Union financing
1. 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 ) .
2. 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.
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.
Stakeholder network
1. The Commission shall establish a stakeholder network. The stakeholder network shall support the work of the Coordination Group and its subgroups upon request.
2. 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.
3. 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.
4. 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.
5. 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.
6. The Coordination Group may invite members of the stakeholder network to attend its meetings as observers.
IT platform
1. 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.
2. 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.
3. 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).
Evaluation and reporting
1. 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.
2. 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).
3. 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).
4. The Commission shall, if appropriate, present a legislative proposal based on that report in order to update this Regulation.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
