Health committee will co-lead health data space dossier in the European Parliament –

Health committee will co-lead health data space dossier in the European Parliament –

Despite the initial decision to assign the European Health Data Space exclusively to the European Parliament’s civil liberties committee (LIBE), it has now been agreed that the committee for health (ENVI) will co-lead the file, which expands the EU data regulation.

“It is the final decision of the Conference of Committee Chairs (CCC), that it should be a case of shared competency — joint committees LIBE and ENVI. So we are both on equal footing dealing with the EHDS,” the chair of the LIBE committee, Juan Fernando López Aguilar, told EURACTIV.

According to Aguilar, the CCC decision was made after ENVI objected to the initial committee allocation. Now, ENVI and LIBE will be in charge of the file under rule 58 of the Rules of Procedure of the European Parliament.

Following the Commission proposal presented in May, it was decided that LIBE would lead the file through the European Parliament, despite talks of shared competence with ENVI. This decision was made after examining the legal basis of the proposal.

One of the main competencies of the LIBE committee is in the areas of transparency and the protection of individuals with regard to the processing of personal data, while ENVI is the main reference point in the European Parliament for everything related to public health.

The European Health Data Space is the first sectorial legislation meant to build on the Data Governance Act and the Data Act, respectively the horizontal legislation on data governance and a recently presented EU law on data-sharing.

“The EHDS is not about health measures, it’s about health data measures — exchanging patients’ data in a safe environment that’s supporting and promoting research on medicines or treatments,” said Aguilar.

“It’s about data protection and supporting digital services according to the usual parameters — or criteria for safety and liability — including the use of artificial intelligence in health, which is usually within the competence of the LIBE committee,” he added.

Health stakeholders were still worried that the health community would not get enough of a say on the file and sent out a call for ENVI to have shared competence in July, asking it to “ensure a patient-focused approach” and “consider the views of healthcare professionals and the wider health community”.

Health stakeholders pleased

The decision to have both committees leading the file has pleased health stakeholders.

“We support the development with this file and believe the joint competence is appropriate given the complexity of the file,” said Jamie Wilkinson, healthcare biotechnology director at EuropaBio, a biotech industry group.

“The issues discussed are extremely broad and likely that even with ENVI and LIBE steering the wheel jointly, it will be a challenging one given it is hard to find experts that can cover all the elements in the file,” Wilkinson added, saying that “the file is likely to have a more balanced discussion” with two committees at the steering wheel.

The patient organisations were equally satisfied with the decision as “both committees will have complimentary competencies and expertise necessary for the file”, according to Jelena Malinina, patient data director at EURORDIS, the European Organisation for Rare Diseases.

“LIBE will contribute to the proposal from the perspective of the protection of the rule of law and fundamental rights, data protection, security and justice, as well as determine legal interaction between the EHDS and other related EU laws. ENVI will complement with their expertise on public health,” Malinina told EURACTIV.

“Both sides are important since the EHDS proposal is a cross-cutting file not only linked with public health but also with EU’s single market and enforcement of the fundamental human rights and data protection principles,” she added.

The European Patients Forum (EPF) said in a statement that “the file will require an understanding of the specificities of the health sector”.

“Ultimately, the goal of the EHDS is delivering better healthcare for patients through effective and ethical sharing of health data,” wrote EPF, whose director of policy, Kaisa Immonen, had previously warned that “all of these topics, you need to have health-specific knowledge”.

ENVI chair Pascal Canfin was contacted for a comment but did not respond.

[Edited by Gerardo Fortuna/Zoran Radosavljevic]

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