German benefit assessment under European scrutiny.

Following the European Commission’s legislative proposal on Health Technology Assessment (HTA) at the end of January 2018, many European and national health organisations are on alert. The overall objective of the proposal is to strengthen cooperation between the national HTA agencies. This involves full harmonisation of HTA at the clinical evaluation level for all medicinal products subject to the centralised approval procedure and for certain medical devices. In addition, it will become mandatory to collaborate on joint clinical assessments and use this information as the basis for national pricing and reimbursements. Member States will no longer be allowed to carry out their own assessments. 

 

Currently there is voluntary cooperation on HTA as part of the European network EUnetHTA. Strategic but non-binding cooperation has received project funding from the Commission for years. However, due to the diversity of the healthcare systems, assessment results from EUnetHTA have not been directly used for assessments by Germany’s Institute for Quality and Efficiency in Healthcare (IQWiG) or decisions by the German Federal Joint Committee (G-BA). According to the Commission, the reason for this lies in the voluntary nature of the project group. This is now set to change. 

EU subsidiarity control mechanism not triggered

Following the eager but anxious wait for the draft legislation to be published, Member States had the option of triggering the subsidiarity control mechanism until the beginning of April. Under this system, national parliaments can submit a reasoned opinion to the Commission when they consider that a proposed law does not comply with the principle of subsidiarity or there is a conflict with national competences. 

 

Both the German Bundestag and Bundesrat spoke out against the proposal because they believe it does not comply with the principle of proportionality as the proposal does not take into consideration national specificities such as the benefit assessment system in Germany and its direct integration into national health insurance legislation. However, the German Federal States refrained from submitting a reasoned opinion because the supply of medicines is a federal matter. 

 

France and the Czech Republic also submitted reasoned opinions as they believe the proposal will significantly interfere with health policy, which is the responsibility of the Member States. While EU-wide cooperation is desirable, it is up to Member States to decide whether or not to accept HTA assessments. Although recommendations at EU level are seen as useful, binding standards go beyond the Commission’s competence. Poland (in the form of a resolution) and Spain also opposed the proposal. In Spain, an official reasoned opinion was not submitted due to disagreements in Parliament over the grounds. 

 

In the end, there were not enough objections in the EU to trigger action from the Commission. The Commission only has to review a legislative proposal for compliance with the principle of subsidiarity when there are reasoned opinions from at least one-third of the 56 votes allocated to the 28 Member States. In this case, 19 votes were needed to trigger a review but only 3 were received. 

Member States divided

In mid-April, the Member States in the Council Working Party on Pharmaceuticals and Medical Devices had the opportunity to discuss the HTA proposal. The focus was on the proposed legal validity of EU-wide scientific assessments of relative effectiveness. France, the Czech Republic, Poland, Hungary, Denmark, Sweden, Spain and Germany were critical of the proposal. Proponents of the proposed law were Croatia, Greece, Portugal and the Netherlands. Belgium, Malta, Latvia and Austria took a moderate position. Austria will take over the Presidency of the Council from 1 July 2018. 

 

If the Council were to decide on a resolution today, the proposed legislation could be prevented by the Member States using a ‘blocking minority’. The draft regulation must be adopted by a qualified majority in the EU Council. This in turn means that at least four Member States, representing more than 35% of the EU population, can prevent the proposal. 

 

The next Council Working Party on HTA meets in Brussels on 7 May 2018. 

Social democrats take over reporting in European Parliament

In the European Parliament, MEP Soledad Cabezón Ruiz (S & D, Spain) has been appointed rapporteur on the committee responsible for health (ENVI). The shadow rapporteur from Germany is Gesine Meißner (ALDE) and from France, Françoise Grossetête (EPP). The Spanish rapporteur’s commencement in May 2018 will be very interesting because although the European Parliament is fully behind the Commission's proposal, the Spanish Parliament takes a critical stance. 

Health insurance funds call for improvements to the HTA proposal

Germany’s statutory health insurance funds are closely following the proposed legislation. They are for continued cooperation between HTA agencies at European level because this allows for better and more comprehensive use of HTA in the decision-making of national healthcare systems. However, the EU Commission’s current proposal goes far beyond what is necessary and intervenes in existing national systems. They therefore reject the proposal being implemented in its current form. Existing cooperation should continue and be progressively expanded, but the guiding principle of European cooperation should be a strong role for the Member States’ HTA agencies, with administrative support from the European Commission. 

 

More information can be read online here.