REPORT on pandemic influenza preparedness and response planning in the European Community

10.5.2006 - (2006/2062(INI))

Committee on the Environment, Public Health and Food Safety
Rapporteur: Adamos Adamou

Procedure : 2006/2062(INI)
Document stages in plenary
Document selected :  
A6-0176/2006

MOTION FOR A EUROPEAN PARLIAMENT RESOLUTION

on pandemic influenza preparedness and response planning in the European Community

(2005/2062(INI))

The European Parliament,

-   having regard to the 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 (COM(2005)0607),

-   having regard to the 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 (COM(2005)0605),

-   having regard to Article 152 of the Treaty governing Community action in the field of public health,

-   having regard to its resolution of 26 October 2005 on the strategy against an influenza pandemic[1],

-   having regard to the international Donor Pledging Conference on Avian and Human Iinfluenza, Beijing, of 17 and 18 January 2006 and the Declaration made at that conference,

-   having regard to the WHO global influenza preparedness plan (document WHO/CDS/CSR/GIP/2005.5),

–   having regard to Rule 45 of its Rules of Procedure,

–   having regard to the report of the Committee on the Environment, Public Health and Food Safety (A6‑0176/2006),

A. whereas the recent developments of increased numbers of cases of avian influenza and of human casualties from it in Asia, Africa and also in European countries are increasing concerns, and whereas there is a need to address this disease at its roots and to assist affected countries and countries at risk in need,

B.  whereas the key issues in both the Communication on pandemic influenza preparedness and the Communication on strengthening coordination on generic preparedness are the preparation and testing of national plans, coordinated by the Commission, surveillance by and networking among national reference laboratories to identify pandemic strains quickly, effective outbreak management through the provision of timely advice, the early notification of cases, the provision of outbreak assistance and the coordination of the responses of Member States, and the adequate and timely supply of vaccines and anti-viral drugs,

C. whereas the drafting of national plans should aim to:

- ensure the necessary coordination between Member States,

- prevent panic amongst the public,

- combat any trafficking which could arise if there were genuinely serious risks,

- determine the sites to be isolated as a priority,

- draw up lists of the population groups to be vaccinated as a priority,

- ensure fair distribution to all of products for use in combating the epidemic,

D. whereas the surveillance of influenza infections among animals, in particular among bird populations, is important and a requirement of Community law,

E.  whereas anti-virals constitute the first pillar of medical prevention and intervention until vaccines become available,

F.  whereas the European Union must provide logistic and financial assistance with the development of vaccines,

G. whereas there is a need to strengthen communication with and among national institutes responsible for public health surveillance, risk assessment and monitoring,

H. whereas public awareness should be increased by means of information campaigns, and whereas it is also important to undertake complementary reforms in related sectors and to mitigate the socio-economic effects on the poorest people and households,

I.   whereas public announcements must reflect the current state of medical knowledge and whereas anti-outbreak recommendations for the general public must be scientifically justified, universally understandable and practicable,

J.   whereas, since 2003, significant numbers of infected poultry around the world have died or been destroyed, jeopardising commercial poultry production and particularly the livelihood of small and medium-sized livestock farmers,

K. whereas any pandemic would be likely to affect different Member States in different ways,

L.  whereas the problem of avian influenza infection is a global problem and needs to be addressed in close cooperation with the World Health Organization (WHO),

M. whereas the provision, within the context of a long-term strategic partnership, of adequate financial and technical support to developing countries that are either affected or at risk, and particularly the least developed countries, will be vital to controlling global threats to finance, trade and safety arising from avian influenza,

1.  Welcomes the above-mentioned Commission Communications on pandemic influenza preparedness and response planning in the European Community and on strengthening coordination on generic preparedness planning for public health emergencies at EU level as well as the assessments of national pandemic influenza plans that are currently being undertaken by the European Centre for Disease Prevention ('the ECDC'), the Commission and WHO, European Region;

2.  Stresses that one of the most important aspects of properly dealing with the problem of a possible human avian influenza pandemic is having the correct, scientifically proven, information regarding drugs, vaccines, natural resistance to the disease as well as reliable epidemiological data;

3.  Welcomes the ECDC 's work in identifying, assessing and providing information on influenza-related threats and its commitment to helping Member States and the Commission prevent a pandemic outbreak; stresses that sufficient funding should be guaranteed for the ECDC's operations;

4.  Stresses that the Commission must play a strong coordinating role between the Member States in all activities relating to pandemic preparedness in the European Union and that it should strengthen the ECDC 's capacity to identify the key public health measures that must be taken in the event of a pandemic;

5.  Calls on the Commission and the Member States to take account of the relevant observations, reports and on-the-spot investigations of the ECDC and to ensure that those Member States whose planning to combat a pandemic is substandard supplement and upgrade their plans, since the nature of the risk is such that all Member States must be fully prepared;

6.  Considers that, 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;

7.  Considers that in Member States there is a need for strong political commitment to preparedness planning, increasing resources and research, the resolution of complex legal and ethical issues, and developing common solutions and cross-border co-operation;

8.  Considers that an action plan specifically for the European institutions should be drafted in case travel restrictions prevent international meetings such as those of the Council and Parliament;

9.  Emphasises that rapid and decisive action must be taken to control avian influenza and so prevent a human pandemic, first of all with respect to animal health, as this is the primary source of risk, and that significant measures, including a full assessment of hospital bed capacity at Member States level, must also be taken to prepare for a possible human pandemic, so that the means to control it should it occur, are available; considers that particular attention should be paid to developing further the capacity to produce pandemic vaccines and anti-virals in Member States and at European level and strengthening the infrastructure in the animal and public health sectors; considers that, in this connection, the European Union should provide logistic and financial assistance with the development of vaccines;

10. Points out that pandemic influenza simulation exercises are vital in order to test the effectiveness of each Member States' national pandemic influenza plans and that they should be conducted regularly, as a precautionary measure, even if there is no pandemic outbreak; emphasises that the results of and lessons learned from these exercises will be important to the efforts to improve plans and their interoperability;

11. Stresses that these simulation exercises should be extended to outlying regions and rural areas;

12. Acknowledges the need for detailed scenarios for the protection of children and young people against the avian influenza A virus (H5N1) to be drawn up and introduced;

13. Emphasises that there is a need to strengthen surveillance systems, rapid reporting and alerting systems, data analysis and epidemiology for animal and human diseases, so as to enable the early detection and identification of avian and human infection and to enable the rapid implementation of effective counter measures;

14. Stresses that, at the same time, rapid assessment is required of the immediate socio-economic impact of avian influenza and of compensation issues and associated incentives;

15. Welcomes the unequivocal commitment to transparency and information sharing made by the Member States, the Commission and the ECDC and emphasises the importance of rapid sharing of information and of biological specimens derived from suspected and confirmed cases among humans and animals so as to facilitate adequate and comprehensive preparedness and response; calls for the strengthening of cooperation between reference laboratories to speed up the identification of viruses and maintain constant monitoring of any possible mutations;

16. Urges the Commission, the ECDC and the Member States 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;

17. Notes that, following the example of the ECDC, communication strategies at national and European level should be improved and should include the publishing of regular reports on the internet, the use of e-mails or restricted websites for professionals and the media;

18. Stresses however that Member States should examine the best ways of approaching their citizens, so 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;

19. Stresses the importance of education and correct information in the event of crises and that appropriate instructions should cover not only compliance with hygiene rules but also the provision of information in areas such as mobility, transport and employment;

20. Calls for reliable information on the threat of a pandemic to be provided through the European supervisory system;

21. Acknowledges that a potential solution for strengthening communication with national institutes responsible for public health surveillance is to develop an early warning and response system to be operated by the ECDC for the coordination of risk assessment and monitoring;

22. Stresses that 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;

23. Calls for well-structured and multidisciplinary collaboration among experts in human and animal health, specialists in the fields of virology, epidemiology, pathology and agriculture, as well as communication experts and experts in translating science into policy at a global level; suggests, therefore, the creation of a European Influenza Task Force, coordinated by the Commission, on which the European Parliament is represented and in which all the above-mentioned fields of expertise are brought together at European level; emphasises that this Task Force should work together with representatives of European vaccine and antiviral industries;

24. Urges that European research and development programmes on emergent diseases be launched immediately to develop antivirals, antibiotics and vaccines reliably and more quickly;

25. Emphasises that the planning and assessment of national pandemic preparedness plans must be multi-sectoral and involve all relevant ministries and stakeholders; stresses the importance of ordering vaccines in advance;

26. Draws the attention of European authorities and those of the Member States to the desirability of consolidating stocks of antibiotics to treat complications of influenza;

27. Stresses that the existing surveillance network established through Community co-funding (European Influenza Surveillance Scheme, EISS) provides a good basis for carrying out this crucial task but needs to be further developed and supported, as should the network of laboratories dealing with influenza in the Community;

28. Stresses that planning for obtaining and using 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;

29. Calls on the Commission to liaise with vaccine manufacturers to evaluate progress towards vaccine production capacity increase and equity of supply in pandemic situations and to 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;

30. Considers 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;

31. Emphasises the role of the European Medicines Agency, EMEA, in determining the use and effectiveness of anti-virals and pandemic vaccines, as well as its role in detecting and investigating any adverse effects or reports of reluctance to take medication; calls in this connection for the early establishment of the 'conditional authorisation' procedure provided for in Article 14(7) of Regulation (EC) No 726/2004;

32. Calls on Member States to increase orders of seasonal influenza vaccines in line with WHO recommendations to assist the pharmaceutical industry in increasing the production capacity of influenza vaccines, to cope with the substantial increase in demand that an influenza pandemic would bring;

33. Calls 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; calls on countries to provide for potential cover for 25 to 30% of the population with available antivirals:

34. Stresses that full, accurate and practical implementation of the national legislation transposing the Community directives on health and safety at work is of vital importance in ensuring the adequate protection of workers, particularly those in high infection risk groups; emphasises that employers must assume their specific obligations laid down by Community law (for example risk avoidance, risk assessment, prevention and protection measures), in accordance with Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work;

35. Stresses that political and scientific commitment should be translated into the provision of human and financial resources and support for research and development in order to promote new, swift methods of producing antiviral drugs and vaccines with the capacity to meet the greater needs arising in a pandemic, particularly to combat new strains of viruses;

36. Welcomes the proposal for a regulation establishing the Solidarity Fund (COM(2005)0108) and in particular its provisions concerning public health emergencies and measures to protect the population against imminent heath threats, including meeting the cost of vaccines and the supply of medical products, equipment and infrastructure;

37. Points 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;

38. Welcomes the Commission's pledge of EUR 80 million to third countries to combat influenza and a further EUR 20 million to research funds earmarked from the 6th Research Framework Programme, bringing the total Commission pledge to EUR 100 million;

39. Urges the Commission to work for a more coherent international framework in the follow-up of the Beijing pledging conference that goes beyond crisis management and addresses the issues of building up a better infrastructure for animal health in developing countries, as well as advancing research in animal health products that can be used in developed as well as developing countries.

40. Calls on the Commission to study ways of maintaining smoothly operating essential services, such as markets, banks, hospitals, and others, in the event of the outbreak of a pandemic;

41. Stresses that sufficient financial support must be provided in the context of international collaboration with Asian and African countries currently affected by avian influenza, to improve their surveillance and disease control capacities;

42. Calls on the Commission to submit to the European Parliament and the Council, at regular intervals and for as long as the risk of a pandemic lasts, a report on the epidemiological developments of the avian pandemic, new scientific advances in drugs and vaccines, and the level of preparedness in the Union and the Member States;

43. Points out that the European Union has a legitimate reason to provide technical, scientific and economic assistance to countries already affected and in particular to contribute to raising global awareness and to a global master plan coordinated at international, regional, sub regional and national levels, with a proper road map and timetable, to be endorsed by international and regional organisations as well as by national governments;

44. Urges the Commission and the Member States to work closely with neighbouring states and WHO Europe to ensure that neighbouring States' monitoring and emergency response systems are fully developed and effectively implemented;

45. Calls on the European Union to seek, through international bodies, the conferral of a genuine power of inquiry and monitoring on WHO regarding epizootics and pandemics in all countries in the world;

46. Instructs it President to forward this resolution to the Council, the Commission and the Member States and WHO.

EXPLANATORY STATEMENT

INTRODUCTION

Outbreaks of highly pathogenic avian influenza (HPAI) viruses in domestic poultry have been increasing since the late 1990s and have affected poultry in Europe as elsewhere. Essentially there are two forms of risk to human health: either direct infection of humans with the avian virus, or - potentially - the emergence of a new pandemic strain of type A influenza. Considering the massive exposure in Asia there have been very few human infections resulting from HPAI.

The human health impact of HPAI epizootics in general was very small - and almost unnoticed - until 1997. Infections were minor and usually self-limiting. The appearance of one particular type, A/H5N1 in Asia, changed this when infection of humans with a high mortality rate was detected during an outbreak of HPAI A/H5N1 in Hong Kong in 1997. This pattern of infection has continued as huge epizootics have extended across the domestic poultry populations of South East Asia. In the some 140 reported human infections in Asia during 2004 and 2005 mortality is around 50%. Mild and asymptomatic infection seems to be rare and the indications are that transmissibility of A/H5N1 to humans is still very low even for those directly exposed. In addition, there has been no efficient person-to-person transmission as yet.

The infection has now also appeared in birds in several European countries (Romania, Kazakhstan, Ukraine, Croatia and Turkey), in several European Union ones (Italy, Austria, Germany, Greece, France and the occupied part of the Cyprus Republic), in Africa and it appears that as we speak it is still spreading. The direct risk to the health of people in Europe from A/H5N1 is very low, but not zero. The risk is almost entirely confined to certain groups of people (those who have close contact with infected domestic poultry). For those people who have no contacts with domestic or wild birds the risk, according to the European Centre for Disease Prevention and Control, ECDC, must be almost non-existent.

THE RAPPORTEUR'S COMMENTS

The Rapporteur points out that confusion in people’s minds about avian influenza and pandemic influenza is massive and many people and authorities seem to equate the arrival of A/H5N1 in Europe with the arrival of a pandemic virus. He thus points out that communication strategies at a national and European level should be improved and that Member States should examine the best ways of approaching their citizens, in order for information to reach the whole population.

The Commission should play a strong co-ordinating role between the Member States and the ECDC. The Commission Communications on Pandemic Influenza Preparedness and Response Planning in the European Community (COM (2005) 607) and Generic Preparedness Planning for Public Health Emergencies at EU level (COM (2005) 605) should be read and understood in conjunction with various guidelines and advice on the issue as well as the National Influenza Plans. The triumvirate when it comes to influenza is:

1) WHO recommendations and EU communications and legislation;

2) Technical information and guidance such as those on the ECDC and WHO web-sites (eg. ECDC Travel Advice);

3) National plans and guidance.

Communication on Pandemic Influenza Preparedness

For the Commission, the Early Warning and Response system (EWRS) remains the mainstay of communication. The experience with SARS and two Europe-wide exercises including one on pandemic influenza indicates that there is a need to strengthen communication mechanisms with the national institutes responsible for public health surveillance in charge of the risk assessment and monitoring functions. A potential solution would be to develop a EWRS component operated by ECDC for the coordination of the risk assessment and monitoring function. This will ensure the communication on emerging health threats between ECDC and the national institutes in charge of public health surveillance. However, there will still be a need for Member States to communicate measures taken through a Commission mechanism like the EWRS at a stage prior to the implementation of control measures. That said the current mechanism tends to overload users with outputs in a crisis. Further training of users will assist up to a point, but probably new mechanisms will be needed to communicate effectively in such circumstances.

There is no specific section on multi-sectoral planning at national level though there is some mention of this in the conclusions and this should now be accepted as crucial. More attention should be paid to how events and actions in one country affect others (e.g. closing borders).

The role of EMEA is somewhat unclear. Some of the most important tasks in a pandemic will be rapidly determining the use and effectiveness of anti-virals and then at a later stage the pandemic vaccine. Similarly, there is a need to detect and investigate any adverse effects, reports of reluctance to take medications. It is suspected that in a pandemic the normal EU measured pace of such activities would be far too slow. Therefore, it is important to clarify who would be responsible for this work so that preparations can be made, protocols written and agreed upon.

In more general terms the Rapporteur points out that planning for obtaining and using pandemic vaccines is in most countries underdeveloped and for this reason measures should be taken to further develop it. It is equally important to eventually give the Commission a mandate to establish a Community stockpile. The Commission is also advised to liaise with the vaccine manufacturers in order to evaluate progress towards vaccine production capacity increase and equity of supply in pandemic situations.

The Rapporteur welcomes the fact that sufficient financial support is provided in the context of international collaboration with Asian and African countries currently affected by avian influenza in order for them to improve their surveillance and disease control capacities. In addition to the above, the European Union should provide technical, scientific and economic assistance to the already affected countries and in particular contribute to raising global awareness and a global master plan coordinated at international, regional, sub-regional and national level with a proper road map and timetable.

Communication on Generic Preparedness Planning

One specific concern with this Document is that it is not clear how the disease specialists will be drawn into a specific emergency so that analyses and actions will be evidence-based. Past experiences of emergencies, such as white powder releases (2001) and SARS (2003), is that these place particular strains on the scarce Community specialists who are simultaneously required to give advice and local, national and EU levels. The Rapporteur does not feel that the mechanism of having directories of experts would work in a crisis, as such experts are then needed for work at national level. An alternative, more robust mechanism would be to have additional investment in key "gap" areas and generic specialists through agencies such as ECDC.

PROCEDURE

Title

Pandemic influenza preparedness and response planning in the European Community

Procedure number

2006/2062(INI)

Committee responsible

Date authorisation announced in plenary

ENVI

16.3.2006

Committee(s) asked for opinion(s)
  Date announced in plenary

LIBE
16.3.2006

Not delivering opinion(s)

        Date of decision

LIBE

19.4.2006

Enhanced cooperation – date announced in plenary

 

Rapporteur(s)
  Date appointed

Adamos Adamou
29.11.2005

Previous rapporteur(s)

 

Discussed in committee

21.3.2006

4.5.2006

 

 

 

Date adopted

4.5.2006

Result of final vote

+:

–:

0:

42
0
2

Members present for the final vote

Adamos Adamou, Liam Aylward, Irena Belohorská, Johannes Blokland, John Bowis, Frederika Brepoels, Chris Davies, Avril Doyle, Mojca Drčar Murko, Edite Estrela, Jillian Evans, Karl-Heinz Florenz, Matthias Groote, Françoise Grossetête, Cristina Gutiérrez-Cortines, Satu Hassi, Gyula Hegyi, Marie Anne Isler Béguin, Dan Jørgensen, Christa Klaß, Eija-Riitta Korhola, Holger Krahmer, Urszula Krupa, Peter Liese, Jules Maaten, Linda McAvan, Riitta Myller, Miroslav Ouzký, Frédérique Ries, Guido Sacconi, Carl Schlyter, Richard Seeber, María Sornosa Martínez, Antonios Trakatellis, Thomas Ulmer, Åsa Westlund

Substitute(s) present for the final vote

María del Pilar Ayuso González, Sergio Berlato, Philip Bushill-Matthews, Milan Gaľa, Erna Hennicot-Schoepges, Miroslav Mikolášik, Bart Staes, Glenis Willmott

Substitute(s) under Rule 178(2) present for the final vote

Elisabeth Jeggle

Date tabled

10.5.2006

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