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Health technology assessment

The EU wants to strengthen EU cooperation on health technology assessment (HTA). The main purpose of HTA is to provide policy-makers with evidence-based information, so they can formulate health policies.

The EU wants to strengthen EU cooperation on health technology assessment (HTA).

HTA can be a powerful tool in dealing with access to medicines.

The evaluation of a new health technology is a multidisciplinary process that reviews the medical, economic, organisational, social and ethical issues related to the use of a new health technology.

The review is performed in a systematic manner to compare the added value of a new health technology with an existing one. HTA is used with the aim to improve the quality and efficiency of public health interventions and to make healthcare systems more sustainable.

During the review of a health technology the following aspects are usually considered:

  • whether it works better, equally well, or worse than existing alternative treatments
  • the therapeutic effects and also the potential side-effects
  • the influence on quality of life
  • the means of administration
  • the cost
  • the impact on the organisation of healthcare systems in the administration of the treatment

In recent years, a number of member states have applied HTA and it has become an important part of evidence-based decision-making in the health field.

Examples of health technologies are:

  • medicinal products
  • medical devices
  • diagnostic and treatment methods
  • rehabilitation and prevention methods

Why do we need it?

The main purpose of HTA is to provide policy-makers with evidence-based information, so they can formulate health policies that are:

  • safe
  • effective
  • patient-focused
  • cost-effective

HTA is also used by national authorities to help decisions on which technology should be reimbursed at national level.

On 31 January 2018, the Commission adopted the proposal for a regulation on health technology assessment.  

It comprises four main areas of work at EU level:

  • joint clinical assessments (JCA)
  • joint scientific consultations
  • identification of emerging health technologies
  • voluntary cooperation on health technology assessment.

It also intends to set common rules for national clinical assessments. By far the most important scope of EU level action are the joint clinical assessments of centrally authorised pharmaceuticals and of certain medical devices meant to assess the merits in terms of clinical effectiveness of that technology compared to another health technology.

HTA network

The HTA network connects 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. The HTA Network aims to support cooperation between national authorities, including on the relative efficacy and short and long-term effectiveness of health technologies.

While participation is voluntary, all EU countries have applied for membership and participate. The HTA Network is supported on scientific and technical issues by a 3rd joint action under the health programme, called EUnetHTA, which ran from 2016 to 2020.

 

EUnetHTA

  • supports efficient production and use of HTA in countries across Europe
  • provides an independent and science-based platform for HTA agencies in countries across Europe to exchange and develop HTA information and methodology
  • provides an access point for communication with stakeholders to promote transparency, objectivity, independence of expertise, fairness of procedure and appropriate stakeholder consultations
  • develops alliances with contributing fields of research to support a stronger and broader evidence base for HTA while using the best available scientific competence

In the Council

All member states favour enhanced cooperation on HTA at EU level, but see the balance between voluntary and mandatory elements sometimes very different.

The main concern of delegations is to clarify how the proposal once adopted would influence national decisions on the reimbursement of medicines or medical devices by national health insurance schemes. In this regard, a large majority of delegations consider that member states should have the possibility to carry out national clinical assessments when necessary.

Other important issues identified by delegations are linked to the quality and timely delivery of JCA and to the structures, procedures and methodologies for achieving these. All delegations agree that JCA must be at least as good as national clinical assessments and must be available sufficiently early to be used in national decision-making.

The proposal has been discussed in the Working Party on Pharmaceuticals and Medical Devices.

On 9 November 2021 the Council gave its final greenlight to the new regulation. Council agreed on its position on 24 March 2021 and on 22 June 2021 struck a political deal with the European Parliament.

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Last review: 4 February 2025