with applicable regulatory frameworks, and has represented clients in non-contentious and contentious matters before data protection authorities, national courts and the Court of the Justice of the EU.

Kristof is admitted to practice in Belgium.

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Photo of Anna Sophia Oberschelp de Meneses Anna Sophia Oberschelp de Meneses

Anna Sophia Oberschelp de Meneses advises on EU data protection, cybersecurity, and consumer law. Her practice covers the full range of Europe’s digital regulatory framework, including GDPR, ePrivacy, NIS2, the Cyber Resilience Act, the AI Act, the Digital Services Act, the Data Act…

Anna Sophia Oberschelp de Meneses advises on EU data protection, cybersecurity, and consumer law. Her practice covers the full range of Europe’s digital regulatory framework, including GDPR, ePrivacy, NIS2, the Cyber Resilience Act, the AI Act, the Digital Services Act, the Data Act, the European Health Data Space, and EU consumer protection law, including product safety, product liability, and consumer rights legislation. She focuses on the operational side of compliance — helping clients design policies and processes, draft documentation, and build the internal frameworks needed to meet regulatory requirements in practice.

She also advises on contentious matters, drawing on experience managing investigations before national regulators and proceedings before national courts and the Court of Justice of the European Union. She works closely with Covington’s disputes teams on matters at the intersection of regulatory compliance and litigation.

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