Brussels, 8 December 2011
Q&A: Health Security in the EU
Why does health security need to be strengthened in the EU?
The Commission's assessment of past public health crises, such as the pandemic (H1N1) 2009, has revealed shortcomings in the current health security framework. Gaps have been identified in risk assessment, preparedness and response planning and crisis management capacities through EU level public health structures.
It is known from experience that lower levels of preparedness in the affected Member States and in the affected sectors will weaken and delay the EU response capacity and negatively impact the situation in other Member States. It has also become clear that the majority of health crises are not confined to just one sector (i.e. health, food safety, environment, transport, national security). At present not all sectors of society are sufficiently prepared to deal with an emergency which impacts on public health.
Also, there is currently a discrepancy in the ways to address different public health threats. EU legislation to control communicable diseases has been in place since 1998. Now it is time not just to strengthen these formal instruments, but to extend them to other serious cross-border health threats, such as those caused by other biological agents or those of chemical, environmental or unknown origin.
Finally, at global level, the International Health Regulations entered into force in 2007 with provisions for a more comprehensive framework on health security. This also affects the EU, as during global health crises there are obvious links between EU level activities and those of international public health organisations.
How will the proposal address these challenges?
In response to these challenges, this proposal will extend the existing framework of communicable diseases to cover risk assessment, risk management and risk communication aspects of all serious cross-border threats to health. In practice, the following areas of preparedness response will be targeted:
Coordination at EU level of the preparedness and response planning for serious cross-border threats to health, including improving the access to vaccines and other medical countermeasures against these threats (e.g. by including the possibility for joint procurement in particular for pandemic influenza vaccines)
Monitoring, notification and scientific assessment at EU level of risks from these potential threats, to provide sound and independent scientific advice for responding appropriately to a health emergency
Public health response and the public health measures needed to prevent or limit the spread of public health threats and reduce their effects
Formalising the Health Security Committee (HSC) - currently an informal body - for the coordination of public health measures dealing with serious cross-border threats to health in the EU.
Linking EU action on health threats with other international organisations and with third countries, through agreements and sharing alerts and response. This includes better coordination in the EU of the implementation of the International Health Regulations by Member States and closer collaboration between the EU and the WHO on preparedness for and response to public health emergencies of international concern.
What types of health threats will the new legislation cover?
The categories of serious cross-border threats to health and related agents to be covered by the new legislation are:
Threats of biological origin, relating to communicable diseases or caused by biotoxins1 and special health issues such as antimicrobial resistance and healthcare associated infections
Threats of chemical origin like those caused by acute release of dangerous substances deliberately or during an accident or an explosion
Threats of environmental origin, including extreme weather conditions such as heat waves and cold spells
Public health emergencies of international concern
Threats of unknown origin
The scope of the proposal does not include radiological or nuclear threats to health, as these are covered by the EURATOM Treaty.
How will health emergencies confined to Europe be handled?
Health emergencies in the European Union will be managed through a coordination of public health measures at EU level.
Today, for health emergencies confined to the EU, the EU can only put in place public health measures for humans in the case of communicable diseases. In these cases, the EU can adopt guidelines on protective measures and information to the public at EU level. The current legislation also allows communicable diseases to be placed under EU surveillance, with Member States under the obligation to notify and alert cross border threats. The new proposal extends such co-ordination action to all types of health crises – biological, chemical, environmental, or of an unknown nature.
The proposal also foresees that the European Commission recognises a public health "emergency situation" independently from the WHO. This will allow the European Union to use existing pharmaceutical legislation to quickly authorise medicinal products and therefore make vaccines immediately available on the market in the absence of such a decision by the WHO.
Finally, the proposal allows the EU to take "common temporary public health measures" in order to complement measures of Member States. This can only be done where the coordination of national responses proves insufficient to control the spread of serious cross-border threats, and where the protection of the health of the population of the Union as a whole is jeopardised.
What will the Member States' preparedness plans include?
The national preparedness plans will include the basic elements each Member State should have in place to be ready for a public health emergency. This could cover, for example, arrangements for readiness in the hospital systems, arrangements for stockpiling medical products to deal with an outbreak and draft measures to prepare for outbreaks, such as school closures or banning mass gatherings during a pandemic.
What is the changing role of the Health Security Committee?
In 2001, after the terrorist attacks in the US and the deliberate release of anthrax, the EU Health Security Committee (HSC) was set up at the request of EU Health Ministers. Since that time, the HSC has been an informal advisory group on health security at European level. It brings together high-level representatives from the Ministries of Health of the 27 EU Member States, Norway, Iceland and Switzerland under the Commission's chairmanship.
The HSC provides a platform for exchange of information between the Member States and the Commission, gives advice and recommendations on preparedness, ensures coordination of preparedness plans, and discusses the lessons learned from past health emergency situations. During a crisis, the HSC ensures exchange of information on public health measures in order to ensure coherence of actions by Member States to protect human health.
The new legislation will formalise and strengthen the role of this committee. In practice this means that the HSC will formally be given the task to advise EU countries and the Commission on policy, strategy, and technical issues related to health security, coordinate preparedness and response planning and coordinate public health response.
What was the European Commission's role in the 2009 flu pandemic?
In April 2009, a novel strain of human influenza A (H1N1) was first identified in Mexico and the United States and quickly spread around the world. This pandemic affected all EU Member States and caused 2 900 deaths in the 27 EU countries, Iceland, Norway and Switzerland by the time the pandemic was officially declared over.
The Commission led EU coordination to exchange information on surveillance, case definition and measures taken by EU countries to respond to this novel flu virus, with the European Centre for Disease Prevention and Control monitoring the situation on a continuous basis. Throughout the crisis, the Commission held daily audio meetings with the EU's Health Security Committee and national contact points of the Early Warning Rapid Alert System (EWRS) – which requires the national authorities to notify each other of measures taken. It was also in permanent contact with other key partners such as the European Medicines Agency (EMA), the WHO and the Global Health and Security Initiative (GHSI).
The Commission also coordinated a simplified fast-track procedure for granting marketing authorisation for pandemic influenza vaccines, authorised 3 products for marketing in the EU, and coordinated vaccination strategies.
The lessons learned from the H1N1 Pandemic have been instrumental in producing the proposed Decision on preparedness and response to serious cross-border threat to health adopted today.
What lessons were learnt from the response to the 2009 flu pandemic?
The Commission and the EU Member States have set up a number of evaluation processes on the national and EU response to the pandemic, which identified a number of lessons learnt on areas for improvement as follows:
Preparedness plans need to be flexible to allow for situations where a pandemic is less deadly than expected. The proportionality of response is particularly important for medical interventions, which in general are heavily demanding on resources.
Investing in surveillance should continue to detect the number of cases and deaths and to describe the genetic characteristics of the virus. The minimum set of necessary data should be agreed in advance of a pandemic and epidemiological data should be more harmonised and integrated in national plans. Investment in research should be increased and modelling should be promoted and developed at European level.
Business continuity planning should be enhanced to explain in a generic, simple and flexible way how each company can prepare itself. Social partners and private and public sectors should cooperate better on preparation and response.
It is essential to identify and establish a relationship of trust with stakeholders and the media before a pandemic. The use of new social media will offer new possibilities for reaching specific target groups. A plan for conducting polls or surveys on behavioural patterns of target groups should be established and shared before a crisis.
Purchasing procedures for medical countermeasures should be reviewed to better adjust the quantities ordered to actual needs. Solutions for the joint purchasing of vaccines and antiviral medications should be explored to ensure equitable access at the lowest possible price and to increase authorities’ negotiating power.
The report of the European Parliament on evaluation of the management of H1N1 influenza 2009-2010 highlighted major differences between the preparedness of EU Member States and lack of genuine cooperation weakened the EU's overall preparedness. In September 2010, the Council highlighted the need to improve surveillance, communication and matters related to medical measures.
Link to Council conclusions:
How has the Commission taken these lessons been taken on board?
The initiative adopted today will strengthen the preparedness of the Member States by establishing common procedures and shared standards, sharing of resources, and improving the exchange of expertise and information. The proposal foresees that the Commission adopts recommendations which in particular address the preparedness of critical sectors of the society and guidelines on protective and control measures to be taken on serious cross-border threats to health, including communication messages and good practice with the public.
Capacities for rapid and efficient response will be reinforced and effective containment and mitigation of serious cross-border health threat incidents will be ensured.
The initiative also seeks to better balance access to and availability of medical countermeasures between Member States.
What is the advantage of joint procurement?
'Joint procurement' means combining the procurement actions of 2 or more contracting authorities, so that there is one tender published on behalf of them all. Joint procurement activities are not new. In a number of Member States the public authorities have been buying together for years, but not all Member States have experience in this area. There are several benefits to joint procurement of vaccines and other medical countermeasures:
Getting a better deal – combining purchasing activities can lead to economies of scale
Savings on administrative costs – the total administrative work for a group of authorities will be reduced
Skills and expertise – joining the procurement actions of several Member States will also allow for the pooling of expertise. Smaller Member States will particularly benefit from this
How will joint procurement work in the new legislation?
First of all, it will be on a voluntary basis. The Member States and the EU institutions may agree on common procurement of medical countermeasures. This will be called a 'Joint Procurement Agreement' and will respect the following conditions:
Participation is open to all Member States at any time
The rights and obligations of Member States not participating in the agreement are respected
The agreement does not affect the internal market, does not constitute a discrimination or restriction of trade and does not cause distortions of competition
Rules of the Financial Regulation will be respected.
See also IP/11/1516
Examples of threats already covered in the existing Community legal arrangements:
Influenza, Measles, Anthrax, Botulism, E. coli, Malaria, Avian flu in humans and West Nile virus; Tuberculosis and Severe acute respiratory syndrome (SARS); Creutzfeldt-Jakob disease; Cholera