The European Journal of Public Health Advance Access originally published online on April 6, 2006
The European Journal of Public Health 2006 16(2):119-120; doi:10.1093/eurpub/ckl034
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Viewpoints |
Pandemic influenza: are Europe's institutions prepared?
Sandra Mounier-Jack and Richard CokerECOHOST, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7Ht, UK
Correspondence: Sandra Mounier-Jack, Research Fellow, ECOHOST, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7Ht, UK, tel: +44 207 612 7802, fax: +44 (0) 207 612 7812, e-mail: sandra.mounier-jack{at}lshtm.ac.uk
In December 2005, the new European Centre for Disease Prevention and Control (ECDC) indicated that the European Union's (EU) preparedness for a possible influenza pandemic would be ‘more or less’ complete by 2007 and noted ‘Europe will be much better prepared than any other part of the world’.1 Over the past year there has been considerable activity in planning, coordinating, and testing preparedness planning by EU institutions to meet this aim. But if effective protection is to be achieved, more attention still needs to be paid to efforts to stimulate research and development, redress inequalities in the distribution of resources including vaccines and antiviral drugs, and strengthen the coordinating role and authority of national and international institutions.
According to a survey presented at the EU-World Health Organization (WHO) joint workshop in Copenhagen in October 2005 30 of the 52 states and territories of the WHO European region had published national influenza pandemic preparedness plans, and a further 18 had draft plans.2 Within the EU, 19 countries indicated that they had published a plan, and six plans were being finalised. During 2005, EU institutions demonstrated a leadership role in coordinating and assisting member states' preparation efforts. This work has included workshops where preparedness plans and best practice approaches were communicated and debated and, in November 2005, the issuance of two official communications outlining and clarifying the specific role of EU institutions in response to the health threat.3,4 Again in November 2005, the European Commission (EC) led a large-scale desktop simulation exercise (termed ‘Common Ground’) to test the robustness and coherence of member states' responses to influenza pandemic scenarios in Europe. Whilst there have been informal murmurings about the inadequacy of the institutional response, somewhat disappointingly the formal conclusions (and the scope for rapidly learning any lessons) were set to be circulated in March 2006 at the earliest, 5 months after the exercise took place.
The ECDC itself, which is just over 1 year old, has been energetically supporting the EC in its preparedness planning through technical expertise in several areas including risk assessment, scientific advice to support public health recommendations, the evaluation of member states' preparedness, and as a focal point for information and expertise. A primary function of the ECDC has been to coordinate the surveillance system through its support to dedicated surveillance networks such as the European Influenza Surveillance Scheme (EISS) and to provide critical capacity for early detection and the characterisation of influenza strains. During these early days for the ECDC, it is anticipated that ‘facilitation’ (rather than leadership) will be offered to outbreak assistance teams (OATs), teams of highly trained experts deployed to investigate outbreaks.3 Since April 2005, ECDC has been an operational focal point for the Early Warning and Response System (EWRS). In the past, the EWRS has been criticised by Member States following simulation exercises. If operational effectiveness is to be maximised, the roles of all EU institutions will need to be clear not only to those working in these institutions but to stakeholders in all member states. As a pandemic unfolds, political and institutional arrangements are likely to be tested—hopefully not to breaking point.
Despite important achievements over the past year, the EC is facing challenges in a number of important areas, including vaccines and antiviral drugs.
For the first time in history, influenza vaccine could be made available during an influenza pandemic. For this to occur, surveillance, characterisation, and production capacity need to be harnessed rapidly and effectively. With vaccines being the cornerstone of the international response to a pandemic, Europe has a grave responsibility. Up to 6.2 billion people worldwide could benefit from protection. Yet, though 65% of global vaccine manufacturing capacity sits within Europe, this currently represents annual manufacturing capacity of only 190 million doses. And with 50% of production being distributed outside Europe, this leaves the EU with only 90 million trivalent doses for a population of 477 million inhabitants.5 Clearly, vaccine research, development, and manufacturing capacity need to be enhanced. This is both a European and a global imperative. To date, EU initiatives have involved the publication of guidelines for the registration of vaccines, including guidance to support fast track licensing procedures (including use of ‘mock-up vaccine’ dossiers to speed procedures) by the European Agency for the Evaluation of Medicinal Products (EMEA). The EMEA has also waived fees on the licensing process for pandemic vaccines. In December 2005, four companies announced their intention to prepare mock-up dossiers in the coming months—one, for GSK, was submitted on 6 January 2006.
Despite the likely global nature of pandemic influenza, at present most financing of research and development for vaccines is assumed by the US and not by Europe (even though, as noted, manufacturing is located in Europe). In order to go some way to redress the balance, in 2004 the EU set up a fledgling public private partnership programme (PPP) in collaboration with vaccine institutes and public health agencies of EU member states. The programme's purpose is to fund vaccine research and development.6 However, although associated with the PPP, manufacturers will not receive financial support. The recent call for proposals on influenza pandemic research of 
20 million will not fundamentally alter the research financing issue.7 Indeed, it has been pointedly argued that unless the EU provides support to manufacturers, some vaccine companies will remain reluctant to fund major research and development projects including full-scale large clinical trials.8
Coordination of vaccine distribution raises a number of thorny challenges in Europe, particularly because of limited vaccine manufacturing capacity. The EU advocates adherence to the WHO policy of extending risk group coverage and uptake of seasonal influenza vaccine6 in order to raise systemic capacity. To this effect, the EC wrote to all member states encouraging them to increase vaccine purchases and, notably, to enter into advance agreements with vaccine companies for flu pandemic vaccine supplies.9 Only six European countries including four from the EU have announced such agreements and all are relatively affluent western European nations. Whether other nations have entered into advance agreements but insisted these remain secret is unclear.8 Whilst nation states clearly have a responsibility to secure public health protection for their own population, where a scarce good is concerned powerful interests mean that unequal distribution between states is likely to result. Europe's institutions have a moral if not legal responsibility to coordinate supplies equitably where a novel serious vaccine-preventable infectious disease is concerned. Inequitable advance agreements (and incentives and procedures which may be less than transparent) not only threaten the effectiveness and efficiency of multilateral coordination and planning efforts, but also present a danger to public health, and challenge political coherence. Countries without vaccine production capacity remain concerned that they may be left out in the cold when a serious pandemic emerges. The EU is faced with an important challenge: Is it possible for EU institutions to assume an effective and timely supra-national coordination and management role, with the appropriate and transparent authority, for vaccine development and distribution? Or will member states' narrow self-interest resist the EU gaining this authority?
Antiviral drugs raise similar yet more immediate questions. The EU has entered into discussions with all antiviral drugs manufacturers and has encouraged member states to stockpile antivirals. To support member states with more modest purchasing power, and in an attempt to make the provision of drugs more equitable across the EU, in April 2005 the EC proposed the establishment of a Solidarity Fund4 through which expenses incurred through the purchase of antiviral drugs in the event of a pandemic would be reimbursed. The Fund, which will cover all EU countries and accession countries, would pay up to 1 billion or 0.5% of the Gross National Product of the affected country.4 To increase the regional response capacity, the EC has also suggested setting up an advance funding mechanism,4 a proposal awaiting the approval of the European Council and the European Parliament. In the meantime, within the EU it is principally the most affluent countries that have stockpiled significant quantities of antiviral drugs thus far. Population coverage of antivirals in France, for example, has now reached around 50% of the population—while many countries, especially from the east, have no publicly acknowledged stockpiles (Mounier-Jack, Coker, unpublished report). Marked differences in the provision of antiviral drugs for different countries' populations are emerging—raising, as above, questions about equity and the role of the EU.
The challenge for the EU and its institutions is, whilst acknowledging the subsidiarity principle, to provide during an emergency the robust and coherent structures and procedures necessary to coordinate and lead regional surveillance and response efforts effectively and efficiently. An illustration of the challenge is the inter-operability of European national plans, an issue noted by the EC as being important.3 The EU must play its role in ensuring consistency in operability in specific areas such as border control, and vaccine and antiviral drug policy—yet much still needs to be done.
At the European level, in addition to the institutions already mentioned, the influenza Public Health Preparedness and Response Planning Group (PRPG) was set up following the SARS epidemic to advise the EC on public health emergencies. The EC will operate a secure general rapid alert system called ARGUS whose task is to ‘ensure that relevant information is shared forthwith with all Commission services and national authorities’. ARGUS will ‘interlink all Community rapid alert systems and a crisis coordination centre’.3,10 The EC has also proposed that a new body, the Health Emergency Operating Facility (HEOF), located in Luxembourg, will ensure liaison between national health emergency operations' facilities.10 There is a serious question about how, in practice, all these new structures will operate alongside other EU agencies and national institutions. Command and control structures and procedures within the EU need to be clear to all. The perceived duplication and multiplication of roles and responsibilities is confusing- and, in an emergency, risks resulting in chaos. Yet it may be that this lack of clarity reflects a political failure to address more fundamental issues—what the role of the EU should be at a time of public health emergencies. Leadership is a necessity. And pandemic influenza may test which institutions Europeans wish to be led by when it comes to a regional response—national or regional? If national, political responses are likely to be very different in countries of the EU and governed principally by narrow domestic self-interest alone.
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1 Dow Jones AP. EU pandemic preparedness to be completed by 2007-EU agency. 2005.
2 WHO. 2nd joint WHO/EC Workshop on Pandemic Influenza Preparedness Planning, in 2nd joint WHO/EC Workshop on Pandemic Influenza Preparedness Planning. Copenhagen: WHO, 2005.
3 European Commission. Communication from the Commission to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions on strengthening coordination on generic preparedness planning for public health emergencies at EU level. Brussels: European Commission, 2005.
4 European Commission. Communication from the Commission to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions on pandemic influenza preparedness and response planning in the European Community. Brussels: European Commission, 2005.
5 International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). IFPMA Briefing, preparing the next pandemic. 2005. Available at: http://www.ifpma.org/ (Accessed 9 January 2006).
6 EU. Towards sufficiency of pandemic influenza vaccines in the EU. 2005. Available at: http://europa.eu.int/comm/press_room/presspacks/avianflu/influenza_key03_en.pdf (Accessed 9 January 2006).
7 EU. 6th framework contract-Call SSP-5B INFLUENZA. 2005. Available at: http://europa.eu.int/comm/research/fp6/ssp/index_en.htm (Accessed 9 January 2006).
8 Fedson DS. Preparing for pandemic vaccination: an international policy agenda for vaccine development. J Public Health Policy 2005;26:4–29.[CrossRef][Web of Science][Medline]
9 Karcher F European Commission, DG Sanco. In Second European influenza conference, Malta, September 11–14, 2005. Malta.
10 European Commission. Interim document: technical guidance on generic preparedness planning for public health emergencies. Available at: http://europa.eu.int/comm/health/ph_threats/Bioterrorisme/keydo_bio_01_en.pdf. Editor. 2005 (Accessed 24 February 2006).
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