On January 12, 2025, the Health Technology Assessment Regulation (HTAR) officially came into force, marking a significant milestone in European healthcare, and therefore for patients with allergy and chronic respiratory diseases.
For the first time, the EU has established a cooperative framework to harmonise and streamline the processes that precede the market entry of new health technologies (i.e. medicines, vaccines, medical devices, and other innovative products).
After two decades of intricate technical and policy groundwork, the EU Joint HTA framework promises to make these highly regulated procedures more efficient, scientifically robust and patient-centred.
Why is an EU joint HTA framework needed?
Until now, the scope of the commercialisation of new health technologies — such as medicines and medical devices — has been determined through Health Technology Assessments (HTAs) conducted individually by EU member states. These national assessments evaluate the added value, clinical effectiveness, costs, and broader societal impact of healthcare interventions. However, the fragmented approach has often led to unnecessary duplication, inefficiencies, and inconsistent patient access to same technologies across countries.
What will the EU HTA Regulation change?
The EU HTA Regulation introduces a unified framework to address these challenges by:
- Harmonising processes: It reduces discrepancies in how HTAs are conducted across member states.
- Improving efficiency: By pooling resources at the EU level, the regulation reduces duplication of efforts and accelerates assessments.
- Enhancing scientific rigor: Shared expertise strengthens the quality of assessments.
- Focusing on patient needs: Patients and clinicians will be systematically consulted during HTA preparation, ensuring their perspectives shape the outcomes.
- Engaging stakeholders: HTA stakeholders—including patient organisations—will play an active role in the process.
The regulation introduces joint clinical assessments at the EU level, which will inform the decision-making of national pricing and reimbursement authorities. This harmonised approach will allow new health technologies to reach patients more efficiently and we also hope that it will lead to more equitable access across the EU.
Why does HTA matters to patients?
The HTAR marks a significant advancement for patients. By streamlining HTA processes, it empowers individual health Ministries with EU-level assessments to inform national decisions on which medicines and medical devices should be prescribed, under what conditions, pricing and reimbursement schemes.
Key benefits for patients include:
- Faster access: Harmonised assessments will enable quicker decision-making, reducing delays in the availability of new treatments.
- Wider availability: Patients across all member states will have more consistent access to health technologies.
- Patient involvement: For the first time, patients and their organisations are formally included in the HTA process, ensuring that their real-world experiences and needs are central to decision-making. Having such EU-level patient perspective will be crucial to ensure patients will get the access to the health solutions they need.
What’s next?
The HTAR has begun its phased implementation:
- As of January 2025, it applies to marketing authorisation applications for oncology medicines and advanced therapy medicinal products (ATMPs).
- By January 2028, the regulation will extend to orphan medicines.
- By 2030, it will encompass all medicines, including those for allergy, atopic eczema and airways diseases.
This phased approach ensures a smooth transition while allowing for the gradual scaling of the system. Organisations like EFA will remain actively involved, monitoring the regulation’s implementation and contributing to the HTA Stakeholder Network to represent patient interests.