The objective of the proposed ordinance is to carry out a uniform European benefit assessment of new technologies in relation to established therapeutic approaches. The non-clinical evaluation regarding economic, social and ethical aspects remains in the sovereignty of the Member States. Ideally, the regulation should already be adopted by the European Parliament and the Council in 2019, enabling implementation and enforcement in 2022. On 22 March 2018, the German Bundestag unanimously adopted a subsidiarity complaint on the EU Commission’s draft of the 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. More Infos >>>
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. More Infos >>>