On 22 March 2018, the German Bundestag unanimously adopted a complaint of subsidiarity on the EU Commission’s draft regulation on the benefit assessment of health technologies. EU Health Ministers met on 22 June 2018 to discuss HTA. In particular, the larger Member States are opposed to a binding European HTA. Smaller Member States without their own HTA institutions tend to support the Commission’s proposal. (http://www.consilium.europa.eu/de/meetings/epsco/2018/06/21/)
In the meantime, France and Germany shared a common position aimed at safeguarding the competences of the Member States. Joint evaluations should have no binding effect on the Member States and should provide the option for an opt-out. Institutionally, the European Commission should only be given administrative powers whereas the assessment itself should be organized by the Member States, in order to maintain the institutional balance. Of particular importance is the definition of the methodology of the benefit assessments, which is not yet regulated in the draft regulation. According to the French / German ideas, the methodology should be regulated in the proposal itself. The methodological requirements are an essential component of HTAs / benefit assessments, which are currently defined on a national basis and differ substantially between the Member States. While some Member States focus on methods of evidence-based medicine and evaluate the patient-relevant benefits and added value in relation to one or more appropriate comparative therapies, other countries tend to use cost-benefit assessment methods.
The European Commission has already carried out several Health Technology Assessments within the framework of the Joint Action Programme (EUnetHTA) in order to test the feasibility in principle at European level. (https://eunethta.eu/assessments/)