LegalizeRegulation (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 (Text with EEA relevance)
The Coordination Group shall ensure the preparation of reports on emerging health technologies expected to have a major impact on patients, public health or healthcare systems. Those reports shall in particular address the estimated clinical impact and the potential organisational and financial consequences of emerging health technologies for national healthcare systems.
The preparation of the reports referred to in paragraph 1 shall be based on existing scientific reports or initiatives on emerging health technologies and information from relevant sources including:
(a) clinical study registers and scientific reports;
(b) the European Medicines Agency in relation to upcoming submissions of applications for marketing authorisation for medicinal products referred to in Article 7(1);
(c) the Medical Device Coordination Group;
(d) health technology developers on the health technologies they are developing;
(e) members of the stakeholder network referred to in Article 29.
The Coordination Group may consult stakeholder organisations which are not members of the stakeholder network referred to in Article 29 and other relevant experts, as appropriate.
SECTION 4
Voluntary cooperation on health technology assessment
Article 23
Voluntary cooperation
The Commission shall support the cooperation and the exchange of scientific information among Member States on:
(a) non-clinical assessments on health technologies;
(b) collaborative assessments on medical devices and in vitro diagnostic medical devices;
(c) HTAs on health technologies other than medicinal products, medical devices or in vitro diagnostic medical devices;
(d) the provision of additional evidence necessary to support HTAs, in particular in relation to health technologies for compassionate use and obsolete health technologies;
(e) clinical assessments of health technologies referred to in Article 7 for which a joint clinical assessment is not yet initiated and of health technologies not referred to in that Article, in particular health technologies for which the report on emerging health technologies referred to in Article 22 has concluded that they are expected to have a major impact on patients, public health or healthcare systems.
The Coordination Group shall be used to facilitate the cooperation referred to in paragraph 1.
The cooperation referred to in paragraph 1, points (b) and (c), of this Article may be carried out using the procedural rules established in accordance with Article 3(7) and Articles 15 and 25 and using the format and templates established in accordance with Article 26.
The cooperation referred to in paragraph 1 of this Article shall be included in the annual work programmes of the Coordination Group and the results of the cooperation shall be included in its annual reports and on the IT platform referred to in Article 30.
Member States, through their designated member in the Coordination Group, may share national assessment reports on a health technology not referred to in Article 7, in particular on health technologies for which the report on emerging health technologies referred to in Article 22 has concluded that they are expected to have a major impact on patients, public health or healthcare systems, to the Coordination Group through the IT platform referred to in Article 30.
Member States may use methodological guidance developed pursuant to Article 3(7), point (d), for the purpose of national assessments.
CHAPTER III
GENERAL RULES FOR JOINT CLINICAL ASSESSMENTS
Article 24
National clinical assessment reports
Where an HTA, or its update, is carried out by a Member State on a health technology referred to in Article 7(1), that Member State, through its designated member in the Coordination Group, shall provide the national assessment report on that health technology to the Coordination Group through the IT platform referred to in Article 30 within 30 days after its completion.
Article 25
General procedural rules
The Commission shall adopt, after consulting all relevant stakeholders, by means of implementing acts, general procedural rules:
(a) ensuring that the members of the Coordination Group, its subgroups, as well as patients, clinical experts and other relevant experts take part in joint clinical assessments in an independent and transparent manner, free from conflict of interest;
(b) on the selection and consultation of stakeholder organisations and patients, clinical experts and other relevant experts in joint clinical assessments at Union level.
Implementing acts referred to in paragraph 1 of this Article shall be adopted in accordance with the examination procedure referred to in Article 33(2).
Article 26
Format and templates of submission and report documents
The Commission shall adopt, by means of implementing acts, the format and templates in respect of:
(a) dossiers for information, data, analyses and other evidence to be provided by health technology developers for joint clinical assessments;
(b) joint clinical assessment reports;
(c) summary joint clinical assessment reports.
Implementing acts referred to in paragraph 1 of this Article shall be adopted in accordance with the examination procedure referred to in Article 33(2).
CHAPTER IV
SUPPORT FRAMEWORK
Article 27
Union financing
The Union shall ensure the financing of the work of the Coordination Group and its subgroups, and of the activities in support thereof, which involve cooperation with the Commission, the European Medicines Agency, the Medical Device Coordination Group, expert panels and the stakeholder network referred to in Article 29. The Union’s financial assistance to the activities under this Regulation shall be implemented in accordance with Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (17).
The financing referred to in paragraph 1 shall include financing for the participation of Member States’ designated members of the Coordination Group and of its subgroups in support of the work on joint clinical assessments and joint scientific consultations, including the development of methodological guidance, and on the identification of emerging health technologies. Assessors and co-assessors shall be entitled to a special allowance compensating them for their work on joint clinical assessments and joint scientific consultations in accordance with internal Commission rules.
Article 28
Commission support for the Coordination Group
The Commission shall support the work of the Coordination Group and act as its secretariat. In particular, the Commission shall:
(a) host in its premises the meetings of the Coordination Group and of its subgroups;
(b) decide on conflict of interest in accordance with the requirements set out in Article 5 and in the general procedural rules to be adopted in accordance with Article 25(1), point (a);
(c) request the dossier from the health technology developer in accordance with Article 10;
(d) supervise the procedures for joint clinical assessments and inform the Coordination Group about possible breaches thereof;
(e) provide administrative, technical and IT support;
(f) set up and maintain the IT platform pursuant to Article 30;
(g) publish the information and documents, including the Coordination Group’s annual work programmes, annual reports, summary minutes of its meetings, and reports and summary reports of joint clinical assessments, on the IT platform, in accordance with Article 30;
(h) facilitate the cooperation, in particular through the exchange of information, with the European Medicines Agency on the joint work referred to in this Regulation related to medicinal products, including the sharing of confidential information;
(i) facilitate the cooperation, in particular through the exchange of information, with expert panels and the Medical Device Coordination Group on the joint work referred to in this Regulation related to medical devices and in vitro diagnostic medical devices, including the sharing of confidential information.
Article 29
Stakeholder network
The Commission shall establish a stakeholder network. The stakeholder network shall support the work of the Coordination Group and its subgroups upon request.
The stakeholder network shall be established through an open call for applications addressed to all eligible stakeholder organisations, in particular patient associations, consumer organisations, non-governmental organisations in the field of health, health technology developers and health professionals. The eligibility criteria shall be set out in the open call for applications and shall include:
(a) proof of current or planned engagement in HTA development;
(b) professional expertise relevant to the stakeholder network;
(c) geographical coverage of several Member States;
(d) communication and dissemination capabilities.
Organisations applying to become part of the stakeholder network shall declare their membership and sources of funding. Representatives of stakeholder organisations participating in activities of the stakeholder network shall declare any financial or other interests in the health technology developers’ industrial sector which could affect their independence or impartiality.
The list of stakeholder organisations included in the stakeholder network, the declarations of those organisations on their membership and sources of funding, and the declarations of interest of representatives of stakeholder organisations shall be made publicly available on the IT platform referred to in Article 30.
The Coordination Group shall meet with the stakeholder network at least once each year in order to:
(a) update stakeholders on the joint work of the Coordination Group, including its main output;
(b) provide for an exchange of information.
The Coordination Group may invite members of the stakeholder network to attend its meetings as observers.
Article 30
IT platform
The Commission shall set up and maintain an IT platform consisting of:
(a) a publicly accessible webpage;
(b) a secure intranet for the exchange of information between members of the Coordination Group and its subgroups;
(c) a secure system for the exchange of information between the Coordination Group and its subgroups with health technology developers and experts participating in the joint work referred to in this Regulation, as well as with the European Medicines Agency and the Medical Device Coordination Group;
(d) a secure system for the exchange of information between members of the stakeholder network.
The Commission shall ensure appropriate levels of access to the information contained in the IT platform for Member States, members of the stakeholder network and the general public.
The publicly accessible webpage shall contain, in particular:
(a) an up-to-date list of the members of the Coordination Group and their appointed representatives, together with their qualifications and areas of expertise and their declarations of conflict of interest after the finalisation of the joint work;
(b) an up-to-date list of the members of the subgroups and their appointed representatives, together with their qualifications and areas of expertise and their declarations of conflict of interest after the finalisation of the joint work;
(c) the rules of procedure of the Coordination Group;
(d) all documentation under Article 9(1), Article 10(2) and (5) and Article 11(1) at the time the joint clinical assessment report is published, under Article 10(7) in the event that the joint clinical assessment was discontinued, and under Articles 15, 25 and 26;
(e) the agendas and summary minutes of the Coordination Group’s meetings, including the decisions adopted and voting results;
(f) the eligibility criteria for stakeholders;
(g) the annual work programmes and annual reports;
(h) information on planned, on-going, and completed joint clinical assessments, including updates carried out in accordance with Article 14;
(i) the joint clinical assessment reports considered procedurally compliant in accordance with Article 12, together with all comments received during their preparation;
(j) information on Member States’ national clinical assessment reports referred to in Article 13(2), including information provided by Member States on how joint clinical assessment reports were considered at national level, and Article 24;
(k) anonymised, aggregated, non-confidential summary information on joint scientific consultations;
(l) studies on the identification of emerging health technologies;
(m) anonymised, aggregated, non-confidential information from the reports on emerging health technologies referred to in Article 22;
(n) results of the voluntary cooperation between Member States undertaken pursuant to Article 23;
(o) where a joint clinical assessment is discontinued, the statement pursuant to Article 10(6), including a list of the information, data, analyses or other evidence that were not submitted by the health technology developer;
(p) the procedural review of the Commission according to Article 12(3);
(q) standard operating procedures and guidance regarding quality assurance pursuant to Article 4(2) and (3);
(r) the list of stakeholder organisations included in the stakeholder network, together with the declarations of those organisations on their membership and sources of funding, and the declarations of interests of their representatives, pursuant to Article 29(4).
Article 31
Evaluation and reporting
No later than 13 January 2028, the Commission shall present a report to the European Parliament and to the Council on the application of this Regulation. The report shall focus on reviewing:
(a) the added value for Member States of the joint work carried out pursuant to Chapter II and, in particular, whether the health technologies subject to joint clinical assessments in accordance with Article 7 and the quality of those joint clinical assessments correspond to the needs of Member States;
(b) the non-duplication of the request of information, data, analyses and other evidence for joint clinical assessment in terms of reducing the administrative burden for Member States and health technology developers;
(c) the functioning of the support framework set out in this Chapter and, in particular, whether there is a need to introduce a fee-paying mechanism through which health technology developers would also contribute to the financing of the joint scientific consultations.
No later than 13 January 2027, Member States shall report to the Commission on the application of this Regulation and, in particular, on the consideration of joint work pursuant to Chapter II in their national HTA processes, including the way joint clinical assessment reports have been considered when carrying out national HTAs pursuant to Article 13(2), and the workload of the Coordination Group. Member States shall also report on whether they have considered methodological guidance developed pursuant to Article 3(7), point (d), for the purpose of national assessments, as referred to in Article 23(6).
In the preparation of its report, the Commission shall consult the Coordination Group and use:
(a) the information provided by Member States in accordance with paragraph 2;
(b) the reports on emerging health technologies prepared in accordance with Article 22;
(c) the information provided by Member States in accordance with Articles 13(2) and 14(4).
The Commission shall, if appropriate, present a legislative proposal based on that report in order to update this Regulation.
CHAPTER V
FINAL PROVISIONS
Article 32
Exercise of the delegation
The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
The power to adopt delegated acts referred to in Article 9(5) shall be conferred on the Commission for an indeterminate period of time from 11 January 2022.
The delegation of power referred to in Article 9(5) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.
As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
A delegated act adopted pursuant to Article 9(5) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
Article 33
Committee procedure
The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
Where the Committee delivers no opinion, the Commission shall not adopt the draft implementing act and Article 5(4), third subparagraph, of Regulation (EU) No 182/2011 shall apply.
Article 34
Preparation of implementing acts
The Commission shall adopt the implementing acts referred to in Articles 15, 20, 25 and 26 at the latest by the date of application of this Regulation.
When preparing those implementing acts, the Commission shall take into account the distinctive characteristics of the medicinal product, medical device and in vitro diagnostic medical device sectors.
Article 35
Amendment to Directive 2011/24/EU
Article 15 of Directive 2011/24/EU is deleted.
References to the deleted Article shall be construed as references to this Regulation.
Article 36
Entry into force and date of application
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 12 January 2025.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Strasbourg, 15 December 2021.
For the European Parliament The President D. M. SASSOLI
For the Council The President A. LOGAR
(1) OJ C 283, 10.8.2018, p. 28 and OJ C 286, 16.7.2021, p. 95.
(2) Position of the European Parliament of 14 February 2019 (OJ C 449, 23.12.2020, p. 638) and position of the Council at first reading of 9 November 2021 (OJ C 493, 8.12.2021, p. 1). Position of the European Parliament of 14 December 2021 (not yet published in the Official Journal).
(3) OJ C 438, 6.12.2014, p. 12.
(4) OJ C 421, 17.12.2015, p. 2.
(5) OJ C 269, 23.7.2016, p. 31.
(6) OJ C 269 I, 7.7.2021, p. 3.
(7) OJ C 263, 25.7.2018, p. 4.
(8) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union 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, p. 1).
(9) 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, p. 1).
(10) 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, p. 176).
(11) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
(12) OJ L 123, 12.5.2016, p. 1.
(13) 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, p. 45).
(14) 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, p. 67).
(15) Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121).
(16) Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ L 18, 22.1.2000, p. 1).
(17) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1).
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