WRITTEN QUESTION P-2512/01

by Lousewies van der Laan (ELDR) to the Commission

(7 September 2001)

Subject: Foot-and-mouth disease: review of EU non-vaccination policy

In response to question E-1195/01(1) in March of this year, the Commission states that it fully supports a review of the current approach towards vaccination, but it points towards the lack of political support for such a review in both the Council and the European Parliament. The Commission states that this lack of support reflects the well identified limitations of such a policy which include, but are not limited to, trade implications.

In April of this year, however, the European Parliament expressed its clear political support for a review in resolution PE 303.051 (European Parliament resolution on the statement of the European Commission on foot-and-mouth disease in the European Union), calling on the Commission to review immediately the basic non-vaccination policy of the European Union.

At this time, the first week of September 2001, there is clear evidence that the FMD crisis is not yet fully contained. This fact is especially worrying, since the disease is much harder to contain in winter than in summer. In addition there is a risk that FMD is becoming endemic among wild animals in the UK.

Considering that the calculations on which the non-vaccination policy was based in 1991 took into account only one outbreak of FMD every 10 years, does the Commission agree that the very real chance of having another consecutive winter of FMD crises should lead to an urgent reconsideration of the non-vaccination policy before the winter breaks?

The Commission correctly states that trade implications are at the root of the non-vaccination policy. Would the Commission agree that the FMD crisis last winter taught us that the negative impact on many sectors of the economy far outweighs the impact that generalised prophylactic vaccination would have on EU external trade? Does the Commission agree that the economic impact of non-vaccination depends on the frequency and intensity of outbreaks? If so, where is the turning point from positive to negative economic impact?

What steps has the Commission taken so far to ensure that if a review of the non-vaccination policy should lead to generalised prophylactic vaccination, sufficient vaccine would be available at short notice should another FMD crisis break?

(1) OJ C 364 E, 20.12.2001, p. 58.

Answer given by Mr Byrne on behalf of the Commission

(25 October 2001)

The Commission position is that there was no support in the Council or the Parliament for a review of the approach towards vaccination in the context of the current outbreak. However, the Commission fully accepts that there is a consensus in all institutions for a thorough review immediately this outbreak has been successfully eradicated.

Currently a limited number of outbreaks of Foot-and-mouth disease (FMD) are reported in certain defined areas of the United Kingdom. The protective measures introduced by Commission Decision 2001/145/EC of 21 February 2001 concerning certain protection measures with regard to foot-and mouth disease in the United Kingdom(1), the day of the first FMD-outbreak in the United Kingdom, and now laid down in Commission Decision 2001/356/EC of 4 May 2001 concerning certain protection measures with regard to foot-and mouth disease in the United Kingdom and repealing Decision 2001/172/EC(2), have effectively prevented the spread of the disease from the United Kingdom to the rest of the Member States and Northern Ireland during a period when 40 and more outbreaks were reported each day. The prolonged tailing off in disease incidence underlines the imperative needs of maintaining a high level of vigilance in all Member States.

If the epidemiological situation would require recourse to vaccination, this would be possible within the framework of the current legislation, which provides for the possibility of emergency vaccination. If deemed necessary by the Standing Veterinary Committee, where the FMD situation is under continuous review, a decision similar to those taken for the United Kingdom and the Netherlands could be immediately adopted by the Commission in this regard.

In the aftermath of this crisis a comprehensive and thorough review of the Community policy on the prevention and control of FMD is already scheduled. To mention some of the landmarks in this process the Commission wishes to refer to the publication by the World Organisation for Animal Health (Office International des Epizooties (OIE)) of the new edition of the Manual of Standards for Diagnostic Tests and Vaccines in August 2001, the recent Research Group meeting of the European Commission for the Control of Foot and Mouth Disease of Food and Agriculture Organisation (FAO) on diagnosis of and vaccination against FMD, the Immunological Working Group of European Medecines Evaluation Agency (EMEA) on the FMD-Monograph of the European Pharmacopoeia, the session of the FMD and other exotic diseases Commission on the new FMD-chapter in the International Animal Health Code of the OIE, the scientific seminar organised by the Commission on Developement of prevention and control strategies to address animal health and related problems in densly populated livestock areas in the Union held in Brussels on 26 September 2001, and last in chronology the International Conference on the Prevention and Control of FMD, organised by the Belgian Council Presidency and scheduled for December 2001.

Because any change in Community policy on the control of FMD ought to be seen not only within an European but also an international context, the recommendations of the aforementioned events will undoubtedly play an important part in the preparation of a Commission proposal to the Council for a new Directive on Community FMD control measures.

The calculation of the costs related to the current FMD outbreak has not been accomplished at this stage. Therefore, it is not possible to compare these costs with the advantages of a FMD control policy with prophylactic vaccination.

However, the Commission agrees that in general the economic impact of an outbreak of FMD in non-vaccinated livestock depends on, amongst other things, the temporal and spatial pattern of the outbreaks, the density of livestock in the affected area, time and extent of the restrictions applicable in the affected areas, the commercial activities of the livestock sector affected by the control measures, but to a large extent also on the rapidity the veterinary services can eliminate infected premises.

Indeed, the prohibition of prophylactic vaccination against FMD in the early 90s was supported by a cost/benefit study, which was carried out in the late 80s, when prophylactic vaccination was still widely carried out, suggesting that the Community would have benefited from this policy in the case of about two to four FMD epidemics of medium size each 10 years.

The validity of this study was fully confirmed in the 90s and until 2000, when four virus incursions in the Community were successfully controlled without giving rise to large epidemics. Under these circumstances, the Community clearly benefited from the adopted policy, in terms of a remarkable decrease in the number of FMD outbreaks compared with the80s, considerable savings on vaccination costs, and evident advantages on intra-Community trade and export to third countries of live animals and their products.

The Community antigen bank contains 39,2 million vaccine equivalent cattle doses of antigen of several serotypes and strains of the FMD virus, including 10,5 million doses of serotype O antigen, which is sufficiently homologous to the current UK strain. About one million doses of antigen can be formulated into vaccine within four days and about seven million doses within two weeks. In addition, about 1,5 million doses of vaccine might be available within similar delays from the reserves kept in the national vaccine banks of certain Member States. Furthermore, throughout this epidemic the Commission has been storing for immediate supply 300 000 doses of ready-to-use vaccine that included also a suitable O-strain. This vaccine was only most recently released for emergency vaccination in Turkish Thrace, when an outbreak of FMD type O was reported close to the Greek border.

In case of urgent need many more million doses may be produced within a few weeks by a number of private companies in the Community that produce this vaccine routinely for marketing in third countries.

(1) OJ L 53, 23.2.2001.

(2) OJ L 125, 5.5.2001.