Regulation (EU) 2021/2282 on health technology assessment and amending Directive 2011/24/EU

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Series Details L 458, Pages 1-32
Publication Date 22/12/2021
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Summary:

Regulation (EU) 2021/2282 - adopted by the European Union on 15 December 2021 - setting out an EU-wide framework for health technology assessment. This is a text with EEA relevance.

Further information:

Health technology assessment (HTA) is a multidisciplinary process that summarises information about the medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased and robust manner. Its aim is to inform the formulation of safe and effective health policies that are patient focused and seek to achieve best value.

This Regulation establishes a support framework and procedures for cooperation of Member States on health technologies at an EU level. It introduces a mechanism whereby any information, data, analyses and other evidence required for the joint clinical assessment of health technologies is submitted by the health technology developer only once at EU level. It also lays out common rules and methodologies for the joint clinical assessment of health technologies.

Cooperation on HTA at EU-level was launched in the 1980s. Three Joint Actions (EUnetHTA JA) were carried out comprising a number of projects. Directive 2011/24/EU - also known as the Cross-Border Healthcare Directive - established the HTA Network in 2013 to provide strategic and political guidance to the scientific and technical cooperation at EU-level.

The draft law for this Regulation was tabled by the European Commission on 31 January 2018. The aim was to improve cooperation among EU Member States and thus to introduce amendments to the Cross-Border Healthcare Directive.  The proposed Regulation covered new medicines and certain new medical devices, providing the basis for permanent and sustainable cooperation at the EU level for joint clinical assessments in these areas.

The plenary of the European Parliament adopted a negotiating position on 14 February 2019, followed by the Council of the European Union on 24 March 2021. An informal agreement between the co-legislators on a compromise text for this draft law was reached on 22 June. This was formally endorsed by the Council on 9 November, followed by the Parliament in its December session. The Act was signed by the co-legislators on 15 December 2021 and published in the Official Journal on 22 December 2021.

Source Link Link to Main Source http://data.europa.eu/eli/reg/2021/2282/oj
Related Links
Official
EUR-LEX: COM(2018)51: Proposal for a Regulation on health technology assessment and amending Directive 2011/24/EU http://eur-lex.europa.eu/legal-content/EN/ALL/?uri=COM:2018:051:FIN
EUR-LEX: SWD(2018)41: Staff Working Document accompanying the Proposal - Impact Assessment https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=SWD:2018:41:FIN
EUR-LEX: SWD(2018)42: Staff Working Document accompanying the Proposal - Executive Summary of the Impact Assessment https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=SWD:2018:42:FIN
Official Website of the European Network for Health Technology Assessment (EUnetHTA) https://eunethta.eu/
European Parliament: Legislative Observatory: Procedure File for Proposal on Health technology assessment (2018/0018(COD)) https://oeil.secure.europarl.europa.eu/oeil/popups/ficheprocedure.do?reference=2018/0018(COD)
European Parliament: Legislative Train Schedule: Health Technology Assessment (HTA) https://www.europarl.europa.eu/legislative-train/theme-deeper-and-fairer-internal-market-with-a-strengthened-industrial-base-products/file-health-technology-assessment
European Commission: DG Health: Public Health: Health technology assessment https://ec.europa.eu/health/technology_assessment/overview_en
General Secretariat of the Council: Policies: Health technology assessment post 2020 https://www.consilium.europa.eu/en/policies/health-technology-assessment-post-2020/
European Commission: Press Release, 31/01/2018: Assessing health technology in the EU: Commission proposes to reinforce cooperation amongst Member States https://ec.europa.eu/commission/presscorner/detail/en/IP_18_486
European Commission: Q&A: Commission proposal on Health Technology Assessment (31 January 2018) https://ec.europa.eu/commission/presscorner/detail/en/MEMO_18_487
Council of the European Union: Press Release, 24/03/2021: Health Technology Assessment: Council agrees its negotiating position https://www.consilium.europa.eu/en/press/press-releases/2021/03/24/health-technology-assessment-council-agrees-its-negotiating-position/
European Commission: Press Release, 22/06/2021: Commission welcomes the move towards more innovative health technologies for patients https://ec.europa.eu/commission/presscorner/detail/en/ip_21_3142
Council of the European Union: Press Release, 22/06/2021: Health Technology Assessment: Informal deal between Council and European Parliament https://www.consilium.europa.eu/en/press/press-releases/2021/06/22/health-technology-assessment-informal-deal-between-council-and-european-parliament/
Council of the European Union: Press Release, 09/11/2021: Council green lights new rules on health technology assessment, improving access to medicines and simplifying procedures https://www.consilium.europa.eu/en/press/press-releases/2021/11/09/council-green-lights-new-rules-on-health-technology-assessment-improving-access-to-medicines-and-simplifying-procedures/
European Commission: Press Release, 13/12/2021: Health Technology Assessment: Commission welcomes the adoption of new rules to improve access to innovative technologies https://ec.europa.eu/commission/presscorner/detail/en/ip_21_6771
S&D EP Group: Newsroom, 13/12/2021: S&Ds: with the Health Technology Assessment, we take another step towards a European Health Union https://www.socialistsanddemocrats.eu/newsroom/sds-health-technology-assessment-we-take-another-step-towards-european-health-union

News
Politico, 08/01/2018: Brussels gets into drug business https://www.politico.eu/article/brussels-to-find-out-how-much-it-can-do-on-drug-pricing/
EurActiv, 10/01/2018: Commission reassures ‘worried’ member states on Health Technology Assessment https://www.euractiv.com/section/health-consumers/news/commission-reassures-worried-member-states-on-health-technology-assessment/
EurActiv, 31/01/2018: EU unveils health technology bill https://www.euractiv.com/section/health-consumers/news/eu-unveils-health-technology-bill/
Reuters, 31/01/2018: EU proposes joint studies to speed acceptance of new medicine https://uk.reuters.com/article/idUKKBN1FK1DX
EurActiv, 28/05/2021: New EU health innovation rules edge closer https://www.euractiv.com/section/health-consumers/news/new-eu-health-innovation-rules-edge-closer/
EurActiv, 25/03/2021: Portugal gets mandate to negotiate health technology assessment law https://www.euractiv.com/section/eu-council-presidency/news/portugal-gets-mandate-to-negotiate-health-technology-assessment-law/
Pharmaceutical Technology, 29/06/2021: Industry hopes dashed after EU compromises to squeeze through cross border HTA agreement https://www.pharmaceutical-technology.com/pricing-and-market-access/industry-hopes-dashed-eu-compromises-hta-html/
MedTech Dive, 06/07/2021: As EU-wide health technology oversight law nears passage, industry is not pleased https://www.medtechdive.com/news/as-eu-wide-health-technology-oversight-law-nears-passage-industry-is-not-p/602836/
EurActiv, 15/12/2021: European Parliament adopts long-awaited health technology regulation https://www.euractiv.com/section/health-consumers/news/european-parliament-adopts-long-awaited-health-technology-regulation/

Commentary and Analysis
EPRS: Briefing, June 2018: Strengthening EU cooperation on health technology assessment - Initial Appraisal of a European Commission Impact Assessment https://www.europarl.europa.eu/thinktank/en/document.html?reference=EPRS_BRI(2018)621813
EFPIA: News & Events, 23/06/2021: EU HTA; compromise but at what cost? https://www.efpia.eu/news-events/the-efpia-view/statements-press-releases/eu-hta-compromise-but-at-what-cost/
MedTech Europe: Press Release, 01/07/2021: EU Regulation on Health Technology Assessment (HTA): MedTech Europe remains highly sceptical about the added value for health systems and citizens https://www.medtecheurope.org/news-and-events/press/eu-regulation-on-health-technology-assessment-hta-medtech-europe-remains-highly-sceptical-about-the-added-value-for-health-systems-and-citizens/
EPRS: Briefing, December 2021: Boosting cooperation on health technology assessment https://www.europarl.europa.eu/thinktank/en/document.html?reference=EPRS_BRI(2018)614772
Van Bael & Bellis (VBB): News & Insights, 12/11/2021: Council of EU Approves Health Technology Assessment Regulation https://www.vbb.com/insights/corporate-commercial-regulatory/council-of-eu-approves-health-technology-assessment-regulation
EFPIA: EFPIA statement on adoption of Health Technology Assessment Regulation (14 December 2021) https://www.efpia.eu/news-events/the-efpia-view/statements-press-releases/efpia-statement-on-adoption-of-health-technology-assessment-regulation/

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