Explanatory Memorandum to COM(2003)441 - European Centre [for Disease Prevention and Control] - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2003)441 - European Centre [for Disease Prevention and Control]. |
|---|---|
| source | COM(2003)441  |
| date | 08-08-2003 |
Communicable disease outbreaks can pose a significant threat to the health and well being of the European Union's citizens, as shown during the recent spread of the SARS virus (Severe Acute Respiratory Syndrome) and in the anthrax alerts of late 2001, which were thought to be due to bio-terrorism. In a European Union where millions of people cross internal and external borders each day, tackling health threats requires a much closer co-operation between Member States, the European Commission, the World Health Organisation and affected countries around the world. The European Union citizens place a very high value on the protection of their health. Communicable disease outbreaks, or other threats such as the deliberate release of chemical or biological agents from terrorist attacks, can cause considerable anxiety to citizens and huge costs to society, even when the number of cases remains relatively small. A major outbreak such an influenza pandemic could have catastrophic consequences. The draft European Convention of the future of the European Union has identified common safety concerns in public health matters as an area where Community competencies should be consolidated.
Since 1999, the Commission has managed a Communicable Diseases Network. This is currently based on ad hoc cooperation between Member States within the legal framework of Council and Parliament Decision 2119/98/EC. However, there is a need for a substantial reinforcement of this system if the European Union is to be in a position to control communicable diseases effectively. In 2000 and 2001, two external evaluations of the Network highlighted weaknesses in the functioning of existing structures and reviewed options for a more effective response capacity at the EU level. In 2002, the State Epidemiologists from the Member States gave their view on the future of the surveillance of communicable diseases at the European Union level and favoured the creation of an EU-level centre. In addition, in 2002, the Network Committee also adopted conclusions favouring the creation of an EU coordinating centre.
In June 2001, the European Council meeting in Gothenburg asked that the possibility of creating a European surveillance and early warning system on health issues be examined. The European Union's Employment, Social policy, Health and Consumer Affairs Council, at an extraordinary meeting held on 6 May 2003 to discuss SARS, and at its 2 June 2003 meeting recognised the need to strengthen the EU preparedness to deal with disease outbreaks within its borders. The Commission's intention to propose legislation creating a European Centre for disease prevention and control was widely supported.
The present proposal aims at creating a European Centre, able to provide a structured and systematic approach to the control of communicable diseases and other serious health threats, which affect European Union citizens. The creation of a European Centre for Disease Prevention and Control, an independent European agency, would mobilise and significantly reinforce the synergies between the existing national centres for disease control. The Centre would provide EU policy makers and citizens with authoritative and independent scientific advice on serious health threats and recommend control measures, thus enabling a rapid and effective EU-wide response. The technical work to be conducted between national disease control centres requires shared ownership of objectives, tasks and operations and pooling of resources at EU-level. The European Centre would create this shared ownership and facilitate the joint use of skills and resources to discharge common responsibilities in fighting serious health threats. The Commission would maintain its' overall supervision and existing decision making powers under Decision 2119/98/EC, in close consultation with the Member States through the Network Committee. The Commission's memberships in the Management Board would also ensure the coherence of the Centre's work with other Community policies dealing with health issues (e.g. development aid, research) and with international organisations, such as the WHO.
Contents
- 2. International health threats in the 21st century
- 3. Limitations of the current community network's activities
- 4. The European Union needs a Centre for Disease Prevention and Control
- 5. Main tasks of the European Centre
- Scientific opinions
- Early Warning and Response
- Technical Assistance
- Emergencies and Communication
- 6. The European Centre should be small but influential
- 7. The administrative structure
- 8. Making the transition from the current structure
- 9. Conclusion
Communicable disease has always been one of the major threats to human health. What has changed in the past few years is the growing realisation that natural outbreaks of communicable disease can still threaten both technologically advanced regions of the world such as the European Union as much as developing regions of the world with little health infrastructures. The possibility exists that a communicable disease outbreak could be started deliberately ("bio-terrorism"). In our increasingly interconnected and global world, a disease outbreak in one country can be spread internationally in a matter of hours or days.
In controlling a disease outbreak, time is of the essence. Every day lost in identifying the threat, deciding on control measures and implementing them can result in the outbreak spreading further. These lost days can mean the difference between a small outbreak and a serious epidemic. If the disease or pathogen involved is particularly lethal, then delay may cost lives.
Speed of reaction is of particular importance within the European Union. Products and people flow freely between EU Member States and controls have been abolished at internal borders. A small communicable disease outbreak in one country can become an international public health threat if national control measures are ineffective: for example, if a disease outbreak is not detected and contained in a timely way, if national authorities give out inconsistent or incomplete information, or even fail to notify other countries of the outbreak. Through migration or tourism, the SARS virus was able to spread in just in a few weeks from China to Europe, the Americas, and Asia. SARS was spread internationally by the movement of infected people. Since the deliberate release of anthrax in the US in late 2001 security services and authorities responsible for civil defence are taking the threat of 'bio-terrorism' attacks very seriously.
Lack of appropriate co-ordination structures regionally and internationally can contribute to this problem. A rapid, effective and co-ordinated response to health threats is therefore critical. In the SARS outbreak the shortcomings of present model of disease control were well demonstrated. Delayed detection of an ongoing outbreak allowed the virus to be spread by air travel from China to Canada, where an infected traveller was able to spread the virus among health care personnel in a Toronto hospital. Only after the WHO issued global health alert on March 12th, 2003, when the public as well as health professionals were informed about SARS, could measures to contain its spread be properly implemented. In the case of SARS, however, without international collaboration between health experts it would not have been possible to identify the virus and gather knowledge about its epidemiology in such a short time.
Major communicable disease outbreaks impact the whole of a society, not just its health sector. For instance, the SARS outbreak had an immediate, negative impact on economic growth in the Asian countries it affected. SARS may also, more indirectly, have had a negative impact on the EU economy. Taking rapid and effective action against a disease outbreak, and thus being able to reassure citizens that the outbreak has been contained, will protect Member States' economies, as well as their public health.
Under Article 152 of the Treaty, the European Community recognised the need to work more effectively on public health threats. The Community Institutions gave this practical effect with the adoption of the Council and the European Parliament Decision 2119/98/EC setting up a network for the epidemiological surveillance and control of communicable diseases in the European Community. This Decision envisaged the creation of Europe-wide surveillance and early warning and response mechanisms.
As far as early warning and response is concerned, the Network has partially fulfilled its coordinating role, but has not been able to fully follow up on the required technical actions and interventions. For epidemiological surveillance, specialists from the national institutes concerned, who already survey each disease group, were asked to create the so-called dedicated surveillance networks (DSN). Together these form the network of networks, which constitute the basis on which the Community network functions.
The Commission's role in coordinating activities has been limited to operating the system of EU subsidies that co-finances the dedicated surveillance networks, and designing and operating the telematic pilot system on the Early Warning and Response System (HSSCD/EUPHIN). The Commission has barely the financial and technical resources necessary to fulfil these functions. The Network Committee has been utilised for scientific advice and coordination purposes in ways that go far beyond the limited regulatory role foreseen for it in the 1998 Decision. The growing demands being placed on the Committee demonstrate the pressing need for a substantial reinforcement of resources if the expectations for health protection at EU level are to be met.
The basic formula for cooperation amongst Member States and the Commission in the framework of Decision 2119/98/EC is not being questioned. What is required is a much-extended capacity to provide independent scientific advice and effective operational coordination. Both the disease surveillance and the early warning and response activities needs more trained specialists to assess, investigate, and analyse outbreaks across Europe and abroad, particularly when there is a significant potential threat to the health of EU citizens. In some outbreaks, there have been several investigation teams from different Member States investigating the same phenomena with slightly different methodologies, sending samples to different laboratories, and finally each of them reporting separately.
It has become evident that the Communicable Disease Network cannot develop much further without new structures and arrangements to support Member States and the Commission in fulfilling their tasks. The more diseases the Network covers with the dedicated surveillance networks, the more the risk of fragmenting its structure has become apparent. These dedicated surveillance networks have been financed using annual subsidies from the Public Health Action Programme, in competition with many other projects. With ten new Member States in 2004 it will be impossible to continue with the existing structures and resources if surveillance activities in the Member States (and other partner states in the dedicated surveillance networks) are to be continued efficiently.
The ability to respond to an international health threat is profoundly influenced by the extent to which relevant issues have been studied in advance, and whether preparedness plans are in place for co-ordinated action. To address the threat of influenza, the World Health Organisation (WHO) has been working on a global pandemic plan, to facilitate the development of national plans. A complementary EU level preparedness plan is needed to facilitate the exchange of information between the European Community's laboratory and surveillance networks and to ensure that appropriate vaccines, antiviral agents and other materials can be made available rapidly. A European Centre could harness all these measures in a coherent and cost-effective way.
The public health responsibilities of the European Union have increased substantially, with the implementation of the Amsterdam Treaty and with rising expectations on the part of its citizens. This is reflected in many ways in the demands put on the Member States and the Commission to cooperate more closely both at EU level and internationally. Recent health threats have illustrated that one Member State alone does not generally have all the expertise available to address all possible aspects of a threat. It is only through intense and constructive international collaboration that the necessary expertise can be assembled. The added value is not only coordination but also pooling the expertise.
During the last three years, the Commission has initiated three external evaluations on the performance and improvements to be introduced in the operation of the Community network for communicable diseases (europa.eu.int/comm/dgs/health_consumer/index_en).
The first evaluation produced in September 2000 by the Institute of Public Health, North Rhine Westphalia, with the London School of Hygiene and Tropical Medicine and Public Health Laboratory Services (UK), focused on the weak points in the functioning of the existing structures, analysing transnational outbreaks of 5 diseases. It requested the Commission to put in place a framework for long term stability and sustainability of existing and new disease specific networks and recommended the development of some 15 types of actions at Community level which are all supporting the principles addressed in the present proposal. These cover such issues as EU level preparedness, EU coordination of outbreak investigations, and provision of assistance by experts on behalf of the European Union.
The second evaluation was completed in December 2001 by the Belgian Scientific Institute of Public Health in consultation with epidemiological institutes from all Member States, Norway and the WHO. It demonstrated the willingness and preparedness of the national competent bodies to participate in setting up a Community response capacity. It supported a strong central coordination mechanism supported by European technical co-ordination structure outside the Commission but financed by the Community budget and starting on a pilot scale as soon as possible.
Thirdly, in June 2002, the State Epidemiologists from the Member States gave their view to the Commission on the future of the surveillance of communicable diseases in Europe. They confirmed the coordination tasks identified in the two previous studies and concluded in favour of sufficiently resourced permanent technical coordinating structure at European level. They held the same view at a public seminar held in November 2002 in Brussels under the auspices of the European Parliament.
In line with Decision 2119/98/EC the Commission conducted an internal evaluation of the operation of the Community network during 2002 and submitted it to the Network Committee. The Committee endorsed the recommendations on the tasks to be preferably transferred to a European coordinating Centre. The Committee also considered the Commission did not have enough access to well trained specialist staff and that Commission arrangements for networking, surveillance and early warning would therefore be insufficient. The running of an internal operation in the Commission services would not be less costly and would not create the sense of shared ownership, which an independent centre would provide.
These orientations, already mentioned in the conclusions of the European Council at Gothenburg in June 2001, were reiterated during the extraordinary meeting of the Council of the European Union (Employment, Social policy, Health and Consumer Affairs) on 6 May 2003 and their subsequent meeting on 2 June 2003, where the idea of creating a European Centre for disease prevention and control was widely supported.
Member States epidemiological centres must have a privileged place in this cooperation. It will probably be from their resources that most of the exchanges of cooperation will take place. For example, their officials are likely to be essential partners in running dedicated surveillance networks, training actions, and intervention teams. The existence of such resources in the Member States means that a large European Centre is not needed. Arrangements to give the Centre access to resources in national centres will be the key to keeping the Centre a relatively small, but effective, coordinating entity. The Centre will provide a structure enabling experts from different Member States to work together, for example, in WHO global outbreak investigation teams, and facilitating the subsequent sharing of results. The Centre would work with national public health institutes in equal partnership.
The Centre would allow quick mobilisation of expert staff from the Member States to be used in European Community intervention teams for epidemiological investigation, and for on site check ups and risk assessments. There would be a core technical expertise in the Centre to provide technical assistance to the Commission, and to undertake technical collaboration with Member States and the WHO. The Centre would coordinate laboratory actions with microbiological laboratory networks. The Centre would be a source of information for all partners; the information given must be timely, accurate, easily understandable by users and adjusted to the different needs of the EU Institutions, Member States, public health institutes, the media, the public. When the Commission is preparing policy proposals or draft legislation, the Centre could provide authoritative scientific advice and technical input.
The Commission believes that an independent agency would be the best approach to enhance cooperation in an enlarged European Union. Such an agency - the European Centre for Disease Prevention and Control - would focus on communicable diseases, where there is already extensive experience of European cooperation and other emerging serious health threats. It would facilitate collaboration by the Commission and the Member States with other partners (e.g. third countries and international organisations, such as the WHO). This proposal provides for an appropriate legal base and a dedicated new budget line in the Community Budget. The role of the Centre in this Regulation is to be a visible centre of excellence to which the Commission and the Member States can go for authoritative advice and opinions.
In view of the scope and the mission of the Centre, there is also a need for coordination with other Community agencies, especially the European Food Safety Authority (EFSA) and the European Agency for the Evaluation of Medicinal Products (EMEA), both of which also deal with health assessments, early warning, and risk communication. There must be a clear commitment to avoiding duplication of work between agencies.
Epidemiological surveillance and networking of laboratories
The Centre would develop epidemiological surveillance at European level. In this work, the Centre could either use its own staff, staff from the dedicated surveillance networks (DSN), or, in some instances, it could subcontract tasks to a national centre of excellence. This gradual integration of epidemiological surveillance will lead to the harmonisation of surveillance methodologies, including better comparability and compatibility of the surveillance data collected in the Member States. The Centre could also identify and maintain networks of reference laboratories, and enhance the quality assurance schemes of microbiological laboratories.
To maintain high standards in the surveillance, early warning and response network, the necessary staff and technical resources need to be in place in the Member States and at the Community level. The Centre would facilitate the training of expert staff and provide opportunities for them to gain useful hands on experience. It could also serve as a place where the Member States could second officials from national institutes to work a limited period as part of their career development.
There is already considerable experience of cooperation between Member States' public health institutes on communicable diseases. Recognised procedures for cooperation, accepted by all, already exist. It therefore makes sense for the Centre to focus initially on communicable diseases, though it should also be able to deal with other emerging health threats if needed.
Public health decisions have to be based on independent scientific evidence. The Centre will support the Commission and Member States by providing this. The Centre would contribute to public health policies by providing scientific assessments and technical support, based on its scientific excellence, and maintained through its own expertise and that existing in the Member States. If there is insufficient scientific expertise in the Centre, or in the disease surveillance networks, the Director may, in consultation with the Advisory Forum, set up independent scientific panels for this purpose drawn from recognised scientific authorities and academia.
Scientific issues arising in the area of communicable diseases vary widely, ranging from questions of clinical medicine and epidemiology through to standardisation of laboratory procedures. Creating one permanent scientific committee to cover all these issues would not, therefore, be appropriate. The Centre would, instead, bring together scientific expertise in specific fields through its various EU-wide networks and via ad hoc scientific panels.
The Advisory Forum, consisting of scientists from public health institutes in the Member States, would support the Director in ensuring excellence and independence of the Centre's scientific work. The Centre would issue scientific opinions in accordance with procedures defined in the Regulation.
Information made available through EU funded research projects and other EU agencies, such as European Food Safety Authority (EFSA) and European Agency for Evaluation of Medicinal Products (EMEA) would have to be used by the Centre where appropriate. Its scientific panels would not be allowed to duplicate work done elsewhere. The Centre should foster, develop and steer applied scientific studies to enhance policy development and also studies to develop and enhance its own operation effectiveness. To avoid duplication, the Centre will co-ordinate its research capacity building and scientific actions with those of the Member States and the EU Framework Programme on Research.
To be effective the early warning and response system (EWRS) requires around the clock availability of specialists in communicable diseases. Whilst the responsibility for action will remain with Member States and the Commission, technical operation of the EWRS would be undertaken by the Centre and its networks.
The Centre would coordinate, as appropriate, with relevant EU agencies, such as the European Food Safety Authority, and with other alert systems, such as those run by the WHO. Response is a key element in preparedness and control of outbreaks. Rapid reaction can ensure a disease outbreak is limited and prevent its deteriorating into a wider crisis. The Centre will be a source of assistance and advice to the Commission and the Member States in managing these risks.
The Centre's rapid reaction capacity could cover more than the European Union itself, to similar structures in such areas as the EEA/EFTA, and candidate countries. When requested, it would send an EU-team to investigate an outbreak of an unknown human disease in a European country. The Centre should also have the ability to support, if necessary those Commission services that give humanitarian aid or other types of assistance in response to disease outbreaks in third countries. In these situations, the technical assistance should be co-ordinated with the appropriate Commission services, and relevant EU programmes. The Centre would have a particular role in defining action in those states that might import the disease. In the case of an outbreak investigation mission, depending on the identification of the source of the outbreak (environmental, food, animal, chemical, deliberate release etc.) other appropriate EU agencies, and the WHO may have to be involved, in order to strengthen the coherence of the combined efforts avoid duplicating activities.
The Centre should have a major role in coordinating the response to serious health threats of EU-wide significance. The need for co-ordinated action is of pivotal importance, taking into account all the actors involved in emergencies. For example, public health authorities, civil protection, the military and civil society may all need to be involved in responding to an epidemic. Considering the relatively small size of the Centre, however, it will only be able to take on such a coordinating role where the health threat is of direct relevance to its operational goals.
Objective, reliable and easily accessible information is essential for the general public and as well as for decision-makers in the Commission, Member States, and international organisations. The Centre will communicate about its activities and results, and disseminate information tailored to meet the needs of its different audiences. Using various media and communications tools, the Centre will ensure that its information is easily accessible, reliable, and understandable.
The Centre would remain small in terms of human resources, but possessing a far larger influence through its synergy with national institutes. The staff will include relevant specialists, such as epidemiologists, public health experts, microbiologists, logisticians and medical writers, as well as administrators.
The Centre will be funded from the Community budget, based on a proposal from the Commission and approved by the Budgetary Authority. Total annual costs in the beginning of its operation would be around 12 Mio EUR and after five years around 48 Mio EUR.
Within this budget, in addition to its normal running costs, the Centre should have an appropriate contingency budgetary, of up to 5 Mio EUR when the Centre is fully operational, to enable it to respond speedily and adequately to public health threats, when needed. The contingency budget must be sufficient to cover the breadth of operations which might be called for in such diverse settings as outbreak investigations, in the European Union or elsewhere, deliberate release of biological agents, or controlling a potential influenza pandemic. The Centre should also have a consultative role in providing scientific advice in crises, such as in an influenza pandemic, where public health is involved.
As with other similar independent Community agencies, the Centre will have a three pillar administrative structure:
- A Director and his/her staff. The Director will be responsible for everyday administration, as well as the preparation and implementation of the Centre's work programme.
- A Management Board will ensure that the Centre carries out its missions and tasks, by adopting its annual work programme and financial regulation. The structure of the Management Board - representatives appointed by the Commission, representatives appointed by the Council, and representatives of stakeholders - is intended to provide supervision of the activities of the Centre and at the same time ensure coherence with action under Community policies and national initiatives.
- An Advisory Forum, which will be composed of members chosen from senior scientific personnel form the national competent bodies. The Advisory Forum will be a mechanism for exchanging information and pooling knowledge, as well as monitoring the scientific excellence of the activities of the Centre.
There is a budget in place from the Public Health Action Programme to carry out some of the preparatory work to set up the Centre. Until 2006, external expertise can be used to prepare the integration of the existing Dedicated Surveillance Networks into the Centre. Projects dealing with capacity building, dissemination of information and training might be candidates for early integration into the new structure.
It is also important for relevant laboratories to become involved in European level surveillance activities. The Commission will enhance the development of laboratory networks, including those European laboratories with the capacity to handle highly contagious micro-organisms, like smallpox virus. It will maintain and update the support databases and develop the Early Warning and Response system (EWRS) further. The procedures for effective exchange of information will also be developed.
Before the Centre becomes operational the Commission will concentrate on making the intervention teams, currently set up on a national basis in an ad hoc manner, more effective. This will be done in collaboration with the Member States taking account the Commissions existing actions in third countries in particular in liaison with the WHO. Running high quality surveillance, early warning, and response is not possible without trained specialists, with a variety of expertise at national and EU level.
The Task Force on deliberate release of chemicals and biological agents (BICHAT) was set up by the Commission in 2002 to identify the special needs in surveillance and response that might be necessary should a terrorist attack be envisaged. The Task Force comprises a number of seconded national experts from the Member States over a limited time period and it reports through the Health Security Committee of personal representatives from the Ministers of Health of the Member States. Eventually the work of the Task Force will need to be taken over by the Centre.
The dangers posed by communicable diseases do not diminish. Multiresistant tuberculosis, HIV/AIDS and more recently SARS remind the European Union to be on its guard. Enlargement reinforces the need to put in place adequate EU-level capacity, building on Member States' systems and the existing Communicable Disease Network, to respond to such health threats. The creation of a European Centre for Disease Prevention and Control will ensure efficient networking and pooling of Member States' scientific expertise and facilitate more effective preparedness planning. By doing this, the Centre will strengthen the EU capacity to react to future health threats.