Medicinal Products

HC Deb 17 June 1986 vol 99 cc1003-17 10.15 pm

The Parliamentary Under-Secretary of State for Health and Social Security (Mr. Ray Whitney)

I beg to move, That this House takes note of European Community Documents Nos. 9630/84 and 5752/86, proposals for draft Directives and a Recommendation, and Amendments to the proposals, on the marketing and testing of medicinal products, and of the supplementary explanatory memorandum from the Department of Health and Social Security dated 8th May 1986; endorses the aim of strengthening biotechnology in respect of medicinal products within the Community; and welcomes continued progress towards removing the remaining barriers to trade between member States, whilst fully protecting public health. These proposals deal with European Community rules for the testing and marketing of medicines. This is a complex and highly technical subject. I cannot avoid detail, but the House will be primarily concerned with the principles underlying the detail. I shall therefore concentrate on the principles.

The marketing of medicines in the Community is governed by Community legislation — directives —adopted between 1965 and 1983. Subject to certain specific exceptions, such as vaccines, which have not yet been brought within the scope of European Community rules, national regulatory authorities are bound to apply the provisions of the pharmaceutical directives when considering an application for marketing authorisation. In addition, a Council recommendation has been adopted containing guidelines for the preparation and consideration of marketing applications covering a number of safety and efficacy aspects. United Kingdom arrangements for applying Community legislation in this field operate under the provisions of the Medicines Acts of 1968 and 1971, and subordinate orders.

Some of the proposals now before the House concern veterinary medicines as well as medicines for human use, and as such are a matter for my right hon. Friend, the Minister of Agriculture, Fisheries and Food, but where this is so, the particulars are similar, and DHSS and MAFF interests are identical. My remarks therefore apply to both where relevant.

My right hon. and learned Friend the Paymaster General and Minister for Employment, when he was Minister for Health, submitted, on 22 January 1985, an explanatory memorandum which described the proposals as they were drafted at that time, and identified a number of issues which required careful study, and possible amendment before they could be accepted. I shall deal with those issues later.

Discussions in Brussels, which are still in progress, produced explanations and some textual amendment. My right hon. Friend the Minister for Health therfore submitted a supplementary explanatory memorandum to the House on 8 May. I shall also expand on this later. Also, the European Commission forwarded, on 5 March 1986, some amendments to its original proposals. These Commission amendments represent reactions to opinions expressed by the European Parliament, and also, in the Commission's own words, take account of scientific and technical developments since the initial Commission proposals were submitted". This batch of Commission amendments was dealt with in my right hon. Friends explanatory memorandum, also dated 8 May 1986.

It will, I think, help the House if I explain that the primary purpose of all European Community regulation in this area is the protection of public health. That is the overriding consideration, but associated with that purpose is a determination not to hinder the development of the pharmaceutical industry, and trade in medicinal products. In the medium term our aim is to harmonise national regulations and standards of assessment, and so on, so as to achieve the free movement of medicines between member states. In any case, we plan to abolish all Community internal barriers to trade by 1992. This state of affairs is intended to apply to medicines by way of the mutual recognition of national marketing authorisations granted by individual countries. I need hardly add, in this context, that when mutual recognition is eventually achieved, there will be no lowering of United Kingdom standards of protection for the public.

I turn now to the subject matter of the proposals. They represent further progress down the path towards mutual recognition. They extend the opportunities and, in some cases, the obligations for national regulatory bodies to discuss issues concerning particular products before individual decisions are taken. Such discussions will assist the development of mutual understanding which is a prerequisite of mutual recognition. They will help also to identify and to deal with differences of view in a positive way, focussing on specific and concrete issues.

Priority will be given to biotechnology and other "high technology" manufacturing processes. Thus, the exchange of views provided for in these proposals, and the development of agreed opinions, will assist not only progress towards mutual recognition but the pharmaceutical industry by the establishment of certainty in respect of national regulatory requirements on a Communitywide basis in these very important and rapidly developing areas of science. There is no doubt that industry faces problems because of the varying requirements as between member states, and even more so when uncertainty exists about regulatory requirements because of large sums of money need to be invested early to secure a competitive position.

The proposals consist of a package of measures, four directives and a recommendation. Some touch on the general issues which I have already mentioned. Others contain more detailed improvements to the existing rules. The proposed recommendation simply adds another 14 guidelines on safety and efficacy considerations for the preparation and consideration of marketing applications. These guidelines were produced by extensive discussion in the Committee for Proprietary Medicinal Products which deals with medicines for human use. The guidelines were the subject also of consultation with representatives of the pharmaceutical industry. I believe that they are non-controversial.

The first proposed directive is new. Its most important element is the introduction of compulsory reference to the CPMP or the Committee for Veterinary Medicinal Products for applications involving major biotechnology innovation. The range of applications concerned is identified in the annex to the proposal at list A of the first directive. The directive also encourages reference to the Committee for Proprietary Medicinal Products or Committee for Veterinary Medicinal Products, in agreement with the company concerned, for other "high technology" products as described in list B of the annex. As I have already said, the Government agree with the European Commission that co-ordination in this highly complex and rapidly advancing area of science is good for the public, manufacturers and the European economy.

Mr. Tony Marlow (Northampton, North)

As my hon. Friend will accept, this is a technical and complex issue, but perhaps he will answer two questions. First, with a view to what is happening to the LD50 test, does the directive mean that United Kingdom patients are likely to be subjected to medicines that have not undergone the strict testing undergone by current medicines? Secondly, will the directive affect parallel imports—products which are made before the patent has expired in this country but which can be made in another country? If so, will it be to the detriment or to the benefit of the United Kingdom's pharmaceutical industry?

Mr. Whitney

If my hon. Friend will bear with me, I shall come later to the LD50 test. As for parallel imports, the directive will not have a detrimental effect on the United Kingdom's pharmaceutical industry.

The improvements to the text and explanations received have removed the concerns expressed in the 22 January 1985 memorandum. I shall not go into them in detail unless asked to do so.

The first proposed directive, in article 5, also introduces for medicinal products arrangements similar to those already in place for the generality of products, whereby the Commission and other member states are notified of proposed new technical regulations. The idea is to prevent the imposition of unjustifiable technical barriers to trade between member states, by allowing time before new regulations come into force so that all those concerned have an opportunity to raise objections, and to have those objections considered. The Government fully support this measure.

I turn now to the second and third proposed directives. I can deal with these together, because they contain similar measures; the first covering medicines for human use, the second covering veterinary medicines. Each contains two distinct elements. Neither element presents the United Kingdom with any difficulty. The first element introduces arrangements designed to assist the rapid updating of data requirements in support of marketing applications.

The Government agree that data requirements should be kept under review and modified promptly as indicated by experience and the advances of science. We also accept that it is a sensible way to avoid unnecessary delay on such important, if technical matters; we are perfectly content to accept qualified majority voting; and we do not think it essential to progress through all the exceptionally long European corridors involving, as they do, the Council of Ministers and the European Parliament, and so on. I am also reassured to learn that the so-called "committees for adaptation to technical progress" will, in fact, consist of people with special expertise in this field nominated by member states—the same people as form the Committee for Proprietary Medicinal Products and the Committee for Veterinary Medicinal Products.

The second element amends particulars required in support of marketing applications under parts 1 and 2 of the annex to directive 75/318/EEC and directive 81/852/EEC as relevant, dealing respectively with "Physico-chemical, Biological, or Microbiological Tests" and "Toxicological and Pharmaceological Tests". It may assist hon. Members if I say that the amendments of the annex to directive 765/318/EEC and the corresponding amendments to directive 81/852/EEC were added in March of this year under EC document 5752/86, whereas the amendment to part 2 of the annex to directive 75/318/EEC and the corresponding amendmemt to directive 81/852/EEC were in the original 1984 document.

The "part 1" amendments, as they are known, bring into effect detailed improvements to the text recently agreed by the CPMP and the CVM P. The "part 2" amendments are perhaps of more general interest. They do two things. The first is to require that safety tests are undertaken in compliance with the principles of good laboratory practice. The second removes the absolute requirement to determine the dose level of a prospective medicine which results in death for 50 per cent. of the animals used in the test.

My hon. Friend the Member for Northampton, North (Mr. Marlow) will recognise that I am referring to the lethal dose 50 test. For other hon. Members I should perhaps explain that the LD50 test is one of a battery of tests to establish the toxicity of a new substance before it is tested in human beings. Scientists now universally agree that the arbitrary choice of a 50 per cent. death rate is inappropriate. The appropriate death rate will be determined on a scientific need basis for each substance and will usually be lower than 50 per cent. This will avoid the unnecessary death of animals, which I am sure hon. Members will welcome.

Mr. Marlow

Will the Minister undertake to guarantee, although we are all quite properly concerned to reduce the unnecessary death of animals, that the level of protection for the human patient will be at least as high as it has been in the past?

Mr. Whitney

Within the limits of my own capabilities. It is a scientific determination and the careful judgment is that the scientific need basis, to which I have referred, will give the sort of guarantee that my hon. Friend is seeking and, indeed, that the Government must insist upon. Therefore, we share that objective.

I now turn to the fourth proposed directive. Yet again, the proposals are in discrete parts. The first, and more important concerns the data which must be submitted in support of an application for marketing authorisation. These are dealt with in article 4 of directive 65/65/EEC. The proposal is for amendment of Article 4.8, which deals with the results of tests and trials.

In general, applicants must provide the results of tests and trials, but where the constituent or constituents of a product have a well-established medicinal use with an acceptable level of safety—like many of the medicines that we can buy over the counter without a doctor's prescription—it would be ridiculous to require detailed data for each new application. What would be the point of using animals to produce unreliable models of possible effects in man in respect of a substance which had already been used by man himself for many years? The general rule to provide data is therefore relaxed in such circumstances.

On the other hand, it is important to take account of the valid commercial interests of innovatory companies, so that the results of their original research and development cannot be pirated. This protection of the results of original work is particularly important when companies are obliged to supply details in several languages for discussion in the CPMP or CVMP, and where patent protection may not be available, or patentable only with considerable difficulty, as with biotechnology medicines such as insulin or interferon, which are analogues of natural substances.

The picture is complicated by differences in practice between the regulatory bodies of the various member states. Some are more stringent than others in pressing for test results in respect of the constituents of products which are already on the market. Others, says the Commission, give an unfair advantage to copiers by using commercial information supplied to the original licence holder when assessing the copy application.

The Commission tried to reconcile the somewhat conflicting interests described above in its proposed amendments to article 4.8. The original proposals were generally acceptable to the United Kingdom. But we are not so clear about the effect of compromise suggestions made during negotiations. There seemed to be a possiblity that efforts to obtain maximum harmonisation of practice between member states would produce a text which went too far towards obliging national regulatory bodies to demand test results for already well-known constituents.

That was the stage that we were at when my right hon. Friend the Minister for Health signed the supplementary memorandum on 8 May. But my officials have now been able to study the new text in detail, and they have satisfied me that their anxieties were unnecessary. The problem, in fact, turned on interpretation.

The second, and comparatively minor part of the revision of directive 65/65/EEC — I interject here, no doubt to the relief of some hon. Members, that this is the last point of detail that I propose to bring to the attention of the House—repeals the obligation to mark external packages of narcotics with a double red band. The intention of that marking was to help pharmacists to keep all such products under proper surveillance, but experience has shown that the markings are also at least as helpful to drug addicts or thieves who, on breaking into pharmacies, can quickly identify their loot.

As I hope I have made clear, the proposals contain useful improvements and additions to the present arrangements for controlling the safety and the marketing of medicines within the Community. At the same time, they provide assistance to research-based pharmaceutical companies, particularly those engaged in biotechnology, and represent useful progress towards removing the remaining barriers to trade between member states. I invite the House to agree that we should welcome adoption of the proposals contained in European Community documents 9630/84 and 5752/86.

10.32 pm

Dr. John Marek (Wrexham)

The proposals are very technical, and it is extremely difficult to judge their merits. There is no doubt about the content of the proposals, because I can read English, but I have no direct research experience of this matter, and so it is difficult for me and, I suspect, for most hon. Members to judge their merits.

Nevertheless, when drugs are imported, it is important to know exactly what they contain. It is also important to know about the conditions of manufacture, and to know what impurities may exist, particularly in the case of parallel imports. I am not against importing generic substitutes, but the proper concern of British pharmaceutical companies—that they should be able to continue research and development in the United Kingdom —must also be protected. Of course, that can be subject to licences of right, and to generic substitution once patents have run out.

There are now substantial imports from the EEC, and we should know exactly their quality and content, in order to protect the public. On the one hand, the public must be protected and, on the other hand, one must not stifle innovation in research and development.

Given my initial statement about my limitations in understanding the proposals, I can give them a cautious welcome. The amendments ought to strengthen public safety without doing damage to the research and development required in producing new pharmaceuticals using biotechnology. Existing directives will be amended so that a new biotechnological product must be considered first by the CPMP, which is the expert EEC committee, before the DHSS can give a product licence. That is to the good as a principle in itself.

There are limitations, but one does not want to delay unnecessarily the introduction of important new drugs. Provided the committee does not deliberate too long—I do not think it will—it can only be to the advantage of the public if it examines any biotechnological product. Therefore, we have no objection to that.

We have to be careful that we do not remove responsibility from the Minister on product licences. Responsibility for what is marketed in this country should remain with the Minister. He will have his expert committees which should continue to advise him.

There is a danger that if the Common Market produces an expert committee, say, the CPMP, which has all the information available to it, it will perhaps accrete to itself such power that national committees may more and more take for granted the word of the EEC experts committee. Nothing must he taken for granted. Anything that the CPMP considers should be taken into account by our national expert committee, but it would be a pity if the investigative function of the expert committees of member states was not used as much and those committees relied almost exclusively on the opinion of the CPMP. Therein lies a danger. Provided we do not allow that to happen, the referral of products to the CPMP is an advance that I welcome.

I understand that there will be standardisation of data requirements within the EEC. That should speed up the introduction of new products and drugs, so long as public safety requirements are not relaxed.

In explanatory memorandum 8232 on document 9630/84, paragraph 2.4 says: The arrangements for rapid data updating involve the establishment of a Committee for the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Proprietary Medicinal Products Sector. This Committee would be chaired by a representative of the Commission, and act by qualified majority (as also would the council of Ministers when considering Committee proposals). The Commission is also given power to effect changes to data requirements on its own account if the Council of Ministers has not acted on the Committee's proposals within three months. There are certain doubts in my mind about that. I know that the arrangements are for data updating, but there is a possibility of the committee acting by qualified majority. I wonder whether the Minister can envisage the United Kingdom losing out, perhaps if it voted against a proposal but was outvoted by a qualified majority.

The committee is for the adaptation of directives on the removal of technical barriers to trade, but I do not know exactly what the committee will consider. For example, it could consider the importing of more drugs into this country. Am I right in thinking that the United Kingdom could object to proposals to allow an increase in drug imports, with less stringent controls and safety built into the conditions, but we could be outvoted by a qualified majority? If that is so, or if there is a similar situation, there is cause for concern. I hope that I have misunderstood that paragraph. If I have, I would welcome the Minister's comments so that he can put my mind, and, I am sure, other people's minds at rest.

Paragraph 5.3(c) of the same document refers to The requirement to consult the CPMP and the CVMP before Member States can grant or revoke marketing authorisations for the listed range of products. That paragraph will be put into the directive. I welcome it, if it is a matter of introducing new products. Provided that there is no unnecessary delay, the intention to consult the CPMP and the CVMP is good. On the other hand, I wonder what happens the other way round. Let us suppose that a product has a product licence, but for some reason it has to be taken off the market. Again, I may have misunderstood the provision, and I may be asking a naive question, but I believe that it is important. Will the United Kingdom retain its right to revoke a product licence for any product immediately without having to consult the CPMP about it? If the Minister can say anything about that, I should be grateful. Indeed, that requirement is one of the controversial elements in the directives. It is controversial from the point of view of revoking a product licence. But it is not controversial if it is a matter of introducing a new product.

I welcome the extension to medicinal products of the community "stand-still" arrangements concerning draft technical regulations of a member state. That can only be good if there is prior compulsory consultation, and delay if an objection is raised. I also welcome the removal of the absolute requirement in determining dose levels of a drug for human use which results in the death of 50 per cent. of the animals used in the test. The Minister referred to it as the LD50 test. I am persuaded by the scientific evidence, of which I have seen quite a lot, and to which the Minister referred, that it is no longer necessary to have an LD50 test.

I hope that that relaxation of the absolute requirement will be used by the United Kingdom, and that fewer animals will have to die as a result of experiments. I am persuaded that that can be done with no detriment to public safety standards. I say as an aside that, if there are any tests on patients, all patients should be told that they are being tested. There has been some doubt about that in recent times. The matter does not come within the directives, but perhaps the Minister should take it on board. Sometimes there must be tests on patients, and there is no harm in that so long as the tests are properly controlled, and the patients must know what is happening; if the patients are children, their parents should be told. In other words, proper control must be exercised.

Another important proposal is the provision to ensure a 10-year period of protection from the date on which the marketing authorisation was granted. While I do not object to that in principle, I do not want to see it as a first step in extending protection from 10 years to 16 or 20 years or perhaps even longer.

Problems could arise with the phrase "essentially similar products", words which appear in the English translation of the directive. Difficulties may arise with the definition of that phrase. Perhaps the Minister can put our minds at rest on that.

EEC document 5752/86 emanates from a letter from the Vice-President of the Commission of the European Communities, Lord Cockfield, to Mr. Hans van den Broek, President of the Council of the European Communities. It amplifies some of my concern about the definition of substances and the meaning of words. Page 7 contains this insertion in the directive: the description of the substance, set down in a form similar to that used in a descriptive item in the European Pharmacopoeia, shall be accompanied by any necessary explanatory evidence, especially concerning the molecular structure where appropriate; it must be accompanied by an appropriate description of the method of synthetic preparation. Where substances can only be described by their method of preparation, the description should be sufficiently detailed to characterise a substance which is constant both in its composition and in its effects. Probably no substance is absolutely constant in its composition and, therefore in its effects; substances over time change in their composition, and I should not be surprised if the toxicity of some substances changed over time. If the passage that I quoted is all that is being added to the directive, I wonder whether it will enable us to define sufficiently precisely substances when product licences are being granted. Shall we be able to assess them when considering if they are "essentially similar" to other substances? That might be consideration in deciding whether to give them 10-year protection. I am not convinced from the paragraph I quoted that we have the provision sufficiently accurate for there to be no doubt about its application in any of the cases that I cited.

On the same theme is the question of the provision of information. Annex 1 to the Council recommendation relating to tests in document 9630/84 deals with placing proprietary medicinal products on the market. Paragraph 3(b) says: Whatever species or strain of animals are selected it is essential that the following information should be provided, age, sex, weight, origin and the time in the laboratory before tests, whether or not the animals are classified as being free or specific pathogens, whether or not the animals have been vaccinated or submitted to any other procedure. Details of housing and environmental conditions should be given. Access to and the nature of the diet and the availability of water should be stated. All the above factors are known to affect the acute toxicity of substances. I am sure that all the information is necessary to make a decision on the toxicity of substances, but is it sufficient? The document says nothing about that. Does the Minister have any information on that?

In addition, there is a problem about the definitions and their interpretation in the various member states. It may well be that some definitions will be applied in different ways. Under the new British legislation there will be licences for animal experiments, and so on, and I hope that there will inspectors to make sure that there is control and standardisation in Britain, so that when any tests are performed the public can be sure that they have been done properly and not on the cheap.

Shall we simply take on board the testing and analyses of other member states and accept that their standards must be high enough? What criteria will the Minister use? Is he worried that the procedures in other member states may not be as good as those in the United Kingdom? I do not say that in any political way. I hope that all hon. Members would wish to be satisfied about that.

Other questions can be asked about the proposals, but apart from matters of detail there are a few essential questions. Will safety and the confidence of the public in medicines and medicinal products be increased, and will research and development into new medicines be encouraged, or at least not discouraged? Will the proposals help in animal replacement in experiments where that is practical and possible? Will there be a greater exchange of views among experts in the various fields? I hope that the House will bear in mind my earlier comments about the European experts committee. Finally, will new important medicines become available more quickly on the market?

The answer to those questions will probably be yes, but I hope that the Minister, with the advice and expertise available to him, will be able to answer the questions before the end of the debate.

10.53 pm

Mrs. Edwina Currie (Derbyshire, South)

The Chamber may have emptied, but the subject that we are talking about tonight — the generation of drugs through biotechnology—is probably as important in our lives and is likely to be as important in future as the effect of South Africa on our lives today and I am glad to have an opportunity briefly to discuss it.

I think that it was Magnus Pike who pointed out that the creation of drugs through fermentation has been with us as long as there have been human beings and the first thing that Noah did when he came off the ark was to learn about fermentation and then get very drunk.

I take a personal and a constituency interest in the matter as the brewing industry in Burton-on-Trent, which is of long-standing, provides a large volume of materials for parts of the pharmaceutical industry in my constituency through companies such as English Grains Ltd. They will be pleased to see the stand taken by the Government in the Minister's letter of 8 May 1986, to which my hon. Friend referred, which said that full test data, will not be a mandatory requirement for the new applications in respect of well-established products, because that is exactly what the pharmaceutical companies in my constituency are producing — well-established, long-used products. To have to go through the whole business of re-testing them simply to satisfy a Common Market directive would be arduous.

I should also like to congratulate whoever produced "Biotechnology: A Plain Man's Guide." It emanates from the laboratory of the Government Chemist. Perhaps I ought to ignore the sexism of the title, but I am delighted to see that the person on the front who looks so puzzled at the whole business is, indeed, a man. For that reason I refuse to take exception to the title. The book is first-class and I hope that people producing documents in other Government Departments will take a leaf out of it.

It is easy to understand and easy to find one's way around. It links the different departments extremely well and is full of delightful little cartoons, such as two bugs discussing whether to eat a piece of cake.

The sections in the book that refer to Wales, Northern Ireland and Scotland are highlighted by, in the case of Wales, a lady with a daffodil, in the case of Scotland, a bearded chap with bagpipes, and in the case of Northern Ireland, a leprachaun with a shamrock sticking out of his hat. Things like that make it easy to follow. The sense of humour and the style of the person who wrote this to be commended.

My own links with this industry started some 20 years ago when I was employed for a while in the product-testing laboratory of Eli Lilley and Company in Speke near Liverpool. Part of my job resulted in my getting the cold shoulder from a lot of the people that I travelled home with, because it involved taking bacteria, feeding them agar agar and Bovril, allowing the bacteria to grow — and, as a result, to become exceedingly smelly—then testing the effect on them of various concentrations of drugs, such as penicillin and penicillin derivatives. The trouble with doing that job was that the pong clung to one's hair and skin and riding home on the bus was a rather unpleasant experience for all the other passengers. For doing that job I was paid £10 a week. I suspect it was quite a dangerous way to test commodities and I sincerely hope that nobody messes about in quite that way these days.

When trying to understand the material that is before the House, I noted with interest that Eli Lilley and company is still very active in the field of biotechnology and last year had the largest single number of patents granted in biotechnology in the United States of America. The company had 28 out of just over 1,000 patents. In the last three years over 3,200 patents have been granted in the United States of America, so we really are into a growth industry. I have seen estimates that the biotech market will grow to 100 billion dollars by the year 2000, which is not very far away. The sad thing is that although two thirds of these patents were of American origin, and one third were not of United States origin, the largest single other country was Japan. The Common Market countries are a long way down the list and last year the United Kingdom had only 32 patents approved in the USA. That is barely more than than patents granted to one company, Eli Lilley. From what I could see, the total from all the Common Market countries came to less than 100—in other words, less than 10 per cent. of the number of patents granted in the United States. That is sad when we consider that the origins of this extraordinary technology were entirely British and resulted in a number of Nobel prizes, the most recent being awarded to Cambridge university in 1984.

Biotechnology is a strange world. It is a world of immortal cells that will go on reproducing themselves indefinitely. It is a world of activities and ideas that we can only begin to grasp. I suspect that when these changes were first announced and first became the subject of investigation by such organisations as the Common Market we probably overestimated the possibilities. They are certainly coming now.

Recently some hon. Members were given a demonstration in the Commons of some of the diagnostic techniques that are the subject of today's papers. We were shown, for example, the development of the Wellcome Foundation in the detection of AIDS. We were shown the possibilities that are soon to become commercial in which a pinprick of blood will be taken, perhaps in a doctor's surgery, and will be tested for a wide range of reagents and reactants in the blood and will enable us to detect instantly whether someone is suffering from an illness or what the course of a chronic illness might be. Some of these commodities are already on sale so we are not talking in these documents about theory. Human growth hormone, for example, and insulin are already available. Treatments for such diseases as herpes, hepatitis B, thalassaemia, sickle cell anaemia and so on, are being actively worked on and tested under these regimes. It is hoped that a great deal of the work will help cancer patients, and much research is being funded by cancer charities, which is to be welcomed.

My hon. Friend the Member for Northampton, North (Mr. Marlow) asked about changes involving animals and animal testing. The question about the LD50 test for animals is raised in directive 75/318/EEC. I am by no means a qualified scientist, but the material is specifically genetically engineered and intended for a particular purpose and a particular species. Our main concern is about human beings. Therefore, it seems peculiarly inappropriate to use that test. We shall not learn much from the effect of that material on animals. We want to learn of the effect on people. I should be grateful if my hon. Friend the Minister will clarify that matter when he replies.

It is nice to know that the new mechanisms for creating this material will to a large degree obviate the use of animals. When the technology started animals such as mice were used for the original antibodies. Now companies such as Celltech are using mechanical bioreactors on an enormous scale. It is nice to know that this is a British company. It was set up some five years ago by the National Enterprise Board, partly as a response to our complete failure to patent some of the ideas we had been developing and getting Nobel prizes for. Despite the activities of the NEB it is now 85 per cent. privately owned, and it is doing well. It has, for example, the world's first licence to be granted by the United States' Government for bulk production of monoclonal antibodies, and is selling the stuff by the kilogramme. That is absolutely fantastic and will open up the opportunities for research in a big way.

I hope that my hon. Friend the Minister will bear in mind the comments made about safety. Recently, in the United States there has been a case, referred to in the literature, not concerning human material hut an animal vaccine for use against pig pseudorabies. It was licensed for use last January—not six months ago—and within four months its product licence was removed because of an action brought by the Environmental Protection Agency in the United States in which it was alleged that testing had not been done properly. It was apparent from the evidence circulated that the real anxiety was that genetic material might be leaked into the environment and have damaging effects, like of which none of us could guess at. The response of the health inspectorate in the United States — which rejoices in the acronym APHIS, the Animal and Plant Health Inspection Service—was that the vaccine would go into the pig and no further, and that there would be no environmental leakage. Nevertheless, it is a matter of some concern.

In the light of some of the anxiety about pesticides and the effect of their inappropriate storage and use, these EEC directives on manufacturing and testing are not sufficient. We need to be reassured about storage use, and training for use of those materials, especially when we are talking not only of human vaccines and drugs, but animal and plant use. It is essential that we maintain the highest standards so that we can reassure the public.

Provided we retain an awareness of the dangers of dealing with these powerful commodities, I hope that that with encouragement and careful Government supervision across Europe much more rapid progress can be made.

11.3 pm

Mr. Charles Kennedy (Ross, Cromarty and Skye)

The hour is late and the Minister is facing an unprecedented degree of harmony across the Floor on a health issue. Therefore, I intend to be extremely brief.

Without being flippant about the speech of the hon. Member for Derbyshire, South (Mrs. Currie), I must say that I endorse her views about the inherent sexism in the presentation of the document to which she referred but which I have not had the opportunity to see. The caricaturing inherent in that title can equally be applied on a nationalist level to display everyone in Ireland as a shamrock-waving leprechaun and everyone north of the Border as a bagpipe-playing Scot. I hasten to say that we certainly play the bagpipes better than we play football these days, but that is another story.

For once, I find myself supporting a Government motion. It seems to be eminently sensible. I will not repeat the qualifications and proper reservations which have already been expressed.

I agree with the hon. Member for Derbyshire, South about the crucial importance of biotechnology to the future of medicine. There is a revolution in primary health care. The Health Service, at local level, through the general practitioner's surgery, can meet many of the demands which hitherto were considered to require specialist treatment of a more exclusive type — I use that word advisedly. The revolution has been made possible by the growth and development of biotechnology techniques.

It makes good common sense to have as free an internal market in Europe as possible, consistent with the maintenance of adequate health and safety levels.

It is important to stress that, in drawing up these directives and the accompanying material, the Commission has said that the most recent Directive (83/570/EEC) will lead towards the establishment of a genuine common market for medicinal products by evolutionary process, but that medicinal products derived from biotechnology and other forms of advanced technology cannot wait. The hon. Member for Derbyshire, South referred to the briefing, which we both attended, on some of the developments that are taking place. It is evident from the expert and informed opinion of the British companies involved that there is some urgency. I echo what the hon. Member for Derbyshire, South and the companies have said to the Department and I trust that the Minister will make satisfactory progress. We shall certainly give him support.

I am glad that the Government are welcoming the continuing progress towards removing the remaining barriers to trade between member states in the Community. In that respect, I support these measures.

With regard to research and development, reference has been made to the general concerns of the United Kingdom industry. At a recent annual dinner which some of us attended, the Minister for Health laid great stress on the tremendous contribution which the pharmaceutical industry makes to research and development, and to exports. That is correct, and I hope that the Government will see their way to negotiating with the industry a better deal on potent life. That would enable a better deal for the industry and permit greater opportunities for the research taking place in Britain to remain a domestically based development capacity and, therefore, an export potential. In the past, patents have passed on to North America or Europe at the expense of the British economy and developments.

Subject to the obvious expressions of concern about the maintenance of adequate standards of health and safety for the public, we welcome these proposals.

11.9 pm

Mr. Roger Sims (Chislehurst)

We have a successful and innovative pharmaceutical industry. To the extent that these proposals will enable and facilitate the development and marketing of products in the Community, they are very much to be welcomed.

I am worried, however, that in the earlier memorandum, dated 3 October, among the items which the Department described as "Controversial Elements" was (e) The security of commercially confidential information. This is clearly an important matter. Although, once established, a product may be protected by patent, information might have to be passed under these proposals before the patent application has gone through. We know from experience that there are some not too far away from these islands who are quite likely to steal information and use it. A product and enormously expensive research by British firms could be seriously undermined.

In the later memorandum, dated 8 May, we are simply told: We are satisfied with the progess of discussions in Brussels so far on all the features listed in the previous memorandum. That seems a rather vague reference to this all-important matter of the security of commercially confidential information. I wonder whether, in winding up or later, my hon. Friend will assure me and the industry that the matter has been covered fully and that his officials are satisfied that the earlier reservations have been met.

11.11 pm

Mr. Whitney

With the leave of the House, I should like to reply to the debate.

This has been a short but interesting and informative debate. I assure the House that any suggestion that British standards will be limited or degraded by these measures is unjustified. Our standards will unquestionably remain as high as they are at present. The arrangements for determining responsibility for how drugs may be marketed will also remain in force. Whatever arrangements might be proposed to remove remaining barriers to trade between member states by 1992, we shall insist on retaining the right to deal with medicine in a way which suits United Kingdom conditions if we consider such action to be necessary.

Mr. William Cash (Stafford)

Could I have my hon. Friend's assurance that there is nothing in the directive—

Mr. Deputy Speaker (Mr. Harold Walker)

Order. the hon. Gentleman has just walked into the Chamber. He has not heard anything of the Minister's speech or that of any other hon. Member. I hope that he is not trying to reopen matters that he could well have understood if he had been here at the beginning of the debate.

Mr. Whitney

Thank you, Mr. Deputy Speaker. If my hon. Friend has any misgivings, no doubt we can exchange correspondence on the matter.

The hon. Member for Wrexham (Dr. Marek) asked about testing procedures in other countries and whether they are as high as in Britain. The UK licensing authority will continue to have the benefit of the expert independent committee, the Committee on Safety of Medicines, which will continue to examine critically all the scientific evidence to satisfy itself about the safety, quality and efficacy of products for which licences have been applied for.

My hon. Friend the Member for Chislehurst (Mr. Sims) asked about commercial secrecy in consequence of applying the obligatory consultation procedure, in addition to the usual protection offered by the requirement imposed on the participants in relevant Community committees. There is also the additional protection that is offered in the fourth directive, with which I dealt in my opening speech, of the 10-year indirect protection for the original licence holder of scientific data needed to support an application. This would prevent someone who obtained confidential information about a product from using it to obtain marketing authorisation for a copy product.

We also had our own worries in the context of confidentiality about the reference to the use of ad hoc groups of experts or highly qualified outside consultants. However, when we explored this matter in discussions we found that it was a semantic difficulty and that what the Commission had in mind was no different from the existing CPMP and CVMP arrangements. Confidentiality continues to be of great importance, and I assure my hon. Friend that we shall watch the matter with extreme care.

Concern was expressed by the hon. Member for Wrexham about the Government's right to revoke licences. It would be unacceptable if the effect of any of these proposals were to delay the removal of what might be a public health hazard—for example, a medicine that was shown to have unacceptable side effects. The revised text that is now before us makes provision for emergency action, when necessary, without prior consultation. We are now fully satisfied with the arrangements.

I have covered most of the main points. In particular, I hope that I have covered the points raised in the, as always, impressive contribution of my hon. Friend the Member for Derbyshire, South (Mrs. Currie). If I have not covered all her points, I shall seek to do so in correspondence.

The hon. Member for Wrexham quite properly ended his remarks by asking whether these measures will increase public confidence and encourage research and development and whether they will make a beneficial contribution to reducing the use of animals in testing and promoting greater interchange in the pharmaceutical industry within the European Community. I give the House an unqualified assurance on all those points.

These are sensible measures. They will help in the creation of a common market within the European Community, at the same time maintaining standards in the crucial areas of pharmaceutical and veterinary products.

Therefore, I commend the documents to the House.

Question put and agreed to.

Resolved, That this House takes note of European Community Documents Nos. 9630/84 and 5752/86, proposals for draft Directives and a Recommendation, and Amendments to the proposals, on the marketing and testing of medicinal products, and of the supplementary explanatory memorandum from the Department of Health and Social Security dated 8th May 1986; endorses the aim of strengthening biotechnology in respect of medicinal products within the Community; and welcomes continued progress towards removing the remaining barriers to trade between member States, whilst fully protecting public health.

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