The new EU-wide health technology assessment for innovative drugs

21. Apr 2022

Members can receive the calendar invitation and dial in details by RSVP’ing to Hilary Stiss at hstiss@bio.org

In the European Union, drug approval has long been centrally regulated: EMA approval applies to the entire EU. Health Technology Assessment (HTA), on the other hand, was not centrally regulated across Europe, but was previously the exclusive responsibility of the individual EU member states.

With the European Union’s new HTA Regulation, HTA of new therapies is now regulated at the European level for the first time. The aims are to speed up access to new therapies, reduce duplication of work and harmonize clinical evaluation. The new European HTA procedure is to be carried out in parallel with the European approval process. The EU HTA Regulation, which came into force in January 2022, creates the legal and organizational framework for cooperation between member states in joint clinical evaluations of new medicines and the associated scientific consultations. The framework now needs to be substantiated: Over the next three years, the processes, methods and requirements of EU HTA will be further prepared by the EUnetHTA21 consortium and shaped by the member states as well as the EU commission. The new centralized HTA process will initially cover newly approved oncology drugs or advanced therapy medicinal products (ATMPs) starting in January 2025 and will then be gradually extended in two further steps to all drugs with obligatory EMA approval.

In this workshop, the importance of the new EU-wide HTA scheme for the biotech industry will be presented. What do innovative companies already need to consider so that they are ideally positioned for the new EU-wide HTA process that will apply from 2025? What developments in harmonization are foreseeable and how will the new procedure differ from the national procedures that exist today, for example in Germany? What needs to be considered already now in study planning in order to be ideally positioned for Europe in 2025?


The following experts provide an overview of the new procedure and its implications for innovative biotech companies:

  • Alexander Natz, Secretary General, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE): Overview of the status of the harmonized EU HTA procedure, political aspects, and an outlook on the details of the procedure that still need to be regulated.
  • Ana Palma, Senior Director Global Head of Market Access & Access Policy at Sobi – Swedish Orphan Biovitrum: Orphan drug development in the context of HTA harmonization: the views of an innovative biotech company
  • Antje Behring, Department Head Pharmaceuticals, G-BA (German Federal Joint Committee, Germany’s HTA Agency): The planned Europe-wide HTA harmonization from the perspective of a European HTA-Agency.
  • Norbert Gerbsch, Department Head Public Affairs, IGES Institut (moderator): Integration of the harmonized EU-HTA procedure into the clinical and regulatory development of a new drug, technical aspects as well as an outlook on expected effects of the harmonized procedure on clinical trial planning.
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