Events to be reported within the early warning and response system
1. Outbreaks of communicable diseases extending to more than one Member State of the Community.
2. Spatial or temporal clustering of cases of disease of a similar type, if pathogenic agents are a possible cause and there is a risk of propagation between Member States within the Community.
3. Spatial or temporal clustering of cases of disease of a similar type outside the Community, if pathogenic agents are a possible cause and there is a risk of propagation to the Community.
4. The appearance or resurgence of a communicable disease or an infectious agent which may require timely, coordinated Community action to contain it.
ANNEX II
Procedures for information, consultation and cooperation under the early warning and response system
1. Activation level 1: information exchange
(1) If information collected in one or more Member States or coming from other recognised sources suggests that an event is likely, the competent authority responsible for determining measures to protect public health in each Member State concerned shall, via the network, inform their counterparts in other Member States and the Commission without delay of the circumstances and background. On receipt of this information, the competent authorities in concerned Member States shall express their opinion on whether measures by other Member States or coordinated Community actions assisted by the Commission are necessary.
(2) The Commission and the concerned Member States shall ensure continuous mutual and rapid exchange of information they receive and shall keep other Member States up to date.
(3) The competent public health authorities in the Member State(s) concerned shall assess, in cooperation with the structures and/or authorities, the information collected without delay to ascertain if an event with a public health threat exists.
(4) The Commission may convene an extraordinary meeting of the network committee or of experts proposed by the committee to ensure the transparency and effectiveness of any eventual action.
2. Activation level 2: potential threat
When information on an event or indications for such an event point to a potential public health threat, the competent public authorities in the Member State(s) concerned shall inform their counterparts in other Member States and the Commission without delay on the nature and scope of the potential threat and the measures they intend to take themselves or in association with other concerned Member States, the Commission or other parties.
2.1. Verification and evaluation
The competent public health authorities in the Member State(s) concerned shall assess, in cooperation with the structures and/or authorities, the information collected without delay to ascertain if an event with a public health threat exists.
Field epidemiology expertise, laboratory support, clinical and other essential expertise shall be available as technical assistance for any further investigation within Member States. The Community or individual Member States may provide them if requested by the Member State concerned.
The Commission shall assist in coordinating the precautionary measures in preparing for any possible public health threat.
The Commission may convene an extraordinary meeting of the Network committee or of experts proposed by the committee to coordinate necessary action.
2.2. Deactivation
If the final risk assessment concludes that no public health threat has developed, and no action or only local action is required, the competent public health authorities in each Member State concerned shall inform their counterparts in other Member States and the Commission without delay on the nature and scope of those measures they have taken or intend to take.
In the absence of objections within three days by other Member States or the Commission, no other action for the early warning and response system is required.
3. Activation level 3: definite threat
If an event results in a public health threat, the competent public health authorities in the Member State(s) concerned shall inform their counterparts in other Member States and the Commission without delay on the nature and scope of the potential threat and the measures they intend to take themselves or in association with other concerned Member States, the Commission and other parties.
3.1. Coordination of measures
The competent public health authorities in the Member State(s) concerned shall without delay inform other Member States and the Commission on the progress and results of the measures taken.
The Member States and the Commission shall coordinate further measures to be taken at Community level in conformity with Articles 3 and 6 of Decision No 2119/98/EC.
The Commission shall support Member States in coordinating their efforts to cope with the public health threat and to ensure protection of the population.
The Commission may convene an extraordinary meeting of the Network committee or delegates nominated by the committee to coordinate action.
3.2. Deactivation
The system shall be deactivated after the agreement of the Member States concerned, who shall inform other Member States and the Commission.
4. Information to the general public and concerned professions
If an event arises, Member States shall without delay provide suitable information material to concerned professionals and the general public and shall inform them of the measures adopted.
The Commission and Member States shall inform concerned professionals and the general public of any guidance agreed at Community level and shall inform them without delay when the public health threat is over.
