Public health threats

The European Medicines Agency (EMA) is committed to supporting global efforts to respond to existing and emerging public health threats, such as antimicrobial resistance, falsified medicines, biological and chemical threats and emergencies such as outbreaks or pandemics. The Agency has a number of mechanisms in place to contribute to global responses to such challenges.

Health threats plan

EMA has developed a health threats plan describing how the Agency operates during an emerging health threat, allowing for a rapid and efficient response:

The plan sets out the roles and responsibilities of EMA's scientific committees and staff during a public health threat.

The overall aim of the plan is to:

The plan also describes EMA's communication with the EU Member States, international partners, stakeholders and the public in the event of a crisis.

It also covers operational aspects such as providing rapid scientific advice for products under development and fast-track approval of medicines such as vaccines and antivirals to prevent or treat a disease caused by an emerging virus.

Planning for, responding to and communicating on serious health threats is a priority in the European medicines agencies network strategy and complements ongoing European Commission initiatives in this area. 

Bringing together best expertise

EMA can bring together and support groups of European experts with specialised knowledge in areas such as antimicrobial resistance, biological and chemical agents used maliciously, infectious diseases, vaccines and clinical trial design to contribute to a global response to public health threats.

These groups can also give advice to medicine or vaccine developers on scientific and regulatory matters.

Facilitating development of medicines and vaccines

EMA can mobilise a number of tools to help speed up the development of medicines and vaccines in the event of an emerging threat or an outbreak, depending on the circumstances. These include:

EMA is committed to establishing close contact with developers of treatments or vaccines for emerging health threats.

Working with international partners

EMA works closely with European and international partners, including the European Commission, World Health Organization and European Union agencies, including the European Centre for Disease Prevention and Control, to address existing and emerging threats as well as during public health emergencies.

The Agency also cooperates with international anti-counterfeiting trade agreements and other criminal-law instruments, such as the Council of Europe's Medicrime convention and the Organisation for Economic Co-operation and Development (OECD) project on counterfeiting and piracy.


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