Implementing the EU Health Technology Assessment Regulation (EU HTAR)

The development of health technologies is a key driver of economic growth and innovation in the European Union (EU), since health technologies constitute an innovative sector of the economy and form part of an overall market for healthcare expenditure that accounts for 10 % of the EU gross domestic product.¹ Medicinal products, medical devices (MDs), in vitro diagnostic medical devices (IVDs) and medical procedures, as well as measures for disease prevention, diagnosis or treatment, embody health technologies that can enhance the accuracy and efficiency of diagnoses and treatments, leading to better patient outcomes.

Health Technology Assessment

The Health Technology Assessment (HTA) is a scientific evidence-based process that allows competent authorities to determine the relative effectiveness of new or existing health technologies, focusing specifically on the added value of a health technology in comparison with other new or existing ones. This process is able to contribute to the promotion of innovation, which offers the best outcomes for patients and society as a whole and is an important tool to ensure proper application and use of such technologies.

The HTA can improve the scientific evidence used to inform clinical decision-making and patient access, including when a health technology becomes obsolete. With that in mind, the HTA covers nine domains of clinical and non-clinical aspects. The four clinical domains of assessment concern the identification of a health problem and current health technology, the examination of the technical characteristics of the health technology under assessment, its relative safety, and its relative clinical effectiveness. The five non-clinical assessment domains concern cost and economic evaluation of a health technology, and its ethical, organisational, social and legal aspects.

As such, the outcome of a HTA is used to inform decisions concerning the allocation of budgetary resources in the field of health, like the establishment of pricing or reimbursement levels; and assisting Member States creating and maintaining sustainable healthcare systems, while at the same time stimulating innovation to deliver better outcomes for patients.

The European Health Technology Assessment Regulation (EU HTAR)

In 2015, the European Commission (EC) declared its intention to introduce an initiative on HTA to increase coordination in order to avoid multiple assessments of a product in different Member States and improve the functioning of the Single Market for health technologies. As such, in 2021, the European Health Technology Assessment Regulation (EU HTAR) was adopted to enable the development of a joint perspective.

The framework for a joint HTA cooperation includes joint clinical assessments (JCAs), joint scientific consultations (JSCs), the identification of emerging health technologies, and common procedures and methodologies to be used across the EU. The key principles of the regulation state that the joint assessment is valid only on the five clinical domains, with the economic assessment or any conclusion related to pricing and reimbursement remaining at the national level with each Member State.

Progressive Implementation EU HTAR

Since its inception, the EU HTAR was envisioned to be progressively implemented; as such, last year the stakeholder network was established, which includes patient associations, non-governmental organizations in the field of health, health technology developers and health professionals. During 2024, there will be the adoption of implementing acts, and methodological and procedural guidance; and it is envisioned that by January 2025, new oncology medicines and advanced therapy medicinal products (ATMPs) will start to be assessed at EU level. In 2028, orphan medicinal products will be added to the joint work; and in 2030, all new medicines will come under the scope of the new regulation.

In relation to MDs and IVDs, only high-risk devices with high impact on patients, public health and EU health systems will be clinically assessed jointly, with each Member State retaining the assessment on all non-clinical domains.

Conclusion

The regulation aims to streamline the assessment process for new health technologies across the EU. By harmonizing clinical evaluation, it reduces duplication of efforts among Member States, leading to more efficient use of resources and faster access for patients to innovative treatments. Furthermore, a more streamlined and transparent HTA process can provide clearer pathways for the approval of new technologies, hopefully encouraging more innovation within the healthcare sector.

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