EMA has published a plan outlining how it would respond to an emerging cross-border threat to health, such as an influenza pandemic.
The health threats plan is based on the Agency’s pandemic influenza plan published in 2006 and reflects experience gained during the 2009 (H1N1) influenza pandemic as well as the Ebola outbreak in Western Africa in 2014-2016. The plan would also be triggered in the event of acute hazards including threats of chemical, environmental and unknown origin.
Planning for, responding to and communicating on serious health threats is a priority in the EU Medicines Agency Network Strategy to 2020 and complements ongoing European Commission initiatives in this area. It is an essential element in enabling the European Union and its Member States to better protect citizens in the event of a public health crisis. EMA’s role is to provide the best possible scientific and regulatory advice to support Member States in taking the necessary public health decisions. Because of the international context of health threats, support to international efforts is to be expected.
The health threats plan provides internal guidance on the Agency’s activities during a health threat, for example on the roles and responsibilities of its staff and scientific committees. It also covers procedural elements, such as rapid scientific advice for products under development and the fast-track approval of medicines, e.g., vaccines and antivirals for the prevention and treatment of a disease caused by the spread of an emerging virus.
The overall aim of the plan is to:
- initiate and coordinate scientific and regulatory activities by involving all interested parties at EMA and in the European medicines regulatory network, including expert groups, national competent authorities and the European Commission, as well as the European Centre for Disease Control (ECDC) and Official Medicines Control Laboratories (OMCLs), where relevant;
- manage and coordinate discussions on the development, authorisation and surveillance of relevant medicines to be used to address the health threat;
- provide the European Commission, national competent authorities, public health authorities in the Member States and the ECDC with the outcome of the review of medicines ; and
- provide support to international partners, stakeholders involved in the research and development of medicines, and to public health authorities outside Europe, for example the World Health Organization (WHO).
The plan also describes EMA’s communication with the network, stakeholders, international partners and the public in the event of a crisis.
The health threats plan does not cover incidents related to safety and/or manufacturing issues related to specific medicines, which are handled through the EU Incident management plan (IMP) and the operations of the incident review network (IRN) that deal with product-specific incidents.