2797

2793

2790

2750

SP(2006)3311

SP(2006)3310

2739

Results of vote in Parliament

The European Parliament adopted a resolution based on the own-initiative report drafted by Adamos ADAMOU (GUE/NGL, CY) in response to the Commission communication on pandemic influenza preparedness and response planning in the EU. Determined to enhance the EU’s readiness to deal with a flu pandemic, Parliament voted by 612 votes to 26 with 7 abstentions. It welcomed the Commission Communications as well as the assessments of national pandemic influenza plans that were currently being undertaken by the European Centre for Disease Prevention and Control (ECDC), the Commission and WHO, European Region. The Commission must play a strong coordinating role between the Member States in all activities relating to pandemic preparedness in the EU and it should strengthen the ECDC's capacity to identify the key public health measures that must be taken in the event of a pandemic.

Parliament called on the Commission and the Member States to take account of the relevant reports and on-the-spot investigations of the ECDC and to ensure that those Member States whose planning to combat a pandemic was substandard upgrade their plans, since the nature of the risk was such that all Member States must be fully prepared. In the event of an influenza pandemic in the EU or in neighbouring States, the Commission should within 24 hours be able to adopt crisis measures such as quarantine and disinfection measures at airports in connection with flights from certain regions and travel restrictions.

Significant measures, including a full assessment of hospital bed capacity at Member State level, must be taken to prepare for a possible human pandemic. Parliament acknowledged the need for detailed scenarios for the protection of children and young people against the avian influenza A virus (H5N1) to be drawn up. Particular attention should be paid to developing further the capacity to produce pandemic vaccines and anti-virals in Member States and at European level. In this connection, the EU should provide logistic and financial assistance with the development of vaccines.

Parliament went on to state that pandemic influenza simulation exercises were vital in order to test the effectiveness of each Member State's national pandemic influenza plans, together with a need to strengthen surveillance systems, rapid reporting and alerting systems, data analysis and epidemiology for animal and human diseases. Rapid assessment was also required of the immediate socio-economic impact of avian influenza and of compensation issues and associated incentives. The Commission, the ECDC and the Member States were urged to put in place a system for the continuous exchange of information between them and affected countries and thus to assist in the development of best practices.

In addition, sufficient funds should be made available by the Commission and the Member States in order to provide people with more pertinent, understandable and tangible information and thus raise public awareness. Parliament suggested the creation of a European Influenza Task Force, coordinated by the Commission, on which the European Parliament was represented. This Task Force should work together with representatives of European vaccine and antiviral industries. European research and development programmes on emergent diseases must be launched immediately to develop antivirals, antibiotics and vaccines reliably and more quickly.

Parliament stressed that planning for obtaining pandemic vaccines is in most countries underdeveloped and measures should thus be taken to further develop it in accordance with WHO recommendations by giving the Commission a mandate to order vaccines and establish a Community stockpile. The Commission was asked to liaise with vaccine manufacturers to evaluate progress towards vaccine production capacity increase and equity of supply in pandemic situations. It should also address, together with the Member States, questions of liability and the establishment of a European mechanism for equitable distribution of pandemic vaccines that does not breach contractual agreements established by Member States. Parliament considered that the Commission should take steps to ensure that sufficient antivirals and vaccines are available for those who are exposed to the virus in the event of an outbreak in one or more Member States, and it emphasised the role of the European Medicines Agency, EMEA, in determining the use and effectiveness of anti-virals and pandemic vaccines.

Parliament called on the European Union to take the necessary measures to obtain adequate stocks of antivirals and to establish a compulsory licensing system with businesses which produce antivirals to guarantee mass production of these antivirals. Countries should provide for potential cover for 25 to 30% of the population with available antivirals.

It pointed out that adequate funding should be provided in the 7th Research Framework Programme in order to support projects addressing various aspects of pandemic influenza and other epidemics including joint research with pharmaceutical companies on cell-based and DNA vaccines.

Finally, Parliament pointed out that the European Union had a legitimate reason to provide technical, scientific and economic assistance to countries already affected and in particular to contribute to raising global awareness.

T6-0259/2006

Debate in Parliament

The Council held an exchange of views on pandemic influenza preparedness and planning, focusing specifically on the steps to be taken, at EU level, in order to be prepared in case of a human pandemic influenza.

Delegations expressed their views concerning the establishment of a European strategic stockpile of antivirals and the number of treatments that this stockpile should comprise, the virtual or actual nature of the stockpile, the moment when the stockpile should be established. The exchange of views followed-up the discussion at the informal meeting of Health Ministers in Vienna, in February and April 2006. Discussion on legal, technical and financial aspects of this issue will continue under the forthcoming Presidency.

2733

2730

A6-0176/2006

A6-0176/2006

The committee adopted the own-initiative report drawn up by Adamos ADAMOU (GUE/NGL, CY) in response to the Commission communication on pandemic influenza preparedness and response planning in the EU. The report referred to the recent increase in the number of cases of avian influenza and human casualties from it in various countries, and stressed that it was a global problem which must be addressed in close cooperation with the WHO.

MEPs said that the Commission must play "a strong coordinating role" in pandemic influenza preparedness and that, in the event of a pandemic in the EU or in neighbouring states, it should be able to adopt crisis measures within 24 hours, such as quarantine and disinfection at airports as well as travel restrictions. They called for the creation of a European Influenza Task Force, coordinated by the Commission and on which Parliament would be represented, bringing together experts from relevant fields such as human and animal health, virology, epidemiology, pathology, agriculture and communications.

The committee called for improved cooperation and information-sharing between the Commission, the Member States and the European Centre for Disease Prevention (ECDC). Communication strategies at both national and EU level should be improved and Member States should ensure that information reaches the whole population, including the old, the young, the illiterate or those who do not have access to modern means of communication. Sufficient funds should be made available by both the Commission and the Member States for information campaigns.

The report emphasised that "significant measures" must be taken to prepare for a possible human pandemic, including a full assessment of hospital bed capacity at Member State level and regular pandemic simulation exercises (including in outlying regions and rural areas). It also acknowledged the need for specific scenarios for the protection of children, as well as the need to strengthen surveillance and alerting systems.

MEPs called for European R&D programmes on emergent diseases to be launched immediately to develop new antivirals, antibiotics and vaccines reliably and more quickly, and for sufficient funding to be provided under the 7th Research Framework Programme for projects on pandemic influenza and other epidemics. The Member States were urged to provide for potential cover for 25 to 30% of the population with available antivirals, while the Commission was asked to ensure that sufficient antivirals and vaccines are available for those exposed to the virus in the event of an outbreak in the EU.

In other recommendations, the report called for sufficient financial support to be provided to Asian and African countries struggling with avian influenza to improve their surveillance and disease control capacities, and urged the Commission to work for a more coherent international framework to help build up a better infrastructure for animal health in developing countries and advance research into animal health products.

PE371.949

PE370.248

PURPOSE : to adopt plans on pandemic influenza preparedness and response planning in the EU.

CONTENT : this Communication outlines the key elements and sets of actions of the Community Pandemic Influenza Preparedness and Response Plan. Implementation will require more detail to be developed for those charged with operational tasks in the Commission, the ECDC, the EMEA and the Member States’ authorities. It will need periodic revision in the light of international discussions and on the basis of experience, during seasonal influenza and from cross-countries exercises.

Close co-operation will continue under the auspices of the Commission between human and animal health authorities and experts at national and European level in the area of influenza virus infections. In this context, a mutual exchange of experiences in contingency planning is of major importance, as contingency plans in animal health are already well established and have proven to be effective in the past. Preparing and responding to influenza pandemics presents a formidable challenge and requires increased efforts by the Member States and the Commission. This should be done as part of a more general approach to public health emergencies, in order to use scarce resources effectively, benefit from the widest possible expertise and keep procedures and functions manageable and as simple as possible; the Commission has published a communication on generic public health emergency planning to aid these efforts. The European Centre for Disease Prevention and Control (ECDC) can provide a structured and systematic approach to the surveillance and control of influenza and other communicable

diseases that might affect the people of the European Union. The ECDC can mobilise and significantly reinforce the synergies between the existing national centres for disease control and will no doubt help the Commission and the Member States to deal effectively with influenza.

Inter-sectoral action will be a key issue in tackling pandemic influenza. Many actions have already been undertaken at national and at EU level to ensure that measures in the various sectors of policy are effective and coordinated. But more needs to be done and the Commission and the Member States are carrying work forward in this respect. Particularly important will be the tackling of the pandemic problem at its source; the external action of the Community, in this respect, is important in helping the competent international organisations and third countries to face up to a possible pandemic and reduce its spread and impact.

A crucial element of responses to a pandemic at any level is to ensure that they are multisectoral and encompass services outside the health sector. Member States and the Commission must, therefore, have in place and update strategies for planning and coordination that will facilitate multi-sectoral collaboration.

The development of plans for pandemic influenza involves the principles and components of a planning process presented in the Commission Communication on strengthening coordination on generic preparedness planning for public health emergencies at EU level. Application of this planning process to pandemic influenza has identified the following key topics on which to base the EU pandemic influenza plan:

Planning and coordination : EU added value can be achieved by improving coordination and communication among the Commission and the Member States with assistance from the ECDC, other European agencies such as the EMEA and the European Food Safety Agency (EFSA), and with the WHO; Monitoring and assessment : the most important task of the surveillance and diagnostic systems of the Member States is to provide early detection and characterisation of pandemic strains from clinical or other specimens and a reliable risk assessment as to its potential to cause widespread outbreaks in humans; Prevention and containment : a key countermeasure for preventing influenza is vaccination. As part of the prevention and containment plan the following could be pursued: provision of estimates of the need for vaccines, anti-virals and antibiotics from Member States according to the likely scenarios for their use; determination of priority groups for vaccination, when vaccine is in short supply; establishment of options for public health measures to minimise morbidity and social disruption when there is rapid accumulation of cases of influenza; collection of information from manufacturers about production capacities and plans for vaccines, antivirals and antibiotics. The Commission agreed with the Member States a policy document on public-private partnership (PPP) between public bodies and the vaccine industry to deliver influenza vaccine to the EU population in the shortest possible time in the event of influenza pandemic; Health system response : it is important that hospitals have well established emergency plans to handle numerous cases and ensure continuity and resilience, clinical guidelines are ready, supplies are available and staff is aware of admission criteria. It is Member States responsibility and competence to ensure that citizen have access to best practice and it is a Community objective that inequities in this area are smoothed among countries and regions. Moreover, staff working in health care should be aware of and trained in infection control measures; Communication : a communications plan has to be prepared for each phase and level. The more serious the threat, the more important it will be to ensure efficient communication to the general public and to the media.

COM(2005)0607
EUR-Lex

PURPOSE: to adopt plans to strengthen coordination on generic preparedness planning for public health emergencies at EU level.

CONTENT : public health emergencies are dominated primarily by events related to pathogens transmitted from person to person or through unsafe food or products; or through animals and plants or by harm to individuals by the dispersion or action of biological, chemical or physical agents in the environment. Common to all such emergencies are assets and resources to be used and consequence management aspects to go through in developing emergency or contingency plans.

This communication identifies the key building blocks of generic preparedness planning. It is based on experience gained through the exchange of information and sharing between the Commission and Member States of plans concerning smallpox and pandemic influenza and extensive work with the help of the Health Security Committee and the Community Network for the epidemiological surveillance and control of communicable diseases in the European Community. This led to the elaboration of a detailed technical guidance document which contains individual attention points, objectives, checklists and division of public health roles and functions for Member States, for relevant Community Agencies and for Commission services for each of the key components of the planning process. This technical guidance document is continuously updated with contributions from the Member States and the Commission services competent for the relevant sectors of Community action. It also sets out the topics that need further work and additional efforts in order to inform and reinforce national plans and enhance coordination at EU level.

The overall goal is to assist Member States in developing their plans and factoring in the EU dimension, with its body of laws in various sectors with a bearing on public health emergency plans. The Communication together with the technical guidance document provides the backbone for developing core elements in national plans, addressing generically different types of health threats, whether anticipated (such as pandemic influenza) or unexpected (e.g. a SARS–like epidemic) and aims at improving the interoperability of such plans. The framework for cooperation in generic preparedness planning in the EU covers three main activities:

sharing national plans and making comparisons, evaluations, in particular through joint tests and guidance on peer reviews of plans, and improvements on the basis of specific checklists set out in the technical guidance on generic preparedness planning; identifying the contribution and role of existing Community legislation and ensuring that national plans take them fully into account, as well as examining the need for further Community measures; examining and improving implementing arrangements, which could help improve the timely flow of information and the interoperability and congruence of plans and responses.

The key components that need to be fully addressed in order to arrive at public health emergency plans are:

1. Information management : it involves surveillance and medical intelligence, data from sensors and monitors and meters of all sorts, clinical and epidemiological data, health data and statistics, and data on products, goods, infrastructure and services relevant to the emergency. Clinical and laboratory diagnosis is part of the organisation of information management, both to identify unknown agents and to confirm known agents. Member States are responsible for diagnosis and the Community, through reference laboratories, together with the ECDC, provides a EU-wide cooperative platform on laboratory and quality procedures, collating clinical data and secondary confirmation, which, however, needs to be improved further.

2. Communications : the distribution of accurate and timely information at all levels is critical in order to minimise unwanted and unforeseen social disruption and economic consequences and to maximise the effective outcome of the response.

3. Scientific advice : the preparation and rendering of scientific advice needs to be integrated in the management of the emergency, through the establishment at all levels and areas of structures such as

groups of experts or committees and through rapid consultation on risk assessment and examination of the scientific and technical basis for options for response. Once the emergency has been recognised, scientific guidance, including predictions based on scientific modelling, should be available on options for response and recovery and the resilience of key systems such as water supply, sanitation, health services and medical goods and supplies, etc. shelter sites and rescue structures and protection materials, ports and transport networks, warehouses and communications systems. Member States and the Commission are working together to improve the predictive capability of models.

4. Liaison and command and control structures : the three phases of a response during a public health emergency are detection-diagnosis, control and treatment, but these may exist simultaneously during the emergency. The interaction between the three poses serious problems in terms of taking the right steps and following the proper course of action throughout the response by all the intervening actors

and resources. The Commission is setting up the ARGUS system which interlinks all Community rapid

alert systems and a crisis coordination centre with appropriate coordinating structures to ensure timely initiatives and responses in each area of Community policy in case of emergency.

5. Preparedness of the health sector : catering for the persons affected will vary from one Member State to another, depending on the health infrastructure and care organisations in each. Resources for epidemiological and laboratory investigation are pooled and shared at EU level to a considerable degree through networks with the help of the Commission and will be overseen and further improved by the ECDC. The Commission proposes in the future Community Programme for Health and Consumer protection 2007-2013, to support projects on the establishment and the maintenance of a trained and

permanently available core group of public health experts for global rapid deployment to places of major health crises together with mobile laboratories, protective equipment and isolation facilities.

6. Preparedness in all other sectors and inter-sectorally : the processes required to deal with public health emergencies beyond the health sector work in two ways: they serve to prepare other sectors to assist the public health authorities in medical interventions, such as triage, isolation, quarantine, treatment and medicine administration and vaccinations, and they also serve to introduce and apply measures dealt with mostly by other sectors, such as logistics. Preparedness in other countries is crucial if the European Union is to be protected from health risks that could spread from these countries to the EU. Addressing a co-ordinated approach inside and outside the EU is required to protect the health of EU citizens from already known and unanticipated health threats. As regards the external policy, the EU is already working with third countries and international organisations, in particular, the UN agencies, such as the Food and Agriculture Organisation (FAO), WHO, the World Bank, etc, to assist countries affected by public health emergencies. Moreover, the Commission facilitates increasing involvement of the European Neighbourhood Policy (ENP) partners in the European networks, such as on communicable diseases and has action plans with Ukraine, Moldova, Israel, Jordan, Morocco, and Tunisia.

COM(2005)0605
EUR-Lex

PURPOSE : to adopt plans on pandemic influenza preparedness and response planning in the EU.

CONTENT : this Communication outlines the key elements and sets of actions of the Community Pandemic Influenza Preparedness and Response Plan. Implementation will require more detail to be developed for those charged with operational tasks in the Commission, the ECDC, the EMEA and the Member States’ authorities. It will need periodic revision in the light of international discussions and on the basis of experience, during seasonal influenza and from cross-countries exercises.

Close co-operation will continue under the auspices of the Commission between human and animal health authorities and experts at national and European level in the area of influenza virus infections. In this context, a mutual exchange of experiences in contingency planning is of major importance, as contingency plans in animal health are already well established and have proven to be effective in the past. Preparing and responding to influenza pandemics presents a formidable challenge and requires increased efforts by the Member States and the Commission. This should be done as part of a more general approach to public health emergencies, in order to use scarce resources effectively, benefit from the widest possible expertise and keep procedures and functions manageable and as simple as possible; the Commission has published a communication on generic public health emergency planning to aid these efforts. The European Centre for Disease Prevention and Control (ECDC) can provide a structured and systematic approach to the surveillance and control of influenza and other communicable

diseases that might affect the people of the European Union. The ECDC can mobilise and significantly reinforce the synergies between the existing national centres for disease control and will no doubt help the Commission and the Member States to deal effectively with influenza.

Inter-sectoral action will be a key issue in tackling pandemic influenza. Many actions have already been undertaken at national and at EU level to ensure that measures in the various sectors of policy are effective and coordinated. But more needs to be done and the Commission and the Member States are carrying work forward in this respect. Particularly important will be the tackling of the pandemic problem at its source; the external action of the Community, in this respect, is important in helping the competent international organisations and third countries to face up to a possible pandemic and reduce its spread and impact.

A crucial element of responses to a pandemic at any level is to ensure that they are multisectoral and encompass services outside the health sector. Member States and the Commission must, therefore, have in place and update strategies for planning and coordination that will facilitate multi-sectoral collaboration.

The development of plans for pandemic influenza involves the principles and components of a planning process presented in the Commission Communication on strengthening coordination on generic preparedness planning for public health emergencies at EU level. Application of this planning process to pandemic influenza has identified the following key topics on which to base the EU pandemic influenza plan:

Planning and coordination : EU added value can be achieved by improving coordination and communication among the Commission and the Member States with assistance from the ECDC, other European agencies such as the EMEA and the European Food Safety Agency (EFSA), and with the WHO; Monitoring and assessment : the most important task of the surveillance and diagnostic systems of the Member States is to provide early detection and characterisation of pandemic strains from clinical or other specimens and a reliable risk assessment as to its potential to cause widespread outbreaks in humans; Prevention and containment : a key countermeasure for preventing influenza is vaccination. As part of the prevention and containment plan the following could be pursued: provision of estimates of the need for vaccines, anti-virals and antibiotics from Member States according to the likely scenarios for their use; determination of priority groups for vaccination, when vaccine is in short supply; establishment of options for public health measures to minimise morbidity and social disruption when there is rapid accumulation of cases of influenza; collection of information from manufacturers about production capacities and plans for vaccines, antivirals and antibiotics. The Commission agreed with the Member States a policy document on public-private partnership (PPP) between public bodies and the vaccine industry to deliver influenza vaccine to the EU population in the shortest possible time in the event of influenza pandemic; Health system response : it is important that hospitals have well established emergency plans to handle numerous cases and ensure continuity and resilience, clinical guidelines are ready, supplies are available and staff is aware of admission criteria. It is Member States responsibility and competence to ensure that citizen have access to best practice and it is a Community objective that inequities in this area are smoothed among countries and regions. Moreover, staff working in health care should be aware of and trained in infection control measures; Communication : a communications plan has to be prepared for each phase and level. The more serious the threat, the more important it will be to ensure efficient communication to the general public and to the media.

COM(2005)0607
EUR-Lex