To be published as HC 981-ii

House of COMMONS



Environment, Food and Rural Affairs Committee

Bovine TB Vaccination

Tuesday 26 February 2013

Bernard Van Goethem, Francisco Reviriego, Koen Van Dyck and Jacqueline Minor

Evidence heard in Public Questions 102 – 177



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Oral Evidence

Taken before the Environment, Food and Rural Affairs Committee

on Tuesday 26 February 2013

Members present:

Miss Anne McIntosh (Chair)

Richard Drax

George Eustice

Mrs Mary Glindon

Neil Parish

Ms Margaret Ritchie


Examination of Witnesses

Witnesses: Bernard Van Goethem, Director for Veterinary and International Affairs, DG Health and Consumer, Francisco Reviriego, Head of Sector, Disease Control and Identification in Unit SANCO/G2 Animal Health, Koen Van Dyck, Head of Unit SANCO/G4 Food, Alert System and Training, and Jacqueline Minor, Head of the Commission Representation in London, gave evidence.

Q102 Chair: Good afternoon and welcome to our witnesses. Just for the sake of the record, could you individually introduce yourselves, starting with Mr Van Goethem, just saying who you are and the position you hold, if you would. Or if we start on the right, Mr Reviriego? Espanol? Okay. Encantada de encontrarte. If you would like to introduce yourself and give your position, we will move along that way.

Francisco Reviriego: Thank you; it is a pleasure for me. My name is Francisco Reviriego and I work in the Directorate of Mr Van Goethem. I am Head of Disease Control and Identification.

Bernard Van Goethem: My name is Bernard Van Goethem, and I am Director in the Commission in charge of veterinary and international affairs.

Jacqueline Minor: Good afternoon. I am Jacqueline Minor. I am Head of the Commission’s Representation Office in London.

Koen Van Dyck: Good afternoon, my name is Koen Van Dyck. I am working in the Directorate of Bernard Van Goethem, and I am the Head of the Food and Feed Hygiene Unit.

Q103 Chair: Thank you. We are immensely grateful to you for being here this afternoon, and we apologise for the delay. Obviously our role is as legislators as well as taking evidence, so we are very grateful to you for your patience. I wonder if we could set the scene at the outset: how many other Member States experience bovine TB to anything like the extent that we have experienced?

Bernard Van Goethem: I wanted to start with that and I have brought with me some maps of Europe with the prevalence of TB in Europe. I think it will be useful for the Members to see a bit and to have an overview of the situation in Europe.

Chair: Do continue.

Bernard Van Goethem: If you see the map of Europe, and I include all the Member States, the situation is different between what we call the old Member States and the new Member States. You can still see that the vast majority of the European Union is on the map in green, which means officially free of tuberculosis, which is the highest status that is defined in the legislation of the European Union.

You have some countries like Spain, Portugal and the south of Italy, and then on the right side Hungary, Romania, Bulgaria and Greece, which have a less high status. Then you have the spot on the island, the southern part of GB, and the island of Ireland, which has the worst status in Europe. It is not the best situation. You see Scotland on the northern part, which has gained the status of officially free of tuberculosis, if I remember, two years ago.

We face a situation here that is without precedent in the European Union. That is why over the last three years we have intensified the help from the European Union to that part of the European Union, to try to eradicate tuberculosis. My personal point of view-and this is my personal point of view-is that during and due to the BSE crisis, things have not been implemented properly: the eradication programme, the obligation that the Member States reach the status of officially free of tuberculosis.

There is, of course, an incentive in our legislation to obtain this status, because when you obtain this status you can export bovine animals to the continent in a much easier way. Due to the restrictions that were imposed during the BSE crisis, there was less incentive for the farmers to try to gain this status of officially free of tuberculosis. Over the last four years all the stakeholders, by which I mean the industry in the UK, but also the Government, have tried take a grip-excuse my English, it is not my mother tongue, so I am trying to do my best-together to reinstall and put forward and implement rules that would allow them to slowly gain this status again.

For that purpose, the European Commission has adopted and financially supported the eradication programme, which was presented by the UK for the eradication. I recollect that it is the highest financial contribution that the European Commission has put forward to eradicate disease in the European Union. We have a budget for the eradication of animal disease in general that is around €200 million for all diseases over the entire European Union. We are spending this year, and we have spent last year, €31 million to contribute to the eradication of TB in the UK. Financially speaking that is the programme for us that has, at present, the highest priority to help the farmers, but also to allow them to trade more easily and to gain-

Q104 Chair: Okay. If we open up to questions, if we may. Thank you. Can I just ask: there is a timeframe for the decision to be taken, which we will come on to. If the UK, for example, adopted a cattle vaccination programme within the EU legislative framework as it currently is, would we be allowed to export a live animal and for that meat to go into the human food chain in the European Union?

Bernard Van Goethem: First, it is clear that the present legislation prohibits the use of the TB vaccination of animals. It is not foreseen in the legislation, because so far the vaccine does not exist. It is not foreseen in the European Union legislation, but also in the OIE international legislation. There are no rules established, meaning that animals that would be vaccinated would not be allowed for trade. That is absolutely-

Q105 Chair: For trade? You see, we are in this Catch-22: you wish us to eradicate bovine TB from our herd; we wish to eradicate bovine TV from our herd. You will remember Catch22, the film that was going round in perpetual circles. We are there now. We need your permission to vaccinate, or we could vaccinate cattle that are only destined for the UK market. You would have no problem with that, because there would be no circulation of the meat in the EU trade. Mr Reviriego, do you want to comment?

Bernard Van Goethem: The vaccination of cattle is, as I said, not foreseen in the legislation and therefore is not allowed. Of course, research has to go on; field trials have to be performed. There is the flexibility to foresee in a programme, and that is what the Ministry in the UK is doing at present, reflecting on a programme to see the efficacy of the vaccine, which is claimed to be efficient.

Q106 Chair: You are not saying that we cannot vaccinate; you are saying that we need to set the parameters for the-

Bernard Van Goethem: I say it is prohibited by EU legislation, but the research has to go on.

Q107 Chair: Is the current legislation there to prevent the spread of disease in cattle or is it to prevent any threat of TB passing to humans? What is the purpose of the current legislation?

Bernard Van Goethem: The international rules foresee that, not only from an animal health point of view but also from a public health point of view, to protect also humans from tuberculosis, you have to reach the status of officially free country or region of tuberculosis.

Q108 Chair: Right. How do you think we can reach the officially free status if we do not vaccinate?

Bernard Van Goethem: Research for a vaccine started in UK some years ago; it might-I insist, it might-be a tool to help eradicate tuberculosis. All the other Member States, all the countries around the world, have been able so far to eradicate TB; I do not think in one or two years, it takes five to 10 years. We have had the experience now of the new Member States which, when they entered the European Union, had the status that was not as good as the rest of the European Union. It took them five to 10 years to reach the level of officially free of tuberculosis, and that was without the use of a vaccine.

For us, the vaccine might be a tool that might help to eradicate TB, but there are basic rules, which are and have been implemented all around the world for decades, which allow the eradication of tuberculosis.

Q109 Chair: Is Britain the only country that has given protected status to badgers in the European Union? Is that the case?

Bernard Van Goethem: I do not know. It might be, but badgers also exist on the continent. There are other livestock, wildlife or other species that are also contributing to the spread of TB on the continent that are not badgers. The wildlife is part of the problem, but it is not the only problem, far from that, and that needs to be highlighted. Sorry for my English again.

Chair: You are very welcome. We could continue in French, but I do not think it would be permitted.

Q110 Richard Drax: Certainly not if I was speaking it, sadly. Has the UK Government applied for a derogation to enable it to conduct field trials of the cattle vaccine and DIVA test?

Bernard Van Goethem: There has been formal contact at the highest level between the Secretary of State and Commissioner Borg and our previous commissioner, to explain. That was made clear in the letter that the Commissioner signed to Mr Paterson, which I think you have, explaining how the system would work. At present, as far as I know, they are in contact with my staff to prepare a programme, a largescale field trial, which would be discussed with us to try and see on a large scale format if this vaccine would work or not, if you are referring to the vaccination.

Q111 Richard Drax: How long do you think all this might take before it has all got the go-ahead? There are talks going on now?

Bernard Van Goethem: Yes, yes. There are reflections going on-

Q112 Richard Drax: When will the talking stop and the action start?

Bernard Van Goethem: There has been a meeting in Cardiff in December of last year, where all that was also discussed between our officials and the officials of the Ministry, to see how to put forward a programme with all the guarantees necessary to avoid those animals being considered any danger for the others.

Q113 Richard Drax: I understand. When do you think it is likely the talking will stop and the action will start?

Bernard Van Goethem: I understand, but it is not in our hands. It is up to the UK Ministry to come forward with a programme. I understood that they are working very intensively on it as we speak. I understand also, from seeing in scientific papers, that field trials are being performed as we speak outside the European Union by a researcher from the UK.

Q114 Richard Drax: Would field trials in countries outside the EU be an idea?

Bernard Van Goethem: Any data that would substantiate the efficacy and the efficiency of a vaccine would be taken into account for upholding the vaccine.

Q115 Chair: Could you explain to the Committee about these field trials? Are you familiar with the results of the field trials?

Bernard Van Goethem: The idea was discussed, and now it is to elaborate and to put in place all the barriers, the framework to be able to implement it-

Q116 Richard Drax: There is no action yet, is there?

Bernard Van Goethem: As far as I know, no.

Richard Drax: A lot of talk.

Q117 Chair: Is the purpose of the field trial to establish a vaccine that will differentiate in the animal, between an animal that has been vaccinated and an animal that is infected?

Bernard Van Goethem: That is one of the data which is needed from the field trial, but there are a lot of other data. Is the vaccine efficient?

Q118 Chair: Is it not quite important to proceed with these field trials?

Bernard Van Goethem: As far as I know we do not have data proving that the vaccine is efficient.

Q119 Chair: Are you saying there is no political will?

Bernard Van Goethem: No, not at all; not at all. I am saying that to be able to efficiently start a vaccination campaign-leaving the legislation aside; purely from a scientific point of view-before starting to use a vaccine you have to ensure that the vaccine is efficient.

Q120 Chair: How do you know if you have not used it?

Bernard Van Goethem: Exactly. That is why field trials are ongoing outside the European Union, but those are not the only data that we need from the field trials. You mentioned the DIVA strategy, which is also very important. At present there is nowhere in the world where you could start the vaccination campaign without being able to differentiate the vaccinated animals and the non-vaccinated animals, but you have a lot of other data which are important: is the live vaccine strain that you are injecting in the animal shed by the milk? Is it infectious for humans? There are a lot of data that are needed to ensure that the vaccine is efficient and safe, and then you get the authorisation to use it.

There is another important idea that also came out. The first time it came into the public arena was during the FMD crisis in 2001, and a bit later in 2007: is the public ready to accept vaccinated meat? We know the debate, which was on-going at the time in Europe, about allowing vaccinated meat to be put on the market, especially in that case where the agent is not purely an animal disease, like foot-and-mouth disease in the past, but is also an agent that can constitute a public health risk.

Q121 Chair: Can I just put to you the question I asked a little earlier? Under the current legislation, could a farmer vaccinate his animal in the UK now?

Bernard Van Goethem: No. There is no vaccine approved, so it is prohibited.

Q122 Neil Parish: Good afternoon Bernard. The Commission has provided a tentative timetable for the use of a cattle vaccine, which is 2023-this is a possibility and a potential end point. In 2010 the UK reported that a vaccine might be available for use by 2015. Why is there such a marked difference between where the UK may be and where the European Commission is on the timescale, or do you not believe there is a vaccine available yet?

Bernard Van Goethem: As you mentioned, 2023 is the end of the process. You have seen the timetable in the letter of the Commissioner; there are various steps that are needed to arrive to something that is at present a hypothesis. The first important part is the two first years, where, as is mentioned in the annexe of the letter, we need a large-scale trial under EU field conditions to see if the vaccine is efficient. If that is the case-

Q123 Chair: That is wonderful and we would all like to do that, so what is preventing it from going ahead?

Neil Parish: We have not had the trial of it yet.

Bernard Van Goethem: We are awaiting the results of the trial.

Q124 Chair: Why can we not have the field trial now? This is what we cannot understand; why can we not have the field trial now?

Bernard Van Goethem: As I said earlier, the UK is now putting on paper a programme, a largescale field trial, which would give us and the scientific community the data necessary to evaluate the efficiency and the efficacy of the vaccine.

Q125 Chair: Could you just be clear what the criteria are to permit that trial to go ahead, because the annexe does not say anything particularly. The annexe in the letter from Mr Borg, of 14 January, does not actually specify the criteria.

Bernard Van Goethem: I agree, but in the letter itself, in the middle of the second page in the fourth paragraph, you have as an example a list of data, of gaps that need to be filled before vaccination could take place. I can mention the performance of the vaccine and the level and duration of the protection. If your vaccination only protects for one year it is a neverending story: you have protection from disease or infection, meaning if the animal is vaccinated and then infected maybe it would not develop the disease, but it would still be infected. Those are parameters that could be even worse, because then you have vaccinated animals and you do not see it. A lot of data are needed before the vaccine is put on the market. They are all listed in that letter.

Q126 Neil Parish: Can I press you on the timescale? What is your view currently of the vaccines that are out there, because I think it has been reported that they are only 65% accurate, or whatever. Is that your view as the European Commission currently?

Bernard Van Goethem: I have read the same data as you: about 65% protection. I do not know if it is for an annual vaccination, but if you keep in mind that there is a high prevalence of TB in GB, but still it is not 80%––we are talking about 10%. Keeping in mind that there are ways to eradicate TB, like movement control, clear restriction on the farms-all the usual veterinary measures that you apply when there is a disease-and if the vaccine is only efficient for 65%, the efficacy of that vaccine, if it is to be done each year, is residual, if you compare it to all the other measures, which are efficient and which have proven to be efficient over the last decades.

That is why we urge-and that is also mentioned the Commissioner’s letter-that all other measures have to be implemented: control and avoiding a lot of movement between farms. That is a very specific point in GB, where there is a lot of movement of cattle, which is an important way to transmit disease. There is much more movement of cattle in the UK-

Q127 Neil Parish: We take that on board. Today we are particularly interested in the vaccine. If-and it is a very big word "if"-if there was a vaccine that was available, does the political will exist across Member States to enable a fast track for the use of BCG vaccine?

Bernard Van Goethem: If, if-

Neil Parish: If-I know it is a big word.

Bernard Van Goethem: If you would use the vaccine once on cattle and you would eradicate the disease, of course there would be incentive for everybody to use it. At present it is not the case, but there is a political will. I repeat, there is a clear political will, not only from the Commission, but also from all the other Member States, to help the southern part of GB and Ireland as much as we can to eradicate this disease. As I said, it is the most important financial support we give, and we give it with the support of the other Member States. What we give to the UK we do not give to other Member States, so it is clear that there is a big political will to help eradicate TB in the UK.

Q128 Neil Parish: I think you have partially answered the next question, and that is what can the UK do to bring the timetable forward, and that is probably have the field trials and make sure that there is a vaccine that works. Is that the case?

Bernard Van Goethem: Yes.

Neil Parish: That is a good short answer. Madam Chairman, thank you.

Q129 Chair: What can the UK do to bring forward the timetable to meet your criteria?

Bernard Van Goethem: As I said, they are working on the programme, which has a lot of implications. You do not design a programme in half an hour. You have to see what you do with the animals. You have to see what you do with the offspring of the animals. You have to see what you do with the meat. You have to control the movement. It is not something you can write on one piece of paper; it will be a heavy programme, which we are helping the UK to draft, and we are waiting to discuss that with them. I can assure you that they are giving the highest priority to that in the veterinary service in Defra.

Q130 Mrs Glindon: Are you surprised that the UK Government applied for "in principle" marketing authorisation when, in your words, "more studies are required to address food safety concerns"?

Bernard Van Goethem: I did not understand that question, I am sorry.

Mrs Glindon: Do you think the UK Government should not be going for a conditional "in principle" marketing authorisation when there are concerns, as expressed by yourselves, around food safety issues? Do you think we have-I was going to say jumped the gun-you have been pre-empted?

Chair: You talk about the knowledge gaps: are we in the UK getting ahead of ourselves, is what Mrs Glindon is asking, by trying to market before-

Bernard Van Goethem: You need a lot of data before you use a vaccine. It could harm the animal, but it could have a public health impact also. Unless you make a field trial you do not know that. If I take what I said earlier, if you are using a vaccine and you realise only afterwards that when the animal is infected it continues to shed tuberculosis in the milk, it is becoming a real public health risk. Therefore, you need field trials and you need data before you authorise a vaccine, even temporarily.

Q131 Mrs Glindon: You have mentioned some of your concerns earlier, but what are your main concerns, for example, in relation to food safety?

Bernard Van Goethem: As mentioned in the fourth paragraph of the second page of the Commissioner’s letter, there are safety issues that need to be addressed before a vaccine can be used. You see possible shedding of the live pathogen by vaccine into animals.

Q132 Chair: We are going to come on to the skin test in a moment, but before we leave the vaccination, I would just like to pin you down, right? It strikes me that you answered in the positive to Mr Parish just now. You answered in the positive. We would like to know, is there anything preventing the UK from conducting field trials now? We would then have the information to answer all your questions, so we are on your side. You want to help us; we want to help you.

Bernard Van Goethem: The UK, as I said, is trying to establish a programme, the field trial, which will be discussed with us, and then they will be able to start if we have ensured that all the safety nets are there to protect spreading of disease or any public health risk.

Chair: Okay, that is progress; that is good.

Q133 Richard Drax: I think what this gentleman is trying to say is the ball is very much in our court.

Bernard Van Goethem: Yes, yes, that is what I was trying to say.

Richard Drax: We have to come up with something and get on with it.

Bernard Van Goethem: Yes. I think this meeting, which was organised in Cardiff in December, which was the meeting with all the stakeholders-I was not there, but Mr Reviriego was there-was the key moment for everybody to realise how important it was to design that programme.

Q134 Chair: I just want to clarify: if you vaccinate the beast, the cow, it will come up as a reactor, right? Jacqueline Minor is nodding. There is a distinct difference, and this is quite important to have a successful vaccination programme. You have an infected animal, which is clearly infected and will demonstrate all the signs of infection. If you vaccinate the animal then obviously you are putting a little bit of that TB into the animal. What I am trying to be clear is: do we have the scientific knowledge in Europe or anywhere in the world as to how you can distinguish between an animal that reacts to the vaccination, because it has been vaccinated, as opposed to an animal that is infected?

Bernard Van Goethem: For the moment the reply is no, not at present..

Q135 Chair: Is that also one of the purposes of the field trial?

Bernard Van Goethem: That is also one of the purposes of the field trial, because in the field trial, you do the free animals or clearly infected animals, Mr Chair.

Chair: Madam Chair is fine. I do not want to worry colleagues any more than they are already.

Bernard Van Goethem: You also have to take into consideration all the examples I gave about what is happening when you vaccinate, and I am not talking about TB, I am talking in general, because we have simply no experience with TB vaccination. Nobody knows what they are talking about. If you vaccinate an animal when he is infected, but when the disease does not yet show, what is happening?

Q136 Chair: Let me take a clean beast: I have a beast in my herd, which I have not, but say I had an animal, which, before we vaccinate shows it is clear of TB. Then you vaccinate and it will show a reaction. I am trying to ask about the purpose of the field trial: are we currently unable to distinguish between a vaccinated animal and an infected animal?

Bernard Van Goethem: Yes, we are not able to at present.

Q137 Chair: Excellent. And that is one of the purposes of the field trials?

Bernard Van Goethem: One of multiple purposes of the field trial.

Chair: We have the letter, and we shall publish it. Thank you.

Bernard Van Goethem: We have published it.

Q138 George Eustice: I wanted just to establish other aspects of the timetable, because the European Commission set out this idea that, of course, it starts with field trials, 2015-16. There are then a number of other stages: 2016-17 is a marketing authorisation procedure; 2017-18 is a debate about veterinary conditions to allow the use of the vaccine; and then finally the practical experience of piloting. Could those be condensed and run in parallel? For instance, I do not see any reason why you could not have a debate about the veterinary conditions under which a vaccine would take place, at precisely the same time that you are going through the marketing authorisation procedure. You could condense some of those things, do all of them, but do them together rather than wait for one stage to be completed before you even begin the next.

Bernard Van Goethem: You can always shrink the timetable, but you have to convince the scientific community and the international community. As I said, it is not only EU legislation; it is also the international legislation, which needs an amendment of the OIE code. That is a quite a lengthy process, which would also give the blessing of the international community to such a programme. If the consequence of something we do in part of the EU is that all our exports will be jeopardised from the entire EU, it would, of course, not be supported by other members of the European Union.

Q139 George Eustice: You do not think it is possible to condense it?

Bernard Van Goethem: It is possible to shrink it, but field trials are field trials.

Q140 George Eustice: What is interesting is it is suggested that the field trials only take about a year, but it is this term "practical experience using the vaccine". That is a full five years; I just wonder whether that could be started earlier and finished much earlier?

Bernard Van Goethem: The first one, which is the most important, is the field trial. One of the purposes of the field trial is to see how the calves of vaccinated animals will react. There are a lot of things: you need to wait for an adult to become pregnant, to have a cow. There are a lot of issues. There are things that take the time that nature requires. The debate between the scientific community and legislation of course could overlap, so it would be possible to shrink a little bit, but not to reduce it by half, that is for sure.

George Eustice: Could you get it down to, say, five years? Do you think that would be possible if you were to run some of those processes alongside one another?

Q141 Chair: Is it open to negotiation?

Bernard Van Goethem: It is not open to negotiation. It was clear in the Commissioner’s letter that you have to take it step-by-step: let us first see if vaccination is useful. As Mr Parish said before he left, it might only be useful in only 65% of the cases. That is, as I said earlier, with all the other measures that we know are efficient, that have been applied throughout the world for decades and we know work; 65% in addition to that: the efficiency is residual, marginal.

Q142 George Eustice: If the field trials conclude that it is 95% successful, in that case can we speed up the remaining parts of the timetable?

Bernard Van Goethem: If you find a marvellous vaccine that you inject once, a diseased animal becomes healthy: fine. Life and biology is sometimes not like that.

Q143 Ms Ritchie: Does the European Commission have any concerns about the accuracy of the current tuberculiun skin test, and should the legislation not allow for other tests should more effective ones become available?

Bernard Van Goethem: The efficacy of the tuberculin test to detect non-infected animals is nearly 100%. When the skin test does not react you are nearly sure.

Q144 Chair: Which skin test; both skin tests?

Bernard Van Goethem: The tuberculin test?

Ms Ritchie: We have two skin tests. The primary screening test is a single intradermal comparative cervical tuberculin test. Then there is the second one, the ancillary gammainterferon diagnostic blood test.

Bernard Van Goethem: The second one you mentioned is not approved at international level; research is ongoing. We have asked the EFSA to advise us on the efficiency and efficacy of that skin test, but for the moment it is not approved in the European Union, nor is it recognised at international level. Currently there is only one test that is recognised throughout the world.

This test, as I said, when the animal does not react you are nearly sure that it is not infected: it is not 100%, I would say between 95% and 100% sure that the animal is not infected. The animals that do react are between 50% and 94%, which is called the median sensitivity. When the animal is reacting to the intradermic test, you have between 50% and 94% sensitivity of the test. That is why, when it is positive, normally you have to redo a test to see if it is really infected.

Chair: Apparently the second test is used in part of the European Union.

Francisco Reviriego: The gammainterferon test is allowed to be used now as an ancillary test in conjunction with the normal tuberculin skin test, in order to find more infected animals. It is not a test that is prescribed to be used for trade. We know from the scientific angle that the test works, because EFSA has recently issued a scientific opinion in which the scientists wrote in a clear manner that the test works, but it has not been approved yet in the EU or at international level. We hope that the test can be used soon, but it will still take a while to get it through in Paris, in the World Organisation for Animal Health, and also in Brussels, because we need to change the legislation, and this can only be done by the Council and the European Parliament.

Q145 Chair: Should we not have field trials?

Francisco Reviriego: We already have a good scientific basis for the gammainterferon test.

Q146 Ms Ritchie: Do you think that there is any possibility that you would want to use or you would want to give legislative effect to other tests in order to make the whole procedure foolproof? I represent a constituency in Northern Ireland where there is a considerable level and quite a lot of TB reactor herds.

Francisco Reviriego: There is nothing that should stop us to move to approve this test.

Q147 Ms Ritchie: That is the second test?

Francisco Reviriego: Yes, the gammainterferon test; we should.

Q148 Ms Ritchie: What is the timescale for that, if you decide to go down that road?

Francisco Reviriego: As I said, this has to be done in the EU in the Council and the Parliament, and we are in the middle of the adoption of a new Animal Health Law, that will be a legislative framework. Only later on will we review this particular legislation.

Q149 Richard Drax: The movement of cattle has been enhanced in this country earlier this year. Are you satisfied with the new rules and regulations, or could the UK have done more?

Bernard Van Goethem: It is clear in the letter. As I mentioned earlier, in the UK, or in GB at least, there is much more movement of cattle between farms than anywhere else in Europe. There is a habit of moving cattle from one farm to another to sell it to somebody, and all that does largely contribute to spreading tuberculosis. One of the main issues we had, which was presented by the UK in the programme we are approving this year, where we helped with €31 million, is the strengthening of the movement control in farms and between farms in Great Britain.

That is one of the key issues, and we have been reassured at all levels in Defra that stricter movement controls will be applied for the movement of cattle between farms when animals are found positive, before they go to the slaughterhouse, and so on. There are a lot of measures there, which, in my personal point of view, are much more important to implement in the UK than the ideal hypothesis for the future that the vaccine will help.

Q150 Chair: Would you like to share with us what these measures are?

Bernard Van Goethem: They are in the letter.

Chair: We are back to the letter. Right, okay.

Richard Drax: Chairman, we have we have asked the second question three times already, so I am not going to ask that one again.

Chair: You might have more luck.

Q151 Richard Drax: If a vaccination programme is found that is going to work, you would fast track it as fast as you could, would you not? You would be very supportive of that?

Bernard Van Goethem: Yes.

Q152 Mrs Glindon: What impact will the new European Animal Health Law have on the control and prevention of bovine TB?

Bernard Van Goethem: As Mr Reviriego said earlier, within the Commission we are at the final stage of approving the proposal, which will be transmitted to the European Parliament and the Council. This Animal Health Law will give an overarching framework on all rules linked to animal health, being for trade of animals, being for eradication of disease, being for animal health rules for products-I mentioned the meat that could be contaminated earlier. It will give an overall framework, which will be then implemented through what we call a delegated or implementing act, which is a new way of building European legislation since Lisbon.

Q153 Chair: At what stage are we consulted? At what stage are national parliaments consulted?

Bernard Van Goethem: The national parliaments are consulted when the proposal is issued. The head of the organisation knows more about the procedure, but the national parliaments are, indeed, consulted, and can give evidence to the Commission.

Jacqueline Minor: In terms of the proposed framework legislation, that will be available for scrutiny by national parliaments before it makes its way through the legislative procedure in Europe, so before adoption by the Council of Ministers, including, of course, by the UK Government and by the European Parliament. That is the framework legislation, but, as Bernard said, the framework legislation will then provide for implementing legislation, or secondary legislation.

Q154 Chair: Which instrument is it? A decision, a directive, a regulation?

Jacqueline Minor: The framework will be a proposed regulation.

Bernard Van Goethem: A regulation.

Jacqueline Minor: A regulation, yes.

Q155 Chair: A regulation that is directly applicable?

Jacqueline Minor: Yes.

Bernard Van Goethem: Yes, it is.

Q156 Chair: You are saying, Jacqueline Minor, that it will come to us, or come to the home government?

Jacqueline Minor: All proposed Commission legislation is sent to national parliaments now, under the Lisbon Treaty, for consideration. National parliaments are invited to issue an opinion, which is then taken into consideration by the Commission. In addition, of course, I presume that the work of this Committee will inform the positions adopted by the UK Government in the Council of Ministers as the legislation is discussed and debated. The regulation will have to be approved by a qualified majority of the Member States.

Q157 Chair: Just remind me, because if it is a directive it can be implemented and transposed into national legislation. If it is a regulation it has to be directly applicable as it is. Therefore a parliament or a national government can vote against, but cannot amend. Is it normal to use a regulation as opposed to a directive for this type of legislation? Mr Reviriego is smiling.

Bernard Van Goethem: It will be a framework. All the real substance will be done through an implementing or delegated act, which are not necessarily regulations. If it is a delegated act the European Parliament has the right of veto. If it is an implementing act the UK Government, in the form of the Committee which is taking place in Brussels, will vote with the voting right, which is applicable-

Q158 Chair: It is potentially going to be adopted by comitology?

Bernard Van Goethem: No, no. I said the implementing acts. If I-

Chair: Hang on a minute; you cannot have a regulation that is implemented. I thought it was directly applicable?

Jacqueline Minor: The regulation itself will be adopted as primary legislation: adopted in co-decision by the Council and the Parliament.

Q159 Chair: This will have huge implications for our industry. What consultations have there been with the UK industry to date?

Jacqueline Minor: There have been extensive consultations with all stakeholders-including industry and including British industry-prior to preparing this proposal. There is an impact assessment, which will be published alongside the proposal and which will contain a summary of all the consultations that were carried out and the responses to those consultations. That, again, will be available for consideration and scrutiny by this Committee.

To come back to your earlier question, so the framework law will be a Regulation of the Council and the Parliament. The framework law will then grant the power to take either implementing measures or delegated measures.

Q160 Chair: Who decides?

Jacqueline Minor: There will be a proposal as to which it should be for different types of rules; that will form part of the proposed regulation, but that can be amended by the Council and the Parliament as it goes through the legislative procedure. Once the regulation has been agreed by Council and Parliament then those powers will be exercised to put in place the detailed measures on a number of important issues.

Q161 Chair: So if after the primary regulation it is delegated legislation the European Parliament can block it; if it is implemented the UK Government could block it in-is this the Committee of Experts? It is comitology.

Jacqueline Minor: These are the new comitology terms under the Lisbon Treaty.

Q162 Chair: Okay. We signed up to this, did we?

Jacqueline Minor: We did.

Q163 Mrs Glindon: The second half of the question is will this new law bring an opportunity to amend the directives that prevent the vaccination of cattle against bovine TB? What is the timetable for its agreement?

Bernard Van Goethem: The proposal for the Animal Health Law will replace all the existing legislation linked to animal health, so it will repeal something like 60 different legislative acts that exist at present. It will also repeal the existing Directive, which does not allow the use of vaccination, but it will be replaced, as Jacqueline explained, by a new framework. That framework will need to be implemented, which will be fed by implemented or delegated acts.

Chair: We are busy trying to fit in with the current legislation, whereas you are busy trying to amend it.

Bernard Van Goethem: We are trying to review all the legislation and make it easier to work with. The timeframe we have for the Animal Health Law is a presentation to the Parliament and the Council before the summer break. I do not expect with the new procedure established by the Lisbon Treaty that the Council and the Parliament will be able to adopt that in less than two years. It will be huge legislation that afterwards, as we said earlier, needs to be completed by an implemented or delegated act. We have to work and we have to think within the existing legislation.

Jacqueline Minor: I raised an important point, because the proposal is likely to make it easier to change the rules on vaccination. Currently they would have to be changed by primary legislation, so it would have to be a proposal for a directive of the Council and the Parliament. Within the framework of the new legislation, once adopted, it would be possible to change the rules on vaccination by a delegated measure, which would be much quicker in principle.

Q164 Chair: That is whether it goes under delegated legislation or implemented legislation. That is what they are telling you. Is that the case?

Bernard Van Goethem: Yes.

Chair: Thank you for that. We shall obviously watch that very closely.

Q165 George Eustice: I wanted to come back to the reasons why the UK and Ireland are specifically affected by this. The incidence, as your presentation at the start showed, is incredibly high here. You have talked about cattle movements being high and things like that, but are there any other reasons beyond that, because it is still such a huge difference?

Bernard Van Goethem: My personal point of view is that, because of the BSE crisis, there have not been the incentives for the farmers to properly apply the rules. They knew that they would not gain anything in terms of exports if they would be officially free or not, because they were blocked for the export by the BSE restrictions. For me that is one of the major issues or problems that arose in the past.

Q166 George Eustice: I do not quite understand. Can you just explain that in a bit more detail, I do not quite understand why that has caused-

Bernard Van Goethem: The BSE restriction had an influence on the––

Jacqueline Minor: I think the point that Bernard is trying to make is that to have TB free official status grants advantages in terms of facilitating trade, but those advantages would in any case have been denied to British farmers because of BSE measures. The incentive to achieving TB free status was absent for a long period for the United Kingdom, because they would not have been able to benefit from the usual advantages attached to TB free status.

Q167 George Eustice: You mentioned that other countries had managed to become TB free by pursuing the types of things you talked about, but did they do that from the same starting point that the UK and Ireland were in, or did they do that from a much lower level of incidence?

Bernard Van Goethem: If I go back into the past, there was also high incidence of TB on the continent as well. If you look at the incidence in the UK it has grown in 10 years. Where you started 10 years ago-I do not know if it is on the map, but we have other graphics here-you see that the incidence has grown over the last 10 or 15 years. The situation was much better at that time. There has also been the influence of the FMD outbreak where you needed to restock, so there was a lot of movement of animals. There is perpetual and uninterrupted movement of animals between farms, restocking farms. When your farm is infected only sending one animal to the slaughterhouse or sending the animals to a specific farm where they will still continue to grow before sending to slaughter: you miss the movement control on the farm. That is the key issue.

Q168 George Eustice: Has Ireland been affected by all those same things?

Bernard Van Goethem: The situation in Ireland, on the island I mean, is not as bad, as you see on the map, as it is in the-

Q169 George Eustice: No, but it is still pretty bad, is it not, compared with the rest of Europe?

Bernard Van Goethem: If you look on the second map I have distributed, you have 4.3 for Ireland, whereas you average 11.7 for the UK. Keeping in mind that Scotland is free, the prevalence, especially in the south and west part of GB, is really, really high.

Q170 George Eustice: Can we get from this 10% to 0% by changing movement?

Bernard Van Goethem: Yes, by applying all necessary measures that exist to eradicate TB and get the officially free status, yes, you could get to 0%.

Q171 George Eustice: In your conversations with Defra, do they agree with your analysis on that?

Bernard Van Goethem: Yes, of course. That was repeated in the letter you have, and it was acknowledged by Mr Paterson, who replied a couple of days later, saying-

Chair: We have the letter.

Bernard Van Goethem: We are transparent; always transparent.

Q172 Chair: Thank you very much. I would just like to ask very briefly about Schmallenberg virus in sheep. Do you envisage any trade implications for the European Union of this disease?

Bernard Van Goethem: Schmallenberg is a disease which appeared in the Dutch, German and Belgian area one year ago now; it has spread throughout Europe. It is not a disease that deserves international rules. It has some implications for individual farmers, but not for the Union as a whole. If I look at the incidence of the damage it has caused on a large scale-not for individual farmers, I am talking globally-statistics for the first year show 6% of sheep herds would be affected in one way or another. That might only consist of one newly born deformed lamb. It can take the proportion of more lambs in the herd.

Q173 Chair: Are you aware that Russia has imposed a ban on sheep coming from the Netherlands, Belgium and Germany?

Bernard Van Goethem: I could stay for a long time making a list of what Russia has banned from the different Member States in relation to live animals, animals for slaughter, meat, seeds. They have a long list of restrictions they have imposed over the last six months or one year on the export of various commodities from the European Union. Let us start with live pigs-

Q174 Chair: Time does not permit, but what steps are you taking to ensure that Schmallenberg does not pose a risk to human health, or are you convinced that it does not?

Bernard Van Goethem: As soon as the disease was notified first by the Dutch authority and then confirmed by the German, we immediately asked the European Food Safety Authority, the EMA here in London and the ECDC in Stockholm to see if it would pose a public health risk. The reply was clearly that Schmallenberg does not constitute a public health risk.

Q175 Chair: When might a vaccine be available?

Bernard Van Goethem: Research is ongoing. I think that the European Union has financed up to €3 million a programme for the research of a vaccine. The companies are working on it. My personal point of view is that, if the evolution of Schmallenberg is like that of a similar virus existing somewhere else in the world, you will see a first wave, as we saw on the continent last year, and then there will be a global immunity, which will be throughout the livestock in the European Union, and you will not see any disease any more. Personally, I doubt whether, from an economic point of view, the pharmaceutical industry, if it is not easy to develop a vaccine, will want to conduct a lot of research into a vaccine that might not be used a lot.

Q176 Chair: If there was a vaccine and if the animal was vaccinated, would that be allowed to be freely exported to other Member States? You are being inconsistent here: why can you vaccinate a sheep and put that into circulation, but you are saying we cannot vaccinate a cow against TB? You have got to be consistent here surely?

Bernard Van Goethem: I am consistent; I have always been consistent.

Q177 Chair: Is it because Schmallenberg is in Belgium, Germany and the Netherlands, and because bovine TB is in Britain? Tell me that is not the case?

Bernard Van Goethem: Schmallenberg is throughout Europe. We have never even thought that a disease transmitted by a midge could spread so quickly throughout Europe. It is everywhere. It has been made clear by the World Organisation for Animal Health that this disease did not deserve any rules at an international level. Vaccination can be done; vaccines can be produced by industry, approval can be requested, but there will be no restrictions implemented by European rules or by international rules on Schmallenberg: neither the disease nor the vaccination. Despite that, some third countries have taken unilateral action to ban the import of live animals, or products, or semen, from the European Union to those third countries.

Chair: Can I thank you very much indeed Mr Van Dyck, Madam Minor, Mr Van Goethem, Señor Reviriego; thank you very much indeed for being with us, being so generous with your time, and being so patient with us for the delay earlier. We are immensely grateful to you. I am sure we will see and hear from you again, I hope, on matters of animal health. We are most grateful to you.

Prepared 6th March 2013