Health technology assessment

Strengthening EU cooperation beyond 2020

In 2016, the European Commission started work on strengthening EU cooperation on Health Technology Assessment in response to calls from EU countries, the European Parliament, and interested parties to ensure its sustainability beyond 2020. In its 2017 Work Programme, the European Commission announced that this would extend to improving the functioning of the single market for health technologies.

Legislative proposal

A legislative proposal was adopted by the European Commission on 31 January 2018. It is the result of an extensive reflection process following the results of the impact assessment outlined below. It has been sent to the European Parliament and the Council with the aim of adoption by 2019. The proposal and related information can be found here:

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 summarises the potential impact of specific options in a report. An independent board (Regulatory Scrutiny Board) assessed the report before issuing its opinion. The impact assessment and supporting documents can be found here:

Stakeholder consultation

  • 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.

Related information