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Summaries of EU Legislation

    Health technology assessment

     

    SUMMARY OF:

    Regulation (EU) 2021/2282 on health technology assessment

    WHAT IS THE AIM OF THE REGULATION?

    • Regulation (EU) 2021/2282 aims to improve the evidence base for assessing new health technologies (e.g. new medicines and medical devices) and to support European Union (EU) Member States in taking timely and evidence-based decisions on patient access.
    • The regulation amends Directive 2011/24/EU on the application of patients’ rights in cross-border healthcare (see summary).

    KEY POINTS

    Health technology assessment

    A health technology assessment (HTA) is an evidence-based scientific process that enables national authorities to assess the relative effectiveness of new or existing health technologies. It focuses in particular on the added value of a health technology compared to other new or existing technologies.

    The regulation sets out rules on the use of common methods, procedures and tools for an HTA throughout the EU, specifically:

    • a support framework and procedures for cooperation between Member States on health technologies at the EU level;
    • common EU rules and methods for joint HTA work, including joint clinical assessments (JCAs);
    • a mechanism whereby all information, analysis and evidence required for the JCA of health technologies is submitted by the health technology developer only once at the EU level.

    Scope

    • The regulation focuses on common scientific and clinical aspects of HTAs.
    • Member States’ HTA bodies will conduct JCAs of new medicines and certain high-risk medical devices.
    • These bodies will also engage in joint scientific consultations (JSCs) to advise technology developers on clinical study designs that generate appropriate evidence.
    • HTA bodies will also conduct joint ‘horizon scanning’ of emerging health technologies with a potentially significant impact on patients, public health and healthcare systems.
    • Member States can also engage in further voluntary cooperation activities, such as on health technologies other than medicines and medical devices, or on economic aspects of HTAs.

    Coordination group

    • The regulation sets up a Member States Coordination Group on HTAs, with members designated by each Member State.
    • It will oversee the joint technical work carried out by subgroups of national representatives for specific types of work such as JCAs or JSCs.
    • It aims to ensure that the joint work carried out is of the highest quality, meets international standards of evidence-based medicine and is timely. It will operate in an independent, impartial and transparent manner.
    • The coordination group reviews and approves joint work (e.g. JCA reports, methodological and other guidance documents).

    Member State obligations

    • Member States must ‘give due consideration’ to the JCA reports.
    • They are required to annex the JCA report to the national HTA report and to report on how each JCA report was given due consideration in the assessment at the national level.

    Implementing act concerning joint clinical assessments

    An implementing act, Implementing Regulation (EU) 2024/1381, lays down detailed procedural rules for JCAs of medicinal products at the EU level, as regards:

    • cooperation, in particular by exchange of information, with the European Medicines Agency on the preparation and update of JCAs of medicinal products;
    • interaction, including the timing thereof, with and between the coordination group (see above), its subgroups and health technology developers, patients, clinical experts and other relevant experts during JCAs of medicinal products and their updates;
    • general procedural rules on the selection and consultation of stakeholder organisations, patients, clinical experts and other relevant experts in JCAs at the EU level;
    • the format and templates for dossiers with information, data, analyses and other evidence to be provided by health technology developers for JCAs;
    • the format and templates for JCA reports and summary JCA reports.

    FROM WHEN DOES THE REGULATION APPLY?

    Regulation (EU) 2021/2282 entered into force on 11 January 2022. It will apply from 12 January 2025.

    BACKGROUND

    For further information, see:

    MAIN DOCUMENT

    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 (OJ L 458, 22.12.2021, pp. 1–32).

    RELATED DOCUMENTS

    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 (OJ L, 2024/1381, 24.5.2024).

    Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, pp. 1–175).

    Successive amendments to Regulation (EU) 2017/745 have been incorporated into the original text. This consolidated version is of documentary value only.

    Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, pp. 176–332).

    See consolidated version.

    Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (OJ L 88, 4.4.2011, pp. 45–65).

    See consolidated version.

    Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, pp. 1–33).

    See consolidated version.

    Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, pp. 67–128).

    See consolidated version.

    last update 30.07.2024

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