About HTA

Health technology assessment (HTA) is the process of assessing the added value of new health technology (e.g., medicinal products, medical devices, diagnostic tests) compared to current standards of care. The main aim of HTA is to provide policymakers with information so that they can formulate sound, evidence-based health policies.

Until now, the HTA process has been in the hands of the individual Member States, resulting in inefficiencies and repetitions of similar processes, during different timeframes, across the 27 EU countries.

Member States have begun collaborating on HTA at EU level in 2006 with the creation of the European Network for Health and Technology (EUnetHTA), a joint effort to promote coordination and standardisation for the different Health Technology Assessment bodies across Europe. However, as stated in the European Commission impact assessment, this voluntary collaboration “has had a limited impact, as the joint network was used only marginally in HTA national decision-making bodies” and led to a series of inefficiencies and duplication of work.
This network will be replaced by the Regulation on Health Technology Assessment (HTAR), which establishes a permanent framework for joint work throughout the EU Member States.
The new legislation, adopted in December 2021, will come into force in January 2025 and will follow a stepwise-approach

  • Initially

    the HTAR will focus on new oncology medicines and advanced therapies (ATMPs)

  • From 2028

    orphan drugs will be included in the scope

  • Starting from 2030

    new medicines and certain medical devices will be integrated

The joint work at EU level will focus on the clinical effectiveness and safety of new health technologies compared with existing technologies. Non-clinical areas, such as economic evaluation and ethical or social aspects, will remain under the responsibility of national HTA bodies.
A Coordination Group of HTA national or regional authorities has been established, and it will be responsible for overseeing the joint work in four areas

Collaborative Clinical Assessments
The joint clinical assessments will produce joint reports assessing the health technology on its clinical aspects.
Scientific Guidance for Clinical Studies
The joint scientific consultations will provide scientific advice to health technology developers on clinical study designs that generate appropriate evidence.
Anticipating Emerging Health Technologies
The identification of emerging health technologies will help health systems prepare for them.
Enhanced Voluntary Health Technology Cooperation
Member States may also engage in further voluntary cooperation, e.g., on health technologies other than medicines and medical devices, or on economic aspects of HTA.
In addition, one of the new features introduced by this Regulation is the mandatory involvement of patients in joint technology assessment work. HTA at national level often does not involve patients in the assessment of health technologies, whereas patients' direct knowledge of the side effects and impact on quality of life will contribute to a better and more comprehensive assessment of their effectiveness.

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