EU Member States and stakeholders support strengthened EU cooperation on HTA – but only without legal force

Tue, 2018 / 07 / 31

About the author

Ihr Ansprechpartner Prof. Matthias P. Schönermark, M.D., Ph.D.
Prof. Matthias P. Schönermark, M.D., Ph.D.
Founder and Managing Director
Fon: +49 511 64 68 14 – 0
Fax: +49 511 64 68 14 18
More Contact Info
The debate about the European Union (EU) Commission’s proposal to harmonize health technology assessment (HTA) for new medicines and medical devices among EU member states continues. Not only German politics strongly critized the proposal. It has also received negative opinion from France, Czech Republic, and Poland because the proposal interferes with member states’ responsibility for medical care and management of health services. Moreover, there is no legal basis within the EU Treaty to enforce HTA cooperation. With written objections from these four EU member states, there is a qualified minority against the proposal in the Council of the EU.

The EU Ministers of Health also discussed the proposal at the meeting of the Council for Employment, Social Policy, Health and Consumer Affairs on June 22nd in Luxemburg. Especially large member states rejected the proposed legal force because of too big national differences with respect to decision-relevant issues such as the selection of comparators and the judgment of patient relevance of clinical endpoints. However, some of the smaller states that do not have established national HTA procedures appreciated the legal binding whereas others fear the resulting costs for expensive innovative drugs. Despite these different views all member states agreed that HTA cooperation should be improved and better structured. Therefore, the EU Commission’s proposal should be refined including a voluntary approach to EU-wide cooperation for HTA.

To include the views of stakeholders into the discussion, the EU Commission met healthcare providers, patient representatives and other experts on July 9th in Brussels. The discussion indicated that HTA should be given a fair chance to become more structured, sustainable and efficient for an optimal use of resources and sharing of expertise across the EU.

SKC will keep following this interesting political debate to best support the market access of our client's innovative medicines and medical devices in Germany.

BY Prof. Matthias P. Schönermark, M.D., Ph.D., managing director and Lydia Gibson, M.Sc. psychology

Sources:
MAP BioPharma: Commission’s HTA proposal in trouble after four countries object
Councel of the European Union: Outcoume of the 3625th Council meeting
Deutsche Sozialversicherung Europavertretung: EU-Gesund­heits­mi­nis­ter bera­ten HTA (German only)
European Commission: The way forward for HTA cooperation – the views of stakeholders
European Commission: Stakeholders confirm support for strengthened EU cooperation on HTA
to the top