Select Committee on European Scrutiny Second Report


COM(00) 462

Draft Council Directive on Community measures for the control of classical swine fever.

Legal base: Article 37 EC; consultation; qualified majority voting
Department: Agriculture, Fisheries and Food
Basis of consideration: Minister's letter of 11 December 2000
Previous Committee Report: HC 23-xxix (1999-2000), paragraph 9 (15 November 2000)
To be discussed in Council: Following receipt of European Parliament opinion
Committee's assessment: Politically important
Committee's decision: Cleared


  7.1  Classical swine fever (CSF) is a viral infection which gives rise to a very high mortality, and strenuous efforts have therefore been made to limit its spread whenever a case occurs. The detailed rules applicable at Community level are based on the slaughter of infected animals, the destruction of their carcases and any meat derived from them, and the establishment of movement restrictions on pigs in the area around the infected site. Also, as it is not possible to distinguish between vaccinated and infected pigs, this policy has since the late 1980s been underpinned by a ban on systemic preventive vaccinations, with vaccination being used only in emergencies, and after confirmation of the disease. However, because of the high density of pigs in some Member States, some outbreaks in recent years have been very costly. It has, therefore, been suggested that greater account should be taken of the most recent knowledge and experience of eradicating the disease, and of the development of new diagnostic tools and vaccines.

  7.2  This led the Commission to put forward in September 2000 the present proposal, which suggested a number of changes to the existing provisions, and consolidated in a new Directive the other numerous amendments which have been made over the years. The main change proposed related to the use of vaccination, and was based on the view expressed by the Scientific Committee in 1997 that this might be more extensively applied under the current non-vaccination policy if so-called marker vaccines — which can provide protective immunity distinguishable from the immune response arising from natural infection with the CSF virus — were available. However, the Commission also pointed out that the Scientific Committee still strongly supports the non-vaccination policy, since it considers that insufficient data exists at present to evaluate properly the marker vaccines being developed, and that it is not yet possible to distinguish vaccinated infected pigs from non-infected ones.

  7.3  The Commission therefore stressed the need to be "very cautious", and it accordingly proposed that, within the framework of the current non-vaccination policy, provision should continue to be made for the use of vaccines in emergencies. In addition, it envisages that the eventual use of marker vaccines would be permitted, subject to:


—  the availability of suitable discriminatory tests (on which research is in progress);


—  a case-by-case authorisation for Member States intending to use these vaccines in an emergency; and


—  an in-depth examination of the results of the vaccination campaign, and the controls carried out on farms where vaccines have been used.

  7.4  A decision would also be taken on the trade restrictions to be applied in respect of the areas where vaccine has been used.

  7.5  In her Explanatory Memorandum of 24 October 2000, the Minister of State at the Ministry of Agriculture, Fisheries and Food (Baroness Hayman) said that the proposal is based on sound veterinary principles, and is supported by the Government. She added that some of the changes proposed are already enshrined in UK legislation and control practices, but that "decisions to vaccinate in any particular circumstance would require very careful consideration".

  7.6  In the conclusion to our Report of 15 November 2000, we noted the Government's support for this proposal, but we said that there were nevertheless certain aspects of it on which we would welcome clarification. First, although we understood that the existing Directive permitted the use of vaccines in an emergency, it was not apparent whether (and, if so, how) the conditions under which these could be used in future would be different from those applying at present. Secondly, in so far as the proposal would permit the use of marker vaccines at some future time, we asked the Minister to confirm that this usage would be confined to emergencies. Thirdly, we were concerned that the Commission appeared to be asking the Council, before the necessary scientific validation had been completed, to decide upon the conditions under which such vaccines would be used.

Minister's letter of 11 December 2000

  7.7  In her letter of 11 December 2000, the Minister says that, although the obligation on a Member State to submit a detailed emergency vaccination plan to the Commission is not new in itself, the proposal sets out a number of new conditions, including the main criteria to be considered before the plan can be approved (Annex I). It also now states that a Member State must include in this plan the criteria that will be considered to decide whether vaccination or depopulation will be applied in contact holdings, and must include the clinical and laboratory examinations to be carried out on samples taken from the vaccinated holding and any other holdings located in the vaccination area, particularly if a marker vaccine has been used. The new proposal also makes provision for a Member State to introduce emergency vaccination before Commission approval, provided a vaccination plan is submitted and the Commission is informed before vaccination is started. The plan will then be reviewed immediately by the Standing Veterinary Committee (SVC), which may request amendments or additions before it is approved. In addition, the plan must prescribe that all the pigs in holdings where vaccination is to be used will be slaughtered as quickly as possible after completion of the vaccination operations, and any fresh meat produced from them will either be processed or marked and treated.

  7.8  As regards marker vaccines, the Minister says that a decision to use these, if and when they become available, would not be taken lightly, and would be based on sound veterinary grounds which suggested that this would be the best course of action for controlling and eradicating the disease. She confirms that the present proposal would establish provisions for the use of such vaccines in emergencies, within the framework of the current non-vaccination policy, but that this would also be subject to the availability of suitable discriminatory tests (on which research is in progress), a case-by-case authorisation that might be accorded to the Member State which intends to use the vaccines, on-the-spot checks on the implementation of the campaign by veterinary experts from the Commission, and an in-depth evaluation of the results of the vaccination campaign and of the controls carried out on the farms where vaccines have been used (including inspections by the Food and Veterinary Office). The Minister also stresses that any marker vaccine that became available would be subject to the same strict regulatory procedures of the Veterinary Medicines Directorate as any other new vaccine.


  7.9  We are grateful to the Minister for this further information, and now clear the document.

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Prepared 26 January 2001