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European Commission Directorate General for Health and Consumer Protection Avian Influenza in the EU: Legislation, Outbreak Management and Decision Making ASEM Workshop Beijing, 12-14 November 2007. Avian Influenza Legislation and current Situation in the European Union. Topics.
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European Commission Directorate General for Health and Consumer Protection Avian Influenza in the EU: Legislation, Outbreak Management and Decision Making ASEM Workshop Beijing, 12-14 November 2007 Avian Influenza Legislation and current Situationin the European Union
Topics • Control measures for Avian Influenza • Additional measures for subtype HPAI H5N1 • AI Surveillance and Situation in 2007 (as of 12/10) • Vaccination • Financing • Conclusions
EU Control Measures - Directive 2005/94/EC • Applicable as of 1 July 2007 • Notification and measures for LPAI H5 and H7 • Measures differ for HPAI and LPAI • Scope: Poultry and ‘other captive birds’ • “Stamping out” (including pre-emptive culling) • derogations possible - (endangered species, zoo birds, etc.) • Zoning at 3km and 10km radius with movement restrictions for live poultry, poultry products (fresh meat, eggs, manure), vehicles, persons
Zoning • Census-identification of poultry holdings • Increased biosecurity • Veterinary clinical examinations of all poultry holdings • Derogations from movement restrictions possible after assessment of epidemiological situation and examinations at holding • Collection of samples for laboratory investigations (>LPAI) • to assess further spread • to authorise derogations from movement restrictions
HPAI H5N1 in poultry Decision 2006/415/EC • Area A (higher risk) includes: • 3km protection & 10km surveillance zone established by the Directive • Area B (lower risk) - buffer zone around • Provides for additional detailed restrictions, in particular for by-products (game trophies, manure products, untreated feathers, pet food etc.) • Area description published in Official Journal of the EU • Transparency for other MS and trading partners
Zoning Buffer zone Area B Protection Zone 3 km 10 km Surveillance Zone
EU Control Measures - Directive 2005/94/EC (contd) • Additional laboratory investigations in pigs (mixed holdings) and if appropriate in other mammals • Cleaning & disinfection • Legal basis for routine surveillance in poultry and wild birds • Emergency and preventive vaccination • Community and National Reference Laboratories -Diagnostic Manual • National contingency plans (1/9/2007)
Biosecurity in poultry farms Decision 2005/734/EC • Identification of “high risk areas” for HPAI introduction in (MS) • - migratory flyways, poultry/wild bird density, season, experience • - continued review based on risk assessment • Prevention of contact between wild and domestic birds • - confinement or protection by coverings/netting • - no use of surface water, prevention of feed contamination • Early detection systems & prompt reporting in poultry farms • < water/feed intake, production data, egg drop,> morbidity/mortality)
HPAI H5N1 in wild birds Decisions 2005/731/EC (1) 2006/563/EC (2) • Notification of increased wild bird morbidity/mortality • 2) Establishment of Control & Monitoring areas • Size/shape of area (along rivers, lake/seas shores) and duration of measures decided on basis of risk assessment, geographical and ecological factors • Surveillance/Biosecurity heightened in poultry farms to detect/prevent virus introduction • Restrictions on movements of live poultry, hatching eggs, fresh poultry meat, by-products • Ban on hunting, birdgatherings and game bird release
AI surveillance • Surveillance programmes according to revised harmonised guidelines in poultry and wild birds areco-financed by the Commission • July 2005-Dec 2006 ~ 2.9 M€ • 2007 ~ 2,5 M€ • Dead wild bird surveillance provided in most cases early warning for subsequent poultry outbreaks • (2006 - F, SE, DK, HU, not DE) • Not in HU and UK in 2007!!!
New EU rules for AI vaccination • Since entering into force of Directive 2005/94/EC on 3 February 2006 new legal basis for vaccination can already be used • Emergency Vaccination • Preventive Vaccination • Establishment of vaccine banks (national and EU) • Community approved vaccines by accelerated EMEA procedure • 2 inactivated vaccines (H5N2 and H5N3 )
New EU rules for AI vaccination (contd) • Submission of vaccination plan according to DIVA strategy • Plan must describe disease situation, risk factors, area, number of holdings/birds to be vaccinated, species, vaccine characteristics, envisaged duration • Formal approval by Commission Decision after opinion of the Standing Committee on the Food Chain and Animal Health (SCoFCAH)
Emergency vaccination Short term measure - on basis of a risk assessment concluding that there is a significant and immediate threat of avian influenza introduction or spread posed by: (a) an outbreak within that Member State (b) an outbreak in a nearby Member State or third country
Vaccination: Provisions for movements • Movement restrictions for live poultry, day-old chicks, eggs for hatching or consumption, fresh poultry meat • within, into and towards outside the vaccination area in particular when moved to other MS • Re-enforced cleaning & disinfection of transport means • Requirements for emergency vaccination as laid down in Directive are applicable until adaptation to national situation and after review at the SCoFCAH
Vaccination: Intensified surveillance • Clinical and laboratory testing in vaccinated holdings and other holdings located in emergency vaccination area to monitor: • - epidemiological situation • effectiveness of vaccination campaign • authorised movements of vaccinated birds • Serology in sentinel birds, unvaccinated birds and for efficacy control in vaccinated birds • ‘Diva test’(iIFA) in vaccinated birds/sentinels • PCR, virus isolation in vaccinated birds, sick/dead birds
Preventive vaccination Long term measure – based on outcome of a risk assessment concluding that certain areas of the MS territory, types of poultry husbandry or categories are at a specific risk for AI exposure
Preventive vaccinationplans for poultry • Voluntary as alternative to confinement • France: ducks and geese flocks in free range in areas at risk until mid 2006 • The Netherlands: hobby (backyard flocks) and free range layers in the whole country (to be prolonged?) • Research orientated field study • Germany: (3 commercial holdings) until late 2008 • Densely populated poultry area • Italy: since 2000 mainly against LPAI H7, since 2004 bivalent vaccine, cease end 2006
Preventive vaccination of zoo birds Decision 2006/474/EC • Vaccination plans of 17 MS approved • Biosecurity measures to avoid wild bird contact • Individual identification • Registration, reporting • Serological testing prior and after vaccinations • Movement restrictions and certification • Administration and doses according to manufacturer
Financing Council Decision 90/424/EEC • Member States obtain financial support from the Community • in case of an outbreak: • 50% of the value of the killed birds, eggs, destroyed feed • 50% for cleaning, disinfection, destruction of equipment • For Emergency vaccination plans • 100 % of vaccine cost • 50 % of costs for performing vaccination • Preventive vaccination plans are not EU co-financed
Conclusions • Major efforts have been made in the EU Member States to prevent, early detect and contain AI in particular HPAI H5N1 • Measures taken have so far successfully reduced the impact of the disease on animal (and public) health (no serious sickness or fatality in humans!) • More flexible legislation allows adapting to specific and evolving disease situations
Thank you for your attention! For further information: http://ec.europa.eu/food/animal/diseases/controlmeasures /avian/index_en.htm