WEDNESDAY 28 OCTOBER 1998

PROFESSOR PHILIP JAMES and DR ANDREW CHESSON

  660.  Is it more important to improve the quality of the committees' advice or the method of their operation?
  (Professor James)  I think it is more important to improve the method of their operation by having much more effective support and by having much clearer specification of what the processes are within the Commission. Then we just do not come into a problem blind but know that a particular DG has had a meeting with a Standing Committee, that this issue arose because there was a dispute between x and y on such and such and that is why the question has been put to us. Then we could begin to understand how to address that issue instead of just having "what do you think about this" and a very preliminary limited explanation. I think there is a lot that the Commission can do and I think it is in the process of recognising that. I am not in the business of attacking the Commission today, they are desperately struggling to cope in my view.

  661.  Professor James, we turn to the question of stopping the clock. Under the proposed revision of Directive 90/220 it is proposed to stop the clock while the scientific committees are consulted to resolve inter-Member State disputes, even though if the clock was not stopped the committees would still have three months in which to formulate and deliver their advice. In that context are you in favour of stopping the clock?
  (Professor James)  I am in favour of stopping the clock but Dr Chesson is under the gun on GMOs. Perhaps Dr Chesson will respond and disagree if he wishes.
  (Dr Chesson)  I think in practice the clock is automatically stopped. You are quite right that often there is a three month period but you have to remember that most of this is being done on a voluntary basis. If this was a full-time committee or if you had experts who were seconded permanently to these committees then I think the three month period might be a reasonable time span, particularly given the time available to people who actually have to evaluate very complex dossiers. Sometimes people do not understand quite how large they are. I once had delivered 84 volumes of a dossier on virginiamycin resistance. This is not something you would take home and read overnight. The expectations and the amount of information you have actually to consider requires time. If the evaluation is going to be sound and thorough then it seems to me that one should not force a time period for a reply.

  662.  Can I ask just as a matter of information, is all this having to be done in all of the languages of the Community?
  (Dr Chesson)  The tendency is for the working language to be English, as you might expect, certainly in the working groups. In the plenary sessions there is simultaneous translation. The dossiers are provided usually only in one language and that is not necessarily English.
  (Professor James)  Could I add that stopping the clock is a very sensitive issue. It is exasperating for some groups and industry, for example, to put forward a proposal and find that wherever they go at each step the clock has been stopped. I think we need to look at that in terms of the mechanism by which the approval process is gone through. If Andy Chesson has 84 volumes to consider on one particular topic then you can hardly expect an international group to come to a conclusion on that within three months. However, the issue is how many steps has it gone through before this key set of decisions is taken. I think that is where the improvement should be rather than in specifying that he not only has to give up his Sundays, he has to give up his days at the institute routinely as soon as somebody somewhere demands that he reads another 84 volumes.

  663.  So you are in favour of stopping the clock?
  (Professor James)  Yes, I am in favour of it but I think we could get a more efficient method of analysis which in effect speeds the general process up but does it properly. I think we need both and that is the challenge.
  (Dr Chesson)  If I could just make one comment. I think in relation to genetically modified crops we are going to run into a problem where the time spent on evaluating these materials is actually going to increase and not decrease. That relates to the way in which the legislation is going to be handled. At present scientific committees are asked to consider the crops under 90/220 primarily for release. If the material has a food application then it will also be considered by the Scientific Committee for Food, under EC No. 258/97, and we are about to have introduced a novel feeds regulation to match the novel foods regulations, so if it has a feed implication it is liable to be examined under the novel feeds legislation. So it is going to be very crucial as to how those various pieces of legislation are organised and how the scientific committees are organised to deal with them. My personal view is that it ought to be a one-stop process, that a composite committee ought to be able to respond under all three pieces of legislation. What concerns me is information passing from one group to another group asking almost exactly the same questions and requiring almost the same evaluation in each case. I think that is a foolish waste of time. The other thing that concerns me about that process is that there is a tendency for things to slip between the cracks between the various evaluations. You may have a case where you have a genetically modified plant which one committee has a slight concern about but not necessarily enough to suggest that it should not be released for growth in Europe and a second committee may have a slightly different qualm about the same material but the two never get together and therefore there is never any overall weight of evidence which would mitigate or question the safety of this material. There is a great deal of danger in splitting up what is essentially a single problem, a single evaluation, and being seen to be handled by a number of different committees and processes.
  (Professor James)  That is exactly what we are going to consider. Having realised this in talking with Andy Chesson I wrote to the chairman of the Scientific Steering Committee and he circulated my letter dealing particularly on GMOs. It is these sorts of issues that we think we should be tackling as a coherent whole. We are proposing that we need to rethink this in terms of the way the Community handles the problem.

  664.  There are obvious implications for the developing world through the use of GMOs but could you say what the implications are for developing countries considering international property rights and also the use of patents which might actually affect them adversely?
  (Professor James)  As some of you know I am Chairman of a United Nations' Commission at present looking at future food needs on a world basis. I was privileged to be asked to do this by Richard Jolly who is the leader of the UN Development Report. Dr Gro Brundtland and Mabul ul Haq and I were appointed as the three commissioners. Dr Gro Brundtland now is in charge of the World Health Organisation and had to decline and Mabul ul Haq, former Treasurer of Pakistan and founder of the UN Development Reports, unfortunately passed away suddenly earlier this year as you will know. We have been looking at your problem and we meet again in Madras in three weeks' time to look at these very issues. There have been two recent major meetings in Britain. You may be familiar with the Royal Society meeting on this issue and the Rank Prize Fund meeting which has just been published in New York on feeding a world population of more than eight billion people. If you also look at the work of the new director of the Rockefeller and the way in which the Rockefeller Foundation is going about tackling this problem then it is clear that they are very conscious that there is a huge issue of the Third World. If you look at global food needs we have a problem of whether we can keep putting up the plant yields, because that is fundamental to being able to feed the world. The way in which one puts up the yield is by manoeuvring, choosing, selecting crops that can handle a limited water supply, salinity, and so on and so forth far more effectively. The amount of land that is going out of production is at the moment worrying because of the huge growth of the mega-cities. The Third World has an enormous need for help. What you are pointing out is exceptionally important and was highlighted by UNESCO two or three weeks ago: there is a huge intellectual or, if you like, capital asset gap between the First World and the Third World. If you look at the new analyses, and I have recently been to Washington to the International Food Policy Research Institute, they have come to the conclusion that the Third World has a desperate need for enhanced agricultural research. In Europe we have tended to conclude that agricultural research post-war now needs to stop or be reduced substantially because we have got too much food being produced. On a Third World basis, however, agricultural research is desperately needed because to get the increased crop yield you need the best new developments—of selection with this selection to include GMOs. The question is how are you going to get that through on a practical basis. I think that we tend to go for magic bullets too often when we look at Third World issues. New analyses suggest that if we are going to make progress we have got to have the same major community involvement that has been shown, for example, in Tanzania, in Thailand, in parts of India, the Tamil Nada project and so on. I think that M S Swaminathan, the ex-director of the Rice Research Institute, is convinced that we have to have a panoply of different crops, not just a few GMO crops. I think that if Britain is interested in helping the Commonwealth and the Third World it should be seriously thinking about how best to develop schemes with Third World countries so the marvellous capital assets in intellectual terms of British science and of British companies can be linked in a way where the Third World does not believe that they are being raped—I choose the word advisedly—by companies and other Governments who make use of precious assets from, for example, the Amazon Jungle in terms of crop varieties. How are we going to cope with that? I think it is a huge challenge that has not been addressed properly as yet.

  665.  Going on looking at patent law over these issues there are countries which in the present system in reality on the ground will not be able to afford certain crops. Peasant farmers will not be able to afford these enhanced crops. How is that gap going to be bridged?
  (Professor James)  I think it is a major issue and I do not have an instant answer. The research community, particularly in the United States, for example in the Rockefeller Foundation and elsewhere, are very much involved in charitable funded work for the Third World where they are trying to protect patents. I think there is a potential for a new dimension of private-public partnership where in fact national governments with World Bank/IMF support became involved. The IMF and the World Bank, I am sorry to say, in the current crisis have shown a complete failure to look at the social, economic, agriculture and human dimensions of structural adjustment. They are not recognising that actually a much more sophisticated response is needed. I would be in support of the World Bank and the IMF being much more locked in with the major companies in trying to develop new ways by which the Third World can profit where the industrial countries know that they are not going to get the same return but they have not put in all that money themselves either. So it is a joint venture for Third World benefit.

  666.  Can I just ask one more question. There was some talk that the Australian Seed Bank were thinking of actually patenting seeds within what is seen as almost a global resource, they are actually patenting seed stock. Do you think that is tenable?
  (Dr Chesson)  Personally, no. I am very concerned about the whole restrictive process of patenting of genetic information, cotton being a classic example. I think there are a number of issues that come out of this technology. There are serious dangers for the Third World. One I can see is actually the increasing emphasis on cash crops for Third World countries. This has already proved to be a major problem for many African countries where you get international companies producing cash crops of little value to the actual country itself but pushing the food production for that country out into the marginal lands. As we see more and more GM crops with higher value products it is going to be increasingly attractive to grow crops like this where there are low labour costs. I think that is going to put even more pressure on the existing lands within the Third World. There are dangers concerned with the introduction of GM crops in the Third World. There are clearly very good potential benefits but I am not sure that these are always given the highest priority by breeding companies which are based essentially in the US, in Europe, in Canada and in the developed world. For instance, you would probably have more impact on nutrition in the Indian Sub-Continent by increasing the degradability of the rice straw fed to buffalo and other animals than actually increasing the seed content of that rice because this would have a major impact. I think you would be hard put to suggest to breeding companies that they could get an economic return on doing that sort of research. I echo very much what Professor James was saying. I think the only way forward is for Government to encourage a partnership in which scientists from the Third World are not actually brought over to countries and put to work in research institutions for the benefit of the research institutes, but are possibly organised such that they can do research within multinational companies on projects which those multinational companies might not have given a high priority. I am sure there is a mechanism under those circumstances for working out IPR to the benefit of both. There are ways forward if one is reasonably imaginative.

  667.  It is unclear from the Directive whether the scientific advisory committees, when called in to resolve inter-Member State disputes, will comment solely on the dispute or whether it will re-examine the entire dossier. Bearing in mind what you said earlier would the latter concern you and is that the more likely outcome at the moment?
  (Professor James)  I think that in coping with a particular question quite often there seems to be a very narrow area of dispute. In practice when you look at it some of the issues are really quite broad. It seems to me that most of the scientific disputes in Europe will already have gone through a scientific committee which will have looked at the entire dossier of data. I do not think it is as bad as you may think. If some quirk comes up and you think a terrible committee is going to take another three years before it comes up with a view on it, then I do not think that is going to happen. I think that we can get into trouble, as we discovered on Friday on bones and BSE, if we take a very narrow perception of what is being disputed within the standing committees. I think one has to take a breadth of perspective without necessarily going back and re-examining the whole dossier. I am sorry, that is not a straight answer.

  668.  So you do not think that the scientific advisory committees are being abused? You do not think they are being asked to put aside the wrong questions? They are overloaded but they are not being misused.
  (Professor James)  On the whole I do not think they are being misused because I think DG XXIV is really very intent on developing a new culture which is very different from the old culture. They are, in a sense, protecting us from the old schools. How that is going to work through I do not know. I do not think that they are abusing us. Certainly in my experience we get quirky questions from other Directors General which have very complex political reasoning behind them and usually we discover what that is and then we come back and give the general picture without regard to the political machinations.

  669.  Can I ask you a question about the precautionary principle. Do you agree that the step by step approach of the precautionary principle is the way to proceed with genetic modification? Is it being implemented in the United Kingdom in the right way in handling GMO release applications?
  (Professor James)  I think Dr Chesson is better answering that but I would make a general point about the precautionary principle. This has come to me powerfully in the last 12 months in terms of BSE. If you take the precautionary principle to its extreme you will say "I think there is a theory that there is a problem in this particular area, therefore if there could be a problem we will not actually allow anything to proceed until in fact we have got a beautiful scientific analysis of whether that theory might be operating or not". In practice I think that if one takes that to the extremes that I have seen some scientists taking with BSE, one would get to the point at which you would shut down the whole of the agricultural food supply in Europe, and I mean that literally. In terms of GMOs I do not have enough practical experience of that step by step approach to know whether that is a big problem in Dr Chesson's committee.
  (Dr Chesson)  I have a horrible feeling that it is actually an excuse for inaction. Bear in mind what has happened with antibiotic resistance markers that are used in the selection process with GM plants. There has been an enormous debate over the last few years about the use of such markers. The interesting thing is that the companies have responded to this debate because they still have a market to sell their crops, they are still very anxious to get these crops into Europe and growing in the US. They have responded by actually improving their technology to the point where the products that are coming on line now simply do not have antibiotic resistance markers. I am not convinced that if there had been a precautionary principle in action there would have been the same incentive, if you like, for the companies to make those changes. I suspect that it can work in both directions. If you have the precautionary principle it also seems you know precisely the question that will need answering before you allow the next stage to proceed. Again, I am not sure how you actually arrive at that question.
  (Professor James)  I was involved in the novel foods where we were pretty angry there were antibiotic resistance markers coming through into the food chain. We explicitly stated so in our public releases and so on. I think that the precautionary principle is, if you like, a very good way of starting because you are thinking about all sorts of issues. The question is do you stop everything on the basis of theory. I think that is back to the discussion about trust. You have to get to the point where you have people with genuine concerns so involved in the process that they realise that it is reasonable to go forward not knowing everything at this stage. If there is real concern you put in mechanisms whereby you can survey the potential impact of the changes so you can have an early warning should there be a problem. If you do not believe that balancing the judgment is really the issue, then you need to give me examples of how there might be some obscure problem which emerges when a balanced judgment is made. We are always going to have that problem when we are trying to make judgments. I think to balance the argument we need a lot of different groups involved in the committees, so you can build reassurance. For example—people who are very much involved in Friends of the Earth ought to be brought into this discussion and not rubbished; neither should the industrial companies be rubbished. We have got to build a new mechanism for getting a proper interchange so we understand the dimensions of these issues.

  670.  You expressed your concern about the use of antibiotic resistance marker genes, and we have had many discussions about that in this Committee, should they be banned and are there other genes to use? Would you have the same concerns about the use of fish genes in plants? We have heard about a gene from the arctic chard being used in some plants as a sort of anti-freeze.
  (Dr Chesson)  As I said, you have to look at everything on a case by case basis. You have quoted two examples which are quite radically different. Yes, I would have questions to ask in both cases. Those questions would be specific to the genes that are being introduced. If one can answer satisfactorily those questions then my concerns would be allayed. If one could not answer satisfactorily then of course one would not be able to clear something as safe for release.
  (Professor James)  If I may come in, let us take the fish gene, which I am afraid I did not know of but Andy Chesson would doubtless. If that introduces an anti-freeze component I think that it is proper that in a committee one should look at the dimensions of what that might signify and one should think of all sorts of different areas of concern that might arise. You need to sit in on some of our British committees, where we run around with all sorts of crazy ideas before saying "okay, that does not seem to be an issue". I think we need more of that but done in a reassuring and involved stakeholder context. Then we will begin to make better progress.

  671.  We have been talking this morning about the situation that meets us at the moment. Would you not agree that we are going to see a torrent of new developments in the years ahead? We are only scratching the surface of this. How are we going to cope?
  (Professor James)  I am not sure that I know the answer. I think that one has to look at it piece by piece but, in addition, one needs to have the ability to pull back and say, for example, on this issue about herbicides whether in fact there are going to be major impacts on the environment and so on. That is a very proper concern. There is a quantitative issue there as well as the specifics relating to each gene. I think it is very important that we have expert committees that are not just relating to the minutiae of a genetic modification but are dealing with the broader issue. If a torrent of genetic manipulations is on the way are there special questions that we need to think of now by virtue of having a multiplicity of changes in that particular sector of plants, or indeed animals? I think the GMO changes in terms of animals are likely to be much slower because of the huge antagonism to major changes in animals as distinct from plants. That is the view that we had in the Novel Foods Committee. We took on the public dimension of concern and therefore did not allow, for example, various gene manipulations to enter the food chain even though it had been shown that the genetic construct had not gone into the animal. We were so concerned that people would feel outraged by the idea of eating an animal which had been subjected to genetic manipulation. Although the ethics expert on our committee said that putting a human gene into an animal is ethically entirely appropriate, I and many other members of the committee thought that might be correct in strict almost legalistic ethical terms but one had to deal in a societal context with people's understanding. I think that we need this interactive debate. It is not a question of persuading people that everything is all right. It is a question of moving forward, if possible on a consensual basis. We cannot do that unless we do take the broader view as well as dealing with the specifics of each singular gene.

  672.  I wonder if I can just take you back briefly to the precautionary principle and the concerns that it should not be interpreted as not being able to make any movement forward unless everything is known, because I would accept that not everything can always be known. I wonder if you could just describe whether you think it is possible to combine the precautionary principle with an adequate assessment of the scale of risks so that you get a feel for occasions when the scale of risk is sufficient that you do want to take a more precautionary approach and occasions when the scale of risk is less.
  (Professor James)  Thank you for a very penetrating question. One of the groups that I am involved with in Brussels is dealing with exactly that and that is the discussion that I had with the former CMO, Ken Calman: how do you begin to put a new dimension on risk analysis? There was a Treasury report on this last year as to how you look at the risk in environmental risk, human health risk and so on. I think that what has come through to me in the last year's struggle on the BSE risk is that we really have to move into a new dimension of understanding and start to express risk in a more meaningful way, not simply for the purpose of communication but for understanding. For example, the Health and Safety Executive perceives that if you are in the oil, mining or nuclear industry crudely speaking one in a million risk is the threshold for acceptable risk. People employed in that industry know that they benefit from that industry and the trade unions and everybody involved thinks that one in a million is reasonable. As I said to the Scientific Steering Committee in Brussels last week, that means that in Britain we should "allow" 50 cases of new variant CJD to be running as a routine per year in Britain. That is of course unacceptable. It is unacceptable because we are in a different dimension, because the whole society is exposed and they did not make the choices and see any selective benefits and so on. I think we are actually going to have to think through in a new way an integrated view of risk and set it out in a more explicit way and involving stakeholders. Then we can come to a judgment, and an explicit judgment, about the risk. Traditionally in Britain we have taken a completely different view from the United States on risk. In the United States they have gone down the quantitative analytical approach whereas in Britain a group of experts have decided that, on balance, something is acceptable. I think by virtue of all the anxieties about food in Europe we are going to have to go much more down the American route of being more explicit, more analytical, more effective at communicating relative risks and better at demonstrating why we are making judgments in these different dimensions. Until then we are going to be challenged to use the precautionary principle on the basis that we are making all sorts of judgments with so little evidence at hand. I am not giving you a straight answer but I do believe that in trying to cope with risk we ourselves as scientists are going to have to go into a new dimension of thinking and analysis which some of us have not coped with terribly well hitherto.

Chairman:  I think that brings us to the end of the questions that we wanted to ask you. Professor James, Dr Chesson, thank you both very much indeed, on behalf of the Committee, for having come and given us extremely interesting and helpful evidence. Thank you.