Emergency research and innovation aspects of the preparedness and response plans and the use of clinical trial networks and data-sharing platforms
Article 9
1. Where this measure is activated, the Commission and Member States shall, after consulting the Health Crisis Board, activate the emergency research and innovation aspects of the Union prevention, preparedness and response plan referred to in Regulation (EU) 2022/2371 . 2. The Commission shall support access to relevant data from clinical trials, but also to real-world data. If possible, the Commission shall build upon existing preparedness research initiatives such as Union-wide and international networks for clinical trials as well as observational studies including strategic cohorts, supported by digital platforms and infrastructures, such as high performance computing, enabling the open sharing of findable, accessible, interoperable and reusable (FAIR) data, as well as the activities of the national competent bodies supporting availability and access to data, including health data, in accordance with Article 15. 3. In setting up actions on clinical trials, the Commission shall involve the EMA Emergency Task force established by Regulation (EU) 2022/123 as well as existing networks, such as the European Clinical Research Infrastructure Network, while ensuring compliance with Regulation (EU) No 536/2014 of the European Parliament and of the Council ( 14 ) as well as coordination with ECDC. 4. The participation and contribution of the Union, and that of the Member States, in the emergency research and innovation aspects of the Union prevention, preparedness and response plan shall be in accordance with the rules and procedures of the Multiannual Financial Framework programmes.