§ 3.45 p.m.
§ Lord Howie of Troon rose to move, That this House takes note of the report of the Select Committee on Science and Technology on Regulation of the United Kingdom Biotechnology Industry and Global Competitiveness (7th Report 1992–93, HL, Paper 80).
§ The noble Lord said: My Lords, the aim of the committee's inquiry was to investigate suggestions which had been made, largely in industry, that the current regulations governing biotechnology were likely to place United Kingdom companies at a competitive disadvantage compared with competitors especially in the United States and Japan. In fact, our study of the implementation of those regulations led us to believe that there were some elements of uncompetitiveness even within the Economic Community.
§ The committee was aware right from the beginning that those regulations were only one factor governing the competitiveness of the firms in question. We noted that such matters as the availability of investment funds and intellectual property rights, for example, were at least equally, if not sometimes even more, important.
§ Very briefly, the committee's findings were as follows: (a) Biotechnology is already in everyday use and offers substantial benefits to mankind; (b) Separate regulation of GMOs (genetically modified organisms) in contained use is not needed; (c) The deliberate release of GMOs, with some exceptions which we note in the report, is not inherently dangerous, although some people contend that it is; (d) The United Kingdom regulations, which are based on Community directives, take an unduly precautionary line and are based on obsolescent information; (e) The current regime is unscientific in so far as it fails to discriminate between activities which involve real risks and those which do not. By real risks, I mean risks which can be measured by some acceptable form of risk assessment.
§ The committee made quite a large number of recommendations, which are summarised in Chapter 7 of the report, and summarised even more briefly in paragraphs 1.8 on page 10. The main recommendations are that, first,
§ "the Government must press for amendment of the EC contained use Directive so as to substitute a risk assessment system in place of the current classification of risk according to size of operation and pathogenicity"
§ "The Government must press for amendment of the EC deliberate release Directive to enable certain activities, as selected by a group of EC national experts, to be exempt from the present provisions";
§ and thirdly that,
§ "as a matter of principle, GMO-derived products should be regulated according to the same criteria as any other products".671
§ We believe that the present process-based system of regulation should be confined to those areas where it is absolutely necessary and that we should move towards product-based regulation so far as industry is concerned.
§ We also recommend that the DTI deregulation task force should review the current regulations with a view to revising them, and where necessary attempting to revise the EC directive.
§ At this point I should interpose the fact that the committee's inquiry was not aimed at deregulation as such in the manner of the Government, who dislike regulation. The committee was not part of the Government's deregulation process or strategy. I hope to make that quite clear.
§ Lastly, the committee recognised that there is a need for the promotion of public understanding of biotechnology, which would be promoted mainly by the industry concerned but certainly by government departments as well.
§ The committee received somewhat over 100 written submissions, some of them quite substantial. We heard from 30 witnesses or groups of witnesses. Most of those witnesses and submissions came from industry or academia, but we heard also from government departments, the Community and environmental groups.
§ Speaking personally—as chairman, I do not wish to commit my fellow members of the committee to this part of my speech but I hope that they will not dissent too much from it—I found the evidence impressive, though I felt that the Commission's evidence amounted largely to stonewalling. I was not at all impressed by the witnesses sent to us by the Community. I do not feel that they were of any great help to us in our deliberations. I was disappointed too in the performance of Greenpeace, which was immovable in its opposition to genetic modification of any kind. It is important in dealing with a subject of this kind that the views of environmentalists such as Greenpeace and other groups from whom we heard evidence should be heard and studied. Nevertheless, I found Greenpeace disappointing. Not all my colleagues may agree with me but I thought that I should make my views clear.
§ The departmental witnesses, who were mainly from the Department of the Environment and the Health and Safety Executive—there were others from agriculture and food and so on—were naturally cautious. But the Health and Safety Executive was more adventurous than the others. It seemed to think that in some cases the existing regulations were too strict and that their implementation was sometimes too severe and could possibly be relaxed. On the other hand, the practitioners from industry and the academic world almost all believed that the regulations were much too strict and that the hazards presented by GMOs were exaggerated in most people's minds.
§ In paragraph 5.8 (on page 31) of the report, the committee states:
§ "Their [the practitioners'] arguments were that the caution shown by the scientific community in the 1970s had been excessive and could now be relaxed; that the perception of risk posed by genetic modification had been founded on false premises; that fears about deliberate release had been misplaced; 672 that the act of genetic modification was in scientific terms far more precise and predictable in its effect than the largely serendipitous acts of nature and selective breeding; and"—
§ what is important—
§ "that no known accident had ever occurred either from contained use or deliberate release of a GMO".
§ Those are strong conclusions arising from the very strong evidence that was presented to the committee day after day in the course of its inquiry.
§ Some witnesses went so far as to say that scientific modification was more safe than the ordinary modification in the evolutionary process. The committee itself does not press that point. An interesting example of that view came from Professor Kornberg, who illustrated his beliefs with an analogy. He said that there are two ways to feed a fire or a furnace with coal. One can gather up a shovelful of coal and shove it into the fire, including anything else which happens to be present in the coal, such as cigarette ends and bits and pieces of rubbish. That is a generalised way and in fact it is the evolutionary way. The other method is to feed the fire with a pair of tongs, carefully selecting pieces of coal and only pieces of coal, discarding the odd bits of rubbish. Professor Kornberg explained that that was an analogy with the scientific method of genetic modification; namely, one puts in the good bits and leaves out the bad bits. The committee found that analogy a graphic and convincing illustration of facts that were presented to it over and over again.
§ At this point I must draw attention to an error in the report. It led one of the witnesses to suggest that the committee had misunderstood his evidence. Right at the top of page 33, in the first three lines, Professor Mark Williamson of the University of York is quoted as saying:
§ "The vast majority of the biotechnological developments that are known about at the moment will have no safety implications for the environment".
§ The committee then refers to the complete account of his written evidence, which is in another volume of the report. Unfortunately, one word was left out in the publishing process. Those who are concerned with publishing, as I am in my private life, will realise that when a word is left out in the publishing process it is almost always the most important word in the sentence. At some stage of the process the word "new" was left out. Professor Williamson should have been quoted as saying that the developments:
§ "will have no new safety implications for the environment".
§ Professor Williamson was aggrieved that we misrepresented him, although it was wholly inadvertent. As was said, his full evidence, including the necessary word "new", appears at page 206 of the second volume of the report, where the rest of his evidence is given in full. He goes on to say in that evidence:
§ "However, there is a small possibility of a major environmental effect".
§ It is important to mention that he says that.
§ Some prominence has been given to Professor Williamson's views in the press, for example, in the Independent last October, when the report was published. But the committee did not rely on his evidence to come to a conclusion. Its conclusions are based on the totality of the evidence and the combined evidence of a very substantial number of witnesses.673
§ Professor Williamson urged caution. So did the committee. The committee recommended that:
§ "the United Kingdom Government, in concert with other countries active in biotechnology, presses the [European] Commission to amend the Directive"—
§ that is the deliberate release directive—
§ "to enable certain activities to be exempt from the present provisions. Those activities should be selected by a group of EC national experts on which the United Kingdom would be represented by ACGM and ACRE".
§ The committee, therefore, is aware of the need for caution. At the same time, it suggests that, in the light of experience, approval for some activities can be speeded up. It is important to note that nowhere in the report did we ask for a free-for-all, though some people suggested that we had. In that respect the committee is closer to the 13th Report of the Royal Commission on Environmental Pollution than might appear at first sight and, indeed, than some people might think—the Royal Commission not excepted.
§ In 1989 the Royal Commission said in one of its conclusions,
§ "We see no environmental justification for preventing releases that are considered safe from proceeding".
§ That is the position of the Royal Commission and it is the committee's position as well. As I said earlier, the committee was aware of factors other than regulation which bear on the competitiveness of biotechnology. I mentioned investment funds and the problems of intellectual property. The condition of the macro-economy has some bearing on that and so too does the strength or weakness of the science base in Britain. Particularly important in that respect is the public awareness of science. Public understanding not only of science but also of biotechnology is crucial.
§ Biotechnology is not new, even if genetic modification is. I do not like the use of the phrase, "genetic engineering". For reasons of which many Members of this House will be aware, I prefer, "genetic modification". I hold a specific view, of engineering. Processes like fermentation and the selective breeding of animals and plants have been used for generations. That is biotechnology, though it is different from the genetic modification which we are discussing.
§ In the committee's view, genetic modification is another step on a well-trodden path. It is not something that came completely out of the blue, as it were, though perhaps not everybody would agree with that. While there is no extreme antagonism to biotechnology in Britain, there is some scepticism. As I sat listening to some of the witnesses it seemed to me that some people were critical of biotechnology and sceptical in regard to unspecified and as yet unmeasurable benefits. At the same time, they were less sceptical—some were not sceptical at all—in regard to unspecified and unmeasurable dangers. They suffered a change of attitude and did not look at the two points in an objective way.
§ There is therefore important work to be done in educating the public. The committee believes that biotechnology will gain public acceptance in the fullness of time as it comes to be seen as useful and desirable. That is perfectly natural. In the meantime 674 positive public education is needed. That is the business of industry, the Government and, in the long term, the schools. We made recommendations in that direction.
§ In relation to educating the public, the committee did not believe that foodstuffs produced using GMOs should be labelled, though people pressed the use of labelling on us. We were not against people labelling products voluntarily, though we did not believe it should be insisted upon. We noted immediately that the safety of food is already subject to wide regulation and felt that there was no need for more. In this case labelling would give the public a wrong signal. For example, as the labelling of cigarettes is meant to convey some form of harm—sometimes fatal harm—so insisting on the labelling of GMO foodstuffs would give a similar but mistaken signal to the public. Our committee did not support it, whatever any future committee may say. As The Times newspaper put it in a leader last October,
§ "What we need to know about a genetically-engineered tomato is not how it was created but whether it is safe to eat".
§ Finally, I thank the members of the sub-committee—the individual Members of your Lordships' House—who guided me through the inquiry and produced a report which I believe to be extremely important, warts and all. We were greatly helped by our clerk, Mr. Rhodri Walters, who has since moved on to other responsibilities in the House, and to Sally Roger of the Committee Office. We were given strong backing, too, by Mr. Brian Richards, our specialist adviser, and Dr. Simon Shackley, who analysed overseas regulatory practices for us. Without their help the report would have been a somewhat limp affair. I thank too all those who gave evidence to the committee, whether written or oral, for it was on their evidence that the committee's conclusions and recommendations were based. I beg to move.
Moved, That this House takes note of the report of the Select Committee on Science and Technology on Regulation of the United Kingdom Biotechnology Industry and Global Competitiveness (7th Report, 1992–93, HL Paper 80).—(Lord Howie of Troon.)
§ 4.7 p.m.
The Earl of Cranbrook
My Lords, I am glad to have this opportunity to congratulate the noble Lord, Lord Howie of Troon, and his Select Committee on the report, and the noble Lord, Lord Howie, in particular on his admirably clear introduction to it. As a chartered biologist and natural pedagogue I am delighted also to see the admirable layman's guide to genetics and genetic manipulation that appears in the report, including the glossary of definitions and technical terms. I am sure that it will be of great educational benefit in this House, if not more widely in the public domain, and I welcome it.
The noble Lord, Lord Howie, and indeed the report at an early point in paragraph 4.3, identified the 13th Report of the Royal Commission on Environmental Pollution as an influential previous study. I speak as a member of that commission for the decade following 1981. The first point to emphasise is that the Royal Commission's report dealt only with a part of the broad 675 sweep that was covered by the Select Committee. We need to recognise that it was exclusively directed towards issues arising from the release of GMOs into the environment. It was concerned with planned releases but also addressed the question of accidental escapes from contained laboratories or sites of commercial production.
The Royal Commission study was carried out between 1986 and 1989. At that time events were moving rapidly in the field. Our conclusions benefited enormously from the advice and participation of leading practitioners in the UK and elsewhere. They were the scientists who were personally, in their laboratories, involved in studies leading up to planned releases. They wanted to get on with the job and were therefore deeply concerned to operate within a framework that would both protect the environment and satisfy actual or potential public anxiety.
The commission's report is prefaced by the words of the late Lord Zuckerman, who was, incidentally, my doctoral supervisor. He said:Governmental action to guard against possible environmental disaster has never turned out to be either premature or unnecessary".—[Official Report, 20/10/88; col. 1313.]I believe that, in the present case, events have shown that judgment to be wise and true.
Unlike the proceedings of the Select Committee—I have before me the floppy version; there is also a three volume version with evidence—the reports of the Royal Commission are not backed by the evidence, which in any case would be unmanageably voluminous. I hope that your Lordships will judge that the statutory remit of the commission and the varied qualifications and background of the commissioners are enough to ensure that its reports and its advice are based on careful, scientific objectivity.
I too should like to refer to Sir Hans Kornberg, who I have always regarded as one of this country's most quotable men. I was pleased to see, with respect, that he rebutted the noble chairman's leading question (question 776 on page 164 of the evidence) where the noble Lord suggested that the commission had been "slightly hysterical"—those are his words—in its approach. I cannot accept the suggestion in paragraph 6.10 of the Select Committee's report that there was at that time no basis for the recognition of public concern, nor the implication, in paragraph 5.13 of the report, that the views of biological scientists on the subject had not been accepted at that time by the Royal Commission. I am glad in this context to take note of the correction to Professor Mark Williamson's words—a small word but with a big meaning in context—to which the noble Lord, Lord Howie, has drawn our attention.
The 13th report of the Royal Commission made the key point that the deliberate release into the environment of GMOs raises quite different issues from their uses in a secure laboratory. The two kinds of activity are rightly subject to separate regulatory regimes. This distinction is not always sufficiently recognised in the Select Committee's report.
The purpose of the recommendations in the 13th Report of the Royal Commission were to make it, 676possible to identify proposals for release that raise concerns and deal with them appropriately on an individual basis".The Royal Commission also observed quite clearly that relaxation of the controls over GMOs and their releases can be undertaken on the basis of further experience of actual releases. I remind your Lordships that in 1989 the commission explicitly said that it expected that there would and should be changes in the regulatory regime as understanding grew.
As members of the Select Committee know, the present regulatory procedures derive from the Environmental Protection Act 1990. Since February 1993 applications to release GMOs to the environment in the United Kingdom have been handled by the Department of the Environment. The Department of the Environment biotechnology unit has scrutinised and granted consent to 11 applications since it took over this responsibility, which indicates fairly well the rate at which things are moving.
At present each application is also submitted to the Advisory Committee on Release to the Environment (ACRE) for consideration and approval before consent is granted by the Secretary of State. The 1992 regulations on the deliberate release of GMOs require applicants to provide two statements to support the evaluation of a proposed release: one setting out technical information and the other being a risk assessment statement. It is true, as the report emphasises, that the technical information contains 89 points which are prescribed in the legislation, but applicants are free to use these in the way best suited to their needs. It is also true that the present regulation allows a period of 90 days for the scrutiny of applications. It seems to me essential to preserve this maximum to safeguard reliable scrutiny.
The Department of the Environment has issued guidance about how to apply for a consent to release or market GMOs, including a framework for risk assessment which builds on the Royal Society's definition of hazard and risk, which was the result of very considerable study. I understand that the guidance has been used by applicants, with satisfactory results. My own view is that, in unfamiliar ground such as this, the approval system has to start by being strict. It must be right that no consent is granted unless and until the department is fully satisfied with an applicant's risk assessment and confident that a GMO can safely be released. I think it is scarcely fair to characterise the present arrangements as "Byzantine", as the Select Committee does in paragraph 1.8, or even as over bureaucratic and unscientific.
As another illustration of the rate at which things go, there have now been 75 releases of GMOs to the environment in the United Kingdom since 1986, and well over a thousand such releases worldwide, including more than 300 in the European Community—over 150 of those (half of them) since the 1990 EC directive came into force. I understand that the approach to risk assessment adopted by other member states is similar to that used in the United Kingdom.
It may be useful if I take up a few minutes in restating the Royal Commission's position in the light of later developments. The 13th report recognised the 677 importance of identifying, types of release which could be exempted from government scrutiny and/or categories of organism for which proposals for release should he treated differently. It also recognised that it might ultimately be possible to replace controls directed specifically at genetically modified organisms—GMOs—by reliance on wider product controls. The Select Committee report goes into the issue of product controls at some length and uses the phraseology of "vertical" and "horizontal" controls. But it is important to realise that, for the type of GMO for which release to the environment may be sought, in many cases product controls are not available as an alternative.
The Department of the Environment has already announced its intentions to streamline the process by introducing a "fast track" process for some generic products, which are to be identified by ACRE. I am sure that this will be welcome to scientists and others working in areas that by now have become familiar—because we have moved on from 1989. All parties now recognise that, in time, as experience of dealing with applications builds up, ACRE should be in a position to make generic recommendations which would cover the majority of applications.
In his evidence Sir Hans Kornberg speculated about the position the Royal Commission might take if it were to reconsider the evidence today. Although it is not the usual practice of the commission to return to the subject of previous reports, it has issued a statement to clarify its position. It may be helpful if I draw the main points of the statement to the attention of the House. First, the commission is glad to note that the Department of the Environment now considers it justifiable to streamline the regulatory procedures by introducing a fast track for certain releases. I understand that ACRE has accepted the proposal in principle provided the Government continue to follow its advice over implementation. This would have the Royal Commission's full support. The proposal goes some way to meet the views expressed by the Select Committee as summarised by the noble Lord, Lord Howie. In due course, further streamlining of the procedures may become possible without creating unacceptable risks to the environment.
Secondly, the Royal Commission's overall conclusion is that the department's arrangements for scrutinising applications for the deliberate release of GMOs to the environment are soundly based scientifically and at the same time are flexible, within the framework of a step-by-step approach to innovation which the 13th report envisaged as the basic safeguard in the regulatory system. The commission is therefore satisfied that the department is adopting a sensible case by case approach and content that the biotechnology unit of the Department of the Environment is carrying out its task satisfactorily.
For the moment, however, I do not believe that the Commission would want to follow the Select Committee in identifying, in the words of the noble Lord, Lord Howie, as "much too strict" control over the deliberate release of GMOs into the environment. I am sure that the Commission would not countenance the wholesale removal of controls over this particular 678 activity. So I am glad to hear the noble Lord. Lord Howie, state clearly that in this key concern the Select Committee is at one with the Royal Commission.
§ 4.20 p.m.
§ Lord Perry of Walton
My Lords, I must apologise to the House because I may have to leave before the end of the debate to be at a previous appointment. Therefore, I am grateful to my noble friend Lord Whaddon for agreeing to change places with me in the order of debate. Perhaps I may also point out that the Chief Whip's office has indulged in a bit of remarkable biotechnology by changing my sex. I am not Baroness Perry, I fear.
It was a fascinating experience to have been a member of the sub-committee whose report is under consideration today. Biotechnology is enormously interesting and important. I would like, first, to pay tribute to our chairman, my friend, the noble Lord, Lord Howie of Troon, who handled us and our witnesses with great skill and with a lightness of touch that kept everyone in good humour even when dealing with the most serious of issues. I agree with everything he said today.
I myself was particularly interested in the problems of the control of the products of biotechnology. That is perhaps not surprising because I spent 15 years of my life as a member of the British Pharmacopoeia Commission which laid down the standards for all medicines. For six years I was director of the department of biological standards at the National Institute for Medical Research, which acted as the control laboratory for the Department of Health in the application of the Therapeutic Substances Act. The Act controls the toxicity and the efficacy of all therapeutic substances which are not pure chemicals so that the dose cannot be determined simply by weight. Each batch must be tested biologically by comparing it with a standard preparation. The substances covered included at that time vaccines, antitoxins, hormones and antibiotics.
I mention all this, first, because I am anxious to show that I did have a lot of experience of control mechanisms but, secondly, because I want to discuss one particular example from the past which is in some ways analogous to the problems posed by the products of genetically modified organisms.
Much of what I shall say concerns the question of balancing risks. All control measures depend on determining that balance. When it has been determined, those who draft the control regulations are nearly always challenged and called upon to justify their decisions, explaining how the risks were estimated and, even if the estimates are accurate, whether the balance chosen is an acceptable one.
Some 30 years ago, when I was director of the department of biological standards, poliomyelitis was a disease that provoked much fear. There were annual epidemics of varying severity which left many, both children and adults, dead or permanently paralysed. One could, after each epidemic, calculate the risk, that year, of a person being attacked by the disease. By adding the 679 risks year after year one could estimate the risk for an individual being attacked by the disease sometime during his or her life.
Let us assume that that risk was something like one in 100. While I was director, a new vaccine against poliomyelitis, devised by Jonas Salk, was introduced. The Salk vaccine was, after a few years, superseded by the Sabin vaccine, the one currently used. The Sabin vaccine is a living attenuated virus, given by mouth on a lump of sugar. It produces an infection in the recipient which causes no harm but also produces lasting immunity against virulent poliomyelitis viruses. The Salk vaccine, on the other hand, was made by a method often used for bacterial vaccines but not for virus vaccines. The method consisted of growing living strains of virulent poliomyelitis virus and then treating them with formaldehyde. If the right amount of formaldehyde is used, it makes the virus non-infective but leaves its ability to produce temporary immunity unimpaired. It has to be injected. The manufacturing process is very delicately balanced between leaving a little bit of the virus still active or affecting it so badly that its antigenicity is lost and therefore no immunity conferred.
That balance was upset in the laboratories of one American manufacturer and, as a result, 10 children died and over 100 were paralysed by the residual active virus in some of the batches. On the other hand, many more children were saved from naturally occurring attacks of poliomyelitis as a result of the whole campaign. I was at that time required in my job to sign the certificate saying, "This batch of vaccine is safe". Since it went into about 100,000 children, it was not a very comfortable feeling.
The accident led to a full-scale inquiry into control methods in general. The public demanded a safe product. It was very very difficult for the media or for the general public to comprehend that no control method could ever give an absolute guarantee of safety. Tests depend on sampling each batch. However carefully the batch is mixed, there can be no guarantee of complete homogeneity. Thus the only way of securing absolute certainty is to test the whole lot, which does not leave any to inject into patients.
We have to deal with a balance of risks. There is, for any child, a chance of contracting the disease if left unimmunised. If the sampling techniques used in testing batches of vaccine give a probability of, say, less than one in 1,000 that there is any active virus left, is that good enough when the risk of contracting the disease is one in 100 over a lifetime? Most people would say "no". There seems to be something much worse about getting a disease because someone injected you with the bug than getting it during an epidemic by act of God. But most people might settle for a risk of one in 100,000. Overall, the chance of getting infected in the years the Salk vaccine was used were of the order of one in half a million.
Perhaps we may take a second example of the balances of risk. We can choose to look at what happens to people who are exposed to a nuclear power station. Here the balance is more complex because, first, the 680 benefits of using nuclear power from avoiding atmospheric pollution are benefits to mankind as a whole and not, like immunisation, benefits to the individual, whereas the risk of damage is a direct risk to the individual living in the environs of a nuclear power station. Secondly, the risks are extremely difficult if not impossible to quantify because there is a paucity of clear evidence. The risks of atmospheric pollution and the resultant global warming are not immediate and people are less frightened by future risks even though they may threaten the survival of the entire human species. But it is that threat that makes it absolutely necessary to try to estimate the balance of risk even in such a difficult case.
When we come to biotechnology, we have situations which are analogous both to the polio vaccine and to nuclear radiation. At the moment almost all the products of biotechnology which are already on the market in this country are those which are controlled under the current regulations for the contained use of genetically modified organisms. Most of them are medicinal products such as human proteins, new vaccines and diagnostic agents. For these products the situation is analogous to that which arose with the poliomyelitis vaccine.
A good example is human insulin. This is manufactured by taking the gene that provides the instructions to a human cell to produce insulin and inserting it into the genome of a bacterium. When those bacteria are grown in cultures, which can be done on a large scale and very quickly, they all dutifully produce human insulin. The bacteria can then be killed easily and effectively and the insulin separated and purified. There is no remaining trace of any genetically modified organisms; and we are left with a preparation of human insulin that is indistinguishable from preparations made by any other method. It is true that while bacteria are easily destroyed, DNA is remarkably robust. It is probably true that the very robustness of DNA was a necessary factor in evolution taking place at all. It is perfectly easy to devise tests which can be applied to each batch of the insulin to ensure that there is no remaining DNA.
We thus have a situation where there is a very small risk to the individual given the human insulin for his diabetes; and a very significant risk to him of allergic reactions to all the insulins from other species. Both risks can be estimated with some accuracy and a balance struck. It is overwhelmingly in favour of using these products of biotechnology and of controlling them just as one controls products not derived from genetically modified organisms. That is what we strongly recommend in our report.
On the other hand, if the decision is taken to release a genetically modified living plant or animal into the environment, the situation is very much more complex. As has been said, by selective breeding people have produced new varieties of roses, potatoes and grapes, of dogs and cattle and pigs—varieties that have some specially desirable characteristic. This causes no outcry; it is just good farming practice. Yet it is quite obviously interfering with nature. If, however, a new variety is produced in the laboratory, people are instinctively much more sceptical about letting it loose. It is seen as interfering with nature in a way that is of an altogether 681 different order. Yet in most cases the risks are no greater than releasing a new variety produced on the farm by selective breeding.
In saying that, I do not mean to gloss over—I am sure that the committee did not mean to gloss over—the fact that, especially where pathogenic organisms are concerned, there is a real need for very great care. But the fact that there are situations where that very great care must be taken should not be allowed to dictate all the control procedures for the vastly greater number of instances of vanishingly low risk.
I am arguing the case for a much more sensible and sensitive drafting and application of the control regulations. Currently they exert a very considerable depressant effect on British industry and we must change that, for the biotechnology industry will be of enormous economic importance in the next few decades. The whole thing is beset by the emotional reactions of a public whose fears are very real but are usually based on the scarey stories put out by the tabloid press and other media and on a total lack of understanding of the facts. A similar problem exists with other situations where the issue is emotionally upsetting, like living near nuclear power stations. Politicians are necessarily sensitive to the irrational fears of their constituents and they are advised by a Civil Service that is itself relatively ignorant.
The noble Lord, Lord Tombs, of Brailes, in his Mountbatten Lecture in November this year, summed up the situation very cogently. He was dealing with an understanding of industry. I am referring to an understanding of the biotechnology industry and I cannot resist quoting his words. He said:From Government we require some quite fundamental changes in attitudes and practices. Let us first examine the role of politicians. Few of them have any experience of working in, much less managing, industry; yet they have a deep belief in their abiliiy to shape and inflnence industry, sometimes through direct intervention and sometimes through studied neglect.A degree of humility and self-questioning would be a welcome development. The scientific method of hypothesis, controlled experiment and modification of the hypothesis if necessary, is foreign to the attitude of politicians driven by a Parliamentary timetable but an occasional recollection of the fate of major industries at the hands of politicians of both parties should give pause for thought.In general, the advice received by Ministers from their departments leaves much to be desired and, since pressure of time often forces them to rely upon such advice, the shortcomings are serious. They stem from the essentially amateur approach of the Civil Service, which I suppose they would prefer to call generalist. It is rare indeed to find a senior civil servant with any knowledge of science, engineering or accountancy yet this lack does not appear to innibit the offering of advice on highly complex and sometimes technical matters where numeracy and some acquaintance with the technology of the issues would be valuable. This lack is compounded by the practice of moving civil servants every three years or so, usually to departments far removed from the individual's experience. As a result, in my experience, the quality of advice given is often very poor and is usually concealed from the outside world for a wide variety of procedural reasons.This approach is a luxury we cannot afford. Maybe we can afford to take a relaxed attitude to cricket, but the economic performance of the country is much too important to us all to be treated in such a casual way.I cannot find a better way to describe the situation that faces the biotechnology industry.
But what about public understanding? I spent 12 years building the Open University, one of the most 682 effective ways of providing access to education to the adult population, so I am particularly concerned about the public understanding of biotechnology. We heard a great deal of evidence at the sub-committee about the need for such public understanding and about the lack of adequate steps to provide it. The Engineering and Science Research Council carried out a survey for the Department of Trade and Industry on the public perception of biotechnology. It showed that the public put most trust in such bodies as Friends of the Earth and Greenpeace for advice, information and opinion and least in the newspapers, multinational companies and government.
We received a lot of criticism of the media, which were accused of being more interested in controversy than in information. The Confederation of British Industry said there was no government department which acted as a champion with a clear remit to promote biotechnology. Professor Weatherall said, and I quote:I don't think that the British biotechnology industry is sufficiently aware of the importance of taking the public along with them. Nor do I think that government is aware of the importance of the public appreciation of biotechnology and its implications".The Biotechnology Joint Advisory Board in 1991 said,there is a strong case for publicly funded initiatives to improve public perceptionsand our final recommendation was that DTI should respond positively to that.
We desperately need a more rational approach and this calls for a much better informed public, a much better informed Civil Service and a much better informed Parliament.
In summary, the vital messages in our report are, first, that the Government must act to ensure a more sensible and sensitive drafting and implementation of the regulations to control the products of biotechnology; and, secondly, that they should play a much more active role in improving the public perception of biotechnology. In my view—I hasten to add that this is my view—financial resources for this should be provided by industry, academia and Government but the lead must be given by Government. I commend the report and these messages to your Lordships.
§ 4.48 p.m.
§ Lord Brain
My Lords, I shall follow what the noble Lord, Lord Perry of Walton, said as I develop my speech, but I should like first to thank the noble Lord, Lord Howie of Troon, for the excellent way in which he introduced this complicated and broad report. The noble Lord, Lord Perry, said that the House needs educating and we have already had a very good lecture on what biotechnology is about, and how it affects us all, in the speech of the noble Lord, Lord Howie.
I speak as a scientifically intelligent layman who has not had the advantage of serving either on the Select Committee or on a commission, as have previous speakers, but I should like to pick up the main point that this is a question of public understanding and education. The vital recommendation is that relating to the development of public understanding. The idea that the subject should be dealt with in schools is fine but that is not the generation that forms part of the electorate at the 683 moment; it is not the group that is influencing public opinion at the moment. A two-pronged approach is needed on the education side.
Taking the schools approach, I noticed in the report a suggestion that the subject might be included in the schools' general curriculum. That would be fine if one could be sure that the problem of biotechnology was taught by someone who was scientifically literate and who had been educated in understanding biotechnology. Earlier this afternoon some of us heard comments on a report in which it was said that 25 per cent. of the people teaching science in schools had no scientific background. It would be a disaster if that 25 per cent. was made responsible for teaching biotechnology or an understanding of it.
As the noble Lord, Lord Howie, said, biotechnology has been with us for a long time. Different yeasts for making beer and bread have been selected. There is also grain, or perhaps something closer—the breeding of cows and race-horses. My theme, to the extent that I shall be talking on a theme, will be related to pharmaceuticals and the biotechnology of pharmaceuticals. Penicillin was one of the earliest biotechnological processes. Look how many lives that has saved. There were never any scares that something would be released accidentally into the environment.
Again, on the subject of education, I support fully what the noble Lord, Lord Perry, said about the education of those in the design of the regulations and the control of this technology programme, but to what extent is biotechnology different from the manufacture of pharmaceuticals? Many of the hazards are the same. The process of obtaining the answer is different. The method of biotechnology is a much more accurate way of obtaining the answer in manufacturing pharmaceuticals. If one is manufacturing something chemically, there is a risk of producing an isomer. For those who can remember the thalidomide cases, the problem was that there was an effective, active, element in its manufacture, but, unfortunately, there was what was thought to be an inactive isomer which in fact caused the thalidomide disaster.
If one is using a biotechnological technique, one does not make the isomer. One cuts off the small amount of amino acid or protein that one wants to use, targets it onto a carrier and targets and designs the active element to treat the disease, or the ailment, or to attack the virus that one wishes to attack. The methods by which the process has to be designed means that one can detect what is going on much more accurately than can be done pharmaceutically. There is no contamination, and the whole process can be better controlled.
I am aware that there may be escapes of active elements during the process, but escapes of acids, solvents and such things already have to be contained. The chemical and the biochemical industries are well aware of the necessity for containment.
I have had the advantage of going around a biotechnology development plant. I was astounded at the way it was controlled, the understanding the people had of the problems and the great skill that they were using. That is why we have to keep up to date. The 684 regulation side is important. It must be sufficiently restrictive—I emphasise the words "sufficiently restrictive"—but it must be responsive to changes in methods of manufacture and the changes in controls, and the only people who know what they are—this again supports the statement made by the noble Lord, Lord Perry—are those who are doing the job. I agree that the HSE is learning fast, because its staff are the people who go onto the shop floor and it is at the sharp end. That is most important, but one must be aware that there are problems.
There needs to be careful control of the regulatory procedures and the information that has to be given during those procedures. If a company is working with a particular amino acid or set of carriers, that information is commercially important. It is needed for regulatory purposes, but it must be used for regulatory purposes only. There must be no risk of leaks. If one is developing a process in which there are one or two active elements, but it is necessary to use 50 or 100 carriers, that means 50 applications and 50 times the risk of a leak of information.
Another piece of information which is just as important, and even more likely to leak out sometimes, is when someone has ceased to apply to use a particular product, or amino acid, because they have discovered that it is of no use. Should that information leak out to a competitor who is working on a similar project, that competitor would then be able to stop the process. That would be to the commercial disadvantage of the first applicant. One must be careful. I know that we have Chinese Walls and such things, and I know that one always hopes that they are effective. I think, and hope, that in this country they are. However, there is always the risk that if there is a European committee someone may be indiscreet and let out, "We have had an application for product so and so". That may point someone in that direction, because we should not forget that, for example, in France the regulator of today may tomorrow be the managing director of a biotechnology company, or he may have come from a biotechnology company to do his regulating. It is not like our Civil Service, although that may be an advantage or a disadvantage so far as concerns our Civil Service. It is something about which one needs to be aware. An exchange of information is always valuable for regulatory purposes, because it is pointless to regulate unnecessarily.
I suggest that when the regulations are set out by Act of Parliament, or by order, they should contain a clause that insists that they are looked at three or five years later, and perhaps revised, or amended, as necessary in the light of the development of techniques. When legislating for anything like this, it is difficult to anticipate in a fast-moving industry such as biotechnology, the developments that may occur three or five years later. We need a revision programme. One of the problems with European directives is that at the moment the Commission is so busy producing them that it does not have time to go back and look at what it has already produced and to think about revising them. I have said enough. I support the repot.
§ 4.50 p.m.
§ Lord Wade of Chorlton
My Lords, as a layman and one who has virtually no scientific background it was a great privilege for me to be invited to sit on the committee. I admired the way in which our chairman, the noble Lord, Lord Howie of Troon, conducted the proceedings. I enjoyed also working with those members of the committee who were far more knowledgeable about the issues and the opportunity that was presented for learning more about the subject.
The committee received evidence from a large number of scientists and industrialists and from people who were against biotechnology. Indeed, some were against any new developments. A number were worried about this particular technology. As I listened to the evidence I was struck by the ability and the clarity of expression of the scientists, their great understanding of the subject, their awareness of the ramifications of the technology and their certainty about what was and was not safe. I was struck by the fact that those who were against the new developments had no scientific evidence to support beliefs that were dominated more by prejudice than by knowledge. I came away with not the slightest doubt that those who gave the scientific evidence had to be listened to. I support very much the conclusions of the Select. Committee.
Biotechnology is no great mystery. It has occurred in the development of mankind and the products of society ever since time began. I have spent most of my life as a cheese maker. I am probably a more practical biotechnologist—although I would never have believed it—than many of the people involved in the committee's study. As the evidence emerged it became clear that many fears are not related to the actuality of the new technique—it is merely a technique and not a great new approach—but to a lack of understanding.
As I listened to the evidence I became aware of the enormous benefits which the technology provides for all. We are able to carry out techniques in a clearer, more precise and more effective way. If developments took place in the course of nature, the introduction of new projects and ideas would take time and possibly many mistakes would be made.
The noble Lord, Lord Perry, mentioned the pharmaceutical industry and the many benefits which every person in the world now derives from its new products as a result of biotechnology. We all use diagnostic agents, which would have been impossible to operate only a few years ago. Antibiotics have been mentioned. Great possibilities are being opened up in food production as regards better productive and more economic methods. We all use detergents, and every day commodities are being produced more efficiently as a result of this technology. Advances are being made in leather production. We are becoming world leaders because, as a result of biotechnology, we can be more efficient in production. The same applies to paper production, the development of novel foods and plastics and polymers. More importantly, the technology will help us to preserve our living ecosystem, about which so many people are anxious. It will also help a great deal in the protection of the environment.
686 I shall leave other noble Lords to deal with the scientific aspects of the subject but there are also important economic and environmental aspects for our future. I do not need to remind noble Lords that in the next 50 years we anticipate that the world's population will double from 5 billion to 10 billion. Many new scientific methods will be required to deal with that because we must preserve the environment that people want while at the same time create the wealth that they will demand and the services and resources that they will use. There is not the slightest doubt that the development of biotechnology will make possible more than we ever dreamed of a few years ago.
It is essential that our society gives every possible encouragement to those who are developing biotechnology, those who wish to invest in it and those who need every opportunity to get new products onto the market. It is quite clear that there is not the inherent danger that only a few years ago it was believed existed. Although one would never criticise those who a few years ago made the decisions about regulations without today's knowledge, it is right and proper that the regulations should continually be reviewed in the light of new knowledge and opportunities which the technology presents. We should respond to them in a positive way in order to encourage further investment.
That is all I feel it appropriate for me to say about the report. I support and encourage its recommendations and I hope that the Government will respond to them positively. I wish to take this opportunity to tell your Lordships that, as a result of being involved in the Select Committee, I and my noble friend Lord Soulsby were given the opportunity to lead a delegation of biotechnology scientists to the United States in order to look at its industry. By a happy chance my noble friend Lord Soulsby went to Washington and I went to San Francisco. The weather that I had was a great deal better than the weather he had to suffer. It might be interesting to remind your Lordships of what we learnt on the trip and of the approaches which are taken in the United States, which might help us to be as positive.
We visited various people and took evidence from them. One of the first people we went to see was Steven Burrill who is the technology specialist of Ernst &Young. In that capacity he has world-wide responsibility for all Ernst & Young's contracts in the area of biotechnology. He made some interesting comments. He felt that scientists left the UK and went to the US because they could not become rich enough in the UK. That has a lot of underlying meaning. He went on to tell us that the biotechnology and pharmaceutical sector in the United States is already a 150 billion dollar-business, greater than the electronic business was at the same stage of its development. He thought that we were in the middle of a new industrial revolution of which the capital markets would decide the final success.
Although we have discussed in the report the implications of regulations, one cannot divorce the implications of those regulations on the availability of capital, which is the very life blood of all new developments. Mr. Burrill went on to say that a very important factor is the Government's attitude because government regulations decrease the predictability and 687 therefore the financial support. In all aspects of such developments we must always remember that predictability encourages venture capital and makes things possible.
Mr. Burrill explained to us, as did many other people in the US, that it now costs between 150 million dollars and 200 million dollars to take a biotechnology product from the idea to the marketplace; that is, to take it through all the regulation processes, to introduce it to the public and to get it accepted in the marketplace. Those figures show that such investment is practical and possible only if one is developing a product for a large marketplace. Those in the United States believe that their marketplace is just about big enough. But as costs continue to escalate, even they are becoming anxious and are having to look further than the US marketplace.
In developing the advance technologies which are now possible and which will bring benefits throughout the world, people are looking for world markets. However, if we are to have a world market, we must have a world-based regulatory system. Wherever there is investment people will need to know that they will be able to get a return on it and that that product will be marketable and made available throughout the world.
Therefore, one aspect at which all governments need to look, if they see the advantages of this new technology, is the need to ensure that we work towards a regulatory system which is effective and equal throughout the world so that investment in one place can be attracted in the knowledge that it will be possible to obtain a return on a worldwide basis.
We visited the University of California Technology Transfer Company. We were enormously impressed by that organisation. It had been set up by the universities of California specifically to commercialise the new technological developments coming from those universities. The company was responsible for the licensing, the patenting and the marketing of those products. It was explained to us that throughout the campuses of the University of California, 40,000 academics are involved in the development of new technologies. I know that in the course of putting together the report, noble Lords were concerned that, if we are to have new ideas and innovation, we must encourage young people to think about it and to be motivated to develop new ideas. They must know also that they will benefit by their development. In California alone, there are 40,000 young minds concentrating on developing something new and better for all mankind. What a wonderful resource that is.
One other important issue was pointed out to us by a Denise Gilbert who was then a US analyst with a large firm of stockbrokers which looked specifically at the biotechnology industry. She told us that one of the important roles that our Government could play in helping the world scene would be to give more information to American analysts and companies about our system of quality product control in the biotechnology industry. Very often biotechnology products produced over here have to go through another system in the United States because the Americans do not understand the basis of the system on which they 688 have already been passed and agreed over here. That increases the cost of products produced in this country. Again, that is an area where we must forge links with other countries if Britain is to take advantage of this great opportunity to become a centre for the development of biotechnology.
It is quite apparent from the reports and the evidence that there is still too much diversity of regulation throughout EC countries. Unless we rectify that, it will become more and more difficult to have standardised regulations throughout the world. That is clearly the first step. The simplified approaches suggested in our report, which make such enormous sense, should be quickly put into effect.
I ask your Lordships to look at page 58 of the report. Paragraph 6.31 states:It is a logical consequence of our analysis of product and process regulation that work on further process based EC Draft Directives on GMOs should cease forthwith. Furthermore we wholeheartedly reject the concept of a "Fourth Hurdle" of socio-economic need as an additional criterion in product regulation of biotechnology".We included that sentence because, in the course of the evidence we heard, it was suggested that the Commission is now being urged to consider that fourth hurdle before allowing certain products to go onto the marketplace. It seemed to us—and it seemed to me in particular—that once we have to prove the need for the development of a new product, it will be extremely unlikely that such a new product ever comes into existence because it is virtually impossible to prove need. We hardly need most of the things that we enjoy. It is not possible to look at this matter on the basis of need. I hope that if the time comes at which we must consider that idea, we should throw it out. I have much pleasure in supporting the report.
§ 5.5 p.m.
§ Lord Beaumont of Whitley
My Lords, I too thank the Select Committee for its report and in particular, the noble Lord, Lord Howie, for his introduction of it. I have benefited from the discussion so far and in particular, from the speeches of the noble Earl, Lord Cranbrook, and the noble Lord, Lord Brain.
I am rather unhappy that there has not been more discussion on some of the ethical issues, both in the examination and report of the committee and in your Lordships' debate. It is slightly sad that there is no speech from the Bench of Bishops on that extremely sensitive area.
I shall concentrate on one small but important part of the report; that is, the deliberate release of genetically modified organisms. Your Lordships may well ask, when looking at the impressive qualifications of noble Lords taking part in the debate, what qualifications I have. The answer is that I do not have very many qualifications. I have a rather poor degree in agriculture, and I am the son of a very successful and quite inspired animal breeder. In passing, I should say that much sleight of hand has been going on this afternoon by those who suggest that the kind of thing which my father did and was proud to do is on the same kind of level as the genetic engineering which is taking place today and which is planned for the future.
689 I was the founder director of a body called the Green Alliance, which gave evidence to the committee and which has commented since on the committee's report. I make it quite clear that, although I admire Greenpeace and I believe that there is a certain amount in the stand which it has made, I am not talking about Greenpeace. I am talking about the Green Alliance which is a small, perhaps elitist, body of concerned people who are prominent in public life and who are interested in such subjects.
The director of Green Alliance, Julie Hill, gave evidence to the committee. She has been a member of the Advisory Committee on Release to the Environment since 1990. That should be firm evidence that she is not against the whole question of the development of the release of GMOs. If she were, it would not be possible for her to sit on a government committee advising on consents for release.
However, it is fair to say that the Green Alliance is in favour of pro-active regulations which aim to minimise the possibility of environmental damage from this technology. When I refer to the Green Alliance, I identify myself with its views because I have read and accepted its arguments and discussed them with many people.
I believe that the committee's report is unduly dismissive of the arguments put to the committee that GMOs may pose environmental risks and that its criticisms of the regulatory system for deliberate release are in many ways misplaced. I believe that the noble Lord, Lord Howie, said towards the end of his speech that it seemed to him that some witnesses seemed sceptical of the benefits and not at all sceptical of the hazards. It seems to me absolutely right that we should be sceptical of the benefits and not of the hazards. We all know Murphy's Law when it comes to hazards and we all know of a great many pies in the sky which eventually come to nothing. It is better, as they say, to be safe than sorry. That is so even if it means risking some advantage in global markets. The report concluded that the UK regulations, which are based on EC directives,take an excessively precautionary line".It seems to me that that view amounts to a dismissal of the concerns voiced in the 13th report of the Royal Commission on Environmental Pollution, about which the noble Earl, Lord Cranbrook, has spoken to us this afternoon. That report was admittedly published in 1989 and, together with the EC directives, had a strong influence on the development of UK regulations. Some of our most eminent scientists, including the noble Earl, Lord Cranbrook, sit on the Royal Commission and evidence was taken from a wide range of expert witnesses.
The report describes the Royal Commission's findings as cautious and draws attention to the fact that the Royal Commission did not recommend against releases per se. That may be so but the Commission did consider the potential risks great enough to recommend, in terms which could hardly be described as cautious, that, 690the addition of commercial pressures to the quest for scientific knowledge makes it even more important to develop a system by which the environmental risks arising from genetic engineering are evaluated, regulated and minimised".The report contends that practitioners of the technology take the view that fears about deliberate release have been misplaced and that the hazards were minimal or non-existent, although this is acknowledged to be,with certain theoretical exceptions following deliberate release".Those theoretical exceptions are, unfortunately, unspecified.
There is little direct evidence cited in the committee's report in support of the argument that the hazards are over-emphasised. There is a comment from the AFRC which bases its reassurance on one limited and considerably criticised set of experiments, the PROSAMO programme—planned release of selected and modified organisms. There is a comment from one of the UK's largest plant breeding companies who contend that it is impossible inadvertently to create a weed. However, that ignores the possibility of transfer of genes over several generations, and it has been argued that it could take decades for weedy characteristics to become apparent. I would say in parenthesis there that it is, I think, fairly common sense that if one spends one's time developing organisms which are resistant to their natural predators, one is apt to produce something which may, if not take over the world, at least cause a considerable problem in the future.
We have already heard about the unfortunate omission of the word "new" from the quotation of Professor Williamson. I would suggest that the effect that that may have had on the committee's report has been minimised because the committee argued from that. It was not for no reason that Professor Williamson was, as I understand it, quite angry about the whole incident.
The evidence cited in the committee's report does not, in our view, amount to a scientific or rational reappraisal of the risks outlined in the Royal Commission's report. It certainly does not amount to a body of evidence that should reassure us about the environmental impacts of deliberate release. The fact is that we have little scientific evidence about the long-term effects of deliberate release. Little has happened to update our knowledge in the past four years. The six years' experience of releasing GMOs is nothing when one considers that significant changes in the natural environment can take place unnoticed over decades and then unexpectedly accelerate.
For instance work is being done to improve the killing ability of certain viruses that are specific to insects; yet there are still unanswered questions as to what determines the host range of these viruses in the wild, and how they persist in the environment. Parts of plant viruses are being grafted into plants themselves to confer resistance to infection; yet the possibility of recombination of virus particles to produce new diseases has not been discounted.
Crop plants are being engineered to be resistant to the spray of herbicides and that raises the problem which I have already mentioned. It should be stressed that in the 691 EC experiments in all these fields have gone forward so far with appropriate safeguards because a regulatory system is in place to consider the possible dangers and unknowns and put conditions on the release. Unregulated or less regulated releases in pursuit of any of these lines of inquiry would be another matter altogether.
The report's assertion that the,regulations fail to discriminate between activities involving real risk and those which do not",seems to be based on a misunderstanding of their purpose. In order to come to a view about the degree of risk posed by any given release, it is essential to scrutinise releases and that will only happen if a regulatory system is in place.
It is therefore important to reject the call for regulations that apply only to work which is not in the low to negligible risk category, which the committee does not define in its report. Releases judged by the present regulatory system to be of low risk may be so because of the conditions that are put on their release, the way they are managed or the monitoring required. This would not be possible if they were put entirely outside the system.
We can only hope that once the dust has settled from the DTI's deregulation drive—I know that it has been said that this has nothing to do with this debate; nevertheless it is the context in which this report has come forward—it will be possible to return to a proper debate about the future of risk assessment for releases of GMOs. The message of the Strasbourg conference was that, while it is possible to be reasonably confident that releases taking place under present procedures will not cause problems, at least not immediate ones, it is impossible to be confident about the long term effects of many of the possible applications of the technology. Here I entirely agree with what is being said about education, provided that education does not just mean propaganda for the advantages of biotechnology unregulated, which has sometimes seemed to be slipped into the argument. If it is proper education, it is absolutely essential. We need to move the debate outside the small circle of regulators, scientists and industry representatives to a wider circle of those with environmental expertise and concerns.
The future of biotechnology will in part be determined by the acceptability to the public at large of different types of environmental risks and a debate now may help prevent wholesale rejection of the technology later. In closing, I go back to the point I made earlier; that it is right to be sceptical of benefits that are promised and it is right not to be sceptical of hazards because, as we know, hazards, diseases and disasters can occur across the world. Hazards can cause immense harm to the human race and indeed to the future of this planet.
§ 5.18 p.m.
§ Lord Walton of Detchant
My Lords, it has been a privilege and a pleasure to have served on the sub-committee so ably chaired by the noble Lord, Lord Howie, and so very well served by its clerk and its 692 expert adviser. I hope that I may at the outset repeat, as other noble Lords and our report make clear, that regulations governing the new biotechnologies, and in particular those governing the release of genetically manipulated organisms, are in the UK at present significantly more restrictive than in countries such as the USA, Japan and Australia.
The regulatory system in the United States is firmly product based and the US Government have argued strongly that regulations should be based on demonstrated risk and should not depend solely on the fact that an organism has been genetically modified. In Japan the government accept the advice of the Organisation for Economic Co-operation and Development to the effect that biotechnology does not demand specific legislation. By contrast the EC directives to which the noble Lord, Lord Howie, has referred, and upon which current UK regulations are based, are much more stringent and seem to have resulted from the fact that many of those concerned with their formulation believe that these methods carry much greater hazards than experience has shown to be the case.
It is also true that implementation of the directives within member states has varied. Germany and Denmark in particular have taken a very strict line, while in this country we have implemented a very demanding regime extending the contained use regulations to cover animals and plants as well as the micro-organisms specified in the EC directives.
As the noble Lord, Lord Howie, said, and as other members of the committee have confirmed, it is proper to continue to have process-based regulations on current lines for research and development in the very limited areas where regulation is required; that is to say, work involving pathogenic organisms and for deliberate release of GMOs outside the "no negligible risk" category. I must say to the noble Lord, Lord Beaumont, that in my opinion that category has been adequately defined. Work on further process-based EC directives should surely cease forthwith, as the noble Lord, Lord Wade, said, as the current regulatory framework places the UK biotechnology research and development at a significant competitive disadvantage vis-a-vis our principal overseas competitors.
It is essential that in this country we should revert to a product-based system of regulation while taking full account of any potential risks, even though those which are potential only have been greatly exaggerated by many organisations and individuals. Clearly, too, universities and research councils should be exempt from paying fees on applications for deliberate release, and our report stresses the importance of seeing that applications under existing regulations should be processed in much less than the present limit of 90 days. It also follows, as several noble Lords have said in this debate, that a major programme of public information and education, especially of the young, is needed to combat what I fear is much of the ill-informed and mischievous propaganda that has bedevilled this subject in some segments of the public domain.
One only has to consult the autumn 1993 edition of the Medical Research Council News to learn how vital 693 biotechnology is proving and will prove to be in relation to the future economic well-being of this country. I do not propose to comment on those techniques which are proving increasingly fruitful in the agricultural and veterinary fields, while I note with pleasure the recent initiative of the Agricultural and Food Research Council inviting greater public debate on the genetic modification of plants. However, I wish to emphasise that value creation in biotechnology is shown to be substantial in relation to human therapeutic products. The increasing number of biotechnology companies which are thriving in the UK pays due testimony to this important development, as does the fact that the British pharmaceutical industry, one of our greatest successes in innovation and development and in our export markets, is also intimately involved in this field.
I should point out (with apologies to the noble Lord, Lord Howie) that for some years now we have had genetically engineered human insulin. Monoclonal antibodies developed by biotechnology have become increasingly important in diagnosing human disease. Some such antibodies are now proving to be effective in treating sepsis and rheumatoid arthritis. Innumerable developments have also been achieved already in the management of cancer, of autoimmune disorders and of a variety of inflammatory diseases, many based on important research discoveries in molecular biology and immunology.
Without question this is one of the fastest growing and most exciting sectors of British industry. Nothing should be allowed to stand in the way of exploiting the discoveries which are now emerging almost every week and which carry a huge potential for future improvement in human health, always accepting that the methods employed and the products so produced must be shown to be safe. The regulatory framework under which those companies work must therefore be sufficiently flexible to allow rapid exploitation of discovery and invention.
British and British-based scientists are without question leading the field in several such areas. We simply must not allow their efforts to be frustrated or stifled by excessively bureaucratic administrative procedures and by substantial financial barriers.
Perhaps I may be allowed to highlight one particularly exciting field which is developing apace; namely, that of gene therapy. Drugs based on developments in such technology may be used not just to treat inherited disease resulting from single defective genes but can also play an important role in disorders such as cancer, inflammatory diseases and AIDS. Every week or two we learn that another defective or abnormal gene responsible for causing an inherited human disease has been located to a particular point on a specific chromosome in human cells. In many instances such discoveries have been rapidly followed by full characterisation and sequencing of the abnormal gene and in some instances by discovery of the missing product which the abnormal gene fails to produce or of the abnormal combination of amino acids which alternatively some genes produce and which damage human tissues.
The gene responsible for the Duchenne and Becker varieties of muscular dystrophy, progressive and 694 ultimately fatal disorders in which I have had a lifelong interest, fall into the former category. The missing gene product—namely, dystrophin, a constituent of the membrane which covers the normal muscle cell—is absent or severely deficient in those conditions, thus allowing a progressive process of muscle cell breakdown. Active work is now going on in this country and in many other parts of the world in order to find a means of delivering the dystrophin gene construct into the human muscle cell in order to restore muscle function and thus to control or, it is hoped, to cure the disease.
One such method involves the splicing of a mini-construct of the dystrophin gene, that is an appropriate segment of DNA, to a harmless virus which could then be given to the affected individual in order to carry the missing substance into the cells throughout the patient's body. There are as yet many obstacles in the way of such a development, but work along those lines is moving fast and the existence of muscular dystrophy in some strains of animals which have a similar defect of dystrophin is helping greatly.
In yet another inherited disease—namely, cystic fibrosis —an alternative method of delivering the gene is being used by packaging the missing DNA material into tiny fatty envelopes called liposornes, which can then be inhaled into the lungs; organs which are severely damaged in that disease.
Those are but two of the conditions in which the prospect of gene therapy is within sight of becoming a reality. Such developments of course require cloning of the relevant segments of DNA: that is, reproduction outside the human body of multiple copies of that specific portion of the DNA molecule which is missing and must therefore be replaced in the body Such work is one of the fundamental processes in this field of biotechnology. It is good to know that the Government have established an informal regulatory and supervisory mechanism by setting up a committee, to be chaired by the distinguished paediatrician, Dame June Lloyd, to oversee, I am confident, in a suitably precise but nevertheless supportive way, work in this and other related fields in the UK. Such work is crucial to the future of medical and biotechnology research.
I could quote many other possible developments, but I feel it appropriate to raise another important area of anxiety which was ventilated during the deliberations of our sub-committee, although it is not specifically mentioned in our conclusions and recommendations; that is, the question of the patenting of human genes.
Correspondence which I have had on this matter with the Patent Office and with the right honourable lady, the Secretary of State for Health, has not totally allayed the anxiety felt by myself and by many other doctors and scientists who believe it to be unethical to patent segments of the human genome. Similar concerns were expressed by me and other neurologists at a recent meeting of the American Neurological Association in Boston, USA, as we have learned over the past few years that a number of DNA segments with as yet no known function have already been the subject of applications for patents by US scientists. Until recently the position in the UK appeared to be that, following the 695 example of the US National Institutes of Health, the MRC had felt it prudent to file applications for the patenting of gene sequences obtained at the MRC Human Genome Resource Centre, in an effort to protect the UK industry should such patents be granted. The view generally held was that while it was improper to patent human gene sequences within the human body, those derived from cloning DNA segments outside the body could properly be the subject of such patent applications. Most of us concerned with research into human genetic disease feel that the latter, too, is unethical, believing that all such discoveries should be made available to the medical community at large throughout the world without the payment of substantial royalties, particularly as the prospect of effective gene therapy draws nearer.
I was glad to learn that the US Patent Office recently raised significant objections to such patent applications and that the MRC has decided in consequence against filing any further patent applications for DNA sequences of unknown function, but will share them immediately with other researchers through databases. I can only express the hope therefore that any further applications will be discouraged for the reasons that I have given.
I am happy to commend to the House this exciting and far-sighted report in the preparation of which I was privileged to play a minor part.
§ 5.30 p.m
§ Baroness Platt of Writtle
My Lords, the debate occurs during Budget week, an issue which is no longer the business of this House. Nevertheless, we are all responsible citizens, sensitive to the dilemmas presented in balancing the national budget.
As medical science progresses, the general public gradually come to trust a new operation and to demand the cure that it provides. There are now waiting lists for hip operations whereas in the 1970s people regarded such operations as risky. Expensive pills which our parents would have refused are taken willingly today. Our health service costs more as a result, and to meet public demand public expenditure rises. That is true in other departments of state also. How do we pay the resulting bills? We must manufacture useful and desirable products both to fulfil our own needs and to export successfully in a competitive world.
Recently the Government published a White Paper, Realising our Potential, the theme of which is similar. It states:The understanding and application of science are fundamental to the fortunes of modern nations. The history of the UK has shown the intimate connection between free trade, the application of science to tradeable products, and national prosperity. Science and engineering also make a most important contribution to improved public services and the quality of life. For example, recent developments in the bio-medical sciences have made possible the improved diagnosis and treatment of disease and allowed a greater emphasis on preventative medicineThose benefits are self-evident.
As a nation we are rather good at biotechnology and its applications, whether that means scientists researching or industry applying the results of that research. We 696 are talking about a growth industry whose potential in generating income abroad and fulfilling our own needs is great. It will not help us as a nation to strangle that industry at birth through excessive regulation and the demand for conformity with time-consuming bureaucracy, as my noble friend Lord Wade said when he highlighted what is possible in the USA. Crops can be planted only at certain times of the year. Those who apply for patents must be able to do so at an early stage or they lose their competitive advantage. Delays caused by answering many questions and waiting several months for permits will prevent a firm's success.
Biotechnology is a comparatively new field of science. One can understand early regulators erring on the side of caution because of its complexity and novelty, and because they foresaw risks that, thankfully, were not realised. However, we have been fortunate in this country. Scientists and engineers involved in the development of the technology have been cautious and have avoided risks and the possibility of catastrophe. The committee was impressed by the careful and highly responsible way in which experiments were carried out by good laboratory and industrial practice and the resulting processes and products that developed.
I cannot pretend to an in-depth understanding of all the ramifications of the subject. It was fortunate that we had on our committee noble Lords who have that understanding. That has been amply and ably demonstrated by noble Lords today. I leave the detailed comment to them. We are grateful to our splendid chairman, the noble Lord, Lord Howie of Troon.
Perhaps that complexity gives a clue to the balance needed in the future. Our witnesses talked of "transparent regulation", "reasoned and reasonable regulation" incorporating stringency at first,followed by relaxation as a record of safety and sound practice is established".The aim of such regulation has been to build a strong foundation of public confidence which is essential if the public is to buy and use the new products. Otherwise our industrial competitiveness in the field will never be realised successfully either at home or overseas. Our report lays out in detail how that can be achieved and emphasises the importance of risk assessment in judging the degree of control necessary. It draws attention also to the good work carried out by the Health and Safety Executive and to the fact—it must never be lost sight of—that general food regulations will apply equally in that field and are strict in themselves.
The other side of the penny relates to how the public view the developments. The complexity of the subject and the domination of jargon in its description makes that difficult. Simple explanations and vivid examples of its beneficial effects in so many fields have to be developed to demonstrate those benefits both to children at school and the public at large.
I am a member of COPUS which is referred to in our report. In so many Select Committee reports, we refer to one of the major obstacles to progress as being the lack of in-depth understanding of science and technology among the general public and among specialists such as lawyers, shipowners and operators, media people, and even—dare I say it?—Members of Parliament. In 697 connection with the report, we commend in particular the MAFF Foodsense Factsheets. Those are available only on request at present. I hope that the firm recommendation of the Office of Science and Technology report Realising our Potential about promoting public understanding of science and engineering will be taken seriously. We hope that government themselves, through the school curriculum and in colleges and universities, will put that recommendation into action. We hope that they will support wholeheartedly the activities of organisations such as COPUS, the Engineering Council, the Royal Academy of Engineering and others concerned in the imaginative creation of interest in science and technology so that the subject becomes more fully understood and accepted by the public at large. As a society we need to appreciate fully how much we depend for our health, comfort and quality of life on sensible development of science and technology. We are a long way from realising that goal at present.
Too often media presentations are superficial and not based on clear scientific fact. They can so easily undermine public confidence in new products and processes. That has happened to a certain extent in Germany. We received evidence of German firms moving into the UK where they felt they could develop their products more successfully as our regulations are not so stultifying as those in Germany. However, that gives no ground for complacency as regulators can be more favourable in other countries such as the USA and Japan and even in some other countries in Europe. The world is a global village. International companies establish their activities in the most favourable environment that they can find to develop their products and sell them worldwide.
Of course, our regulations should not be weak. They must protect public safety. But that must not mean excessive bureaucracy. I hope that the proposed deregulation Bill referred to in the gracious Speech will lead to considerable progress in the field. I hope also that the Government, and through them the European Community, will pay serious and urgent regard to the recommendations of the report. Time is not on our side.
§ 5.40 p.m.
§ Lord Nathan
My Lords, I had the privilege of serving on the Royal Commission on Environmental Pollution during its study of the release of genetically engineered organisms to the environment which resulted in its 13th report. Professor Beringer was one of our specialist advisers during that study. I had previously served on the commission under the distinguished chairmanship of Sir Hans Kornberg and I mention their names because both were witnesses to the Select Committee during the study for the report under consideration today. Their evidence is central to the short point I wish to make. Sir Hans seems a popular person from whom to quote, and I shall do so.
The report fails, in my view, to give sufficient weight to the impact of public attitudes and perceptions upon the industry involved in genetic engineering, which offers the prospect of major improvements in medicine, industry and agriculture and is likely to lead to new 698 commercial products and elimination of or reduction in environmental pollution. Many noble Lords who have spoken previously and who have a vast knowledge of the subject have mentioned that.
However, this new technology attracted much anxiety from the time of its early development. There was concern stemming from the belief that scientists are manipulating something as fundamental as life itself and that the relationship of living things to their environment is complex and imperfectly understood. Although they lay outside our remit and were not considered by us, we were aware that ethical, social and political issues were in the minds of the public, relating, for example, to animal welfare, possible use for military and terrorist purposes and such matters as human gene therapy and the fundamental question of whether mankind should seek to create new forms of life.
I subsequently became concerned in questions relating to animal welfare as chairman of the Animal Procedures Committee, which published a chapter on that difficult subject in its annual report for 1990. In it, the noble Lord, Lord Soulsby, played a very prominent part.
I was greatly concerned that the Royal Commission should undertake the study which it did in order to forestall widespread opposition to the development of the science and thus stultify all activity i n the field, including the creation of an industry based upon it. I was much supported in that view of the importance of the matter by those in industry to whom I spoke. Nor was it at that time, or I believe, at present, pure fantasy. In Germany, a report to the West German Parliament had recommended a moratorium on the release of certain genetically engineered—if I may use the term—micro-organisms, while in the USA action by local and national groups had delayed or prevented some release experiments. Indeed, in the USA there was a vigorous movement to ban all such developments.
Taking account of the failure of the nuclear industry to address those problems—which they are now vigorously seeking to remedy—it was desirable to tackle them early by establishing a regime of control which would have the confidence of the public. That would necessitate the maximum public availability of information about everything which was being done in the context of releases to the environment.
It has been mentioned that there have been no accidents and I do not wish to spread alarm and despondency, which I do not feel at all. However, it came to our notice when we were studying the matter for the Royal Commission—and this is referred to in paragraph 9.32 of our report—that there had been a release to the environment in Argentina by an American company. There was a trial of a vaccine concerned with rabies which was produced with the assistance of some form of genetic modification. Argentina was chosen because there were no controls there, whereas there was a moratorium on such experiments in the United States.
It was put to us that, consequent upon that, cattle had been vaccinated with the experimental vaccine and that other cattle who were running with them had become infected. It was also put to us that attendants of the cattle had themselves become infected in the same way by 699 accident. An alternative explanation which has been given to me is that those were purposes of the experiment. That is to say, it was an objective to determine whether or not the vaccine would result in the infection of cattle running with those which had been vaccinated. It was an objective to see whether the attendants would be so infected. I cannot believe that anything quite so ghastly and unethical as that could have been in the minds of those who were in charge.
Thus there are serious ethical objections to the way in which that trial was conducted and it also illustrates the kind of dangers that result from the unregulated release of genetically modified organisms.
That, as well, of course, as the environmental impact, is the context of the proposals made in the Royal Commission's report for a statutory framework for control, the establishment of a release committee and provisions about access of the public to information. Scientists on the commission considered that each proposed release should initially be considered by the committee, recognising that with experience there could be relaxation by the release committee, for example, in relation to categories. However, in the view of our scientists, that was for the future—a future which I believe has now arrived.
I think it right also to say that the recommendation we made, which is to be found in paragraph 8.5 of our report, suggested the structure of statutory control by a framework statute with regulations made under it, precisely in order that they might be changed without undue difficulty, as technology, experience and knowledge advance. Therefore, the notion that the regulations—good or bad—which were initially introduced should be altered was completely in our minds at the time we were dealing with the report.
Since many releases to the environment were likely to arise in the context of field trials of new products, a problem arose in connection with the provision of adequate information to the public without undermining the commercial viability of the development and therefore damaging the incentive for innovation. It therefore appeared that there was a need for some development of patent protection to cover this new field of invention. I note the paragraphs in the Select Committee's report about that, paragraphs 5.83 to 5.86, but they do not seem to me to take us much further. I believe that some steps have been taken to address the problem, though I am not aware of the detail. Perhaps the noble Lord, Lord Howie, or the Minister in her reply could advise your Lordships' House on it. The withholding of information from the public would not, in my view, by itself be a satisfactory option.
I note from paragraph 5.91 of the report that witnesses pointed out that public opinion of biotechnology in the UK,was more benign than, say, in the United States, Germany or Switzerland. 'The United Kingdom has not so far had to suffer from the extreme antagonism and vandalism seen in Germany or the Netherlands or from people such as Jerry Rifkind in the United States, but acceptance cannot be taken for granted and there is a ground-swell of antibiotechnology feeling which could well be mobilised'".700 That is from the evidence of the Society for General Microbiology at page 185 of the report. Absence of acceptability could jeopardise not only the development of UK industry, but also the entry into this country of others who wish to take advantage of the scientific expertise and facilities that are available here. It would therefore defeat the very purposes that the committee seeks to promote.
Strong arguments are advanced for deregulation, as for instance, at paragraph 6.41:We therefore recommend that the DTI Deregulation Task Force review the contained use and deliberate release regulations",I note what the noble Lord, Lord Howie, said about this matter, which rather modified my understanding of what was intended there.
The section on public understanding begins, as follows at paragraph 6.42:There is no evidence within the United Kingdom of the extreme antagonism against biotechnology and its products that has emerged in some other countries…. We see no reason to believe that such antagonisms will necessarily develop here".But I wonder whether that is due to the regime put in place precisely for that purpose which the committee wishes to remove.
I turn to the evidence of Sir Hans Kornberg and Professor Beringer to which I referred at the beginning. At paragraph 802 on page 168, Sir Hans said:for agricultural products I would guess there is probably none yet on the market, or if there is, it must be on the fingers of one hand. Indeed, the big hurdle is still, as Professor Beringer has already indicated, that nobody quite knows how to market these products and get them accepted by the public. We have already seen statements in the press in the United States—I saw such reports last year—of chains of ice cream manufacturers who said that they would never use milk which had been genetically modified. Restaurants have said that they would never use any plant materials that had been genetically modified.At paragraph 804 on page 168, Professor Beringer says:I just wanted to add something in relation to marketed products in the United States and that is, to me, a very great concern to what has happened to the Flaur Savr tomato, where Campbell is on record as saying they are backing off this area, because of public perception. What the truth of this is, we are not sure, but there does appear from reading the literature of people against the technology, that they are using as an excuse now inadequate supervision and risk assessment and so comments that I have heard that we should move very rapidly to vertical assessment, product based assessment and to cut down on the amount of environmental risk assessment, may themselves be self-defeating until such time as these things are publicly dealt with".I want to see the United Kingdom biotechnology industry develop and prosper no less than do Sir Hans, who is a leading protagonist, Professor Beringer and indeed the committee. What I fear is that the adoption of the recommendations to which I have referred will defeat that purpose.
§ 5.53 p.m.
§ Lord Soulsby of Swaffham Prior
My Lords, I am sure that this House will be immensely grateful to the noble Lord, Lord Howie, for introducing the debate on this report. It is a topic of great importance to the economy of the United Kingdom, and holds out enormous potential for benefits to the health and welfare of humans and animals. It also raises ethical issues, and those have been mentioned in the present debate.
701 It was my great privilege and pleasure to be a member of the Select Committee under the very able and (shall I say?) at times humorous—chairmanship of the noble Lord, Lord Howie of Troon.
The old biotechnology, as we have heard from previous speakers, including the fermentation of foods or wines and even, more modernly, pharmaceuticals such as penicillin, has been with us for some considerable time. But the new biotechnology is only of the order of 20 years in development, and follows from discoveries some 40 years ago by Watson and Crick on the function of DNA.
It has been said that biotechnology is the next major scientific frontier, and will probably have a greater impact than the computer or the microchip. It has also been said by some that it may well be the last major frontier. I do not share that view. But there is no doubt that it will clearly be a major source of wealth creation to this nation; and following on from that, will lead to the betterment of the health and welfare of our nation and other nations in the world. It is also very clear from the evidence that we received that the United Kingdom is very good at biotechnology, a fact which is freely admitted by our competitors—the major ones being the United States and Japan. Consequently, we should not let restrictive regulations hamper our national and international competitiveness—as indeed is perceived to be the case not only in this country but also overseas. Indeed, that was the original reason for the Select Committee's report.
We heard much opinion to that effect from various witnesses. But the clearest confirmation of that situation came at first hand when a few of us—as the noble Lord, Lord Wade of Charlton, said, he and I and some others—had the privilege of undertaking an OSTEM, an overseas science and technology expert mission, to the United States. As my noble friend said, the weather that he experienced in San Francisco was somewhat superior to the weather that we had in Washington. The basic scientific leadership of this country was fully acknowledged in the United States; but the competitive disadvantage was also fully acknowledged in that country.
I do not believe that anyone would deny the need to regulate biotechnology, which these days includes genetic modification. That need is accepted by all. Initially, the regulatory process, which started in the 1970s, was very strict indeed. At that time I was living in the United States and I played a very minor part in that regulation. But as scientific knowledge and understanding has increased, it has been possible to relax regulations based on science. Relaxation of the regulations is, and should be, science-based. That is probably a major difference between the United Kingdom and, for example, the United States. The regulatory process in the USA is science based, whereas in this country, as the report indicates, other issues come into play, including that of the necessity for the research.
What does that restrictive regulation imply in terms of economic growth and development in this country in particular? First, we were told—and there is good evidence for it—that venture capital is not as freely available in this country as it is elsewhere. Indeed, we 702 heard that even British venture capital was. going overseas, whereas the flow of venture capital to this country from overseas was very poor. Secondly, post-venture capital, or development capital, is similarly affected and is not as freely available. A further point is that small businesses are often seriously affected by the time taken for the regulations to work, and there is the cost of applying for those regulations. In fact in the United States there is no charge for research workers undertaking biotechnological research in laboratories. But as we heard from the noble Lord, Lord Howie, the DoE has now streamlined some of the regulations. That is very welcome indeed.
Should it be felt that I or other noble Lords have painted too gloomy a picture of the effect of regulation on economic development, let me draw your Lordships' attention to the situation with our near neighbours in Europe, where unduly strict regulations and public opinion (including what is known as the Fourth hurdle) may and indeed have forced some major pharmaceutical companies to leave their native country and go elsewhere. Examples of that are Hoechst and Bayer moving from Germany and Ciba-Geigy leaving Switzerland. Some see this country as a location for their biotechnological work. Nevertheless some American-owned companies based in this country have decided to move their research and development back to the United States. That cannot be of benefit to the economy of the United Kingdom.
Noble Lords would find it tiresome if I were to go on at length about the US regulatory procedures. However, I believe that it is important to note that the USA believes that this is a technology for paramount economic development. With an annual market of £8 billion a year and an estimated growth of 28 per cent., it is guided by a public philosophy of legislation which seeks deliberately to base regulation on scientific considerations and to avoid new regulations when existing ones will suffice. There is strong collaboration between regulatory departments and a transparency of operation which generates a strong degree of confidence in the legislators and on the part of the public in general.
That raises the important requirement of greater understanding and better education of the general public about biotechnological issues. Much of it can start with primary education. As my noble friend Lord Wade of Chorlton said, biotechnology is no great mystery. Despite the jargon, it is not a science that is too difficult to understand. During meetings of the committee, members were privileged to participate in a fascinatingly simple experimental system. In a committee room we isolated DNA in a test-tube. We all discovered immediately that we were biotechnologists and that the long, white material was capable of being extracted from a simple solution.
Perhaps one of the greatest concerns about biotechnology is the transgenic organism and its release into the environment. We have heard much about that this afternoon. Several bodies gave evidence both at the committee and subsequently. They sensed the danger of some killer organism that may be released at great hazard to the population or feared that an evil genius practising eugenics in man might take hold of the 703 technology to the disadvantage of all. There is concern, and I admit that it is genuine concern, about easing regulations on genetic manipulation for use in animals, especially in agriculture. The objections include the charges of tinkering with nature, playing God and creating unnatural animals. Objections are accompanied by the fear that the welfare of animals will inevitably be affected.
But one of the greatest causes of poor animal welfare and suffering in this world is disease. The control of disease is probably one of the greatest contributions that can be made to the betterment of animal welfare in general. That is now very much more within our grasp than ever before by improving animals' native resistance to disease by means of transgenesis or by producing new vaccines based on genetically modified organisms to combat major, harmful, dreadful diseases, such as rinderpest in cattle in the Tropics, equine herpes infection in horses in this country and rabies on the Continent.
The welfare of man also can benefit enormously from this new technology—in the provision of crops and livestock that can utilise areas of the world in which hitherto man and his animals could not sustain a livelihood. The health and welfare of animals is particularly important in the developing world, where biotechnology will help enormously. It may be of interest to noble Lords to know that still 85 per cent. of the energy required for agricultural input in the world in general is derived from animals, despite the energy produced by the internal combustion engine in the western world. Any effect on the animals which provide that energy will produce a reduction in the health and welfare of the human populations associated with it. So the betterment of animals in the third world will be of direct benefit to the health and welfare, happiness and indeed longevity of the human population in those areas too.
I believe that any claim that genetic engineering of animals is out of step with modern attitudes to animals is wide of the mark. I certainly know that my own veterinary profession in particular is very anxious that constraints should be placed on the genetic engineering of animals. The welfare of the animal must not be compromised and nor must the welfare of the animal's offspring. I believe that genetic engineering can offer much to improve the welfare of animals rather than reduce it, because of the accuracy that it brings to breeding and planning of animal production.
We must have biotechnology and regulation of biotechnology too. I do not believe that there can be any debate about that. But the process must be logical and science-based. This report sets that out logically, clearly and concisely. I am happy indeed to recommend it to your Lordships.
§ Lord Whaddon
My Lords, I take the opportunity to thank the House for giving me the privilege of serving for four years on the Select Committee. Of all the years that I have spent in both Houses, those four years have been the most rewarding. It has been a great privilege to 704 serve on a committee that has such expertise at its service, both among its members and in the witnesses who came before it. Indeed, the Select Committee on Science and Technology shows the House of Lords at its best, bringing unrivalled experience and qualification to bear on important subjects in an objective way. It is amusing to think that it would not be possible to bring together such an organisation by an elected process.
Twenty-five years ago, in a more plebeian capacity in another place, the chairman of the committee was my Whip—and a good one. But he was an even better chairman than he was a Whip. I thank him and congratulate him.
Of the subjects considered over the past four years, many were interesting and worthwhile but none compared to the study of genetic engineering and its regulation. Science generally progresses by infinitely small, painstaking steps gradually extending the frontiers of knowledge. But here and there will come the sudden realisation of a new view of the world. There has been reference to computers; I think of Darwin. His theories were both feared and disdained. They were understood by few at first but later accepted by everyone. The spin-offs affected not only biology, but also politics and religion. They resound still throughout the world.
Genetic engineering is another example. We have barely begun to taste its implications. Only a few people understand what is happening. Far too many have the feeling that it produces a form of Frankenstein. That is complete nonsense. It is a God-given tool that must be used for the benefit of our people and our industry. The apprehension is ill-based. The genie is out of the bottle. We must live with it and do so happily.
The Commission directives are rightly criticised in the report. It is regrettable that it took such an ill-informed view of developments. It appeared to be out of its depth and did not really understand what it was dealing with. In fact, it clearly ignored the advice of its experts. It is said that power without responsibility has been the prerogative of the harlot throughout the ages. But power without understanding is equally damaging and undesirable. I am afraid that that is what we are faced with. The more restrictive aspects of the directives must be resisted. Unfortunately, the restrictions placed on European industry by the directives caused much damage and handed totally unnecessary advantages to the United States and Japan.
One specific product of genetic engineering with which I am familiar illustrates some of the problems that may need to be faced. I refer to beta-interferon. I have a strong feeling that the real problems of genetic engineering will not be technical. We have the competence to deal with them. There are considerable social and economic difficulties just around the corner which the Commission's directives do not address and which we must face as they arise.
I see some difficult decisions arising with regard to beta-interferon. Interferon has been recognised for many years as a tantalising and promising tool for medicine. But it was only recently that it became possible for pure beta-interferon to be produced by the use of GMOs. Suddenly there was enormous interest. A few weeks ago 705 in the United States it was licensed for use against multiple-sclerosis. I must declare an interest. It is not financial but personal. I suffer from that condition and naturally I take a great interest in what is happening.
Although the general public had little understanding of genetic engineering, it is astonishing how many people with MS were converted to its use as they learnt of the potential benefits of beta-interferon. People would give almost anything to get their hands on it. Up to now it has been available only in microscopic quantities.
§ The Earl of Longford
My Lords, perhaps I may interrupt to ask the noble Lord, who is so enthusiastic about genetic engineering, whether it has any bearing on human conduct. If so, what?
§ Lord Whaddon
My Lords, indeed it does, and I hope to illustrate that. There was a stampede of all those suffering from multiple-sclerosis—I use that as an example—to obtain the beta-interferon. It will not be available in bulk for a number of years. In the meantime Her Majesty's Government are setting up trials. There is considerable pressure on the Government to keep the trials as short and restricted as possible so that licensing in this country can be finalised in the quickest possible time.
No one could be keener than I to see the product on the market. But it is vital that the tests are carried out thoroughly in accordance with true scientific principles. They must be adequate both in scope and length. It would be tragic to, get it wrong, not only with regard to beta-interferon but also with regard to similar products which are coming along.
The product has enormous financial implications, relevant to the whole country. The financial press estimates that the potential market is around 5 million dollars a year. Indeed, if only half the patients in the UK were treated with it, the cost to our health service would be £250 million a year. And it would be imported. That is just one product. Over the next few years how many similar products will arise, all of which seem to be exceedingly expensive? We can see the country facing import bills of billions of pounds for a handful of genetically produced products. It is imperative, not only for the patients but also for the prosperity of the country, that we are at the forefront of production of genetic pharmaceuticals. I urge Her Majesty's Government to ensure that the tests are carried out in a scientific manner.
The Government have been keen to tell us of the importance they place on subsidiarity with regard to European legislation and regulations and how keen they are to deregulate where regulation is not necessary. In regard to the regulations from Brussels on genetic engineering products, they have a perfect chance to prove their point. Let us see whether they are prepared to stand by their principles in the interests of the British people. The prizes are tremendous. We must not lose them.
§ 6.19 p.m.
§ Lord Carter
My Lords, I join other noble Lords in thanking my noble friend Lord Howie and his committee for producing this interesting., thorough and enthusiastic report. "Enthusiasm" is a vvord we do not often use about reports in your Lordships' House, but when I read the first few paragraphs of the report which summarise it I was struck by the litany of praise for biotechnology. The argument of competitive disadvantage is agreed; we are told that it is an exciting technology; that it is continually evolving; that the benefits are well proven; that there are enormous future benefits; that early fears are unfounded; that the deliberate release of GMOs is not inherently dangerous; that the regulations are excessively precautionary; and that the safety regulations are bureaucratic, costly and time consuming. The committee was certainly very enthusiastic in its endorsement and it seems to have accepted the scientific arguments in favour almost without hesitation—what I would describe as a utilitarian approach to the subject.
I have to confess in reading the report to one still small voice of doubt. I have the honour to be a vice-president of the British Nuclear Test Veterans Association. I have to point out that there have been situations in the past where sincerely held scientific views have turned out to be wrong and indeed have had some fatal results. The industry that we are considering is only 20 years old. I wondered whether the committee might have been slightly more guarded in its enthusiasm for the techniques and the systems suggested.
Paragraph 1.8 refers to the importance of understanding. It states that,promotion of public understanding of biotechnology is important but should not preclude evolution of regulation".So there is evolution before public understanding. But in paragraph 5.91 the same point is made rather differently. It states:A number of witnesses spoke of the connection between regulation and public perception, and of the need to improve public understanding… Indeed, public understanding, if adverse, can in some ways be considered as another factor governing competitiveness".Those two quotations seem to be slightly at odds with each other.
A minority of the witnesses felt that the various techniques were inherently risky. In paragraph 5.8 we find that the practitioners thought that the hazards were minimal or non-existent, a not very surprising conclusion which was accepted by the committee.
Clearly, the agriculture and food industries have a major interest in biotechnology. I was not completely convinced by the arguments advanced in paragraph 5.18 regarding the creation of a so-called weed species. The committee has either slightly missed the point or I have. Some 40 years ago, when I was taught agriculture, I first heard the not very helpful definition that a weed is a plant in the wrong place. If herbicide resistance were to be built in through biotechnology, this could lead to possible dangers. The transgenic cultivars will not be competing with the wild species, as the report says, but with the cultivated species. Indeed, I was struck by the remark in paragraph 5.18: 707If I were a plant breeder, and in fact I am responsible for a lot of them, I would be quite offended by any implication that I could inadvertently create a weed".That seems to be a concept of infallibility that is almost papal in its scope.
The report mentions cross-pollination between transgenic plants and indigenous species and seems to imply that there is no problem. I was puzzled by that. As a grower of oil seed rape I spend a great deal of time avoiding cross-pollination between high and low erucic acid varieties. If you are a grower of herbage seed you spend a great deal of time zoning to make sure that there is no cross-pollination. If you are a seed grower of almost any plant or variety you take an enormous amount of trouble to avoid cross-pollination. That is the case with a normal cultivar. Why is there apparently no danger with a transgenic plant? Perhaps I have missed the point. If so, I should be happy to be corrected.
The report contains the slightly curious argument that toxicity, allergenicity, breeding problems and other hazards are acceptable in genetic modification because they also occur in natural breeding—that makes them acceptable. But are they any different in kind as well as degree?
When I read the "Opinion of the Committee" I was struck by the last sentence of paragraph 6.1. I substituted the words "nuclear technology" for "biotechnology", a point touched on by the noble Lord, Lord Perry. I shall deliberately misquote paragraph 6.1:The uses and products of nuclear technology demonstrate just how great is the potential for applying nuclear technology in areas of fundamental importance to the quality of life".I am sure that the nuclear scientists and technologists would agree with that statement. Some politicians would certainly agree with it. I suspect that there would be deep distrust among the general public. Argument by analogy is usually dangerous, but I do not think it is completely unfair in this case.
Paragraph 6.26 deals with the labelling of food. It states:We do not accept that GMO derived foods or food constituents are inherently dangerous. We do not think that a case can be made for the universal generic labelling of such foodstuffs. We therefore recommend that the Food Advisory Committee reject calls for such labelling".I understand the arguments that the report has produced but at the same time I would draw the attention of the House to an extremely interesting book called Your Food: Whose Choice which is produced by the National Consumer Council. It states:A Europe-wide survey in 1991 … suggests that public understanding of biotechnology is very low; indeed only one in five respondents felt capable of answering the questions. A second study in the Netherlands in the same year found that the amount and type of information influenced the level of acceptance of the product. Where foods were presented as new products, but with no reference to genetic engineering, they were rated positively; if it was revealed that they had been made using genetic engineering, the acceptance level was lower".I wondered whether the argument set out in the paragraph on labelling was a post-hoc argument.
I should also like to say a few words about a subject touched on by the noble Lords, Lord Nathan and Lord Soulsby. I refer to the question of ethics. I understand immediately that this was not strictly within the terms of reference of the committee. I thought it was significantthat 708 that in the summary of the Opinion of the Committee in Chapter 6 the word "ethics" does not appear and the subject is not discussed. It was mentioned in one way or another by 15 witnesses but so far as I can see it was not dealt with in the chapter on the Opinion of the Committee. I felt that that was a surprising omission. It is almost as if the ethical considerations do not exist—and, as I said earlier, the utilitarian arguments prevail.
There are fundamental ethical questions about the relationships between people and animals. There is less concern about plants. At Question Time today I asked a Question about animal welfare. If we look at some countries in southern Europe we can see what happens when there is no concept of an animal's welfare rights. The subject needs a debate in itself and a report in itself, but because so many of the witnesses mentioned the issue I felt that, although it was outside the committee's terms of reference, at least the chapter entitled "Opinion of the Committee" could have dealt with the ethical argument very briefly.
On the subject of animal welfare and ethics, I was also struck by the evidence given by the Farm and Food Society to the inquiry into the Ethics of New Breeding Techniques for Farm Animals. The society set out a series of proposals for consideration to be taken into account before the licensing of research. They are:The precise aims of the work. What are the expected benefits to humans/animals? Is the result expected to fulfil a recognised need?"—the so-called fourth hurdle.Are there alternative methods of reaching the desired goal?…Are there practical means of avoiding the problem in the first instance?… Does the proposed work change the intrinsic nature of the animal? Is biotechnology the only answer? If the work is performed, what is the estimated number of animals likely to be involved? What degree of suffering will these animals be exposed to?Is it possible that, even if the experiment is successful, further problems may arise: (a) in the animals themselves; (b) in their offspring?".
Finally, the report asks whether the work could create other problems in the welfare, environmental and social and economic fields.
That is a big list. I do not believe that the procedure is unreasonable or that process of thought in studying the licensing of research. I imagine that the committee is satisfied that this is the kind of procedure which has been followed in all the cases which they have examined.
I believe that the committee has dealt well with the global competitiveness argument. Together with the noble Lord, Lord Beaumont of Whitley, I am still not sure about the views on the release of GMOs. There is genuine concern about this aspect of biotechnology, as mentioned by the noble Lord, Lord Soulsby. I believe that all noble Lords will agree that bland assurances are not sufficient.
I certainly agree with the committee that a proper policy of public education in this matter is required. We hear so often the comment that if only people understood better what we are doing. Although it has already been referred to, it is worth repeating—that is to say, the quotation from paragraph 5.91 which is the 709 survey by the ESRC for the DTI showing the perceived trustworthiness of the sources of advice. Noble Lords are aware that the most preferred sources were:Friends of the Earth, Greenpeace, New Scientist magazine, the conservation groups and scientists who work in universities, in that order. Working up from the bottom of the list were: tabloid newspapers".There is a surprise!
This is a very brief response to a very big report. Although I agree entirely with the exciting possibilities of biotechnology, when I read the report I had the feeling that the committee had gone ever so slightly overboard in their enthusiasm for it. Having said that, there is a statistic which I never tire of repeating to farming and non-farming audiences. I refer to the forecast for the increase in world population by 2020. That forecast is probably reasonably accurate. If it is—and one assumes only a very small increase in the food consumption of the one fifth of the world which is inadequately fed—world agriculture in the next 27 years has to produce as much food as has been produced in the last 10,000 years.
Clearly, we must understand and appreciate that biotechnology will have a great deal to do with solving that problem. I agree with the committee that biotechnology, under a proper system of regulation and control, will have a lot to offer. I conclude by once more thanking the noble Lord, Lord Howie, and his committee for a very interesting, informative, and thought-provoking report.
§ 6.32 p.m.
§ The Parliamentary Under-Secretary of State, Department of the Environment (Baroness Denton of Wakefield)
My Lords, even before I enjoyed the privilege of membership of your Lordships' House, I was well aware that the one publication which would always bring benefit to a subject is a House of Lords' Select Committee report, and today is no exception. On behalf of the Government, I should like to pay tribute to the noble Lord, Lord Howie of Troon, and the members of the committee. We must be grateful for their time, energy, commitment and constant search for answers. From today's debate it has been very obvious that the participants took great pleasure in that membership. We have today all listened with great interest to what has been said on the effect of regulation on the competitiveness of the United Kingdom's biotechnology industry. That is rightly identified as global competitiveness. I for one have learnt much from the many and valuable contributions.
Biotechnology is already an important enabling technology within many sectors of UK industry and it is set to grow. It is truly cross-sectoral and promises to transform many aspects of everyday life; better and novel approaches in health care, to which the noble Lord, Lord Whaddon, drew attention; improved agriculture and, not least, in my own department's area, environmental protection. As my noble friend Lord Wade pointed out, there is great practical benefit ahead. Biotechnology will be an important part of the United Kingdom's high technology future.
As a result of accumulating experience, confidence in 710 modern biotechnology is now rapidly increasing. With the benefit of this experience many of the fears associated with the technology in the early 1970s have now been clearly exposed as unfounded. This increasing understanding has quite rightly led to evolution in appropriate areas of regulatory control. The need for this process of change has been recognised consistently by government and our advisers and is made explicit in my department's White Paper This Common Inheritance and in the tiered controls available in the Environmental Protection Act 1990. The flexibility in the UK legislation and in the European Community directives themselves, has allowed us to move quickly to adapt to this evolutionary need.
The Select Committee reported and the noble Lord, Lord Walton, drew particular attention to the continuing concern of industry about the burden of controls. While I am relieved to see the committee's conclusion that this may not be the major cause of restraining the growth of UK biotechnology, the Government are rightly concerned that the regulatory burden should only be commensurate with the risk. I hope that some of the recent developments described today will have alleviated many of these concerns. The Biotechnology Industry Government Regulatory Advisory Group will no doubt help in this.
Global competitiveness is at the very heart of the Government's industrial policy. Consequently, the DTI task forces set up under the Prime Minister's deregulation initiative, reviewed the case for regulatory change in biotechnology. While I note the firm disclosure by the noble Lord, Lord Howie, that the committee's work was no part of that initiative, I should also like to reassure the noble Lord, Lord Beaumont, that the deregulation initiative is not aimed at a free-for-all but at removing regulations sensibly and where restrictions are without purpose—in many cases, where they have been made layer on layer.
The case for regulatory change in biotechnology is therefore well reviewed and bilateral discussions between government and industry produced results which were in full agreement with existing policy. These will be reflected in our response to the Select Committee's report.
In the White Paper which my noble friend Lady Platt mentioned, Realising our Potential: a Strategy for Science, Engineering and Technology, we clearly recognise the importance of biotechnology in our decision to establish a new biotechnology and biological sciences research council. That will come into being on 1st April 1994. It will combine the current work of the Agriculture and Food Research Council and the biotechnology and biological sciences parts of the Science and Engineering Research Council. That seems an eminently logical and sensible move in view of all that we have heard this afternoon.
The sense of confidence surrounding this new technology has been aided by a cautious regulatory approach. Following a call in 1976 from scientists for a moratorium on genetic engineering, the United Kingdom established the Genetic Manipulation Advisory Group to give government safety advice. Later, the Royal Commission on environment pollution, 711 under the distinguished chairmanship of the noble Lord, Lord Lewis of Newnham—perhaps I may say how pleased we were to have contributions today from both the noble Lord, Lord Nathan, and my noble friend Lord Cranbrook, who were members of that important Royal Commission—addressed the problem of the deliberate release of genetically modified organisms. Their step by step approach has underpinned government policy since and forms the basis of the new regulations introduced earlier this year to bring in measures for environmental protection.
The Government consulted widely on the implementation of these regulations not once but twice, in an effort to ensure that all views, including those of industry, were represented in the finished product.
We have heard this afternoon that UK scientists and industry are "good at biotechnology". That is true. I am also delighted to be more optimistic about UK investment in biotechnology. Although there is evidence that some of the US sources, to which my noble friend Lord Soulsby referred, are drying up, there is evidence that it is slowly being recognised here that this is an area of great opportunity. I am particularly pleased that that is recognised in relation to many small firms. The UK regulatory bodies, guided by the Advisory Committee on Genetic Modification, and the Advisory Committee on Releases to the Environment, work hard to keep it that way. Over the past years, these bodies have been advising on legislative controls that balance the need for safety and public reassurance with the minimum of constraint on industry and researchers.
Furthermore, in the light of 10 months' experience with the new regulations, I feel sure that the vast majority of practitioners will agree that, while the appraisal of hazards to humans and the environment is carried out pragmatically, it is done with a high degree of scientific rigour yet well within the statutory time limits. Recent guidance on risk assessment from both advisory committees has helped greatly in this respect and allows us to take a lead in Europe.
We recognise that the system of controls established by the directive on the contained use of genetically modified organisms is bureaucratic. We join the noble Lord, Lord Howie, and many others in that view, but this is not a risk issue—rather, it is an administrative one. We have identified a number of measures which can be taken to remedy that. They range from alerting industry to the potential for flexible operation of the current regulations, within the scope allowed, to the drive this October at the competent authority meeting in Rome for changes to the contained use directive.
Concurrently, the classification of organisms into "low" and "high" hazard groupings is under review in Europe to make it more workable. The UK is leading in this review. I assure the noble Lord, Lord Whaddon, that there can be no greater fan of subsidiarity than myself, but, as my noble friend Lord Wade pointed out, we have to be extremely careful when we are working with biotechnology in global markets. We must not hamper industry. I am pleased that the aim is simplification, so 712 that an application to a single authority will allow people to market throughout the whole Community. That seems to be a sensible solution.
Meanwhile, the majority of the work carried out in containment in the UK continues to be subject to no more than good laboratory, or industrial, practice, as endorsed by the Select Committee and under requirements common to biological hazards in general.
There have been a number of recent developments on deliberate release of genetically modified organisms too, again as a result of experience. In October, the Advisory Committee on Releases to the Environment recommended the introduction of "fast-track" procedures for clearance of some low-risk genetically modified organisms, as foreseen in the second year report to This Common Inheritance.
The first list of organisms which will qualify for these procedures is currently under discussion by the Advisory Committee on Releases to the Environment. It is expected to be announced shortly and will be published as guidance notes as soon as possible. I am pleased to say that this list will compare favourably with the US notification scheme and will have the same turn-around time—30 days. The list will be reviewed at frequent intervals in order to add—or, indeed, remove—GMOs as experience is gained. I believe that both the noble Lords, Lord Brain and Lord Nathan, will be pleased that it is recognised that here is something that is moving fast.
Evolutionary change is also apparent in Europe. Criteria for "simplified procedures" under the deliberate release directive have recently been agreed unanimously and information requirements for individual releases are being reduced and made more organism specific. The UK is playing a leading role in these negotiations.
Within the OECD, we have been one of the main driving forces behind moving away from a cross-sectoral (or process-based) approach to a product-specific approach to biotechnology safety. This has led to new initiatives designed eventually to lead to OECD-wide product approval schemes for genetically modified crop plants, biological pesticides and bioremediation agents.
I should like to touch on the comparisons that have been made with the United States, although I recognise the need to reply to the report in much greater detail. The United States system is so complex, involving multiple pieces of legislation from multiple agencies, that sometimes US officials themselves do not understand it, and GM provisions are embedded in much ostensibly non-GM legislation, which is always a cause of difficulty. It sometimes appears simpler because practitioners see only a tiny part of it. I am delighted that some US firms are envious of the European systems.
My noble friend Lady Platt mentioned Japan's competitiveness. I should point out that in Japan there have been in total two releases of GMOs, compared with 75 in the United Kingdom, some 350 in the Community and about 600 in the United States. I feel that, instead of running down British industry, which I 713 am delighted that we have stopped doing, we might be in danger of running down British regulation, which stands well against the competition.
The product-based approach in the OECD is consistent with our commitment to push in Europe for moves towards more product-specific regulation of genetically modified organisms. This has already happened with medicinal products. Others will follow. Any additional process-based legislation is neither required nor welcome.
As well as protecting human and environmental safety, sound regulations should help to build public confidence in the products of modern biotechnology. Indeed, there is no doubt that the success of any product, particularly in the agriculture and food sectors, depends on such confidence.
The Government have launched a number of initiatives to foster understanding, including support for science festivals and grant schemes. I very much hope that today's debate will help that understanding, because most noble Lords, including my noble friend Lady Platt, have been at some pains to point out that this issue is nowhere near as difficult as people assume from the outside. The national curriculum now allows the concepts of biotechnology to be introduced to all our children. I hope that the lack of understanding will not be as long term as the noble Lord, Lord Howie, feared.
I noted one particular point in the written evidence that was submitted by the National Consumer Council which I think that both the noble Lord, Lord Carter, and I would say represents an important view on this matter. In its conclusion, it states that the gap between scientific knowledge and public perception can be very wide indeed. It may be the former which drives industry, but it will be the latter which determines its success. I think that it is important that we continue to ensure that the scientific players in this field do not say that, if someone cannot understand what they are doing, it is that person' s fault—rather, it is that they are failing to explain the matter simply. That causes great concern.
I was interested to note the comments of the noble Lord, Lord Howie, on his reaction to evidence from Greenpeace. Since joining the Department of the Environment, I have been concerned that too often the heroes in the environmental field are those who identify the problems. It is crucial that we make heroes, and increasing numbers of heroes, of those who identify the solutions. We are talking today about the engineers and technology people. We have to get out those messages. I can assure your Lordships that that is at the top of my agenda.
I shall give some comfort, I hope, to the noble Lord, Lord Perry. All those reviewing applications in the directorate of the chief scientist at the Department of the Environment have a PhD in biological sciences, and two have direct experience in the biotechnology industry. Continuous scrutiny and all enforcement work is carried out by staff qualified and experienced in microbiology. I have been impressed by the knowledge and experience in this area of the people with whom I have worked on this report.
The noble Lord, Lord Walton, raised the issue of the patenting of the human genome. That has been 714 addressed in the draft EC directive on the legal protection of biotechnological inventions. The UK Government support measures contained in the draft directive to prohibit the patenting of the human body, or parts of it, but it is, of course, as the noble Lord will understand, still very much a moving target at the moment.
The noble Lord, Lord Nathan, asked about patent protection and how long it was reasonable to withhold from disclosure commercially sensitive information. No such period is laid down. Sensitive information is withheld for as long as it is sensitive. The patent authorities were involved closely with the preparation of the regulations on that point. Substantial protection is built into the regulations.
On the question asked by the noble Lord, Lord Walton, about universities and research councils paying less—I believe that is the issue—I must reply that the Government's policy is to operate full cost recovery for consent schemes such as the deliberate release of GMOs. However, costs can be reduced if a consent covers a programme of work extending for a number of years and several release sites and is related to the degree of scrutiny likely to be involved.
Safety has been discussed throughout the debate. I am grateful to the noble Lord, Lord Nathan, for drawing attention to what happens when there is an unregulated trial. The trial was stopped arid the scientific procedures called into question. The existence of a precautionary regulatory regime is intended to ensure that accidents do not happen. That approach is common throughout Europe, the United States and the OECD countries.
I suspect that the noble Lord, Lord Carter, and I have similar feelings about this afternoon's subjects. It is such a big report that it is almost impossible to reply to it. This afternoon, I can cover only some of the issues that have arisen during the debate. I wish that I had time to tell your Lordships about the "flavour-savour" tomato which is just two months from the market in the United States. As the Select Committee chose to have the debate before the Government's response, we shall be able to cover all the important matters raised in that response. I promise your Lordships that Hansard will be read carefully to ensure that that is so.
I hope however that the Government have demonstrated that the system of regulations in place in the UK is sensitive to the protection of human and environmental safety. It is also sensitive to the legitimate needs of this country's industry, large and small, to operate on a level playing field in a free-market economy. It is a system which will continue to evolve.
The Government will maintain such a system in England, Scotland, Wales and Northern Ireland. We shall promote it throughout the European Union; and, finally, we shall promote it in the OECD and internationally via the United Nations. We join all noble Lords who have spoken today in wishing to see the United Kingdom biotechnology industry grow and prosper.
§ 6.55 p.m.
§ Lord Howie of Troon
My Lords, as chairman of the Select Committee, I have been subject this afternoon to an unusual quantity of praise. So much so, that I wish that the debate had gone on for another hour or so! I do not expect anyone else to agree with me, and I shall not detain your Lordships for very long. I wish to say just a few things about the remarks which have been made. First, I thank my colleagues on the committee who spoke. They put flesh on the bare bones of my introductory remarks. The noble Lord, Lord Perry, spoke about risk evaluation and gave examples. The noble Lord, Lord Wade of Chorlton, spoke about the availability of capital, which is an important matter. The noble Lord, Lord Walton of Detchant, demonstrated that there was a body of scientific talent on our committee. The noble Baroness, Lady Platt, spoke of the economic effects of the industry and of risk assessment.
The noble Lord, Lord Soulsby, spoke about the important effects caused in Germany by over-rigid regulations. He drew our attention to the undesirability of the fourth hurdle. The committee spent a good deal of time considering the fourth hurdle. Unfortunately, I have forgotten what the other three are. Although I have been told several times, I can never remember. I need not be told now, because it is in the evidence. The fourth hurdle means that one will not be permitted to do something unless there is a perceived need for it. We believe that the need would not be demonstrated by a form of licensing or permission but by the market itself. We have said that there should be no fourth hurdle. That is also the view of the Commission, although it will no doubt find some way of slipping it in by the back door. The noble Lord, Lord Whaddon, was very kind. He drew attention to the good example of Interferon. Those noble Lords are my friends, and I am glad to thank them for the kindness they have shown to me.
I wish to say just a few words about the Royal Commission and the remarks made by the noble Earl, Lord Cranbrook, and the noble Lord, Lord Nathan. It was not my intention, or that of the committee, to fall out with the Royal Commission. However I believe that we managed to do so slightly. I apologise for that, but I hope that I have said enough during the debate to show that we are much closer to the Royal Commission's views than may have been suspected last month. I hope that that is so.
The noble Earl, Lord Cranbrook, drew your Lordships' attention to a question which I had asked of Sir Hans Kornberg. I asked him at one point whether the Royal Commission had been hysterical. Put baldly like that, that seems to be a gratuitously insulting remark. However, if your Lordships look at the evidence you will see that that question arose directly from comments about hysteria which Sir Hans had made in his answer to the preceding question. There was nothing gratuitous about the question. It was asked in context. We did not believe that the Royal Commission was hysterical, and Sir Hans agreed with us.
I was extremely grateful to the noble Lord, Lord Nathan, for reminding us of what was in the 13th report. At times I found it difficult to know which report he was 716 talking about but I shall study Hansard closely and sort it out. The noble Lord mentioned public understanding, as did other noble Lords. He quoted the ubiquitous Hans Kornberg, saying that we had failed to give sufficient weight to that in the report. That may be so but noble Lords should not forget that that was not what our report was about. It was not about the public understanding of science; nor was it about biotechnology as a whole; it was about the effect of regulation on the industry. In so far as we dealt with such matters as the availability of capital, public understanding and so forth, we went a little beyond our remit but kept well within the flexibility that is allowed to a Select Committee.
I found the comments of the noble Lord, Lord Brain, extremely interesting. He modestly said that he knew nothing about science and proceeded to demonstrate that he knew a great deal about it. I thought that that was a fairly low trick! I shall read his remarks tomorrow. The noble Lord too spoke of public understanding, which is crucial. The noble Baroness, Lady Denton, underlined that.
The noble Lord, Lord Beaumont of Whitley, told us that he was the founder director of Green Alliance. Julie Hill, the director of Green Alliance, appeared before the committee. I found her to be an extremely sensible and sensitive witness. We paid considerable heed to what she told us, in particular because of her attitude which was free of "green" dogmatism. Of course, she had her stance, and correctly so, but it was non-dogmatic and sensible. We paid considerable attention to what she said.
The noble Lord, Lord Beaumont, raised the omission of the word "new" from the evidence of Professor Williamson, for which I apologised. I believe that the noble Lord is under a slight misapprehension. The omission of the word "new" in no way affected our conclusions because it occurred during the publishing process long after our conclusions had been reached. It was an undesirable error but not one which led to our making mistaken conclusions—
§ Lord Beaumont of Whitley
My Lords, of course I am prepared to accept what the noble Lord is saying. Do I understand that in the daily minutes, which the committee will have received, and the transcript of that day Professor Williamson was correctly recorded and that therefore what the committee had written to consider was correct but not what was finally printed?
§ Lord Howie of Troon
My Lords, the situation did not arise quite like that because Professor Williamson did not appear as an oral witness. The sentence that we quoted was from his written evidence, which is printed in full on page 206 of volume I. However, the omission is regrettable and we are covered in shame for it.
I am glad that my noble friend Lord Carter spoke of the small, still voice of doubt. But it is important that such a thing should exist in a matter of this nature. The first piece of public education on which we should embark is to assure the public at large that the Select Committee is not calling for the regulations to be swept aside. In no way are we looking for a free-for-all. We merely suggest that the regulations should be modified 717 where appropriate and under control themselves. That is the first public perception which should be clarified if the debate goes much further.
The noble Lord, Lord Carter, raised a further matter of extreme interest. He said that ethics were not dealt with in our report. To be frank, I did not think that ethics arose. I do not believe that the ethics of this science are any different from those of science as a whole. It did not seem to be necessary to add an extra ethical dimension to the issue. The noble Lord is an agriculturist and ethics arise in relation to the treatment of animals and not in the biological science in so far as it relates to animals. It is right that animals should be treated properly at every stage in the business and no one would argue about that. But in this case the ethics are no different from those which apply to the experimentation of animals—or at any rate, I do not think so.
I should like to make one last remark about my noble friend, Lord Carter, with which I hope he will agree. He drew attention to the fact that Friends of the Earth and Greenpeace are thought to be the most trustworthy organisations. That may be so; it is a reflection of public perception. A number of years ago when I was more involved in nuclear industry matters I had a good deal to do with Friends of the Earth. It was in the days of the amiable and delightful Walter Patterson and the extremely witty and amusing Amery Lovins. They were two splendid men, but I should not have turned to them for the most objective opinion on nuclear power. I should have turned to them for a clear explanation of their stance on nuclear power, with which I would not agree—
§ Lord Carter
My Lords, I was saying that it is significant that people believe that Greenpeace and Friends of the Earth are the organisation to go to. That is the crucial point. It is not that they are the right organisations but that people believe that they are.
§ Lord Howie of Troon
My Lords, I agree entirely. Perhaps it shows a high-heeled claim. The noble Baroness, Lady Denton of Wakefield, explained the Government's attitude in clear terms. It is fair to say that since the committee investigated the matter things have moved on a little. There have been changes in the regulations which are all to the good. The committee did not refer to them, of course, because they did not exist when it was at its work.
The noble Baroness mentioned the system in the United States. It is true that that system might be complex on paper, but as regards the industry there it appears to work reasonably well. It works with more flexibility and a good deal more speed than our system. It may be that there is bureaucratic work in the background which takes time, but as regards the industry the system is not as burdensome as ours. At any rate, that was the committee's opinion.
Although the noble Baroness explained the Government's attitude clearly, she did not say what I wanted to hear. That is not surprising because I wanted to hear an undertaking to accept all our recommendations. I know that that cannot be done right away and we await her full reply when it is published in a few weeks' time.
718 I have spoken for long enough; the debate has lasted a long time. I commend the Motion to the House.
§ On Question, Motion agreed to.