Proposal for a Regulation on health technology assessment and amending Directive 2011/24/EU

Author (Corporate)
Series Details COM (2018) 51
Publication Date 31/01/2018
Content Type ,


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.

Further information:

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;
2) on joint scientific consultations whereby developers can seek advice from HTA authorities;
3) on identification of emerging health technologies to identify promising technologies early;
4) on continuing voluntary cooperation in other areas.

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.

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Commentary and Analysis
EPRS: Briefing, June 2018: Strengthening EU cooperation on health technology assessment - Initial Appraisal of a European Commission Impact Assessment
EPRS: Briefing, April 2019: Boosting cooperation on health technology assessment

Politico, 08/01/2018: Brussels gets into drug business
EurActiv, 10/01/2018: Commission reassures ‘worried’ member states on Health Technology Assessment
EurActiv, 31/01/2018: EU unveils health technology bill
Reuters, 31/01/2018: EU proposes joint studies to speed acceptance of new medicine
EurActiv, 28/05/2021: New EU health innovation rules edge closer
EurActiv, 25/03/2021: Portugal gets mandate to negotiate health technology assessment law

EUR-LEX: SWD(2018)41: Staff Working Document accompanying the Proposal - Impact Assessment
EUR-LEX: SWD(2018)42: Staff Working Document accompanying the Proposal - Executive Summary of the Impact Assessment
Official Website of the European Network for Health Technology Assessment (EUnetHTA)
European Parliament: Legislative Observatory: Procedure File for Proposal on Health technology assessment (2018/0018(COD))
European Parliament: Legislative Train Schedule: Health Technology Assessment (HTA)
European Commission: DG Health: Public Health: Health technology assessment
General Secretariat of the Council: Policies: Health technology assessment post 2020
European Commission: Press Release, 31/01/2018: Assessing health technology in the EU: Commission proposes to reinforce cooperation amongst Member States
European Commission: Q&A: Commission proposal on Health Technology Assessment (31 January 2018)
Council of the European Union: Press Release, 24/03/2021: Health Technology Assessment: Council agrees its negotiating position
European Commission: Press Release, 22/06/2021: Commission welcomes the move towards more innovative health technologies for patients
Council of the European Union: Press Release, 22/06/2021: Health Technology Assessment: Informal deal between Council and European Parliament

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