Last updated: 3 December 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.
| Date | Update(s) |
|---|---|
| 3 Dec 2024 | New section 2025 Work Programme (HTACG) added. |
| 2 Dec 2024 | In the section Meeting outcomes from various groups, link added to Flash report – Member State Coordination Group on HTA (HTACG) (28 November 2024) |
| 19 Nov 2024 | New section added entitled Webinars |
| 2 Nov 2024 | Table in Section Implementing acts updated to add information and link to Commission Implementing Regulation (EU) 2024/2745 of 25 October 2024 |
| 29 Oct 2024 | Table in Section Implementing acts updated to add information on Public consultation: Implementing Regulation on joint scientific consultations on medical devices and in vitro diagnostic medical devices at Union level |
| 25 Oct 2024 | Table in Section Implementing acts updated to add information on the adoption of the implementing regulation that sets out the rules for the management of conflicts of interest of those involved in joint clinical assessments and joint scientific consultations under the Health Technology Assessment (HTA) Regulation. |
| 24 Oct 2024 | Table in section Implementing acts updated to add link to the published Commission Implementing Regulation (EU) 2024/2699, the second of six implementing regulations of the Regulation on Health Technology Assessment (Regulation (EU) 2021/2282). |
| 18 Oct 2024 | Table in Section Implementing acts updated to add information on the adoption of the implementing regulation which sets out the rules for cooperation with the European Medicines Agency in the joint work carried out under the Health Technology Assessment (HTA) Regulation. |
| 2 Oct 2024 | Table in section Implementing acts updated to add information on ongoing public consultation: Implementing Regulation on joint scientific consultations on medicinal products for human use at Union level |
| 28 Sep 2024 | Link in the section Is there a rolling plan available for the implementation of the HTA Regulation? updated to the rolling plan of September 2024. |
| 24 Sep 2024 | Section Guidance and other documents to add link to the document Guidance on the validity of clinical studies for joint clinical assessments. |
| 20 Sep 2024 | In the section Meeting outcomes from various groups, link added to Flash report from the 10th meeting of the Member State Coordination Group on HTA (HTACG) 19 September 2024. |
| 21 Aug 2024 | In the section Meeting outcomes from various groups, link added to Summary minutes from the 3rd Meeting of the Health Technology Assessment Stakeholder Network (11 June 2024) |
| 27 Jun 2024 | In the section Implementing acts, information added on consultation concerning the third of six acts with the title below. COMMISSION IMPLEMENTING REGULATION (EU) …/… of XXX laying down, pursuant to Regulation (EU) 2021/2282 of the European Parliament and of the Council, detailed procedural rules for the cooperation of the Member State Coordination Group on Health Technology Assessment and the Commission with the European Medicines Agency in the form of exchange of information as regards the joint clinical assessment of medicinal products and medical devices and in vitro diagnostic medical devices and as regards the joint scientific consultation on medicinal products and medical devices |
| 21 Jun 2024 | 1) Title of Section Guidance updated to Guidance and other documents. 2) Added link to document entitled Joint clinical assessment of medicinal products: Submission of early information by health technology developers published 21 June 2024. |
| 14 Jun 2924 | New section Guidance Documents added. |
| 12 Jun 2024 | New section Meeting outcomes from the Member State Coordination Group on Health Technology Assessment (HTACG) added. |
| 30 May 2024 | New section entitled Implementing acts added. |
| 23 May 2024 | Section Important dates updated with information from a news announcement from the Commission. |
| 3 March 2024 | 1) 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 2024 | In the section Is there a rolling plan available for the implementation of the HTA Regulation? link updated to plan of Feb 2024. |
| 9 Feb 2024 | Item 3, a link to a stakeholder meeting added under the heading Further Information. |
| 24 Oct 2023 | Heading Is there a rolling plan available for the implementation of the HTA Regulation? added, plus relevant content. |
| 5 Oct 2023 | Under 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
- developers can request the involvement of HTA bodies when applying for EMA scientific advice.
- the outcome of the procedure will be a scientific advice letter from EMA and individual written recommendations from participating HTA bodies. The selection criteria are available in the Guidance on Parallel EMA/HTA body (HTAb) Scientific Advice for the Interim Period.
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 September 2024) here.
| Date | |
|---|---|
| 11 Jan 2022 | The new Regulation (EU) 2021/2282 on Health Technology Assessment entered into force.6 |
| 23 May 2024 | Today, 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 2025 | The 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 2028 | Orphan medicinal products to be added to the joint work.7 |
| 13 Jan 2030 | All new medicines will come under the scope of the regulation.7 |
The HTA Regulation foresees the adoption of implementing acts, detailing the procedural rules for the different elements in the Regulation. Further information is provided in the table below:
| Implementing Regulations | Current status |
|---|---|
| Commission Implementing Regulation (EU) 2024/1381 of 23 May 2024 laying down, pursuant to Regulation (EU) 2021/2282 on health technology assessment, procedural rules for the interaction during, exchange of information on, and participation in, the preparation and update of joint clinical assessments of medicinal products for human use at Union level, as well as templates for those joint clinical assessments This is the first of six acts which must be adopted before 12 January 2025, the date of application of the HTA Regulation. | Adopted by the Commission on 23 May 2024 |
| Commission Implementing Regulation (EU) 2024/2699 of 18 October 2024 laying down, pursuant to Regulation (EU) 2021/2282 of the European Parliament and of the Council, detailed procedural rules for the cooperation of the Member State Coordination Group on Health Technology Assessment and the Commission with the European Medicines Agency in the form of exchange of information as regards the joint clinical assessment of medicinal products and medical devices and in vitro diagnostic medical devices and as regards the joint scientific consultation on medicinal products and medical devices These rules define the information to be shared: • for planning and forecasting of joint clinical assessments and joint scientific consultations; • for identifying patients, clinical experts and other relevant experts to be involved in these joint procedures; and • on general scientific and technical matters related to health technology assessment. The Implementing Regulation also concerns the security of sharing and protection of confidential information exchanged between the European Medicines Agency and the HTA secretariat within the Commission, and with the Member State Coordination Group on HTA and its subgroups. This is the second of six acts which must be adopted before 12 January 2025, the date of application of the HTA Regulation. | Adopted by the Commission on 18 October 2024 |
| Commission Implementing Regulation (EU) 2024/2745 of 25 October 2024 laying down rules for the application of Regulation (EU) 2021/2282 of the European Parliament and of the Council as regards the management of conflicts of interest in the joint work of the Member State Coordination Group on Health Technology Assessment and its subgroups These rules aim to ensure that EU-level assessments of new health technologies are conducted in an independent, impartial and transparent manner, free from conflicts of interest. In particular, the rules provide an assessment framework for exclusions from and limitations to participation in the joint work on HTA, based on the declared interests. These rules will apply to all parties taking part in joint clinical assessments and joint scientific consultations, including representatives in the Member State Coordination Group and its subgroups, the appointed assessors, co-assessors and patients, clinical experts and other relevant experts involved in these joint procedures. This is the third of six acts which must be adopted before 12 January 2025, the date of application of the HTA Regulation. | Adopted by the Commission on 25 October 2024 |
| Public consultation: Implementing Regulation on joint scientific consultations on medicinal products for human use at Union level On 1 October 2024, the European Commission launched an online public consultation on the draft implementing act on joint scientific consultations on medicinal products for human use at Union level under the Health Technology Assessment (HTA) Regulation. The draft implementing act provides detailed procedural rules for the joint scientific consultations, covering: • the submission of requests from health technology developers; • the selection and consultation of stakeholder organisations and patients, clinical and other relevant experts; • cooperation with the European Medicines Agency (EMA) where a health technology developer requests the joint scientific consultation to be carried out in parallel with EMA’s scientific advice process. The HTA Regulation foresees the adoption of implementing acts, detailing the procedural rules for the different elements in the Regulation. | Feedback period between 1 Oct 2024 – 29 Oct 2024. |
| Public consultation: Implementing Regulation on joint scientific consultations on medical devices and in vitro diagnostic medical devices at Union level On 29 October, the European Commission launched an online public consultation on the draft implementing act on joint scientific consultations on medical devices and in vitro diagnostic medical devices at Union level under the Health Technology Assessment (HTA) Regulation. Your contribution can provide important information and insights on the implementation of the HTA Regulation. The draft implementing act provides detailed procedural rules for the joint scientific consultations, covering: • the submission of requests from health technology developers for joint scientific consultations on medical devices and in vitro diagnostic medical devices; • the selection and consultation of stakeholder organisations and patients, clinical experts and other relevant experts in such joint scientific consultations; • cooperation with the groups of independent experts (expert panels) which support the scientific assessment and advice in the field of medical devices and in vitro diagnostic medical devices. This cooperation will be relevant for cases where a health technology developer requests the joint scientific consultation to be carried out in parallel with the expert panel consultation. | Feedback period between 29 October 2024 – 26 November 2024 |
| Date | Document title | About the document |
|---|---|---|
| 23 Sep 2024 | Guidance on the validity of clinical studies for joint clinical assessments | This guidance helps to define, classify, and assess the certainty of clinical study results in an objective, reproducible and transparent way. It covers the analysis of data from different types of single clinical studies. This guidance complements the guidance documents previously adopted by the Member State Coordination Group on outcomes for joint clinical assessments, on quantitative evidence synthesis for direct and indirect comparisons and on reporting requirements for multiplicity issues and subgroup, sensitivity and post hoc analyses in joint clinical assessments. Source: European Commission |
| 21 Jun 2024 | Joint clinical assessment of medicinal products: Submission of early information by health technology developers | This document is a good starting point to find out basic information about HTAS and procedural aspects. |
| 13 Jun 2024 | Guidance on outcomes for joint clinical assessments | This guidance will help: -Member States’ authorities define the scope of the assessments -assessors report all the elements that Member States need for the national appraisal of the clinical added value of health technology. |
| 13 Jun 2024 | Guidance on reporting requirements for multiplicity issues and subgroup, sensitivity and post hoc analyses in joint clinical assessments | This guidance describes how assessors should deal in practice with multiplicity issues and complementary analyses in joint clinical assessment (JCA) reports. |
| 13 Jun 2024 | Scientific specifications of medicinal products subject to joint clinical assessments | This information document made available to clarify the scientific specifications of ‘new active substance’ and ‘therapeutic indication of treatment of cancer’ to determine if a medicinal product shall be subject to joint clinical assessment (JCA) between 12 January 2025 and 13 January 2030. |
| Date | Item and Title |
|---|---|
| 11 Jun 2024 | Summary minutes from the 3rd Meeting of the Health Technology Assessment Stakeholder Network |
| 10 Jun 2024 | Flash report from the 9th Meeting of the Member State Coordination Group on HTA (HTACG) 10 June 2024. |
| 20 Sep 2024 | Flash report from the 10th meeting of the Member State Coordination Group on HTA (HTACG) 19 September 2024 |
| 2 Dec 2024 | Flash report – Member State Coordination Group on HTA (HTACG) (28 November 2024) |
Source: European Commission
You can view Version 1.0 of the 2025 Work Programme – Member State Coordination Group on HTA (HTACG) (dated 28 Nov 2024) here.
Here is a link to The EU HTA Regulation: Webinar for health technology developers of medicinal products held on 15 November 2024.
- In this webinar, the Chairs and Co-chairs of the Member State Coordination Group on Health Technology Assessment and its subgroups explain the process for joint clinical assessments and joint scientific consultations.
- The webinar is targeted at representatives of health technology developers of medicinal products.
Source: European Commission
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
7. Factsheet on the implementation of the HTA regulation, 5 October 2023 – European Commission.