Written by Nicole Scholz (1st edition),
The European Commission has proposed a regulation on health technology assessment (HTA). HTA is a research-based tool that supports decision-making in healthcare by assessing the added value of a given health technology compared to others. The proposal covers new medicines and certain medical devices, and would provide the basis for permanent EU-level cooperation in four areas: joint clinical assessments; joint scientific consultations; identification of emerging health technologies; and voluntary cooperation on other aspects of HTA. Member States would still be responsible for assessing the non-clinical (economic, ethical, social, etc.) aspects of health technology, and for pricing and reimbursement. While Member States could choose to delay their participation in the joint work until three years after the rules enter into force, it would become mandatory for all after the sixth year.
Stakeholders have broadly welcomed the proposal, with the medical devices industry reportedly being more sceptical. The legislative process is in its early stages. In the Council, the Working Party on Pharmaceuticals and Medical Devices is dealing with the file. The Parliament’s Committee on the Environment, Public Health and Food Safety is expected to consider the rapporteur’s draft report in summer 2018.
- March 2018: ‘Boosting cooperation on health technology assessment‘ (1st edition)