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Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU (Text with EEA relevance)

article  5

CELEX:  32021R2282

Transparency and conflict of interest
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.
Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU (Text with EEA relevance)

article  5

CELEX:  32021R2282

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.
Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU (Text with EEA relevance)

article  5

CELEX:  32021R2282

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.