Environment, Food and Rural Affairs Committee - Minutes of EvidenceHC 258

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Oral Evidence

Taken before the Environment, Food and Rural Affairs Committee

on Tuesday 19 March 2013

Members present:

Miss Anne McIntosh (Chair)

George Eustice

Barry Gardiner

Iain McKenzie

Sheryll Murray

Neil Parish

Ms Margaret Ritchie

________________

Examination of Witnesses

Witnesses: Mr David Heath MP, Minister of State for Agriculture and Food, Professor Ian Boyd, Chief Scientific Adviser, and Nigel Gibbens, Chief Veterinary Officer, Defra, and Professor Glyn Hewinson, Chief Scientist, Animal Health and Veterinary Laboratories Agency, gave evidence.

Q415 Chair: Minister, welcome. Good afternoon and may I thank you and your team very much indeed for being with us and participating in our inquiry into bovine tuberculosis vaccination? You may just like to introduce your team for the record, if you would.

Mr Heath: Certainly. I am accompanied by: Professor Hewinson, who I think has already given evidence to your Committee on this subject; Professor Ian Boyd, our Chief Scientific Adviser within the Department; and Nigel Gibbens, the Chief Veterinary Officer.

Q416 Chair: I shall start by looking at the timetable and the expectation in the public’s mind as to when vaccination might be available. It was believed and the Department for Environment, Food and Rural Affairs (Defra) indicated that its aim was to have both the Bacillus Calmette–Guérin (BCG) and the Differentiating Infected from Vaccinated Animals (DIVA) test licensed by 2012. Obviously there has been quite a degree of slippage in that. Now we have been told that "they could not be used in the field before 2015". On what basis was the 2015 date selected?

Mr Heath: I shall start and I am sure my colleagues will want to add more details. As you will know, Miss McIntosh, we had a valuable discussion recently with Commissioner Borg in setting out the possible timetable for a legalisation process for both the vaccine and the DIVA test.

Chair: We will come on to that.

Mr Heath: Sorry; you do not want me to go on to that yet?

Chair: If you could, set the scene.

Mr Heath: I was simply saying Commissioner Borg then wrote to us to say that his view, and I think it was a realistic view, was that we were talking about an approximately 10year process for everything to happen. Within that, there are obviously benchmarks, some of which are the field testing of the vaccination and the various regulatory processes that then follow. What we are talking about, in the first instance-what I understand your question to be about-is when we might be able to be testing the BCG vaccine and the DIVA test in field conditions. Is that right? Have I understood correctly?

Q417 Chair: It is just that now we are looking at a date of possibly 2023 for a vaccine actually being implemented. The expectation of the public for the use and implementation of a vaccine seems to be wildly out of kilter with what they were led to believe by the Government.

Mr Heath: I think we have always said that this would be a very long process. There is a big difference between having a viable vaccine, which we have at the moment up to a point, and the process of making that legally available within this country, under EU law. Perhaps Professor Hewinson would like to say a few words about the expectation in terms of the timing of the trials that we envisage.

Chair: That would be most helpful. Professor Hewinson, welcome back.

Professor Hewinson: Picking up on that, the letter refers to the 10year time point as when you might be able to incorporate vaccination as a use across trading partners in Europe. 2015 was envisaged for when you might use the vaccine under field conditions, which is in line with the letter from Commissioner Borg in terms of rolling out the vaccine to start vaccinating in the field, but those would be field trials.

Q418 Chair: Perhaps I am not being very clear. The Committee would just like to understand how you reached the 2015 date.

Mr Heath: I am sorry, Miss McIntosh, if we are not being clear. We have been asked now to produce a model for how we will carry out field trials. We need to discuss that with the EU authorities. We need to satisfy them that what we have in place is satisfactory, as far as they are concerned. We also have to deal with area selection; we have to have people who are prepared to take part in such trials; and there will be biosecurity and other implications for the area that is selected. We would like that to happen at the earliest possible opportunity. It is not a question of not having the vaccine, because we are dealing with the BCG vaccine, as you know, which is already available. It is a question of being able to demonstrate that in UK conditions.

I am not trying to be either vague or difficult in not giving you a precise answer; I am saying we will do that as quickly as we can. It is realistic to say that 2015 would be about the time that we would have field trials actually happening. If we can bring it forward from that, the Department will be delighted, but we are also realistic that there are a lot of rivers to cross along the way.

Q419 Chair: Without putting words in your mouth, it was an underestimate of the time that the process would take?

Mr Heath: No; as I say, if we are talking about field trials, we are talking about the same date, although I would love it to be earlier than that. I do not think we have ever said that there would be a time when we would have a vaccine that we could freely use in this country, which would be legal under EU regulation, within anything like that timescale. We have always said it would be a very long process, and what Commissioner Borg has said in his letter is to confirm exactly that point.

Q420 Barry Gardiner: Sorry, Minister; I just want to clear up a confusion here, because in the Defra document, Bovine Tuberculosis: the Government’s approach to tackling the disease and consultation on a badger control policy, which was published in 2010 by the Department, you stated, "Due to the need to change EU legislation, which is a lengthy process, we anticipate that a cattle vaccine and a DIVA test could not be used in the field before 2015." That was the date that was set then. Were you intending that to mean for field trials, although you did not say that, or was it, as the implication was, that by 2015 you would actually be able to use it?

Mr Heath: Mr Gardiner, as you know, I was not in my present post in 2010, so I cannot speak for what was in the minds of the people who wrote that then, but I am interpreting it in the context of what I know to be the case now.

Nigel Gibbens: Producing a vaccine that can be deployed is a difficult thing to do, as you all know. Even though BCG has been around for a long time, with cattle and deploying in the field, you have the challenge of being able to distinguish between vaccinated and infected animals. You will have heard this before. In parallel with being able to do the work to show that BCG can be at least effective enough to start looking at it as a candidate vaccine, you also have to produce a test-that is novel work done by Glyn and his team-to be able to differentiate one from the other. This all takes time. During the time we have been looking at producing vaccines, we have been doing research and development, and these dates are aspirational. That is why they say, "We do not expect it before" date whatever. What we have now is a much clearer set of conditions that the Commission has set out, which gives us another timetable to work to.

Q421 Neil Parish: This is one of the problems: there is too much aspiration out there and not enough facts. There is no doubt that we have taken a lot of evidence in this Committee about vaccine and the availability of vaccine. I think I am right in saying that the efficacy of the vaccine is only between 58% and 65%. It is being tested in Ethiopia and Mexico so far. Dare I challenge that they may not be the best countries to test it in? Now we are saying that the public is expecting this vaccine to be this great silver bullet to cure the problems we have with TB. How can Defra manage public perception of this much better because, at the moment, they are inclined to think it is just around the corner? Dare I say that some people are perhaps putting that prophesy out there, but it is not? As a Government and as Defra, we need to be absolutely clear that a vaccine is at least to 2023 away, even if we could actually use it across Britain and across Europe then.

Mr Heath: Mr Parish, that has been exactly the point of view that we have been expressing in the debate in the House of Commons and elsewhere, saying that it really is nonsense to suggest that we could do this tomorrow, if only we were not so stupid and obstinate as to refuse to do it. Nothing would delight me more than to have an effective vaccine as part of the array of tools that we can use for bovine TB, and at the earliest opportunity, but the fact remains that we have this conundrum that we have, up until now, not even been able to test it in UK conditions. As you say, we have tested it in countries that arguably are not desperately similar, in terms of their environment, to our own.

We would dearly love to be able to demonstrate effectiveness or otherwise in UK conditions. That is why we made the approach to Commissioner Borg to see what the process would be from now, given that we now have a diagnostic test. We need to demonstrate that both the vaccine and the diagnostic test are effective and then go through the various regulatory and legal hurdles in order to allow them to be used in UK conditions. That is inevitably going to be a long process, which is why we have to develop a strategy that includes all the possible methods we have to bear down on bovine TB, rather than relying on a single one.

I should also say, as you raised it, that because of the level of efficacy of the vaccine, we will always be in a position where, even when we are able to deploy it, we will want to be using a variety of means in order to seek to eradicate bovine TB. It will not be the silver bullet that finally removes the infection from this country.

Q422 Neil Parish: I very much appreciate your answer, but how can we actually get that much more out in the public arena? I should perhaps have checked what is on Defra’s website, because I am pretty certain that lots of people think that this cattle vaccine is only a year or two away and will cure all of our problems, when we do need actually to deal with infected wildlife as well as infected cattle. It has to be absolutely clear to the public. We have to be honest with the public exactly where and on what timescale this vaccine will or will not be available.

Professor Boyd: That is absolutely correct. We are approaching this in a structured way by producing a TB eradication strategy, which should be published by June. We expect that to show all the methods that are available for eradication, when they are going to come on line and what their contribution is going to be to the ultimate eradication of TB. That has to be expressed in very plain language and it has to be expressed very clearly, so that the public can see exactly where vaccines and other methods fit into the pattern of implementation of a TB eradication strategy.

Q423 Ms Ritchie: Minister, what is the outcome of the review by the Veterinary Products Committee of the application for the cattle vaccine?

Mr Heath: I think Professor Hewinson is better placed to answer that, so I shall ask him to do so, if I may.

Professor Hewinson: We have received some feedback from the Veterinary Medicines Directorate as a result of the meeting with the Veterinary Products Committee, and it has been very helpful to outline a route to field trial. The clear route outlined is that one needs to get an animal trial certificate, and they have outlined a number of further experimental data that would be required in order to achieve an animal trial certificate. Those are along the lines of what we described the last time I came in front of the Committee: looking at whether BCG is excreted in the milk of lactating animals-further assurance on that-looking at how long the BCG persists at the site of injection and whether there is any dissemination of the BCG into tissues, so that there is assurance of the meat and milk products; and the final area is looking at whether there is any reversion to virulence of the BCG vaccine.

Q424 Ms Ritchie: Does the Veterinary Medicines Directorate require further information before it will issue an animal test certificate, other than what you have already told us?

Professor Hewinson: We are meeting with them tomorrow to discuss the experiments around how we might approach that. The Veterinary Medicines Directorate cannot tell us exactly what they should do, but they can advise which areas we need to create the data from, and then we would submit that data for further review.

Q425 Ms Ritchie: Through the Chair, would you be able to come back to us in writing, on foot of your meeting tomorrow, with any further advice that you may have been given or any further guidance?

Professor Hewinson: I am sure we could do that.

Q426 Ms Ritchie: On what date do you expect to see full marketing authorisation?

Professor Hewinson: The other part of the advice that we are given is that they would not be allowed to give us full marketing authorisation until EU legislation is changed, because there is antituberculosis legislation.

Q427 Chair: Minister, are you surprised at the cumbersome procedure to gain marketing authorisation?

Mr Heath: We have always been very conscious of the fact that this is a very cumbersome process. I am very glad that we are now getting it properly under way, and the Commissioner was actually very helpful to us. I felt that his letter was a very positive response to our need. Nothing about European Union legal process ever surprises me, in terms of its cumbersome nature. I knew it was going to be a long, hard process, and we have to jump an awful lot of hurdles along the way.

Q428 Chair: I know we are going to come on to talk about European Commission procedures, but we heard in evidence that the Commission is reviewing animal health regulations and coming up with a novel EU regulation.

Mr Heath: What we hope they will do is to provide the legal basis for eventually lifting the ban, which is not clear at the moment. We have been pressing very hard to influence the Commission’s thinking on this to make sure that what emerges is a clear legal basis on which, eventually, once we have satisfied all of the requirements that we need to along the way, they will be able to lift the ban.

Q429 Chair: Is the Republic of Ireland in a similar position?

Mr Heath: We work very closely with the Republic of Ireland on this, because obviously they have a similar situation, as, up to a point, does France.

Q430 Neil Parish: If field trials take place as the law stands at the moment, what is the status of meat and milk from those cattle that are injected with a vaccine? Can it be used?

Mr Heath: This is one of the things we need to satisfy the European Commission on because, frankly, we need to have an outlet for that meat and milk, assuming it is safe, which is viable in order to help fund the trials. It would be a rather unacceptable offer to any participating farmers: "Please take part in this test. By the way, you won’t be able to sell anything for the next few years."

Q431 Barry Gardiner: Minister, I understand that you were not in position in 2010 when the report I referred to earlier was produced, but between the four of you, you represent the corporate memory of the Department back to that time. I wonder if you could tell us, given what you said about the need to change EU legislation in this regard by 2015, what was the first action and proposal that you made to the EU, after that statement in 2010, to try to break that EU logjam, as it were, or to broach the issue?

Mr Heath: Can I be clear? I am afraid we are not a desperately good corporate memory, in that I think all of us-

Barry Gardiner: I am sure you have been briefed.

Mr Heath: With the possible exception of Professor Hewinson, we have been put in post since, which is why I am not in a position to put myself entirely in the mindset of-

Q432 Barry Gardiner: If you cannot, could you write to us setting that out?

Mr Heath: Can I answer your question? There are stages that we have to go through first. It is no good going to the Commission asking for a proposal for field trials until we have not only the vaccine that we have shown to be viable within its limits, but also the diagnostic test, the DIVA test, which we also need to have shown is viable. It is only when all those factors are in place that we could make a sensible approach. Our judgment earlier this year, or late last year, was that all those factors were now in place and we were able to make an approach to the Commissioner, which is exactly what we did. The Secretary of State and I had a very valuable and positive meeting with Commissioner Borg, and the outcome is as you know.

Q433 Barry Gardiner: Really what you are saying is that it is only since, effectively, the end of last year and the beginning of this that you feel that you have been in a position to make that approach.

Mr Heath: That is right.

Q434 Barry Gardiner: Thank you. That does rather suggest that a 2015 timeline for this to be used in the field was never a realistic option, given that you had a better handle on how long it would take to go to the VMD and the AHVLA and get this preliminary stage under your belt.

Mr Heath: That depends on your interpretation of what was written in 2010. If you interpret that as being a vaccine that was freely available for use across the UK, then I think it was an optimistic assessment. If, on the other hand, you interpret it as being used in the field in the sense that we will be, I hope, using it in the field in 2015, it is exactly accurate.

Q435 Barry Gardiner: It says "used in the field", not "used in the field trials". Let us move on and go from where we are now, which is the letter from Commissioner Borg to the Secretary of State. The Commission has said to us that it is waiting for the UK Government to submit plans for the conducting of those field trials for the vaccine and the DIVA test. Have you had confirmation from the Commission that field trials can take place in the UK, despite the EU ban on vaccination?

Mr Heath: We are in the process of discussion. Mr Gibbens has been talking to his counterparts in the European Commission, so perhaps I could ask him to answer that question, in the first instance.

Nigel Gibbens: You have seen that the letter sets out a number of tests. Quite a cluster of them around safety will be dealt with in the process of the VMD application that is now in place. Although, because of the law, they cannot issue a full authorisation, they will not issue any authorisation at all until we have dealt with a cluster of safety issues. Then you are looking at the performance.

Q436 Barry Gardiner: Would you like to outline those safety issues for the Committee?

Nigel Gibbens: Glyn mentioned this earlier. This is whether the BCG will be excreted in milk, for how long it will be present in the meat of the animal at the injection site or elsewhere, and what are the issues in relation to the food chain. That does require some more work, and the VMD wants to make sure they get it right. It is important to recognise that we are not doing this just for a UK audience; we have to persuade the EU audience, so we have to get it right. That addresses a lot of the issues.

In parallel, we need to plan what field trials will look like. The Commission has made it very clear in their letter that they want really quite extensive trials before they will consider that we have gathered enough evidence to go forward and make any changes at EU level. Similarly, we have the rest of the world to look at, which will also look at it in the same way. There is a bit of an interaction here. You mentioned earlier that we need to make sure that we have confidence around safety, such that meat and milk can be marketed, so that we can plan trials using, essentially, our commercial herd, in a way that is affordable. We now have to do that work in parallel, and we will be in dialogue with the Commission about it.

Q437 Barry Gardiner: There is, at the bottom of the first page of Commissioner Borg’s letter, an interesting paragraph that suggests there may be another precondition. He says, "In the past four years the Commission has allocated considerable funds to support the UK bTB programmes…We therefore expect significant improvements in the epidemiological situation in 2013 that show efficient use of Union funds. This is absolutely necessary in view of a further renewal of the EU financial support to this programme." Are you in a position to tell the Committee whether that significant improvement in the epidemiological situation this year actually obtains?

Mr Heath: I can give a political answer to that, rather than a scientific answer.

Barry Gardiner: I think the Commission will probably want a scientific one.

Nigel Gibbens: I will follow up with a technical one.

Mr Heath: I believe the intention of the Commissioner there was to remind us that we have signed up to a variety of actions in this country, which we have set out as part of our bTB eradication plan. Any backsliding from that would be taken as being a dereliction of duty on our part, and the EU would take that into account. It was really reminding us that, not only do we have to take forward the work that we are doing on vaccine, but we also have to take into account the work that we have done in tightening up our biosecurity and animal movement areas, and, indeed, the proposals for testing our badger cull proposals, which were all part of the package that we have agreed with the EU.

Nigel Gibbens: The technical answer is very similar. Because we have an eradication plan with the EU, we set out our proposals and they have sought a strengthening of the measures across the board. Dealing with wildlife is one component, but cattle measures are an important component too and, in the last year, we have made some very significant changes. We have changed the proportion of the country on annual testing, so we are looking harder for the disease. We have increased the restrictions on farmers, so they now find it harder to move animals. They are looking to us to tighten the rules around premovement testing, where that makes disease control sense, and it does. We will be looking to take that forward.

That will all strengthen our TB control measures. The phrase "the epidemiological situation improving"-we know and they know that that will take a long time, but they want to see us delivering on a comprehensive package of control measures that justifies the spending of EU money. We have to show that we maintain that. We also need to monitor what is happening and strengthen, where necessary, and they will look for that reassurance every single year.

Q438 Barry Gardiner: That is very interesting, because what you have said, Mr Gibbens, is what they are looking for is outputs, not outcomes, yet what Commissioner Borg’s letter suggests is that they are looking for outcomes, not outputs.

Mr Heath: Can I say that, quite apart from the letter, we discussed this point in the meeting with Commissioner Borg, and he made it very plain that he expected us to deliver what we had committed to doing under the proposals that we had previously agreed with the EU. That is exactly what he said in the letter, but he underlined that point. He said, basically, and I’m paraphrasing, "Don’t expect us to play ball with you if you promise and don’t deliver."

Q439 Barry Gardiner: I am sure that that would inevitably be the case. I am pleased to have your reassurance that there is nothing further that has been demanded in terms of outputs. Can I just check with you? Point 5 in the annex to the letter-this is the timetable now right the way through to 2023 as the end point with the EU-says, if all the above is done, "Possible EU rules on vaccinated animals and herds to enter intra-Union trade". Then it puts in this other phrase "in parallel with amendments of international standards (OIE Terrestrial Code and Diagnostic Manual) [2023]". I just want clarity here that, once we have got to that point, having done everything that goes before in Commissioner Borg’s letter, and we get to 2023, we have not overlooked the "in parallel with amendments of international standards". What are the international standards and what are the amendments to them that will have to be brought in to make sure that 2023 is genuinely an end point and not a new departure point?

Mr Heath: Can I say I think it would be a tragedy if it was a new departure point? I entirely agree with you, Mr Gardiner, that we need to look at that. What this is saying is that the outcome, in legal terms, has to be consistent with what we hope to achieve in practical terms. That will involve the Commission looking at changes in EU law. They will have to take into account any other parallel factors that come into play. Of course we understand that, but I do not think we have had drawn to our attention any particular instances that we can expect, within a 10year period, other than the commitment that he made to try to provide the legal clearance which we have asked for.

Q440 Barry Gardiner: Minister, do you not think it is rather essential that you now write back to Commissioner Borg to ensure that when in 2023 we get to the point where we have possible EU rules on vaccinated animals entering into intraUnion trade, we have clarity on what the additional amendments to the international standards might be, how long it might take to get those international standards amended and who the appropriate authorities are that would have to sign them off?

Nigel Gibbens: What the EU is referring to is the OIE, the World Organisation for Animal Health. It is a standardsetting body. It sets out both guidelines for member countries to follow in securing safe trade in animals and their products, and guidelines on the tests that they should use. Clearly that is very relevant when you are talking about trade in live animals vaccinated for TB against a background in which the vaccine has not previously been used. Those international guidelines will need to be looked at in parallel, and we are already in discussion with the OIE about what they expect. That is part of the work that will have to be done, and we will need to take those two things forward in parallel. This is exactly what the Commission is flagging up.

Mr Heath: It is a constant dialogue.

Q441 Barry Gardiner: Thank you. Mr Gibbens, you are absolutely confident that, when we get to 2023 and we have fulfilled all the other obligations that the EU requires of us, we will not then have a further hurdle to jump? That will have already been negotiated in parallel?

Nigel Gibbens: We are looking to do two things at the same time. The World Organisation for Animal Health is a body that has its own governance. It has a general session that meets every year that signs off changes so, to land this, you have to encourage the Organisation to put forward the changes and then get all the member countries to sign up to those changes in that general session.

Q442 Barry Gardiner: How many member countries are there?

Nigel Gibbens: 175 or thereabouts.

Q443 Barry Gardiner: How long does it normally take for those 175 countries to agree a new set of standards?

Nigel Gibbens: The OIE is quite swift in terms of international standardsetting bodies so, given a good scientific underpinning, it can be done in one year. It is often done in two-one year for the committee to get a good understanding of the proposals, and then another year to go through. Sometimes it takes longer if they are contentious, but it is not out of line with the way the EU operates, or this timetable, but we will have to work on it. I cannot offer you a guarantee now that that process will not have some difficulty.

Q444 Barry Gardiner: Would it be that the OIE needs to see it, having negotiated all the hurdles within the EU, before they are prepared to consider a change in their own rules? Is that likely?

Nigel Gibbens: I will stay with this because I go to the EU often. They do not work on the basis of what the EU does. They are an independent body that existed a long time before the EU and they operate independently. What they will want to see, though, is very much the same scientific evidence, and they, of course, will be reassured by the work that we do to persuade, first, the Veterinary Medicines Directorate, and subsequently the EU and its bodies, of the scientific underpinning of a cattle vaccine and the test that goes with it. The job to be done, and we have already started, is to carry those two things forward in parallel.

Q445 Chair: Could I just ask, are we expecting legislation then? There is the EU regulation, we think, on animal health, which will be directly applicable if it is a regulation, so there would not be a long implementation process in this country. Are we assuming that this is going to be dealt with under that EU regulation, or is it going to be dealt with under separate EU regulation?

Mr Heath: I do not think we are absolutely clear about that process, if I am honest with you. That is one of the things we are talking to the Commission about. They have set out where they think the end point is. Once we have established the scientific credentials, we need to continue to discuss the legislative process with them, because we are not at that point yet. I would be loth to give you an absolute answer that turned out to be incorrect, Miss McIntosh, but we will be guided by their view of what is required.

Q446 Chair: It might be helpful just to have a note of what your current understanding is, because there appear to be two parallel processes going on. One is the current process that you have outlined here today and in earlier sessions, and the other is this other process, which is throwing everything up in the air and coming down with a new European animal health regulation.

Nigel Gibbens: Can I just try to clarify again? What Mr Gardiner was alerting us to was this point in the letter about the OIE. The OIE is an international standardsetting body. It is not a legislator as such, but it sets standards. It does it by adopting those standards at a plenary session that happens once a year in May. That is the thing that has to be achieved. The reference to both the standard and the manual is one says what the rules for trade are, what tests you might expect of your cattle, and the other is the manual that says what the approved tests you can use are, where we would want our DIVA test to appear. We have to do both those things, but it is a standardsetting process, so it is simply the adoption of a standard by that body. There is no further legislative process separate to that.

Q447 Barry Gardiner: My point to you, Mr Gibbens, and to you, Minister, is that I suspect it is unlikely that, until you are at the point where you can persuade the Commission that it is now time for a change in the EU rules, you will be able to persuade the OIE that it is time for them to change their standards. Therefore, it could well be that there is an extended period here.

I have a final question in relation to this, again with specific reference to the Commissioner’s letter: he has talked about there still being many knowledge gaps and fundamental scientific information that is not yet available. On page 2 of his letter, he says that "Future studies should also address food safety concerns," and then "human health concerns." Here he puts in brackets, "BCG is the only vaccine available for humans and its use in cattle may lead to the selection of BCG-resistant strains of bTB that may affect also humans." Now, I am no epidemiologist, so forgive me if I misinterpret this, but please put me right. My understanding of what he is saying there is that one would need to have epidemiological studies that show that there is no such effect and transmission to bTBresistant strains that could eventually cross into human pathology. How are you structuring a test to show that and how many years would it take to successfully show that no such transference could take or is taking place?

Mr Heath: My lay view is that BCG has been in constant use for a very long time now, in dealing with TB, and resistant strains have not yet appeared, up to the efficacy of the vaccine.

Q448 Barry Gardiner: They are alluding to a specific possibility that they are concerned about and that they expect us to be able to plug the knowledge gap about.

Mr Heath: Mr Gardiner, I understand exactly the point you are making. As I say, I am simply giving a lay view. In terms of establishing that to the satisfaction of the regulatory authorities, I don’t know whether Professor Hewinson would like to comment.

Professor Hewinson: It is a conceptual concern. To show that experimentally would be extremely difficult. Obviously, one would need to discuss the design of such a trial with them, but you would first look for changes in M. bovis during your vaccine field trials. You would collect the strains of M. bovis, during those field trials, to see if there had been any consistent changes in the organism.

Chair: I imagine it is fairly academic, because TB is rife in many countries in North Africa. It potentially could be introduced through human-

Barry Gardiner: It may be academic, Chair, but it is a precondition that the Commissioner has put in place in this letter. Therefore, I think Professor Hewinson is absolutely right in talking about the need to speak to them about precisely what would constitute such a trial and how one might go about constructing it and proving it to the satisfaction of the Commission. Again, we do not want to be in a position where we think we have done enough, but then they say, "But we told you back in 2013 that we expected this and you have not done it."

Q449 Chair: Can we have an answer and then we will move on?

Professor Hewinson: I think that is right; this is part of the dialogue that you would have to develop in terms of design.

Nigel Gibbens: I think Professor Hewinson is right. The Commission has raised all the concerns it considers should be addressed. One way of addressing a concern that is quite speculative-this one-is to look at all the factors that might lead to the risk it says we should address, and consider what needs to be done to have reassurance, so to carry out a risk assessment. The strong parallel is between the use of BCG targeting human tuberculosis for many, many years, with BCG having not changed in its efficacy. Your starting point in that discussion should be there, and I believe that is where we should start and then we should consider whether we need to build on that evidence.

Q450 Neil Parish: Going back to meat trading, are there any vaccinated beef or milk products being traded across the world at all at present?

Nigel Gibbens: We believe that vaccination has been used in New Zealand without any restrictions on the use of milk or meat.

Professor Hewinson: In one area of New Zealand, I think they are orally vaccinating their cattle and those animals are, I believe, going into the food chain.

Q451 Chair: Could I just seek clarification, because I am still not clear? Mr Gibbens, you said that the IOE just sets the standards and how the tests are to be done, but presumably they have to be given legislative effect. The report that we have seen from the Northern Ireland Assembly’s sister committee to this one clearly says that there is legislative change to be pursued. The Committee would like to know what the legislative change is and how long you think it might be, so that we do not have a piece of string that we cannot define.

Nigel Gibbens: There is specific EU legislation that requires to be changed.

Chair: That is what I am asking.

Nigel Gibbens: That is the legislative change we need to pursue. The OIE, in its job, sets standards; it does not set international regulations that must be complied with by countries. Countries then choose whether or not to follow those standards. Of course, they would be very wise to. It creates an expectation. What happens between OIE standards and EU law is those standards underpin a lot of our requirements. That makes us, as the EU, in line with the international standard and, therefore, not likely to get challenged under the World Trade Organization (WTO). That is what the standards are for. Once they are adopted, there is no more legislative change to make, other than those legislations that you hold domestically or at EU level.

Q452 Chair: First of all, could you identify which EU legislation needs to be changed, and is it different from the EU regulation that is currently being discussed on animal health?

Nigel Gibbens: The EU regulation is the opportunity to enable a change. The two specific pieces of legislation are one on disease control, which says that vaccination of cattle cannot be used, and another on trading cattle, which requires the standard TB skin test to be applied. Both of those, in effect, would have to be amended, and where we are now is the framework of law is changing, giving us probably more opportunity than we would otherwise have to secure those changes.

Q453 Chair: Is that within the frame of 2023?

Nigel Gibbens: Yes, and that is what the Commission is saying with the timetable it has set out for us.

Q454 Chair: Is that independent of the EU regulation that we heard about on animal health?

Nigel Gibbens: No; these things are linked. The change to the framework of EU law is the new EU animal health law. We have yet to see a draft, but we have been working to make sure that draft contains an enabling measure to allow us to use cattle vaccines. We expect to see that draft this spring/early summer, and then it will enter the normal EU process of negotiation which is likely to take two to three years. It will not be quick, but it is still within the timescale that we are looking at.

Q455 Chair: If I am correct and that is an EU regulation, then it has to be directly applied as it leaves Brussels, so it is absolutely essential we have our arguments put and supported by other member states. Is your reading of the situation that the other member states are going to support us at that point?

Mr Heath: I think that is very difficult to judge at the moment. We are obviously making our concerns known to other member states. A key to this is having the support of the Commission. Without that, we certainly are not going to get to where we want to be. Even then, I can give no guarantee that the other member states that are not in the same situation as the United Kingdom and Ireland particularly are, in this respect, are going to want to accommodate us. We can create the atmosphere, I hope, over the next few years, as we do our field trials, as we report on them, as we suggest that we are making real progress on this, in order to make that a reality. It would be very foolish for any Minister to assume that other member states will support anything that we say in the context of the European Union without a lot of hard work going on, in the background and over the next few years, to make it a reality.

Q456 Chair: Will it be a ministerial decision in the Council of Ministers or will it be experts meeting in comitology and committee?

Mr Heath: I think it will be both. Will it not?

Nigel Gibbens: It will be both. The enabling regulation will be Ministers in the Council of Europe and the European Parliament in parallel. You are familiar with this but, because it is enabling legislation, any further changes will be by comitology. Comitology does not mean it is just experts; it still has reference to Council and Parliament.

Chair: That is very helpful. We got there. Thank you very much indeed.

Q457 Sheryll Murray: Can I turn to testing cattle? Minister, given the greater sensitivity of the gamma test, why is it not used alongside the skin test in areas where TB is prevalent, such as the south-west?

Mr Heath: I am not dodging the question; I am simply going to pass it to the Chief Veterinary Officer, because he is better placed to answer it than I am.

Nigel Gibbens: The gamma test is more sensitive than the skin test. Therefore, it does offer you some advantages. It has the disadvantage that it gives you a higher number of animals that do not really have TB and that you end up taking off the farm. Our policy on using that test is to use it where we have reason more aggressively to seek to remove infection. For that reason, it is used in the lowrisk area, where we are seeking to eliminate disease and keep it eliminated, and in those herds in the highrisk area where there is a particular problem and we are seeking to move on from repeatedly using the skin test and, hopefully, clear a herd. There is an element here of the cost effectiveness of the use of the test, so we are using it sparingly, but we are targeting it to where it will have most effect.

Mr Heath: I think there is an argument for using it more. Again, I speak as a layman rather than a specialist, but I think that there may be a case, and I would certainly like the Department to look at this again to see whether there is better scope for using it, particularly in areas with high incidence.

Q458 Sheryll Murray: Could you tell me what steps the Government are taking to improve the performance and reduce the cost of the gamma interferon test?

Mr Heath: Do we have particular research programmes in that area?

Professor Hewinson: Do you mean the gamma interferon test itself or the DIVA test that is based on gamma interferon?

Sheryll Murray: Gamma interferon.

Professor Hewinson: At the moment, I do not think we have much of a research programme that is looking at improving the gamma interferon test, based on tuberculin testing. The companies that make the gamma interferon test are always looking at trying to improve the format and reduce the cost. The focus of the research is really on improving the gamma interferon test as a DIVA test, as opposed to the normal gamma interferon test.

Q459 Chair: We are coming on to vaccination of badgers, but could I just ask a general question? The incidence in the cattle herd in the UK has gone up significantly over the last 1012 years. The incidence in Northern Ireland and possibly other parts of Ireland as well seems to have gone down. To what might we attribute that fact, Mr Gibbens?

Nigel Gibbens: Sorry; could you just clarify the incidence?

Q460 Chair: Yes. If I am correct, the figures show that the incidence of bovine TB in the UK-well, English herds especially, or British herds-between 1986 and 2009, has gone up hugely. The level and incidence rates in Northern Ireland and possibly also other parts of Ireland as well seem to have gone in the opposite direction; they have gone down. Is there any particular reason for this, any context?

Nigel Gibbens: We have experienced an escalation in our epidemic at least partly to do with the challenges that we faced in 2001. There was a step change in the epidemic in 2001. Northern Ireland does face a similar challenge to ours and its approach to wildlife has not yet changed. We are in the same place as Northern Ireland with wildlife. The difference on the island of Ireland is in Southern Ireland, where they are culling badgers and where they are seeing a greater reduction in the incidence of TB.

Q461 Chair: 2001 was the year of foot and mouth. Is there a direct correlation? Professor Boyd, you are nodding as well. Was there a direct correlation, Mr Gibbens?

Nigel Gibbens: 2001 caused a hiatus in our TB testing. It meant that we were not able to pursue the control measures that we constantly pursue in the way that we had done before, and it disrupted the movement of cattle, in that a lot of farmers needed to restock their herds. With the benefit of hindsight, looking back, you can see that that seems to have seeded more TB, more widely than it had been before. That increased the level of TB in our cattle.

Chair: That’s helpful. Thank you very much indeed.

Q462 George Eustice: Given that we had a very long discussion earlier about how difficult it is to get through the licensing process to get a cattle vaccine, I want to turn to the possibility of vaccinating badgers. You have made available a fund, initially of £250,000 a year, for that. In your written evidence, you told us that it was only going to be used in the two pilot cull areas. Could you explain why you are only doing it in the pilot cull areas?

Mr Heath: Sorry, injectable vaccine?

George Eustice: Yes, a vaccine for badgers.

Mr Heath: It is actually being used in a wider area than that and we are cooperating with a lot of other bodies that are interested in pursuing the option of badger vaccination. Badger vaccination is part of the toolbox that we have. It is, again, not wholly efficacious, as you will be aware. It is not an easy route and, certainly, as you will also be aware, we are looking very hard at whether there is an alternative of an oral vaccine available for badgers, which might make for easier administration and cheaper administration, frankly. Nevertheless, it is part of the armoury we have available. Nigel, the details on where exactly it is being used at the moment-do you have a mental map of the country?

Nigel Gibbens: I do not have a mental map.

Q463 George Eustice: The written evidence we have here says "Defra has made available up to £250,000 per year in the form of a grant scheme, use of which in the current financial year has so far been limited to support for vaccination of badgers in the two badger cull pilot areas and to subsidise the lay vaccinator training."

Mr Heath: That is actually a very key part, Mr Eustice, if I may say. We are making the training places available, which allow for lay vaccination elsewhere.

George Eustice: In terms of actually spending the money on the vaccine itself-

Mr Heath: It is not our view that it is the most effective use of that resource at the moment.

Nigel Gibbens: The badger vaccine deployment project does pursue learning about how badger vaccine can be effectively used by injection, and that is going ahead in Gloucestershire, I believe; then there is a variety of places where badger vaccine is being used. It is being used by the Wildlife Trust in some areas. We are supportive of a range of places where it is being used. We are building knowledge about how you can effectively vaccinate using an injectable vaccine; learning more about how effective it is is much more challenging.

Q464 George Eustice: How far away is an oral vaccine, in your view?

Mr Heath: Professor Hewinson is the one who can answer that, but unfortunately it is not making quite as quick progress as I had hoped a little while ago. Mr Hewinson.

Professor Hewinson: I think I gave evidence to you about the progress last time.

George Eustice: Yes, you did. It is already on the record.

Professor Hewinson: We have not made much more progress since last week.

Mr Heath: I wish we had.

Q465 Ms Ritchie: First of all, to go back to the Northern Ireland Assembly, I represent a constituency in Northern Ireland and the Northern Ireland Assembly has made several proposals. Really, it is a mixture of culling and vaccination. I was wondering whether you had formed, Minister, any view or any assessment of that. That is a view that has been, shall we say, adopted by the Dairy Board (UK), which has an interest in Northern Ireland. They suggested that to me only last week.

Mr Heath: On what is happening in Northern Ireland, we certainly are taking a very close interest in what they are doing. I do not think they would claim that it is an eradication package. They are testing the various hypotheses in the field and we can certainly learn from what they are doing. As I say, I do not want to overstate the case, nor do I want to be critical of what they are doing, because actually it is extremely useful to our sum total of knowledge. Nevertheless, I do not think that they see what they are producing as a package that will significantly bear down on or even eradicate-certainly not eradicate-bovine TB in Northern Ireland.

Q466 Ms Ritchie: As a supplementary to that, Minister, are you or your officials talking to the devolved Minister in Northern Ireland or her officials about their ideas, their proposals and their outworking?

Mr Heath: Yes, we are, but I will pass over to my colleagues who do the talking.

Nigel Gibbens: Yes, we are, but the Minister has covered this very well. They are pursuing quite a novel approach. Wales looked at it from a Welsh point of view, and we work with them as well. There is at least a monthly liaison meeting. They could not show a benefit. The island of Ireland could be different. We understand why it is being pursued in Ireland, and we are interested to see the results. Yes, we do; we are in constant dialogue.

Q467 Chair: Could I just ask why you are limiting support for vaccinating badgers to the cull areas?

Mr Heath: As I say, we do not believe that this is the most effective or certainly costeffective tool that we have available at the moment. We are very happy to look very carefully at work that is being done with the injectable vaccine. The equation, I suspect, would change if we had an oral vaccine. Certainly the injectable vaccine, for all its limitations, is a useful part of what we have available and it may play a bigger part in the future, if we find the right circumstances to use it. It may be the case that there will be areas where it is the most effective way of dealing with the wildlife reservoir of infection, so I do not rule out expanding the programme in places, but our judgment at the moment is that it will be most effective in the areas where we are using it now. At the same time, we want to provide support, both in kind and in other ways, to those people who want to trial its use elsewhere and we will look very carefully at the results.

Q468 Chair: In different regions, are you checking the prevalence and the level of TB in the badger populations, in areas where it is currently not endemic?

Mr Heath: We are constantly trying to assess where the infection is. I proffer this as not necessarily where we are yet, but we need to look again at whether we do postmortem testing of casualty badgers to have a better picture. I personally would like to see that. I want our officials to look very carefully at the cost effectiveness of that as a proposal, before I commit to doing so. I want to know what is going on, both in the cattle population, but also in terms of the wildlife population as well.

Q469 Chair: Would you publish the findings?

Mr Heath: I see no reason why we should not.

Nigel Gibbens: That covers it very well. On where the vaccine is used, we are quite keen to encourage work with any groups to deploy vaccine where we can foresee a benefit. This might be on the edges of culled areas, where you are looking to protect those badgers on the edge, or it might be at the edge of the highly infected area, where you can deduce that there is a threshold between badgers that are infected and badgers that are free. We would very much like to keep the free badgers free. There are lots of places where you might usefully deploy vaccine, if you can do it cost effectively.

Q470 Iain McKenzie: Minister, a number of NGOs now have trained vaccinators. How is the Government co-ordinating their efforts?

Mr Heath: They are not Government officials; therefore, it is not really our responsibility to co-ordinate them, but we are very happy to talk to them and learn from them about what they are doing, where they are doing it and the results. It is rather the other way round: they are co-ordinating themselves and we are learning from their experience, and offering as much support as we can.

Q471 Iain McKenzie: What is Defra doing to address the concerns that access to the badger grant scheme is not straightforward and that financial support was not provided for many months?

Mr Heath: I am not sure that that is a real, genuine criticism. Of course, I listen to what people say. Certainly as far as our lay vaccinator courses are concerned, which is the biggest contribution that we make, those continue to be freely available and there are vacancies. I do not think it is a reasonable criticism to say that we are not doing enough.

Q472 Iain McKenzie: Why do you exempt farmers and make them ineligible for the grants to train vaccinators?

Mr Heath: I do not have an answer to that, because I was not part of the design of the scheme. I do not know if my colleagues do. I do not want to give you a false answer. I am sorry; we will write to you on that because, as I say, I am afraid I simply do not know the answer to that.

Q473 Chair: To return for a moment to cattle field trials, how long do you imagine that the field trials will last-what sort of period of time?

Nigel Gibbens: We are designing the trials now, and that process will determine how long we have to run the trials for. I am not dodging your question: we will have to design trials that meet our needs and the expectations of the EU. They will be large and long trials, so we must be talking about years, not months, but we are pre-empting the work we are doing to design the trials at the moment.

Q474 Chair: Are you envisaging it might be difficult, the fact that you are going to agree the legislation before the field trials are completed? Will it pose a problem that the legislation-you have just given us the timeline of the next two to three years-may be agreed before you have conducted the field trials?

Nigel Gibbens: No, it will not happen that way round.

Mr Heath: We may get as far as the enabling legislation, but that simply provides a legal basis for going further. I do not think there are any circumstances in which we would persuade the Commission to proceed with specific legislation, until we could satisfy them that we had met their requirements.

Chair: Thank you. I am very grateful.

Q475 Barry Gardiner: Professor Boyd, just very quickly, Defra’s written evidence states that there is currently no direct evidence that vaccination of badgers will result in reduced transmission of TB to cattle. You have said that you have an expectation, but that there is no written evidence for that at the moment. Defra prides itself on proceeding on the basis of, I think the phrase is, "best available science". Is that right? Can you just clarify what you are saying here? Is this proceeding on the best available science, insofar as you are conducting an experiment or insofar as there is scientific evidence that says that this is the right way to go?

Professor Boyd: In terms of vaccination, are you talking about?

Barry Gardiner: Vaccination and cull, if you like, yes.

Professor Boyd: There are a number of lines of evidence that support various different types of actions. The main line of evidence that Defra uses is the Randomised Badger Culling Trials (RBCTs), which they have spent about £50 million on running, which were cullbased trials. Now, if we wanted to have the equivalent for vaccination, we would need to go through an equivalent type of design and we are not in a position to do that. We are into a very different situation with vaccination to try to understand what its efficacy might be. That is about learning on the job, as it were. It is adaptive management of the process. That tends to produce rather messy results, where it is really very difficult to interpret the outcome. In contrast to that, we have a lot less messy results with respect to culling. That is one reason why Defra is looking at the culling, because it is much more evidencebased than a vaccination procedure.

Q476 Barry Gardiner: We are trying not to get into the culling as a principle here, at the moment. I do not want to go down that rabbit hole, or badger sett. What I do want to do, though, is to ask you, very clearly, why it was then, given you have just confirmed to me that Defra tries to operate on the basis of best available science, that when the 127 Marine Conservation Zones were up for consideration, you changed the criteria for that consultation and consideration from "best available science" to, I think the words were, "robust science" and "best science"; and indeed why you excluded any information pertaining to them that was over 12 years of age.

Mr Heath: You have a team who are here on animal health.

Barry Gardiner: I am talking to the chief scientist who was responsible for the criteria change.

Mr Heath: Professor Boyd may be able to answer that. I don’t know.

Professor Boyd: I am willing to take that on. With respect to Marine Conservation Zones, we have been very clear about the criteria that are being used to develop the evidence base for the decisions that are being made about which zones should be put forward for conservation.

Q477 Barry Gardiner: Sorry; you have changed the criteria. You have changed those criteria from the "best available science" to "best science". You have excluded evidence that is over 12 years of age. Also you have changed the ecological network definitions by which you are going to judge whether there is a coherent ecological network.

Professor Boyd: With respect, I think you are splitting hairs with respect to the semantics. "Best available science" and "best science" are, in my view, the same things.

Q478 Barry Gardiner: Why did you change it then?

Professor Boyd: I cannot answer that but, as far as I am concerned, they are the same things.

Barry Gardiner: The consultation changed from "best available science".

Professor Boyd: They are the same things. With respect to the question about 12 years, I cannot answer that specifically, but I can give you a general response to that about why I think that might be the case. It is that the marine environment, in particular, is a highly dynamic system and information that is old is likely not to be very relevant. I can provide you with a written response on that, if you wish.

Barry Gardiner: I would be very grateful.

Mr Heath: Miss McIntosh, just to return for a moment to badgers, I think I might just add two things about the vaccination of badgers, the first of which is, of course, the selfevident point that vaccinating an infected animal does no good at all. They are still infected. You cannot cure a badger by vaccination. The other thing to stress is that I would very much like us to have a more effective way of identifying infected badgers, just as I would like us to have the best possible mechanism for identifying infected cattle. I would much prefer to be targeting our efforts on infected badgers, rather than having to take a widerspectrum approach. I am hoping that those who are working in this area will eventually be able to provide us with options that are better suited to identifying infected animals.

Q479 Sheryll Murray: Could I come back, Professor Boyd, to the comparison we have just heard between the sites for the badger situation and Marine Conservation Zones? Clearly Marine Conservation Zones are being introduced for a completely different reason and they are looking at an ecosystembased form of conservation. We are not looking at eradicating any disease through the implementation of Marine Conservation Zones. Am I correct there?

Professor Boyd: Absolutely. Marine Conservation Zones are a totally different subject from the management of badgers.

Sheryll Murray: You should not really make that comparison. It is misleading.

Professor Boyd: They are completely different. There is no readacross whatsoever, as far as I am concerned.

Barry Gardiner: Except in the quality of science that you would wish to apply.

Professor Boyd: One could read that across pretty much all activities within Defra and Government.

Barry Gardiner: You should be able to.

Professor Hewinson: I just come back to the issue of trying to collect data in order to give some evidence base, which is difficult for the effect of vaccinating badgers on TB and cattle. How do you try to collect that data? It also refers to another question about what we are doing to try to co-ordinate efforts. As part of the training process, when a vaccination area is chosen, there is a common database in which to upload the locations of where badgers are vaccinated, so that we can look, over time, at whether there has been an effect on cattle TB. This is the adaptive response. It is not as clean and as good as a trial based on RBCT, but I would put the case that, if there are going to be voluntary vaccinations, they should be co-ordinated, so that we can at least try to get some data as to the effect of vaccinating badgers on cattle herds.

Q480 Chair: Moving to the Schmallenberg virus, Minister, are you aware of the scale of the Schmallenberg virus now, and have you been able to do an assessment of the impact of the virus on the livestock industry this year, not just in sheep but in cattle as well, and what the financial implications will be for the industry and for each individual farmer?

Mr Heath: I am very aware of the prevalence of Schmallenberg. It has now been identified in every county in England, which is obviously of concern. I am very aware of the impact on individual farmers of the consequences of infection with the disease, both in terms of sheep flocks and cattle herds. We sometimes forget the cattle herds, simply because the impact was first seen in flocks.

What is more difficult, I think, is to put that into the context of overall disease patterns, overall losses on farms and the definitions of levels of impact, because the EU recognises this as being a lowimpact disease. Now, I think that it is quite difficult. Someone who is on a farm facing a considerable number of malformations or stillbirths in their flocks will say, "Well, it is not very low impact for me." Nevertheless, in purely quantitative terms, in purely epidemiological terms, that is true. In terms of its economic impact, it has not had a huge impact across the country. For individuals, it has had a very significant impact.

The good news as far as Schmallenberg is concerned, or at least what we hope is the good news, is that we do believe that there is a degree of immunity following infection, which may persist for some time. It may be that they were infected last year; it is manifesting itself this year, in terms of the births, but that has actually conferred a much higher level of resistance for future years. Therefore, we may actually see very much less impact in the future on flocks and herds. I certainly hope that is the case.

Q481 Chair: Could you just share with us what proof you have of this immunity?

Mr Heath: It is largely from European comparisons, where Schmallenberg has hit first, but I think the Chief Veterinary Officer would be a better person to answer that question.

Nigel Gibbens: Schmallenberg is a newly found virus, so our expectations of immunity are based on what we know of its near relatives in that virus’s family and they do seem to produce a strong immunity. It is reasonable to expect that it would last at least a year. The other evidence we have is that we are now in the second year. We looked quite hard to see where the disease affected England last year, and it was all across the South and the East, up towards the Midlands. We have seen a lower impact on those herds and flocks this year and, in the last summer, it spread to the rest of the country and we see a higher impact in those herds and flocks, which tends to support the fact that you have immunity coming from last year to this year, and we are seeing disease in herds that were not previously affected.

Q482 Chair: The incidence in cattle seems to be a lot higher and farmers are specifically asking about immunity. If they lose a calf this year, what is the position with the cow next year? Presumably you do not have that information.

Nigel Gibbens: The expectation for cattle is the same as for sheep so, if a herd is exposed to Schmallenberg, the adult animals that only show a transient disease-what happens with Schmallenberg, as you have heard before, if we are talking about cattle, is if a cow gets infected at the right stage of pregnancy, the major impact is yielding a deformed offspring. That process, it is reasonable to expect, will give you an immune cow for the coming year. For cattle as for sheep, we should expect previously exposed herds to be protected in coming years, but it is a new disease, so we are still pursuing the research on that.

In terms of the number of cattle affected, we are hearing those reports too. Schmallenberg has definitely spread throughout the country. We looked for it; we found it. The experience from Europe is that, when it passes over a geographic territory, the number of herds and flocks exposed is really very high indeed so, when farmers are looking, they find that their animals have produced antibodies to Schmallenberg. In terms of their losses, whether they have not had a calf when they expected one or whether they have had calf losses, as opposed to a deformed calf from which we can potentially find the virus, there could be many causes. This has been a particularly hard year for farmers. It is not my job to tell farmers how their businesses are going, but it has been particularly hard and it has put pressure on nutrition, which has an impact on the likely success of the whole herd and other diseases that might affect cattle.

Q483 Chair: Effectively, you do not know whether they will be immune or not.

Nigel Gibbens: We cannot give an absolute guarantee, but it is likely.

Q484 Chair: What should a farmer do if he has a case of Schmallenberg in either sheep or cattle?

Nigel Gibbens: When a farmer sees the impact of Schmallenberg through deformed newborns, whether they are sheep or cattle, that is the impact of disease that was introduced to that herd or flock several months earlier. At the time that they see disease, there is nothing that they can do. They have a duty of care when they are lambing or calving to make sure that they look after the welfare, because these deformed animals are hard to calve, so that is very hard for them. Having done that, they are looking towards the coming year and then, with their vet, they ought to consider the exposure of their herd. We will, I am sure, come on to the production of a vaccine by commercial companies in due course but, if there is a vaccine available, a farmer will need to make a decision as to whether it is worth using that vaccine. If his herd has already been exposed, they may not want to do that.

Mr Heath: Can I just add one more thing in terms of information for farmers? I had a meeting with interested parties, including representatives of the farmers’ unions. Following that meeting, it was clear that we needed to give as good information as possible to farmers. We have produced a leaflet, which has been made available since. I think it was on every seat at the National Farmers Union conference recently, and the Committee, if it has not seen it already, might like to look at what was produced.

Q485 Chair: Is it available on your website?

Mr Heath: Yes, it is, but we can make the leaflet available to the Committee, Miss McIntosh, so that you know what advice we are giving to farmers.

Q486 Chair: I was specifically asked by a farmer what advice you are giving. Is this the right time to be closing veterinary laboratories, like those in Thirsk, Truro and others, in rural areas where we really could be doing with them to do postmortem checks, such as the chief vet has just advised?

Mr Heath: We have to make sure that we have viable laboratory services across the country, capable of reacting to whatever situation we face. I am satisfied that we do have that with the measures that we are taking. It is not easy, I have to say, to make sure that we have a system that is adequate to the task, but I believe we have done so. The AHVLA and others make sure that we have the competence, which you would expect, as a Committee, the Government to have. I am sorry to keep on deferring to Nigel, but he is the Chief Veterinary Officer and it is relevant to his area.

Q487 Chair: It would be helpful. Where are farmers in the south-west and farmers in North Yorkshire meant to take the dead lambs and dead calves to be checked?

Mr Heath: Perhaps you can explain what we actually do.

Nigel Gibbens: We need to have an effective surveillance system that gives us both geographic and species coverage. Of course the network of laboratories is relevant to that, but actually what is most important is, as you said, the ability of farmers to submit to laboratories, wherever they are. We are currently looking at the outcome of the consultation on what we do on surveillance next, but it is very important to realise that the thing that Government can do that isn’t increasingly being provided by private labs or private vets is the toplevel investigation that deals with the unknown disease, the thing we have not seen before-something like Schmallenberg-or allows us to respond very quickly to the emergency diseases, like foot and mouth disease. We need to concentrate on that.

To do that, the historic shape of service that we have had, which is essentially a subsidised diagnostic service, is not now delivering the cover that we need and we need to look at what we should do to make that better. That is what the consultation is all about and that is why we might have to face some tough choices about how we make this better.

Chair: I just leave you with the thought that moving it from North Yorkshire to Newcastle does not seem an obvious choice.

Q488 Neil Parish: I shall move on to vaccines but, before I do, can I echo the Minister’s words? To individuals, this disease is a terrible thing. Not only does it seem to be killing cows and lambs, but there have been cases, certainly in south Devon and elsewhere, where quite a number of adult cattle have been affected as well as sheep, so it has a major impact. I do not know whether you would like to comment on that before I just move into vaccine.

Nigel Gibbens: We are familiar with the clinical signs in adult cattle. They are transient but, if it hits a dairy herd and spreads through a dairy herd, then-

Neil Parish: Cattle are being lost through it.

Nigel Gibbens: Cattle are being lost? We would be very interested to see those cattle because, across Europe and the experience we had last year, we were not seeing adult mortalities. With this disease, that would be extremely surprising. With the farmer, with their vet, we should be looking to make sure that what has happened is being properly attributed to Schmallenberg, because I suspect it would not be. As I alluded to before, we are here to do the further investigation that helps to unpick those unusual things.

Mr Heath: Mr Parish, can I make this point? I know you will know this but just for the record, a key factor here in terms of the effect on a particular flock or herd is synchronicity of tupping, that they go to the ram at the same time, as they do in order to produce Easter lambs. If the midge happens at exactly the wrong time, then you will have high levels of infection in a single flock. If the midge arrives a week or so earlier, then you have immunity and it is good news.

Q489 Neil Parish: I want to pursue the vaccine now. How far away is the vaccine? What are the economics of it? Will farmers use it? Will you advise farmers to use it? What is the situation?

Mr Heath: It is very difficult to answer that question, because there are commercial judgments involved and it is not for us to secondguess the commercial view of the pharmaceuticals. We know, because they have let it be known, that a vaccine is in the process of development. I think we are at the point of it being before the VMD.

Nigel Gibbens: It is with the Veterinary Medicines Directorate and it is quite advanced in the process, but it is not finished yet.

Mr Heath: We are quite close to it.

Q490 Neil Parish: What is the timescale then?

Nigel Gibbens: It is the VMD’s process and they have just taken further evidence. We hope that what the companies have come up with will satisfy their needs as to safety. There are no guarantees, but we are very hopeful we will see it before the next breeding season.

Mr Heath: Our problem is that the VMD, quite rightly, is very jealous of its independence and its process and would certainly not like to be leaned on by the Department for Environment, Food and Rural Affairs.

Q491 Neil Parish: I can understand that. Is there an argument for identifying a stock that would have been exposed to the disease, and is therefore likely to be immune to infection, to see whether the immunity does last for a length of time or not? Surely that is an argument. If an animal gets it and then is immune for the rest of its life, or most of its life, then there is probably not the same argument to use a vaccine. If it is not, or it is only for a year or so, then there is an argument, so are you doing any tests on that?

Nigel Gibbens: One of the things we did very early on-this is a good example of collaboration across Europe-is, with the European Commission, come up with a suite of research strands looking at all the key things that we needed to know. Length of immunity is one of them. I do not think that is being pursued in this country, but it is being pursued in the EU, so we will get that information.

Q492 Neil Parish: Do you not think it would be a good idea to pursue it here?

Nigel Gibbens: The point was that we would each play a role and we would use what research money we had to best effect. We do not need to duplicate what is being done elsewhere.

Q493 Neil Parish: I understand that but, present company excluded-I have to be quite blunt with you-we have had evidence before this Committee before where Schmallenberg was more or less, "Oh, well, it’s not going to be much of a problem. The sooner it runs through the whole of our sheep flock and cattle, the better, and then it will be all over." Certainly, the experience of individual farmers in Devon and elsewhere is pretty excruciating at the moment. I would like to see Defra taking a slightly more-dare I say it-sympathetic view on this than some of the evidence that we have had before this Committee, both last year and this, where it was almost dismissed as an irrelevance. I take it that is not your view.

Mr Heath: If I can answer that, Mr Parish, I hope I have already impressed upon you that I certainly do not see it as an irrelevance.

Neil Parish: I am not targeting your good self or the previous Minister. It is evidence that came here from a scientific background that I was not happy with.

Mr Heath: I understand that. It does not stop me hoping that exactly the circumstances you suggest are right: that it does, across the country, confer an immunity, which means that the levels of infection and certainly the levels of manifestation, next year, are much lower; and we will not then have it return before a period of time. We were discussing this earlier, in terms of what the patterns in epidemiology are. It would be typical of a disease of this kind if there was a periodicity to it. Perversely, of course, that might be a disincentive to the producers of the vaccine, thinking, "Well, is there any point in us going into commercial production of something that might only be used once now and then not for a dozen years or more?" Who knows? We do take it very seriously and I certainly am very well aware of the consequences.

Q494 Neil Parish: Going back to the previous question, we do need this evidence as to whether they are going to have longterm immunity.

Mr Heath: There is no reason to suppose that sheep and cows in this country will behave in a different way, in epidemiological terms, to those on the near continent, in very similar conditions. If we can benefit from the research that is being done now, there really is very little point in duplicating it.

Q495 Neil Parish: I can understand that, but can we actually help them with their research then? I really think it needs to be taken a little more seriously than it has been in the past.

Mr Heath: We have commissioned some work with the Pirbright Institute to look at the way that the disease actually operates, the way the midges spread the disease, so there is an area of expertise, which we are using our resources on. It is not what you are describing, in terms of the conferred immunity; it is a different area, but I think it is complementary and means that, at the end of the day, we have a much better picture.

Q496 Chair: It would be very helpful if you could possibly drop us a line on that, Minister.

Mr Heath: Yes, of course. I would be very happy to.

Q497 Chair: A couple of quick questions, if I may: just going back to the BCG vaccine, given the incidence in camelids, would the cattle BCG vaccine be applicable to camelids?

Mr Heath: I do not know the answer to that. Nigel, do you know the answer to camelids? I do not think we have had incidence in camelids, have we?

Nigel Gibbens: I do not think we have done any work on BCG in camelids, but I am going to pass it to my research colleague here.

Mr Heath: Sorry, BCG. I thought you were asking for Schmallenberg. I do apologise. I was still thinking Schmallenberg.

Professor Hewinson: Again, it is to do with the regulatory hoops that you would have to jump through. Just because you can get a licence for one species, you still have to go through the same types of regulatory studies in terms of safety and efficacy in another. You cannot take BCG for badgers and use that evidence to say that it would work in camelids. Equally, you cannot take the data from cattle and say you would do it in camelids. You would actually have to go through the safety and efficacy studies in camelids.

Mr Heath: Having given you completely the wrong answer a moment ago, can I say I am watching very carefully the situation with camelids? I am very much aware of it and I constantly ask the Department for their views on whether we should be taking any further actions in terms of camelids.

Q498 Chair: It was just a point of information: from the date of the skin test, how quickly are TB reactors removed from the farm? Would you have a timescale, Mr Gibbens?

Nigel Gibbens: There is a target that the Animal Health and Veterinary Laboratories Agency works to of uplifting within 10 days. They pretty regularly hit that or beat that target. There is a requirement on the farmer to isolate positive animals, so that they cease to be a risk to the herd. The reality is, of course, the day before the test was read, they were in with the rest of the herd. You do what you can to prevent spread of disease.

Chair: Thank you. You have all been immensely patient and very generous with your time. Can I thank you all very much indeed for participating in our inquiry? We are very grateful.