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 Wednesday 27 February 2013

Members present:

Miss Anne McIntosh (Chair)

Richard Drax

George Eustice

Barry Gardiner

Neil Parish

Ms Margaret Ritchie


Examination of Witnesses

Witnesses: Jackie Atkinson, Director of Authorisations, and Anna-Maria Brady, Head, Biologicals Team, Veterinary Medicines Directorate, gave evidence.

Q178 Chair: Good afternoon and welcome. Thank you both very much indeed for participating in our inquiry into bovine tuberculosis vaccination. Could I ask each of you to introduce yourselves and give your position for the record?

Jackie Atkinson: I am Jackie Atkinson. I am the Director of Authorisations at the Veterinary Medicines Directorate, which is an executive agency of the Department for Envirionment, Food and Rural Affairs (Defra).

Anna-Maria Brady: I am Anna-Maria Brady and I am Head of the Biologicals Team, which is the group that deals with assessing veterinary vaccine applications.

Q179 Chair: Thank you both very much indeed for participating. Can I just ask a general question about the European Commission’s approach to vaccination? Do you think the Commission’s approach is consistent regarding the bovine TB cattle vaccine and the potential sheep Schmallenberg virus vaccine?

Jackie Atkinson: That is probably going outside the VMD’s remit. Our role is in authorising veterinary medicines. In terms of deployment and whether you declare a disease as one that warrants restrictions on vaccinations or warrants trade constraints, that falls outside the VMD’s remit.

Q180 Chair: If it is a notifiable disease, would that help expedite a vaccine?

Jackie Atkinson: In terms of the timescales for dealing with an application for a marketing authorisation, there are a number of factors that affect that. Would it be helpful to set the scene a little bit for marketing authorisations and timescales?

Q181 Chair: I will ask the question in a different way. If you take the Schmallenberg vaccine, for example, what does processing an application for marketing authorisation involve?

Jackie Atkinson: I will take you through the steps. The first thing to say is that Schmallenberg is an emerging disease. The type of application that we are dealing with is called a provisional marketing authorisation. This is a UKbased scheme that is intended to allow the company to apply for this type of provisional marketing authorisation, which would allow them to market the product while they continued to generate all the data they would need for a full marketing authorisation.

As has widely been reported and has now been confirmed in a statement, Merck Sharp & Dohme (MSD) submitted a provisional marketing authorisation application to us at the end of August. The first step in the process at VMD is that we go through a process called validation. It is really quite a simple process: we use checklists to do this, and it means looking at the dossier provided on quality, safety and efficacy, and looking to see that there is information in each of the sections provided. We do not make any judgment at that stage about whether the data is adequate; we are just making sure that everything is there that will allow us to proceed with our assessment.

So we did the validation of the MSD application. There were a few things that were missing-for example references; unless we have the references we cannot do the full assessment, so they had to provide those. Then, by the middle of September, their application passed validation. In terms of the next stage in the process, we do an assessment. We initially assess all the data and we produce an assessment report. In that assessment report we develop a list of questions for the applicant.

We went through that process and sent the questions to the company at the end of November. We then waited for them to compile their responses and put all the information together. We got a response from them at the end of January. To highlight something, during that period of time, a lot of people were asking what VMD were doing. In fact we were waiting. It was very helpful that MSD-because of the interest in this and the problems of some misinformation-allowed us to put out a statement about the timings. This is not something we can usually do because it is commercially confidential.

So we received the responses to the questions at the end of January. We are in the process of assessing those responses now. Can I now talk more generally about the process rather than this specific application?

Q182 Chair: Yes. It would be helpful if you could give the Committee a timeframe that showed whether this was unique, or whether it was fairly typical of how long the process would be to bring an application of marketing authorisation from start to finish.

Jackie Atkinson: In terms of the company bringing forward their application to VMD, they were very quick. The disease was really only recently identified, so they were very quick in bringing forward their application. In part they were able to develop a vaccine quite quickly because there were a lot of similarities to the blue tongue virus vaccine, so they were able to adapt their technology and respond quickly. The company were very quick in developing a vaccine and pulling the data together. In terms of our processes, we completed our initial assessment about three weeks earlier in the process than we would usually.

Q183 Chair: You have not said how many months.

Jackie Atkinson: It took us 70 days to assess the application from passing validation to reaching our conclusions from the initial assessment and sending questions.

Q184 Chair: Will there have been trials of the vaccine? When it comes to market authorisation, what stage is the vaccine at?

Jackie Atkinson: When the data package was submitted to us, there was supporting data in there. Perhaps AnnaMaria could say a little about the type of data we had at the outset.

Anna-Maria Brady: This was an application for a provisional marketing authorisation. This scheme is there to allow a response to a situation of need. Therefore, the data that would come forward would not be as extensive a data package as one might expect for a full marketing authorisation. There are certain data derogations that are acceptable, given that the product will still be at a stage of incomplete development. It will be very near full development but it will not be at the stage that would normally be acceptable for a marketed vaccine for a full MA package. So in terms of efficacy, one might expect that there would be little or no information on the duration of immunity, because those are longerterm studies. The sort of data package that will be provided is based on laboratory trials, mainly, which can be conducted as proof of principle of the action of the vaccine. There are also unlikely to be field trials for such an application because, again, those are longerterm investigations.

Q185 Chair: I am just a little bit concerned. When it is given marketing authorisation, is it at that stage that the company would proceed to do field trials?

Anna-Maria Brady: We will assess the application in terms of an overall benefit/risk assessment, taking account of all the information that is there. A provisional marketing authorisation is granted for a very limited period of time. There will be conditions put upon it to generate further information by which to upgrade it to a full marketing authorisation.

Q186 Chair: But it will not have been tested on an animal at that stage?

Anna-Maria Brady: Yes, it will have been tested on an animal. It will have met key safety and key efficacy parameters.

Q187 Neil Parish: So this year, have sheep and cattle been given the vaccine to know whether they have then been infected or not? What stage are they at?

Anna-Maria Brady: I do not think we can really go into the details of the data package because that is a commercially confidential issue.

Q188 Chair: We will respect that, but are you able to hazard a guess at a date when the Schmallenberg vaccine might be available?

Jackie Atkinson: I can take you through the next steps in the process and then give you an indication. We have the responses in. They have to go to our Biologicals Committee, which involves people from VMD, other Government departments and also independent experts, if we consider that necessary. That is the step we are at now. We take a decision at that stage about whether we need to go to the Veterinary Products Committee, which is an independent committee, for advice. I would say, with this particular type of vaccine, because it is very similar technology and issues that we have dealt with before, it is unlikely we will go to the Veterinary Products Committee.

The next stage will be sending a final list of questions to the company, and it will depend how long they take to answer those questions as to the timescale for us making a final decision. Whether our decision is positive depends on what they tell us in those answers. I would put it in a more general context and say, with a provisional marketing authorisation application such as this, if the company is responsive, fairly quickly, to dealing with our questions and deals with them appropriately, then 10 months from start to finish is a reasonable timescale. If we think about the period of risk and when we want the vaccination to be used, which will probably be in early autumn-September-whilst I cannot say it will be guaranteed that there is going to be a provisional marketing authorisation at that stage, it could be the case. It depends how the company deals with the questions that we put to them, when we put them to them.

Neil Parish: So it could be this September?

Jackie Atkinson: It could be.

Q189 Chair: But that is for the next stage. That is when it would actually be available for use on animals?

Jackie Atkinson: That would be when we would be able to issue a provisional marketing authorisation. That means that it can be administered and used. The company are required to do further work but it would be used for vaccination.

Q190 Chair: When does the provisional marketing authorisation become a permanent marketing authorisation?

Jackie Atkinson: When we grant the provisional marketing authorisation we tell them exactly what additional data we expect them to generate to get a marketing authorisation. It will depend how long it takes them to do that work to apply to convert it to a full marketing authorisation. There is an example with the blue tongue virus vaccines. They were originally provisional marketing authorisations and in the meantime they have done the work and most are now converted to full marketing authorisations.

Q191 Chair: Is the process and the timescale the same if it is from the public sector, through the Animal Health and Veterinary Laboratories Agency (AHVLA), or from the private sector through a company?

Jackie Atkinson: When we are dealing with an application, the interactions we have with the applicant, the way we approach the assessment, the rigour and robust approach to our assessment is the same whether it is Government or the pharmaceutical industry making the application.

Q192 Ms Ritchie: Do you liaise with potential applicants, such as the AHVLA, before an application is made, in order to ensure that all the relevant information is provided from the outset and the risk of delay is therefore reduced?

Jackie Atkinson: We always encourage applicants, whether they are industry or Government, to come and talk to us in advance. We encourage them to do that as soon as possible because if they come and talk to us just before they submit the application, it is really too late for us to help them get the right data package together. Perhaps my colleague can say a little bit about some of the interactions we had with AHVLA in the lead-up to the cattle Bacillus Calmette–Guérin (BCG) application.

Anna-Maria Brady: Since 2000 we have been involved in meetings with AHVLA and other stakeholders. Between 2000 and 2007 there was a TB Steering Group, which VMD staff took part in, giving regulatory advice. After that we had meetings with AHVLA as the applicant, giving them presubmission advice both on the badger vaccine and the cattle vaccine. We have had about 25 meetings since, between 2000 and 2011.

Q193 Ms Ritchie: Regarding the BCG cattle vaccine, what further information did you request from AHVLA in November 2012, and why was it not provided at the outset?

Anna-Maria Brady: Actually, we requested the information in June 2012 and they responded in November 2012.

Q194 Ms Ritchie: Can you provide us with an assessment of why they were four to five months in providing that information?

Anna-Maria Brady: In terms of the normal timescale, it is up to the applicant to take the necessary time to answer the questions. We would normally anticipate that six months is a reasonable timescale to respond to questions and they responded within that timeframe.

Q195 Ms Ritchie: Defra announced that the assessment process for BCG cattle vaccine may take up to a year. When do you expect to conclude your work?

Anna-Maria Brady: We are in the final stages of our work. My colleague has already referred to the Veterinary Products Committee and the application has been considered by that committee recently. We are dealing with the final questions from that committee to be sent to the applicant.

Q196 Ms Ritchie: Can you provide an estimated timescale in relation to that?

Anna-Maria Brady: Again, that is going to be up to the applicant, in terms of how they respond to the final questions.

Q197 Ms Ritchie: Will you be pursuing the applicant in that respect?

Anna-Maria Brady: We do pursue applicants. We have to take the practicalities into account around the questions we have asked. We do, in our own organisation, have timescales that we consider acceptable for responding, and we will pursue in those times.

Q198 Neil Parish: In 2010, Defra said they aimed to have a vaccine and differentiating infected from vaccinated animals (DIVA) test licensed by 2012 but they could not be used in the field before 2015 due to the need to change EU legislation. Did the Government consult you on the indicative timetable for the availability of the vaccine and how you update the timescale of the whole thing?

Anna-Maria Brady: I am not entirely sure that that question is within our remit to answer. That is really for the applicant to address in terms of the timescale they have put on the development of the product.

Q199 Neil Parish: You are the licensing authority, are you, or what?

Anna-Maria Brady: Yes.

Q200 Neil Parish: Let me rephrase the question then. Are you able to license a vaccine for use in this country if it is not allowed to be used in the EU?

Jackie Atkinson: The situation at the moment is that European legislation and also UK national legislation says that where there is a prohibition on use, we cannot issue marketing authorisation, nor are we able to issue a provisional marketing authorisation. We have known that, and Defra has known that, so we have always worked on the principle that our assessment will be giving an inprinciple decision; we would not actually be able to take it all the way through to the issue stage. My understanding was that the goal was to have VMD’s assessment of the data to be able to then talk to the Commission, with that robust assessment of quality, safety and efficacy to take to the Commission as a basis to take forward a discussion in terms of changing the legislation. The recent Commission letter has changed things around from what was expected in terms of the process. The output from the Veterinary Products Committee will be a list of questions. We are going to break the list down to the questions that we would need to issue an inprinciple provisional marketing authorisation and the extra data we would expect to see for a full marketing authorisation, and we also plan to include a list of questions that will explain what would be required to get an animal test certificate. To explain, to conduct field trials in the UK it is necessary to have an animal test certificate. We think it will be helpful to set out exactly what will be required in order to proceed with that.

Q201 Neil Parish: When Defra came up with the original idea in 2010, when they said they aimed to have a test licence by 2012, did they get that information from yourselves? Where did this information come from, for them to make the statement?

Jackie Atkinson: Through these regular meetings there will be discussions on usual timescales and what might be reasonable timescales from start to finish in terms of reaching a decision on a particular authorisation. That was only around inprinciple decisions, not actually being able to use the vaccine itself.

Anna-Maria Brady: I would point out that we did not actually receive the application until 2012. So in terms of timescale before 2012, that is in the applicant’s hands.

Q202 Neil Parish: Defra are now saying that the use of the vaccine is many years away. Where has this change of tack or change of thought come from? Is that an unfair question?

Jackie Atkinson: I think there may be others who are better placed to answer that question than VMD.

Q203 Neil Parish: Would you like to add anything, Ms Brady?

Anna-Maria Brady: I have to say that the development of the vaccine is a complex process.

Q204 Neil Parish: In fairness, it was still a complex process back in 2010. Why is it more complex than it was, or why did they come to that conclusion then?

Anna-Maria Brady: That question has to be directed to the applicant.

Q205 Chair: We are coming on to Europe now, but we learnt yesterday that the Commission is looking at amending animal health legislation and bringing out a framework regulation. Would you, as a licensing authority, be consulted on such proposals as to how they will impact on yourselves and animal health in this country?

Jackie Atkinson: We certainly would not lead on animal health law.

Q206 Chair: No, but would you be consulted?

Jackie Atkinson: Colleagues in Defra would highlight to us specific aspects that could be relevant. So we would have input to that process.

Chair: That is helpful, thank you.

Q207 Barry Gardiner: Are you surprised at the Health Commissioner’s request for more studies to address food safety concerns with the BCG cattle vaccine? How would that affect your work?

Jackie Atkinson: In terms of our assessment, we identified issues around consumer safety, relating to both meat and milk. Those questions were put to the applicant. We have seen those responses and formed a view on them. The Veterinary Products Committee has largely supported those views.

Q208 Barry Gardiner: What are the views? Do you want to set them out for the Committee?

Jackie Atkinson: In terms of further information being required, our views are fairly well aligned with the Commission views on where additional data is required. So, from our point of view, further information and assurances on human safety are required.

Q209 Barry Gardiner: How does it affect your work? Have you taken that into account so that it does not affect your work? Or do the Commissioner’s requests here impact on you at all?

Jackie Atkinson: The Commission letter is very recent, so we had already formed our views on where the deficiencies were in the data, put them to the company and were already part way through assessing responses when they arose. We read them with interest but they did not change our own views.

Q210 Neil Parish: In their tentative timetable, the European Commission have earmarked 2016-17 for the cattle vaccine to undergo a marketing authorisation procedure. From what we learnt yesterday, it might be further away than that. Why does it take so long and how does that fit in with the work you are trying to do? Also, the Commission seems to want the test to take place outside the EU rather than inside.

Jackie Atkinson: The Commission’s timetable in terms of applying for a marketing authorisation envisages the field trials being conducted first. They give an estimate of how long it would take to do those studies. The duration of your study will depend on what you want to prove. A study could take five years but you could design a study for one or two years instead. The Commission timetable was only indicative in that sense.

Q211 Neil Parish: You would not know, with respect, how long the vaccine would work if you did the test over only one or two years. You would not know whether you had to inject each year or what, would you, if you did it only over one or two years?

Jackie Atkinson: In terms of getting a full picture, with a longer study, you may get a longer duration of immunity. Are they not usually proven in the laboratory?

Anna-Maria Brady: It would be a mixture. The field trials that are being alluded to in the discussions that have come forward are extensive field trials that will not just be investigating things like duration of immunity. They will be looking at many aspects in the field that have not been examined yet, because we have only seen laboratory data, effectively.

Q212 Neil Parish: Are you proactive with the EU Commission or not over this issue? Or is it not your role to be proactive?

Jackie Atkinson: On the particular aspect of changing the legislation and deployment of vaccination, that is not an aspect we liaise with the Commission on.

Chair: I think we are moving onto that now, if we may.

Q213 Barry Gardiner: Defra said that they would need advice from the Commission, suggesting that validation of the DIVA test by the World Organisation for Animal Health (OIE) and an opinion on cattle vaccination from the European Food Safety Authority might be prerequisites for any Commission proposal that would provide a legal basis for cattle vaccination. How might you be involved in the UK efforts to change EU policy regarding a BCG cattle vaccine?

Anna-Maria Brady: Would it be useful if I set the scene on the DIVA aspects that we have seen?

Barry Gardiner: Please, yes.

Chair: I think we understand, but you might just spell out what the DIVA test is. People might think that we are the divas, being the politicians.

Anna-Maria Brady: Basically, the DIVA approach is to differentiate a vaccinated animal from an infected animal. This is a key necessity for a vaccine being used where there is surveillance for a disease and, in the case of cattle tuberculosis, it is a statutory surveillance scheme. So the ability to differentiate an infected from a vaccinated animal is a key need. In terms of this vaccine, they have incorporated that approach within the vaccine because the strain of the vaccine differs slightly from the wildtype infection organism. It is possible to exploit that difference in tests to differentiate.

Part of our remit in examining a vaccine that comes forward with a claim for the DIVA approach is to ensure that any claims that are made around a DIVA approach are scientifically valid; if it is based on the structure of the vaccine strain organism, that that is scientifically valid; and that any test needed for use in the field is a valid test. That is our remit and we have seen that information and made an assessment of it as it stands.

Q214 Barry Gardiner: For example, would you be involved in discussions with the European Food Safety Authority?

Anna-Maria Brady: We would not be directly involved in those discussions, no. This is a national application and therefore we are assessing it on a national basis. Because there is statutory legislation in the UK and Europe underpinning cattle tuberculosis surveillance, that involves the European scenario but that is not within our own remit.

Q215 Barry Gardiner: What do you think the key obstacles to changing EU policy on a BCG vaccine are?

Anna-Maria Brady: I do not think that is for me to comment upon. It is not within the remit of VMD.

Q216 Barry Gardiner: Let me ask you a slightly different question then. If you heard the evidence from yesterday, it was suggested that this is a problem of cattle movements and improved biosecurity, and the vaccine, in their eyes, does not seem to be the nub of this. Do you ever feel that you are labouring in the vineyard in vain?

Anna-Maria Brady: Again, that is not for me to say. As a regulator, my role is to assess applications we receive. We decide whether they are valid or not. If it is a valid application, it arrives in my team, and our role is to assess it against the legislation.

Barry Gardiner: Beautifully deflected.

Q217 Chair: I referred earlier to the animal health framework regulation. We were told by Mr Van Goethem that he thought this would make the application for a vaccine, and for the changing of the law at the European level, easier. Would you have a view about that? No? All right.

Q218 George Eustice: I will bring it back to technical veterinary things. I want to pick up on what Neil was saying earlier because it is relevant to this. You said that you effectively concurred with the EU that there were gaps in the knowledge about the current BCG vaccine. Do you concur about the timescale needed to research those gaps? Is it a decade that we need to research those? Based on your experience looking at other vaccines, such as Schmallenberg where we can do it in 10 months rather than 10 years, could we fill those gaps in, say, two years?

Jackie Atkinson: The point is that the only bit we could comment on is the next stage, which is the identified need for a field trial. I have to say that I took a different message from the Commission yesterday. I actually thought that, by referring to the Commission letter, their expectation is for field trials in the EU. I know they mentioned maybe using studies outside the EU but I think they were really thinking of those as supportive studies. At this stage we can only look to the next step, which will be a field trial in the UK with an Animal Test Certificate. It comes back to the issue of how long that will take. It depends what people want to prove in that study. It is all around the design of that study. That will dictate the length of that study and the subsequent steps. The Commission really need to see that robust evidence. My view is that what they are looking for is that concrete evidence before them, which says, "Yes, this is a safe and effective vaccine". Until they have that, the argument is rather theoretical for them.

Q219 Chair: May I put it another way? The Commission clearly said yesterday that they want to have field trials first then marketing authorisation. What you just told us, in relation to Schmallenberg virus, was that you do it the other way. How are we ever going to get around this circular argument? Does what the Commission is saying invalidate the work you have already done?

Jackie Atkinson: The big difference is that with Schmallenberg there are no restrictions on vaccination. That means that we can issue a provisional marketing authorisation, so people can continue to generate field trial information in the UK while the product is used. The difference with the cattle BCG is this prohibition, which means that, even if we reach the point where we say that we are very happy to issue a provisional marketing authorisation, the law prevents us.

Q220 George Eustice: Where does that come from, though, that prohibition?

Chair: Is it from the Commission?

Jackie Atkinson: The prohibition is in the European legislation.

George Eustice: Why does it not prohibit the Schmallenberg one if there is no more evidence-

Q221 Chair: I put this to you, as I put it to the Commission yesterday. Schmallenberg exists in just about every European country. It started in France and the Benelux countries. For the moment it is primarily the UK and Ireland that have high incidence of bovine TB. Do you see any correlation in the way they are approaching vaccination here?

Anna-Maria Brady: I think you have to take the wider context. Cattle tuberculosis is a zoonotic disease; it can be transmitted to humans. That is partly why there is statutory surveillance.

Q222 Chair: But we do not know about Schmallenberg virus, do we? Is it not a little premature to draw that conclusion?

Anna-Maria Brady: Possibly, but we know what we know. We do not know about Schmallenberg, as you say. It is an emerging disease and the historical scientific context around it is still to be explored, in terms of the longerterm effects. We do know a lot about tuberculosis. That is why there are such strict provisions around tuberculosis. The vaccine we are looking at is a live vaccine for use against a zoonotic disease that has statutory surveillance. The requirements around that vaccine are much greater than around a disease such as Schmallenberg, which is not notifiable and there are no legal restrictions around it.

Q223 Chair: Could you just respond a little more fully to Mr Gardiner’s question about the Commission seeming to think that bovine TB was all down to cattle movements?

Anna-Maria Brady: I do not think that is within our remit to comment on, and I would not have the personal knowledge to comment on it.

Q224 George Eustice: I want to come back to the point I raised earlier, because this is a key point. Leaving aside what the European Commission think, you agree with them on what the gaps in the knowledge are, but given that you know what the gaps in the knowledge are, are you not in a position to judge how long a field trial should take? Do you know what type of field trials are necessary to fill those gaps?

Anna-Maria Brady: We know what the gaps are.

Q225 George Eustice: What sort of work is needed to fill those gaps?

Anna-Maria Brady: We are a regulatory authority that assesses the data and the gaps. It is for the applicant to make the decision about how they address those gaps because they have to put the financial resources into addressing those gaps. While we are happy to indicate the knowledge that we need to see, we cannot actually do more than that.

Q226 George Eustice: I understand that, but having seen lots of other vaccines going through, surely you must, just by your experience, have a sense that this is probably a year or two years, rather than 50 years-just a ballpark idea. Is it 10 years? Are the Commission right that it is a decade of work?

Jackie Atkinson: It does come back to the issue of what they want to prove in the study.

George Eustice: You know what they need to prove.

Jackie Atkinson: If they want to prove something simple, and a short duration of immunity, then there will be a shorter study. If they want to demonstrate that it is going to prevent transmission and ultimately allow eradication, taking account of all the different control approaches that we might have in the UK and all the different elements, such as DIVA, it is a much longer study.

Q227 George Eustice: Is the longer study what you want?

Jackie Atkinson: No, I have no views on whether it should be a short or long study. I am entirely neutral on that.

Q228 George Eustice: What are you trying to prove? Are you trying to prove that it is durable or are you trying to prove that it is not a public health-

Anna-Maria Brady: We do not try to prove anything; that is for the applicant to prove.

Q229 Chair: You will be familiar with the letter from Commissioner Borg of 14 January to the Secretary of State, Owen Paterson, on the bovine tuberculosis eradication programme 2013 and the conditions that were set out therein. Would you say that these are reasonable conditions, or are they just pushing the deadline further and further away about when a vaccine might be available, particularly in the annexe where they set down the conditions and talk about "practical experience on the use of the vaccine and DIVA test under the new rules"? Does it seem reasonable to you that it can be met within a fiveyear timeframe?

Jackie Atkinson: As to the first step requiring EU field trials and whether that is reasonable, yes, we agree that is reasonable and necessary. Is it reasonable in terms of saying 2015-16 may be the duration but then, equally, they talk about two to five years? I am sorry, but it comes back to the question of what you are trying to prove in that period of time. That will affect the length of study. I agree there is a need for field studies, but-

Q230 Chair: I presume that we are trying to prove that the vaccine is efficient?

Jackie Atkinson: When we receive an application, the applicant tells us what they want to put on the labels. For a vaccine it might say, "This will prevent disease". Then they will have to design a study to demonstrate prevention. Equally, they may say it would be enough, and I am not suggesting it is in this case, to have a claim to reduce a particular clinical sign, linked to a particular disease, and then they will design a study to prove that point. It does come back to what they want to prove. If it is ultimately linked to eradication, they want to prove prevention, I would anticipate. That is something that is harder to prove.

Anna-Maria Brady: We also need to bear in mind in this particular case that they have to address the DIVA aspects in the field as well. So the field trial or field trials will need to look at various aspects of the claims around the vaccine. They will not just be the claims around efficacy per se; they will also be around the DIVA aspects. That is liable to be quite a complex trial.

Q231 Chair: Is it provable?

Anna-Maria Brady: I cannot say.

Q232 Neil Parish: What discussions do you have with your equivalent bodies in other member states about vaccines? On TB vaccine, are you talking to the Republic of Ireland, as they have a particular interest on this? On Schmallenberg, surely there must be work being done all across Europe, because of the amount of Schmallenberg disease across Europe. Do you have any contact with the appropriate bodies in other member states?

Jackie Atkinson: We certainly have a European network where we talk on a regular basis to our counterparts on issues. Taking the Schmallenberg example, it is possible for European applications to go forward, in which case there would be a co-ordinated assessment. Until that happens, there will not be those types of discussions in the context of an application. The scheme that we are operating is entirely a national scheme, so we would not be liaising with them in terms of our assessment and the output from that. Informally, though, we have quite a good network and we would usually get some intelligence and feedback if others are dealing with a similar type of application under a national scheme. I would say, in terms of Schmallenberg, at this stage we are not getting any sense from others that they are doing something similar, but I cannot guarantee that they are not.

Q233 Neil Parish: With Schmallenberg I think they have had it for nearly three years in parts of Europe. Are you surprised that we are now coming forward with a vaccine and it has not come forward from other member states in Europe?

Jackie Atkinson: I do think there is a benefit in the UK legislation because we have provisional marketing authorisations, which is a national scheme. We know that other countries look to us and like that model. In fact, the Commission is revising veterinary medicines legislation and looking at some of the lessons to be learned from that. The parallel is bluetongue virus vaccine. The UK was the first country to have a provisional marketing authorisation to allow the use of the vaccine. When it went through the European procedure, it took considerably longer-some 12 to 18 months later.

Q234 Neil Parish: On the TB vaccine, what is the Republic of Ireland doing? Are they doing work on a vaccine? What is happening there, do you know?

Jackie Atkinson: The application we have is only a national application. It is a national marketing authorisation application. The system is such that it is not possible to put marketing authorisation applications into more than one country without there being a co-ordinated assessment, so we know there cannot be an application in Ireland from the AHVLA because the law would require us to have a joinedup approach to our assessment. It is only a UK marketing authorisation application at this stage.

Q235 Chair: A company wishing to introduce the vaccine and market it across 20howevermany member states would have to go through a similar exercise in every member state. What would the cost be?

Jackie Atkinson: There is quite a complex landscape of different procedures. In the scenario where a vaccine is first authorised only in the UK, and then the company wants to place it in other markets, there is something called a mutual recognition procedure. Other countries look at our assessment report and are asked to recognise our decision. There are also other procedures. One is called a centralised procedure where a single application and all countries work together on a single decision. Then there is something that sits somewhere between the two, where everyone works from the outset together in a co-ordinated way. The cattle BCG and Schmallenberg are UKonly applications at this stage.

Chair: Thank you; that is very helpful.

Q236 Richard Drax: Is that what a limited marketing authorisation is?

Jackie Atkinson: At the top level, there are exceptional marketing authorisations. There are two types of provisional marketing authorisation; one is a stepping stone to a full marketing authorisation. Then you have a limited marketing authorisation, which is the other arm. A limited marketing authorisation is, again, a UK scheme, and the idea is that there are some markets for certain species and disease combinations where a company or Government are never going to go away and do all those studies, because it is unrealistic or impractical. A limited marketing authorisation is recognising that you have a product where the benefits outweigh the risks but people are not being forced to go away and do more studies to convert it to a full authorisation. The badger BCG is a limited marketing authorisation.

Q237 Richard Drax: Presumably, from what you have just said, it is unlikely to go on to receive full marketing authorisation unless it is such a success that everyone wants a piece of it or it gets exported elsewhere, or what?

Jackie Atkinson: Yes, it will be for the holders of the authorisation to decide whether they want it as a full marketing authorisation and whether there is a benefit in doing the additional work required to obtain a full marketing authorisation. From our point of view and from the VMD’s point of view, a limited marketing authorisation means that there is an annual reassessment. In that, we look at two things: whether a new product has come along with a full marketing authorisation in the meantime-which is unlikely in this scenario-and what type of side effects have been reported to us from use of the vaccine in the field. That would look at: have there been any problems in badgers as a result of the vaccine and have there been any problems in people as a result of the vaccine? We look at that information and, if that is all okay, it continues until the next annual reassessment, which we trigger.

Q238 Chair: Is there a normal lifespan for the marketing authorisation, if it is a full marketing authorisation?

Jackie Atkinson: A full marketing authorisation is initially issued for a fiveyear period, after which it is renewed. Beyond that there are no further renewals unless there are concerns. For a limited marketing authorisation, while we can set a renewal period, we do not have to because we have this annual process, and in the case of the badger authorisation there is no renewal date set for that, so it will just be subject to this annual process.

Chair: May I thank you on behalf of the Committee? You have been extremely helpful and patient with us. Thank you very much for participating and being so generous with your time. We are very grateful. Thank you very much indeed.

Examination of Witnesses

Witnesses: Carl Padgett, Past President, British Veterinary Association, and Neil Blake, Chairperson for the British Cattle Veterinary Association’s Government/Agencies Liaison Working Group, gave evidence.

Q239 Chair: May I welcome you both most warmly? Could I ask you, for the record, just to introduce yourselves and give your positions?

Carl Padgett: I am Carl Padgett, past President of the British Veterinary Association and veterinary practitioner.

Neil Blake: I am Neil Blake, Chairperson of the BCVA Government/Agencies Liaison Working Group, and a farm animal veterinary practitioner in north Devon.

Chair: We are very grateful to you for participating in our inquiry. Before we proceed to questions, we have a little bit of housekeeping. I should state that I was your guest at dinner last night, just so it does not look like we are too cosy.

Neil Parish: I am an associate or an honorary member of the BVA, so I had better declare that.

Q240 Chair: You will have heard the previous speakers and probably followed some of the discussions yesterday. What would you say was the normal timeframe, in your experience, for a vaccine to reach the marketing stage?

Carl Padgett: That is a difficult question to answer for practitioners who are not directly involved with vaccine development. Often we do not know of many vaccines until they get to the nearmarket point and some of the marketing activity starts occurring from those manufacturers. Also, vaccines vary and diseases vary so there is no stock answer. In general, a rule of thumb I have always had is that bacteria are much larger, bigger, more complex organisms than viruses, and so making a vaccine to find the protective elements of bacteria is a lot harder. That is a general rule of thumb I have used.

Q241 Chair: Do you believe that the European Union has been completely consistent in its approach to vaccines, if you look at the Schmallenberg virus and the bovine TB for cattle vaccine?

Carl Padgett: From the activity I have seen, I have no reason to believe they are being inconsistent.

Q242 Chair: Something you say in your written evidence is that vaccination can play an important role in eradicating TB. However, a policy of vaccination should take place alongside other control measures. Would you just like to elaborate on that a little bit?

Carl Padgett: As with many other diseases, vaccination itself is rarely the pure answer. We have to adopt as many of the relevant control mechanisms as possible in the disease mix that is happening in whatever species are actually harbouring the infection. So vaccination is certainly one tool; it is available and we should learn how best to deploy it, to use it to its best effect. However, it is very rare that that would be the only answer in any disease I am aware of. Other measures need to be employed.

Neil Blake: I would add to that in terms of a similar disease, paratuberculosis in cattle, where you have a vaccine that is potentially available but you would use all other control measures to address the presence of infection before you go down the route of vaccination. It would be an aid to control; it would not be something you rely on. Generally speaking at the moment, with paratuberculosis, you would use a vaccine for damage limitation, rather than as something from which you would expect to achieve control and eradication from a herd.

Q243 Chair: How accurate do you think the current tuberculosis skin test is?

Carl Padgett: We can go from the studies that Defra have the figures for. If we look at sensitivity, spotting those animals that are affected, there is a range of 60% to 80%. The more you undertake the tests-on lots more animals, on a full herd, for example-the sensitivity goes up because the more it is repeated, the more chance there is of finding the infected animal, so sensitivity increases. It is highly specific so you do not get many false positives with that particular diagnostic test.

Q244 Chair: The Commission said yesterday that, in their view, they thought it was 99% effective. You are saying 80% effective.

Carl Padgett: Specificity is 99.9% or greater. That means that, if you took 100 negative animals, 99 of them would come back as truly negative and one false positive might occur, to agree with a 99% figure.

Q245 Chair: Can the result be affected by another disease in the animal or the fact that the animal was pregnant? Would that have an implication for the skin test?

Carl Padgett: A number of infections have been looked at. There is certainly speculation about the role of bovine viral diarrhoea (BVD, which alters the immune status of the herd involved. So, are we getting the same reaction to the skin test when it is effectively an immune reaction that we are testing for? There is some work from the University of Liverpool recently that indicated the role of liver fluke in reducing the sensitivity of the test.

Q246 Chair: Do you think that non-reactive cattle are a source of transmission of TB?

Carl Padgett: With the characteristics of the test we have at the moment, it is highly likely that some herds have infected animals left at the end of the testing procedure, yes. Indeed, some work from Cambridge at the moment is looking at that. They published something saying along of the lines of one in four or five cleared herds may still have infected animals in them.

Q247 Chair: Do you think the skin test should be used in conjunction with other tests, such as the ancillary gamma interferon diagnostic test?

Carl Padgett: I think we have to try to deploy it as best we can within the armoury of other diagnostic tests, yes. One thing we need to remember about the skin test is that it has served worldwide, although in slightly different patterns and protocols for use, as a very good diagnostic and eradication tool. If we look at lowinstance areas of the country at the moment, it serves well there in the eradication of infection and the little foci of infection that appear. So it is a very good test that can actually eradicate the disease when we are dealing with the infection in focused elements of individual herds.

Q248 Barry Gardiner: It must be an awful thing to have to tell a farmer that one of their herd has reacted as positive. It can really devastate that farmer’s livelihood, can it not?

Neil Blake: Yes, it can. It is a difficult conversation to have every time it happens. Unfortunately, in the last 10 years or so, it is happening with increasing regularity. Yes, it is always a difficult conversation and I suspect Farm Crisis Network, for example, are a lot busier nowadays than they used to be.

Q249 Barry Gardiner: That means that the pressure placed on vets not to report, particularly where the results are borderline, is a real pressure. It is a human pressure.

Neil Blake: With every disease on a farm you are working with farmers to try to alleviate the problems associated with that disease. TB is a statutorily controlled programme. You apply the test diligently and we are required to notify where we discover disease. That is what we endeavour to do. So, irrespective of the difficult conversations we have to have, we are pretty well trained in terms of delivering that bad news.

Q250 Barry Gardiner: You will be aware of the practice on Anglesey last year where they were suspended from testing pending the completion of retraining of the staff, because the audit of their testing had shown that they were not being as rigorous as they ought to have been.

Carl Padgett: I am not aware of the specifics of the case as such, but I understand the generality. Yes, quality assurance of TB testing is a major issue and we have to have measures and procedures in place that ensure the test is being undertaken to the best of the veterinary surgeon’s ability to give the best results. We have a population of veterinary surgeons who are no different from any other human beings. Some people unfortunately, as with any system, may cut the odd corner or two, or feel that they have the most expeditious route of delivering the test. We therefore have to have an independent quality control mechanism, developed more robustly and delivered to ensure that veterinary surgeons are testing to the best of their ability. My own belief is that most of them are.

Q251 Barry Gardiner: This is a very sensitive area, and I am trying to ask these questions sensitively because I respect the job that these guys have to do and it is a tough one. Wales has adopted an auditing programme. Should we have an audit of tests in England to ensure there is not an underreporting of TB reactors by vets?

Carl Padgett: We should have an auditing system in place, and indeed we are involved with helping AHVLA develop one that makes sure testing is done properly, rather than for the avoidance of underreporting.

Q252 Ms Ritchie: In your written evidence you state that you do not support the policy of trapping and testing badgers adopted by Northern Ireland. Why is that?

Carl Padgett: We do not support that policy in England and Wales at the moment, rather than not supporting it in Northern Ireland. In England and Wales, the modelling work that was undertaken for the Welsh Assembly Government actually showed that that was one of the worst options. That was largely because the diagnostics for badgerside testing have a low sensitivity of about 50%. So arguably, in simple terms, for every two infected badgers that are trapped and tested, one will be vaccinated and released and one will be culled and removed. So we still have the disturbance in the badger population from that proportion that has been culled. That can create perturbation. What you have actually done is release infected badgers back into that perturbed population. Potentially you could make the perturbation effect worse than removing badgers on a pure culling exercise alone; that is what the modelling showed. The potential difference in Northern Ireland is that the badger population is very different, so actually the modelling might come out with different sums. At the end of the day, it is a modelling exercise.

Q253 Ms Ritchie: I also understand that we are awaiting progress reports from the Department of Agriculture and Rural Development in Northern Ireland. Have you received any such reports as yet?

Carl Padgett: Not as yet, but I was talking with the Chief Veterinary Officer of Northern Ireland just the other week, when I was across in Belfast, loosely about that work. It is still ongoing, as far as I am aware.

Q254 Ms Ritchie: Do you have any idea when it is expected?

Carl Padgett: No.

Q255 Chair: Could I just put to you the number of tests carried out in 2001 and the number of tests carried out in 2011? In 2001 the total number of tests on herds was over 13,000. In 2011 that went up to 76,000. The total number of tests on cattle in 2001 was over 1 million. In 2011, the number of total tests on cattle was over 7 million. You may not be able to answer this, but why do you think there was suddenly a great increase in testing?

Carl Padgett: There are two aspects to that. One is the actual spread of the disease and infection. The infected area is getting bigger so that naturally leads us to move more animals from fouryearly testing to annual testing as infection is found. That means many more tests are undertaken.

The other aspect is that the riskanalysis procedures for actually classifying the herd testing intervals have expanded the annual area somewhat. That is to try to cover some of the concerns the Commission had that maybe we were not testing robustly across a wide enough area often enough, that we had too many fouryear testing areas butting up to annual areas. However, the decision made in this country was that it did seem a peculiar thing to do and it would be best for us to make the decision anyway to expand annual testing. That, therefore, has increased the number of tests being done, not just because the disease has spread but purely because a surveillance programme has been rolled out.

Q256 Chair: It has led to a significant number of slaughters. There were 6,000plus cattle slaughtered in 2001. More than 34,000 cattle were slaughtered in 2011. That will be a direct correlation with what you have suggested.

Carl Padgett: Yes, it would. There is an element of seeming to chase the infection outwards when we apply the Commission directive in terms of eradication to the letter. When we find an infection we move to the next farm along and find it again. So we are following that leading edge. Indeed, one of the focuses at the moment is to try to take a bit of a variation from the traditional way of rolling out surveillance testing, and try to jump in front of that edge.

Q257 Chair: Returning to what you said about the fact that any vaccination should be used alongside other control measures, can you think of any country that has eradicated bovine TB that has not addressed the reservoir in the wildlife?

Carl Padgett: If there has been a significant reservoir in the wildlife that has been maintaining the infection and the risk to cattle-so unlike the spillover hosts, where the infection will still spill out from the cattle population into another population, but it has no real epidemiological significance back to cattle; it is selflimiting and sorts itself out in that population-countries that have those infections have not necessarily addressed that wildlife host. Where you have a wildlife host that is a maintenance host, and infection is crossing backwards and forwards between the two and it is a significant reservoir, I am not aware of any country that has eradicated the infection without addressing that reservoir.

Chair: That is very helpful, thank you.

Q258 Neil Parish: Good afternoon. In your written evidence you cast doubt on the effectiveness of a badger vaccination policy in areas where TB in badgers is endemic, because the vaccine does not cure an infected badger and it still carries on spreading disease. How do we actually know where these areas are? Do we do testing of the badgers? Do we do enough? Do we know where the real infected areas of badgers are?

Neil Blake: Within AHVLA, certainly with the case of new breakdowns, there is an effort to try to identify the source of the breakdown. It is easier in terms of different spoligotypes, different strains of TB, which are isolated and they can maybe home in and determine whether it is to do with translocation movement of cattle. In terms of the endemic parts of the UK, that is more difficult to determine but the analysis that has come out of recent work associated with the randomised badger culling trial indicates that about half the breakdowns in those areas are attributable to infection from wildlife. Certainly what we see on the ground would support that. It is difficult to get absolute corroborative evidence to state that as a fact but it is certainly what we see on the ground.

Q259 Neil Parish: I take it that the badger carries bovine TB, so therefore, if a cow gets TB, you cannot necessarily tell whether that cow got the TB infection from another cow or whether it got it from a badger. Is there any way of telling that or not?

Neil Blake: Not at that stage, no.

Q260 Neil Parish: If you get a lot of breakdowns in a given area do you then test the badgers? Does Defra test the badgers? Does anybody test the badgers?

Neil Blake: Not that I am aware of. There has been work where you would collect data from road traffic accidents. There is the work associated with the RBCT that was looking at the prevalence of infections in badgers. On an ongoing basis at the moment, my understanding is that it is not widely undertaken.

Q261 Neil Parish: If farmers find infected badgers on their land or badgers that have died and are very emaciated and are likely to have died from TB, are they able to take them anywhere to get them tested?

Neil Blake: There is a system where they can report that. I am not aware of what proportion of those might then get investigated further. That is probably a question for AHVLA, rather than us in the field.

Q262 George Eustice: Before we leave badgers, obviously one of the practicalities is just in trapping and injecting them, which is itself quite a practical task. There has been previous talk about having some kind of oral vaccine. Is that realistic? Given that we seem to be in nevernever land in terms of a vaccine for cattle, is that something that could be done?

Carl Padgett: It is very realistic from the work that is ongoing. I do not know enough of the detail, again, because it is being developed in studies that are similar to the studies for the injectable vaccine. We have had oral vaccines for other diseases but again I go back to the difficulties of bacterial infections. There are challenges with making sure that we can deliver a BCG vaccine in a proper bait that will make sure the correct target animals eat that bait and it is not going out to other species and with whether it is safe for other species. There are other challenges there for an oral vaccine but if they could be met, certainly it would be a much more practical answer.

Q263 George Eustice: Are they easier to meet than a cattle vaccine, in your view?

Carl Padgett: I would not like to say. The challenges are immense on both sides.

Q264 George Eustice: I want to talk about the biosecurity and movement restrictions. The clear message we had from the EU Commission representatives yesterday was very much that the real problem we have here in the UK is that, since bovine spongiform encephalopathy (BSE), there has been less incentive for farmers to take proper care of hygiene issues. Also that, after foot and mouth, the restocking led to largescale movements of cattle, which was responsible, they said, and the culture we have of moving cattle around to large markets and that kind of thing was the real problem. You said earlier that you cannot deal with this problem just with a vaccine, which I understand. Is it possible to deal with it without a vaccine, just by sorting out these movement restrictions that the Commission said were the real cause?

Carl Padgett: I do not think it is. In the outputs of the Commission and their various visitations over the years, I have yet to be wholly convinced that the Commission fully understands some of the challenges we are up against in this country and in Ireland too, with the picture of TB that we have. I do not buy the BSE story and the foot and mouth story. If we take BSE, there was still an incentive domestically to remain free of TB, to ensure that trading was able to occur and not be locked up. So there is still an incentive there, regardless of the international element of the trade that was stopped at that time. It may be true that resources from AHVLA, Defra-the Ministry of Agriculture, Fisheries and Food at that time-were focused on getting rid of BSE. So maybe a little eye off the ball may have occurred, but not to the extent where we have allowed TB to stretch forever in front of us.

If we take foot and mouth, where testing did pause for a little while, while we were trying to concentrate our resources on getting rid of that disease in 2001, infection was transported with restocking, up to Cumbria for example. But the testing processes put in place immediately after those outbreaks had been found eradicated that infection in those translocated environments. So the testing process works when we have cattleonly breakdowns. What we have in a significant part of this country is a mixed reservoir of infection, with not only cattle but wildlife, which is providing an extra dynamic that testing alone in cattle is struggling to cover.

Q265 George Eustice: So their suggestion that other European countries solved this problem by following certain approaches to movement restrictions does not apply to the same extent, or is there anything further we ought to be doing on that?

Carl Padgett: We can always look at movement restrictions. We have to be as proportionate as possible. We could put in sufficient movement restrictions to kill the industry. What would that do for us in terms of having a future cattle industry if we just stopped all cattle movement tomorrow? It certainly would not stop all TB transmission tomorrow because we would still have the wildlife element coming in from outside. We can go all the way down that scale. We have to be proportionate. Whenever we identify an area of risk or behaviours that are risky, we need to try to challenge those behaviours and try to stop those movements that are occurring that are most risky. I will let Neil pick up on riskbased trading possibilities in a second. We do have to look at movements but, again, it is not the whole story.

Neil Blake: I was just trying to remember my thoughts on that as it was coming up. There are several aspects to your question. One is the reminder that, in the absence of wildlife reservoir infection, in the parts of the UK where we do not have that, we are able to get rid of TB with existing diagnostics. As far as disease translocation is concerned-the movement of disease with the movement of cattle-ever since 2006 we have enhanced the cattle controls. Premovement testing is there as an additional safeguard against that risk. It is not 100%, of course it is not, but it is an additional safeguard against translocating disease from one part of the country to another, so there is a lot of tightening on the cattle controls that have been put in place in the last six or seven years. Not all of those have been popular but most of them you cannot argue with from a disease perspective.

Alongside that, with riskbased trading disease transmission, TB is not unique in that regard. With all endemic disease there is merit in trying to reduce the risk of transmitting that disease from one herd to another via the movement of cattle. I would not view TB in isolation. I do not think we should ever view TB in isolation in that regard. To an extent, routine surveillance is probably better for TB than for some of the other diseases that are out there, because we do have premovement testing as a prerequisite for moving cattle from endemic areas.

Q266 George Eustice: Are you satisfied with the speed at which the AHVLA turn around test results? Does the Government have sufficiently robust data management to monitor the spread of the disease?

Neil Blake: Do you meant in terms of the general statistics or the specific breakdowns?

George Eustice: Basically, the data management system, so they know where problems are and where they have originated.

Neil Blake: From a practitioner’s perspective, there are problems with the flow of information and co-ordination of the programme. That is a belief that I have and I think it is a belief that is shared by many. We could improve. The passage of information could be improved on the current state of play. A lot of frustration for a lot of us is that we do not have consistent linking between AHVLA, ourselves on the ground and the farmer. It still is really quite a fragmented process. You do get some information in terms of the confirmation of disease on an individual farm. There is obviously a time lag. It is fairly straightforward if they find visible lesions, and there is a time lag in trying to culture that bacteria. On the bigger picture regionally and nationally, I would say there is room for improvement in terms of that passage of information and the ability to involve all in the process of TB control.

Q267 George Eustice: You mean by just making it much more available about which farms are infected?

Neil Blake: I think in greater involvement of local practitioners who have a real handle of what is going on on the ground. Wales is probably the best example of what could potentially evolve. They have much better and much more efficient use of local vets on the ground, in terms of biosecurity advice, not just in endemic areas but also in TBfree areas. You are trying to get in ahead of the problem again. You are trying to offer advice that reduces the risk of disease spreading and also advice to try to limit the damage of ongoing transmission of disease on the farm. For both of those elements there are, in my mind, very positive movements in Wales where they are looking to explore and make greater use of the vets on the ground.

Q268 Chair: I should know the answer to this but is the sixday rule part of the control restrictions for this or for BSE and foot and mouth? I mean the sixday rule that, if you take cattle through a red market, you either have to send them to slaughter or you take them home and you cannot move anything for six days.

Carl Padgett: It is effectively in place for hyperinfectious conditions such as foot and mouth. So it comes from the foot and mouth controls.

Q269 Chair: I know my farmers would like to see it lifted but do you think it is necessary that we keep it?

Carl Padgett: I think, with hindsight, if we had another outbreak of foot and mouth as explosive as the last one in 2001, and we had only just got rid of the sixday rule, we would rue the day we got rid of the sixday rule.

Q270 Chair: Could we not suspend it and then reimpose it?

Carl Padgett: I would answer that by asking how we would suspend it because we do not know when that incursion is going to happen.

Chair: I will let you loose on my farmers.

Q271 Ms Ritchie: Are some breeds of cattle more susceptible to bovine TB than others? If so, might this be down to habitat or genetics?

Carl Padgett: That is a very complex area and I am not a geneticist who has studied that in depth. There have been suggestions that dairy cattle breeds, for example, may be more susceptible, or lines within dairy cattle. When you look at all the different management practices in farms it is quite hard to tease it out and to actually apply any benefits from that across a whole industry to improve some degree of genetic resistance; I am not sure how practical that would be. So yes, academically, it looks like there is an indicator that there is some genetic resistance, but how practical it would be to utilise I am not sure.

Q272 Ms Ritchie: Have you seen any particular research in this area? I know you say you are not a geneticist but have you seen research and an evidence base that would suggest either direction?

Carl Padgett: I have been made aware of one output from the Roslin Institute, which suggested somewhere along the lines of 18% heritability in dairy cattle.

Q273 Neil Parish: I want to talk about other animals, especially alpacas, llama, outdoor pigs, deer and sheep. Should we be taking these breeds more seriously and what measures should we put in place? As far as I am aware, certainly for alpacas and llamas, you do not actually have to notify where you have moved those animals to. There is nothing really laid down. What is your view on these other animals? Have they potential to spread the disease? We have quite a number of alpacas and llamas in the West Country.

Carl Padgett: Do you want to pick that up directly with your West Country experience?

Neil Blake: There are concerns. We have made representation before about ensuring that some of those issues are addressed. However, the caveat is that, to date, in terms of the potential for the spillover hosts Carl was alluding to earlier, they are susceptible to infection and acquire infection, but they are not thought to be significant to the ongoing transmission. So yes, they are significant where they occur but are they significant in the general spread of TB? The data to date suggests that they are not of great significance in that regard.

Yes, I think there needs to be consistency in the application of the rules and regulations that pertain to bovine TB control but we still have to get things in perspective. By far the greatest risk is cattle and wildlife. It is sensible to focus most of our efforts and resources where the greatest risk is thought to be.

Q274 Neil Parish: You talked about wildlife; what about deer?

Neil Blake: They are locally significant rather than significant in the widespread area. We would recognise in parts of north Devon that there are local pockets where we might feel that they are of greater significance than others. Generally it is thought that levels of contact between deer and cattle are likely to be far lower than between badgers and cattle, so the potential for transmission between the species is lower. It would be way down the list behind badger and cattle interaction as a risk factor.

Q275 Neil Parish: Therefore you are saying that while some of the deer may well have TB, they are much less likely to infect cattle?

Neil Blake: That appears to be the case, but locally it can be significant. That is my understanding.

Q276 Neil Parish: I have one final question on alpacas and llamas. You have quite a lot of alpacas and llamas where they might take the male and transport them across the country. Are you still not worried that we do not really know where these animals are?

Neil Blake: I certainly did not say I was not worried about the movements. There are aspects of what goes on that need to be tightened up. There is the potential with translocation of undetected infection; of course there is. Knowing where these animals are going and having better information in that regard is going to be a help.

Carl Padgett: In an ideal, non-resourceconstrained world, I would love to have all species with similar compulsory arrangements as there are for cattle. But is that the best bang for our buck when we are in the situation we are in at the moment? I am not sure, given the risk scenarios Neil has just outlined. That does not mean that there should not be some responsibility taken for understanding the movements of these animals and recording them, so that we know where we are and are minimising the risk. If we do not even achieve that bit, what are we saying to the farmers who are being subject to controls and have breakdowns on their farms? Those farmers feel there is a level of inconsistency. It is not a level playing field. When they have that pocket of infection next door to them, it is a real risk situation for them, so they feel that the playing field is exceptionally unlevel. We have to deal with the argument about credibility in the system as well, and try to ensure that those species are dealt with appropriately but without diverting such significant resource that we are taking our eye off the main ball.

Neil Blake: We have personal experience with several outbreaks in camelid populations. It is a frustration and a concern but, again, I come back to the point I made earlier on about TB. It is not the only disease out there. It is better to offer biosecurity advice to any livestock keeper ahead of movements than for those movements to occur prior to that advice being given.

Q277 Neil Parish: Is it unreasonable to ask those with camelids to run a database, which can actually show the movements of those animals, albeit on a voluntary basis? Is that not possible or a good idea?

Carl Padgett: I think that is reasonable. I am not very closely in touch with the camelid world but I was of the belief that the camelid industry was looking at voluntarily trying to come together to do that kind of thing and take their responsibility on board.

Q278 Barry Gardiner: Trained members of the public are allowed to vaccinate badgers. Am I right in thinking that they are not allowed to vaccinate cattle? If not, why not?

Carl Padgett: The answer at the moment is because no one is allowed to vaccinate cattle, of course. If we take the general principle, I am not sure it is absolutely correct. The actual process of vaccinating an animal is a simple technical process. What we do not yet understand about vaccination of cattle is what other administrative recordkeepingtype certification issues may follow to ensure trade can continue to occur. It may well be that, at the end of all the debates on how best to deploy the vaccine as and when it becomes available, certification at the end of the process might have to say, "I vaccinated that animal by a veterinary surgeon" as the requirement for trade as a health statement. Then it would be the vets.

Barry Gardiner: Like horse passports.

Carl Padgett: Possibly, yes.

Barry Gardiner: They have not done a terribly good job, have they?

Q279 Chair: To be fair, I am assuming that every bovine that goes from the farm to market is passported currently and that passport goes with it.

Carl Padgett: It has a passport, yes.

Q280 Chair: So one certification procedure would be that you would mark it on that passport. Just to help the Committee, is there any one organisation that administers the passports for cattle? Which is that organisation?

Carl Padgett: It is basically the BCMS-the British Cattle Movement Service.

Q281 Chair: So the position with horses is different?

Carl Padgett: Very different.

Q282 Chair: How many do they have?

Carl Padgett: I think the last number was up towards 100. I would not swear to that but it is lots.

Q283 Chair: If the DIVA test was being employed, would you suggest that cattle would have to be tested every time they are moved, or would it be marked on their passport and that would be sufficient? I am just pursuing this idea of certification. If the DIVA test eventually is recognised, would it be a oneoff test or would it have to be tested every time the cattle was moved?

Carl Padgett: My understanding of the principle is that the testing procedures that are currently in place would still apply in vaccinated animals. The DIVA test would be used to differentiate those that actually react to that skin test to make sure that it was a natural infection and not a vaccinated infection, so it would be applied to those animals that were the ones causing concern. That is my understanding at the moment.

Neil Blake: Yes, that would sum it up pretty neatly. If we are moving into the realms of the DIVA test, the big caveat to it all at the moment is what we do not know; there is a lot more work that needs to be done to demonstrate the sensitivity and specificity of these tests, both the vaccine itself and the DIVA test. A worstcase scenario, for example, is if you skin test a positive animal that is a genuine reactor, which tests negative to the skin test. The things to overcome are: what is the status of that animal? In the worstcase scenario you have cleared an animal that is still a reactor. There is a lot more work still to be done.

Touching on what was said earlier, the complex nature of this bacteria and the complex nature of the diagnostics challenge should not be underestimated. One of the points we have been trying to get across is the need to manage expectations.

Q284 Chair: We are coming on to that. Do you have any indication at all of what the cost of the vaccine and the DIVA test might be?

Carl Padgett: No.

Q285 Chair: Is there a risk that it might be prohibitive for farmers and it could just be too expensive?

Neil Blake: It would come down. This comes back to the efficacy and confidence in a vaccine or a programme. With any vaccine I would be advising my client on a cost/benefit basis, and crucially on my confidence in the efficacy of that vaccine. All those questions and all those facts would come into play. When you look at the cost of delivering a programme or adding vaccination or DIVA testing into it, you have to look at the potential benefits. How effective is it going to be? Will it be associated with, in conjunction with other measures, a reduction in TB? There is bound to be a cost associated with any additional measure. We have to be shrewd about trying to look beyond the initial cost and see, all the time, the potential benefits of what we are trying to do. Ultimately, the best way to save money with TB is through reducing the disease.

Q286 Richard Drax: Has Defra done enough to explain to the public the process involved in developing the cattle vaccine and the chances of the vaccine and the DIVA test successfully controlling that disease?

Carl Padgett: We are back to managing expectations again. In my own contact with the Department, I think the work that has been done there has always been pretty realistic about the true practicality of delivering a vaccine and managing those expectations. With the greatest respect to all the Members here, it is an easy thing for a politician making statements-I am looking at Ministerial or Secretary of State level over the years-to take vaccine as an answer that is a good news story and lock onto it like a favourite sweet in a sweet shop. I understand that; it is human nature, at the end of the day. That actually creates an expectation that is not always deliverable. I understand how that has happened and I would not necessarily blame anyone for it. We are where we are because everybody wants that panacea. We have a wider issue of educating even the public at large about exactly what the limitations of vaccination across the board are: what are the pros and cons of vaccination? Everybody thinks that as soon as you have a vaccine, that is the end of the story, for whatever disease it is that we are talking about. It is not always the case. That element of public education could be managed better.

Q287 Richard Drax: Is bovine TB "the most pressing animal health problem facing the UK today"? That is a quote taken from Mr Paterson, in effect. He thinks it is. Would you agree that it is the most pressing animal health problem in the UK today?

Carl Padgett: I would personally, certainly in the cattle industry, but I would say across the agriculture industry, yes.

Q288 Ms Ritchie: Are there any lessons that can be learnt from the response to brucellosis?

Carl Padgett: What do you mean by "the response to brucellosis"? Could you just expand please?

Ms Ritchie: The Family Farmers’ Association caution that "no wild and ubiquitous animal was harbouring the disease, so the case is not at all parallel". Several people who submitted written evidence to us mentioned the successful vaccination campaign against brucellosis back in the 1940s and 1950s. The disease, according to the Family Farmers’ Association, was "to dairy farmers in the 40s and 50s what TB is now". Have any lessons been learnt?

Carl Padgett: I will pick up half of that and let Neil pick up the other half. In the first half I will deal with the technicalities. There are a lot of lessons that could be learned from the technical issues of delivering a vaccination programme on a nationwide basis to try to eradicate the disease: what you have to roll out, how you have to put your resources in place, and so on. So we could learn from that. Neil will answer with respect to the disease itself.

Neil Blake: I was not in practice when the brucellosis eradication programme was taking place but it is clear to me that the diseases are very different beasts. TB is a very much more complex issue to address. I agree with Carl: you could learn some lessons from the delivery mechanism of a programme like that but in terms of what it is going to achieve, that is a completely separate issue.

Q289 Neil Parish: Could I also raise a point? I think brucellosis was very much cowtocow and animaltoanimal. There were no other vectors, as far as I am aware.

Neil Blake: Exactly.

Q290 Chair: But it was zoonotic, so it could transfer to humans.

Neil Blake: As is, potentially, bovine TB.

Q291 Chair: How did we eventually eradicate it?

Carl Padgett: By vaccination in this country.

Q292 Chair: So not restricting movements?

Carl Padgett: And restricting movements where infections were in place. Indeed, work in Northern Ireland recently has got to the point of achieving eradication there of the small foci of infection that were there. Again, it was based on surveillance, reporting of infection, testing and removal of animals.

Neil Blake: You have to caution against suggesting that the way to go is exactly mirrored by brucellosis. As you say, it is a completely different entity. We have a much more complex disease picture in which wildlife is a significant part of the problem. You cannot make direct parallels with the control programme for brucellosis. Yes, you can look at the way vaccination was delivered, but those are the mechanics of delivering a programme, rather than looking at it as if it is going to achieve the desired goal.

Chair: That is helpful; thank you very much indeed.

Q293 Neil Parish: What is your perception of the incidence of Schmallenberg virus so far this year, and what advice do you give to farmers who suspect they may have animals infected with the disease?

Carl Padgett: I trust my learned colleague who is dealing with it on a daily basis at the moment.

Neil Blake: We have had quite a lot of experience of this over the last six or seven months. We know that the virus was very prevalent and very active in July and August, through the summer months. We saw significant problems in several early lambing flocks around that time, which have subsequently experienced problems with deformed lambs at lambing time around about Christmas. On the cattle side of things, again, we have experienced some. The effects have been variable but in some situations it has been very significant. Early on it was with the dairy herds, in particular, where milk production was hit, and now, interestingly, as you would expect given the expected passage of disease, we are seeing deformed calves coming through in the last one to two weeks. On the ground, yes, we saw it as very active back in the summer and we are seeing the effects of that. It varies in terms of the effects by herd; we get some herds where we find little effect and others where we are finding quite serious impacts.

Q294 Neil Parish: On some flocks of sheep, especially early on, some farmers were losing up to 30% of lambs and more, so it has had a devastating impact. We did have evidence from Defra vets who said that the sooner everything has it, the sooner they would have immunity. I thought that was slightly heartless, to be blunt. Also, should we be more proactive on vaccine and actually try to stamp it out in that way, rather than just letting it spread everywhere?

Neil Blake: My view on vaccination is a little bit like that on BCG. We want to have confidence that it is effective and is going to do the job we want it to do. Yes, I think there is real merit in having a vaccine available. There is certainly information on the highvalue flocks that they would have loved to have had a vaccine prior to the rams going in back in the summer. They will use it next season if it is available. The experience we have had locally is that there will be a proportion of farmers out there who will seize the vaccine if it is available.

Q295 Chair: Would you give us an indication of what you think the economic impact is? It was actually the deputy chief vet who said to just let it waft over and that it is not doing any harm.

Neil Blake: At the moment a lot more work needs to be done. The official statistics are the ones that go through AHVLA from the submissions. So early on, when they were mapping the spread of infection, there was a subsidised route, where you were submitting samples and there was no cost direct to the farmer. That has changed subsequently, so the discussion is had at a farm level as to whether we investigate what we suspect to be Schmallenberg virus (SBV) or not; we all know that the statistics are not a reflection of the true prevalence out there. There is a risk in terms of all the processes ongoing at the moment. In my mind, there is a risk of reducing or dismantling the veterinary infrastructure and surveillance infrastructure that is out there. We need to have a robust system in place and we need to do more work with SBV to assess the true impact. My instinct is that it has been very significant in certain farms, which have taken a big hit, but I could not put an economic figure on it.

Q296 Barry Gardiner: So you would not agree with Nigel Gibbens that it is a lowimpact disease?

Neil Blake: Our experience on the ground is that there have been variable effects. In some herds we have detected SBV antibodies, so we know that those cattle or sheep have been exposed to it and it appears to be an incidental finding. In others, there is no doubt in our minds that it has had quite a significant effect.

Q297 Barry Gardiner: Can you talk about the impact on nonpregnant adult cattle and sheep?

Neil Blake: With sheep, our experience on the ground is that the effect on the adults was not hugely significant, but it is different in the dairy herds, for example, where we have seen quite significant production loss associated with acute infection when it has been passing through the herds. We are talking, probably, about four litres of production. We have a couple of cases locally where we reckon it was probably four to eight litres a cow down whilst the infection has been ripping through the herd. That is a real hit that can easily put farmers into economic difficulty.

Q298 Barry Gardiner: Some farmers have said that they believe they have lost cattle through Schmallenberg. Do you have any evidence that it can be fatal?

Neil Blake: This comes back to surveillance ability and the funding available to properly look at the effects of the virus. We have had situations where, in a few cases, herds have lost adult cows during the course of the passage of SBV infection through the herd. I am careful how I word that and I am saying, "during the course of". We do not know because there may have been other factors at play in those herds. It may be that SBV was the final straw that put extra pressure on those cows. We do not have the definitive answers to that but we have had situations where we know SBV was active at the time they got the production loss, and they lost cows at the same time. There are not many but we have had a few.

Q299 Chair: Do you accept the argument about immunity: that if the animal gets the virus in the first year of life and then gets pregnant, it can build up an immunity? Do you agree with that?

Carl Padgett: We have seen the statements of Professor Drew noting how animals react to being infected by viruses in the same family, so one would hope that immunity is good, but the proof does not seem to be there at the moment. I want to pick up the point that was mentioned before that maybe what we need to do is have the virus go right through the country and, Bob’s your uncle, we now have naturally immune flock and herd status. That is not how endemic diseases-because that is what it would have effectively become by then-tend to work in reality. They tend to ebb and flow, so you will go through a period where there is a high level of natural immunity, then that will wane and we will get another disease picture. So it does tend to go in a sinewavetype fashion.

Q300 Chair: So do you foresee a need for a vaccine for Schmallenberg?

Carl Padgett: Absolutely.

Neil Blake: Yes.

Q301 Chair: How do you recommend it should be deployed in order to achieve the most costeffective impact, given what you were saying earlier, Mr Blake?

Neil Blake: Those are discussions that you are probably going to end up having on a farmbyfarm basis. I cannot see that it is ever going to be a compulsory vaccination programme. I am not sure in my own mind that there is merit in that anyway. I certainly think that it would be one of those, like other endemic diseases that are present in the UK, where we will have those discussions and will advise accordingly. There is certainly merit in it, there is certainly value in it, there is certainly need for it and hopefully it will be available for the next season. It is down to the licensing and regulatory authorities whether that vaccine becomes available in time.

Q302 Chair: Should the farmers have to bear the cost?

Carl Padgett: If it is going to be an endemic disease, which it looks like it is going to be, I would struggle, given the spread over the whole of Europe, to contemplate eradicating it with the midge being the vector. With most other endemic diseases, farmers, I am afraid, bear the cost and make the choices as to what control measures they are going to put in place. So unless one had a compulsory vaccination programme nationwide, which I simply cannot see being proportionate to this infection, I suspect farmers will have to bear the cost.

Interestingly though, with this discussion of low impact, there is of course the danger that the market is talked down, and so investment in vaccination does not occur. That is what I am particularly scared of. This is high impact for individual farmers that have that high impact. It may be relatively low impact industrywide or have impacts in ways we do not yet fully understand, so we have to be careful that we do not demonise the virus and make everyone scared of it, and blame it for absolutely everything, but we also need to proportionally make sure that, when Schmallenberg is involved, we identify it properly to stimulate true investment in vaccine production.

Q303 Neil Parish: In the 1980s, I had enzootic abortion. Some ewes became immune but it was only when we started to use a vaccine that we really stamped it out. They are not exactly the same diseases but do you see some similarities there?

Chair: I will take that as a no.

Neil Blake: I think you treat each disease on its merits and you have to fully understand the pathogenesis, the transmission, the modes of transmission and how best to counter that transmission. A crucial difference between enzootic and Schmallenberg is that Schmallenberg is vectorborne, and enzootic is transmitted from sheep to sheep. They are not directly comparable.

Q304 Chair: If there is conflicting evidence about whether it is going to be endemic or whether it is going to waft over, what is the best approach to take at this time to the Schmallenberg virus? Is it that we should proceed with the vaccine?

Carl Padgett: I think we should be proceeding with the vaccine. I would like to see further surveillance being encouraged, so that we understand as much as possible of the infection and the disease picture that it causes. We simply do not understand that sufficiently at the moment. There is no real incentive for farmers to submit samples at the moment. Why should they pay for tests for an infection that they cannot do anything about controlling at this moment in time?

Neil Blake: There is one word of caution on this as well. If we are going to gather more information, it has to be industryled and work in partnership. We also have to be careful when we gather more information that it is as accurate as we can make it. One of the concerns, and this happened to a degree back in the bluetongue days, is that everything gets blamed on the new kid on the block; so when Schmallenberg crops up, everything gets blamed on Schmallenberg, which is clearly not the case. Again, it highlights the need to have joinedup thinking and a flow of information; we have a lot of information through the area we cover. We are not collating that information at the moment to get the best picture of what is happening out there. We can look at other countries but field conditions and livestock densities vary throughout Europe. Our part of the world is a very livestockdense area, so the question is: is the effect of the virus the same here as it is elsewhere? We do not know because we are in the relatively early stages in terms of the passage of the virus through the country. It has really hit this year; it barely hit last year.

Q305 Chair: Are you concerned at all about liver fluke in sheep in the UK?

Neil Blake: Yes, I am hugely concerned about liver fluke, the increasing prevalence and the increasing significance of it. It is something that we have observed, this year in particular, where, as an example, farmers in our part of the world would treat a lot of flocks and herds for liver fluke at the end of a season if they felt the need. This season they probably had to go through two treatment cycles to be confident they have kept it under control. It is more akin to the situation in Ireland, for example, where they would be treating regularly through the season. The succession of wet years and the warm climate is not helping us in that regard. Historically we have usually had cold winters where the fluke would become dormant, so you get two or three months in the year with no active infection. We are seeing active liver fluke now on the wrong side of Christmas, in January. We have not seen that in our part of the world until probably this year.

Q306 Chair: You mentioned, Mr Padgett, that you thought it would be difficult to introduce compulsory vaccination across Europe or even here. If farmers were to be compensated for the loss of stock due to Schmallenberg, might that encourage them to notify?

Carl Padgett: I am sure it would. Compensation mechanisms always incentivise some form of involvement. Again we go back to the issue of proportionate measures for this particular infection. Whether that is proportionate or not is something about which I would have to be persuaded.

Chair: On behalf of the Committee, I thank you, Mr Padgett and Mr Blake, for being so generous with your time and contributing to our inquiry. I am sure we will meet again very soon. Thank you very much indeed.

Prepared 5th June 2013