Has a cost benefit analysis ever been undertaken to justify the existing programme of eradication in the UK? The UK, in common with many European countries, is in dire financial straits and cut backs are expected in many areas. What about bovine TB? We put this question to Ministers and DEFRA in March 2010 and sent them a copy of the report 'Public health and bovine tuberculosis: what's all the fuss about?' by Paul R and David J Torgerson. The response is below.
CCU Ref: DWOE178656 April 2010
BOVINE TB Thank you for your email of 26 March regarding bovine TB (bTB) and the copy of the opinion paper by Torgerson & Torgerson to which you refer. I have been asked to reply.
Whilst the paper may have a point in pure monetary terms of human lives saved (or clinical cases of TB prevented) by the bTB control programme, we should not lose sight of the fact that the costs of an existing disease control intervention are often easier to quantify than the benefits, some of which may be rather intangible.
As stated in the paper, under EU Animal Health legislation (not only Council Directive 64/432/EEC), there is a legal obligation on every Member State to draw up and implement a plan for the eradication of bTB from their respective territories. The UK plan is approved and co-financed by the European Commission. It is simply not a realistic option for the UK Government to seek derogation from Directive 64/432/EEC (which applies to all Member States), or to expect that the Commission would grant it. Were the bTB surveillance and control programme to be terminated, the Commission would probably impose an automatic ban on all live cattle exports from the UK and instigate costly infraction proceedings against the UK government. The trade of cattle between England, other parts of the UK and especially with Scotland (designated as an officially TB free [OTF] region last September) would be severely disrupted.
Additionally, Mycobacterium bovis infection would be expected to spread out of control not only within the national cattle herd, as implied in the paper (and evidenced after just a one-year suspension of testing during the 2001 epidemic of Foot and Mouth Disease), but it would also spill over more frequently to other domestic and wild mammals (including pets) at a much higher rate and over a wider geographical range than at present.
Furthermore, the absence of a national bTB surveillance regime on UK cattle farms would have knock-on effects on OTF guarantees for meat and (especially) dairy products. The wholesomeness and safety of UK beef and dairy products would likely be called into question by importing countries (both EU and rest of the World), regardless of any meat inspection and milk pasteurisation procedures in place. The current drive in food safety regulation is also to produce uncontaminated, safe products at source, rather than apply chemical or physical treatments to render them safe. Although pasteurisation of milk and dairy products is generally considered an effective and efficient way of eliminating the risk of foodborne human M. bovis infection, pasteurisation failures are also known to occur and the procedure is not universally applied to all milk sold in England and Wales. It would be impossible to impose or enforce a ban on the personal consumption of raw milk and dairy products on farms, etc.
To address your reservations regarding the relevance of bTB control to public health I must point out that the majority of M. bovis infections in humans are chronic and latent. Clinical cases of TB confirmed by culture represent only a fraction of the total population infected. The majority of human M. bovis infections diagnosed in the native UK population involve reactivation of old infections in elderly persons who contracted them before the advent of compulsory bTB testing of cattle herds and the widespread adoption of pasteurisation by the dairy industry. Whilst the incidence of clinical human M. bovis infections has been low for several years due to a combination of control measures, a sudden rise in the prevalence of M. bovis infection in cattle and other animals in the UK would lead in turn to a marked increase in the risk of zoonotic TB due to milk, airborne or cutaneous transmission. This would affect farmers and other sectors of the population most likely to come into contact with infected animals. Many of those human infections would remain subclinical for the time being, but a proportion of those would be expected to emerge as cases of TB disease several years after the exposure.
The current test and slaughter regime is helping to contain the prevalence and geographical spread of bovine TB at a relatively low level. Hilary Benn announced in the House of Commons on 25 March that the Veterinary Medicines Directorate (VMD) issued an authorisation for Badger BCG vaccine on 24th March 2010. This vaccine provides another tool in the box of measures for tackling bovine TB. Development of cattle vaccines continues. The earliest projected date for the use of a BCG cattle vaccine with a differential diagnostic test to Differentiate Infected from Vaccinated Animals (a so-called 'DIVA test') is 2015.
Vaccination on its own would not be sufficient to eradicate the disease and even less so if the prevalence of infection is high and widespread in a range of species when the vaccine becomes available. We need a holistic approach.
I hope I have provided sufficient clarification of the Government’s position on this issue.
Lee Hodkinson Defra - Customer Contact Unit
Customer Contact Unit Defra
13 Mar 2013, 6:01 PM
Figures from Defra published today.
These statistics were released today, Wednesday 13th March 2013, according to the arrangements approved by the UK Statistics Authority.
The key points relating to GB national statisitcs in December 2012 are :-
The provisional December 2012 incidence rate is 4.5%, compared to 4.9% in December 2011. However, care needs to be taken not to read too much into short term figures, especially as this figure includes a number of unclassified incidents. As such, the incidence rates are subject to further revisions as more tests and their results for the period are input.
The number of new herd incidents during the period January to December 2012 was 5,171 compared to 4,901 for January to December 2011. The number of tests on officially TB free herds was 73,627 during January to December 2012, compared to 62,481 during January to December 2011.
The number of cattle compulsorily slaughtered as reactors or direct contacts was 37,753 during January to December 2012, compared to 34,247 during January to December 2011.
An issue has been identified with the statistics relating to the number of herds that are not officially TB free. These statistics will be published once additional quality assurance checks have been completed.
29 Jan 2013, 6:15 PM
FREEDOM OF INFORMATION REQUEST DATED 28/01/13
REQUEST FOR INFORMATION: EUROPEAN UNION ANIMAL HEALTH LAW (EUAHL).
Thank you for your latest request for information which we received on 17th January 2013 about the proposed new European Union Animal Health Law (EUAHL). We are handling this request as a routine correspondence.
Defra says on its website that - "An opportunity to provide a future legal basis for vaccination of cattle against TB is likely to be created by the proposed new European Animal Health Law, which is currently under consideration by the European Commission"
Can you please advise on progress re this and forward the draft document which I assume has been produced by now?
I can confirm that we do not expect the Commission to publish its EUAHL proposal for negotiation with the Parliament and Council until at least the end of March 2013. When the Commission does publish its proposal we expect it to propose powers (for primary legislation) that will enable it to agree specific rules for cattle TB vaccination under secondary legislation, which would be negotiated separately.
There is a section on the 'Future possible use of vaccine in cattle'. Whilst it indicates some progress it seems it is STILL years away - one wonders why such proposal for trials wasn't undertaken years ago - in fact it is highly likely it is only being seriously considered now because of the active campaigning of those who are so against wildlife culling.
The following extractis typical of delaying tactics. Some odd comments when one considers that the BCG vaccine is one of the longest used and safest vaccine - no such attention given to other vaccines that are brought in very quickly with less knowledge and experience of use - and also consider the continued and often routine use of antibiotics for animals, despite the known consequences of resistance for future and impacts on human health!
"Scientific knowledge on bTB vaccination was reviewed during a recent technical workshop held in Cardiff. The outcome of the workshop clearly indicates that the hypothetical use of the only candidate vaccine (live BCG vaccine) presents still many knowledge gaps, in particular concerning the performance of the vaccine (level and duration of protection, protection from disease or infection), safety (possible shedding of the attenuated live pathogen by vaccinated animals), conditions for use (age of animals, type of herd) and suitability of candidate DIVA test(s)."
24 Jan 2013, 1:03 PM
Via MG response from Defra's TB Programme dept dated 23/1/12 REQUEST FOR INFORMATION: RFI 4564 CATTLE VACCINE AGAINST BTB
Thank you for your latest request for information, which we received on14th January 2013 about your previous request (RFI 4564). We are handling this request as routine correspondence.
1. Have you received an "in principle decision from VMD"? 2. If yes what was their decision? and what is your next activities to allow the vaccine to be used in England and Wales. 3. If no, why not and when do you now expect a decision? 4. What is the current status of the new EU Animal Heath Law?
I can confirm 1. No, we have not to date received a decision from VMD. 3. The VMD are currently reviewing the application and clarifications provided by Defra. We cannot predict when a final decision will be reached. We expect to hear the outcome of VMD’s considerations in February/March but at that point they can if they think it necessary still seek further clarifications. 4. Proposals are still at the draft stage and have yet to be form
18 Jan 2013, 6:43 PM
The new Animal Health and Welfare Board for England has now publicised the Summary of Responses from the 'Call for views on strengthening the bovine TB eradication programme and new ways of working'. The results seem heavily weighted in favour of increased, improved testing, bio-security, veterinary liaison etc - hardly surprising I suppose bearing in mind the vested interests of vets and the significant proportion of vets that responded.
In autumn 2012, the Animal Health and Welfare Board for England (AHWBE) invited views on bovine TB including issues such as different approaches to tackling TB, delivery of TB testing, reactor removal and compensation, advice and support, and insurance.
This informal approach aimed to gather evidence from people reflecting personal experience and practical knowledge of the disease. More than 600 people wrote or emailed, came along to one of the regional workshops, or filled in the Farmers Weekly-hosted online survey.
The Summary of Responses to the informal dialogue, along with verbatim reports from each of the regional workshops are available on the AHWBE website here: http://www.defra.gov.uk/ahwbe/work/bovinetb/ and the Summary of Responses is at www.defraconnect.defra.gov.uk/assets/e/5/b/5/8145070a67d27966ecf80c21f0d750f92a4d80fda404851450/AHWBE%20Call%20for%20Views%20on% 20Bovine%20TB%20-%20Summary%20of%20Responses.pdf
18 Jan 2013, 5:56 PM
According to Defra 31,146 (23,159 in England) cattle were slaughtered as reactors or direct contacts From January to October last year , compared to 27,788 over the same period in 2011.
New herd incidents (January to October) were 4,146 (3,983 over the previous 12 months). However, the rises in TB cases coincided with an increase in the number of tests on officially TB free herds, from 50,954 in 2011 to 60,218 last year. 6,861 cattle herds were under restrictions in the UK from January to October last year, including 4,991 in England.
The above figures were released by DEFRA on 16 January and are based on TB testing results obtained by the Animal Health and Veterinary Laboratories Agency (AHVLA).
28 Dec 2012, 11:57 AM
The Welsh Assembly government has just received EU approval for its 'Wales TB Eradication Plan 2013'. Wales currently has a comprehensive range of measures in place to deal with bovine TB,, including increased TB testing, improving biosecurity and vaccinating badgers against the disease.
The 2013 Plan sets out the bTB eradication policies that will be implemented during the year and also includes data on the epidemiology of bovine TB in Wales over the last five years and targets for TB testing and plans for badger vaccination in 2013.
Interestingly significant sums of money are available from trhe EU to help tackle bTB - the 2013 plan serves as an application for EU funding for certain measures in the programme, including contributions toward compensation for animals slaughtered and testing costs.
12 Dec 2012, 6:30 PM
On 10 December MG asked Defra: 'Please advise if and when you will start reporting the monthly number of overdue Btb tests.'
Defra responded on 11/12/12 saying 'We are just carrying out final quality assurance checks on the overdue test statistics. Assuming these don’t uncover any problems, it is expected that we will resume publishing the overdue test statistics in January or February.'
9 Dec 2012, 5:51 PM
Email received from MG on 7/12/12.
When tracking BTb rates in West Wales, we calculated cattle slaughtered per 1000 tests. This gave a much better indication of the trend.
The more you test the more false positives you get. In West Wales 2010 there were 900,999 tests. So if we use the Defra 99.9% specificity (some think it is lower), then there were 900 false positives. The total number of reactors was about 4000, hence 22% of reactors were false.
We also discovered that a significant number of herds under restriction were due to overdue tests (in some cases more than 50% - at the end of 2010 in West Wales there were 678 herds under restrcition and 454 overdue tests ie 67% of total). Defra haven't published overdue test numbers since late 2011. I wonder why?
We noted that as the special biosecurity measures (introduced in the West Wales' IAA) took effect the number of cattle/1000 tests reduced quite quickly but the number of herds under restriction hardly moved. Needless to say we used the former figs in our messages whilst WAG used the latter.
When Defra stopped publishing county level stats last year we were unable to effectively track what was happening in West Wales.
7 Dec 2012, 8:04 PM
Email response from a vet today re the forum posting on 6/12/12 at 5.21pm.
DEFRA is always very quick to point out that apparent reductions in the proportion of infected herds may simply reflect increased testing of TB negative herds, but apparently equally quick to try and show an increased incidence when they up the testing rate.
With such a poorly sensitive test, the more you test an infected herd the more likely you are to pick up infection. So an increase in positive tests doesn't necessarily reflect an increased incidence; rather just improved detection of infected cattle and herds through greater testing effort. The problem with DEFRA's data is that the testing effort and associated rules are always changing so they aren't comparing like with like in terms of measuring trends over time.
I'm quite sure the NFU and FG is fully aware of this. However, acknowledging flaws in the data clearly doesn't support their political agenda, which seems to remain doing all they can to justify a badger cull.
6 Dec 2012, 6:22 PM
Freedom of information request and response below. It is an interesting reply and it would seem there is a financial incentive for Defra to continue to with the test and cull policy which would be lost if they introduced vaccination? this could explain the reluctance to introduce cattle vaccination?
I asked about EU co-financing of bovine TB controls between 2010 and 2012 (www.defra.gov.uk/animal-diseases/a-z/bovine-tb/controls). . Please could you please let me have a more detailed breakdown regarding how the 31.2 million euros from the EU have been/are being spent? Has this money been received yet? I understand similar amounts have been received in previous years? Could you please also give a detailed breakdown for the two previous years, ie 2011 and 2010?
The response (ref: FOI 5103 dated 27/11/12) was as follows:
The funding for 2012 has not yet been received, as it is paid in arrears following an assessment by the EU Commission of the eligible expenditure for the year in question. We would therefore not receive any funding until later in 2013.
However following a routine in-year review, the EU has recently voted in support of reducing the maximum allocation to €31m. The Commission will contribute the following lump sums towards TB testing costs:
i) €0.5m per domestic animal sampled for Gamma Interferon test or suspected positive in the slaughterhouse; ii) €1.5 per tuberculin test; iii) €5 per gamma interferon test; and iv) €20 per bacteriological test.
In addition, the Commission will co-fund 50% of TB compensation costs up to a maximum of €375 per animal.
The funding received is used to offset the TB testing and compensation costs incurred by Defra, Welsh Government and the Northern Ireland Executive. The funding will be split proportionately between Defra and the Devolved Administrations on the basis of the number of TB tests carried out and animals slaughtered for TB purposes in each country. Statistics for England and Wales used to determine this split will be available on Defra’s website when available in 2013. http://www.defra.gov.uk/statistics/foodfarm/landuselivestock/cattletb/regional/
We have not yet received funding for 2011 as the Commission is still assessing the level of eligible costs. The maximum allocation for the UK in 2011 is €26.5m and the possible split between Defra and the Devolved Administrations will be determined using the regional statistics tables in the link above.
In 2010, the UK was allocated €27m towards its TB testing and compensation costs. We have received this funding. The split of funding was 68.2% for England (£14,707,882.26); 10.4% for Wales (£2,242,844.22); and 21.4% for Northern Ireland (£4,615,083.29). In 2010, Defra was responsible for funding the majority of TB testing in Wales, so the proportion split is different to the total testing effort in England and Wales respectively. Budgets were further devolved in April 2011, so that now the Welsh Government is responsible for funding all TB testing in Wales and consequently will receive a greater proportion of the EU funding as a result.
A more detailed breakdown of the split for 2010 has been provided and can be emailed on request by using the contact email for this site.
6 Dec 2012, 5:21 PM
Recent DEFRA figures show 24,685 cattle were slaughtered to August this year due to bovine TB - a 5.1% rise on 2011. In 2011, 23,477 cattle were slaughtered during the same reporting and 21,390 in 2010. There were 3,353 new herd incidents during the period January to August 2012, compared to 3,312 for the same period in 2011.
However, the number of tests on officially TB-free herds was 49,714 in January to August 2012, compared to 41,267 in January to August 2011. A total of 7,286 herds were placed under movement restrictions because of a TB incident at some time during the period January to July 2012.
In total, 91,288 cattle have been slaughtered in the UK due to TB since January 2010 until August this year.
16 Nov 2012, 12:34 PM
The latest Defra stats tables updated 14th Nov 2012 are on their website.
They've changed the format into multiple spreadsheets within one file.
First glance still shows nothing to support their scaremongering.
Scroll down to bottom of following pages for downloads.
There used to be a regional file in the same format as the national stats with all the same columns but for each individual county. This was very useful and one does wonder why it seems to have disappeared? I think we can guess why!
20 Sep 2012, 2:34 PM
'Notable decrease in bTB' according to Defra. (www.defra.gov.uk/statistics/foodfarm/landuselivestock/cattletb/national)
Statistics released 12/09/12 reveal the following:
There has been a notable decrease in the incidence rate over the past 6 months, mainly as a result of an increased number of tests on unrestricted herds compared to last year. The AHVLA are currently carrying out a data checking exercise to validate these test statistics.
The provisional June 2012 incidence rate is 4.2%, compared to 6.0% in June 2011. However, care needs to be taken not to read too much into short term figures, especially as this figure includes a number of unclassified incidents. As such, the incidence rates are subject to further revisions as more tests and their results for the period are input.
The number of new herd incidents during the period January to June 2012 was 2,706 compared to 2,720 for January to June 2011. The number of tests on officially TB free herds was 41,656 in January to June 2012, compared to 34,667 in January to June 2011.
The number of cattle compulsorily slaughtered as reactors or direct contacts was 18,213 in January to June 2012, compared to 18,081 in January to June 2011.
31 Aug 2012, 7:52 PM
Why, if Defra wanted to do field trials and deploy BCG, did they did not start getting permission from Brussels when they started the work?
31 Aug 2012, 7:48 PM
MR sent DEFRA further questions.
Your response to RFI 4564 attached stated:
"The studies to generate validation data in vaccinated cattle are expected to be completed and data analysed by Easter 2012. If it is deemed that no further studies are needed, our plan is to make an application to the OIE (World Organisation for Animal Health) in summer 2012 for international certification of the test"
Can you please advise: if work was completed by Easter 2012 or if not when is completion expected and if the application has been made to the OIE or if not , when it is expected to be made.
The DEFRA reply was as follows:
The studies described to generate validation data from AHVLA’s prototype DIVA test in BCG-vaccinated experimentally-challenged cattle were completed and analysed by Easter 2012. The OIE was asked to evaluate the test but because there were no data from the field (since TB vaccination of cattle in the field is prohibited by EU law) but rather (by necessity) the test performance had been evaluated in a limited number of experimentally vaccinated cattle they could not accept this validation. We have subsequently put the dossier to experts at a number of international reference laboratories seeking their views on our results and our approach to validation and are awaiting their advice. This will be used to inform what other experimental and field studies would be needed for the OIE to accept validation of the test. As things currently stand the UK would need a derogation to undertake field trials in England or any field studies would need to be carried out in non-EU countries. The latter would not be ideal for validation of the DIVA test since ordinarily these studies would be carried out under the field and environmental conditions of the intended country of use.
31 Aug 2012, 7:45 PM
MR sent us this response from DEFRA to a Freedom of Information request for information.
Cattle Vaccine for Bovine TB Freedom of Information Request
Thank you for your follow up request asking for additional information about a cattle vaccine for bovine TB, an oral badger vaccine, DIVA test and steps the government has taken to change EU law to allow vaccination.
You have challenged the use of exemptions set out in the original correspondence for why documents are not being released to you. As referred to in Annex A of our previous letter, if you are unhappy with the service you have received in relation to an FOI request and you wish to make a complaint or appeal against our decision you should write to Brendan Walsh, Head of Defra’s Information Rights Team at Area1B, Ergon House, Horseferry Road, London, SW1P 2AL, (email: firstname.lastname@example.org) who will arrange for an internal review of your case. Details of Defra’s complaints procedure are on our website.
The remainder of the points you’ve raised are not FoI matters. Your first issue concerns evidence. You may have already seen the latest addition to the Defra website concerning cattle vaccines. http://www.defra.gov.uk/animal-diseases/a-z/bovine-tb/vaccination/cattle-vaccination/ This briefly explains the challenges faced in licensing this vaccine and provides a small number of references suitable for web page presentation.
But you are of course right and BCG has been used in numerous vaccine studies since 1911 in cattle – see Annex C. Although studies are sometimes difficult to compare - as a variety of vaccine strains, challenge strains, vaccination and infection routes, and ways to measure protection have been applied – the results of the majority of these studies have demonstrated considerable protection. The results of controlled field studies are more variable but the overall majority also demonstrated protection including recent studies conducted in Mexico (Lopez-Valencia et al., 2010) and Ethiopia (Ameni et al., 2010).
Studies investigating the efficacy and safety of BCG Danish Strain 1331 (a commercially produced strain widely used as human vaccine) required for licensing have been completed by Defra’s Animal Health and Veterinary Laboratories Agency and these data have been included in the recently submitted licensing application to the Veterinary Medicines Directorate (the UK’s regulatory body for veterinary medicines) for assessment. Provided it is satisfied with the safety, quality and efficacy data, VMD would be able to confirm that requirements to obtain a marketing authorisation have been met/fulfilled. If circumstances remain unchanged and the EU prohibition of the vaccination of cattle against TB is then lifted, the Secretary of State would be able to grant the marketing authorisation for the product. The safety, efficacy and quality data in the marketing authorisation dossier is commercial in confidence and cannot be released at the present time.
Studies to date cannot provide a definite figure for vaccine efficacy when administered to cattle under field conditions in the UK and it is currently not possible to generate these data in the field because of existing EU legislation prohibiting vaccination of cattle against TB (see below). However, small-scale field studies have been carried out recently in Ethiopia and Mexico and depending on the parameters selected the protective effect of vaccination was between 56% and 68%. However, to put BCG in cattle into context: as with BCG in other species it is not 100% effective in preventing TB. Rather, it provides a spectrum of protection: • Some cattle will be fully protected; • Some cattle will benefit from reduced disease; • Some cattle will get no protection from vaccination; and • As far as we know BCG does not have a therapeutic effect in already infected animals. BCG vaccination of cattle could be a valuable tool when used alongside other TB control measures in the UK.
Vaccination of cattle with BCG results in a proportion of animals becoming tuberculin test positive (both to the intradermal tuberculin skin test and gamma interferon blood test) and can therefore lead to false positive results in BCG-vaccinated but TB-uninfected cattle. In parallel with developing cattle TB vaccines, AHVLA is also developing a test to differentiate infected from vaccinated animals (so-called DIVA test. This test, based on the gamma interferon blood test, can be used alongside the tuberculin skin test in vaccinated animals where necessary, to confirm whether a skin test positive result is caused by vaccination or TB infection. The studies to generate validation data in vaccinated cattle are expected to be completed and data analysed by Easter 2012. If it is deemed that no further studies are needed, our plan is to make an application to the OIE (World Organisation for Animal Health) in summer 2012 for international certification of the test. Providing the OIE is satisfied with the fitness for purpose of the test, the earliest we could have OIE validation and certification would be the end of 2012. Your second group of questions concerned the licensing process to which the answers are as follows: We already knew that the ban on vaccination would have to be lifted before vaccination could go ahead and that was clear in the consultation document. A license can only be granted because there is a statutory power to do so. In the case of a cattle vaccine against TB the EU ban on vaccinate precludes the issue of such a license. A license application has been made and if there is an agreement in principle that will be announced.
Thirdly, you ask about the regulatory and technical challenges. These include lifting the EU ban on cattle vaccination, see above and; the amount and quality of evidence required by VMD and the European Commission and other Member States before lifting the ban. These challenges were discussed in the original cattle vaccines policy paper published by Defra in 2008 see http://archive.defra.gov.uk/foodfarm/farmanimal/diseases/atoz/tb/documents/vaccine_cattle.pdf As you say, the vaccine and DIVA test cannot be licensed until the legal ban is lifted. We hope that the period between the lifting of the legal ban on use of vaccine and the granting of a licence for its use can be kept very short. But the first is a pre-requisite of the second.
Fourthly you ask when matters related to the date will be clarified, when the application to VMD was made and when we expect to hear back. An application to VMD for an ‘in principle’ decision on licensing was made on 20 January and we would normally expect to know the outcome in 9-12 months. Indications from the European Commission are that their proposal for an EU Animal Health Law will be put to the European Parliament and Council of Ministers later this year. It is unclear how long it will take before these can be adopted, or what their final form will be. In the meantime we will be doing all we can to ensure the evidence produced in support of the cattle vaccine and DIVA test is sufficient to persuade the European Commission and Member States to lift the present ban. The pathway to what we hope will be a licensed and effective vaccine is clear. It is just the timing that remains unclear, since it depends on the actions of a number of institutions, including the European Commission, Parliament and Council of Ministers. Finally, you asked in connection with the international ban on vaccination what was ‘sufficient evidence for lifting the ban’ and the timescales involved. Sufficient evidence will involve at least an agreement in principle on the part of the VMD to license the vaccine; international certification by the OIE of the evidence regarding the DIVA test; and validation by the European Food Standards Agency (EFSA) of vaccinating cattle against TB. On the basis of this the EC and Member States may seek further evidence. As far as timescale is concerned, the process has started and will be subject to discussions that have yet to take place with OIE and EFSA. These are planned for later this year. However, it would be wrong to guess at a completion date, but we’re doing all we can to influence others to move things on as soon as possible. The Commission has not given a timescale because the necessary legal framework is not yet in place. The Commission has however indicated that they plan to put their proposal on a new AH Law to the European Council and Parliament in the autumn but it is unclear how long this process will take to achieve completion.
A list of published studies re BCG cattle vaccination and the DIVA test was produced.
21 May 2012, 1:40 PM
New figures out for bTB www.defra.gov.uk/statistics/foodfarm/landuselivestock/cattletb/national/
The key points in the latest statistical release, relating to February 2012, are:
The provisional January to February 2012 incidence rate is 4.2%, compared to 4.9% in January to February 2011. However, care needs to be taken not to read too much into short term figures, especially as this figure includes a number of unclassified incidents. As such, the incidence rates are subject to further revisions as more tests and their results for the period are input.
The number of new herd incidents during the period January to February 2012 was 971, compared to 989 for January to February 2011. The number of tests on officially TB free herds was 14,602 in January to February 2012, compared to 13,179 in January to February 2011.
The number of cattle compulsorily slaughtered as reactors or direct contacts was 6,253 in January to February 2012, compared to 6,243 in January to February 2011.
28 Mar 2012, 12:18 PM
'Epidemiology of bovine tuberculosis in Wales, Annual surveillance report for the period January to December 2010'. Some interesting facts in this report.
On 14/3/12 Defra was asked the following questions under the Freedom of Information legislation.
1. Defra stated in 2010 that they aimed to have a Bovine TB vaccine and DIVA test licensed for cattle by 2012.
a. Why and on what evidence was this statement issued?
b. What has changed since (i.e. what is the precise cause of the delay)?
c. What are the current targets and expectations for critical dates in development and licensing, and on what evidence are they based?
2a. What steps have already been taken by the present and previous governments to persuade the EU to permit the UK to amend legislation to allow vaccination of cattle.
b. What steps have already been taken by the present and previous governments to persuade the EU to permit the UK to amend legislation to allow use of the DIVA test?
c. What steps are now being taken to ensure amendments to such law are in force by the time a vaccine and/or the DIVA test are licensed?
3. What, if any, modelling has been performed by, or is available to, Defra to establish the degree of efficacy a Bovine TB cattle vaccine would need to attain if used without cattle culling (except in cases presenting with symptoms of actual and confirmed BTB) so that deployment in England and Wales according to appropriate protocols would have the same efficacy in reducing
of Bovine TB in cattle as the current test and cull policy.
4. If no legislation (other than UK legislation still within the power of Parliament to change) did or ever had prevented use of BTB vaccines, what is the earliest date they could have been licensed and deployed assuming a UK government in power at all material times wanted such a licensing and deployment?
5. We understand the skin test is further compromised in cattle with Johane's disease. As we understand this disease is endemic in the UK (with over 50% of herds infected according to some sources) please let us know what research has been done, or is intending to be done to quantify the effect of this on the existing test and cull regime?
8 Feb 2012, 6:41 PM
More comments from MR 8/2/12:
“....Once a licensed cattle vaccine and effective DIVA test are available, the basis for declaring herds tuberculosis-free will need to change. As part of the ongoing consultation on the new EU Animal Health Law, we will ..."
Why are they waiting - “we will” implies they have done nothing to date.
Defra says they will "be using the strong scientific and technical evidence on the efficacy and safety of the cattle vaccine" - “the strong evidence” - a term that indicates such evidence exists and is of a robust and substantial nature.
Why a 3 year delay between the vaccine and DIVA test being ready in 2012 and changes to legislation? Before the European Communities Act 1972 we could have in a matter of days changed legislation to allow vaccination and hence stop or reduce the seizure and slaughter of cattle/ Is Defra saying that as a result of EU membership we have to wait not days, not a time of our choosing but an uncertain time, a time exceeding three years?
"By the time we came to publish the TB Eradication Programme in July 2011 we were aware that a TB cattle licence could not be issued by the Veterinary Medicines Directorate until the ban on vaccination had been lifted…and we said this in the Eradication Programme. " What measure or authority stops licensing preceding legislation? Why was this not known before, and when the badger cull consultation was published? Even if a license cannot be issued until the ban is lifted, why can the licensing process not be otherwise completed and an announcement to that effect made?
"As I have explained above, we had already said in the consultation that deployment for use in the field could not be before 2015 at the earliest. When we came to publish the Eradication Programme it was clear that significant technical and regulatory challenges remained and this led us to conclude that the 2015 date should be dropped until matters had been clarified."
What were the a) regulatory b) technical challenges and why were they only now apparent?
Or arguably until information on efficacy is available, which Defra imply above (see “the strong evidence”) is now available This means the ban can be lifted NOW.
Lifting of the ban and licensing can be simultaneous, if the preparation for legislating is carried out simultaneously with preparation for licensing.
If matters are so confused and uncertain that no date can be deduced or estimated or even set as a target, a full disclosure of the problem needs to be made, inter alia so that interested and expert parties can propose solutions. If no one outside Defra understands the problem, only Defra can solve it, which is manifestly not happening.
"We still do not have a fixed date by which we expect cattle vaccine to be deployed in the field. However, the details underpinning these uncertainties as requested in your freedom of information request are withheld under exemptions 27 (international relations) and 35 (formulation of government policy) of the Freedom of Information Act".
This seems to extend the meaning of S 27 and 35. It is hard to see how it relates to formulation of Government policy when there is no question of formulating such policy - the Government has already declared the relevant policy specifically to “request” a specific change in EU legislation. The exemption therefore expires under S35 (2) a of the Act.
Alternatively there is an overriding public interest in disclosure as the information relates to a consultation (badger cull) which while now closed was conducted on false information.
Notwithstanding the above the full reasons for arguing that S27 and 35 apply must be advanced and appealed.
"You also asked what steps the government has taken to change EU law to allow vaccination in anticipation of licensing. In brief we are continuing with the work described in paragraphs 83-88 of the TB Eradication Programme for England see http://www.defra.gov.uk/publications/files/pb13601-bovinetb-eradication-programme-110719.pdf".
This states at 88 that the EU Commission WAS asked and sent the UK away until “sufficient evidence” is available. It does answer the question, by clearly implying that nothing further has been done by the Government.
If the EU institutions include a functioning legislature, as appears to be the case, then it must be possible to pass or amend legislation rapidly to meet emerging circumstances, exploit opportunities or deal with emergencies.
Why can the EU not be prevailed upon to graciously grant a derogation or by other means provide relief (vaccination) to hard pressed UK farmers suffering under a failed BTB policy?
Furthermore there is no adequate reason the EU cannot pass the required legislation and make it conditional on relevant licensing of vaccines and the DIVA test.
VMD must have a set of parameters for efficacy to be established - they are set before not after doing tests.
At 84 the same document states: The necessary regulatory studies are nearing completion and we intend to submit an application for a marketing authorisation for a BCG cattle vaccine later this year. While the Veterinary Medicines Directorate (VMD) will be able to confirm whether it is satisfied with the safety, quality and efficacy data provided, it will not be able to grant a marketing authorisation for the product while cattle TB vaccination is prohibited in EU legislation.
6 Feb 2012, 7:31 PM
Email from MR with his comments on the content of the Defra response above.
My overall assessment is that the EU cares little about the problem and has said so to our well lunched diplomats, but it would upset the vested interests in government to admit that we are killing our cattle purely because the EU says we should. Then someone might discover BCG and the DIVA test could have been licensed years ago.
He has given the following comments re the Defra response above.
Re 3 in the posting above:
Quoted paragraph in 3, so, THE evidence. Tested already? May even be ready and waiting for a rubber stamp. Bu 2015 - this is scandalous. Parliament could change it overnight. But we have to REQUEST that our laws are changed.
Re 4 in the posting above:
So Defra did not understand the process when they published the badger cull consultation. Tell the Badger Trust - additional evidence for a judicial review. Causality is not needed to establish a failure of due process - only failure to follow the due process. How can technical difficulties be covered by 27 and 35?
Re 5 in the posting above:
Which says at 84 that 'Defra has invested around £18 million in the development of cattle vaccines and associated diagnostic tools. The necessary regulatory studies are nearing completion and we intend to submit an application for a marketing authorisation for a BCG cattle vaccine later this year. While the Veterinary Medicines Directorate (VMD) will be able to confirm whether it is satisfied with the safety, quality and efficacy data provided, it will not be able to grant a marketing authorisation for the product while cattle TB vaccination is prohibited in EU legislation.'
All the questions we asked DEFRA can then be applied to the VMD being satisfied etc (i.e what stage are they at and what problems if any exist etc etc.
Then follows a simple proposition - VMD must know what the parameters are for licencing. They test and establish they are met. They do not wait to set the parameters until after seeing the test results.
Why can the EU not apply the same process - agreement at least in principle that a licensed vaccine and DIVA test can be used but only when licensed? There is no impediment to a legislature passing legislation that says: “Thou shalt not do it UNLESS the following conditions are met.”
It is very common - typically you may not sell this that and the other, change the use of land, own a firearm, practise as doctor, say you are an architect etc etc unless you have a license or consent to do it. In many such cases a body, other than the state, sets the conditions - architects for instance. So simple to draft amendments to legislation allowing BCG/DIVA test to be used if and only if they are licensed at the time of use.
5 Feb 2012, 6:14 PM
MG has also sent us this Freedom of Information response from Defra relating to cattle vaccine for Bovine TB (Ref: RFI4469). Please note paragraphs are numbered for ease of reference - see next posting.
1. Thank you for your request received on 4 January 2012 asking for documents relating to the way Defra describes the availability of cattle vaccine for bovine TB. As you know we have handled your request under the Freedom of Information Act 2000 (FOIA).
2. In the September 2010 consultation on badger control we said:
“Defra had invested £18 million by the end of the last financial year on the development of cattle vaccines and associated diagnostic tools. We aim to have a licensed cattle vaccine by 2012. This vaccine is BCG (Bacille Calmette-Guérin, the human TB vaccine) which sensitizes cattle to the mandatory tuberculin skin test for some time after vaccination and can lead to a positive result when an animal is not infected with M. bovis (a “false positive‟). Therefore Defra is also developing a diagnostic test to differentiate infected from vaccinated animals (known as a “DIVA‟ test) that could be used alongside the tuberculin skin test, where necessary, to confirm whether the animal is indeed infected. Our aim is also to have the DIVA test approved by 2012.
3. But we also made clear in paragraph 63 of the same documents that... “....Once a licensed cattle vaccine and effective DIVA test are available, the basis for declaring herds tuberculosis-free will need to change. As part of the ongoing consultation on the new EU Animal Health Law, we will be using the strong scientific and technical evidence on the efficacy and safety of the cattle vaccine and the role of a DIVA test to request the necessary changes to EU legislation to lift the requirement for the skin test to be the only test to confer OTF herd status. Due to the need to change EU legislation, which is a lengthy process, we anticipate that a cattle vaccine and DIVA test could not be used in the field before 2015 at the earliest....
4. By the time we came to publish the TB Eradication Programme in July 2011 we were aware that a TB cattle licence could not be issued by the Veterinary Medicines Directorate until the ban on vaccination had been lifted…and we said this in the Eradication Programme. As I have explained above, we had already said in the consultation that deployment for use in the field could not be before 2015 at the earliest. When we came to publish the Eradication Programme it was clear that significant technical and regulatory challenges remained and this led us to conclude that the 2015 date should be dropped until matters had been clarified. We still do not have a fixed date by which we expect cattle vaccine to be deployed in the field. However, the details underpinning these uncertainties as requested in your freedom of information request are withheld under exemptions 27 (international relations) and 35 (formulation of government policy) of the Freedom of Information Act.
6. In keeping with the spirit and effect of the Freedom of Information Act 2000, all information is assumed to be releasable to the public unless exempt.
Defra TB Programme
5 Feb 2012, 6:07 PM
We have been sent copies of correspondence between MG, his MP and the current Minister of State for Agriculture and Food (J Paice). He has given us permission to reproduce below.
Letter from MG to his MP:
During the English consultation on badger culling in September last year Defra stated that they “aim to have a licensed cattle vaccine by 2012” along with the accompanying ‘DIVA’ test capable of distinguishing infected from vaccinated cattle.
The vaccine is BCG which has been used on humans for decades and has been trialed in Ethiopia by a team including UK scientists.Martin Vordermeier and Glyn Hewinson from TB Research Group VLA and Doug Young from Imperial College(see attached report)
This year Defra are saying that they are “continuing to invest heavily in developing a cattle vaccine and an oral badger vaccine but both are still many years away and we simply can’t say with any certainty when they might be ready to deploy.”
This is hardly progress. From an estimate of two years there is now an indefinite delay.
There must be a reason for the delay and there must have been an announcement of the change with full reasons.
Can you please ask the Minister for a full explanation.
Can you also find out what steps the government has taken to change EU law to allow vaccination in anticipation of licensing.
Response from Paice, via MG's MP:
Thank you for your letter of 17 January on behalf of your constituent about bovine TB cattle vaccines.
Cattle vaccination can reduce the risk of infection and onward transmission, and, alongside other control measures, has the potential to make a significant contribution to the control and eventual eradication of bovine TB. Vaccination cannot guarantee that all cattle will be fully protected against TB and is therefore unlikely ever to be suitable for use as a sole eradication strategy.
Developing affordable and usable vaccines for cattle and badgers is our ultimate goal and the Secretary of State has announced that Defra will make available up to £250,000 a year over the next three years to support and encourage badger vaccination. An injectable badger vaccine is already available but there are practical difficulties with this, which means that it is not a realistic option for dealing with the problem in the short term. Developing an oral badger vaccine and a cattle vaccine remains a top priority for the Government, and Defra will be investing a further £20m in vaccines research and development over the next five years, but we cannot say with any certainty when these vaccines might be ready to deploy.
Additionally, cattle vaccines are currently prohibited by EU legislation as the lead candidates are based on BCG, which can interfere with the tuberculin skin test. Some vaccinated cattle could therefore react positively to tuberculin as if infected by TB, and herds could not be declared officially TB-free.
Government continues to invest in vaccine development and are working with the EU to lift the current ban on TB vaccination of cattle and allow the DIVA test to be used as a trade test.
We therefore anticipate that the deployment of a cattle TB vaccine is still several years away and we simply cannot say with any certainty when it might happen.
Full details of the package of measures announced on 14 December can be found on the Defra website at www.defra.gov.uk.
RT HON JIM PAICE MP
Further letter sent by MG to his MP:
Thank you for forwarding the letter from Jim Paice. Unfortunately he has not answered either of my questions. I repeat:
What is the reasons for the change from “aim to have a licensed cattle vaccine by 2012 to “continuing to invest heavily in developing a cattle vaccine and an oral badger vaccine but both are still many years away and we simply can’t say with any certainty when they might be ready to deploy
What steps have the government taken to change EU law to allow vaccination in anticipation of licensing.
Would you please ask the Minister for direct answers to both these questions.
24 Dec 2011, 6:53 PM
We have been sent correspondence by a farmer, who, despite being in the middle of a so called bTB hot spots has never suffered a herd breakdown. We have been given permission to publish the exchange of correspondence that gives a lot of interesting information about the number of officially TB free herds. The farmers conclude that the 'never restricted' figures add significant weight to the criticism that the reporting style chosen by the government and the NFU in their efforts to justify a badger cull is proportionately negative and sensationalised.
The farmer concluded, from the correspondence he received (www.bovinetb.co.uk/admin/admin_article.php?category_id=32) that:
“If we take as an example the Farmers Weekly 'TB Key Facts' http://www.fwi.co.uk/landing-page/livestock/badger-cull/key-facts/ based on a Defra press release. They report that '10.8% of herds were restricted in 2010' but they could equally report that '89.2% of herds were not restricted in 2010. They report that ‘22.7% of cattle farms in the south-west were under cattle movement restrictions in 2010’, instead of saying 77.3% of cattle farms in the south-west were free of TB movement restrictions. And they fail to report that the 25000 cattle slaughtered in 2010 for TB control is less than 0.5% of the 7.5 million cattle tested and is a figure easily beaten by the number of fallen stock on beef and dairy farms in the normal course of events. (Defra DETAILED TB STATISTICS: 1 Jan to 31 Dec 2010 (GB) http://archive.defra.gov.uk/foodfarm/farmanimal/diseases/atoz/tb/stats/documents/10/2010gb.pdf)”
The farmer goes on to say say: “These 'never restricted' figures also counter the argument that the disease is 'cycling' around all of the herds but instead show that the bulk of the problem is most likely made up of the same herds 'cycling' in and out of breakdowns. A map on the NFU's 'TB Free England' site adds weight to this in its efforts to paint a gloomy picture - see http://www.tbfreeengland.co.uk/TB-Graphs-and-Maps/Map-showing-location-and-durations-of-breakdowns-Jul-2009---Jun-2010/ The 'never restricted' figures also demonstrate that far more research could and should have been undertaken along the lines of the report from the Royal Society - 'Bovine tuberculosis - reduced risk on wildlife friendly farms' http://rsbl.royalsocietypublishing.org/content/suppl/2008/12/08/2.2.271.DC1/rsbl20060461supp.pdf comparing farms which remain clear to those that do not”.
The farmer points out that “The high number of 'never restricted' herds also explains the ease with which the Royal Society found their control farms which had remained OTF since 1994, ie. at least ten continuous years clear at the time they were collecting data.n And it is interesting to note that, despite the time which has elapsed since the Royal Society study was undertaken, the figures show that researchers would still have no trouble finding their 'control' herds in the area studied as there are 3367 herds which have never been restricted in the Devon/Hereford/Worcester area”. If you calculate overall totals from the spreadsheet, the result is as follows:
As of 4th Sept 2011
out of a total of 78006 Officially Tuberculosis Free (OTF) herds in GB, 60811 herds have never been under TB restrictions.
If this is broken down into regions then
out of a total of 48363 OTF herds in the East/North/Scot region, 43340 herds have never been restricted
out of a total of 29643 OTF herds in the West/Wales 'hot-spot' region, 17471 have never been restricted
The spreadsheet only gives the total number of OTF herds but the total number of herds overall can be obtained from Defra stats
83636 for GB 50683 for East/North/Scot region 32953 for West/Wales 'hot-spot' region
This confirms that, based on the figures provided by the AHVLA, the percentage of herds which have never been restricted - ie. consistently OTFthroughout - is the majority of herds overall and also by region.
See www.bovinetb.co.uk/admin/admin_article.php?category_id=32 for full story and all correspondence referred to.