European Union's New HTA Regulation

entered into force on 11 January 2022 and will apply on 12 January 2025.

However, its implementation starts now and will continue during the three years until its application.

Almost four years after the European Commission's proposal in January 2018 the ordinary legislative procedure has been completed. After successful interinstitutional negotiations of the both co‑legislators, the Council of the EU formally adopted its first reading position on 9 November 2021, and the European Parliament closed its early second reading position on 13 December 2021.

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

EUR-Lex - 32021R2282 - EN - EUR-Lex (europa.eu)

The EU HTA Regulation entered into force in January 2022 and it will be applied three years later. In the Commission's questions and answers release on 13 December 2021 it is clearly stated, that joint work such as Joint Clinical Assessments (JCA) and Joint Scientific Consultations (JSC) will only be carried out from January 2025.

The three year delayed application period aims to ensure that there is enough time to set up the organisational framework of the HTA Regulation.

European Union's New HTA Regulation

In its press release on 13 December 2021 the Commission considers the EU HTA Regulation in close relationship to several initiatives in the Union's public health sector:

EU's Pharmaceutical Strategy, Europe's Beating Cancer Plan, and the European Health Union.

In this context the HTA Regulation is also about building a new way of cooperating on health in the EU and thus, to enhance coordination at EU‑level in the field of health.

Member States will be able to take more timely and evidence-based decisions on patient access to innovative health technologies within their healthcare systems. The Regulation will not affect the exclusive national competence of Member States for national pricing and reimbursement decisions, but focuses on clinical aspects of HTA, i.e. the relative clinical effectiveness and relative clinical safety of a new health technology as compared with existing technologies. Member States' HTA bodies will conduct Joint Clinical Assessments (JCA) of new medicines and certain high-risk medical devices. They will also engage in Joint Scientific Consultations (JSC) to advise technology developers on clinical study designs that generate appropriate evidence. Moreover, “horizon scanning” exercises will identify, at an early stage, promising health technologies, to help health systems prepare for them.

The Commission anticipates that the new rules for the EU HTA will secure inclusiveness and transparency in the assessment process and increase predictability for Member States' authorities (HTA bodies/agencies) as well as for the pharmaceutical industry and the medical device sector.

The HTA Regulation stipulates that Member States will give due consideration to JCA reports in their national HTA processes. Nevertheless, Member States may complement the JCA with additional clinical and non-clinical analyses that may be needed in their national HTA process. Member States remain responsible for drawing conclusions on the overall value of a new health technology for their healthcare system, and pricing and reimbursement decisions.

Member States will report to the Commission, no later than two years (January 2027) after the date of application of the new HTA Regulation, on:

· the consideration of joint work as well as JCA reports in their national HTA processes.

· the workload of the Coordination Group and on whether they have considered the developed methodological guidance.

The implementing work, starting now, will set up the necessary governance structure (e.g. procedural rules) and preparatory documents to ensure effective application in January 2025. The Commission will:

· set up the Coordination Group;

· establish the Stakeholder Network;

· adopt the necessary implementing and delegated acts;

· facilitate the development of methodology for joint HTA work
by the Coordination Group as required by the Regulation; and

· set up and maintain an IT platform.

The first meeting of the Coordination Group is tentatively scheduled for June 2022. Around the same time, a conference is envisaged to inform a wide range of stakeholder organisations on the new Regulation and its implementation.

In order to support the continuation of EU cooperation on HTA, to support a future EU HTA system and to facilitate the implementation of the new EU HTA Regulation the Health and Digital Executive Agency (HaDEA) signed – on behalf of the European Commission – a service contract (running 24 months, until 16 September 2023) with the EUnetHTA 21 consortium. For the purpose of “learning by doing” and to bridge the gap between the EUnetHTA Joint Actions, which ceased in May 2021, and the application of the Regulation in January 2025, EUnetHTA 21 is tasked with performing JSC and JCA following the intentions of the Regulation. On this working basis non‑product related matters as methodological guidance documents can be developed.

The first Open Call for applications from the pharmaceutical industry for four JSC, starting in January 2022, has meanwhile be closed. These will be consultations in parallel to EMA scientific advice and hence will focus on medicinal products. As announced in the first Stakeholder Kick‑Off meeting on 3 December 2021, EUnetHTA 21 plans a second Open Call for JSCs in September 2022. The actual production of JCAs on medicinal products will start in Year 2 (September 2022 through September 2023) of EUnetHTA 21. In due time separate Project Plans will be developed for the specific JCAs with their respective timelines.