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.
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.