The European Commission has announced a proposal to reinforce co-operation between member states on the assessment of health technology.
The proposal for a regulation on health technology assessment (HTA) will cover the development of new medicines and new medical devices. However, individual member states will retain responsibility for non-clinical aspects of health technology, whether economic, social or ethical.
The new regulation will provide a framework for joint clinical assessments which would act as a basis for permanent and sustainable co-operation at EU level, and will encourage member states to work collaboratively in four main areas:
- Joint clinical assessments of the most innovative technologies;
- Joint scientific consultations with HTA authorities;
- Identification of emerging health technologies; and
- Ongoing voluntary co-operation in other areas.
EU member states have taken part in more than 20 years of voluntary co-operation in this area, but the proposed regulation could ensure they are better able to benefit from efficiency gains. The proposal would seek to address the challenges of regulating health tools in Europe, a process which is currently complicated by each state’s different national procedure.
How have the commissioners responded?
Commissioner for Health and Food Safety, Vytenis Andriukaitis, welcomed the announcement as a major step towards better care for patients: “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.”
Commission Vice-President Jyrki Katainen added that the proposal would not only improve access to healthcare innovations for European citizens, but would also provide a boost to the economy: “Reinforcing … 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.”