Following the European Commission's (EC) adoption of a proposal for a Regulation on health technology assessment (HTA) in 2018, and the European Parliament's agreement on its position in 2019, Member States have now agreed on a mandate to start negotiations with the European Parliament on HTA.
According to data on the draft text for the Regulation on HTA, the development of health technologies is a key driver of economic growth and innovation in the European Union (EU), forming part of an overall market for healthcare expenditure that accounts for 10% of the EU's gross domestic product.
HTA is an evidence-based process that allows for the evaluation of the properties and/or impacts of health technology, and the determination of the relative effectiveness of new or existing technologies. The outcome of HTA is used to inform decisions concerning the pricing or reimbursement of health technologies.
HTA is deemed a valuable tool assisting Member States in creating and maintaining sustainable healthcare systems. The draft Regulation aims at achieving a high level of protection of health for patients and users, and establishes the measures needed for the clinical assessment of health technologies.
The negotiation mandate adopted today is an important milestone. The regulation on health technology assessment, once adopted, will be a major step forward in the field of health. It will constitute a robust framework for cooperation for the benefit of member states, industry and, above all, patients.