EFPIA continues to believe in the undeniable value of creating a common European space to share and access health data, but not at any cost. The lack of agreement at the 7th March trilogue meeting confirms that there are still provisions in the European Health Data Space (EHDS) regulation where minimal or no consensus exist among co-legislators.  

The EHDS could shape the future of health data and Europe’s digital ecosystem, bringing enormous benefits to European patients, healthcare professionals and health systems. Electoral timelines should not interfere with the realisation of this ambition.  

Therefore, EFPIA reiterates its call to the co-legislators to take sufficient time for critical examination of the EHDS draft regulation or risk compromise on alternative measures without proper impact assessment against EHDS original objectives, and impact on EU research competitiveness. 

From EFPIA’s perspective, three fundamental issues remain to be solved:  

• The regulation must enable and protect innovation in Europe: The positions of  co-legislators are in direct contradiction with the existing frameworks for the protection of intellectual property (IP) rights and trade secrets by giving the responsibility to the Health Data Access Bodies (HDAB) to act as a doorkeeper for assessing what constitutes trade secrets and protecting these rights. Data holders must remain involved in all steps of the protection of their IP, including the final right to refuse sharing of data if likely to suffer serious economic damage through the disclosure of trade secrets, as is provided in the Data Act, or the right to defer sharing of such data until there is no economic damage expected through disclosure. This must be addressed to ensure innovation through access to health data will continue.  

• An additional opt out mechanism is not needed: EFPIA is of the opinion that if the EU lawmakers want to insert a general opt-out right in the EHDS Regulation, this right should be limited to the data categories in Article 33 of the proposal for which the general opt-out choice can reasonably be offered, changed, managed and respected, without undue burden on the healthcare system and data holders. 

• Implementation timelines must be appropriate to ensure a smooth roll out and functioning of the EHDS: the possible implementation timelines for the EHDS are not defined, and remain in flux. This needs very careful deliberation because all stakeholders need to agree on the right timeframe which balances the need to give all actors, public and private alike sufficient time to prepare for the legislation (in terms of building sufficient capacity, expertise, infrastructure etc.) but one which does not needlessly delay the creation of the EHDS. 

The EHDS regulation, as the first sectoral proposal on data, has the potential to become a blueprint for other sectors. It will also likely serve as an inspiration for other parts of the world  on how to  harmonise data sharing and access policies across vastly different geographies. With the world watching, there is every incentive to get the EHDS regulation right.