Inside EU Health: EPSCO - Biotech Act, Medical Devices and Urban wastewater treatment; heat action plans; vaccines
EU health ministers to discuss wastewater rules, the Biotech Act and medical devices; Europe lost 200,000 people to heat in 4 years; MEPs and health groups call for stronger vaccine R&D funding in next EU budget
EU health ministers to discuss wastewater rules, the Biotech Act and medical devices
EU health ministers meeting in Luxembourg on 16 June will discuss a broad range of health policy files, with debates expected on the Urban Wastewater Treatment Directive, the Biotech Act and reforms to medical device legislation.
A potentially significant discussion concerns the Urban Wastewater Treatment Directive. Germany has submitted a paper criticising the European Commission’s updated assessment of the impact of extended producer responsibility rules on medicinal products. Berlin argues that the study falls short of ministers’ expectations for a detailed analysis of the consequences for national health systems and the availability of medicines. Germany is calling for stronger safeguards to control costs, a more harmonised EU approach and further consideration of whether other product categories should contribute to wastewater treatment costs.
Concerns over the impact of US drug-pricing policies have renewed interest in greater European cooperation on pricing and reimbursement. Ministers will also discuss pharmaceutical resilience and strategic autonomy during an informal lunch. The Beneluxa Initiative is calling for closer EU collaboration, including faster uptake of EU Health Technology Assessment outcomes and more streamlined reimbursement procedures.
On the Biotech Act, ministers are expected to agree a general approach on the Biotech Act I Directive. The proposal aims to accelerate procedures for certain genetically modified micro-organisms and modernise rules governing organ processing. Separately, ministers will hold their first political debate on the broader Biotech Act Regulation.
Ministers will also review progress on proposed reforms to medical device and in vitro diagnostic regulations. While member states support efforts to simplify the framework, disagreements remain over strengthening more centralised roles for the Commission and EMA, the regulation of AI-enabled devices, fees for smaller manufacturers and international cooperation.
Catherine Feore
Europe lost 200,000 people to heat in 4 years
More than 200,000 people across the European Union and associated countries have died from extreme heat over the past four years, according to the World Health Organisation (WHO), which says most of those deaths could have been prevented.
Speaking at the launch of new WHO guidance on heat-health action plans (12 June), WHO Regional Director for Europe, Dr Hans Kluge, warned that heatwaves are no longer rare weather events but a recurring crisis that is straining health systems and infrastructure while affecting millions of people physically and mentally.
Kluge called for Heat-Health Action Plans including creating cooling centres, expanding urban green spaces, protecting vulnerable populations and adapting working conditions during heatwaves.
“Our goal is clear and our ambition is bold: zero heat-related deaths,” Kluge said.
MEPs and health groups call for stronger vaccine R&D funding in next EU budget
A cross-party group of Members of the European Parliament and leading global health organisations have called on the EU to significantly increase investment in vaccine research and development as negotiations on the next Multiannual Financial Framework (MFF) and Framework Programme 10 (FP10) intensify.
In a joint statement, MEPs joined CEPI and Vaccines Europe, among others, in urging policymakers to treat health preparedness as a core component of Europe's security, resilience and competitiveness agenda.
The signatories warned that Europe risks losing ground to global competitors without sustained investment across the vaccine innovation pipeline, from early-stage research to clinical development and deployment. They called for stronger public-private partnerships and predictable long-term funding for bodies including HERA, EMA and ECDC.
The intervention comes as Europe ministers meeting in the General Affairs Council on Tuesday are expected to discuss the MFF. It also precedes a press conference by the European Parliament's budgetary rapporteurs, who are expected to voice concerns over the Council’s proposal to reduce the overall size of the budget.