The novelties of the regulation on health technology assessment, a key achievement for the European union health policies.

Health technology assessment is a key tool for ensuring healthcare quality, accessibility, and sustainability. The novel European Union (EU) Health Technology Assessment (HTA) regulation of 15 December 2021, in harmonizing the laws of the Member States about the procedures and criteria for the evaluation of health technologies (i.e., medical devices and diagnostic tools), constitutes a significant achievement in the definition of EU health policies. On the one hand, for the European Union, it constitutes an essential driving force for the development of a competitive market for health technologies and, on the other, for European citizens, it guarantees the application of superordinate safety and quality standards with an impact positive on access to health technologies, including expressly also diagnostic medical devices classified in class D by art. 47 of Reg. (EU) 2017/746. As pointed out by the European Commissioner for Healthcare, the regulation identifies a new way for the Member States to cooperate on healthcare matters in the Union. The clinical efficacy and safety of drugs and devices are legal assets that today find their protection in a binding and directly applicable regulatory instrument, superordinate in the hierarchy of sources. Implementing the regulation will also be essential to achieve the objectives of the Union's pharmaceutical strategy and the European plan to fight cancer. The novel HTA European regulation, applicable from January 2025, will ensure inclusion and transparency in evaluating health technologies and increase the predictability of decisions for both Member State authorities and industry.