Commission Implementing Regulation (EU) 2024/2745 of 25 October 2024 laying down rules for the application of Regulation (EU) 2021/2282 of the European Parliament and of the Council as regards the management of conflicts of interest in the joint work of the Member State Coordination Group on Health Technology Assessment and its subgroups

1 Before submitting a signed declaration of interests (‘DOI’) to the Commission and until the Commission has assessed the declared interests in accordance with Article 4, the representatives appointed to the Coordination Group and its subgroups referred to in Article 5(3) of Regulation (EU) 2021/2282 (‘representatives’) may not do any of the following: (a) access the parts of the secure system of the IT platform, as defined in Article 30 of Regulation (EU) 2021/2282 (‘the HTA IT platform’) relevant for the performance of their tasks; (b) take up the roles and responsibilities of a chair or a co-chair in the Coordination Group or its subgroups; (c) take up the roles and responsibilities of an assessor or a co-assessor for a joint clinical assessment or a joint scientific consultation; (d) attend meetings of the Coordination Group or its subgroups for conducting joint clinical assessments, joint scientific consultations, developing methodological guidance for joint work or for preparing reports on emerging health technologies.

2 Before submitting a signed declaration of interests (‘DOI’) to the Commission and until the Commission has assessed the declared interest in accordance with Article 4, patients, clinical experts and other relevant experts referred to in Article 5(5) of Regulation (EU) 2021/2282 (‘individual experts’) may not be selected and take part in a joint clinical assessment or a joint scientific consultation and may not access the parts of the secure system of the HTA IT platform relevant for the performance of their tasks.

1 Representatives and individual experts shall declare in the DOI all financial or other interests, whether of direct or indirect nature, in the health technology developers’ industrial sector, by answering the standard questions listed in the DOI form set out in Annex I to this Regulation. Representatives or individual experts who answer to the questions in the affirmative shall provide further details in the respective sections of the DOI form.

2 Representatives and individual experts shall assume full responsibility in relation to the content of the DOI submitted.

1 The DOI of a representative or individual expert shall be submitted digitally through the HTA IT platform in the form set out in Annex I and shall be accompanied by a comprehensive curriculum vitae (‘CV’) of the representative or of the individual expert based on the Europass CV template. The DOI shall be deemed submitted only if it is duly completed, signed, and accompanied by such CV.

2 When an interest declared in the DOI referred to in paragraph 1 has changed, an updated DOI shall be submitted without undue delay in accordance with the procedure set out in paragraph 1.

1 The Commission shall assess the interests declared in the DOI, as well as the information in the CV of the representative or the individual expert, submitted in accordance with Article 3.

2 If necessary, the Commission may request that the representative or the individual expert submit any additional information needed for the assessment of the declared interests. The representative or the individual expert shall provide that information within 10 days from the day of the notification of the request.

3 Where no further information is needed for the assessment of the declared interests, the Commission shall complete the assessment within 15 working days from the submission of the DOI in accordance with Article 3.

4 If the Commission decides that the declared interest does not constitute a conflict or potential conflict of interest within the meaning of Annex II, the representative or the individual expert may participate in the joint work.

5 If the Commission decides that the declared interest constitutes a conflict or potential conflict of interest within the meaning of Annex II, Articles 6, 7 and 8 shall apply.

1 The DOI shall be valid as long as the representative or the individual expert is involved in the joint work if: (a) no change in the declared interest has occurred; (b) information referred to in point (a) has been confirmed by the representative or the individual expert by the end of each year starting on the day on which the DOI was submitted in accordance with Article 3(1) or (2). Where such confirmation is not provided, the HTA secretariat shall ensure that the representative or the individual expert is no longer involved in the joint work.

2 The DOI and the information on the qualifications and areas of relevant expertise from the accompanying CVs of the representatives shall be made available on the publicly accessible webpage of the HTA IT platform for the period of their involvement in the joint work.

3 The DOI and the information on the qualifications and areas of relevant expertise from the accompanying CVs of clinical experts and other relevant experts shall be made available on the publicly accessible webpage of the HTA IT platform for one year after the finalisation of the joint work in which they participated.

1 If the Commission decides, in accordance with Article 28, point (b), of Regulation (EU) 2021/2282, that an interest declared in a DOI submitted by a representative in accordance with Article 3(1) of this Regulation constitutes a conflict of interest within the meaning of Annex II thereto that is deemed incompatible with the participation in the joint work, the HTA secretariat shall invite the member of the Coordination Group or its subgroup to appoint another representative. The member may re-appoint the same representative once the conflict of interest no longer exists.

2 If the Commission decides, in accordance with Article 28, point (b), of Regulation (EU) 2021/2282, that an interest declared in a DOI submitted by a representative in accordance with Article 3(2) of this Regulation constitutes a conflict of interest within the meaning of Annex II thereto that is deemed incompatible with the participation in the joint work, the HTA secretariat shall ensure that the representative is no longer involved in the joint work and shall inform the representative thereof. The HTA secretariat shall invite the member of the Coordination Group or its subgroup to appoint another representative. The member may re-appoint the same representative once the conflict of interest no longer exists.

3 If the Commission decides, in accordance with Article 28, point (b), of Regulation (EU) 2021/2282, that an interest declared in a DOI submitted by a representative in accordance with Article 3(1) or (2) of this Regulation constitutes a conflict of interest within the meaning of Annex II thereto that is deemed incompatible with taking up certain roles and responsibilities in the joint work, or a conflict or potential conflict of interest in relation to the health technology developer or to the specific health technologies, the HTA secretariat shall inform the representative, the member of the Coordination Group or its subgroup and, as appropriate, the Coordination Group or its subgroups of the conflict or the potential conflict of interest of the representative and shall ensure the enforcement of the measures set out in Annex II to this Regulation.

1 If the Commission decides, in accordance with Article 28, point (b), of Regulation (EU) 2021/2282, that an interest declared in a DOI submitted by an individual expert in accordance with Article 3(1) of this Regulation constitutes a conflict of interest within the meaning of Annex II thereto that is deemed incompatible with the participation in the joint work or a conflict of interest in relation to the health technology developer or to the specific health technologies, the HTA secretariat shall ensure that that individual expert is not selected to be involved in the joint clinical assessment or joint scientific consultation and shall inform the individual expert thereof.

2 If the Commission decides, in accordance with Article 28, point (b), of Regulation (EU) 2021/2282, that an interest declared in a DOI submitted by an individual expert in accordance with Article 3(2) of this Regulation constitutes a conflict of interest within the meaning of Annex II thereto that is deemed incompatible with the participation in the joint work or a conflict of interest in relation to the health technology developer or to the specific health technologies, the HTA secretariat shall ensure that the individual expert is no longer involved in the joint clinical assessment or joint scientific consultation and shall inform the individual expert thereof. The HTA secretariat shall inform, as appropriate, the relevant subgroup, assessor and co-assessor for the joint clinical assessment or joint scientific consultation of the exclusion of the individual expert from the relevant assessment or consultation.

3 By way of derogation from paragraph 1, where in exceptional cases, for example, for rare diseases, no individual experts free from conflicts of interests within the meaning of Annex II that have the relevant in-depth specialised expertise are available, the Commission may propose to the relevant subgroup the appropriate involvement of such individual experts in the joint work considering their conflicts of interest. The same applies where the exclusion of an individual expert in accordance with paragraph 2, would result in no involvement of a patient or a clinical expert in a joint clinical assessment or a joint scientific consultation.

1 If a representative or an individual expert involved in the joint work has a new interest listed in Annex II as constituting a conflict of interest that is deemed incompatible with the participation in the joint work, they shall immediately step down from their roles and responsibilities. The representative or the individual expert shall declare that interest in a DOI submitted in accordance with Article 3(2) of this Regulation. Alternatively, they may declare the interest in writing to the HTA secretariat.

2 If during a meeting of the Coordination Group or its subgroups a representative or an individual expert becomes aware of a new interest listed in Annex II as constituting a conflict of interest in relation to the items on the agenda, they shall immediately declare that interest to the chair or the co-chair of the Coordination Group or its subgroup and to the HTA secretariat and withdraw from the relevant part of the meeting. The representative or the individual expert shall update their DOI without undue delay.

3 If during a joint clinical assessment or joint scientific consultation or a meeting of the Coordination Group or its subgroups a representative or an individual expert becomes aware of new circumstances in which the limitations listed in Annex II apply to them, they shall immediately inform the HTA secretariat and, as appropriate, the assessor, co-assessor, chair or the co-chair of the Coordination Group or its subgroup and withdraw from the relevant assessment, consultation or part of the meeting.

4 If a representative or an individual expert involved in the joint work intends to be engaged in activities with a health technology developer and will therefore acquire an interest listed in Annex II as constituting a conflict of interest that is deemed incompatible with the participation in the joint work, they shall immediately declare that interest in a DOI submitted in accordance with Article 3(2) of this Regulation or in writing to the HTA secretariat irrespective of whether a contract with the health technology developer has been signed or not. Articles 6(2) and 7(2) shall apply with regard to the action to be taken.

5 By way of derogation from paragraphs 1 to 4, where the exclusion or the withdrawal of an individual expert would result in no involvement of a patient or a clinical expert having relevant in-depth specialised expertise in a joint clinical assessment or a joint scientific consultation, the Commission may propose to the relevant subgroup the appropriate involvement of such individual experts in the joint work considering their conflicts of interest.

Members of the Coordination Group and its subgroups shall notify the HTA secretariat in writing, if a representative has resigned or has been removed from their duties, at the latest by the day of their actual resignation or removal.

1 If the Commission becomes aware of information that is not consistent with the information included in the DOI of a representative or an individual expert, it shall inform the representative or individual expert in writing and request a clarification of the situation. The representative or the individual expert shall provide the requested clarification within 14 days from the day of the notification of the request.

2 If the representative or the individual expert does not provide the requested clarification within the period referred to in paragraph 1, the Commission may decide to exclude the representative or the individual expert from participation in the joint work until the clarification is provided and assessed by the Commission.

3 If the requested clarification is provided, and irrespective of the assessment of the interests at issue, the Commission may exclude the representative or the individual expert from the joint work for a period up to 2 years, if the representative or the individual expert failed to declare the interest intentionally or by gross negligence.

4 The HTA secretariat shall inform the representative, the individual expert and, as appropriate, the member of the Coordination Group or its subgroup, the Coordination Group or its subgroups of the decisions of the Commission referred to in paragraph 3 and shall ensure the enforcement of the measures imposed in those decisions.

1 The Commission shall be controller of the processing, through the HTA IT Platform, of personal data of representatives and individual experts collected under this Regulation.

2 The categories of personal data referred to in paragraph 1 of this Article shall be the DOI and CV listed in Article 3 and Annex I, information confirmed in accordance with Article 5(1), point (b), as well as other related personal data.

3 The DOI and CV of patients involved in joint clinical assessments and joint scientific consultations, as well as the information submitted by them in accordance with Article 4(2), shall not be made publicly available. Such documents and information shall be only made available to the Commission when performing its tasks under this Regulation with restricted access on a need-to-know basis and subject to safeguards as required by Article 10(2), point (i), of Regulation (EU) 2018/1725. Such safeguards may include in particular pseudonymisation, prevention of unauthorised access, prevention of unauthorised reading, copying, modification or deletion of personal data, as well as organisational measures ensuring that personnel authorised to process data have access only to data covered by their access authorisation, and that it is possible to verify and establish what data have been accessed, by which member of the personnel and at what time.

4 The Commission shall keep the personal data included in DOI and CV submitted in accordance with Article 3, and information confirmed in accordance with Article 5(1), point (b), as well as other related personal data, of the representatives and individual experts only for as long as necessary for the purpose referred to in paragraph 1 of this Article and no longer than 15 years after the date on which the representatives or individual experts no longer participate in the joint work. The Commission shall review the necessity of storing the personal data every 2 years.

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.