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Bovine Somatotropin

11.46 pm

The Parliamentary Secretary to the Ministry of Agriculture, Fisheries and Food (Mr. David Curry) : I beg to move

That this House takes note of European Community Document No. 8975/89 relating to bovine somatotropin ; and supports the Government's policy that the basis for authorising such products must be a thorough, scientific appraisal to confirm their safety. I shall begin by outlining the Community proposal which we are discussing tonight. It deals with the synthetic hormone, bovine somatotropin--which I will abbreviate to BST, to avoid future risk--which can increase the milk yield of dairy cows. It would allow trials to continue at national level and objective scientific evaluation of the data obtained, both by independent experts in member states and by a parallel expert committee of the European Community.

The Commission maintains that the proposal does not bring into question the current system of evaluation. First, it would require member states not to authorise the commercial use of BST before 1991. Secondly, it would require the Commission to report in more detail to the Council, with proposals if necessary, by 1 October next year. Frankly, we do not know what proposals the Commission has in mind, and we suspect that it does not either.

The present proposal has been put forward by the Commission under article 43 of the treaty. It has been referred to the Economic and Social Council and to the European Parliament for opinion. The ECOSOC's report is awaited. The Parliament will not take this proposal before December, if then, and the Council will thereupon act upon a qualified majority but may be able to give a formal endorsement following discussions at the level of COREPER. Bovine somatotropin is a single chain polypeptide--amino acids which are building blocks for protein--produced by the pituitary gland in all cows. It is both a protein and a hormone. In lactating cows the normal action of BST is to divert more of the animal's food intake to milk production.

The same effect occurs with the administration of synthetic BST, which can now be manufactured by the same genetic engineering processes which have made it possible to produce commercial quantities of insulin, of AIDS-free blood factor 8, and of interferon, which is a valuable drug against certain forms of cancer. Because it is a protein, BST is broken down by digestive mechanisms, and it must be administered by injection. Both chemically and biologically, BST is very different from the growth-promoting hormones banned under European Community and United Kingdom legislation. It has no hormonal action in man. All studies have failed to demonstrate such action in man. Some work was conducted in the 1950s and 1960s to discover whether BST would be effective in overcoming dwarfism in humans. It failed.

As for the framework for approval in the United Kingdom, synthetic BST falls within the legal definition of a medicinal product. It is therefore subject to the controls set down in the Medicines Act 1968. The Act exists to protect public and animal health by ensuring that no product may be marketed in the United Kingdom until all

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data relating to its safety, quality and efficacy--the trinity upon which the scientific advice depends--have been thoroughly scrutinised by qualified scientists and found to be satisfactory. Only when all the data have been evaluated, and the company has provided full and satisfactory answers to any questions which arise during the scrutiny, can a licence be issued.

Although quality and human safety data can be worked up in a laboratory, it is often not possible for companies to provide data on efficacy and animal safety without conducting field trials, which must be authorised under the Medicines Act 1968. This authority, known as an animal test certificate, is issued only when the quality and human safety data permit scientists to draw the firm conclusion that trials may be conducted safely. This conclusion may be drawn for BST, and field trials are currently being undertaken in the United Kingdom and a number of other countries in Europe, including France, Germany, the Netherlands and Belgium, and in the United States. In the United Kingdom, BST products are currently undergoing trials and assessment. The trials have been running for about four years. A maximum of just over 1,000 cows on up to 10 sites have been involved, although far fewer are normally involved at any one time. For example, on 8 November, 56 cows on four sites were being treated with manufactured BST. The milk from the trials is sold in the normal way through the Milk Marketing Board, which pools it with other milk. On 8 November, which was a typical day, it accounted for less than a hundredth of 1 per cent. of total milk supply.

While the scientific standards to be applied are increasingly governed by Community rules--assessment falls under directive 81/851, for example-- responsibility for licensing decisions rests with the national licensing authority, in this case Agriculture Ministers. Why has the Commission made this proposal? Its answer, to judge by its accompanying report to the Council and Parliament, is that time is needed to look at the other aspects of BST use which are not currently being considered as part of the licensing process. The Commission wants to look at the social and economic implications of widespread BST use, should a product licence be issued. It wants to examine the impact on the structure of the dairy industry and the wider implications for the rural economy. It also wants to look at the market impact, if there were to be a reaction by consumers against the use of synthetic BST in cows producing the milk they drink.

These are important questions, even if they are separate from the safety, quality and efficacy criteria in the licensing process. Some argue that they should form the basis of a so-called fourth criterion in that process. That implies a similar, scientific assessment against agreed objective standards. As far as I know, however, no such further test has successfully been formulated.

The social and economic concerns relate essentially to the impact of BST on the structure of the dairy industry and farming generally. The consequences of licensing BST could be widespread, as the Commission has noted in forwarding this proposal. Increases in milk yields and declines in dairy cow and calf numbers could trigger adjustments across the industry. Much depends on the assumptions made--for example, about how cost-effective BST would be and the extent of its uptake by milk producers.

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Depending on those assumptions, it could be further argued that there would be a differential effect on larger and smaller dairy farmers. Hon. Members will know that small farmers are one of the current preoccupations of Brussels. If BST were nevertheless assumed to be attractive to those who produce and market milk, it might also be maintained that its availability in some parts of the Community and not others would confer unfair advantages on farmers in areas where it is available.

To put all this in perspective, however, we should note how matters have already developed in the dairy industry, without any help from BST. In the United Kingdom, milk yield per cow increased by 27 per cent. from 1970 to 1988, and by 2 per cent. after 1984, when quotas were introduced.

There are understandable concerns which go back long before the issue of BST. We have to recognise that there are very few firm facts on which to base calculations and projections. They quickly give way to an essentially subjective forecasting exercise. In the process, it is not easy to isolate the impact of any one factor, such as BST, from all the others, such as breeding developments and improved feeding techniques, which contribute far more to developments in the dairy sector.

The Government take the view that objective scientific evaluation is the only reliable basis for taking action in the veterinary medicines sector. Some questions which fall outside the objective licensing process are legitimate, but answers to them should be found in the political arena and within the scope of policies relating to agricultural production and marketing.

The second group of concerns are those expressed by consumers, and they clearly deserve the closest possible consideration. The licensing process, which I have outlined, already addresses many of those concerns, but there is a broader issue here to be faced by those developing and using high technology in consumer-sensitive areas, such as food production. It is for them to accept responsibility for informing and advising their intended customers. In establishing consumer safety, the Government are directly and intimately involved. The standards applied within our licensing system are rigorous in the extreme, as I shall show.

When applications for authority to conduct trials into BST were considered, the Veterinary Products Committee looked carefully at the data concerning consumer safety and at the possibility that synthetic BST might affect the milk we drink. Milk is not a standard product. It contains many different substances and natural hormones, including BST, most of them in minute, but variable, quantities. The evidence examined by the Veterinary Products Committee showed that use of manufactured BST could lead in some circumstances to an increase in the amount of those substances that was present in milk, although the increases were very small and the amount of the substances remained within the normal range of variability. The substances concerned are milk fat, biotin, which is an essential vitamin, IGF1, which is a natural hormone involved in milk production, and BST itself. The Committee considered that field trials involving the small number of animals I have already mentioned would pose no risk to consumers. Milk from the trials was compositionally and nutritionally within the normal range

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of variability. However, because some members of the committee have retired and others have been appointed since that conclusion was reached, I recently asked the committee to review the evidence afresh. It came unanimously to the same conclusion, and had it not been satisfied on that point, the field trials would not have been authorised and allowed to continue.

Now that the Committee is looking at applications to issue product licences for two BST products, it is considering the implications should BST become widespread. Milk from treated cows might then, potentially, provide half or more of the total supply. In line with that cautious approach, the VPC has sought advice from the Department of Health on the nutritional and health implications of such a development, and its advice is expected soon. With or without the present Commission proposal, there will be no licensing of BST until all objective concerns about consumer safety have been resolved. We are being just as exhaustive in evaluating any possible animal welfare problems.

Companies must know that, if a product is not safe, they will not be allowed to market it. Conversely, they should know that if a product is safe, they will be allowed to market it and to see whether it meets acceptance in the marketplace. Without such an assurance, the industry will cease to invest in the development of new products and it will certainly hesitate before making investments in the European Community. The Government believe firmly in the principle of taking licensing decisions on scientific evidence related to safety, quality and efficacy.

The incentive or disincentive effects of decisions in these matters are not easily confined to a single area of research. We have to bear in mind the potential effects, especially in other parts of the human and veterinary medicines industry, which is both a provider of new medicines and a significant employer. The wider effects also extend to international trade. Unilateral action taken on disputed scientific grounds or mere political expediency can, as experience with the beef hormone problem has shown, jeopardise progress towards better trading relations in the agricultural sector.

The scientific discipline of the licensing system is adapted to meet the objective concerns that are expressed about products such as BST. I have acknowledged that there are wider issues and concerns that are not--and cannot be--resolved in that way, but which deserve study. The Commission plans to follow this up and we shall take a close interest in its findings. The decisions to be taken, however, must be based firmly on the facts. I therefore commend the motion to the House.

11.59 pm

Mr. Ron Davies (Caerphilly) : On 28 November last year I tabled an early day motion calling on the Government to impose a ban on the non- therapeutic use of BST. It was supported by 117 members, mainly but not exclusively, Labour Members. On 29 November the hon. Member for Torridge and Devon, West (Miss Nicholson) tabled a similar motion calling for a ban on the use of BST in the United Kingdom which was supported by 66 Members, mainly, but not exclusively, Conservatives. That cross-party expression of opinion in the House reflects widespread public concern about and opposition to the use of BST in Britain's dairy herds.

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In contributing to this latest chapter of the debate on BST I shall mention one incident in the debate's history which helps to put the Government's position in perspective. The incident was reported in the Farmers' Weekly on 15 July 1988 under the banner headline, "Gummer in Big BST Row". It took place when the right hon. Member for Suffolk, Coastal (Mr. Gummer) was the Minister of State, Ministry of Agriculture, Fisheries and Food.

This evening the Minister had made great play of the fact that he and his Department will be guided, if not bound, by scientific evidence. Before the scientific evidence on which the case for BST has been based had even been collected, the right hon. Member for Suffolk, Coastal went on television to say :

"There is no scientific evidence whatsoever of any kind saying that BST is in any sense dangerous."

Mr. Elliot Morley (Glanford and Scunthorpe) : The right hon. Gentleman is a member of the Synod.

Mr. Davies : As my hon. Friend has said, the right hon. Gentleman may be a member of the Synod of the Church of England, but in this outburst he was implicitly laying claim to the prophetic powers of Isaiah. The right hon. Gentleman's big BST row was a classic example of speaking out of turn. His comments were described as intolerable by an outraged member of the Veterinary Products Committee, the very organisation charged with deciding the issues upon which the Minister had so definitively commented. Were the VPC a court of law--it has a quasi-judicial role in product licensing--the right hon. Member would have been in contempt of court by now for speaking on a matter that was sub judice and might, even now, have delighted us all by thinking holy thoughts in gaol.

However, both the right hon. Member and BST are still before us and the VPC is still conducting its deliberations. The same scientist who was outraged by the Minister's comments last year repeated in an article in The Guardian on 6 October this year :

"BST is a potential health risk to humans and its use should not be allowed."

The same scientist who was appointed by the Government and was a distinguished member of the VPC, continued :

"Assurances from Ministers that BST is safe to drink in milk cannot be justified. The trials prove nothing about its potential dangers to human health and are now ethically questionable. The risk people face in drinking small amounts of BST-milk over a short period of time (during the experiments) is no measure of the risk faced by the whole population drinking nothing but BST-milk once it were approved".

We are still awaiting the final adjudication from the VPC on whether BST meets the trilogy to which the Minister referred and is safe, efficacious and pure. We do know, however, despite the restrictions of the Official Secrets Act, that the committee has already, on several occasions, refused to grant the product licence.

Mr. Curry : I wish to make it clear that members of that committee do not sign the Official Secrets Act but are bound by certain rules of confidentiality which stem from the Medicines Act 1968. The scientist to whom the hon. Gentleman constantly referred voted for the continuation of these trials. It was a unanimous decision.

Mr. Davies : I am glad that the Minister is so well briefed he knows the name of the scientist to whom I refer. Perhaps he will give us a guarantee that the scientist, whose

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term of office expires this December, will not be sacked for breaking the conditions imposed on him under the Medicines Act. Will the Minister guarantee that scientists who have made public statements on the safety of BST will not be sacked?

Mr. Curry : No scientist is sacked if he acts within the law. The only rules of confidentiality that are imposed are those that relate to the Medicines Act. There is no question of the Official Secrets Act being used. Where we consider membership, we shall do so on the merits and not on any extraneous factor.

Mr. Davies : The Minister has started to dig himself a deep hole. In the early part of his speech, he was making it clear that the European Community would have to consider other factors. I am satisfied that when the EC comes to make a decision on BST, it will refuse it--for reasons of convienience and in the light of all the analysis of the welfare arguments and the socio-economic arguments to which the Minister alluded--regardless of whether BST meets the trilogy of conditions--safety, efficacy and quality. The Minister will then have to explain to the various chemical companies how he is taking decisions almost on an ad hoc basis when the products have been submitted to the licensing system and approved. That is the problem that the Minister has created for himself, and which he has to resolve if he is to maintain credibility.

We already know that distinguished members of the VPC have expressed their grave concerns about the safety and efficacy of the product. We also have the benefit of knowing the opinion of the Council of Ministers. When it discussed the issue at length in June of this year, the Minister's predecessor was in the lonely position which has become so familiar to British Conservatives when meeting our European partners. He was alone in speaking against the proposal to refuse a licence to BST. All the other 11 Ministers agreed that the British Government's view was the wrong one.

The opposition to the use of BST shown by the Council of Ministers is shared by consumers and farmers. The National Farmers Union has made crystal clear its view on this issue. At its annual meeting in February, the depth of grassroots feeling against BST forced the union to abandon its policy of fence sitting and take a strong line against BST. The majority view among farmers has become the official view of the NFU. That view is shared by the Farmers Union of Wales, the Scottish union, and the Women's Farming Union. Representing the consumer-producer nexus, the Milk Marketing Board opposed the use of BST. Several large retail outlets, including Tesco, Marks and Spencer and the Co-op have all stated that they will not stock BST-produced milk.

One solution to the vexed question of consumer attitudes to BST has been advanced by the president of the Dairy Trade Federation, Mr. Andrew Dare. Speaking shortly after his appointment in June of this year, he proposed :

"Producers who decide to use this technology must be prepared to segregate their milk and label it accordingly. The consumer will then have the choice of whether to buy it or not."

Mr. Dare is managing director of St. Ivel. He will know as well as any one in the dairy industry that his suggestion is impracticable and would preclude the commercial use of BST. I dare say that that is his intention.

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Both producers and retailers know that much of the esteem in which milk and other dairy products are held comes from their justified reputation for being fresh, pure, natural and unadulterated. They realise the enormous damage that would be done to that reputation, and their livelihoods, if BST were authorised. With authorisation, but without labelling, all milk would be under the cloud of "BST-produced".

Last week, in one of his many TV interviews on the subject of lead contamination in milk, the Minister said :

"I am committed to safety first, and therefore I have taken these very important measures even before we have any evidence, and if I turn out to have over-reacted that seems to me the way the public would like it".

It is a pity that the Minister does not apply that principle more consistently. Producers, manufacturers, retailers, consumers, scientists and welfarists are all agreed that too much is at stake. We are not asking the Minister to overreact but to demonstrate his commitment to safety first.

In countering the preponderant view against its product, the pro-BST lobby has put out highly tendentious propaganda on consumer opinion surveys undertaken on its behalf by reputable market research organisations. One good example was the claim by one of the companies involved in secret trials of BST that because a large majority of the sample had not heard of the hormone, that suggested a lack of consumer concern. What is did not reveal was the attitude of those people who had heard of BST. To claim that because a group of people are ignorant of an issue means that they would be unconcerned if they had heard of it is patently dishonest. I suggest that it does more harm than good to the case for BST.

Mendacious though that claim may be, it is small beer compared with a claim by one representative of the same company. The European marketing manager of Monsanto, Mr. Robert Deakin, speaking at a conference on genetic engineering, referred to those of us who object to the use of BST as "gastronomic terrorists". To my knowledge, that adds a new term to the salesman's lexicon. However, to judge by BST's progress, it has not been notably successful as a popularising catchphrase.

We have seen that, over-hyped Ministers and drug companies apart, the consensus on BST is against its use. I am against the motion not only because I share that majority view but because I am also of the opinion that there must be some consideration of the likely impact of new, sometimes ethically questionable, developments in veterinary science before we give them the green light.

It might help the Minister to know that Lord Plumb, former president of both the NFU and the European Parliament, said in a recent speech to the British Veterinary Association that the debate has moved on from whether there should be a fourth criterion, to the position where it would be "part and parcel" of future licensing. Therefore, he said, referring to the veterinary profession : "The profession must now work to ensure that the so -called fourth hurdle' is as close to scientific evidence as possible".

That is the question to which the Minister should address himself tonight.

The present procedure results in the future of drugs such as BST being determined on political grounds, not on the scientific grounds that the Minister argued. If the

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Minister doubts that, he is at odds with his predecessor who was able to agree with his EC counterparts at the June Council meeting that

"the decision on the future use of BST was a political issue". That was reported in the Agra Europe report on 23 June. Like it or not, that is the position. It seems that the former Minister of Agriculture, Fisheries and Food did like it, for in spite of his later protestations to the contrary, on a visit to a Scottish research foundation in March of this year, he said :

"If an application for a BST licence lands on my desk it will have to go through the most rigorous assessment, including evidence of need, by both the appropriate scientific committee and the European Community".

That is a far cry from the case that the Minister made tonight, when he said that BST must merely meet the three scientific criteria. His predecessor acknowledged that there had to be an assessment of need before he would grant a product licence. Perhaps the Minister can tell us what has changed--apart from the incumbent in office--between the decision of his predecessor in March, demanding, requiring and insisting, using his authority as Minister, that there would be an assessment of need, and thepresent Parliamentary Secretary's explanation of the Government's view that there must be merely the meeting of those three scientific criteria.

If the Minister is now taking a different view, that is between him and this right hon. Friend ; but the reality is that this decision is going to be a political one. We must ensure that all concerned know the basis on which it is taken so as to remove as much as possible the uncertainty facing those who develop new veterinary products. The Government claim that these issues should be decided only on the basis of assessment by scientific criteria because, among other things, that allows the pharmaceutical companies to know where they stand. This position is fundamentally contradicted by paragraph 11 of the MAFF explanatory memorandum on the EC legislation that is before us, which states :

"In the United Kingdom's view the decision whether to authorise BST or not should be taken on the established criteria. The other non-scientific issues including economic implications should be addressed outside the licensing system".

Is it now the Minister's position that there must be an assessment on the basis of scientific criteria, that a decision will then be taken to license the product but that there will be a further evaluation--presumably as part of a political debate--to determine whether that product can be sold, even though it has been granted a product licence? We must draw that conclusion from the Minister's remarks and from his Department's explanation of the EC document. What on earth does it mean? It appears to mean that licensing should take place under existing procedures, but that another evaluative mechanism should be established whereby it is decided on political grounds whether, if a product has been granted a licence, the manufacturers should be permitted to sell it.

Companies that have been involved in producing BST, and those investing in other artificial growth promoters and hormones, will not take kindly to that prescription, for it is a recipe for the political uncertainty which the Minister claims he wishes to avoid. Indeed, what could inject more uncertainty into the minds of the corporate strategists and research scientists?

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If the Government concede that matters other than the purely scientific are to be considered--that is the implication of paragraph 11--surely it is best to incorporate those into the licensing procedures, rather than make the manufacturers jump through two hoops instead of the existing one?

But do the Government concede that non-scientific criteria should be considered? The Minister's predecessor's comments showed that, when he was at MAFF, they did. However, paragraph 10 of the explanatory memorandum says :

"The current procedure offers to companies the assurance that the considerable investment they make to develop new products will not be wasted as a result of Government action except on firm scientific grounds."

If we take paragraph 11 at face value--the one that says that non- scientific issues should be addressed, but outside the licensing system-- nothing could be further from the truth.

Are we to believe paragraph 10 or paragraph 11? Because the Government should come clean and minimise the uncertainty facing pharmaceutical innovation, we think that the socio-economic and environmental criteria should be incorporated into the licensing system. We support the fourth criterion, because we appreciate that it is already a factor in the European deliberations and because we want the procedure to be above board and transparent.

We support the fourth criterion because it is necessary to evaluate the wider effects of new products. In the words of the MAFF explanatory memorandum :

"The authorisation of BST and other comparable products for use in livestock could have a significant effect on productivity with potentially far-reaching implications for production techniques and socio-economic structures in agriculture."

The Minister, in his memorandum, recognises that, yet he refuses to accept the logic of the explanation which his Department has offered.

Given that premise--and I entirely agree with it--it would be irresponsible and negligent in view of the responsibilities that MAFF has to those already in dairying if the socio-economic and environmental impacts of permitting the use of biotechnology were not assessed. Since those effects have to be considered, it would be better that they were examined under a fourth criterion as part of the licensing system, rather than in an ad hoc manner after a licence has been granted.

What could be more undermining of the confidence of the pharmaceutical research establishment than the Government choosing this sort of ad hockery rather than a clearly enunciated and comprehensible fourth criterion? To quote the director of the Commission division responsible for free trade after 1992 : "It should be possible for firms to know in advance what regulatory framework a new product will be subjected to. The Community should play the game according to a strict and fixed set of rules ; it's a little hard on the manufacturer if the goal posts are moved while the game is in progress".

The European Parliament has called for an examination of BST on the grounds of safety, quality and efficacy. It called on the Commission to examine the consequences of the use of BST and consider inter alia the necessity for additional criteria such as social and economic factors. That is the view which the Opposition support and, therefore, we do not endorse the Government's view on the document.

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12.20 am

Mr. John Greenway (Ryedale) : I do not wish to detain the House at this late hour. My hon. Friend the Minister and the hon. Member for Caerphilly (Mr. Davies) have espoused most of the arguments, but two issues need to be addressed : first, the principle of scientific advice and the priority that that should play in the licensing system ; and, secondly, the public reaction to the use of certain medicinal and therapeutic products. The Government are right to pursue the principle that the first priority must be to make scientific advice paramount. Subjective factors should not cloud scientific facts when it comes to licensing.

There is a problem with the fourth criterion, and I listened with great interest to what the hon. Member for Caerphilly said about that. I understand that many farming elements are unhappy about parts of the criterion, and that is something that we shall need to discuss long after this debate. There are dangers, however, in using socio-economic factors when assessing the efficacy of medicinal and therapeutic products. There are dangers especially when we are dealing with the emotive issue of hormones.

There is a public aversion to some scientific applications in the food chain, especially those involving hormones. Milk production is especially sensitive. The hon. Member for Caerphilly was right to draw attention to the benefits that accrue either to the farmer or the consumer, but that is not the primary issue. We have scientific advice, which has been updated in recent weeks, that the results of the trials and tests are safe. I am concerned about the public aversion and its impact on the consumption of milk and dairy products. As the Government have said, as long as a product is safe, it should be for the producer to decide. Such is the nature of the marketing of milk and dairy products, however, that while one producer may decide against the use of BST, another may opt in favour of it. It is difficult, nay impossible, for the customer to know whether any of the milk that he or she consumes could have been involved with BST.

That may leave the customer with one option, and that is not to buy milk or dairy products. That could be disastrous for some farmers. It is a great pity that the BST issue has forced the Government to highlight their efforts--sensible, in my view--to resist EC moves to over-use socio- economic factors to overrule scientific advice on the licensing system for medicinal products. I hope that the trials that are taking place will end soon. Perhaps my hon. Friend will be able to tell the House of the time scale that is envisaged for the continuation of the trials. When they are completed I hope that most farmers will decide against the use of BST. If the priority of agriculture is to restore and retain the confidence of the consumer in the purity of the product, it must be responsive to the genuine concerns of the public, ill informed or misinformed though they sometimes are. The industry must avoid the unnecessary use of medicines and therapeutic applications that create uncertainty or alarm.

It is inevitable that consumer watchdogs will delve into and exploit in whatever way they can the use of BST and hormones in the preparation of milk and dairy products, should some farmers decide to use them. The hon. Member for Caerphilly clearly said that the National Farmers Union has come out strongly against the use of BST, and if most farmers decide against its use, that will

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vindicate the Government's position. There is a case for saying that we must support the principle that scientific advice and evidence should be given first, but that farmers must decide whether to use a product in their farming practices. If scientific advice says that something is safe, it is up to them to decide whether to use it.

The vast majority of farmers will want nothing to do with BST. If consumers and retailers want clear evidence that BST has not been used in the preparation of the milk products bought in their shops, the milk marketing board and other organisations involved in the supply of milk will have to come to terms about that with their producers.

I support what my hon. Friend said, with the caveat that we want the trials to end soon. The use of BST could fundamentally undermine the recovery of our milk and dairy industries.

12.27 am

Mr. Martyn Jones (Clwyd, South-West) : I support the call of my hon. Friend the Member for Caerphilly (Mr. Davies) for a fourth criterion as part of the licensing system for products such as BST. That criterion must be the ethical and environmental effect of such products.

I shall go further and suggest that the provisions of the Medicines Act 1968 under which BST was tested are entirely inappropriate for a completely commercial product such as this, and ethical and social factors should be considered before animal test certificates are granted for a product which by no stretch of the imagination could be called a medicine. Such considerations should stand apart from those of safety, quality and efficacy. But in this case there are serious question marks over safety, too. For instance, we are told that the genetically engineered hormone is identical to naturally occurring BST, but to which one? At least four occur within the cow. What about the spare amino acids in the genetically engineered version? Some versions contain up to eight different amino acids along the chain of the genetically engineered version.

Potentially the most worrying factor is this : what possible control does a producer have over the genetic variability of a fermenter containing billions of E. coli organisms--except the crude measurement of the efficiency of the hormone produced? It is entirely possible that spontaneous mutations may occur in the E. coli organisms used in a fementer, which may lead to the production of a version of BST which, though still biologically active, may be very different in structure and long-term effect. That question cannot be satisfactorily answered with the present state of technology. The other concern that must be considered is the animal's welfare. To say the least, it is somewhat hypocritical of the Minister to acquiesce with the EC in the pre-slaughter injection of papain, a practice which he claims is not inhumane, and yet not act on BST injections in cattle.

We have created by artificial selection cattle which have naturally high levels of BST by breeding for milk production, and now we are considering subjecting them to a massive increase in the levels of that hormone. That must mean an unnatural strain on the animal's physiology. Something must give, and I suspect that in the long term it will be the animal's health.

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The documents that we are considering, by establishing a further evaluation period, and the Select Committee's report, tacitly recognise the yawning gap in the procedure for evaluating novel products created by genetic recombinant techniques, and the use of such products for purely commercial aims.

When all the factors are properly taken into account, the use of BST will be prohibited and any future products should have their ethical and social effects considered before even trials are permitted.

12.30 am

Mr. Michael Stern (Bristol, North West) : I shall not follow the hon. Member for Clwyd, South-West (Mr. Jones) in his doubts about the use of the procedure laid down in the Medicines Act 1968 in evaluating BST. It is generally accepted that the Government have acted with complete responsibility in applying the stringent criteria of that Act to the product. I doubt whether any European nation would be able to show a better record than the Government in the full and proper evaluation of BST.

My concern is not whether the product will be fully evaluated--I share the Minister's doubts about whether a fourth criterion is necessary in determining whether the product should be used--my doubt is in a rather more specific area. My hon. Friend the Member for Ryedale (Mr. Greenway) said that consumers had been ill-informed or misinformed on the nature of the product. Neither description is entirely accurate. The problem is that consumers have not been informed at all.

I represent a constituency of milk consumers. To the best of my knowledge, I do not represent one milk producer. But when a rumour developed in my constituency that one of 10 sites in which BST was being tested was close to Bristol and that the milk was being sold in Bristol, it was impossible to obtain a confirmation or denial. If a product is being tested under the stringent provisions of the Medicines Act, we owe it to the consumers of that product to tell them that either there is no possibility of the product entering the milk they buy, or there is such a possibility.

I accept my hon. Friend the Minister's assurance that the possibility is slight, but however slight it is, we add nothing to the product's credibility by being seen to hide whether that possibility exists.

Despite the EC document and the Minister's comment that testing in Britain has probably been more stringent than elsewhere, he has nevertheless done considerable damage to his case by acting in what might be called a paternalistic way and refusing to inform consumers whether they might have been subject to the test.

12.34 am

Mr. Richard Livsey (Brecon and Radnor) : I do not know how many hon. Members have milked cows frequently, but I have milked hundreds. At the hour of the morning when we often finish our debates, many people are starting to milk their herds.

We cannot ignore the background of Britain's dairy industry. The average yield of the 3 million dairy cows that we are considering is 5,500 litres per cow, and we are told that the application of BST will increase that yield by anything from 10 per cent. to 20 per cent. A potential increase to over 6,000 litres per cow will leave farmers with

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some difficult choices, given milk quotas : they must either go for increased yield and BST, or cut the number of cows that they possess. The implications of that are considerable, especially for small farmers. The implications of milk going over quota, and of increased milk production EEC-wide, are particularly serious, in view of the agony of the milk producers who have gone out of production over the past four or five years, and the 20 per cent. drop in United Kingdom milk production.

The core of the argument, it seems to me, is whether BST will be granted a product licence under the three criteria advanced by the Minister tonight. Will he, indeed, take on board the fourth criterion of economic and socio- economic factors? These are difficult problems for him to wrestle with. In his opening speech, he appeared to discount that fourth criterion, but I think that he was unwise to do so.

The Government's narrow view contrasts with the wider view of the European Community. The Commission's report to the Council of Ministers and the European Parliament states :

"the Community's approach is to be based on the fullest awareness of all the implications."

Most member states are very hesitant about the authorisation of BST ; by contrast, the United Kingdom is regarded as an easy option for a way into Europe for the pharmaceutical companies, as it is the only member state to have allowed BST to be collected and sold unmarked. Why is that the case?

There is concern at the fact that existing techniques do not permit the ready identification of BST in dairy products, because the BST exists naturally in milk. That must give us cause for doubt. Research is currently under way at the university of Munich with the object of finding a method of identifying the hormone in milk in the first place. It is very serious that we cannot do that now, and label it appropriately. BST, if it is to be allowed at all, should not be allowed until such a method is found ; otherwise there will be no opportunity for consumer choice. If the method is found, dairy products from BST-treated cattle should be labelled as such. Concern has also been expressed at the statement by the London Food Commission that artificial BST has one or more extra amino acids at one end of the molecule. The hon. Member for Clwyd, South-West (Mr. Jones) went fully into the matter, so I shall not repeat the argument.

Concern about animal welfare, consequent upon their regular injection, has to be taken into account. There are many questions the answers to which are unknown. What effect will BST have on reproductive performance, on the incidence of mastitis in cows and on calf growth? Will there be an increase in metabolic diseases as a result of BST injection? We do not know the answers to those questions. The Minister said that trials are still taking place. When they have been completed I hope he can give hon. Members answers to all those questions.

As for the socio-economic factors, especially those that relate to small farmers, the Commission's report says that if one assumes that the Community's milk quota regime continues beyond 1992, the use of BST should be reflected in a reduction in the number of cows rather than in an increase in overall milk production. That is likely to be accompanied by a greater concentration of milk production in the hands of larger milk producers an greater pressure on the quota regime. The effect of BST on small dairy farmers is likely to be bad. That must be taken

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