Background

In November 2001 the European Commission invited experts from all over Europe to express their views on ways to improve preparedness for an influenza pandemic at the European Community level. The conference was well attended and key actions to be addressed by public health authorities in cooperation with decision makers and the pharmaceutical industry were identified (1).

Based on the suggestions made at this conference, the Commission’s public health service assisted by a working group of member states experts, has drawn up a Community Influenza Pandemic Preparedness and Response Plan, which is now in its final stage. During the drafting phase the plan was widely discussed within the Commission services, with experts from the European Agency for the Evaluation of Medicinal Products (EMEA), and vaccine and antiviral manufacturers under the auspices of the European Federation of Pharmaceutical Industries and Associations (EFPIA). The results of these discussions are reflected in the final draft. Preparations to adopt the plan as a legal document are underway.

The plan

The main purpose of the plan is to achieve a coordinated Community response in the event of an influenza pandemic. The plan addresses the key components of the response and seeks to identify all concerned parties at Community level and to clarify their roles. It also identifies those Commission and EMEA activities that could facilitate coordination of the activities of member states, and sets the Community’s response in the context of the wider international response.

The various phases of an influenza pandemic are described in line with the guidelines adopted by the World Health Organization (WHO) in 1999, and the main objectives during these phases are stated.

During the interpandemic phase, the main objectives include building up experience of handling influenza outbreaks and epidemics through routine programmes including achievement of high uptake of vaccination among risk groups, ensuring effective surveillance, and confirming any new virus strains and developing candidate vaccine strains.

After the onset of a pandemic, it is crucial to gather sufficient epidemiological information about disease severity in order to implement mitigation and response strategies, to put in place civil emergency plans in anticipation of widespread disruption, and to continue clinical and virological surveillance. Clear guidance on the use of vaccines and antivirals will also be needed.

The plan addresses the European Commission, in particular the Directorates General for Health and Consumer Protection, Enterprise, Research and Environment, the European Agency for the Evaluation of Medicinal Products, the European Influenza Surveillance Scheme, the pharmaceutical industry, the member states, and WHO.

A major chapter of the plan is devoted to describing the role of the European Community during the interpandemic period. The measures proposed are compiled under the headings management and coordination, surveillance, prevention, mitigation and response strategies including the production and use of vaccines and antivirals, civil protection and emergency planning, communication, and research.

Outbreak management

In order to improve outbreak management the plan proposes the establishment of a Community Influenza Pandemic Preparedness Group which should be chaired by the Commission and composed of member states experts on influenza, a representative from the European Influenza Surveillance Scheme, from EMEA and from WHO. The main role of this group is to advise the Commission and the Network Committee, a formal group of member states delegates, which the Commission consults on legislative public health initiatives and on risk assessment.

A second structure being proposed is the Community Outbreak Investigation Team, which should participate in outbreak investigations inside and outside the Community in cooperation with WHO. In the event of an outbreak within the EU, the team can only be activated upon the request of a member state. Activation would also require a favourable opinion of the Community Influenza Pandemic Preparedness Group.

Surveillance

Surveillance is a key element of the plan. The most important task of surveillance is to provide early detection, and characterisation of pandemic strains from clinical or other specimen, and a reliable risk assessment as to its potential to cause widespread outbreaks among humans. Routine surveillance should include information on circulating and emerging influenza virus strains in humans and animals, the burden of disease in terms of severity, and, if possible, information on hospitalisation rates, attack rates, and costs. Specific pandemic surveillance plans have to be in place. During a pandemic, serological data can be analysed in order to predict the age groups that will be most severely affected by the pandemic strain. Monitoring of vaccination coverage, efficacy, and safety for a new vaccine should be heightened.

Further to introducing these standards for surveillance, the plan introduces a wide range of measures to improve surveillance at Community level. The most important measures are to continue funding of human and animal surveillance schemes, to maintain an inventory of laboratory capacities and facilities, to improve cooperation with non-Community and animal influenza surveillance schemes, and to strengthen the support for a Community Network of Reference Laboratories for Human Influenza. The tasks of this network are laid down in the annex to the plan and comprise a range of functions in terms of technical performance, quality control and communications.

Vaccine strategy

Making effective antivirals and vaccines available is the central pillar in prevention, mitigation and response strategies. Industry has recently raised the possibility of making available the powder formula of a neuraminidase inhibitor that can be administered orally. The attractive price and long shelf life make it a suitable candidate for stockpiling. There are, however, technical limitations and the lead time for supply upon order could be as long as 18 months. Therefore, stockpiling at Community level does not appear to be of additional advantage.

Industry is also making considerable efforts to shorten the lead time for the production of vaccines, and prospects, for example through the use of modern cell culture technology, are very promising. Here, the plan points at restrictions and gives possibilities for increasing the availability of vaccines. Community actions to be taken should be addressed at exploring possible legislative restrictions that may prevent transport of virus strains necessary for vaccine production across member states, and at exploring the legal framework for ensuring equity of distribution in the event of a pandemic.

Licensing and testing of pandemic influenza vaccines including new generations is an equally important issue. The plan proposes the replacement of the current review procedure, which is too time consuming, with a rolling review assessment procedure, which would radically reduce the time needed to get the product onto the market. Apart from market authorisation issues, the guidelines to be developed by EMEA should also address the issue of intellectual property rights, to allow the use of high growth reassortants to increase vaccine yield.

The plan also draws a link to the activities of the Commission in the area of civil protection, which are mainly based on Council Decision 2001/792/EC establishing a Community mechanism to facilitate reinforced cooperation in civil protection assistance interventions.

Communication flow

The flow of communication is explained in a flow chart annexed to the plan in the event of the isolation of a new virulent strain both within the EU and outside the EU. The chart illustrates the involvement of the various structures in the decision making process.

Research carried out during the interpandemic period is vital to Community preparation for effective pandemic response. The plan confirms the Commission’s ongoing commitment to encourage and facilitate such research through the provision of funding.

The usefulness and impact of this plan on the state of play in influenza preparedness and response planning at Community level will mainly depend on the implementation of the provisions laid down in the plan. This requires joint forces from both the Commission and the member states. It is hoped that the adoption can be finalised as soon as possible and that all parties will undertake to face the full commitment reflected by the provisions of the plan. Only then can the plan reach the ambitious goals set out.