On 6 Sept 2023 a meeting organized by EFPIA took place, which brought together a diverse group of stakeholders and influential political figures, including MEP Tomislav Sokol, the co-rapporteur for the proposed European Health Data Space (EHDS).
The meeting primarily addressed the sharing of data for secondary use within the proposed EHDS. During the discussions, stakeholders highlighted the European Commission's initial proposal, which did not include opt-in or opt-out mechanisms. These organizations argued that this approach strikes a balance between protecting patients' rights and maintaining the integrity of research activities in the European Union without causing disruptions.
Key points from the meeting included concerns raised by the 32 organizations regarding the potential introduction of opt-out or opt-in mechanisms for secondary data usage. They expressed worries that these mechanisms could lead to disparities in health data and the underrepresentation of specific population groups within the dataset. Their contention was that this approach might increase risks and compromise data reliability. Instead, they proposed enhancing transparency and accountability in the collection of health data for secondary purposes and urged policymakers to avoid adding further complexities to data sharing, such as implementing a broad opt-out mechanism.
This meeting was a continuation of the group's joint statement issued in June 2023, where they outlined the challenges associated with implementing an opt-out mechanism.
Further information can be found here
