Together with a large multi-stakeholder group, representing the entire spectrum of the healthcare ecosystem and consisting of 36 European patient organisations, medical associations, health research infrastructures and health industry associations, we have issued a joint statement to raise the alarm about the significant legislative shortcomings and uncertainties in the proposed Regulation for a European Health Data Space (EHDS).

The multi-stakeholder group is issuing this joint statement in advance of the plenary vote in the European Parliament scheduled on 13 December 2023. In addition, the group is raising its concerns ahead of a COREPER meeting on 6 December 2023 in the hope that Member States will make much-needed changes to the legislative text before reaching general approach.

There remain serious legislative problems with the EHDS, which is now being fast-tracked through both the European Parliament and Council. Stakeholders are concerned that if these problems are not addressed, then the legislation could generate more risks than benefits. The significant degree of legal ambiguity and uncertainty could pose risks for the protection of patient data as well as health research collaborations. As it stands, the potential effects of some of the key provisions in the EHDS are the opposite of what the original policy objectives were aiming for.

Read the statement here.