Stephen Donnelly (Wicklow, Fianna Fail)
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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 such as the NCPE and HIQA, and industry, facilitate business predictability and ensure the long-term sustainability of EU HTA cooperation.

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.