Codes of Conduct are strongly supported by the GDPR as a means of ensuring proper application of the Regulation. It is widely-accepted that the implementation of GDPR in the health research space has been problematic and has not delivered harmonisation.

EFPIA is pleased to confirm that its GDPR Code of Conduct on Clinical Trials and Pharmacovigilance has progressed to the final phase of review by Data Protection Authorities prior to formal submission to the European Data Protection Board for approval. 

EFPIA believes that a GDPR Code of conduct will enable the sector to align on key data protection positions, thereby providing more consistency, more clarity and more certainty for clinical research. It will also bring more certainty to third parties, including patients, ethical committees and hospitals. Furthermore, the code will clarify the linkages between the GDPR and other key sectoral legislation such as the Clinical Trials Regulation, and will  respond to the Commission’s policy ambition for the European Health Data Space to improve data governance in Europe.

EFPIA looks forward to working with the authorities to bring the Code to a successful conclusion.