EFPIA et al discuss opt-out requirements in EHDS

As part of a multi-stakeholder group consisting of 32 European patient organizations, medical associations, research organizations, data collaborations and industry associations, trade group the European Federation of Pharmaceutical Industries and Associations (EFPIA) met European Union officials, including MEP Tomislav Sokol, co-rapporteur, as well as several permanent representations that will hold upcoming Presidencies of the Council of the European Union, to discuss how the European Health Data Space (EHDS) can facilitate health research and innovation to create tangible benefits for patients in the European Union.

The meeting was held in follow-up to a  joint statement issued by the group in June 2023 in which the organisations outlined the challenges of implementing an opt-out mechanism. In that statement, the group agreed that the Commission’s proposal strikes an adequate balance between delivering health-related benefits for patients in the EU and mitigating/eliminating any risks to their rights and interests.

The healthcare community remind that ensuring the trust of patients and other stakeholders in the healthcare system is vital. The group also call on legislators to adopt a consistent, EU-wide approach to unlock the potential value of using health-related data for research and innovation.