Explanatory Memorandum to COM(2005)171-1 - Community measures for the control of Avian Influenza - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2005)171-1 - Community measures for the control of Avian Influenza. |
|---|---|
| source | COM(2005)171  |
| date | 28-04-2005 |
Grounds for and objectives of the proposal
The Commission envisages updating current Community measures on Avian Influenza (AI) laid down in Council Directive 92/40/EEC, with the objective to achieve better prevention and control of outbreaks and to reduce the health risks, the costs and losses and the negative impact to the whole of society due to this disease. The proposed changes in Community legislation on AI control should be made in parallel with amendments to Council Decision 90/424/EEC on Community expenditure in the veterinary field, to bring it in line with this proposal and ensure adequate financial support to the Member States (MSs) in relation to some of the newly envisaged control measures.
General context
AI is a serious, highly contagious disease of poultry and other birds caused by different types of viruses included in the very large virus family called Influenzaviridae . AI viruses may also spread to other animals and humans, usually following direct contact with infected birds. In the human host, the disease may vary from mild conjunctivitis to serious disease, sometimes fatal; during the still ongoing AI epidemic in certain Asian countries, the case fatality rate in humans has been very high.
Due to continuous genetic changes of the disease agents and their possible “adaptation” to newly infected animal or human hosts, the risks posed by the different AI viruses to animal and public health is variable and to a large extent unpredictable. However, current knowledge indicates that the health risks posed by the so-called Low Pathogenic AI (LPAI) viruses - are inferior to the one posed by Highly Pathogenic AI (HPAI) viruses, which originate from a mutation of certain LPAI viruses, namely those of types H5 and H7, and which can cause a disease in poultry with a mortality rate as high as 90%.
As regards public health, data available indicate that HPAI viruses of types H5 and H7 have been responsible for the vast majority of the cases of AI reported in humans, and of all cases of human deaths due to AI viruses.
In general, domestic poultry populations are free from AI viruses. However, certain wild birds (particularly migratory waterfowl, such as ducks and geese) act as a permanent “reservoir” of LPAI viruses, from which they occasionally spread to domestic poultry. No measures are currently available or can be envisaged to stop or reduce virus circulation in wild birds living in nature; this means that there is a permanent risk of introduction of potentially very dangerous AI viruses from wild to domestic birds, and ultimately to other animals and humans.
For unclear reasons, an increase of AI outbreaks has occurred in recent years. Serious AI outbreaks (HPAI) have been recently reported in many different species of birds – including domestic poultry, kept under different husbandry and management practices - in several different areas of the world, and across all continents. These outbreaks have caused the death or killing for disease control purposes of hundreds of millions of birds and very serious losses to the poultry industry worldwide. In connection with these outbreaks, several human cases of infection were also reported, some of them fatal.
In the EU, in the last five years, major outbreaks of HPAI have occurred in Italy (1999-2000) and the Netherlands, with secondary spread to Belgium and Germany (2003). These outbreaks had devastating consequences on the poultry sector and a negative impact on the society as a whole - particularly in the Netherlands, where several human cases of disease also occurred. This was despite the draconian control measures applied by the MSs including massive killing and destruction of poultry and other birds in the affected areas, which often went far beyond the minimum requirements of Directive 92/40/EEC.
After previous EU animal health crises, these outbreaks have prompted further criticisms in the MSs against massive slaughter of animals, due to animal welfare, ethical, social, economic and environmental reasons. The implementation of this measure has had a very negative impact on public opinion, and raised serious criticisms in particular in relation to special categories of birds, such as endangered species or breeds, or pets. The Court of Auditors has also often criticised the Commission due to the economic impact of massive slaughter on the Community budget.
Scientists deem that uncontrolled AI outbreaks, particularly those caused by certain virus types may, following transmission of the virus from birds or other animals into humans, eventually lead to the emergence of a virus fully adapted to humans and able to cause an Influenza pandemic, like the “Spanish flu” of 1917-1919. Such a pandemic could cause millions of human deaths and major socio-economic consequences all over the world.
Directive 92/40/EEC establishes compulsory disease control measures only in case of disease in poultry caused by HPAI. Lessons have been learnt during the recent epidemics. Outbreaks of AI caused by LPAI viruses of types H5 and H7, that subsequently mutated into HPAI viruses have caused devastating consequences. Once mutation has occurred, the virus is extremely difficult to control.
In view of the increased knowledge on the risks for human health posed by AI viruses, the opinions of the Scientific Committee (SC) and the most recent knowledge on the pathogenesis, the epidemiology and the distribution of AI, there is now a clear need to revise and update current legislation to reflect these new advances and experience and to improve disease control of both LPAI and HPAI in future. This will be of direct benefit to animal health and indirectly also human health.
Existing provisions in the area of the proposal
Council Directive 92/40/EEC; Commission Decision 2002/649/EC; Commission Decision 2002/673/EC; By means of Commission Decision 2002/649/EC guidelines were laid down for EC-wide surveys for AI in poultry and wild birds. By Commission Decisions 2002/673/EC and 2004/630/EC MSs' programmes for surveys in poultry and wild birds have been approved and are currently ongoing.
Decision 90/424/EEC on expenditure in the veterinary field establishes that MSs may receive a financial contribution from the Community for some of the measures implemented to control and eradicate AI (HPAI).
Consistency with other policies
Since live poultry is listed in Annex I of the Treaty, one of the Community's tasks in the veterinary field is to improve the health status of poultry, thereby facilitating trade in poultry and poultry products to ensure the development of this sector. Furthermore, a high level of human health protection is to be ensured in the definition and implementation of all Community policies and activities.
Consultation of interested parties
Consultation with MSs in working groups and in electronic exchange on a draft proposal has taken place in July/October 2004.
In October 2004 European NGOs have been consulted on a draft proposal.
As a result of the consultation suggestions on improving of some Articles and Annexes of the draft proposal have been taken into account.
Collection and use of expertise
1. In 2000 the SC delivered an opinion on AI and recommended to amend the definition laid down in Directive 92/40/EEC so that disease control measures are also adopted in case of infection with AI virus strains of low pathogenicity.
2. In 2003 another scientific opinion has been issued on the most recent diagnostic techniques and the use of vaccination against AI.
3. The opinions of the SC are published on:
europa.eu.int/comm/food/fs/sc/scah/outcome_en.
The opinions have been considered in the drafting of the proposal.
Impact assessment
The three policy options identified by the SC in its report of 2000 have been assessed and an impact assessment has been laid down[1].
The result can be summarised as follows:
Option 1: not to change the definition of AI and the control measures laid down in Directive 92/40/EEC, with a recommendation that MSs impose restrictions to limit the spread of LPAI:
To maintain the status quo would not reduce the risk for the Community of future HPAI outbreaks due to uncontrolled circulation of LPAI viruses in poultry farms. The simple recommendation to MSs to adopt national measures for LPAI control would not give sufficient guarantees for improved disease control and a reduction of the related health risks, taking also into account the resistance of operators against stricter control measures which may not be equally imposed to their competitors in other MSs. The implementation of national measures for LPAI surveillance and control by each individual MS may thus lead to serious disturbance to trade in poultry and poultry products and to unfair competition between poultry producers in a market where competition is very high.
Option 2: to change the current definition of AI to also include LPAI, thus establishing the same disease control measures for LPAI and HPAI:
To apply the current HPAI control measures also in case of LPAI would be disproportionate to the risks posed by LPAI to both animal and public health; this could also result in massive killings of animals - with a major negative impact on animal welfare - and very high costs for disease control, in circumstances where such massive killings and costs may not be justified nor sustainable. In the case of LPAI, the implementation of a compulsory and systematic stamping out policy, which would lead to massive killing and destruction of animals, does not appear necessary, although in certain cases it can still be a valid option, taking into account its costs and risks vs. its benefits. Furthermore, several other ancillary disease control measures that are necessary for HPAI, should be applied in a more flexible manner in the case of LPAI.
Option 3 : to change the definition of AI to also include LPAI, but to foresee control measures taking into account the different type of virus and animal host involved:
The major benefit expected from option 3 would be to reduce the risk of HPAI outbreaks in poultry and other birds by means of a better control on LPAI, and by building on an approach that is proportionate to the risk posed by the two conditions. Furthermore, this approach would only be the one which would match the new Chapter of the O.I.E. Code, which is expected to be finally adopted in May 2005 and this would prevent EC disease control measures having a negative impact on international trade.
Contents
Summary of the proposed action
Directive 92/40/EEC would be replaced by a new Directive updating the existing provisions, with the aim of ensuring a better control of AI, taking into account the need to reduce as much as possible the need for massive slaughter of birds.
In accordance with option 3, the following main changes would be introduced to current provisions on AI control:
1. Change in the definition of AI to extend the scope of the control measures also to those LPAI viruses which could potentially mutate into HPAI viruses, however it would make a distinction between the two conditions so that specific control measures can then be applied in relation to the different risks posed by these viruses.
2. Introduction of compulsory surveillance for LPAI in all MSs.
3. New and more flexible provisions on vaccination.
4. New and flexible provisions for the control of LPAI and HPAI in domestic birds other than poultry, such as those kept in zoos or endangered species.
5. New provisions to ensure co-operation between MSs veterinary and public health authorities in case of detection of AI, with the view of protecting human health.
6. Attribution to the Commission, through Comitology procedures, to adopt further and more specific AI control measures and to establish an AI vaccine bank.
Legal basis
Article 37 of the Treaty establishing the European Community.
Subsidiarity principle
The animal health measures laid down in this proposal falls under the exclusive regulatory competence of the Community. There are very few measures which are linked to public health, which are in line with the subsidiarity principle, as MSs are given the full responsibility for example to establish disease prevention measures for staff exposed to poultry infected or suspected to be infected with AI.
Proportionality Principle
The proposal sets out the minimum measures to be applied in the event of an outbreak of AI in poultry and other birds. MSs are free to take more stringent administrative and sanitary action in the field covered by the proposed Directive. Furthermore, provisions are laid down to allow MSs authorities to apply measures proportionate to the different disease situations.
Choice of instruments
The proposed instrument is a Directive.
Other means would not be adequate for the following reasons:
Experiences since 1964 with Community harmonized veterinary legislation have shown that a Directive gives sufficient flexibility for the MSs to apply legislation in the frame of their systems of legislation and administration. See also the comments on proportionality above.
The budgetary implications of this proposal and of the associated proposal to amend Decision 90/424/EEC are indicated in the impact assessment and can be summarised as follows:
The annual additional cost for the Community budget related to the adoption and implementation of the measures indicated above would be 3-8 M€, that means ~5.5M€ on average. These costs should be largely balanced by the savings related to the reduced risks for future HPAI epidemics. Of course, it cannot be precisely indicated to what extent the new legislation would lead to a decrease in the number of future HPAI epidemics, the occurrence of which is still largely unpredictable and can never be totally excluded, given the nature of the risk in question. However, if these measures had been already in place and implemented in the EU in the last five years, one of the two major epidemics which have occurred in the Community would have been most likely prevented. Based on this, it may therefore be estimated that the implementation of the proposed measures could successfully prevent two major epidemics of HPAI in the next ten years.
The expenditure incurred by the MSs concerned for compensating farmers, for stamping out measures and for cleansing and disinfection (expenditure that are in principle eligible for a 50% Community co-financing in accordance with current provisions of Decision 90/424/EEC) in relation to the two major epidemics which recently occurred in the EU has been between 101 and 174 M€. It can therefore be estimated that at the current costs the prevention of two major epidemics would lead to savings for the Community budget of 100M€ or more over a ten year period. This would largely outweigh the additional costs foreseen for the new LPAI surveillance and control measures (~55 M€ in ten years).
Furthermore, thanks to the adoption of other control measures envisaged under the current proposal, including vaccination, other savings should result from the expected reduced size of future AI epidemics. It is, however, extremely difficult to quantify these savings.
Repeal of existing legislation
The adoption of the proposal will lead to the repeal of existing legislation.
European Economic Area
The proposed act concerns an EEA matter and should therefore extend to the EEA.