Thursday, July 4, 2013

EU: FAQ: Serious Cross-border Threats to Health Decision

Below are a few excerpts from a FAQ Memo on the vote taken in the European Union's Parliament to strengthen legislation on the EU's alert and response system to pandemics. 
With this new legislation, they could declare a pandemic outside of the WHO decision to declare one.  Below, bolded in red (mine) Coronavirus, MERS, would fall into the last category, as of today, because we still do not know it's origin...

European Union Press Release

FAQ: Serious Cross-border Threats to Health Decision

Reference: MEMO/13/645 Event Date: 03/07/2013

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.

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