Public health risk assessment
Article 8a
1. The Centre shall provide risk assessments, in accordance with Article 20 of Regulation (EU) 2022/2371, in the case of a serious cross-border threat to health referred to in Article 2(1), points (a)(i) and (a)(ii), of that Regulation, including where it relates to substances of human origin that can potentially be impacted by communicable diseases, or in Article 2(1), point (d), of that Regulation. Such risk assessments shall be provided in a timely manner. 2. Risk assessments referred to in paragraph 1 shall include general and targeted science-based recommendations and options for response as a basis for coordination in the HSC, such as concerning: (a) a forecast of the evolution of a health crisis and the risk of a health emergency; (b) the Member States’ health system capacity to the extent it is necessary for the management of and the response to communicable disease threats and related special health issues, in order to support Member States; (c) identification of vulnerable groups in society; (d) identification of possible protective non-pharmaceutical measures and assessment of their efficacy. 3. For the purposes of paragraph 1, the Centre shall coordinate the preparation of risk assessments, by involving national focal points or Member States’ experts, relevant agencies or international organisations such as the WHO, where appropriate. The Centre shall establish rules of procedure for risk assessments, especially regarding the involvement of experts to ensure that Member State expertise is independent and representative. 4. Where the risk assessment falls outside the mandate of the Centre, and at the request of the agency or body carrying out the risk assessment within its mandate, the Centre shall, without undue delay, provide the agency or body with any relevant information and data that are at its disposal. 5. The Centre shall work together with Member States to improve their risk assessment capacity.