Joint statement at EPSCO Council June 2022: Market entry in Europe for drugs - evidence gaps and potential solutions

At the request of the members of the Beneluxa initiative (Belgium, the Netherlands, Luxembourg, Austria and Ireland) the market entry in Europe for medicines which lack conclusive evidence in comparative effectiveness was brought on the Agenda of the EPSCO Council (Employment, Social Policy, Health and Consumer Affairs Council (Health) on 14 June 2022.

In relation to the new European HTA Regulation (2021/2282) the current evidence gaps (lack of comparative data) for conducting HTA evaluations and potential solutions were highlighted:

  • Europe can only truly establish a structural cooperation on HTA, if HTA agencies receive the necessary comparative data to conduct their evaluations.
  • Member States have acknowledged the need for a more tailored approach to data in adopting the EU regulation on HTA and its provisions for ensuring that the generation of evidence fulfils the needs of the Joint HTA initiative and the national HTA agencies.
  • We believe that we need to find ways to encourage and incentivise that clinical trials are designed from the outset so that they generate not only the information needed for market authorisation, but also the comparative data needed for HTA evaluations.
  • We invite the other EU Member States as well as the European Commission to become aware of this issue that is not limited to our countries alone. Accordingly, we draw your attention to the joint statement from the Beneluxa and Nordic Pharmaceutical forum from June 4th 2021.
  • We value the provisions in the regulation on joint HTA that focus on creating early scientific consultations, potentially addressing both regulatory as well as HTA data requirements. Strengthening early dialogues between companies and HTA agencies are a first way forward to get the set-up of clinical trials right. This dialogue should aim at developing adequate industry guidelines for marketing authorization application dossiers including clear “HTA package” recommendations and requirements.

The link to the full paper is below.

Link to the EPSCO meeting:

Last update: 13 July 2022