WRITTEN QUESTION E-1855/02

by Jan Mulder (ELDR) to the Council

(28 June 2002)

Subject: Amendment of OIE rules on the use of marker vaccines

A proposal to shorten the period after which a region where animals have been vaccinated against foot-and-mouth disease can regain its FMD-free status was approved at the annual General Session of the OIE in Paris in May 2002. (The waiting period was shortened from 12 to 6 months). This is conditional upon serological tests being carried out which show that the disease has been eradicated and that the vaccinated animals do not have the disease. The latter can be demonstrated if emergency vaccinations are carried out with marker vaccines for which corresponding test methods exist.

1. Have EU Member States also called for the period to be shortened to three months, the length of time after which a region can regain FMD-free status following the sanitary slaughter of animals (stamping-out)? If not, why not?

Since adoption of Directive 2001/89/EC(1), the use of marker vaccines has been permitted in the context of measures to control classical swine fever. Such vaccines now exist and have received a favourable opinion from the EMEA in London. Corresponding test methods are currently being developed.

2. Have the Member States therefore called for the OIE rules to be changed so as to shorten the waiting period in the case of swine fever, too? If not, why not?

(1) OJ L 316, 1.12.2001, p. 5.

Reply

(11 November 2002)

1. At its 70th session from 26 to 31 May 2002, the OIE agreed to the reduction from 12 to 6 months of the period after which official disease-free status in relation to foot-and-mouth disease could be regained, and noted that the use of new serological tests made it possible to differentiate the antibodies of vaccinated animals from those of animals that had been in contact with live virus. However, it seems that these new tests, which have not yet been officially validated, are not 100 % reliable in detecting live virus.

Thus if a country which has used emergency vaccination and does not want to slaughter the vaccinated animals, but wishes to recover its disease-free status without vaccination at the end of 6 months (and not 12 as in the previous OIE code), it must provide very detailed epidemiological evidence, including comprehensive use of the new tests on all the animals vaccinated, to convince the OIE of the absence of the live virus.

It should also be noted that the European Commission is currently drawing up a proposal for a Directive to revise and update Community standards in force in relation to foot-and-mouth disease, in the light of the latest scientific and technical developments. Of course, the Member States and the European Parliament will have every opportunity to make their views heard on the measures proposed.

Pending the adoption of new measures, Member States must comply with the rules currently laid down in Directive 85/511/EEC of 18 November 1985.

2. As regards classical swine fever, the new chapter of the OIE Code relating to that epizootic disease is entirely in conformity with the provisions of the Community Directive applicable in this area, namely Directive 2001/89/EC of 23 October 2001.

The basic rule in that Directive is that vaccination is banned, although in certain circumstances emergency vaccination may be possible in accordance with very specific rules. These rules require in particular the presentation of a vaccination plan (which must always be adopted by the Commission), recommend the use of traditional vaccines and authorise the potential use of marker vaccines subject to the development of a discriminatory serological test.

At this stage, research is still being done into such a test, which means that the rules currently in force as regards vaccination should be adhered to, with the consequences which that implies for regaining official disease-free status after any use of vaccination.

3. The Community is not a member of the OIE. The Member States participate in the meetings of that international organisation, of which they are individual members. Since several questions dealt with by the OIE are covered by Community rules, Member States coordinate their positions both before and during those meetings.