EHDS Draft Report Clears Committee Hurdle, Set for December Plenary

Yesterday members of the ENVI and LIBE committees made headway by adopting a joint draft report concerning the European Health Data Space. The European Commission’s proposal aims to grant European citizens control over their health data when shared across borders and to enable the reuse of health data for research, innovation, and policymaking. The regulation would see the establishment of common rules, infrastructure, and a governance framework for the use of electronic health data.

In the draft report, co-rapporteurs Tomislav Sokol (HR, EPP) and Annalisa Tardino (IT, ID) underscored the critical importance of ensuring data protection in compliance with the EU’s GDPR. They also stressed penalties for any misuse of personal health data and advocated for the obligatory storage of health data within the EU. This regulation is deemed crucial, especially in addressing the challenges posed by the COVID-19 pandemic, aiming to promptly gather vital health data for an effective crisis response.

Initially scheduled for November, the plenary vote is now set for December 13, following significant delays due to the intricate technical work required to refine the regulation’s detailed provisions. Upon adoption of their own mandates, both the Parliament and the Council will enter into interinstitutional negotiations known as trilogues.

The Council is also wrapping up its work to agree on a general approach by the end of the year, in order to pave the way for the start of trilogues. The Spanish Presidency has circulated a new compromise proposal that will be on the agenda of the next public health working party meetings. New elements include the opt-out mechanism for primary and secondary use of health data, and amendments to some definitions, which will both serve as the main topics for discussion during interinstitutional negotiations.

ENVI rapporteur Sokol expressed hope for a political agreement before the end of the mandate, calling for collective focus from political groups in Parliament and member states to conclude discussions before the current Parliament and Commission’s mandates expire next year. According to the Commission’s schedule, agreements on legislative dossiers should be reached by the end of February 2024, in order for the legal services to finalise the texts and for Council and Parliament to ratify the agreement by the last EP plenary at the end of April 2024.