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.

European Parliament

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.

EU Council

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.