Health technology assessment

What is health technology assessment? 

The health technology assessment is a multidisciplinary evaluation 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.

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

Examples of health technologies are:

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

Review process

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

• Implementation of the Regulation on health technology assessment (European Commission)

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.

Better cooperation

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

HTA is increasingly used by member states to assess the added value of health technologies and support evidence-based decision making in healthcare. Closer cooperation at EU level can help member states make better use of HTA and share expertise and evidence.

EU cooperation also aims to avoid duplication of work and make the assessment process more efficient. By working together, member states can share common methods, information and expertise while continuing to take their own decisions on the use and reimbursement of health technologies.

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

On 24 March 2021, the Council agreed its position on the directive. 

On 21 June 2021, the Council and Parliament stroke a deal on the text of the new rules.

On 9 November 2021 the Council gave its final greenlight, adopting the new regulation. The regulation entered into force on 12 January 2022.

• Health Technology Assessment: Informal deal between Council and European Parliament (press release, 22 June 2026)
• Council green lights new rules on health technology assessment, improving access to medicines and simplifying procedures (press release, 9 November 2021)