Under plans by the European Commission, the evaluation of medicinal products and medical devices will be carried out at European level.

MS – 01/2018

The European Commission has presented a proposal for strengthening cooperation between EU Member States when evaluating health technologies. In the future, a joint assessment of health technologies will be obligatory at European level, particularly in the field of medicines and medical devices. This will allow Member States to draw on common instruments, methodologies and procedures across the EU, working together in the following four key areas: 


1) on joint clinical assessments focusing on the most innovative health technologies with the greatest potential for patients;  

2) on joint scientific consultations, which enable developers to obtain advice from HTA authorities;  

3) on identifying emerging health technologies so that promising technologies are identified at an early stage;  

4) on continued voluntary cooperation in other areas.  

Opinion of the responsible EU-Commissioners

Vice President Katainen said: ‘Reinforcing Health Technology Assessment co-operation at EU level boosts innovation and improves competitiveness of the medical industry. The healthcare sector is a crucial part of our economy, it accounts for approximately 10% of the EU’s GDP. We are proposing a regulatory framework that will bring benefits to patients all over Europe, whilst encouraging innovation, helping the take-up of high-quality medtech innovations and improving the sustainability of health systems across the EU.’  


The Commissioner for Health and Food Safety, Vytenis Andriukaitis, added: ‘Today, the Commission has put the wheels in motion for better quality, innovative healthcare for the benefit of patients, especially those with unmet medical needs. I also expect this initiative to result in a more efficient use of resources by Member States through the pooling of resources and exchanges of expertise, thereby avoiding duplications in the assessment of the identical products.’ 

Opinion of the GKV

The National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) is of the opinion that it seems difficult to quickly establish joint evaluations given the very different approaches to the follow-up evaluation of medicinal products throughout Europe. There are significant differences between the Member States, both in the legislation and in the methodology of assessments. While some countries, such as Germany, base their decisions on evidence-based medicine and assessing the medical benefit or added value of an active substance, other countries, such as the Netherlands or Sweden, rely on cost-benefit assessments. Different approaches to assessment result in a different selection of comparators for new medicines and a different assessment of patient-relevant endpoints. 


‘At the moment, it isn’t clear how a compulsory benefit-assessment at EU level could be put in place without leading to massive friction in individual countries,’ said Johann-Magnus von Stackelberg, Deputy Chair of the GKV-Spitzenverband. ‘Only once methodologies, the presentation of results, the transparency of underlying data, schedules and the quality of assessments are unified, can there be talk of a mandatory takeover. Until then, the best scenario we can imagine is voluntary participation.’  

Next steps

The proposal is now being discussed by the European Parliament and the Council of Ministers. It will become applicable three years from the date of it being adopted and entering into force. Member States will be given a further three years from the date of application to gradually adapt to the new system.  


The Commission’s proposal can be viewed here.  

You can view the press release from the GKV-Spitzenverband here (German only).