|Author (Corporate)||European Commission: DG Health and Food Safety|
|Series Details||COM (2018) 51|
|Content Type||News, Policy-making|
Legislative initiative tabled by the European Commission on 31 January 2018, aimed at improving cooperation among Member States of the European Union (EU) for assessing health technology.
Health technology assessment (HTA) is a multidisciplinary process that summarises information about the medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased and robust manner. Its aim is to inform the formulation of safe and effective health policies that are patient focused and seek to achieve best value.
Cooperation on HTA at EU-level was launched in the 1980s. Three Joint Actions (EUnetHTA JA) were carried out comprising a number of projects. Directive 2011/24/EU - also known as the Cross-Border Healthcare Directive - established the HTA Network in 2013 to provide strategic and political guidance to the scientific and technical cooperation at EU-level.
The proposed Regulation covers new medicines and certain new medical devices, providing the basis for permanent and sustainable cooperation at the EU level for joint clinical assessments in these areas. Member States would be able to use common HTA tools, methodologies and procedures across the EU, working together in four main areas:
1) on joint clinical assessments focusing on the most innovative health technologies with the most potential impact for patients;
The draft initiative was adopted by the European Commission on 31 January 2018. The plenary of the European Parliament adopted a negotiating position on 14 February 2019, followed by the Council of the European Union on 24 March 2021. An informal agreement between the co-legislators on a compromise text for this draft law was reached on 22 June.
|Subject Tags||Medicines | Medical Devices, Public Health|
|Keywords||Health Services | Healthcare
|International Organisations||European Union [EU]|