1. Introduction



The EU has adopted and published on Dec 22, 2021, a new EU Regulation on HTA (hereinafter HTA regulation) [1], which entered into force on January 11, 2022, and applies as of 12 January 2025. The long interim period will be used to set up the organisational framework contemplated by the HTA Regulation and to adopt a series of implementing measures to fine tune the Regulation’s practicalities, such as the assessment methodology.

The HTA regulation seeks to harmonise and ensure efficient use of resources and to strengthen the quality of HTAs across the EU. It provides a framework for the establishment of a network of Member States’ HTA bodies to support cooperation and exchange of scientific information in a more harmonised way.  

The new HTA regulation amends Directive 2011/24 (the Cross-Border Healthcare Directive) and covers medicinal products, Medical Devices, medical and surgical procedures as well as measures for disease prevention, diagnosis or treatment used in healthcare. 

The regulation is seen as providing consistency and transparency and as being a positive development for European patients, who may receive more equitable and earlier access to innovative treatments. The HTA regulation underlines the need for involving patients and healthcare professionals in the HTA process, the need for transparency, e.g., making the summaries of HTA reports publicly available, including the criteria and rationale for evaluation. However, there is still a need for clarification of methodologies for the assessment of the unique aspects of Medical Devices and IVDs as they are not yet adequately addressed in the HTA regulation.  

The HTA regulation when it applies will initially be limited to oncology products and advanced therapy medicinal products (ATMPs) for the first three years, then extended to orphan medicinal products, and from 30 January 2030, extended to all other therapeutic areas (Regulation (EU) 2021/2282, Article 7 (2)). Adjustments are required to ensure that orphan therapies and ATMPs are dealt with in a flexible way to address current uncertainty about evidence such as real-world data (RWD) or data gaps, which are not sufficiently met by existing traditional approaches to clinical assessment. 

With the HTA regulation, a new balance needs to be found between the need for rigorous evidence and the real-world complexity of gathering such evidence; a balance between regulation and high levels of evidence for Medical Devices and IVDs, and the possibility of other types of evidence for devices associated with low levels of risk.



[1] Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021R2282