Collaboration with the EMA on Joint Clinical Assessments and Joint Scientific Consultations under the HTA Regulation
The European Hematology Association (EHA) welcomes the draft Implementing Act laying down procedural rules for the exchange of information between the Health Technology Assessment (HTA) Coordination Group, the European Commission, and the European Medicines Agency (EMA). The timely and effective exchange of information with relevance for the Joint Clinical Assessments (JCA) and Joint Scientific Consultations (JSC) will be essential for implementation of the Regulation and contribute to achieving maximum synergy and complementarity between EMA and EU HTA.
Key points from EHA's position on HTA:
- Support for expert identification: EHA supports the exchange of information to identify patients, clinicians, and other experts for JSC and JCA.
- Timely information sharing: EHA stresses that information exchange between the HTA Secretariat, HTA Coordination Group, and EMA should not delay sharing timely information with stakeholders and experts.
- Transparency in expert involvement: EHA welcomes the assurance that involvement in EMA evaluations does not exclude experts from participating in JSC or JCA, ensuring transparency in these engagements.
- Conflict of interest (CoI) management: EHA urges the HTA Coordination Group, European Commission, and EMA to adopt a common, transparent approach to CoI assessments, using EMA's Declaration of Interest procedures. This approach aims to reduce administrative burdens and involve top experts, balancing the management of competing interests, especially in rare disease areas.
Why HTA matters:
This initiative is crucial for several reasons:
- Enhanced access to innovative treatments: By streamlining the assessment process for new health technologies, the collaboration aims to accelerate the availability of cutting-edge treatments to patients. This is particularly important for conditions with limited treatment options, such as rare diseases.
- Optimized use of resources: A coordinated approach to clinical assessments and consultations helps avoid duplication of efforts across member states, thereby conserving resources and ensuring a more efficient allocation of healthcare funds.
- Improved decision-making: Access to high-quality, expert-driven assessments supports better decision-making at the national level, ultimately leading to improved patient outcomes and public health.
- Transparency and trust: Ensuring transparency in the involvement of experts and managing conflicts of interest builds trust among stakeholders, including patients, healthcare providers, and policymakers.
The EHA calls for continued collaboration and dialogue among the HTA Coordination Group, the European Commission, and EMA to finalize and implement these rules effectively. This cooperation is crucial to ensuring that high-quality, expert-driven assessments continue to inform health technology adoption and usage, ultimately serving the best interests of patients and public health.
Read our full statement here.
Glossary:
Health technology assessment (HTA): evidence-based scientific process that enables national authorities to assess the relative effectiveness of new or existing health technologies. It focuses on the added value of a health technology compared to other new or existing technologies (Art. 2.5 Regulation (EU) 2021/2282)
Health Technology Assessment Regulation (HTAR): Regulation (EU) 2021/2282 aims to improve the evidence base for assessing new health technologies (e.g. new medicines and medical devices) and to support EU Member States in taking timely and evidence-based decisions on patient access.
HTA Coordination Group (HTACG): The Regulation on health technology assessment (HTAR) established the Coordination Group on Health Technology Assessment (the ‘HTACG’) composed of Member States’ representatives, mainly from HTA authorities and bodies. Their key tasks of are to coordinate and adopt the HTA work carried out by its sub-groups, facilitate cooperation between EU bodies, and ensure appropriate involvement of stakeholder organisations and experts in its work.
Joint clinical assessment (JCA): A joint clinical assessment of a health technology involves scientifically comparing its clinical evidence with other technologies or procedures, focusing on clinical effectiveness, safety, and addressing the health problem (Art. 2.6 Regulation (EU) 2021/2282).
Joint scientific consultation (JSC): provides a non-binding scientific advice, before the start of pivotal clinical trials (after feasibility / proof of concept study), to improve the quality and appropriateness of the data produced by the Health Technology Developer in view of future HTA assessment / re-assessment.
Back