EFA has actively engaged in the EU Health Technology Assessment (HTA) consultation, emphasising the importance of collaboration between HTA bodies and the European Medicines Agency (EMA). This partnership is crucial for integrating patient insights into the assessment of new medical treatments and technologies. EFA advocates for clear guidelines and strengthened cooperation to ensure that patient-centered innovations are effectively supported throughout Europe.
In July, EFA responded to the Health Technology Assessment (HTA) stakeholder consultation on the third implementing act of the HTA Regulation implementation plan, namely the one setting up the rules on the collaboration between the HTA bodies and the European Medicines Agency (EMA).
As part of the implementation plan of the HTA Regulation entered into force in January 2022 and applicable as of January 2025, the European Commission started in 2024 the roll-out of the implementing Regulations that will set up the specific rules for the different processes under the HTA. The draft implementing regulation on the cooperation with the EMA structures how the HTA Coordination Group and the EMA are set to cooperate and exchange information regarding the joint clinical assessment (JCA) of medicinal products and medical devices, and the evaluation of emerging health technologies (EHT).
Welcomed collaboration between the HTA and EMA
EFA welcomed the collaboration between the HTA bodies and the EMA, especially given EMA’s robust experience in involving patient experts and organisations in their regulatory work. EFA recommended the strengthening of the collaboration in the identification of individual experts to be nurtured by the EMA’s proven mechanisms, guidelines and specific units and staff that handles specifically the patient involvement in the EMA processes.
Clarification and alignment on experts’ rights and responsibilities
The proposal on the cooperation with the EMA allows for individual experts to participate in both the EMA and the HTA process. However, the EMA and the HTA procedures have different sets of rights and obligations, as well as confidentiality requirements. Therefore, EFA suggested further clarification and alignment between the two processes, with a clear well-defined framework that can ensure experts’ compliance with the rights and obligations and a comprehensive and consistent contribution to the work of the HTA and EMA. Such a framework that can delineate experts’ responsibilities and confidentiality across both processes would support a consistent and comprehensive contribution to the work of both the HTA and EMA. EFA also highlighted patient organisations’ role in developing concise guidelines for patient experts, that can ensure valuable patient insights and experiences in the complex HTA processes.
Cooperation on identifying emerging health technologies (EHT)
Given the expertise of the EMA on procedures such as the scientific advice on medicinal products, as well as the early dialogues before marketing authorisation applications, EFA proposed further cooperation on the identification of EHTs to enable a full grasp of the regulatory sandboxes necessary to test more patient-centred innovation in healthcare. Such cooperation can be facilitated through the relevant EMA processes and units, such as the Innovation Network (EU-IN) of the EMA, which allows for cooperation between the national competent authorities (NCAs) and the EMA on regulatory matters related to the emerging therapies and associated technologies. To strengthen the cooperation, EFA proposed that the EHT Subgroup of the HTA should become an observer in the EU-IN and benefit from the EMA’s extensive expertise.
You may find EFA’s full reply to the consultation here.