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The New European Era of Patient Care
As the EU embraces faster access to life-changing treatments, its new Health Technology Assessment rules bring patients closer to innovation..
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.
By eEuropa - 6 MINUTES READ
Brussels, January 14, 2025
On 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.
​Who Will Benefit?
Three categories will benefit immediately.
- Patients and Clinicians
Benefit from high-quality, transparent clinical assessment reports that consider real-world patient perspectives.
- Member States
Maintain the flexibility to consider local healthcare contexts, while avoiding duplicated assessments.
- Developers
Submit one single EU-level dossier instead of multiple national submissions, cutting down on cost, time, and bureaucratic hurdles.
Which Parts of HTA Does the Regulation Cover?
The focus is primarily on the clinical aspects of health technology assessment—specifically, relative clinical effectiveness and safety compared to existing therapies
High-level scientific reports, known as Joint Clinical Assessments, are prepared by the Member States’ Coordination Group:
- New cancer medicines and advanced therapy medicinal products (ATMPs) are the first wave to be assessed under the new framework starting 12 January.
- Orphan medicines join in 2028, extending to all new medicinal products by 2030.
Member States can still conduct additional clinical or non-clinical evaluations (e.g., cost-effectiveness) to tailor decisions to their national context.
What Products Are Covered by the Joint Clinical Assessments?
Starting immediately, the Regulation covers new cancer medicines and ATMPs that seek centralised marketing authorisations via the European Medicines Agency (EMA).
From there, the approach is phased:
This step-by-step expansion ensures all stakeholders have time to adapt, while still prioritizing areas with the greatest need for rapid innovation.
From there, the approach is phased:
- 2026: Selected high-risk medical devices.
- 2028: Orphan medicinal products.
- 2030: All new medicinal products.
This step-by-step expansion ensures all stakeholders have time to adapt, while still prioritizing areas with the greatest need for rapid innovation.
How Will Member States Use Joint Clinical Assessment Reports?
Once a Joint Clinical Assessment (JCA) is completed, each Member State:
- Incorporates the published JCA into its own HTA processes.
- May add additional clinical or non-clinical analyses (e.g., cost-effectiveness or specific national disease data).
- Will provide information on how the joint report was considered during the national review.
This blended approach maintains national autonomy over pricing and reimbursement decisions while ensuring a common scientific foundation across the EU.
How Does the New EU HTA Framework Work in Practice?
The new HTA Regulation marks a significant leap forward for patient care and healthcare innovation in the EU. By speeding up access to new treatments and reducing duplication of efforts, it directly addresses unmet medical needs and supports a thriving, globally competitive health ecosystem. For patients, this new era promises quicker, more equitable access to the latest therapies—and, ultimately, better health outcomes.
- Coordination Group
- Each Member State designates experts to a Coordination Group, which supervises all joint technical work (e.g., Joint Clinical Assessments, Joint Scientific Consultations).
- Stakeholder Network
- Established in 2023, this network fosters dialogue between patient organizations, healthcare professionals, and industry representatives to improve transparency and engagement.
- European Commission
- Acts as the secretariat, ensuring timely and transparent processes.
- Provides secure IT platforms for submissions and data sharing.
- Facilitates collaboration with other EU agencies like the European Medicines Agency.
The new HTA Regulation marks a significant leap forward for patient care and healthcare innovation in the EU. By speeding up access to new treatments and reducing duplication of efforts, it directly addresses unmet medical needs and supports a thriving, globally competitive health ecosystem. For patients, this new era promises quicker, more equitable access to the latest therapies—and, ultimately, better health outcomes.
The EU legislation
- EU Regulation (EU) 2021/2282 on Health Technology Assessment (HTA)
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