The new Regulation (EU) 2021/2282 on Health Technology Assessment

Last updated: 23 May 2024

This post is an attempt to provide basic information on Health Technology, its assessment and the new Regulation (EU) 2021/2282.

Click on the ‘+’ sign next to each heading to access the information under each heading.

DateUpdate(s)
23 May 2024Section Important dates updated with information from a news announcement from the Commission.
3 March 20241) Administrative changes to improve readability of the post.
2) New section Important dates added
3) Item 3 added in the section Further Information
16 Feb 2024In the section Is there a rolling plan available for the implementation of the HTA Regulation? link updated to plan of Feb 2024.
9 Feb 2024Item 3, a link to a stakeholder meeting added under the heading Further Information.
24 Oct 2023Heading Is there a rolling plan available for the implementation of the HTA Regulation? added, plus relevant content.
5 Oct 2023Under the section Further Information, link added to Factsheet on the implementation of the HTA regulation (5 October 2023)

Health technology is a diverse field covering for example medicines like new cancer drugs, medical devices like artificial hips and heart valves and other health interventions like new surgical procedures. 1

New health technologies are often complex and expensive, which is why it’s important to be able to make informed decisions before investing in them.  This is what Health Technology Assessment (HTA) does.1

  • It summarises information about clinical, economic, social and ethical issues related to the use of a health technology in order to help Member States make decisions based on evidence.1 
  • In doing so, it also helps ensure that health care is accessible, sustainable and of high quality.1
  • HTA answers clinical questions like: “How well does the new technology work compared with existing alternative health technologies”? It can also answer economic questions like “What costs are entailed for the health system”? HTA is therefore a key tool for Member States to ensure the quality, accessibility and sustainability of healthcare.2

The new Regulation (EU) 2021/2282 on Health Technology Assessment entered into force on 11 January 2022 and it will become applicable from 12 January 2025.6

This Regulation replaces:4

  • the current system based on the voluntary network of national authorities (HTA Network), and
  • the EU-funded project-based cooperation (Joint Actions EUnetHTA)

with a permanent framework for joint work that will also cover:

  • joint clinical assessments,
  • joint scientific consultations,
  • the identification of emerging health technologies, and
  • voluntary cooperation.

More information is provided on EUnetHTA elsewhere in this post.

The regulation will govern the European cooperation between medicine regulators and HTA bodies.

  • Under the new framework, the European Medicines Agency (EMA) and HTA bodies will collaborate in the context of:
    • joint clinical assessments,
    • joint scientific consultations, and
    • the identification of emerging health technologies.
  • The HTA Regulation focuses on clinical aspects of HTA.1
  • Under the new Regulation, Member States HTA bodies will conduct Joint Clinical Assessments of new medicines and certain high-risk medical devices to e.g. compare new and existing technologies, looking at their relative clinical effectiveness and relative clinical safety.1 
  • They will also take part in Joint Scientific Consultations, to advise technology developers on clinical study designs that generate evidence for decision-making.1
  • In addition, “horizon scanning” exercises will identify promising health technologies early, to help health systems prepare for them.1
  • The above is the mandatory scope of the Regulation, but Member States may also cooperate further voluntarily, for example on health technologies other than medicines and medical devices, or on economic aspects of HTA.1
  • While aiming to improve the availability of innovative medicines and certain medical devices for patients in the EU, it will also ensure efficient use of resources and enhance the quality of health technology assessment in the EU by ensuring the sustainability of European cooperation.
  • The establishment of the Member State Coordination Group on Health Technology Assessment, as provided by the regulation, and of a stakeholder network, will give a transparent and inclusive framework to facilitate continued collaboration between partners and reduce duplication of efforts for national HTA authorities and industry.
1. Member States
  • Will be able to pool their HTA resources and expertise.
  • Joint Clinical Assessments will be high quality, timely scientific reports that Member States will take into consideration in their national HTA processes.
  • In this way, the Regulation will support Member States in taking more evidence-based and timely decisions on patient access to new medicines and medical devices. 
2. Patients

Patients will be empowered and clinicians better informed by having access to Joint Clinical Assessment reports that are of high scientific quality, transparent and accessible to the public.

3. Pharmaceutical and medical device industries
  • Developers in the pharmaceutical and medical device industries will have more clarity and predictability concerning the clinical evidence requirements for HTA.
  • Industry will also benefit from efficiency gains when submitting clinical evidence for HTA, since there will be only a single EU-level submission file for Joint Clinical Assessments (rather than, as in the past, multiple parallel submissions to the different national HTA systems).

EUnetHTA started in 2005 as a group of 35 organisations throughout Europe, led by the Danish Centre for HTA (DACEHTA) in Copenhagen which led to the activities of the EUnetHTA Project.

The mission of EUnetHTA was to support collaboration between European HTA organisations that brings added value to healthcare systems at the European, national, and regional level.

EUnetHTA was the preferred facilitator of high-quality HTA collaboration in Europe. HTA agencies considered EUnetHTA an efficient way of collaborating.

The EMAs collaboration EUnetHTA 21 EMA began in 2010 as a project to test out whether early engagement between regulators and HTA bodies could bring tangible benefits for patient access to medicines. Together, they were were able to help medicine developers enhance clinical research and become more efficient in generating the evidence relevant for both regulatory authorities and HTA bodies.5

Over the past three years, EMA and the EUnetHTA 21 consortium have delivered a number of milestones to prepare the EU for the entry into application of the Regulation on Health Technology Assessment.5

EUnetHTA 21 ceased to operate on 16 September 2023, but preparations will continue for the implementation of the Regulation, under the direction of the HTA Coordination Group.4

The EMA and HTA organisations have established a new framework for Parallel EMA/HTA Scientific Advice for the period from 17 September 2023 until 12 January 2025, when the HTA Regulation applies. During this transition period:5

Yes there is.

The rolling plan contains a list of key activities that the Commission has carried out or intends to carry out in preparation for the implementation of Regulation 2021/2282 on Health Technology Assessment (the “HTAR”). The plan is subject to regular review to provide national authorities and stakeholders with the most updated information.

You can view the plan (updated February 2024) here.

Date
11 Jan 2022The new Regulation (EU) 2021/2282 on Health Technology Assessment entered into force.6
23 May 2024Today, the European Commission adopted new rules for the joint clinical assessments of medicines at Union level, contributing to faster access to medicines for EU patients.
-These new rules define the timelines and the steps for conducting EU joint clinical assessments.
-The assessment reports will provide scientific evidence to Member States’ authorities at an early stage after a medicine’s marketing authorisation. This will help them to decide about its use in the national health system, assessing their value on the basis of robust evidence, and thus taking more effective, timely decisions when bringing medicines to the market.
-The rules are adopted under the Regulation on Health Technology Assessment (HTA). This Regulation established a new, innovative approach to harness and pool expertise from across the EU for assessing the effectiveness of new medicines compared to medicines already in use, while supporting healthcare systems to provide quality care for the EU using the latest technologies.
-Today’s rules are the first of six acts to be adopted this year under the HTA Regulation.
-Joint clinical assessments will start as of January 2025 for medicinal products with new active substances for the treatment of cancer and for advanced therapy medicinal products.

Further information is available at the link below.

Source: European Commission
12 Jan 2025The new regulation will become applicable from 12 January 2025.6

New oncology medicines and Advance Therapy Medicinal Products will be assessed at EU level from this date.7
13 Jan 2028Orphan medicinal products to be added to the joint work.7
13 Jan 2030All new medicines will come under the scope of the regulation.7

1. Health Technology Assessment – European Commission

2. From Theory to Practice: Implementing the EU Health Technology Assessment Regulation – Video recording of Stakeholder event, European Commission 30 January 2024. At his event, the Commission provided an overview of the new EU HTA Regulation. This will be followed by panel discussions, featuring local speakers who will discuss key topics related to the implementation of the regulation.

3. Preparing for the implementation of the EU Health Technology Assessment Regulation -Jackie Mulryne et al, 2 May 2024, biosliceblog.com

References

1. The EU Regulation on Health Technology Assessment: investing in the healthcare of the future – European Commission

2 Questions and Answers: Adoption of Regulation on Health Technology Assessment, 13 December 2021 – European Commission

3. The EU HTA Regulation: a new frontier for access to innovative technologies –  Giuseppe Ragucci (BonelliErede), Vincenzo Salvatore (BonelliErede) 25 August 2022- europeanpharmaceuticalreview.com

4. Regulation on Health Technology Assessment – European Commission

5. Towards a permanent collaboration framework for EMA and Health Technology Assessment -bodies – 15 September 2023 – European Medicines Agency

6. Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU -Eurlex

7. Factsheet on the implementation of the HTA regulation, 5 October 2023 – European Commission.