BAKGRUNN (fra kommisjonsforordningen)

(1) Regulation (EU) 2021/2282 lays down a support framework and procedures for cooperation between Member States on health technologies at Union level and establishes the Member State Coordination Group on Health Technology Assessment (‘the Coordination Group’).

(2) In accordance with Regulation (EU) 2021/2282, the members of the Coordination Group and its subgroups are to appoint their representatives who are individuals, on an ad hoc or permanent basis (‘representatives’).

(3) Regulation (EU) 2021/2282 provides for the involvement of patients, clinical experts and other relevant experts (‘individual experts’) in joint clinical assessments and joint scientific consultations. Those experts are to be selected for their expertise in the therapeutic area concerned and act in individual capacity rather than representing any organisation, institution, or Member State.

(4) The conflicts of interests for the assessment of which the Commission is to lay down rules in accordance with Regulation (EU) 2021/2282, concern the conflicts of interests of the representatives and the individual experts in the health technology developers’ industrial sector, who participate in the joint work of the Coordination Group and its subgroups carried out pursuant to Articles 7 to 22 of Regulation (EU) 2021/2282 (‘the joint work’). The management of conflicts of interest of other individuals who might be involved in the joint work by the members of the Coordination Group and its subgroups remains within the responsibility of the Member States who are to ensure that these individuals have no financial or other interests in the health technology developers’ industrial sector which could affect their independence or impartiality.

(5) The relevant activities with regard to the management of conflicts of interest in the Coordination Group and its subgroups should encompass the activities related to the conduct of joint clinical assessments and joint scientific consultations, including where individual experts take part in this joint work, the development of methodological guidance on joint work and the preparation of reports on emerging health technologies.

(6) For the representatives appointed to the Coordination Group or its subgroups, the participation in the joint work should be subject to the submission to the Commission of a signed declaration of interests (‘DOI’) and a curriculum vitae (‘CV’). For the individual experts, their ability to be selected for and to take part in a joint clinical assessment or a joint scientific consultation should be subject to the submission to the Commission of a signed DOI and a CV. When deciding on conflicts of interest in accordance with Article 28, point (b), of Regulation (EU) 2021/2282, the Commission should assess the interests declared in the DOI and the information in the CV of the representative or the individual expert. In case of failure to declare an interest, appropriate measures should be taken.

(7) In accordance with Regulation (EU) 2021/2282, the DOI is to be updated annually and whenever necessary. To ensure that the activities of the Coordination Group and its subgroups are carried out in an independent, impartial and transparent manner at any point in time, it should be specified that an update is necessary whenever there is a change in the information provided by the representative or individual expert. To reduce administrative burden, the representative or the individual expert should be able to confirm the information submitted in the DOI where no change in the declared interest has occurred. Where such confirmation is not provided in due time, the representative or the individual expert should no longer participate in the joint work.

(8) To ensure a uniform approach regarding the interests to be declared and a proper management of the conflicts of interest in the joint work, it is appropriate to set out rules on the content, format and the validity of the DOI, as well as the rules on its submission. As the joint work under Regulation (EU) 2021/2282 is to be conducted in parallel and in close cooperation with the European Medicines Agency and with the expert panels referred to in Article 106(1) of Regulation (EU) 2017/745 of the European Parliament and of the Council (2), the DOI employed in the respective legal frameworks should be aligned as far as possible while preserving the separation of the respective remits of the Coordination Group, the European Medicines Agency and these expert panels.

(9) Pursuant to Article 30(3), points (a) and (b), of Regulation (EU) 2021/2282 and in order to ensure the robustness of the system of the management of conflicts of interest and the highest standards of independence, impartiality and transparency related to the joint work, the DOI of the representatives of the Coordination Group and its subgroups and of clinical experts and other relevant experts involved in the joint work should be made publicly available. The DOI of patients should not be made publicly available. The DOI should be published only so far as necessary to achieve these aims. In particular, the DOI of the representatives of the Coordination Group and its subgroups should be made publicly available for the period of their involvement in the joint work. The DOI of clinical experts and other relevant experts involved in the joint work should be made publicly available for one year after the finalisation of the joint work in which they participated.

(10) Pursuant to Article 5(2) of Regulation EU 2021/2282, interests that could affect the independence or impartiality of the representatives and individual experts are financial or other interests in the health technology developers’ industrial sector. Therefore, it is necessary to define such interests. Moreover, a conflict of interest may arise not only because of the current links to the health technology developers’ industrial sector, but also because of the links in the recent past and in the near future. In order to reduce administrative burden and ensure legal certainty, it is appropriate to define the time periods after which it should be considered that the link no longer gives rise to a conflict of interest.

(11) To ensure legal certainty, rules should be established for the assessment of the submitted DOI and the deadlines within which the assessment is to be completed or within which additional information is to be provided.

(12) At the moment of the assessment by the Commission of the interests declared by the representatives in their DOI, it is not always possible to establish conflicts of interest, as the specific health technology developer or specific health technology with respect to which a conflict of interest might exist might not be under assessment in the Coordination Group or its subgroups at that time. It is not always possible to establish conflicts of interest even where the health technology is already being assessed by the Coordination Group or its subgroups, as a conflict of interest might exist due to the link with the comparator health technology, which might not be yet known at the time of the assessment of the interests declared by the representatives or individual experts in their DOI. Therefore, the Commission should also decide on potential conflicts of interest of the representatives and of the individual experts. Thus, where the relevant situations of conflict of interest arise, the actions to be taken are known without the need for the supplementary assessment by the Commission.

(13) In addition to conflicts or potential conflicts of interest that are readily identifiable, there may be situations of appearance of a conflict of interest. In particular, the roles and responsibilities of the chair and co-chair of the Coordination Group and its subgroups should be considered incompatible with certain interests in the past, as those interests may give rise to doubts about the independence and impartiality of the chair or co-chair. Therefore, it is appropriate to provide for cooling-off periods for the roles and responsibilities of the chair and co-chair of the Coordination Group and its subgroups.

(14) To ensure appropriate access to the relevant expertise, the applicable measures in case of a conflict or potential conflict of interest should vary depending on the declared interest and the roles and responsibilities of the representative or individual expert. They should exclude or limit the participation of the representative or individual expert in the joint work. The Commission acting as secretariat of the Coordination Group (‘the HTA secretariat’) should be responsible for the enforcement of the imposed exclusions from, or limitations of the participation in the joint work.

(15) Under Regulation (EU) 2021/2282, the relevant subgroup is to ensure that individual experts are given the opportunity to provide their input during joint clinical assessments and joint scientific consultations. It is necessary to reconcile, on the one hand, the twofold requirement of independence and impartiality of individual experts, as laid down in Article 5(2) of Regulation (EU) 2021/2282, and, on the other hand, the public interest, referred to in Articles 8(6), 10(4), 18(6) and 18(7) of that Regulation, relating to the need for the relevant in-depth specialised expertise in order to ensure the highest scientific quality of the joint work. Therefore where in exceptional cases, for example, for rare diseases, only individual experts with conflicts of interests within the meaning of this Regulation that have such expertise are available, the Commission may propose to the relevant subgroup the appropriate involvement in the joint work of such individual experts considering their conflicts of interest, while ensuring transparency pursuant to Article 5(5) of Regulation (EU) 2021/2282.

(16) In order to ensure good management of conflict of interest, the members of the Coordination Group and its subgroups should be required to notify the HTA secretariat any changes of their representatives.

(17) Within its specific scope relating to the management of conflicts of interest in the joint work of the Coordination Group and its subgroups, this Regulation lays down, in accordance with Article 5(1), point (a), of Regulation (EU) 2018/1725 of the European Parliament and of the Council (3), the rules for processing, through the IT platform, as defined in Article 30 of Regulation (EU) 2021/2282 (‘the HTA IT platform’), personal data for the purposes of ensuring that the joint work of the Coordination Group and its subgroups under Regulation (EU) 2021/2282 is carried out in an independent, impartial and transparent manner. In particular, it should be ensured that the representatives and individual experts participating in the joint work are free from conflicts of interest with regard to the health technology developers’ industrial sector which could affect their independence or impartiality.

(18) This Regulation should specify the personal data that may be processed for the defined purposes, namely personal data included in the DOI and CV. It should determine that the Commission is to be considered the controller within the meaning of Article 3, point (8), of Regulation (EU) 2018/1725 for the processing of this data through the HTA IT platform. In order to ensure the possibility to verify whether the joint work was conducted in an independent and impartial manner, notably in the event of complaints or litigation, it is appropriate to provide for a retention period of personal data and for its review at regular intervals.

(19) The identity of the patient may reveal the patient’s health status in relation to the subject-matter of the joint clinical assessment or the joint scientific consultation. Therefore, that type of data should be considered a special category of personal data under Article 10 of Regulation (EU) 2018/1725, and the processing of such data should be made conditional on the fulfilment of the criteria laid down in Article 10(2), point (i), of that Regulation, including the set-up of suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular professional secrecy.

(20) The Commission should make the information about the data processing available on the publicly accessible webpage of the HTA IT platform so that the categories of data subjects whose personal data is being processed can be informed of their rights under Chapter III of Regulation (EU) 2018/1725, as well as the means by which they can exercise those rights.

(21) As Regulation (EU) 2021/2282 applies with effect from 12 January 2025, this Regulation should also apply from that date.

(22) The European Data Protection Supervisor was consulted in accordance with Article 42 of Regulation (EU) 2018/1725 and delivered an opinion on 5 July 2024.

(23) The measures provided for in this Regulation are in accordance with the opinion of the Committee on Health Technology Assessment,