The Scottish Government

ANIMAL HEALTH AND WELFARE STAKEHOLDERS GROUP

BLUETONGUE DISEASE MEETING

10:00, 7 March 2008, PENTLAND HOUSE, EDINBURGH

Present

*By teleconference

Introduction

1. Colette Backwell welcomed stakeholders to the meeting and explained that the purpose was to give an update on the disease situation and to agree a position on a Scottish vaccination strategy.

Disease Update

2. CVO Scotland gave a presentation to update stakeholders on the disease situation. All animals moved from the infected area in England between infection arriving on 4th August and the declaration of a Protection Zone ( PZ) have now been traced, and it was found that only one consignment of 7 goats came into Scotland during this time. These have been tested and found to be negative. Since the vector free period began, there had been 521 cattle and 692 sheep moved from the PZ in GB into Scotland: all had been tested and found negative. There had been approximately 700 movements from other Member States into Scotland since 2006, all of which had been post movement tested and found to be negative, to date, apart from one infected cow identified in Kirkcudbright, which was culled to prevent disease becoming established. Checks have also been carried out on databases to further ensure that all animals moved into Scotland from PZs in England have been tested and to date there is no indication that interested animals have moved to Scotland.

3. Stakeholders were reminded that the vector free period would end on 15th March, and farmers must ensure that tests were undertaken for all movements from PZs. The consequences for breaching this regulation could be up to £5,000 fine or 6 months in prison.

4. There had been an interesting development in Northern Ireland where post movement testing on a consignment from Holland showed 8 ELISA positive cows. A follow up test found another animal which had previously been negative to be PCR positive. A third set of tests showed that 4 calves born to 3 of the original 8 ELISA positive cows were PCR positive. The route of maternal transmission was not known previously, and indicates a possible means for the virus to survive over the winter. This raised a new question of how to protect our livestock. The European Commission were looking into how to take this route of transmission into consideration in regulations and had developed a tight set of controls on the movement of breeding animals before mating. They proposed that susceptible animals must be: vaccinated and PCR tested, or; vaccinated after being in a vector free zone for 60 days; revaccinated; naturally immune & ELISA positive 60-360 days before breeding; naturally immune and ELISA positive 30 days before movement and PCR negative 7 days before breeding; vector free for 28 days with negative ELISA 7 days or more before breeding. The first two of these regulations would apply at any time of year, and the rest only during the vector free period.

5. In the UK there had been, as anticipated, little progression of disease during the vector free period. There had been a total of ninety-three cases of Bluetongue disease to date in the UK. The PZ had been extended to Cornwall, but this was at the request of farmers in order to facilitate animal movements. BTV1 had continued to spread from the south of France, and this was being closely monitored. CVO Scotland reminded stakeholders that there is no cross immunity through vaccinating an animal against one strain of the disease. However, multi-serotype vaccines were available for some strains, and there exists the possibility that BTV8 vaccine, when developed, could be incorporated with another strain of vaccine if necessary in the future.

6. CVO Scotland reminded the meeting that stakeholders had agreed a position statement on a vaccination strategy in December, the main points of which were that:

• there should be a targeted use of vaccination to control the spread of disease;

• a compulsory vaccination campaign would likely be needed to achieve sufficient coverage of animals, and resource implications should be managed on a partnership basis;

• should Bluetongue become widespread across GB, containment would no longer be appropriate and a programme of prophylactic vaccination should be pursued.

It was hoped that a collective and unanimous decision could be reached again as to the next steps.

7. The Institute of Animal Health at Pirbright had produced a risk map predicting the geographic spread of Bluetongue by October 2008, which showed significant incursion into Scotland. However, this preliminary model was based on several flawed assumptions, including the use of one temperature reading taken in Sussex for the whole of GB. A second risk map was produced, based on more realistic assumptions, predicting the spread of disease by December 2008 without a vaccination campaign. This showed a far more likely scenario, which indicated little risk of disease in Scotland. A further map demonstrated likely incursion at the same date if a vaccination campaign with 80% uptake were undertaken. This predicted only one small area of disease risk in Scotland. However, the CVO warned that there was a need for caution in basing any action on these assumptions.

8. CVO Scotland noted that he had raised with the European Commission the need to consider allowing vaccination to protect livestock before declaring a PZ on several occasions. However, the Commission's position remained the same: as soon as Scotland vaccinated against Bluetongue a PZ must be declared, and free movement between PZs allowed. This position was currently non-negotiable. This was an important issue as vaccinating too soon would require Scotland to declare a PZ which would potentially open Scotland up to the risk of greater disease incursion. Immunity was likely to take 21 days in sheep and 60 in cattle from the date of vaccination, however, as there was no vaccine yet developed, this was not certain. Vaccine producers were positive about their capacity to produce enough vaccine in time for a potential outbreak, but there were no guarantees and batch failure always remains a possibility.

9. The timing and extent of a vaccination campaign would depend on the circulation of disease this summer. CVO Scotland's veterinary advice would be to vaccinate during the next vector free period when disease spread it is its lowest, and expert advice from Pirbright and abroad supported this position.

10. CVO Scotland recognised that there was some question as to what the extent of vaccination should be, and whether it should be compulsory or voluntary. In veterinary terms, there must be 80% coverage for a campaign to be effective in preventing spread of the disease. It is likely that this coverage would be achieved in the south east of England where disease was at its worst. It was also important to consider the shelf life of vaccine. BTV8 vaccine would receive certification of 12 months shelf life when it is first produced, however, most producers were confident that it would last 2-3 years, as other serotype vaccines currently do. Extension of the shelf life would require part of the batch of purchased vaccine to be tested during the storage period and if successful the Veterinary Medicines Directorate would be able to authorise additional years shelf life for vaccine previously produced.

11. Conditions of trade would also need to be taken into account with regard to when and to what extent vaccination would be undertaken, though the conditions would be the same no matter when vaccination was undertaken. Vaccinated animals should be free to move to non PZs under EU regulations. However the Republic of Ireland and Northern Ireland recently took unilateral action to prevent the movement of breeding females and similar measures can never be ruled out.

12. Epidemiological analysis suggested that the risk to Scotland from Bluetongue disease would be low this summer, though England's vaccination strategy had implications for Scotland. Depending upon the rate and uptake of vaccination, and the extension of PZs, the movement of disease may come significantly closer to Scotland than was currently the case.

13. The English vaccination strategy allows for three possible certification options for a vaccination campaign. Farmers who do not intend to move animals out of a PZ would be allowed to vaccinate their livestock themselves and record this in their medicine book. Where farmers intended to move animals to free areas in other Member States, a veterinary surgeon must carry out the vaccination, record it and provide certification. However, where farmers intend to move their animals to free areas within GB, farmers have the option of vaccinating their livestock themselves, and handing empty bottles back to vets who would then provide certification. CVO Scotland highlighted that there would be a real risk to Scotland if vaccination were not carried out properly. In response stakeholders were unanimously in favour of a 2 tier approach, with some form of veterinary certification for any movement out of a PZ.

Development of a Scottish Vaccination strategy

Timing

14. CVO Scotland informed stakeholders that, based on the latest modelling - which remained a work in progress - he wanted to stress that the risk to Scotland from Bluetongue disease this summer remains low. This reflects experience in Europe over the last 2 years. CVO Scotland would therefore strongly recommend a vaccination campaign during the next vector free period, unless the disease situation changed significantly. As soon as there was one case of Bluetongue in Scotland, and it was confirmed that disease was circulating a PZ would be declared. The PZ could vary in size, but it would be obliged to be open to trade with other PZs and therefore risk the incursion of further disease.

15. There was some discussion about concern amongst the industry that if the disease spread into Scotland this summer, it could cause real problems if Scotland did not have a stock of vaccine ready to protect livestock. Given the shelf life of at least one year, and possibly longer, and the potential of several other European countries ordering vaccine soon, it would make sense to order vaccine now. However, in case of a successful English vaccination campaign which meant no incursion of Bluetongue in Scotland by next winter, stakeholders indicated that they may then not wish to vaccinate during the coming vector free period. NFUS suggested that in this scenario, any vaccine bought by Scotland could potentially be sold to a country in need of it in order to re-coup some cost.

16. Stakeholders agreed that the present disease situation in Great Britain was unpredictable and accordingly recommended that a supply of Bluetongue (serotype 8) vaccine should be ordered. The order should be for a sufficient quantity to vaccinate all susceptible domestic animals in Scotland.

17. Stakeholders also agreed unanimously that any vaccination programme in Scotland would best be carried out during the vector free period, though the provisions of the programme should be kept under constant review in the light of the emerging disease situation in Great Britain. The vaccination programme could contain options to vaccinate on a geographical basis using zones.

Compulsory or voluntary

18. NFUS stated that it supported a compulsory approach to vaccination to ensure that 80% coverage was achieved. It was also more likely that EU co-funding would be available if Scotland took a compulsory approach. Neil Ritchie responded that the history of vaccination discussions was that industry had indicated willingness to pay for vaccine. Whilst the European Commission had offered support for vaccination programmes meeting their criteria on this was now subject to ceilings.

19. BVA Scotland felt that a voluntary campaign, whether or not paid for by industry, would not be taken up sufficiently to achieve 80% coverage, and therefore was in favour of a compulsory campaign. There was some discussion as to what exactly a compulsory campaign would involve, and whether it would mean 100% vaccination across Scotland. Potentially, a compulsory campaign could be put in place only in some parts of the country. CVO Scotland pointed out that economic modelling of the impacts of various scenarios was being carried out, and could help inform the debate once complete.

20. Stakeholders agreed that at the present time they were not in a position to recommend whether the vaccination programme should be voluntary or compulsory until it had had an opportunity to discuss the results of an epidemiological and economic analysis. There was no agreed position on the financing of a vaccination programme.

Geographic targeting

21. CVO Scotland informed the group that it could be advantageous for some areas in Scotland to remain outwith a future PZ in order to retain their disease free status. There was some discussion regarding the possible economic impacts of regulations regarding movement between and through Restricted Zones.

Certification/identification

22. CVO Scotland informed stakeholders that current proposals in England were that only farmers who wished to move their livestock to disease free areas would be obliged to certify vaccination. There was discussion about the possibilities of tagging and cattle passports for identification and the acceptability of veterinary certification on the grounds of farmers vaccinating livestock and handing empty bottles back to veterinary surgeons. BVA Scotland did not think that the Royal College of Veterinary Surgeons would find this option acceptable, and NFUS thought that industry would not either. CVO Scotland confirmed that this method had some precedence, having been used by farmers in South America in FMD vaccination.

23. Stakeholder agreed that certification of vaccination should be on the basis that movements from PZs into free areas should require the same level of certification, whether those free areas are within the UK or other Member States.

Conclusion

24. Colette Backwell proposed that in light of agreement among stakeholders that vaccine should be ordered, it would be inappropriate to discuss the details of any order. Preliminary discussions with the SG's Procurement Team were already taking place, and if necessary, the tendering process could be commenced quickly. CVO Scotland stated that stakeholders would be involved further into the tendering process, when issues of timing and size of orders became clear.

Summary

25. Colette Backwell summarised the main points agreed by stakeholders (see annex).

26. These views would be passed onto the Cabinet Secretary by SG officials to inform any decisions.

27. Stakeholders were asked to consider the wider issues relating to delivery of a vaccination campaign, and how a compulsory approach could work in Scotland.

28. Next meeting: date not set but stakeholders will be kept informed of developments.

Scottish Government Rural Directorate

7 March 2008

Annex

Animal Health & Welfare Stakeholders Bluetongue Meeting:

Stakeholders Agreed Position Statement on Vaccination, 7th March 2008

· The present disease situation in Great Britain is unpredictable and accordingly the industry Group recommends that a supply of Bluetongue (serotype 8) vaccine is ordered. A sufficient quantity to vaccinate all susceptible domestic animals in Scotland should be tendered for.

· Any vaccination programme in Scotland would best be carried out during the vector free period. The provisions of the programme should be kept under constant review in the light of the emerging disease situation in Great Britain. The vaccination programme could contain options to vaccinate on a geographical basis using zones.

· At the present time the Group is not in a position to recommend whether the vaccination programme should be voluntary or compulsory until it has had an opportunity to discuss the results of an epidemiological and economic analysis. There is as yet no agreed position on the financing of the vaccination programme.

· Certification of vaccination should be on the basis that movements from Protection Zones into free areas should require the same level of certification, whether those free areas are within the UK or within other Member States.