The New European Era of Patient Care
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The EU’s new Health Technology Assessment (HTA) Regulation marks a turning point in delivering cutting-edge healthcare to patients across Europe. By harmonizing assessments for medicines and medical devices, it speeds up decisions on pricing and reimbursement, reduces duplication of work, and involves patients and clinicians in the evaluation process. Ultimately, this coordinated approach means faster, fairer access to the latest treatments, enabling more people to benefit from groundbreaking therapies that can improve or even save lives.
Brussels, January 14, 2025On Sunday, 12 January, the long-anticipated EU Regulation (EU) 2021/2282 on Health Technology Assessment (HTA) came into effect, marking an important milestone for healthcare across the European Union. The new EU rules introduce a more coordinated and streamlined way of evaluating medicines and medical devices, helping patients receive innovative and effective treatments more quickly—wherever they live in the EU.
HTA is a scientific, evidence-based process that evaluates the medical, economic, social, and ethical aspects of health technologies, such as new medicines or medical devices. It assesses how well a product works compared to existing alternatives, how much it costs, and the broader impact on patients and society. By focusing on both clinical effectiveness and economic considerations, HTA helps national authorities ensure that their healthcare systems remain accessible, cost-effective, and sustainable.
Until now, individual Member States conducted HTAs independently, often leading to duplication of effort and delays in patient access.
The new EU Regulation introduces:
- Joint Clinical Assessments
- A single EU-level submission for developers, eliminating the need to submit multiple parallel applications.
- Required completion within 30 days after a medicine is authorized, saving valuable time for everyone involved.
- Clear scientific guidance for health technology developers on clinical study designs, ensuring relevant, high-quality evidence is generated.
- Horizon Scanning
- A coordinated process for identifying promising new technologies early, so healthcare systems can prepare and allocate resources effectively.
- Enhanced Stakeholder Involvement
- Direct involvement of patients and clinicians in developing Joint Clinical Assessments and consultations, ensuring that real-world needs are factored into decision-making.
With this framework, the EU is reducing administrative burdens for developers, supporting more efficient use of healthcare budgets, and facilitating faster, wider access to cutting-edge treatments.
Why 12 January 2025?
Although the Regulation entered into force in January 2022, a three-year transition was built in to:
- Set up the organisational framework (Coordination Group, subgroups, Stakeholder Network).
- Draft and adopt implementing acts and methodological guidance.
- Allow Member States to align national legislation with the new EU Regulation.
- Let developers understand and comply with the updated rules.
This grace period ensures a smooth rollout, giving everyone—patients, healthcare professionals, developers, and national authorities—enough time to prepare. Read more…..
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