Germany welcomes the European Commission's initiative for improving the mechanisms to co-ordinate prevention and response in the event of serious cross-border threats to public health at EU level. We support any effort to achieve efficient and transparent crisis management structures. In particular, the formalisation of the Health Security Committee is a necessary step forward. The German government has actively collaborated with other EU member states, the Commission and the European Parliament (EP) to find the best solutions, and will continue to do so in the ongoing negotiations.
When extending the well-established crisis management system for communicable diseases to other health threats, we need to be cautious so as not to endanger functioning mechanisms of the 'acquis' as established by the EP and the European Council. A key concern for us is how to effectively link existing crisis management systems in the food safety, medicinal products and medical devices, and other sectors so that in a crisis, capacities at national and EU levels can be used in an efficient and economic manner. We need to clarify which regulations apply should an event occur and close the gaps where necessary. Indeed, in a crisis, there will be no time for discussions on responsibilities and applicable rules. To create synergy effects and efficiency, instead of additional work devoid of added value, the application of more specialised mechanisms in the food, medicinal products and medical devices areas etc. needs to be given clear priority. In the event of a public health crisis, all resources will be needed and duplication must consequently be avoided. The new system should come into play as an 'emergency back-up system' only if no other mechanism is able to deal sufficiently with the public health aspects. The Health Security Committee should be given a clear mandate to be able to refer cases to the appropriate committees of the Union.
The Health Security Committee should in our view be the central body for member states and the Commission to exchange information rapidly on best practice and to respond to crises. A formalised Health Security Committee will further enhance this exchange with regard to preparedness planning, the evolution of a crisis situation and the necessary re-Karin Knufmann-Happe has been the Director General for
Health Protection, Disease Control and Biomedicine at the German Federal Ministry of Health since 2006.
From 1992 to 1995, she was seconded to the European Commission in Brussels where she worked as a national expert in the 'Pharmaceuticals' Unit of Directorate-General III (Industry). Since February 1995, Knufmann-Happe has held various functions in public service, including Director General for Matters relating to Disabled Persons, Social Assistance' at the Federal Ministry of Health and Social Security.
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sponse. However, collaboration in the Health Security Committee may merely facilitate, but not replace, decisions on national countermeasures. Having preparedness or response measures approved in advance within the Health Security Committee is neither feasible nor useful. The reason is that in a large, federal state such as Germany, preparedness planning includes plans prepared by numerous authorities at federal, land and municipal levels.
Instead of overloading each other with information, member states should decide for themselves, within the Health Security Committee, in which precise areas they wish to have an exchange of information for the purpose of coordinating prevention measures. Over the past eleven years, this practice has proven very successful in the Health Security Committee. Moreover, certain information is of national security concern and cannot be revealed, especially with regards to the prevention of bio-terror.
It is vital for the Health Security Committee to be a permanent committee with changing membership so as to flexibly gather expertise from all sectors concerned according to the crisis situation at hand. The Committee should also be the place where information on an emerging event, in the case of chemical or environmental health threats, is exchanged.
Unlike the threats posed by communicable diseases, other threats do not require a surveillance network for constant monitoring but a crisis mechanism for monitoring only when an event occurs. We doubt the added value of additional networks tying up national resources already tasked elsewhere in a crisis situation. Also, in acute crisis situations we would be better advised to have recourse to established, practiced structures instead of member states, countermeasures must be decided on by those responsible on the ground, that is, at the appropriate national level. We consider delegated acts for common countermeasures at EU level to be incompatible with both the subsidiary principle and the Treaty's comitology provisions. The Commission has presented no convincing examples to justify delegated acts as set out in Article 12 of the Proposal. In particular, any binding common crisis communication is to be rejected. Crisis communication follows the measures to be communicated, not vice versa. It must adapt to the demands of the emerging crisis situation on the ground and can therefore not be unified. Instead, member states should keep each other mutually informed of the measures taken, within the Health Security Committee, so that they will be able to inform their own population if necessary. This practice has proven its worth and should not be confused with harmonised warnings to the population. Since warnings represent public (health) measures with external legal effects, they fall within the exclusive jurisdiction of member states.
Of all of the provisions of the proposal, Article 12 confers the strongest powers on the Commission. But these affect original competences of the member states, while both the possible public health countermeasures and the procedure to be followed according to Article 12 seem too vague. The provision therefore does not contain the specific, non-essential elements required by Article 290 of the Treaty for delegated acts and should be deleted.
SECURITY & DEFENCE AGENDA
The well-established system at the European Centre for Disease Prevention and Control (ECDC) should be preserved. Alongside its surveillance network, ECDC should continue to operate the Early Warning and Response System for communicable diseases (EWRS) within the framework of its independent mandate. Further threats must be reported through other existing systems, as any expansion of the EWRS without a modification of ECDC's mandate and resources would jeopardise a well-established and functioning system. The existing early warning systems must remain unaffected. The Commission itself should take measures to ensure that it receives all of the relevant information from the various early warning systems which operate in different areas. Member states should not be obliged to communicate information and alerts on the same event multiple times via different systems.
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