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European Commission

MEMO

Brussels, 3 July 2013

FAQ: Serious Cross-border Threats to Health Decision

Why does health security need to be strengthened in the EU?

Communicable diseases and health threats caused by chemical or biological agents, or environmental events do not respect borders, which is why the EU needs to be at the forefront of coordination of action if such a threat emerges.

The Commission's assessment of past public health crises, such as the pandemic (H1N1) in 2009/2010 or the e.coli crisis in 2011 revealed shortcomings in the health security framework currently in place. The gaps identified were notably in risk assessment, preparedness and response planning and crisis management.

We know from experience that if one or several EU countries affected by a health crisis are not adequately prepared, any weaknesses will hamper the EU response capacity and negatively impact the situation in other Member States as the crisis spreads. That is why we need a common approach on preparedness planning and risk and crisis response, and a clearly mandated coordination role for the EU.

We also need to address the discrepancy that threats to public health arising from chemical or environmental hazards have so far been treated on an informal basis, whereas EU legislation to control communicable diseases has been in place since 1998. Now we need both to strengthen the formal instruments to address communicable diseases, and to extend them to serious cross-border health threats caused by other biological threats, such as Ricin or Botulin toxin, chemical and environmental threats.

Finally, we need to update our health threats legislation in line with international developments, as during global health crises there are clear links between EU level activities and those of international public health organisations.

How does the Decision address these challenges?

The Decision extends the existing framework of communicable diseases to cover preparedness planning, risk assessment, risk management and risk communication aspects of all serious cross-border threats to health caused by communicable diseases, antimicrobial resistance and healthcare-associated infections, other harmful biological agents as well as chemical and environmental events. In practice, the following areas of preparedness response will be targeted:

  1. 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 (e.g. the possibility for joint procurement, in particular for pandemic influenza vaccines).

  2. 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.

  3. Public health response and the public health measures needed to prevent or limit the spread of public health threats and reduce their effects.

  4. 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.

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:

  1. Threats of biological origin, relating to communicable diseases or caused by biotoxins and special health issues such as antimicrobial resistance and healthcare associated infections

  2. Threats of chemical origin like those caused by acute release of dangerous substances deliberately or during an accident or an explosion

  3. Threats of environmental origin, including extreme weather conditions such as heat waves and cold spells

  4. Public health emergencies of international concern

  5. Threats of unknown origin

The Decision further foresees that health threats other than those covered by the scope may, in exceptional emergency situations - if it is considered that public health measures taken prove insufficient to protect human health - be referred for a coordinated response to the Health Security Committee.

How will health emergencies confined to Europe be handled?

Coordination of public health measures will be managed at EU level.

Until now, for health emergencies confined to the EU, the Union had only a clear legal mandate to coordinate public health measures for communicable diseases. For these cases only, the EU could e.g. adopt guidelines on protective measures and information to the public at EU level. The new Decision once in force will extend the Commission's co-ordination role 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 World Health Organisation (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.

How will the Decision help the EU and Member States to be better prepared for a crisis?

The Decision will ensure that EU countries regularly exchange information on their preparedness activities. Member States produce national 'preparedness plans' which include the basic capacity they have in place to be ready for a public health emergency. These plans cover, for example, readiness by hospitals for increased admissions, arrangements for stockpiling medical products and draft measures in case of an outbreak, such as school closures or banning mass gatherings.

At present, Member States are not legally bound to exchange information on their plans. It is important that this information is shared at European level. Sharing plans would avoid inconsistencies in preparedness between Member States and a weakened EU response. The new rules to exchange information on preparedness planning will help achieve a common "vision" on preparedness and allow establishing plans that are consistent and interoperable at EU level.

What is the 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 was set up at the request of EU Health Ministers. This Committee 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. Until now, the Committee has been an informal advisory group on health security at European level.

The Decision formalises and strengthens the role of this Committee. In practice this means that the Committee will be formally mandated to support the exchange of information between the Member states and the Commission on policy, strategy, and technical issues relating to health security as well as coordinate preparedness planning and public health response. The role of the Health Security Committee will be key in ensuring coherence of actions by Member States to protect human health.

Who will benefit from the new rules?

By having common procedures and standards plus improved sharing of information and expertise, Member States will be better prepared to face a health crisis. Capacities for rapid and efficient response will be reinforced and effective containment and mitigation of serious cross-border health threat incidents will be ensured. This will ultimately benefit all EU citizens who will be better protected in the case of a serious cross-border health crisis.

What is the advantage of joint procurement?

'Joint procurement' means combined purchasing of goods by two or more contracting authorities, so that only one tender is 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:

  1. Ensuring that each participating country gets vaccines for its citizens in case of an outbreak, and getting a better deal – combining purchasing activities can lead to economies of scale

  2. Savings on administrative costs – the total administrative work for a group of authorities will be reduced

  3. 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:

  1. Participation is open to all Member States at any time

  2. The rights and obligations of Member States not participating in the agreement are respected

  3. The agreement does not affect the internal market, does not constitute a discrimination or restriction of trade and does not cause distortions of competition

  4. It will not have any direct impact on the budget of Member states not participating in the joint procurement

  5. The rules of the Financial Regulation will be respected.

For more information:

http://ec.europa.eu/health/preparedness_response/policy/index_en.htm

MEMO/13/644

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