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HTA contributes to improving the availability of innovative technologies in the area of health, such as medicines and certain medical devices. It ensures efficient use of resources and strengthens the quality of HTA across the Union.

HTA provides a transparent and inclusive framework by establishing a Coordination Group of HTA national or regional authorities, a stakeholder network and by laying down rules on the involvement in joint clinical assessments and joint scientific consultations of patients, clinical experts and other relevant experts.

It reduces duplication of efforts for national HTA authorities and industry, facilitates business predictability and ensures the long-term sustainability of EU HTA cooperation.

New Legislation in force from 2022

On December 2021, the existing voluntary network of national authorities (HTA Network) and EU-funded project-based cooperation (Joint Actions EUnetHTA) were replaced by  Regulation (EU) 2021/2282.

This Regulation establishes a Coordination Group of the Member States for the assessment of health technologies and rules and dates of entry into force of the provisions.

The following health technologies will be subject to joint clinical assessments:

(a) Medicinal products for which EU central authorisation must be or may be requested, pursuant to the Regulation (EC) No 726/2004:

• 12 January 2025, for medicinal products with new active substances for which the applicant declares in its application for authorisation submitted to the European Medicines Agency that it contains a new active substance for which the therapeutic indication is the treatment of cancer and medicinal products which are regulated as advanced therapy medicinal products pursuant to Regulation (EC) No 1394/2007 of the European Parliament and of the Council;
• 13 January 2028, for medicinal products which are designated as orphan medicinal products pursuant to Regulation (EC) No 141/2000 of the European Parliament and of the Council (16);
•  13 January 2030, for medicinal products of point (a) other than those referred to in previous dates.

(b) medicinal products authorised in the Union for which a joint clinical assessment report has been published, in cases where an authorisation is granted pursuant to the second subparagraph of Article 6(1) of Directive 2001/83/EC for a variation to an existing marketing authorisation which corresponds to a new therapeutic indication;

(c) medical devices classified as class IIb or III pursuant to Article 51 of Regulation (EU) 2017/745 for which the relevant expert panels have provided a scientific opinion in the framework of the clinical evaluation consultation procedure pursuant to Article 54 of that Regulation, and subject to selection pursuant to paragraph 4 of this Article;

(d) in vitro diagnostic medical devices classified as class D pursuant to Article 47 of Regulation (EU) 2017/746 for which the relevant expert panels have provided their views in the framework of the procedure pursuant to Article 48(6) of that Regulation, and subject to selection pursuant to paragraph 4 of this Article.

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How HTA worked before 2022

HTA provided policy-makers with evidence based information, so they  formulated health policies that were safe, effective, patient-focused and cost-effective. It was used by national authorities to help decisions on which technology should be reimbursed at national level.

​HTA was on voluntary basis.

EU cooperation on HTA had two main components:
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1. 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.

​Structure and legislative framework

• Directive 2011/24 on the application of patients' rights in cross-border healthcare
• Commission Implementing Decision of 26 June 2013
• Rules of procedure

Adopted documents

• Rules of procedure•
• HTA Network Reflection Paper on "Synergies between regulatory and HTA issues on pharmaceuticals"
• Multiannual Work Programme 2016-2020
• HTA Network Reflection Paper on Reuse of Joint Work in National HTA Activities
• Strategy for EU Cooperation on Health Technology Assessment (HTA)
• Multi-annual work programme 2014-2015

Network's meetings

• HTA Network’s meetings (agenda, minutes and documents)

2. EUnetHTA Joint Action 3
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EUnetHTA Joint Action 3 was the scientific and technical component of EU cooperation on HTA. It was launched in June 2016, and run until 2020. The Joint Action was funded by the EU Health Programme and included government appointed organisations (from EU countries, EU-accession countries, EEA and EFTA countries), and a large number of relevant regional agencies and not-for-profit organisations that produced or contributed to HTA in Europe.