The Blue Book traineeship: following the legislative journey of the HTA regulation

Abstract

The European Commission’s Blue Book Traineeship is an opportunity for early-career professionals to gain first-hand experience of EU policymaking and administration. This five-month programme, organised twice a year, welcomes participants from Europe and other non-European countries to gain insight into the democratic processes of the EU while reflecting the European values of diversity and equal opportunities. During my traineeship at the Directorate-General for Health and Food Safety (DG SANTE), I followed the development of the proposed Health Technology Assessment (HTA) Regulation within the Council of the European Union under the Finnish and Croatian Presidencies. This experience provided practical insight into the EU legislative process, from the preparation of a Commission proposal through negotiations between the European Commission, the Council, and Member States to the adoption of legislation. Observing the HTA negotiations was particularly insightful given that healthcare remains primarily a national competence, illustrating the complexity of building consensus while strengthening European cooperation. The traineeship also highlighted the contribution of EUnetHTA and its Joint Actions (JA1, JA2, JA3 and EUnetHTA 21), which laid the methodological foundations for Regulation (EU) 2021/2282 and demonstrated how scientific evidence, policy development, and political negotiation converge to create a common European framework.

This contribution presents the legislative pathway leading to the adoption of the HTA Regulation, complementing the following presentation on its early implementation. The experience strengthened my understanding of the EU legislative process and of the role of European Commission-funded Joint Actions in promoting collaboration, innovation, and methodological harmonisation across Member States.