New regulation on HTA at the European level

Health Technology Assessment is a multidisciplinary process for evaluating health technologies such as drugs, medical devices, and medical apps.

Centralization and harmonization are the key features of the new European legal framework on HTA that entered into force this year and full implementation will start in January 2025. Health technologies will be evaluated on clinical data and evidence on a centralized level. Before the regulation was approved, each country adopted its own system with the result that the evaluation of a vaccine, drug or medical device could vary greatly among the 27-member countries of the European Union. “No more situations will happen where the clinical evidence for a drug, for example, for cancer therapies is evaluated with different methodologies and approaches in France and Germany or other EU countries,” says Rosanna Tarricone, Associate Professor in the Department of Social and Political Sciences and Associate Dean of the SDA Bocconi School of Management, “with this regulation all countries will be perfectly aligned.”

There will be many opportunities and challenges over the next three years until the HTA regulation is implemented in 2025. With the aim of discussing the impact of the new regulation on the future of access to health technologies, the European Commission organized the Conference on the new Regulation on Health Technology Assessment (HTA). There the European Commission's roadmap for the implementation of the new legal framework was presented and a discussion was stimulated with member states' competent authorities, HTA agencies, representatives of industry, health professionals and patients on opportunities and upcoming challenges.

During the conference, Tarricone - the only scholar to be invited to the conference - outlined the main challenges for the full implementation of a harmonized HTA process with a specific focus on medical devices, which have very different characteristics from pharmaceuticals.

From 2018 to 2021, Tarricone facilitated the interaction between HTA agencies of EU member countries by coordinating HOFA (Heads of HTA Agencies) meetings with the aim of preparing the conditions for the promotion of the European regulation among all EU countries.

In recent years , Bocconi has been investing significant resources in research on HTA for medical devices, and there are many projects including some funded by the European Union under the Horizon 2020 Program such as MedTechHTA, with the aim of developing methods for HTA of medical devices. Another is COMED, concluded a few months ago, with the main purpose of improving decision-making processes for the evaluation of digital technologies in European health systems.

SDA Bocconi School of Management