EFPIA welcomes the Commission’s efforts to further harmonise data protection requirements in the EU. The inconsistent application of privacy requirements impedes our industry’s ability to conduct meaningful biomedical research that leads to the discovery of new medicines, and it creates particular challenges for the collection and reporting of safety data concerning medicines. EFPIA also welcomes recognition that the public interest in advances in medical science warrants special rules on the collection and use of personal data for medical research purposes (Art. 83), and justifies collection and use of data for public health purposes (Art. 81(1)). Both of these activities already take place under highly controlled and regulated conditions which are designed to protect patient privacy.