Dáil Éireann Debate, Tuesday - 11 July 2023
754. Deputy Pádraig O'Sullivan asked the Minister for Health if he could outline the extent of his Department and agencies under the remit of his Department have engaged with stakeholders regarding the implementation of the EU HTA regulation; and if he will make a statement on the matter. [33835/23]
View answer757. Deputy Pádraig O'Sullivan asked the Minister for Health to provide an update on the EU HTA regulation, his views on the value of the regulation; if he could outline the likelihood that efficiencies will arise from its implementation that may improve the assessment and reimbursement timelines in Ireland; and if he will make a statement on the matter. [33838/23]
View answer758. Deputy Pádraig O'Sullivan asked the Minister for Health whether his Department is preparing any amendments to the Health Act (Supply of Medical Goods) 2013 on foot of the EU HTA regulation; and if he will make a statement on the matter. [33839/23]
View answerI propose to take Questions Nos. 754, 757 and 758 together.
Health technology assessment (HTA) is a multidisciplinary process that summarises information about the medical, social, economic, and ethical issues related to the use of a health technology. Examples of health technologies include medicinal products, medical equipment, diagnostic and treatment methods, rehabilitation, and prevention methods. Its aim is to inform the formulation of safe and effective health policies, investment and reimbursement decisions that are patient focused and seek to achieve best value.
In Ireland, two agencies are primarily responsible for undertaking HTAs. The Health Information and Quality Authority (HIQA) undertakes HTA relating to medical devices/health technologies and the National Centre for Pharmacoeconomics (NCPE) undertakes HTA relating to medicinal products. The Department engages with relevant stakeholders with regards to HTA and implementation of Regulation (EU) 2021/2282 on HTA.
The 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 HTA in the European Union and ensure efficiency in the evaluation of new medicines and technologies in a consistent way across member states. The initial implementation from 2025 to 2027 will include medicinal products for oncology and advanced therapeutic medicinal products.
The HTAR contributes to improving the availability for EU patients of innovative technologies in the area of health, such as medicines and certain medical devices. It ensures an efficient use of resources and strengthens the quality of HTA across the EU. It provides a transparent and inclusive framework by establishing a Coordination Group of HTA national or regional authorities, a stakeholder network and by laying down rules on the involvement in joint clinical assessments and joint scientific consultations of patients, clinical experts and other relevant experts.
The HTAR will also reduce duplication of efforts for national HTA authorities and industry, facilitate business predictability and ensure the long-term sustainability of EU HTA cooperation.
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 the two configurations of the Co-ordination Group medicinal products and medical devices (and invitro diagnostic medical devices) and on all subgroups which are part of the HTAR governance structure.
The NCPE and HIQA are 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 will be part of an information day with its Beneluxa partners which aims to provide relevant information on the HTAR to stakeholders within those Member States of Beneluxa. In addition, the NCPE have in both 2021 and 2022 provided an update to stakeholders at the annual symposium attended by stakeholders including members from the pharmaceutical industry, patient representatives, and clinical experts.
The Department has also recently engaged with the European Commission to provide nominations to the Committee on HTA. This committee will further assist the Commission in the implementation of the Regulation.
The Department will continue to engage with experts from the NCPE and HIQA to progress implementations of the EU HTA Regulation and its application to Ireland.
