Principles of joint scientific consultations
1. The Coordination Group shall carry out joint scientific consultations in order to exchange information with health technology developers on their development plans for a given health technology. Those consultations shall facilitate the generation of evidence that meets the likely evidence requirements of a subsequent joint clinical assessment on that health technology. The joint scientific consultation shall include a meeting with the health technology developer and result in an outcome document that outlines the scientific recommendation made. Joint scientific consultations shall in particular concern all relevant clinical study design aspects, or clinical investigation design aspects, including comparators, interventions, health outcomes and patient populations. When carrying out joint scientific consultations on health technologies other than medicinal products, the specificities of those health technologies shall be taken into account.
2. A health technology shall be eligible for joint scientific consultations pursuant to paragraph 1 of this Article where it is likely to be the subject of joint clinical assessment pursuant to Article 7(1) and where the clinical studies and clinical investigations are still in the planning stage.
3. The joint scientific consultation outcome document shall not give rise to any legal effects on Member States, the Coordination Group or the health technology developer. Joint scientific consultations shall not prejudice the joint clinical assessment which may be carried out on the same health technology.
4. Where a Member State carries out a national scientific consultation on a health technology that has been the subject of a joint scientific consultation, in order to complement it or to address context-specific issues related to national HTA system, the member of the Coordination Group concerned shall inform the Coordination Group thereof via the IT platform referred to in Article 30.
5. Joint scientific consultations on medicinal products may take place in parallel with the scientific advice from the European Medicines Agency pursuant to Article 57(1), point (n), of Regulation (EC) No 726/2004. Such parallel consultations shall involve the exchange of information and have synchronised timing, while preserving the separation of the respective remits of the Coordination Group and the European Medicines Agency. Joint scientific consultations on medical devices may take place in parallel with the consultation of the expert panels pursuant to Article 61(2) of Regulation (EU) 2017/745.
Requests for joint scientific consultations
1. For health technologies referred to in Article 16(2), health technology developers may request a joint scientific consultation.
2. Health technology developers of medicinal products may request that the joint scientific consultation take place in parallel with the process of receiving scientific advice from the European Medicines Agency. In such a case, the health technology developer shall make the request for scientific advice to the European Medicines Agency when submitting the request for the joint scientific consultation. Health technology developers of medical devices may request that the joint scientific consultation take place in parallel with the consultation of an expert panel. In such a case, when submitting the request for the joint scientific consultation, the health technology developer may make the request for a consultation with the expert panel, where appropriate.
3. The Coordination Group shall publish the dates of request periods and state the planned number of joint scientific consultations for each of those request periods on the IT platform referred to in Article 30. At the end of each request period, where the number of eligible requests exceeds the number of planned joint scientific consultations, the Coordination Group shall select the health technologies that are to be subject to joint scientific consultations, ensuring the equal treatment of requests concerning health technologies with similar intended indications. The criteria for selecting from eligible requests for medicinal products and medical devices shall be:
(a)
unmet medical needs;
(b)
first in class;
(c)
potential impact on patients, public health, or healthcare systems;
(d)
significant cross-border dimension;
(e)
major Union-wide added value; or
(f)
Union clinical research priorities.
4. Within 15 working days after the end of each request period, the Coordination Group shall inform the requesting health technology developer whether it will engage in the joint scientific consultation. Where the Coordination Group refuses the request, it shall inform the health technology developer thereof and explain the reasons, having regard to the criteria laid down in paragraph 3.
Preparation of the joint scientific consultations outcome document
1. Following the acceptance of a request for a joint scientific consultation in accordance with Article 17, the Coordination Group shall initiate the joint scientific consultation by designating a subgroup for the joint scientific consultation. The joint scientific consultation shall be carried out in accordance with the requirements and procedures established pursuant to Article 3(7), point (f), and Articles 20 and 21.
2. The health technology developer shall submit up-to-date documentation containing the information necessary for the joint scientific consultation, in accordance with the requirements set out pursuant to Article 21, point (b), in the timeframe set out pursuant to Article 3(7), point (f).
3. The designated subgroup shall appoint from among its members an assessor and a co-assessor from different Member States to conduct the joint scientific consultation. The appointments shall take into account the scientific expertise necessary for the consultation.
4. The assessor, with the assistance of the co-assessor, shall prepare the draft joint scientific consultation outcome document in accordance with the requirements set out in this Article and in accordance with the guidance documents and procedural rules established pursuant to Article 3(7), points (d) and (f), and Article 20. For medicinal products, in accordance with international standards of evidence-based medicine, directly comparative clinical studies which are randomised, blinded and include a control group shall be advised whenever appropriate.
5. The members of the designated subgroup shall have the opportunity to provide their comments during the preparation of the draft joint scientific consultation outcome document. Members of the designated subgroup may, as appropriate, provide additional recommendations specific to their individual Member State.
6. The designated subgroup shall ensure that patients, clinical experts and other relevant experts are given an opportunity to provide input during the preparation of the draft joint scientific consultation outcome document.
7. The designated subgroup shall organise a face-to-face or virtual meeting for an exchange of views with the health technology developer and patients, clinical experts and other relevant experts.
8. Where the joint scientific consultation is carried out in parallel with the preparation of a scientific advice given by the European Medicines Agency or the consultation of an expert panel, representatives of the European Medicines Agency or of the expert panel, respectively, shall be invited to participate in the meeting, to facilitate coordination as appropriate.
9. Following receipt and consideration of any comments and input provided in accordance with this Article, the assessor, with the assistance of the co-assessor, shall finalise the draft joint scientific consultation outcome document.
10. The assessor, with the assistance of the co-assessor, shall take into account comments received during the preparation of the joint scientific consultation outcome document and submit its final draft, including any recommendations specific to individual Member States, to the Coordination Group.
Approval of joint scientific consultation outcome documents
1. The finalised draft joint scientific consultation outcome document shall be subject to the approval of the Coordination Group within the timeframe set out pursuant to Article 3(7), point (f).
2. The Commission shall send the joint scientific consultation outcome document to the requesting health technology developer at the latest 10 working days after it has been finalised.
3. The Coordination Group shall include anonymised, aggregated, non-confidential summary information on the joint scientific consultations, including on comments received during their preparation, in its annual reports and on the publicly accessible webpage of the IT platform referred to in Article 30(1), point (a).
Adoption of detailed procedural rules for joint scientific consultations
1. After consulting the Coordination Group, the Commission shall adopt, by means of implementing acts, detailed procedural rules for:
(a)
submission of requests from health technology developers;
(b)
the selection and consultation of stakeholder organisations and patients, clinical experts and other relevant experts in joint scientific consultation;
(c)
cooperation, in particular by exchange of information, with the European Medicines Agency on joint scientific consultations on medicinal products where a health technology developer requests the consultation to be carried out in parallel with a process for scientific advice from the European Medicines Agency;
(d)
cooperation, in particular by exchange of information, with the expert panels on the joint scientific consultations on medical devices where a health technology developer requests the consultation to be carried out in parallel with the consultation of those expert panels.
2. 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).
Format and templates of submission and outcome documents for joint scientific consultations
The Coordination Group shall establish in compliance with the procedural rules referred to in Article 20(1), point (a), the format and templates of:
(a)
requests from health technology developers for joint scientific consultations;
(b)
dossiers of information, data, analyses and other evidence to be submitted by health technology developers for joint scientific consultations;
(c)
joint scientific consultation outcome documents.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
