HL Deb 24 June 1997 vol 580 cc1555-68

8.54 p.m.

The Countess of Mar

rose to ask Her Majesty's Government how members of their advisory committees concerned with the licensing and use of organophosphate products are selected for appointment, and whether they are satisfied that the advice they receive is, in every respect, impartial.

The noble Countess said: My Lords, may I say from the start that, by asking this Question, I cast no aspersions on individuals. It is the system with which I am concerned.

There are three main committees which advise the Government on pesticide matters. About 90 per cent. of pesticides are regulated by the Pesticides Safety Directorate, with the remainder being regulated by the Health and Safety Executive. The Veterinary Products Committee, under the Veterinary Medicines Directorate, advises, among other matters, on veterinary medicines which have organophosphates as an active ingredient. The Advisory Committee on Pesticides advises on agricultural pesticides and the Health and Safety Executive advises on non-agricultural pesticides. As far as I can ascertain, it is only the Health and Safety Committee which includes industry and trades unions on its committees.

As well as the main committees there are specialist sub-committees to advise the main committee on safety and licensing aspects. The main committees then report to Ministers with their recommendations. The lead department is the Ministry of Agriculture, Fisheries and Food. I am delighted that the Government are now trying to resolve the conflicting interests within MAFF, where the ministry is expected to promote agricultural production and the interests of farmers and growers while it has a duty to promote consumer and worker health and safety and to protect the environment. There is also an urgent need to review the system of regulation, monitoring and enforcement of pesticide licensing and use.

The advisory committees are all described as "independent", the dictionary definition of which is: not dependent or relying on anybody". I do believe that these committees are independent of government, but I am not so certain that they are independent of the industry which they were set up to regulate. The Veterinary Medicines Directorate and the Pesticides Safety Directorate are both government agencies, dependent for much of their income upon the fees they charge the chemical companies for licensing new products. They rely upon those same companies to carry out safety assessments and to submit authentic data. There is no independent cross-check of that data, as I have established from Answers to parliamentary Questions. The committees need trained and experienced staff. In many cases these people will have come from the chemical companies and, as so many are now on short-term contracts, some will want to return to the industry. The industry is also expected to report to the regulators any adverse reactions in humans, animals or the environment. Does the noble Lord the Minister find this dependence acceptable?

Members of the advisory committees tend to be distinguished academics with backgrounds in research, administration and teaching. With the exception of the Health and Safety Executive committees, there are no lay members and, perhaps surprisingly, no women on the main committees. Are there no distinguished women working in the fields from which the advisers are drawn? Appointments are made by MAFF and members must sign a declaration of their interests in chemical companies. We do not know how the appointment process operates, but there must be an element of personal recommendation. There is nothing wrong with this, as long as it is not the only means by which members are selected. There seems to be a nucleus of about 25 individuals who advise on a number of committees.

The scientific community is very close-knit and because the numbers of individuals in specialties is small, they will all know one another. They are dependent upon one another for support, guidance, praise and recognition. If they wish to succeed, they must run with the prevailing ethos of their group, department or specialism. History is littered with stories of the establishment refusing to accept new scientific discoveries and of the ostracism of the discoverers. The first I can think of is Galileo. There may be a number of reasons why scientists tend to take this stance. Their prestige, and therefore their position in the scientific hierarchy, depends upon the authority which is accorded to their work by their peers and by the wider public. They may therefore resist any challengers to their established doctrine for fear of losing face. There may be subtle pressures put upon them by the larger chemical companies to the extent that any dissent from current thinking and practice might lead to a loss of financial or other support to themselves or to their university department. The influence may be as crude as a threat to move to a country where the regulatory regime is more amenable.

What were the influences which precipitated the unfortunate circumstances under which Dr. Jamal, a member of the scientific panel of the Veterinary Products Committee, was forced to tender his resignation? He has said publicly that his experience with large numbers of farmers and others who are suffering nervous system damage led him to believe that continued use of OPs should be suspended, and he made his opinion known to the chairman of the Veterinary Products Committee before he was ever appointed to the panel.

Those who believe their health has been damaged by OPs and others who are working with them have the distinct impression that the establishment is demonstrating an unwillingness to accept the evidence of hundreds of published scientific papers and thousands of individuals who are ill after using OP pesticides.

Members of the advisory committees may not have any direct interest in the chemical companies, but they will have earned the status which has got them on to the committees after working for the industry either directly or through research on behalf of their universities. Unless they have retired, they will still be involved with colleagues who are dependent on chemical company research funds for the continuation of their departments, and those who are administrators may even be involved in obtaining industry funding. Is it unreasonable to suggest that, no matter how they try to avoid it, these people may be influenced by the pressures placed upon them by the need to ensure the viability of their faculties? Are there not pressures put upon them from outside by implied threats of relocation and the loss of valuable income to the nation?

Are Her Majesty's Government satisfied that the advice they receive is in every respect impartial? "Impartial" means "not favouring one more than another". Impartial advisers will hear and see all the available evidence, test its validity and weigh it in the balance without fear or favour. If there is a lack of evidence to support one side or the other, no balanced conclusion can be drawn. Remember Toyber's dictum: absence of evidence is not evidence of absence.

The Veterinary Products Committee in its report on the Suspected Adverse Reaction Scheme has consistently stated that evidence on the health effects of exposure to OP sheep dips is "inconclusive", without seeking further field or clinical evidence. It has based its advice that OP sheep dips should continue to be used upon that lack of evidence of adverse health effects. It continues to assert that, provided the recommended protective clothing is worn, those involved in sheep dipping will be safe. This is in spite of evidence from the Institute of Occupational Medicine that metabolites from OPs were found in the urine of dippers, whether or not they were wearing protective clothing, indicating that the chemicals had been absorbed. It has also asserted that the inhalation of vapour and spray is not a problem, despite evidence from sufferers. The argument is that no measurable quantities have been found in field tests, while it admits that the equipment used is not able to measure minute doses.

The authorisation procedure relies on the "predictive model". This means that a standard is set based upon the expected effect of a dose of a chemical which is extrapolated from laboratory experiments and conformity with which is deemed to satisfy the safety requirements. Humans are not large rats; even less are they the hens which are used to predict chronic neurological damage. Humans do not all come from the same mould either. It is very apparent that some can tolerate much higher levels of exposure than others. The underlying ethos is that no drug, chemical or medicine can be absolutely safe and that no test method can be devised to ensure that all possible dangers are identified. Against this, unless a very good reason can be given, there is the general imperative that a product must be approved for sale. If the assessment is made on risk/benefit principles, I ask the Minister how many people—men, women and, worst of all, children—must be made ill before a product is seen to constitute a risk?

The existence of a regulatory system has lulled the public into the belief that all products which are licensed as pesticides or medicines have been subjected to rigorous testing and are safe to use provided the recommended safety precautions are heeded. In reality, there are huge gaps in the safety data, particularly for OPs. The public is now beginning to doubt that the system is reliable. Once a licence has been granted for a product it is contrary to human nature to expect that either the licensing authorities or the manufacturers will willingly admit that they have failed to detect effects which subsequently come to light, for to do so is likely to result in huge compensation claims, particularly where the advisers have recommended to government the use of a particular product in order that compulsory treatment or prevention be carried out—for example, the dipping of sheep to control scab or dressing cattle to prevent warble fly infestation. Manufacturers who were forced to withdraw products by the licensing authority without very strong evidence of undesirable effects would not hesitate to sue. This point was made very clear to the all-party group of MPs and me when we met the then Minister, Mr. John Gummer, to ask for a moratorium on OP dips in 1993. Do not these factors have a bearing on the decision-making process of the Government's advisers?

There is no mechanism for an impartial challenge to be made to the fundamental bases upon which the evaluation of a pesticide is conducted. While the regulating authority may take a neutral view, accepting and proposing authorisation criteria, it does not appear to question whether the criteria are adequate. The view that the authority takes may be neutral, but it is not impartial. The developer puts his case but there is no one to put the case against and it does not call for any contrary evidence.

As many have found to their cost, there is a fundamental imbalance between the evidence required prior to the licensing of a product and that required post-release. If damage is alleged to have occurred it must be proven to a very rigorous scientific level, while the scientific evidence required by the regulators need not. Compared with the energy and resources generated prior to licence authorisation, the manpower and funding provided to investigate events which have led to claims of ill-health or environmental damage is minuscule. This results in a procedure which cannot be impartial because the system in which it operates lacks balance.

These expert committees are often required to make decisions upon incomplete evidence, so the only verdict they can give is that of "not proven". This cannot be an impartial response if the resources allocated to field and clinical investigations are inadequate and the evaluators do not qualify their findings accordingly. They rely upon what may be called "constructive ignorance" by being content to rule on the evidence which is before them and avoid a search for information that may lead them to a different decision. That is not being impartial.

Of course, there is also an inherent bias in that human nature decrees that arbiters tend to favour their own judgment and resist the opposite view. The Cairns Committee in its review of the authority which both licensed aircraft as airworthy and was responsible for investigating aircraft accidents coined the phrase "intellectual corruption". Is there not room for intellectual corruption in the deliberations of these committees?

A short while ago I came upon the following quotation from A Pride of Tigers by Sybil Marshall: I fell to wondering why it is that 'experts' so often get things wrong. Once they become experts they know all the answers, so they don't ask questions. They simply reach out and take the most likely ready-made explanation from the peg and use it, whether it fits the case in point or not". OP victims are tired of, and distressed by, a medical profession which tells them that they should see a psychologist, or that conventional medicine can do nothing for them, simply because the medical profession is confounded by the multitude of symptoms with which their patients present, and there is no easy explanation in the medical literature and no clear lead from the Department of Health.

I ask the Minister whether he will ask his right honourable friend in another place to review the means by which appointments to the Government advisory committees are made; whether he will consider creating a pool of suitable candidates from which he can draw by a method similar to that used for jury service; that these candidates should include young scientists, PhD students for example, as well as senior members of the profession; women, and lay people with field experience in using products similar to those to be licensed. Will he look into ways of reducing the dependence of university departments and other research facilities on the chemical industry for funding of research into their particular field? Will he consider the exercise of the precautionary principle rather than risk analysis as the basis for the issue of a licence for a product, especially when there is a lack of toxicity data available? Will he work towards the separation of licensing procedures from procedures to investigate harm caused to humans, animals and the environment by licensed products? Finally, will he make all these procedures open to scrutiny? Is he aware that I have obtained most of the information I have on OPs not from the UK but from the United States under their Freedom of Information Act?

9.9 p.m.

Baroness Park of Monmouth

My Lords, I propose to intervene briefly in the debate to support the noble Countess in yet another aspect of the long battle to establish the truth about the Gulf War syndrome and the role of OPs and to raise a related concern.

On the first point, much of what the noble Countess had to say about possible constructive ignorance and intellectual corruption, and above all about the need to make procedures open to scrutiny, including the way in which committees are appointed, is equally applicable to some of the committees appointed by the European Commission. On a number of issues, ranging from the quality of bathing water to the protection of birds, I have been struck by the lack of transparency which characterises the agenda, the reporting and even the membership of the committees responsible. It is often difficult, if not impossible, to establish what scientific and technical advice has been given, and only too often legitimate requests for information are refused.

It is all the more important therefore that we should ensure the most open proceedings possible on the issue at a national level, especially when the issue is one of public confidence and morale. The public is much more ready to accept bad news than to encounter all the doubts and anxieties that arise from obfuscation. We have good scientists and conscientious public servants. Let us ensure that they are seen to be open to accept even the most inconvenient facts.

My other concern, though somewhat alleviated by the statement yesterday of the noble Lord, Lord Gilbert, that research into OPs is being funded jointly by the Department of Health, MAFF and the HSE, is that the Ministry of Defence should be fully seized of all scientific evidence available to the three main committees listed by the noble Countess and should, in its turn, submit to them whatever scientific, medical or other relevant information on the issue of the effect of OPs may emerge from the inquiry being conducted by the Ministry of Defence in response to the Defence Committee in another place.

An independent co-ordinator, someone who is neither a civil servant in the ministries concerned (the MoD and MAFF) nor a member of any of the existing committees, should be appointed to review all relevant information. Such a co-ordinator should be free to hear evidence given under the equivalent of parliamentary immunity from any present or indeed former member of those ministries who possesses relevant information.

If mistakes were made or information was not considered relevant or sufficiently substantial and was therefore not brought forward, or even suppressed, now is the time to remedy that. That may offer the chance to set the record straight and to ensure that there are no more time-bombs of undisclosed knowledge ticking away. An independent co-ordinator could help to ensure that ministries do not decide that partial evidence is no evidence and therefore take no action. Sufferers from the effects of OPs have been left in limbo for too long. That is not right, and something must be done.

9.13 p.m.

Lord Lucas

My Lords, I offer my support to the noble Countess and my noble friend and what they have said this evening, and I hope that the Minister will take it seriously. I look back at my time in MAFF, which I enjoyed greatly, and at the great quality of the civil servants there, and of our scientific advisers. I do not wish them to think that what I say is any criticism of them.

I look back and think that we set up those committees and used them in a way which led to many of the problems that we faced towards the end of our term in office, and which led to the breakdown in trust between the people of this country and MAFF and what it said.

Looking back, I can understand how we came to set up and use committees in that way. It is clear that MAFF does not have within it, and politicians do not have within their ranks, the expertise necessary to provide answers to difficult scientific questions. From the point of view of public trust, they need to set up committees which have a measure of independence. From the point of view of making decisions, they need to obtain from those committees a single, clear recommendation.

It then became the practice that the Government relied on and enacted the recommendations of these committees. Indeed, they took them as gospel, not to be quarrelled with. It therefore became necessary that the people on the committees should display a great deal of level-headedness and that they should not represent extremes of opinion; that they should be able to agree together and not produce dissenting opinions. Those committees seemed to be selected by a process of networking, as the noble Countess suggested. Clearly, the politicians did not know who the right people were. I suspect that in many cases the civil servants did not know who the right people were. They were discovered by talking to other people and generally finding out through the scientific community who were the best people for the job.

At the time, that seemed to me to be a very reasonable way of going about things. But, now that I look back at all the difficulties we had, I can see perhaps more clearly the imperfections that were present in the system. As the noble Countess said, scientists are human beings; they are subject to bias, like the rest of us. In science, there always has been a strong pattern of consensus. If you were a believer in the Phlogiston theory, when that was right, you would fight viciously people who proposed that it was wrong. That has always been the way that science has evolved. A consensus has been fought against by a few outsiders until it has been overturned and the rebels become the consensus in their turn. We have been using a system to choose people for these committees which is strongly biased towards consensus, principally because we have demanded that at the end of the day the committees produce a consensus themselves.

Scientists are subject to natural biases in that they wish to continue to have careers and they wish their research to be paid for. The two principal sources for that are either the Government and the committees that they set up, which will tend towards consensus and the consensus view of what research should be done, or industry, which will tend towards research which does not undermine its own business.

That process has also led to committees which tend to exclude people from participation. They exclude the industry from open participation, they exclude users and they exclude consumers. Those groups must then make their impact on decisions covertly. Obviously, industry has ways of doing that, but others must develop their own ways of influencing the committees, as it were, in secret.

That leads to a whole process of dissatisfaction, a feeling of cover up and a lack of trust. That bedeviled us in so many aspects of what we were doing in MAFF. Looking back, we believed that we were doing the right thing. We all believed that we were doing the honest thing, that we were taking the right decisions and that we were treating matters fairly and honestly. But the structures that we were using, the structures we had set up, did not allow the public to believe that too.

I believe that other models could he pursued by the Government which would achieve the same effects without the down side. I suggest that the Government might consider the example of the Court of Appeal, with tribunals and, indeed, this House itself, and in the way in which they operate. If the House of Lords sends down a judicial decision by three votes to two that is accepted as a reasonable decision. No one argues with the decision. It is understood that there may not be an absolute, right answer, that there might be two sides of opinion, but it has been decided. Why cannot we have committees in which that level of dissent can be experienced and expressed, but nonetheless we accept their decisions when they come down—or at least we accept them as being the decisions of the committees?

In court, the experts appear as witnesses and not as arbiters. They can be questioned and other points of view can be brought to bear. Access can be had by interest groups and others who are affected by the decisions. The whole thing can be weighed in public before a decision is reached. If at the end of the day the committee arrives at what may be seen as the wrong decision politicians will feel able to intervene, as they would with the court. We in this House have had some long debates about the Government overruling the House of Lords in a decision that it has reached. Why should we feel differently about a scientific committee on a technical aspect of organophosphates, BSE or whatever? Politicians have a role to play. They have recently shown that most strongly in the case of firearms control, where a serious and well set up committee produced recommendations with which we disagreed and we wanted to act more strongly. The Government wish to go further than that. Politicians have a role. They should not feel cowed and unable to play their role because they have set up committees which are so totally expert that the Government cannot claim to have a role in the process.

I believe that this is a matter which should attract the Government's serious consideration. If they wish to avoid the kind of problems which we let ourselves in for during the past five years, I hope particularly that they will bear that in mind when constructing the new food safety agency. We do not know a great deal about it so far, but what has been posited makes it sound like a sort of super committee, which will be so inward turned and so bound up with its own way of doing things that it will, perhaps, need another regulator over it to ensure that the public voice can be heard and influence what the committee chooses to do.

It is enormously important that we should take this opportunity of a new government and of their determination to have open government and freedom of information—all of which I agree with—to reform the structures within MAFF which have so held us back from being seen to do what we have always believed to be right and what I believe officials and scientists in the expert committees have always tried to do; namely, do the best for the people in this country as a whole and to make honest and correct decisions.

9.21 p.m.

The Parliamentary Secretary, Ministry of Agriculture, Fisheries and Food (Lord Donoughue)

My Lords, I want to thank the noble Countess for placing this Question before us and the others who have spoken in the debate. I believe that the quality of the speeches has fully compensated for the fact that they have been few in number.

When, somewhat to my surprise, I took this ministerial position I rapidly realised that it was bound to involve an early encounter with the noble Countess. Given her track record, that was bound to be a daunting prospect. However, I should say that it was also a pleasing prospect. I am grateful to the noble Countess for forcing me to look early on into this important issue. I hope that I and my fellow Ministers will bring a fresh mind to it and that I can encourage the department, as I am sure I can, to take a fresh look at the matter. Some of us have been too long in government, even if it was a long time ago, to assume that fresh looks always mean fresh conclusions, but I can certainly promise a fresh look.

We fully recognise the concerns of the noble Countess about the effects of exposure to organophosphorus products. MAFF Ministers have repeatedly said that there is no scientifically recognised and widely accepted clinical syndrome associated with low level exposure to organophosphate sheep dips. That remains the case so far as concerns our scientific advice. Yet, while this statement so far as it goes may be technically accurate, it does not, I fear, recognise the concerns of the large group of people who clearly believe that they are suffering from the effects of exposure to organophosphorus products.

Therefore, from the beginning, I want to assure the House that we have every sympathy with those individuals. There can be little doubt that the suffering of this group of people is quite genuine and the cause of it must be fully investigated. We are totally determined to look closely into the issue. We shall take whatever steps are necessary, including the relevant scientific and clinical research, to satisfy ourselves that effective consideration is given to those concerns.

Of course the regulatory systems must be based on sound science. But in practice many of the decisions which regulators take are a matter of balance. The advisory committees and the regulatory agencies face the challenge of weighing benefits against safety concerns guided only by the certainty that their knowledge is incomplete. We therefore intend to examine carefully whether the balance of decision making—much of what the noble Countess was saying was about that balance—lies where we and the public believe it should lie.

Our recent proposal to broaden the membership of the advisory committees to include lay members—I am not sure everyone interested in this area has taken that on board—is one step towards this goal. We shall also be meeting the chairmen of the committees to seek to understand, among other things, how they determine what is an acceptable risk and whether the resulting balance reflects the public's concerns. We want to look again at ways to improve the system. We are ready to consider proposals to achieve this and we aim to get the balance right, or more right. I have never achieved perfection in anything in my life and therefore I have to qualify that.

I am sure noble Lords are aware that members of the advisory committees are appointed by agriculture Ministers with the agreement of health Ministers and, in the case of the Advisory Committee on Pesticides, the Secretary of State for the Environment. Members are selected for their scientific expertise relevant to the advice offered to Ministers. The noble Baroness rightly argues that such scientific expertise should be particularly relevant to the health dangers associated with a specific product. That is pertinent and I shall pursue it. I shall also wish to be reassured that sufficient relevant medical expertise is present.

There is full public consultation to seek nominations for membership. Over 80 organisations are consulted and there will shortly be consultation on the replacement and reappointment of members whose term of office expires at the end of 1997. As regards members of the Veterinary Products Committee, recommendations for appointment are subject to the consultation of the Medicines Commission. There is a statutory duty under the Medicines Act to recommend to Ministers persons considered to be well qualified to serve on the Veterinary Products Committee and the other Section 4 committees.

Current membership of the Veterinary Products Committee includes expertise in human as well as veterinary medicine. The committee has a medical and scientific panel set up specifically to look into reports of long-term health effects from the use of organophosphorus sheep dips and advise on research. The chairman of the panel, Dr. Bateman, is also a member of the Veterinary Products Committee. Seven out of the 14 present members of the Advisory Committee on Pesticides, including the chairman, have expertise in the medical field, including human toxicology and occupational medicine.

As a result of the medical and scientific panel's recommendations, the Institute of Occupational Medicine in Edinburgh is to conduct a half a million pound study of long-term, low level exposure to OP sheep dips. The report is expected in 1999. We trust that this will help us further to understand this complex issue. I fully understand the concerns of the noble Countess about the balance of expert advice. My right honourable friend the Minister has already said, as I mentioned, that he is looking at the appointment of consumer or lay representatives on advisory committees in the area of food safety. That will also include committees such as the Veterinary Products Committee.

The noble Countess mentioned women members. I am pleased to inform the House that there are two women, Dr. Gaskell and Miss Gibson, on the VPC and Dr. Carter on the APC. Whether that is enough—whether there are ever enough—to satisfy noble Baronesses in this House remains to be seen. However, I can assure the noble Countess that we are reviewing the system of appointments. Her mention of a panel will be helpful to us when we consider appointing extra people to the committees.

The Veterinary Products Committee discussed Professor James's report on the Food Standards Agency and is submitting comments. The committee had no objection to lay membership or to greater openness and transparency. The Government need to look at the confidentiality provisions of the Medicines Act in order to achieve the maximum openness compatible with the restraints of that Act.

On the difficult question of impartiality, we naturally wish to ensure that the Government receive the best advice from those best qualified to give it. It is inevitable that the expertise of members is valuable to industry too, which will often be looking to the same people. We have to assume that we receive impartial advice. However, if anyone has further considered suggestions—and I include the remarks of the noble Countess and the noble Baroness, Lady Park—on how we can further guarantee impartiality perhaps they will write to me and I shall consider those specific proposals sympathetically.

The noble Countess mentioned financial conflicts. Strict controls exist. For the Veterinary Products Committee, members make an annual declaration of interests. Those are published in the annual report which is part of a composite publication covering the Medicines Commission and other Section 4 committees. The publication also includes the code of practice governing the declaration of interests. As well as that annual declaration, members are required to declare interests at meetings. If interests are declared, the chairman excludes members from discussion or limits their participation, as appropriate.

For the Advisory Committee on Pesticides, there is a statutory requirement that members are appointed only on signature of a declaration to the effect that they have, no financial or commercial interest as would be likely to prejudice the proper discharge of their functions". The appointment of members with some minor connections with industry is not ruled out. Each case is judged against the test of "likely to prejudice".

In addition to the statutory rules, all members are also required to make an annual declaration of all industry interests, however minor, covering both personal interests and those of their employer. This declaration is published in the committee's annual report. So I think I can say to the noble Countess that I am reasonably convinced that financial conflicts of interest concerning members' direct incomes are not of real, practical concern. Whether the financing of research at universities and institutions connected to members is an issue I am not so sure and will investigate further.

I sympathise with the noble Countess's question as to why independent research is not done into the safety of the veterinary and pesticide products that the Government approve. I have asked my officials the very same question. Typically, it takes 10 years to develop and test a product, but the precise formulation will not be settled until the last year or so of development. If government conducted safety tests, these could not begin until very late in the day, delaying availability. It would also mean that work would be duplicated. In an international market different countries could be carrying out the same experiments and achieving the same results. There would be unnecessary experiments on animals and unnecessary suffering.

That said, I am, however, prepared to examine the matter further to see whether there is any sensible and selective way of involving government or some extra independent dimension. Here I think of the suggestion made by the noble Baroness, Lady Park; namely, to double check those cases where there is particular reason for concern. It would probably involve public expense, and I cannot make a commitment to that. However, public health is one of our top priorities.

The approach used by the regulators is to demand all the information generated; and for veterinary medicines there is a legal requirement, including adverse results. Even early experiments on the active compound can be considered by the advisory committees. That gives a broader understanding of the product's properties and is more reliable than simply a limited range of tests carried out by government.

If significant gaps in the safety data emerge during evaluation, then the product is not authorised or approved. In addition, the data have to be produced to recognised standards, including OECD guidelines, and good laboratory practice controlled by the Department of Health.

Having described all these magnificent protections, there may still be ways in which the system can be improved. There may be circumstances, for instance, in which an early dialogue between manufacturers and regulators could result in a wider range of experimental data becoming available on which a scientific judgment can be made. I have asked my officials to look at all the suggestions and arguments advanced by the noble Countess, the noble Lord and the noble Baroness and to consider any practical improvements that could be made on current practice.

Finally, perhaps I may turn to one or two specific points that arose. To the noble Countess, I say that I am also aware that expert committees may balance in one direction or another, even with the best of intentions. I sense that that is possible to smell; it is difficult to assess, and extremely difficult to correct. Nevertheless, I promise her that we will try.

The noble Baroness, Lady Park, suggested that the precautionary concept should be given greater priority. I have great sympathy with that approach and have already asked officials to look into how that might be secured. The House should be aware that the present criteria are safety, quality and efficacy. We will consider whether it is possible to qualify that with the precautionary element. MAFF is closely in touch with the Ministry of Defence, but we will certainly pursue the noble Baroness's suggestion of an independent co-ordinator.

I found the reflection of the noble Lord, Lord Lucas, on his time as spokesman helpful and commendably honest. He aptly described the dilemma of Ministers assessing scientific advice. He described it with painful accuracy and I can assure him that nothing that happened on 1st May has altered that dilemma. He is probably right that the present system is not transparent and open enough. He made helpful suggestions about a better model; we shall look at them in our present review. The one thing that I can promise him is that we are not cowed.

House adjourned at twenty minutes before ten o'clock.