1. This Regulation establishes:
(a)
a support framework and procedures for cooperation of Member States on health technologies at Union level;
(b)
a mechanism which lays down that any information, data, analyses and other evidence required for the joint clinical assessment of health technologies is to be submitted by the health technology developer only once at Union level;
(c)
common rules and methodologies for the joint clinical assessment of health technologies.
2. This Regulation shall not affect Member States’ competence to draw conclusions on the relative effectiveness of health technologies or to take decisions on the use of a health technology in their specific national health context. It shall not interfere with the exclusive national competence of Member States, including those for national pricing and reimbursement decisions, or affect any other competences which concern Member States’ management and delivery of health services or medical care or the allocation of resources assigned to them.
For the purposes of this Regulation, the following definitions apply:
(1)
‘medicinal product’ means a medicinal product as defined in Article 1, point (2), of Directive 2001/83/EC of the European Parliament and of the Council ( 14 ) ;
(2)
‘medical device’ means a medical device as defined in Article 2, point (1), of Regulation (EU) 2017/745;
(3)
‘ in vitro diagnostic medical device’ means an in vitro diagnostic medical device as defined in Article 2, point (2), of Regulation (EU) 2017/746;
(4)
‘health technology’ means a health technology as defined in Article 3, point (l), of Directive 2011/24/EU;
(5)
‘health technology assessment’ or ‘HTA’ means a multidisciplinary process that summarises information about the medical, patient and social aspects and the economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased and robust manner;
(6)
‘joint clinical assessment’ of a health technology means the scientific compilation and the description of a comparative analysis of the available clinical evidence on a health technology in comparison with one or more other health technologies or existing procedures, in accordance with an assessment scope agreed pursuant to this Regulation, and based on the scientific aspects of the clinical domains of HTA of the description of the health problem addressed by the health technology and the current use of other health technologies addressing that health problem, the description and technical characterisation of the health technology, the relative clinical effectiveness, and the relative safety of the health technology;
(7)
‘non-clinical assessment’ means the part of an HTA based on the non-clinical domains of HTA of the cost and economic evaluation of a health technology, and the ethical, organisational, social and legal aspects related to its use;
(8)
‘collaborative assessment’ means a clinical assessment of a medical device or an in vitro diagnostic medical device carried out at Union level by a number of interested HTA authorities and bodies participating on a voluntary basis;
(9)
‘assessment scope’ means the set of parameters for joint clinical assessment in terms of patient population, intervention, comparators and health outcomes requested jointly by Member States.
Member State Coordination Group on Health Technology Assessment
1. The Member State Coordination Group on Health Technology Assessment (the ‘Coordination Group’) is hereby established.
2. Member States shall designate their members of the Coordination Group and inform the Commission thereof and of any subsequent changes. The members of the Coordination Group shall appoint their representatives in the Coordination Group on an ad hoc or permanent basis, and inform the Commission of their appointment and any subsequent changes.
3. The members of the Coordination Group shall designate their national or regional authorities and bodies as members of subgroups of the Coordination Group. The members of the Coordination Group may designate more than one member to a subgroup, including the member of the Coordination Group, without prejudice to the rule that each Member State shall have one vote. The members of the subgroup shall appoint their representatives, who shall have the appropriate HTA expertise, in the subgroups on an ad hoc or permanent basis and inform the Commission of their appointment and any subsequent changes. Where there is a need for specific knowledge, members of the subgroup may appoint more than one representative.
4. The Coordination Group shall, in principle, act by consensus. Where consensus cannot be reached, the adoption of a decision shall require the support of members representing a simple majority of the Member States. Each Member State shall have one vote. The results of the votes shall be recorded in the minutes of the Coordination Group’s meetings. Where a vote takes place, members may ask for divergent opinions to be recorded in the minutes of the meeting in which the vote took place.
5. By way of derogation from paragraph 4 of this Article, where consensus cannot be reached, the Coordination Group shall adopt, by a qualified majority as defined in Article 16(4) TEU and Article 238(3), point (a), TFEU, its annual work programme, its annual report and the strategic direction referred to in paragraph 7, points (b) and (c), of this Article.
6. Meetings of the Coordination Group shall be chaired and co-chaired by two elected members from the Coordination Group, from different Member States, for a limited term to be determined by its rules of procedure. The chair and the co-chair shall be impartial and independent. The Commission shall act as the secretariat of the Coordination Group and support its work in accordance with Article 28.
7. The Coordination Group shall:
(a)
adopt its rules of procedure and update those rules where necessary;
(b)
adopt its annual work programme and annual report pursuant to Article 6;
(c)
provide strategic direction for the work of its subgroups;
(d)
adopt methodological guidance on joint work following international standards of evidence-based medicine;
(e)
adopt detailed procedural steps and the timeframe for the conduct of joint clinical assessments and for updates thereof;
(f)
adopt detailed procedural steps and the timeframe for the conduct of joint scientific consultations, including submissions of requests from health technology developers;
(g)
adopt guidance on the appointment of assessors and co-assessors for joint clinical assessments and joint scientific consultations, including on the scientific expertise required;
(h)
coordinate and approve the work of its subgroups;
(i)
ensure cooperation with relevant Union level bodies established pursuant to Regulations (EC) No 726/2004, (EU) 2017/745 and (EU) 2017/746 to facilitate the generation of additional evidence necessary for its work;
(j)
ensure appropriate involvement of stakeholder organisations and experts in its work;
(k)
establish subgroups, in particular for the following:
(i)
joint clinical assessments;
(ii)
joint scientific consultations;
(iii)
identification of emerging health technologies;
(iv)
development of methodological and procedural guidance.
8. The Coordination Group and its subgroups may meet in different configurations, in particular for the following categories of health technology: medicinal products, medical devices, in vitro diagnostic medical devices and other health technologies.
1. The Coordination Group shall ensure that the joint work carried out pursuant to Articles 7 to 23 is of the highest quality, follows international standards of evidence-based medicine, and is delivered in a timely manner. For that purpose, the Coordination Group shall establish procedures that are systematically reviewed. When developing such procedures, the Coordination Group shall consider the specificities of the health technology to which the joint work relates, including orphan medicinal products, vaccines and advanced therapy medicinal products.
2. The Coordination Group shall establish and regularly review standard operating procedures falling within the scope of Article 3(7), points (d), (e), (f) and (g).
3. The Coordination Group shall regularly review, and where necessary update, methodological and procedural guidance falling within the scope of Article 3(7), points (d), (e), (f) and (g).
4. Where appropriate, and taking into account the methodology already developed by the EUnetHTA Joint Actions, specific methodological and procedural guidance shall be developed for medicinal products, medical devices and in vitro diagnostic medical devices.
1. The Coordination Group shall carry out its activities in an independent, impartial and transparent manner.
2. The representatives appointed to the Coordination Group and its subgroups, and patients, clinical experts and other relevant experts participating in any joint work, shall not have any financial or other interests in the health technology developers’ industrial sector which could affect their independence or impartiality.
3. The representatives appointed to the Coordination Group and its subgroups shall make a declaration of their financial and other interests and update it annually and whenever necessary. They shall disclose any other facts of which they become aware that might in good faith reasonably be expected to involve, or give rise to, a conflict of interest.
4. The representatives who participate in meetings of the Coordination Group and its subgroups shall declare, before each meeting, any interest which could be considered to be prejudicial to their independence or impartiality with respect to the items on the agenda. Where the Commission decides that a declared interest constitutes a conflict of interest, that representative shall not take part in any discussions or decision-making, or obtain any information concerning that item of the agenda. Such declarations of representatives and the decision of the Commission shall be recorded in the summary minutes of the meeting.
5. Patients, clinical experts and other relevant experts shall declare any financial and other interests relevant to the joint work in which they are due to participate. Such declarations and any actions taken as a result shall be recorded in the summary minutes of the meeting and in the outcome documents of the joint work in question.
6. The representatives appointed to the Coordination Group and its subgroups as well as patients, clinical experts and other relevant experts involved in the work of any subgroup shall, even after their duties have ceased, be subject to a requirement of professional secrecy.
7. The Commission shall lay down rules for the implementation of this Article in accordance with Article 25(1), point (a), and in particular rules for the assessment of conflict of interest referred to in paragraphs 3, 4 and 5 of this Article and the action to be taken where a conflict or potential conflict of interest arises.
1. The Coordination Group shall adopt each year, at the latest by 30 November, an annual work programme and subsequently amend it if necessary.
2. The annual work programme shall set out the joint work to be carried out in the calendar year following its adoption, covering:
(a)
the planned number and type of joint clinical assessments, and the planned number of updates of joint clinical assessments according to Article 14;
(b)
the planned number of joint scientific consultations;
(c)
the planned number of assessments in the area of voluntary cooperation, considering their impact on patients, public health or healthcare systems.
3. In the preparation or amendment of the annual work programme, the Coordination Group shall:
(a)
take into account the reports on emerging health technologies referred to in Article 22;
(b)
take into account the information from the European Medicines Agency that is provided by the Commission pursuant to Article 28 on the status of submitted and upcoming marketing authorisation applications for medicinal products referred to in Article 7; as new regulatory data becomes available, the Commission shall share such information with the Coordination Group so that the annual work programme can be amended;
(c)
take into account information provided by the Medical Device Coordination Group established in Article 103 of Regulation (EU) 2017/745 (‘Medical Device Coordination Group’) or other sources, and provided by the Commission pursuant to Article 28 of this Regulation on the work of the relevant expert panels referred to in Article 106(1) of Regulation (EU) 2017/745 (‘expert panels’);
(d)
consult the stakeholder network referred to in Article 29, and take into account its comments;
(e)
take into account the resources available to the Coordination Group for the joint work;
(f)
consult the Commission on the draft annual work programme and take its opinion into account.
4. The Coordination Group shall adopt each year, at the latest by 28 February, its annual report.
5. The annual report shall provide information on the joint work carried out in the calendar year preceding its adoption.
