European Health Technology Assessment

What will happen next?

Mon, 2021 / 10 / 18
The approval of innovative medicinal products is centrally applied for at the European Medicines Agency (EMA), so that it is valid throughout the European Union (EU). On the contrary, the subsequent Health Technology Assessment (HTA) is still carried out at national level. Although this takes into account national and regional specifics such as economic, organizational and ethical aspects, it also leads to less security regarding business planning, duplication of work both for pharmaceutical companies and for HTA agencies, and different availability of the innovative medicinal products on national level despite simultaneous approval.

In 2018, the European Commission therefore published a proposal for a joint clinical evaluation of health technologies within the framework of the HTA. While some member states welcomed the proposal, clear opposition followed, especially from countries with high methodological assessment standards - such as Germany - including a subsidiarity complaint due to too far-reaching interference in national decision-making powers. These differing views of the member states made it difficult to reach a consensus in the subsequent trilogues between the EU Parliament, the Council and the Commission, with the result that a compromise was not reached until June of this year.

Now it is clear that the evaluation of the clinical part of the HTA will soon take place centrally at the European level following official adoption by the Council and the Commission, which is expected before the end of this year. The non-clinical part of the HTA will continue to be assessed at the national level and the decision on the extent of added value will also remain the responsibility of the countries. A three-year implementation phase, which is needed to develop and deploy concretizing tertiary legislation, will initially be followed by a transition period during which the number of centralized clinical assessments will be gradually increased.

As the development of the necessary and concretizing secondary legal acts is only just beginning, many questions currently remain unanswered. In particular, the timing of marketing authorization, central clinical evaluation, and national non-clinical evaluation, as well as their consequences for price negotiations, have not yet been finalized. The methodological basis for the joint clinical evaluation is also still being developed with the involvement of the Institute for Quality and Efficiency in Health Care (IQWiG) and the Federal Joint Committee (G-BA).

We continue to follow the development of the joint European HTA closely and will be happy to support and advise our clients on the strategic market access of pharmaceutical or medical products, both under current national and future European regulation.

Update:

The position of the Council of the European Union for a regulation on health technology assessment has been published on https://data.consilium.europa.eu/doc/document/ST-10531-2021-INIT/en/pdf

On November 9th, the EU Council has accepted the proposal for a regulation on health technology assessment.

About the author

Ihre Ansprechpartnerin  Svenja Sake, Ph.D.
Svenja Sake, Ph.D.
Veterinarian
Fon: +49 511 64 68 14 0 – 0
Fax: +49 511 64 68 14 18
to the top