EFPIA is pleased to announce the submission of its GDPR Code of Conduct on Clinical Trials and Pharmacovigilance to the Belgian Data Protection Authority for formal assessment. This marks an important step in our efforts to support a harmonised, practical, and robust approach to data protection in the pharmaceutical sector.

The EFPIA GDPR Code of Conduct aims to provide a consistent interpretation of key GDPR provisions as they apply to pharmacovigilance and clinical research, aiming to enhance legal certainty and reduce administrative burden across the EU.

It also responds to challenges highlighted in the Draghi Report on European Competitiveness, which calls for reducing legal fragmentation, gold-plating, and inconsistent enforcement of GDPR - factors that risk undermining the EU’s innovation potential. The EFPIA GDPR Code of Conduct seeks to contribute to a more coherent, trustworthy, and innovation-friendly regulatory environment - essential for unlocking the full value of health data in research and development.

EFPIA looks forward to continued engagement with data protection authorities as the approval process moves forward.