Euro Roundup: Parliament approves creation of a European Health Data Space

The European Parliament has approved the creation of the European Health Data Space (EHDS), backing the agreement it reached with the Council 445-142 votes. Industry groups are now focusing on shaping EHDS implementation to address perceived risks.

The provisional agreement is now awaiting formal approval by the Council, after which it will be published in the European Union’s journal and enter into force.

Annalisa Tardino, Civil Liberties Committee co-rapporteur, highlighted as a positive that opt-outs will “ensure that patients have a say in how their data are used.” Tardino said that she “would have preferred even stronger measures,” but “we were able to find a position that can be accepted by a majority.”

Most aspects of the EHDS will take effect two years after the legislation enters into force. Transition periods for some aspects of the requirements, including primary and secondary use of data categories, are four or six years.

Ahead of the vote in Parliament, EFPIA, MedTech Europe, and other groups commented on the terms of the agreement with the Council and shared recommendations for implementing the EHDS. The groups welcomed the agreement, noting the “substantial progress” made by negotiators and welcoming certain changes to earlier drafts. The groups said they “are content to see a text that includes stronger wording on stakeholder involvement, a slightly more harmonized approach to opt-out mechanisms, and increased attention to capacity building in the member states and digital literacy among patients and health professionals.”

While the wording of the EHDS is now agreed upon, there are still opportunities to influence what the law will mean in practice. At least eight elements should be considered to address “some of the challenges remaining in the draft document,” according to the industry groups.

The top recommendation is to “address the risk of a fragmented interpretation and implementation of opt-out and opt-in mechanisms.” The groups are concerned that the mechanisms, which they have repeatedly named as barriers to an effective EHDS, allow patients to opt out of data sharing and empower member states to introduce opt-in mechanisms for the secondary use of data.

The groups want opt-out mechanisms to “be implemented in a harmonized manner across member states to ensure a consistent approach to reduce barriers to cross-border health research.”

Similarly, they are pushing for the opt-in powers to “be accompanied with clear guidance to ensure harmonized approaches across member states, to prevent a patchwork of approaches that may lead to the exclusion of certain patient groups or create obstacles for effective cross-border research.”

The other recommendations cover the need to provide clear information to patients, limit the additional burden on healthcare professionals and ensure systematic stakeholder involvement.

Press Release, Industry Statement

Commission launches Critical Medicines Alliance as EDQM accelerates shortage responses

The European Commission has launched the Critical Medicines Alliance, which will bring together national authorities, industry, and other groups to find ways to address and avoid drug shortages.

The alliance, announced by the Commission in October, has registered 250 members since the beginning of the year. The members will work together to enhance supply security, strengthen medicine availability, and reduce EU supply chain dependencies.

“Key factors being analyzed include an over-dependency on a limited number of external suppliers, limited diversification possibilities, and limited production capacities. This will build on the Commission's vulnerability analysis of supply chain bottlenecks of critical medicines on the Union list of critical medicines,” the Commission said. The alliance will publish its first recommendations this year.

Medicines for Europe responded to the launch of the alliance. The trade group for off-patent drugmakers is part of the alliance and wants to advance “EU procurement guidance in tandem with national market reform that rewards security of supply and a greater use of real-time serialization data to monitor demand and supply imbalances.”

The Commission launched the alliance days after the European Directorate for the Quality of Medicines & HealthCare (EDQM) set out its own response to critical medicine shortages. As EDQM said, the European Pharmacopoeia Commission (EPC) has approved a workflow that will allow experts to quickly produce technical recommendations in response to an ongoing shortage.

The recommendations will cover the preparation of unlicensed medicines that could be used in ongoing shortages of licensed products. EDQM sees the recommendations as a short-term action to mitigate the impact of drug shortages. EPC is trialing the new workflow on two ongoing shortages, namely disruption to the supply of pediatric forms of aprepitant and amoxicillin.

Publication of the recommendations is imminent. The trial will help EPC refine the workflow.

Commission Notice, Industry Response, EDQM Notice

Report on EU single market envisages greater integration for medicines

A report into the future of the European Union single market has called for more integration to ensure the availability of medicines for people across the region.

The European Commission asked the former Italian head of government, Enrico Letta, to find “concrete and ambitious recommendations” for the future of the single market. The resulting report says, “There is no real single market for pharmaceuticals.” While most drugs are approved centrally, national pathways remain an option and drugs approved across the EU are not always available to patients in all countries.

Currently, the single market is built around the free movement of people, goods, services and capital. Letta is proposing to add a fifth freedom to enhance research, innovation and education.

“Among various sectors poised to benefit from the implementation of a fifth freedom, the healthcare sector stands out prominently. Its critical importance, underscored by the recent pandemic, positions it to greatly leverage this new framework which promises to enhance cooperation and drive innovation,” Letta said.

Letta Report, Industry Response

EFPIA supports ‘considered approach’ to regulation of pharma AI tools

EFPIA has set out its position on artificial intelligence, voicing support for the European Medicines Regulatory Network’s “considered approach” to the technology.

The trade group said it is critical that AI regulatory frameworks are “fit-for-purpose, risk-based, non-duplicative, globally aligned and adequately tailored.” EFPIA’s goal is to have rules that enable, rather than hinder, the development of safe and effective treatments that reach patients faster and more efficiently. That goal informs the trade group’s five considerations for AI use and governance.

EFPIA interprets the EU AI Act as exempting drug development tools “because the sole use of these tools is in the R&D of medicines development.” If the tools are covered by the act, the trade group contends they cannot legally qualify as high risk. EFPIA also discussed upcoming guidance from the European Medicines Agency.

“We believe that this upcoming AI guidance, that factors in potential risks associated with use of AI, in conjunction with established, well-functioning legislative and regulatory frameworks for medicines, will ensure appropriate governance of AI use in the development of medicines,” the trade group said.

EFPIA Notice

Euro Roundup: Parliament approves creation of a European Health Data Space

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