The first step in responding to an emerging cross-border health threat, is to assess its magnitude and associated risks. It is important to know:
- Origin: what is the disease or chemical causing the outbreak?
- Transmission: how is it spread (e.g., air-borne like influenza, foodborne like salmonella or spread by mosquitoes like Zika)?
- Consequences: what are the consequences for human health (e.g., causes pneumonia, etc.)?
- Lethality: what is the disease's severity, including the lethality (how deadly can it be)?
The answers to these questions determine the possible options for response. In addition, as with COVID-19, we can be confronted by novel diseases, where we need to plan a response even before we have the answers to all these questions.
Regulation (EU) 2022/2371 puts in place coordinated EU risk assessment mechanisms to cover the different types of cross-border health threats. This involves mobilising expertise from relevant EU and international bodies to provide robust scientific advice to feed into coordinating the response.
Which agencies perform a risk assessment?
Several EU agencies and bodies can be involved in providing the risk assessment at EU level, relying on high-level scientific expertise:
- the European Centre for Disease Prevention and Control (ECDC), if the threat is of:
- biological origin and consists of infectious diseases or antimicrobial resistance and healthcare-associated infections (including where it relates to substances of human origin that communicable diseases that can potentially be impacted by communicable diseases)
- unknown origin
- the European Medicines Agency (EMA), if the threat is linked to medicinal products and medical devices
- the European Food Safety Authority (EFSA), in the case of a serious cross-border threat to health falling under its mandate
- the European Chemicals Agency (ECHA), if the threat is of:
- chemical origin
- environmental origin
- the European Environment Agency (EEA), if the threat is of environmental origin, including those due to the climate
- the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA), if the threat is of chemical origin and falls under the mandate of the EMDCCA
- the European Union Agency for Law Enforcement Cooperation (Europol), if the threat to health:
- emanates from terrorist or criminal activity referred to in Article 3 of Regulation (EU) 2016/794
- is linked to medicinal products, this risk assessment will be carried out in cooperation with EMA
Where the risk assessment required is totally or partially outside the mandate of the Union agencies and bodies, the Commission provides an ad hoc risk assessment. The risk assessment takes into account, if available, relevant information provided by other entities, in particular by the World Health Organization (WHO) in the case of a public health emergency of international concern.