The Scottish Government

BLUETONGUE STAKEHOLDER MEETING

Inverurie Area Office 10.30 am 9th April 2008

NOTE OF MEETING

Present

* Via teleconference

Introduction

1. Cabinet Secretary welcomed everybody to the meeting and thanked those who had made it despite the short notice and venue. He said that the Scottish Government shares the industry's concerns over the potential impact of bluetongue and remains determined to work in partnership with industry to protect Scotland from the threat of bluetongue and to minimise the impact of the disease should it occur. He was keen for industry to take the lead on bluetongue and the purpose of the meeting was to discuss the issues surrounding bluetongue vaccination and to reach an industry decision on the way forwards.

Disease update and vaccination issues

2. CVO Scotland gave a presentation on the current situation. The main points are summarised below.

Infected Premises

3. Before the vector free-period, there were 66 premises infected with bluetongue. During the vector-free period, 90,000 animals were pre-movement tested for bluetongue; of these only 61 animals were found to be infected. This gives us a high degree of confidence that we know where the disease currently is in England.

Imports

4. Despite advice from both Government and industry, imports have been coming into the UK from infected areas in Europe. To date there have been 737 animals imported to Scotland, 5,165 to England and 315 to Wales. Of these, post movement testing has identified 31 PCR-positive animals to England, one PCR-positive animal moved to Wales, and one PCR positive heifer moved to Scotland (Kirkcudbright). These were all culled.

5. Further information on the Northern Ireland import incident in February (where PCR positive calves were born to ELISA positive but PCR negative heifers from the Netherlands) suggests that whilst the immune system of an ELISA-positive pregnant female has sufficient antibodies to remove virus from the bloodstream, the developing foetus does not. This means that there is a real danger of virus overwintering during the nine months of pregnancy. Furthermore, information suggests that the PCR and ELISA negative heifer of Scottish origin that became infected after being housed with the imported heifers did so by either licking birth fluid or eating the placenta from the infected calves, an unforeseen oral route of infection.

6. In light of this, the Commission is currently considering additional controls on the movement of pregnant animals out of a bluetongue restricted area. It is likely that animals will either need to be vaccinated or become immune through recovering from the disease before becoming pregnant in order to allow movement.

7. Two antibody-positive Bukhara deer were imported to Scotland last month. They were confirmed to be not pregnant. However, there is some evidence from an American study in the 1970s that stress can induce a re-emergence of the virus in apparently immune animals. Elk, close relations of red deer, were infected with bluetongue, exhibited viremia for 10 days and then recovered. One hundred days after infection they were injected with steroids to simulate the stress response, at which point they became viremic once more. In light of this one of the Bukhara deer was voluntarily culled on a precautionary basis; the other had died of non bluetongue related causes.

Potential for disease spread

8. Bluetongue virus type 8 has now spread over most of Northern Europe with very few pockets free of disease. In France, there is now a distinct overlap of BTV8 and BTV1 restricted zones. BTV1 cases have now been identified near Bordeaux in south West France.

9. Within the UK, the original modelling work by Pirbright that suggested that infection might reach Scotland by October 2008 in the absence of vaccination in England has now been superseded The latest results suggest that Scotland remains at a low risk of incursion via midge-borne spread from England right up to December 2008. The model suggests that this risk is reduced even further by a successful vaccination campaign in England.

10. However, Defra intend for vaccination to begin in the areas of highest risk and then roll out to the rest of England as vaccine becomes available. This means that the border of the protection zone, and potentially infected and unvaccinated animals, will get progressively closer to Scotland until such animals can move up to the border with Scotland. The risk that this represents will very much depend on the effectiveness of the vaccination campaign in England, which is voluntary. No timescale has been attached to this process as yet - it may depend to some extent on uptake, as vaccine unused in one area can be offered to the next.

Issues surrounding vaccination in Scotland

11. In order to vaccinate, an area must become a protection zone. Despite much discussion with the Commission on several occasions, they are not prepared to move on this, partly due to the lack of a DIVA vaccine that would allow the differentiation between vaccinated and infected animals.

12. Once part of a protection zone, an area is then open to free movement of any animal from any protection zone; Scotland will not be able to legally continue its current requirements for pre- and post movement testing.

13. Since it will take time to rollout a vaccination programme, and since it takes 21 days for sheep to become immune and 60 days for cattle after vaccination, this means that there is a significant period of time when animals are at risk of infection. This is why veterinary advice is that vaccination should ideally be conducted pro-actively during the winter vector-free period, subject to disease developments. Should disease arrive before then, it is envisaged that vaccination would be considered within any protection zone declared.

14. Vaccine supply is not envisaged to be a problem - information received from various pharmaceutical companies is that vaccine yield is high. Although the shelf life has been initially set at 12 months, it is envisaged that this will be extended in line with other bluetongue vaccines once testing can be conducted.

15. There are three basic mechanisms for vaccination:

• Voluntary - Estimated cost £9m - Simplest mechanism. However, evidence from the continent shows that there needs to be at least 80% uptake for a vaccination campaign to be effective. This approach therefore poses a risk of infection to unvaccinated animals, a risk to vaccinated animals as disease is still likely to circulate and no vaccine is 100% effective, and a risk that it will take much longer to reach, and prove, a bluetongue free status.
• Compulsory & farmer administered - Estimated cost £9m - Middle ground. Ensures high uptake and facilitates disease prevention/eradication while keeping costs down. Relies on farmers administering vaccine properly.
• Compulsory & vet administered - Estimated cost £21m - Expensive but ideal in the view of the Commission as vaccine is professionally administered, so this could attract some EU funding. However, the EU funds are unlikely to offset the extra expense.

16. The estimated costs are made up three main categories of expenses:

• Estimated vaccine costs (charged by the manufacturer) £6m
• Estimated distribution costs £3m
• Estimated veterinary administration costs £12m

17. Under the first two mechanisms, some vaccinations would still need to be done by vets: those for animals moving out of a bluetongue restricted area, and possibly those for animals for which the vaccine is not licensed (e.g. deer, goats, and zoo animals under the cascade system).

18. The costs are based on buying 12m doses, enough to vaccinate all livestock in Scotland. However, there could be some exemptions. For example, a variety of zones could be put in place in Scotland. If we did not vaccinate in the Islands, the doses required would drop to 11m, if we left out the whole North West and the Islands it drops to 9.5m. In addition, if we vaccinate during a vector free period, there is no point vaccinating animals that will be slaughtered before the vector free period ends. There is also no point vaccinating animals that will be slaughtered before they will become fully immune.

Discussion on a Scottish Vaccination Plan

19. Cabinet Secretary thanked the CVO for his presentation and opened the meeting for discussion. He emphasised the need for a frank exchange of views and requested that the meeting be considered private. It was agreed that a joint Government/industry statement would be agreed at the end of the meeting.

20. He then asked all those present to present their views on the three fundamental issues that required agreement today so that further progress can be made:

• Should the campaign be voluntary or compulsory?
• Who should pay for what?
• How and where should vaccine be administered?

21. The main points raised are summarised below:

NFUS

• Scottish Government should order vaccine as soon as possible - further delays will risk the Scottish livestock industry losing credibility.
• They re-iterated previous support for a compulsory campaign and acknowledged that there would be monitoring costs associated with this.
• Hill sheep farmers are producing animals of relatively lower value and are less able to carry the cost of vaccination than other sectors.
• This is an exotic disease that Scotland is facing for the first time - while there is an economic threat to individual farmers, there is also a threat to Scotland's wider economy.
• It is important that the Scottish Government takes the lead in the first year - the greater the financial contribution that can be made the better; however it is essential that the process is as simple as possible to avoid administration costs eating into the contribution.
• For year two onwards, funding streams should be made available from the SRDP.
• A limited survey of members suggests that members in the Islands wish to remain a free area and members in southern/central Scotland wish to vaccinate; however the feeling in the Highlands is less clear cut.

NBA

• Scottish Government should order vaccine as soon as possible.
• Members are desperate to get hold of vaccine and are willing to pay in order to prevent a hold up.
• This would be made easier if Scottish Government picks up the legal and monitoring costs and the campaign was voluntary to keep costs down.
• If uptake was not sufficient, would support a move to compulsion later.
• Scottish Government should push/lead the campaign.
• Vaccination should be across the whole of Scotland as animals will not be accepted into protection zones unless they are vaccinated.

SBCA

• As there is no significant difference in the cost to industry between the voluntary mechanism and the farmer-administered compulsory programme, favour a compulsory approach.

NSA (Scotland)

• Scottish Government should order vaccine as soon as possible.
• The campaign should be compulsory with farmers administering vaccine.
• The actual campaign should be held off as long as possible, and then started in the South of Scotland and rolled out Northwards as quickly as possible.

SAMW

• A voluntary campaign is too much of a risk. Only a compulsory campaign will achieve 80% uptake - anything less is a waste of money.

SRPBA

• Campaign should be compulsory.
• Vaccination should be funded via article 69.
• There are potential additional costs for deer farmers.
• There are concerns about wild deer.

IAAS

• Scottish Government should order the vaccine as soon as possible.
• Splitting the country into different zones will cause too many economic problems unless the split is at the Highland Glen.

22. Further discussion followed, following up on some of the points raised.

Compulsory/Voluntary

23. ANM Group queried how important it was to agree a compulsory or voluntary approach at this stage. CVO Scotland explained that a compulsory scheme would require a significant amount of work by Government to ensure that the legislation, monitoring and enforcement mechanisms were in place - this cannot happen overnight.

24. Cabinet Secretary asked if a compulsory scheme would be viewed as an obstacle to agreement by the NBA. The NBA emphasised that their concern was to keep costs as low as possible for industry. CVO Scotland responded that the costs for a farmer-administrated compulsory scheme would be much the same as those for a voluntary scheme, but that the protection provided by a compulsory campaign would be much greater. Cabinet Secretary clarified that the extra costs for monitoring and enforcement arising from compulsion would be for Government to pick up; there would only be extra costs for industry if it was decided to require veterinary administration for all, which did not appear to be the favoured option anyway. On this basis, NBA agreed to support a farmer-administered compulsory campaign in Scotland.

25. NFUS commented that a compulsory scheme would mean that all of Scotland would benefit from the better coverage, that it could help in terms of the speed of roll out and getting to the exit strategy quicker, and that overall it gave the best value for money.

Funding

26. NFUS said that they were delighted to hear that Scottish Government would cover the extra cost of the monitoring and enforcement requirements arising from a compulsory vaccination campaign. However, they stated that they would still like an additional contribution towards the cost of the vaccine, though they accepted that £9m was a difficult sum to find. They noted that this is the first real test of the cost and responsibility sharing approach, and that farmers will be carrying costs for animal gathering regardless of any other conditions, and they asked how much Scottish Government would be prepared to put towards the vaccination campaign.

27. Cabinet Secretary said that he had raised this question at Cabinet the previous day. An agreement had been reached that in recognition of the recent tough times for industry and the importance attached to dealing with bluetongue, a contribution could be found towards costs for the first year.

28. He emphasised that this would have an impact on other areas of his portfolio since the wider budget is not unlimited. He also emphasised that this should not be seen as setting a precedent for funding for future years of bluetongue vaccination, or for vaccination against other diseases. However, he added that he was willing to discuss the wider possibilities for animal health funding via routes such as article 69 or modulation over the coming months.

29. Cabinet Secretary offered funding of 50% of the vaccine procurement costs (i.e. the bill from the vaccine manufacturer) up to a ceiling of £3m, provided that it was fully accepted that this funding was for one year only, and that industry would engage with Scottish Government on the wider health and welfare agenda.

30. NSA said that the industry would be very grateful for this funding, which would show Scottish Governments support to both the livestock industry and the wider rural communities.

31. NFUS were concerned that the distribution costs would still be high. Cabinet Secretary reminded the group that at this stage all the costs were estimates and that Scottish Government would be working hard to minimise all costs along the supply chain. He also reminded the group that this offer of support on vaccine costs was in addition to the not insignificant costs already being borne by the Scottish Government on bluetongue, for example on research and policy development, and the additional costs to come from monitoring and enforcement.

32. SBCA asked what would happen if the English vaccination campaign was more successful than foreseen and Scotland was no longer at immediate risk of getting bluetongue. CVO Scotland said that any decision to vaccinate would be taken in the light of the developing disease situation. Cabinet Secretary explained that this was the risk that Scottish Government was taking on behalf of the industry. Although they would only be paying for 50% of an order (up to the £3m ceiling), Scottish Government would be underwriting the cost of the entire order. If the vaccine was not used, the entire bill would then fall to the Scottish Government. Should this happen, they may try to sell on the vaccine in order to recoup some of the loss.

33. NBA asked whether, since funding would only be offered for the first year, vaccination would still be compulsory in future years. Cabinet Secretary confirmed that it would be. NFUS supported this approach, suggesting that although a reasonably high uptake was expected in England in the first year, the danger was that in future years, the risk will be perceived to be lower and less people will vaccinate under the English voluntary scheme.

34. NFUS said that the vaccination approach and funding agreement arrived at represented a major step forward, answering immediate concerns and providing a map for proactively dealing with bluetongue in Scotland.

Conclusion

35. It was agreed that a consensus had been reached, subject to state-aid clearance for the vaccine funding. Officials typed up a draft agreement laying out the principles of a Scottish vaccination campaign, which was read out to the meeting. The statement was agreed subject to some comments made, which were taken on board; a revised agreement is attached.

36. NFUS lead the Group in congratulating Cabinet Secretary and Scottish Government officials on the outcome achieved.

Rural Directorate - AHW

10th April 2008

JOINT SCOTTISH GOVERNMENT/INDUSTRY STATEMENT

ON BLUETONGUE VACCINATION

Scottish industry stakeholders have identified the threat of bluetongue as their highest animal health and welfare priority. In the absence of a commercial market for bluetongue vaccine, they have asked the Scottish Government to immediately secure vaccine on behalf of Scottish producers.

The Scottish industry/ Government stakeholder group, chaired by the Cabinet Secretary Richard Lochhead, which met on the 9th of April to discuss the control of bluetongue in Scotland, were of the view that the main aim continues to be to keep Scotland free of bluetongue. With this in mind the group agreed that:

• Based on veterinary advice, there is a low but increasing risk of the introduction of bluetongue to Scotland;
• There is an urgent need to secure vaccine to control the spread of bluetongue, should it arise in Scotland;
• The Scottish Government would provide 50% of the costs of the purchase of vaccine, up to a maximum of £3m, for the first year only of a vaccination programme. This is subject to European Commission State Aid approval. It is a significant and unprecedented additional contribution towards promoting animal health and welfare in Scotland.
• Industry will meet the remaining costs of the vaccine and the total cost of vaccine administration in this and future years.
• The Scottish vaccination programme will be compulsory, with vaccine administered by farmers (except where veterinary administration is required e.g. for animal export purposes), and implemented during the 2008/09 winter vector free period, subject to disease developments in the intervening period.
• The Scottish Government already provides significant policy, veterinary and research support to protect Scotland from the threat of bluetongue. In future years, the Scottish Government will meet the additional costs associated with enforcement and monitoring of a vaccination programme.
• Industry and Scottish Government will work together to investigate the potential use of CAP or Rural Development funds to meet future animal health and welfare costs in Scotland.

Scotland has a strong history of partnership working between Government and stakeholders to promote animal health and welfare standards in support of a sustainable livestock industry. Stakeholders acknowledge the value of working with Scottish Government to consider how challenges can be met. The Scottish Government and the livestock industry continue to support the development of a National Agenda for Animal Health and Welfare in Scotland. This will build on work to date in partnership to identify the best prioritisation of resources and address the challenges presented by the current tight spending review settlement and the responsibility and cost sharing agendas in the UK and EU.

The Scottish Government funding of bluetongue vaccine in 2008/9, subject to a ceiling of £3m, is intended to demonstrate its commitment to working with stakeholders in the development of a National Agenda for Animal Health and Welfare. It is also recognition of the industry's crucial role in Scotland.

9th April 2008