Skip to main content
European Commission logo
enen
Public Health

Behind the HTA regulation

Legislative proposal

The European Commission adopted its proposal for a Regulation on HTA on 31 January 2018.

The European Parliament closed its first reading position in February 2019 while the Council adopted its first reading position in November 2021.

Shortly after the vote of the European Parliament in early second reading in December 2021, the Regulation was adopted in December 2021.

Impact assessment

During the development of the legislative proposal, the European Commission performed an impact assessment in line with its Better Regulation guidelines. This established the need for EU action and summarised the potential impact of specific options in a report. An independent board (Regulatory Scrutiny Board) assessed the report before issuing its opinion.

Stakeholder consultation

Prior to the impact assessment phase, an online public consultation on the initiative was launched on 21 October 2016. The consultation, which ran until 13 January 2017, gathered opinions on the future of EU cooperation on HTA. The results are summarised in the impact assessment report and were carefully considered during the development of the legislative proposal.

As part of the consultation several bi-lateral meetings were held with stakeholders, the minutes of meetings with stakeholders are also available.

Inception impact assessment

In September 2016 an inception impact assessment, which constitutes the first step in defining any EU initiative, was published. The document outlines the current state of play, and possible ways forward to address identified shortcomings.

EU cooperation before 2021

Health Technology Assessment (HTA) is an important part of evidence-based decision-making on health in most EU countries.

Before 2021, EU cooperation on HTA had two main components: HTA network and EUnetHTA Joint Actions.

HTA Network

The HTA Network connected national authorities or bodies responsible for HTA.

The network was introduced by Directive 2011/24/EU on the application of patients’ rights in cross-border healthcare to provide strategic guidance and policy orientation for scientific and technical cooperation.

While participation was voluntary, all EU countries applied for membership and actively participated in its activities. The HTA Network developed policy papers and discussed areas of potential collaboration, which were then implemented by the EUnetHTA Joint Actions 2 and 3 below, in accordance with their work plans.

EUnetHTA Joint Actions

EUnetHTA Joint Actions were the scientific and technical component of EU cooperation on HTA, funded under the EU Health Programmes:

  • Joint Action 1 (2010-2012; budget €6 million) started developing joint clinical HTA activities
  • Joint Action 2 (2012-2015; budget €9.5 million) piloted the methodology and activities developed during the first joint action
  • Joint Action 3 (2017-2021; budget €20 million) built on the successes and products of previous joint actions, implemented the strategies of the HTA Network and shifted from piloting to production of joint scientific reports, with increased uptake by national HTA bodies.
    The third joint action had a record number of government appointed organisations from almost all EU countries, as well as EU-accession countries, EEA and EFTA countries, including and a large number of relevant regional agencies and not-for-profit organisations that produce or contribute to HTA in Europe.

In 2017, the European Commission launched a call for expression of interest for a Stakeholder Pool, which started its activity beginning of 2018. The pool included representatives of the main HTA-related stakeholders (patient organisations, healthcare professionals associations, payers associations, industry trade associations). The Stakeholder Pool actively contributed to some of the strategic documents developed by the HTA Network and also to the Commission initiatives in the field of HTA.

In its 2017 work programme, the European Commission announced that it would introduce an initiative on strengthening EU cooperation on HTA to improve the functioning of the single market for health products. Both HTA Network members, EUnetHTA Joint Action 3 partners and many stakeholders’ organisations, provided valuable input to the Commission during the preparation of the proposal for strengthening EU cooperation on HTA.

The European Commission adopted its proposal for a Regulation on HTA on 31 January 2018 and the legislative process was concluded in December 2021.

HTA Network
Structure and legislative framework, Directive 2011/24 on the application of patients' rights in cross-border healthcare, Commission Implementing…