[pic] | COMMISSION OF THE EUROPEAN COMMUNITIES |

Brussels, 16.11.2006

COM(2006)699 final

COMMUNICATION FROM THE COMMISSION TO THE COUNCIL

on transitional prolongation and extension of the mandate of the Health Security Committee in view of a future general revision of the structures dealing with health threats at EU level

TABLE OF CONTENTS

1. Background 3

2. Purpose and scope 3

3. Role of the Health Security Committee in the interim phase (2006-2008) 4

4. Mandate of the Health Security Committee in the transitional phase until 2008 5

5. Conclusions 6

1. BACKGROUND

The Health Security Committee (HSC) was established by the Council in 2001 at the occasion of a discussion following the bioterrorist attacks in the USA where the cardinal role of public health bodies in the fight against bioterrorism was recognised. The Committee is given the responsibility to exchange information on health-related threats and to share information and experience on preparedness and response plans and crisis management strategies. In addition, the HSC ensures rapid communication in case of health-related crises, co-ordinating on preparedness and response, emergency planning at EU-level, and responses by Member States. The members of the HSC were nominated by Health Ministers at the end of 2001.

The Council reviewed the activities of the HSC, on the basis of a report from the Commission services, in 2004. The HSC's mandate was extended to maintain support to Community work on Influenza preparedness.

A Working Party of the HSC discussed in June 2005 the possible scope and terms of references of the Committee, notably in the light of the European Centre for Disease Prevention and Control in Stockholm being now operational, and identified further activities, priorities and deliverables on the basis of the Strategy document on Generic Preparedness Planning for EU public health threats.

The HSC has established relations with:

- The Community Network on communicable diseases[1], in particular with the EWRS (Early Warning and Response System), and the ESCON (Epidemiological Surveillance Component of the Community Network), surveillance and epidemiological activities which are now managed by the European Centre for Disease Prevention and Control (ECDC).

- The European Centre for Disease Prevention and Control (ECDC). The ECDC complements Community activities in public health by delivering technical and scientific advice, risk assessment. The ECDC is now fully operational and is expected to provide continuous scientific and technical support to the HSC.

The work of the HSC, since its establishment in 2001 has led, inter alia, to the adoption of a Commission Communication on cooperation in the European Union on preparedness and response to biological and chemical agent attacks (health security)[2]; Communications by the Commission on pandemic influenza preparedness and response in the Community[3], and on strengthening coordination on generic preparedness planning for public health emergencies at EU level[4].

2. PURPOSE AND SCOPE

This Communication proposes to extend the mandate for the Health Security Committee for the coming three years, also enlarging its scope until a general review of all the legal provisions and other arrangements in the area of health threats is carried out. The Commission intends to come up with appropriate proposals during 2008, including one on the revision of the ECDC Regulation[5]. This review will aim at the creation of a coherent soundly-based framework which will be comprised of the ECDC and the Community Network on epidemiological surveillance and control of communicable diseases, and their supporting structures. TAs a part of this process, the responsibilities of the ECDC and its cooperation with the HSC will also be reviewed, based on the experience resulting from this transitional period.

The following issues will need to be examined as part of this review:

- How to address health threats that are not caused by biological agents (chemical, environmental, radio-nuclear, whether naturally occurring or man-made)

- Further development of inter-operability in preparedness and response to health threats

- Procedures to ensure coordinated communication to the public, in particular during health emergencies

- Ensuring full complementarity of all expert groups and committees working in the area of health threats, both under the Commission and ECDC

- Establishing coherent procedures for the adoption of decisions, recommendations and guidance dealing with health threats

- Integrated operation of existing rapid alert systems in the area of health threats, taking full account of the notification system to be established according to Art. 29 (i) of Directive 2002/98/EC (Community procedure for notifying serious adverse reactions and events and notification format related to human blood and blood components).

- Taking full account of the ongoing implementation process of the revised WHO International Health Regulations.

- Possibilities for observers from neighbourhood and third countries to attend relevant meetings where appropriate

3. ROLE OF THE HEALTH SECURITY COMMITTEE IN THE INTERIM PHASE (2006-2008)

The general review of the structures in the field of health threats will take time, in particular to take account of the evaluation of the ECDC activities planned to be completed in 2008. However, the mandate of the HSC should be updated now, to bridge the interim period.

The core functions of the HSC are two-fold: preparedness and threat management. The first consists of a preparedness forum, convened at regular intervals, the second a pro-active health crisis co-ordination, information exchange and advisory forum, acting on-the-spot in times of crisis, particularly when there are needs for intersectoral or security issues coordination (i.e. significant action extends beyond the health sector). The HSC facilitates coordinated policy decision making between Member States and at EU-level on public health issues that are within its mandate. This includes an input to the implementation process of the International Health Regulations by WHO as set out in the Communication from the European Commission to the European Parliament and the Council on the International Health Regulations[6].

Preparedness: the Communications on Generic Preparedness Planning and the EU Influenza plan stress the importance of preparedness. This needs to address major threats to health and to society, caused by biological, chemical, radio-nuclear, environmental events be they occurring deliberately, naturally, or accidentally. The HSC assesses the scientific and echnical advice provided, inter alia, by EU agencies in the context of the political, social, and economic implications for public health issues. In the context of influenza preparedness, the ECDC will continue to provide decision makers with the scientific advice and support towards improved preparedness at National and Community level. The Committee reviews and coordinates exchange of information on measures to be implemented at national level with regard to their supranational impact.

Threat and crisis management: the Committee members exchange information on health-related threats to ensure rapid communication in case of major health-related crises, advising on preparedness and response as well as on co-ordination of emergency planning at EU-level. This includes sharing and communicating information, co-ordination of information exchange on health-related responses and measures by Member States and co-ordination and cooperation in Europe, where this co-ordination is not provided by the Community Network for communicable diseases. Operational procedures to ensure such co-ordination and timely scientific support by the ECDC in times of crisis will be established.

4. MANDATE OF THE HEALTH SECURITY COMMITTEE IN THE TRANSITIONAL PHASE UNTIL 2008

The Health Security Committee (HSC) provides a forum for high-level representatives of the Member States to co-ordinate and advise on choices and decisions to be adopted either by the Council, the Commission or by MS in preparedness and response to major health threats and to act as an interface between different actors at European level. The HSC provides a forum at European level that coordinates information on intersectoral approaches and health security issues towards co-ordinated measures to the national level.

The HSC contributes to improve the management, at Community level and in the Member States, of health risks, threats and crisis, through addressing multi-sectoral and interdisciplinary questions. It proposes best solutions, focusing on preparedness work for chemical, biological and radio-nuclear (CBRN) threats and major health threats such as pandemic influenza and follow up the work on generic preparedness planning.

The HSC provides a setting to enable Member States’ representatives to meet when action is needed that surpasses the regular outbreak response ensured by the EWRS authorities as foreseen in Decision 2119/98/EC because of its multi-sectorial nature or because the responsibility for action is exclusively with the MS.

The HSC is comprised of high-level representatives of the Health Ministers of EU Member States authorised to make co-ordinated decisions and commitments with respect to preparedness planning and response to major health threats.

Membership of the Committee is restricted to one representative and his or her deputy for each Member State. Nominations by Health Ministers are to be addressed to the Director-General for Health and Consumer Protection at the European Commission. The ECDC and EMEA are represented. Representatives of acceding Member States, WHO, EEA countries and Switzerland are invited to participate as observers in non-restricted discussions. Security clearance is necessary for membership.

The HSC can delegate precise tasks or areas of work to working groups, composed of its members. Experts can be invited to the meetings. Operating procedures and working methods for the Committee and its working groups will be agreed by the Committee.

5. CONCLUSIONS

The Commission invites the Council to adopt conclusions which endorse the mandate of the Health Security Committee as outlined above in section 4 and allow for the continuation of the existing cooperation within the Health Security Committee.

[1] Established by the European Parliament and Council Decision 2119/98/EC

[2] COM (2003) 320 final

[3] COM (2005) 607 final

[4] COM (2005) 605 final

[5] Regulation (EC) No. 851/2004 of the European Parliament and the Council

[6] COM (2006) 552 final