The last all-night consultation on health files this term was called off due to disagreements over patients' right to opt out of having their medical data sent to third parties.
Negotiations between MEPs and the Belgian Presidency on the proposed EU Health Data Space (EHDS) continued into the early hours of the morning before collapsing at first light today (8 March).
The draft regulation proposed by the EU Executive in 2022 aims to govern the transmission and sharing of health data across the EU for individuals, researchers and policy makers.
Attempts to finally work out a compromise solution are fundamental to so-called “secondary uses”, i.e. the reuse of data that has been registered for use in health services but is used by third parties for other purposes. I was frustrated by the discrepancies.
Such secondary uses include the collation of biomedical data such as health records, administrative data, genetic data, genomic data, social data, public registries, clinical studies, research questionnaires, and biobanks.
Related to such secondary uses, Congressional mandates restrict most data sharing and use by third parties, depending on the patient's wishes, to protect against the risk of losing control of health data. It contained a strong opt-out clause.
Failure to include this opt-out “could end medical confidentiality and deter patients from seeking urgently needed treatment due to fear of stigma, which in some cases could lead to suicide,” Congress wrote. said Member of Parliament Patrick Breyer (German/Green Party). He is a negotiator and civil rights activist.
Belgium's proposal is on the table
An opt-out clause was not envisaged in the original proposal, but it is modeled after the EU's framework for data sharing, the General Data Protection Regulation (GDPR), which the EU Enforcement Authority said would allow for anonymized and pseudonymized data. This was because consent was not required for use by third parties. .
Member States believe that anonymization is an effective safeguard against the risk of data processing by third parties, and that opt-out provisions disadvantage the research sector and discourage the development of innovative areas such as personalized medicines. I think that there is a possibility that it may be damaged.
In a bid to break the deadlock, the Belgian EU presidency, which is negotiating on behalf of the EU's 27 health ministers, has proposed a new compromise at the start of closed-door talks, Euronews reported. did.
Belgium's proposal recognized the right to opt-out for all natural persons and left the task to member states to provide “a clear opt-out mechanism.”
However, the Belgian draft includes an exception to the opt-out clause “if requested by a public authority authorized to carry out tasks in the field of public health” and further states:[by] A private organization entrusted with the performance of official tasks in the field of public health. ”
These exceptions only apply in certain circumstances, such as public interest, public health reasons, occupational health reasons, policymaking and regulatory activities, and statistics.
Three sources familiar with the matter said that despite attempts by Tomislav Sokol, a leading parliamentary negotiator (Croatian/European People's Party), to bridge the gap in talks, parliamentarians had too many exemptions and too many restrictions. He believed that the law was too broad and risked stripping Congress of its mandate.
CSDDD again?
According to three sources familiar with the matter, the Belgian president's office also appeared to be inflexible about the proposal.
“Not all member states want EHDS at all costs,” one of the sources said, adding that this dynamic narrowed Belgium's room to negotiate a compromise.
The Belgian president's office wants to avoid a deadlock scenario similar to the one facing the Corporate Sustainability Due Diligence Directive File (CSDDD) in the EU Council, one of the sources said. . Although the final text of the directive file was agreed with MEPs, it remains rubber-stamped in each member state.
A further meeting of EU ambassadors is scheduled for next Wednesday (13 March), with the Belgian Presidency making a final attempt to rescue health data files and a majority of the EU Council confirming its stance on the right to choose. We will confirm whether they are prepared to ease the situation. Out, red flag for Congress.
If that happens, negotiations with lawmakers would resume the next day, one of the people said. Despite the frustrations, one EU source seemed hopeful, saying: “Good progress has been made. We just need more face-to-face time between the co-legislators to finalize the deal.”