Explanatory Memorandum to COM(2000)462 - Community measures for the control of classical swine fever - Main contents
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| dossier | COM(2000)462 - Community measures for the control of classical swine fever. |
|---|---|
| source | COM(2000)462  |
| date | 15-09-2000 |
In recent years the control of CSF has been particularly difficult in some Member States, in particular in areas with a high density of pigs, where a multitude of potential risk factors can hamper the rapid eradication of disease. In particular, the epidemic which occurred in 1997/98 lead to heavy economic costs and losses for the Community, the Member States and the pig-farmers concerned, due to the killing and destruction of a very high number of animals, which is also ethically questionable.
The occurrence and persistence of CSF in feral pig populations, which has emerged in recent years in some areas of the Community and in some neighbouring countries which are likely to join the Community in the coming years, represent an additional and not easily solvable problem. However, the Scientific Committee has recently recommended the implementation of some disease control measures that might lead to an improvement in the situation.
Therefore, there is the need to change some of the measures so far adopted for the control of classical swine fever, to take into account the most recent knowledge and experiences acquired in eradicating the disease, the development of new diagnostic tools and vaccines and the opinions delivered by the Scientific Committee on these issues.
In addition, there is also the need to consolidate the provisions laid down in Council Directive 80/217/EEC of 22 December 1980 introducing Community measures for the control of classical swine fever, which has been substantially amended on a number of occasions.
Indeed, with the specific aim of consolidating Council Directive 80/217/EEC and its amendments, the Commission has already sent a proposal for official codification to the legislator [COM(97) 724 final of 7 January 1998 - 95/0298 (CNS)].
Therefore, in accordance with paragraph 8 of the Interinstitutional Agreement of 20 December 1994 on accelerated working method for official codification of legislative texts and with the joint declaration on the said point, the present proposal recasts Council Directive 80/217/EEC, since it is aimed at:
-consolidating and replacing Directive 80/217/EEC and its amendments;
-introducing some substantial changes to the provisions so far adopted for the control of swine fever, as described below.
Current provisions on CSF are aimed at disease eradication from the Community and are based on the non-vaccination policy, which was adopted in the last decade in the framework of the establishment of the free internal market.
This policy is based on the stamping-out of pigs (depopulation) in farms that are CSF infected. Vaccination may be used in emergencies only, after confirmation of disease, if there is a risk of further serious disease outbreaks.
Indeed, the use of vaccines is seriously hampered by the possibility that, in case of CSF infection, vaccinated pigs may become apparently healthy virus carriers and further spread the disease, but cannot be distinguished from the vaccinated and non-infected ones.
Therefore, certain prevention measures are necessary to avoid the further spread of disease from the areas where vaccine is used. These measures include restrictions on the trade in vaccinated pigs and their products that are not compatible with the free internal market and with the export to Third countries.
These are the reasons that, in the late '80s, induced the Community to ban systematic preventive vaccination, which had been widely applied in some Member States.
However, in accordance with Directive 80/217/EEC, vaccination may be used in case of an emergency. Nevertheless, even if applied as an additional measure in emergencies, vaccination may not be economically viable, as there is little advantage in its application if vaccinated pigs and their products cannot be marketed with ease.
The removal of the restrictions related to vaccination has by and large attained the objective of facilitating trade. This has benefited the pig sector for which the export of pork and pork products to third countries has largely increased in recent years (the degree of self-sufficiency of the Community is about 107% at present). The ban of systematic vaccination has also lead to considerable savings related to vaccination costs.
Nevertheless, since the adoption of the non-vaccination policy the number of outbreaks of CSF in the Community has only slightly decreased when compared with the previous decade.
The very serious and costly outbreaks which have occurred in recent years, and the development of new vaccines, have led to the need to reassess the provisions in force to eradicate CSF, and in particular the ones concerning the use of vaccines.
In accordance with an opinion issued by the Scientific Committee in 1997, in principle vaccination might be more extensively applied as an additional eradication tool in the framework of current non-vaccination policy, if the so-called marker vaccines were available.
By definition, these are vaccines that can elicit a protective immunity distinguishable from the immune response elicited by the natural infection with CSF virus by means of appropriate laboratory tests. If it were possible to exclude the possibility of vaccinated pigs also being virus-infected, the trade restrictions currently applied to pigs if they are vaccinated might no longer be necessary in the case of a proper and successful use of these vaccines.
However, the Committee strongly supported the non-vaccination policy of the Community and recommended carrying out more extensive studies before taking decisions on this matter, as data were not available for a proper evaluation of the products that were being developed and the associated discriminatory tests.
In recent times two new vaccines have been developed, which are now in the process of obtaining the authorization for marketing and could be potentially used as marker vaccines due to some specific features (they only induce immunity against one of the virus proteins).
Therefore, in accordance with the recommendations of the Scientific Committee, the Commission has recently supported a trial simulating an emergency, to test the two recently developed vaccines and the corresponding laboratory tests.
The results of this trial have indicated that the efficacy of these vaccines, although not ideal, might be sufficient to reduce farm-to-farm spread of virus in an emergency situation and therefore potentially useful to reduce the risk of further disease spread in a vaccination area. However, the diagnostic tools so far available are not suitable to distinguish the vaccinated but CSF-infected pigs from the non-infected ones. Therefore, it is necessary to be very cautious on this matter, as the use of these vaccines might not lead to any advantage over the conventional ones.
On the other hand, the experiences gained in recent years have shown that depopulation of infected and where necessary suspected farms can - when quickly and properly applied - effectively prevent further CSF spread and avoid further killing of pigs, even in areas with a high density of pigs. However, the first results of a simulation study on cost-benefit of different CSF eradication strategies suggest that if an 'ideal' marker vaccine were available, it might contribute to further reducing the costs of disease, when applied in an emergency, if there is a risk of a large-scale epidemic.
The present proposal establishes provisions for the use of marker vaccines in emergencies, within the framework of current non-vaccination policy. However, the eventual use of marker vaccines would also be subject to:
-the availability of suitable discriminatory tests (research on this matter is in progress);
-a case-by-case authorization that might be accorded to the Member State which intends to use these vaccines in the case of an emergency situation;
-an in-depth evaluation of the results of the vaccination campaign and of the controls carried out in the farms where vaccines have been used, including inspections by the Food and Veterinary Office.
Finally, a decision would be taken on the trade restrictions to be applied from the area where vaccine has been used. Specific decisions on this matter might be adopted in accordance with the Regulatory Committee procedures established by Council Decision 1999/468/EEC.
Although the principles of CSF control on which current legislation is based are fully confirmed, the present proposal includes other changes to the provisions so far applied, including:
-the notification of cases of CSF in feral pigs, slaughterhouses or means of transport,
-the establishment of a Diagnostic Manual to ensure an improved diagnosis of CSF,
-the epidemiological investigations to be carried out after disease outbreaks,
-the prevention of CSF spread via semen, ova or embryos,
-the re-introduction of pigs into previously infected holdings,
-additional measures that must be applied in the pig farms where classical swine fever virus could have been introduced (so-called contact holdings), and the rules that must be followed in depopulating these farms,
-further and more detailed measures to be implemented following confirmation of CSF in feral pigs, including the information campaigns necessary to increase disease awareness and the possibility of emergency vaccination.
In this proposal the substantial changes to Directive 80/217/EEC have been underlined to allow the legislator an easier comparison between the two texts.
This proposal replaces the proposal for official codification already sent to the legislator [COM(97) 724 final of 7 January 1998 - 95/0298 (CNS)].