Health technology assessment (HTA)
In “Promoting our European Way of Life”
For a brief overview of the key points of the adopted text and its significance for the citizen, please see the corresponding summary note.
Health technology assessment (HTA) is a research-based tool to support decision-making in healthcare. HTA assesses the added value of new or existing health technologies – medicines, medical devices (for example pacemakers, dialysis equipment or infusion pumps) and diagnostic tools, surgical procedures, as well as measures for disease prevention, diagnosis or treatment – compared with other health technologies. The HTA process is performed by currently about 50 European HTA agencies. Fragmented approaches from HTA agencies may have a negative impact on R&D investment in Europe.
The Commission published its proposal on 31 January 2018. The proposed regulation on HTA aims to strengthen EU-level cooperation among Member States for assessing health technologies. According to the Commission, it would not only make innovative health tools reach patients faster, but also boost innovation and improve competitiveness of the European healthcare sector. Building on existing EU cooperation on HTA, including the HTA network and the EUnetHTA joint action, the proposal would provide the basis for a permanent, sustainable cooperation.
The proposal covers new medicines and certain new medical devices. It focuses the future cooperation (the 'joint work') on assessing clinical aspects of HTA, namely: the description of the health problem addressed by the health technology and the current use of other health technologies addressing that health problem; the description and technical characterisation of the health technology; the relative clinical effectiveness and the relative safety of the health technology. Member States would continue to be responsible for assessing non-clinical (e.g. economic, social, ethical, organisational) aspects of HTA, as well as for making decisions on pricing and reimbursement.
The proposal provides for joint work in four areas: joint clinical assessments focusing on the most innovative health technologies with the most potential impact for patients; joint scientific consultations, whereby health technology developers (i.e. the pharmaceutical industry and medical-device manufacturers) can seek advice from HTA authorities; identification of emerging health technologies ('horizon scanning'), with a view to identifying promising health technologies at an early stage; continuing voluntary cooperation on other aspects of HTA.
The cooperation would be Member State-driven, with the Commission hosting a secretariat to provide administrative, scientific and IT support. Participation in the joint clinical assessments and use of the joint clinical assessment reports at Member State-level would become mandatory after six years: following the regulation's entry into force, the Commission proposes a three-year period for adopting tertiary legislation, and another three-year (transitional) period to allow Member States to fully adapt to the new system.
Parliament's Committee on the Environment, Public Health and Food Safety (ENVI) adopted the rapporteur's draft report on 13 September 2018. The committee report was endorsed in plenary on 3 October 2018 (partial vote in view of opening interinstitutional negotiations).
After a debate in plenary on 13 February 2019, Parliament adopted the report in a vote on 14 February, thereby closing Parliament's first reading.
In the ENVI meeting on 4 September 2019, MEP Tiemo Wölken (S&D, Germany) was named rapporteur for the file, following on from last term's rapporteur, MEP Soledad Cabezón Ruiz (S&D, Spain).
On 24 March 2021, following three years of discussions in the Council, Coreper agreed on a mandate for negotiations with Parliament. Three trilogue meetings were held. On 22 June 2021, Parliament and Council reached a provisional agreement. As regards joint clinical assessment reports, Parliament was keen to defend the binding nature of their uptake but had to compromise. It secured the introduction of safeguards to make sure the reports cannot be ignored by Member States.
Coreper confirmed the provisional agreement from interinstitutional negotiations on 30 June 2021. ENVI voted on the provisional agreement on 13 July 2021 (58 votes in favour, 14 against and 6 abstentions).
The Council formally adopted its first-reading position on 9 November 2021. On 30 November 2021, ENVI adopted its recommendation for second reading, which was debated and voted during the December plenary session.
The Regulation (EU) 2021/2282 on health technology assessment and amending Directive 2011/24/EU was signed on 15 December 2021.
The Regulation on HTA entered into force in January 2022 and applied as of January 2025.
References:
- EP Legislative Observatory, Procedure file on Health technology assessment, 2018/0018(COD)
- European Commission, Proposal for a regulation on health technology assessment and amending Directive 2011/24/EU, COM(2018) 51
- Council, Health technology assessment post 2020, website
- Council, Council green lights new rules on health technology assessment, improving access to medicines and simplifying procedures, press release, 9 November 2021
- European Parliament, Deal on boosting member states’ cooperation in assessing health technologies, press release, 22 June 2021
- European Economic and Social Committee, Opinion on the proposal for a Regulation on health technology assessment, EESC 2018/00626
- Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU
Further reading:
- European Parliament, EPRS, Boosting cooperation on health technology assessment, Briefing, December 2021
- European Parliament, EPRS, EU cooperation on health technology assessment, December 2021
Author: Laurence Amand-Eeckhout, Members' Research Service, legislative-train@europarl.europa.eu