Recital (21)

The aim of an advisory body participating in the Union compulsory licensing process is to guarantee a comprehensive, thorough, and concrete assessment of the situation, taking into consideration the individual merits of each case. It is therefore important that the competent advisory body have the correct composition, expertise, and procedures to support the Commission when deciding on whether to grant a Union compulsory licence and on the content of that licence. Union crisis or emergency mechanisms usually include the setting-up of an advisory body ensuring coordination of action of the Commission and relevant Union bodies and agencies, the Council and the Member States. In that respect, Regulations (EU) 2022/2371 and (EU) 2022/2372 provide for a Health Security Committee and a Health Crisis Board, respectively, while an Internal Market Emergency and Resilience Board is set up under Regulation (EU) 2024/2747. Those advisory bodies have the correct composition, expertise, and procedures to address the crises and emergencies for which they have been set up. Where compulsory licensing is being discussed in the context of a Union crisis or emergency mechanism, relying on the advisory body set up under the relevant mechanism allows the Commission to be adequately advised and avoids duplication of advisory bodies that would lead to inconsistencies between processes. However, considering its specific role, it should be ensured that the competent advisory body draws on additional expertise in intellectual property rights, in particular patents, and in the granting of compulsory licences. The competent advisory bodies should be listed, together with the corresponding Union crisis or emergency mechanisms, in the Annex to this Regulation. Where the Union crisis or emergency mechanism does not provide for an advisory body, the Commission should set up an ad hoc advisory body for the granting of the Union compulsory licence (the ad hoc advisory body). The ad hoc advisory body set up by the Commission should be composed of one representative of each Member State and should include a representative of the European Parliament as an observer. The rules of procedure of that ad hoc advisory body should include provisions relating to the avoidance of potential conflicts of interest in order to ensure accountability and transparency.