European Health Data Space (EHDS) - Intermediate status
Rapporteurs in the European Parliament presented draft report
CC – 03/2023
The draft regulation covering the European Health Data Space (EHDS) will be one year into the European legislative
process in May. This dossier is a priority for the European Commission along with the upcoming
review of the pharmaceutical legislation. The search for a unified position in the European
Parliament and the Council continues – time for an
(initial) interim status review.
The rapporteurs responsible in the European
Parliament, Tomislav Sokol (EPP/Croatia) and Annalisa Tardino (ID/Italy),
presented their draft
report about the EHDS in February. Key proposals included the introduction
of an opt-out for the further use of health data for secondary purposes, the
introduction of mandatory data retention within the EU as well as more
stakeholder participation and codetermination in the EHDS Board. During the
political discussion about the draft report, a lot of time was taken up on the
proposed opt-out regulation regarding secondary data use, the protection of
intellectual property rights and co-opting industry into the EHDS Committee.
Rectification of draft report is necessary
DSV continues to introduce its positions
from the DSV
statement. The draft report contains proposals that, from DSV's point of
view, are going in the right direction but there are still some areas that need
to be improved. There is also a lack of alignment of data use for the common
good by ensuring a public return on investment and the regulation that no data
from wellness applications can be included in the EHR, whereas data from
certified health applications can be. No need for regulation is foreseen for
telemedicine for legal system reasons. On the other hand, participation by the
social insurance institutions in the EHDS board must also be planned in. From
DSV's point of view, it must also be ensured that nationally approved EHR
systems will continue to be used after the regulation comes into force. DSV
rejects the new envisaged regulations covering clinical trials and the
exemption of micro-enterprises when registering patient data.
Softer tones can be heard from the Council
as always. The Council’s Working Group on Health meets regularly and discusses
the dossier intensively. The search for compromise continues. So far, three
compromise proposals on different chapters have already been presented by the Swedish Presidency. Some of the amendments proposed by the Swedish Presidency concur
with important DSV demands, e.g. that the member states should be given more
opportunities regarding delegating and implementing the acts.
Reasonable time and regulatory frameworks
The political pressure to conclude ongoing
legislative procedures before the European elections next May is increasing.
The draft report is expected to be adopted by the responsible Committee on Environment, Public Health and Food Safety (ENVI) and the Committee on Civil Liberties, Justice and Home Affairs (LIBE) in the European Parliament before the end of June and to be adopted
by the plenary in September. The European Parliament should then have a mandate
for the trialogue negotiations. The Swedish Council Presidency will continue
discussions about a general approach and they are expected to present a
progress report at the next meeting of the Employment, Social Affairs, Health
and Consumer Affairs Council (EPSCO) to be held on 13 June.
After the summer break, the Spanish, who
will hold the EU
Council Presidency from July onwards, would like to adopt a general
position. Whether this will succeed is not yet certain. The trialogue
negotiations can only start after a general position has been adopted. It
remains to be seen whether such a complex and important dossier can be
negotiated with appropriate care and within realistic time and regulatory
frameworks, not only with regard to the political implementation but also to
the political negotiations.