Obligations of the representatives and individual experts in case of a new conflict of interest
Article 8
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.