Dáil Éireann Debate, Thursday - 6 July 2023
316. Deputy Pádraig O'Sullivan asked the Minister for Health if he will outline the progress being made by his Department to implement the EU Directive 2021/2282 on health technology assessment (HTAR); and how this will impact how HTA is undertaken in Ireland. [33218/23]
Amharc ar fhreagraThe Health Technology Assessment Regulation (HTAR) entered into force in January 2022 and will fully apply as of January 2025. Its purpose is to strengthen the quality of Health Technology Assessment (HTA) in the European Union and ensure efficiency in the evaluation of new medicines and technologies in a consistent way across member states. The European Commission recently sought member state nominations for representatives to the Committee on Health Technology Assessment. This committee will assist in the commission in implementation of the regulation. The initial implementation from 2025 to 2027 will include medicinal products for oncology and advanced therapeutic medicinal products.
Ireland has played a significant role to date both in the implementation through the consortium of EUnetHTA21 and the established HTAR Coordination Group. EUnetHTA21 was tasked by the European Commission (EC) with producing the procedures and guidelines to enable a smooth implementation. Experts from Ireland’s National Centre for Pharmacoeconomics (NCPE) were one of the most prominent contributors to this work.
Following the establishment of the HTA Coordination Group in 2022, which is the main governance body established under the HTA legislation the NCPE’s Head of HTA Strategy and External Engagement was elected by other Member States as the Chair of the group. Ireland is now represented on all subgroups which are part of the HTAR governance structure.
The NCPE is in the process of reviewing local procedures for any adaptations that are required to further enable the smooth implementation of the outputs of the HTAR. It is noted that the HTAR outputs will be a Joint Clinical Assessment report which will clearly outline the evidence and limitations for technologies relative to what is used in practice. Decisions in relation to reimbursement of technologies remain a national competency. In addition, early advice will be provided to Health Technology Developers on what evidence will be needed when they reach the stage of Joint Clinical Assessment.
Ireland, with experts from the NCPE, has been involved in the development of this work and how it will apply in Ireland.
