Voluntary cooperation and voluntary uptake of new concepts in the individual Member States are conducive to the further development of HTA. The initiative for closer cooperation can only come from the individual Member States.

Last year the European Commission commenced a public consultation on strengthening EU cooperation on HTA in order to prepare for further legislative and non-legislative initiatives at EU level. The spectrum of the considerations ranges from long-term, voluntary cooperation in this field through to the joint preparation of complete HTA reports at EU level and the binding use of these reports in the Member States.  

The GKV-Spitzenverband welcomes in its contribution to the consultation the discussion over strengthening EU cooperation on HTA, particularly with regard to medicinal products and medical devices. 

In the German health system, which is steered by a system of self-government, benefit assessments, conclusions about added value and the setting of prices are separated from one another. New medicinal products, medical procedures and medical products are quickly made available for the treatment of patients and are also swiftly assessed. Assessment procedures and decisions are published and are therefore transparent.  

The GKV-Spitzenverband believes that the differences between the Member States’ assessment procedures and their results is not problematic. These differences reflect differing preferences, social conditions and the specificities of the health systems. There are no discernible negative effects on innovation or business predictability.  

Current European cooperation on Health Technology Assessment is considered to be partially helpful because the exchange of opinions and discussions over methodological issues can pro-vide a fruitful impetus to national procedures. Until now, however, the results of this cooperation have been published too late to be included in assessment procedures in Germany.  

The GKV-Spitzenverband is committed to continuing cooperation on Health Technology Assesment at European level beyond 2020. Given the fundamental consensus on evidence-based medicine, an exchange of different methodological approaches provides a gain in knowledge for all participants.  

The initiative for closer cooperation can only come from the individual Member States. Therefore, national assessment bodies should play the key role in how cooperation is managed and organised. Also the European Medicines Agency (EMA) is not suited to managing or organising future European cooperation on HTA because the requirements necessary for this are different to those that are currently authorised. 

Comments by the National Association of Statutory Health Insurance funds on strengthening EU cooperation on Health Technology Assessment (HTA):  

http://dsv-europa.de/lib/02_Positionspapiere/2016-GKV-comments-consultation-HTA_en.pdf