3.G. Round table: European Union policies: the basis for EU legislation and the case of the EU HTA regulation

Abstract

Abstract Among the objectives of the European Union (EU) there is the protection and improvement of European citizens’ health. To this end, several instruments can be enacted at EU level, both of binding legal nature- such as regulations, - and not binding -. EU regulations are binding legislative acts that must be applied across all the EU member states (MS). In the context of the Ordinary Legislative Procedure, proposals are initiated by the European Commission and their development involves two more actors, namely the European Parliament, representing EU citizens, and the Council of the EU, representing EU governments. These act as co-legislators, are requested to review the proposal, and have the right to propose amendments to reach a final agreement on a joint text, often through tripartite meetings on legislative proposals between representatives of the Parliament, the Council and the Commission; these are referred to as ‘Trilogue’ meetings. The EU regulation on Health Technology Assessment (HTAR) was adopted in January 2022, and will become legally binding in January 2025. It provides a first input for the reorganisation of the pharmaceutical market across all EU strategy (Pharmaceutical Strategy). The Pharmaceutical Strategy aims to future proof regulatory frameworks; support industry in promoting research; and foster EU citizens’ access to safe, effective, and high-quality medicines that are used in diagnosis, treatment and prevention of diseases. HTA allows for evidence-informed policy- and decision-making, disentangling the comparative value of health technologies and permits for informed negotiation in terms of pricing, reimbursement and, of course, in terms of establishing priorities for procurement decisions. The HTAR framework allows to overcome specific key challenges stemming from the highly divergent and fragmented HTA procedures across EU MS, ultimately aiming to allow a more timely and equitable access to medicines, vaccines and devices, at EU level, including by allowing a more harmonised approach in terms of dossier submission for companies too. The preparatory phase for the implementation of the HTAR is underway with the establishment of the Coordination Group on HTA (HTACG) and of the HTA Stakeholder Network, the set up of a secure intranet for the exchange of information and the planning of capacity building initiatives. This workshop is intended to provide the attenders with insights into the process behind the development of EU regulation with a focus on HTA regulation and its following implementation. Key messages • European legislative acts set the framework for the protection and the improvement of European citizens’ health and for member states policies. • The EU regulation on Health Technology Assessment will foster European citizens’ access to safe, effective, and high-quality medicines, vaccines and devices and its implementation is underway. Speakers/Panelists Jose A Valverde European Commission, DG Health and Food Safety, Brussels, Belgium Amandine Garde Law & Non-Communicable Diseases Unit, Liverpool, UK Marco Marchetti Italian National Agency for Regional Healthcare Services (AGENAS), HTA unit, Rome, Italy Iñaki Gutiérrez-Ibarluzea Basque Foundation for Innovation And Research (BIOEF), Barakaldo, Spain