The Parliament’s Committees on the Environment, Public Health and Food Safety (ENVI) and Civil Liberties, Justice and Home Affairs (LIBE) jointly discussed the draft report on the European Commission’s proposal for a European Health Data Space (EHDS) on Wednesday 1 March.
ENVI rapporteur Tomislav Sokol (EPP, Croatian) does not expect there to be controversy over the primary use of health data. It only provides for legal adjustments.
He expects more dissent around the secondary use of health data. “The main problem was the role of the patient”. He therefore proposes a right to partially or fully object to this secondary use of data: an ‘opt-out’ which, he believes, would ensure that there is sufficient usable data for secondary use compared to an explicit ‘opt-in’ consent system.
Fulvia Raffaelli, Head of Unit for Digital Health at the European Commission, fears, on the contrary, that this opt-out does not guarantee the quality and representativeness of health data.
The opt-out is supported by Peter Liese (EPP, German), among others. Susana Solis Perez (Renew Europe, Spanish) and Birgit Sippel (S&D, German) are among those that support an opt-in.
In terms of governance, Tomislav Sokol wants to broaden participation to include patients and bodies such as the European Medicines Agency (EMA).
Annalisa Tardino (ID, Italian), rapporteur for LIBE, clarified that this widening of participation extends to industry, patient representatives and health authorities.
Sara Cerdas (S&D, Portuguese) and Tilly Metz (Greens/EFA, Luxembourgish) were not in favour of including industry; this is a “a red line” for Ms Cerdas. Tilly Metz also wants to make access to the EHDS conditional on open science safeguards and accessible and affordable treatment in the EU.
Mr Sokol would like to see additional funding allocated to the future centralised level of the EHDS and that this funding be allocated at the time of the revision of the Multiannual Financial Framework.
He proposes a two-year transition period for independent health professionals and national support for training.
Ms Tardino spoke of data only being activated within the EU, saying that this should not prevent the transfer of data as long as consent is given for this.
The Commission representative believes that this requirement risks the EHDS not being in line with certain European trade commitments and that this provision could affect the quality of services provided by third-country companies by denying them access to European data.
Andrey Kovatchev (EPP, Bulgarian) wanted more clarity and predictability for stakeholders, especially on the interaction of the EHDS with other sectoral legislation. Mr Kovatchev wants the Commission and Member States to introduce time targets for data interoperability between States. This issue was also raised by Kateřina Konečná (The Left, Czech).
Javier Zarzalejos (EPP, Spanish) said his assessment of the report was positive: “We will contribute with constructive amendments”.
Sara Cerdas said that “Article 3§4 needs to be changed, regarding retroactive data that would be included in the data space, because some data might be lost”.
Erik Marquardt (Greens/EFA, German) drew attention to the risk of piracy and called for the possibility of objecting to or restricting each request for secondary use.
Joanna Kopcinska (ECR, Polish) wants a restricted catalogue of data that could be authorised for future processing.
Véronique Trillet-Lenoir (Renew Europe, French) will present amendments, but is in agreement with many of Mr Sokol’s proposals on interoperability, respect for the right to be forgotten, representation of all stakeholders, including the European Parliament, and an adequate budget.
Tomislav Sokol objected to the Greens/EFA claim that there was no reference to anonymisation: “Articles 36, 46 and Recital 49 state that secondary data should not be used in a way that can be traced back to the patient”.
Amendments can be tabled until 23 March and the vote is scheduled for July.
Link to the report: https://aeur.eu/f/5kh (Original version in French by Emilie Vanderhulst)