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Brussels, 29 November 2005
Why did the Commission draw up a new EU influenza preparedness plan?
There have been many developments since the Commission published its last influenza preparedness plan in March 2004. Firstly, the WHO updated its definitions of pandemic phases in 2005, placing more emphasis on pre-pandemic phases e.g. when threats exist in animal viruses or when a new human virus emerges but does not spread efficiently. The WHO recommendations for pandemic preparedness are based on these defined phases, and therefore, this needed to be factored in to any EU preparedness planning. Secondly, the European Centre for Disease Prevention and Control (ECDC) became operational in May 2005, and its central role in preparing for a pandemic needed to be clearly defined in the overall EU plan. Finally, it is necessary to continually review and revise national preparedness plans in light of new information and latest disease situations in order for them to be properly effective. The progression of avian influenza from South East Asia over the past few months, and global concern at the possible the emergence of a new pandemic-causing virus, have made it all the more pertinent that the EU reviews its plan to prepare for and deal with a pandemic.
What are the WHO pandemic phases and EU pandemic alert levels?
The WHO, in its recommendations on pandemic influenza, defines 6 different phases of a pandemic, ranging from Phase 1 (no new influenza virus subtypes detected) to Phase 6 (full-scale global pandemic). Phases reflect the cycle of a pandemic, i.e. inter-pandemic, pandemic alert, pandemic and post-pandemic period. The WHO advice on action to be taken is tailored to each of these phases. The EU has based its pandemic planning to a large extent on the WHO recommendations. However, in its preparedness plan, the Commission has introduced EU alert levels, which relate more directly to the situation in the EU, rather than the global situation encompassed in the WHO phases. For example, WHO pandemic phase 6 could be announced if the disease became widespread in Asia, but may not yet have reached Europe. The EU alert levels (levels 1-4) would occur within a WHO Phase 6 pandemic, and the alert level would rise depending on how widespread and virulent the virus was in the EU.
What are the recommended responses to each pandemic phase in the new influenza preparedness Communication?
WHO Phase 1: No new influenza virus subtypes have been detected in humans. An influenza virus that can cause human infection may be present in animals, but the risk of human infection or disease is considered to be low.
The main public health goal is to strengthen influenza pandemic preparedness at global, regional, national and local levels.
WHO Phase 2: No new influenza virus subtypes have been detected in humans. However, a circulating animal influenza virus poses a substantial risk of human disease. The Communication states that at this phase, pandemic preparedness plans at national and EU-level should be strengthened and their interoperability tested. The main goal is to minimise the risk of the virus being transmitted to humans, and to detect and report such a transmission if it occurs. Cooperation between the pubic health and animal health sectors is important.
WHO Phase 3: Human infection(s) with a new virus subtype, but no human-to-human spread except in rare instances of close contact.
The main public health goal is to ensure rapid characterisation of the new virus subtype, and aim for early detection, notification and response to cases. At this point:
WHO Phase 4: Small cluster(s) with limited human-to-human transmission, but the spread is highly localised, suggesting that the virus is not well adapted to humans.
The main objective is to contain the new virus or delay its spread, in order to buy time to implement preparedness measures. Member States must send information on detected human cases through the EWRS.
Among the responsibilities of the Commission at this alert level are:
WHO Phase 5: Large cluster(s) but human-to-human spread is still localized, suggesting that the new virus is becoming better adapted to humans, but may not yet be fully transmissible. At this point, there is deemed to be substantial risk of pandemic.
Efforts to contain or delay the spread of the disease should be maximised. Member States must send information on detected human cases through the EWRS. Among the responsibilities of the Commission at this phase are:
WHO Phase 6: Pandemic – increased and sustained transmission in general population.
The EU alert level now varies from 1 to 4, depending on how widespread the disease is in Europe. The main public health objective is to minimise the impact of the pandemic. At this phase, the Commission will, amongst other actions, establish a pandemic information and coordination centre, coordinate the development of guidelines on action to be taken by various sectors, and evaluate the impact of measures already being taken. Interaction with all international organisations and agencies to coordinate the response is crucial. The Commission will also facilitate mutual aid arrangements between countries e.g. the mobilisation of immunised health-care workers.
What role is outlined for the European Centre for Disease Prevention and Control (ECDC) in preparing for pandemic influenza?
The mission of the ECDC, which became fully operational in Stockholm in May 2005, is to strengthen Europe’s defences against epidemics. The agency therefore has a central role in preparing for, and responding to, an outbreak of pandemic influenza. The Communication outlines the main tasks of the ECDC, in terms of general influenza preparedness, but also during each of the WHO pandemic phases. The key responsibilities of the ECDC are to identify, assess and communicate current and emerging human health threats, including those caused by influenza viruses. It should analyse and assess, in real time, the human health risk related to latest developments on influenza. On the basis of its assessments, the ECDC should provide relevant and up-to-date scientific information, and timely advice, for effective outbreak management. Another important function allocated to the new agency is the technical operation and round-the-clock monitoring of the early warning and response system (EWRS), which is essential for an effective and coordinated EU response in an outbreak.
What is the Early Warning and Response System?
The Early Warning and Response System (EWRS) is a tool set up by the Commission to link the designated authorities in Member States and the Commission in the case of a health crisis. This highly developed I.T. system allows for the immediate exchange of views on risk assessment and risk management, which is crucial for timely reaction. Member States are obliged (under Decision 2119/98) to relay any information that they have of a public health threat that could have international consequences, through the EWRS as soon as possible. They should also give details of any measures they take to counter the threat. The EWRS has already proven to be a useful tool during a number of public health emergencies, including the SARS outbreak in 2003 and a rabies case in France in 2004 (see IP/04/1050).
What has the Commission been doing to promote EU-level coordination on pandemic influenza preparedness?
The Communication on influenza preparedness adopted today updates the working paper on “Community pandemic influenza preparedness and response planning”, published by the Commission in March 2004. Since the publication of that plan, the Commission has been working with Member States and the WHO to help Member States draw up and improve their own national preparedness plans. All Member States now have pandemic preparedness plans in place.
These were studied and assessed by the Commission, ECDC and WHO, and 2 workshops were held this year (in March and October) with Member States, to address weaknesses and close gaps in the national plans. Work by the Commission and Member States to keep improving and updating national plans as necessary is ongoing.
On 23-24 November, the Commission, Member States, WHO, ECDC and the pharmaceutical industry took part in a command-post exercise on pandemic influenza. The exercise aimed to test communications, information exchange and coordination between Member States, EU bodies and international organisations in a public health emergency. It also tested the inter-operability of national pandemic preparedness plans, and provided an opportunity to put into practice plans that had, up until then, only been on paper.
The Commission has also placed great emphasis on promoting various networks to bring key players together in addressing the threat of influenza. Networks of veterinary and human health laboratories are already in place in the EU, as is an EU-funded network known as the European Influenza Surveillance Scheme (EISS), which monitors seasonal influenza outbreaks each winter. The Commission is now working to establish improved co-operation between EISS, the ECDC and the Community Reference Laboratory for Avian Influenza, as well as other relevant European and international organisations dealing with animal and human health, to ensure better preparation in case of a pandemic. This led, in September 2005, to the adoption of a Technical Guidance Document on procedures for communicating influenza A/H5 events in humans to Member States, the ECDC and the Commission.
What is the Commission doing to help secure sufficient vaccines and antivirals in case of a pandemic?
Member States have been encouraged by the Commission to factor stockpiling of vaccines and antivirals into their national preparedness plans. To help facilitate this, the Commission is promoting a Public Private Partnership (PPP) between the European vaccine industry and Member State authorities. The aim of the PPP is to increase emergency capacity in the vaccine sector and find fast-track procedures for producing, and then authorising, a pandemic vaccine. For antivirals, the Commission is also pursuing talks with industry to discuss the availability of antivirals in different forms and supply difficulties experienced by several Member States.
A Solidarity Fund was proposed by the Commission in April 2004, to reimburse costs that might be incurred in a major public health emergency, to the level of 1000 million euros annually. This would cover part of the costs of vaccines and antivirals, and serve as an incentive for Member States to conclude advance purchase agreements with the industry and help contribute to a more equitable supply. EU Member States will be reimbursed following a proposal by the Commission and a favourable decision taken by qualified majority by the Council.
Has any EU-funded research been carried out in this field?
The European Union has several projects, totalling 12.4 million euros, seeking to develop new technologies to combat an influenza pandemic in the human population, through the development of new vaccines, the establishment of surveillance networks, monitoring drug resistance and examining the use of antivirals.
Why has the Commission drawn up a Communication on preparing for major public health threats?
The September 2001 terrorist attacks in the USA and heightened global concern about bioterrorism, the SARS outbreak of 2003, and the recent fears of an impending worldwide flu pandemic, have all highlighted the need for strong preparedness plans against any public health emergency – anticipated or unexpected. In 2003, EU Health Ministers, recognising the benefit of having a preparedness plan to cover all health threats rather than a proliferation of disease-specific strategies, asked the Commission to develop a blueprint for national generic preparedness planning. The objective of the Communication is to provide Member States with a basis on which to develop generic preparedness plans, while also factoring in EU considerations, such as legislation in various sectors and the role of EU institutions and agencies. This should enhance the co-ordination and interoperability of national plans, thus improving their effectiveness.
How did the Commission develop the plan for major public health threats?
In developing the Communication on generic preparedness planning, the Commission drew on the experience of Member States in establishing national plans for smallpox and pandemic influenza. It also received input from the EU Health Security Committee (Member State health experts who work to develop cooperation on preparedness and response to biological and chemical agent attacks) and the EU Network of the control and surveillance of communicable diseases.
What are the main elements of this Communication?
The Communication on generic preparedness planning for public health threats presents a foundation on which Member States can build their own generic plans, with the main elements that need to be addressed in planning for both disease-specific and general public health emergencies. The document lists the main pillars of generic preparedness planning, namely: Information management; Communications; Scientific advice; Liaison and command and control structures; Health sector preparedness; and Preparedness in all relevant non-health sectors. It then details measures that should be included, or taken into account, in the plans related to each of these pillars. A number of issues are highlighted as being of particular importance in generic preparedness planning. Firstly, Member States should share and compare national plans, evaluating them through joint tests and peer reviews to ensure their effectiveness and interoperability. Implementing arrangements should also be examined regularly and improved as necessary. The document stresses the importance of those who would be in charge in a crisis working together. They should aim to create a common vision on how to manage a coordinated EU response in a public health emergency, and to develop information-sharing networks. Secondly, national plans need to take into account EU legislation in different sectors, as well as EU-level mechanisms for public health crises, and the Communication provides clarification and details on these. Finally, the document stresses the importance of generic health threat plans incorporating more than just the health sector. Equally important are areas such as civil protection, transport, communications, emergency services, investment in laboratories, and international relations.