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Drugs (Export)

Volume 961: debated on Tuesday 30 January 1979

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Motion made, and Question proposed, That this House do now adjourn.—[ Mr. Bates.]

12.58 a.m.

The backcloth of this debate is the selfish exploitation by multinational drug companies of developing countries. It constitutes what the director-general of the World Health Organisation has called drug colonialism, and I hope that the Department of Health and Social Security will take a lead in ending this exploitation of millions of people who live in direst poverty.

The death rate of children in some developing countries is staggering. In many of them one child in three dies by the age of five, compared with one in 50 in Great Britain. In some developing countries children under five account for 50 per cent. of all deaths compared with 3 per cent. in Britain.

The main reasons for this sorry state of affairs are inadequate sanitation, malnutrition and disease. There is, of course, a place for some medical drugs, mainly of the basic type. But the main need is for direct health aid programmes to improve nutrition and sanitation and thereby reduce disease. Yet in 1977 we gave only £25 million in direct health aid programmes to developing countries, whereas we exported over £200 million worth of drugs to them.

It is to these drugs and the way that they are promoted that I want to draw the attention of the House. Some people may say that these are matters for the countries concerned. In fact, the Secretary of State for Social Services, replying to a question from me about the need to ban the export to developing countries of drugs that are dangerous and banned in Britain, refused to do so on the grounds that we should not deny other countries the opportunity of deciding for themselves what medicines are necessary or desirable.

This is a superficially attractive but basically bogus argument since most developing countries lack the resources and expertise to control abuse. Over and above that, they are not being provided with the necessary information. Leaving it to them means abdicating responsibility by this country. Drugs which are dangerous to British people are equally dangerous to those in other countries—be they black, brown, yellow or white.

Another answer, to a question asking about the medical drugs banned in Britain, skated over the real issues by saying that only one drug was banned under section 62 of the Medicines Act 1962 but that others had been withdrawn "voluntarily", as the Minister called it, after appraisal by committees on safety.

Let me emphasise that I am not concerned with the pedantic definition of banning, since it is generally recognised that many drug companies simply withdraw when they think they are going to be banned. I am concerned not primarily with the one that was banned but with those that are dangerous and are, in effect, banned because they have no product licences. Yet these drugs, not permitted in Britain, are legally allowed to be exported to developing countries. Could there be a more revealing example of double standards than that?

Of course, it can be claimed that a developing country exercises negative control by asking for evidence of the status of the drug before importing it. But how effective is this kind of control? Can the Under-Secretary tell us how many complaints are received each year from developing countries about our massive exports of drugs to developing countries?

Developing countries, far from being clear about the efficacy and safety of drugs, must sometimes be bamboozled by the extraordinary and sometimes ruthless methods of drug promotion.

Some outstanding work has been done on this matter by Dr. John Yudkin, who has worked in this field, and Mr. Charles Medawar, of Social Audit. But it is not only these two people, actively concerned though they are, who are involved. The United Nations, particularly the World Health Organisation, Oxfam, War on Want, Voluntary Service Overseas and many other organisations are concerned—and understandably so—and that notable crusader Ralph Nader has raised the issue of drug exports with President Carter.

Phenacetin illustrates the double standards of safety that are being applied. On 14 September last year I wrote to the Secretary of State for Social Services about this drug, and the Minister of State replied that in 1974 the Committee on Safety of Medicines had suggested restricting this to prescription because long-term use could cause kidney damage. It has been on prescription in this country since September 1974. Now the Committee on Review of Medicines has proposed a total ban on this drug and the Government are now going through the necessary procedures to ban phenacetin completely.

So far so good. But Mr. Medawar states that Boots in India and Malaysia has been making it available—as APC tablets—for over-the-counter sales, and incredibly providing no information about possible hazards in the literature supplied with the drug, nor on the label, nor the pack.

The whole question of information about drugs sold in Britain and in developing countries needs urgent inquiry. In this country, drug companies provide doctors with comprehensive data sheets about drugs. It is not so abroad. Doctors abroad depend heavily on information given in their Monthly Index of Medical Specialists (MIMS). MIMS Africa, MIMS Caribbean and MIMS Middle East are the three prescribing guides used in developing countries. Although the information in the developing countries' MIMS and the United Kingdom MIMS is supplied by the same drug companies, there have been serious discrepancies between the information in the prescribing guides in Britain and those in the developing countries.

For example, Dr. Yudkin reported recently that Boots, among others, marketed Tetracycline in Africa and made no mention of the possible risks, nor of the clear recommendation in Britain that it should not be used in children up to 12 years of age. Perhaps Boots thought that African children were less important than European children or it may have had secret medical reasons for hiding this information from African parents. Either way, it owes us an explanation.

Some of the British drug companies are failing to give adequate information about the correct dosage of drugs sold to developing countries, according to Mr. Charles Medawar. He quoted the examples of Migril, a Wellcome product, for the relief of migraine, in which the maximum recommended weekly dose was 12mg in the United Kingdom but 24mg in Africa and Asia. Perhaps Wellcome felt that migraine sufferers in Europe needed more careful and delicate handling than those in Africa and Asia, or it too may have had a secret medical formula which explained the 100 per cent. discrepancy.

Following criticism in Social Audit, the company said it halved the recommended maximum weekly dose of the drug to bring it into line with the United Kingdom. But there is still a discrepancy between the Wellcome information given in the United States—maximum weekly dose 10mg a week—and the United Kingdom and elsewhere—maximum dose 12mg a week. The House will look forward to an explanation from this company.

There can be no moral justification for double standards in the promotion of drugs at home and abroad, especially to developing countries whose health problems are vast and whose resources are limited. They are entitled to at least the same warnings of risks and dangers of any drugs exported to them as anyone else.

We need an international inquiry into the overseas promotional practices of drug companies. In the meantime, we have to ensure that our own practices are above reproach and that information about British drugs is standardised to all buyers whatever and wherever they may be. Such information should include misuse, side effects and contra-indications of all drugs.

The drug companies should undertake to provide the Governments of all developing countries which purchase British drugs with copies of data sheets, British MIMS, adverse reaction warning leaflets, medical review letters and annual reports of the CSM. And the Government should continuously review this provision. They should also check on the quality of drugs exported so as to prevent the export of sub-standard batches. Our reputation is among the highest in the world, but there is international concern about the provision of drugs to developing countries. We can only benefit by raising our standards.

Such policies would, incidentally, benefit Britain, her reputation and her export trade, but their main purpose would be to safeguard the health and perhaps the lives of people in developing countries. This is a worthwhile endeavour. I hope that these proposals, a mere prelude to others, will be carefully considered by the Government and the drug companies. We should be setting standards to be followed by the rest of the world; and whether we are followed or not, we should be setting standards which will do unto others as we would do unto ourselves.

1.12 a.m.

I listened with great interest and attention to the arguments advanced with such conviction by my hon. Friend the Member for Stoke-on-Trent, South (Mr. Ashley).

The main question can be stated quite simply: should we allow the export of medicinal products to developing countries which we believe to be harmful or unsuitable for people in this country? This is a simple question, but, if a fair, responsible and reasonable view is to prevail, I do not believe there is a simple answer. I hope that my hon. Friend will bear with me while I set out some of the more important considerations. In doing so, I should say straight away that many of these are by no means new to the House.

My hon. Friend may recall that when the Bill which became the Medicines Act 1968 was introduced it proposed licensing controls for all medicinal products, whether for the home or export markets. But on Report a provision was included which postponed such controls in relation to exports. The underlying reasons for this are as valid now as they were then, but before I expand on some of these reasons I think it important that the House should appreciate that action on the lines suggested by my hon. Friend by one large exporting nation would have minimal effect unless adopted by other major exporters, particularly in these days of large multinational corporations. Moreover, recognition of this vital point was embodied in the Medicines Act, which makes the lifting of the export postponement provision conditional on international agreement.

I should also add at this juncture that biological products such as antigens, toxins, anti-toxins, sera, anti-sera and vaccines—an important part of our drug exports—are already subject to licensing controls, whether for home or export markets. Therefore, any action taken to limit or stop the sale of such products in this country would automatically bite on exports as well.

Let us first consider what interpretation can be given to the term "ban"—one which, I might add, is not used in any of the medicines control legislation. It infers an "absolute" state and for this reason is rarely applicable to questions of safety and efficacy. It is not surprising, therefore, that we find only one product completely prohibited from the United Kingdom market by an order under section 62 of the Medicines Act. This was an imported product with a very high lead content. But there are many products which have been removed from the United Kingdom market and, indeed, many others which have failed to obtain the necessary marketing authorisation. With all these products, the essential common factor is that they are not on the market because of advice given by expert bodies established under the Medicines Act.

In all these situations, whether by prohibition order, revocation of a marketing authorisation or refusal of an application for a marketing authorisation, the action of the licensing authority can fairly be described as "ban". But they are not "banned" in any dictatorial sense.

Perhaps I might at this stage deal with my hon. Friend's point about phenacetin. My hon. Friend may be under the impression that a further prohibition order under section 62 of the Medicines Act, as discribed in our August 1978 press release, would also prohibit exports of phenacetin-containing products. Although no final decision has yet been made on the making of this order, if made it would not, within the terms of the Medicines Act, exclude all possibility of exportation since the wording of section 62 specifically permits prohibition on
"the sale or supply or the importation"
only. The word "exportation" is omitted from the section and we have legal advice that, although such an order would greatly inhibit exports—since in practice exports would involve "supply" and possibly also a "sale"—there may be loopholes on the basis of international law. Only an order made under section 48 of the Act would secure an absolute ban on exports.

The majority of products are taken off the market because the companies concerned have accepted the advice given by the expert bodies and have voluntarily withdrawn the products or the applications for marketing authorisations of the products. One must therefore ask whether it would be appropriate for the licensing authority to take similar controls for products which are intended for the export market. Would it not jeopardise the relationship which has grown up between the licensing authority, its expert bodies and the pharmaceutical industry?

Also, if I take my hon. Friend's argument to its logical conclusion, would it not be proper to require an undertaking from a foreign Government that they would restrict the sale of drugs to "prescription only" if that were their status in the United Kingdom? This raises the question of what marketing controls exist in developing countries and whether it is right for the licensing authority to take these controls into account in granting marketing authorisations for products intended for export.

Further, if information were not available to a foreign Government for it to make its own reasoned decision, it might be argued that the United Kingdom should accept the need to impose greater control over its exporters. But this is not the position. My hon. Friend may not fully appreciate the effect of the removal of a product—albeit voluntarily—from the United Kingdom market, and it is important that the House should appreciate the consequences.

The majority of foreign Governments base their decision—and I emphasise "their" decision—on whether or not the products they wish to import can legally be sold or supplied on the United Kingdom market. Failure of a United Kingdom company to obtain or retain a marketing authorisation under the Medicines Act for United Kingdom sale will automatically mean a drastic diminution of exports, since foreign Governments could not then be provided with evidence of the product's right of sale in this country.

Let me explain further. To assist exporters, the United Kingdom authority, under section 50 of the Medicines Act, provides at their request an export certificate which confirms the United Kingdom licensing status of its products, thereby serving as proof of that status to a potential foreign customer. The signs are that the demand for such certificates by companies continues to grow. Some 4,000 were issued in 1975, with more than double that number in 1978. It is clear, therefore, that foreign Governments are increasingly relying on the United Kingdom marketing status of the product before allowing importation.

My hon. Friend referred to numbers of complaints from other countries. I shall see what information we can provide for him on that.

There is a further important point here. Whether or not a product is granted a United Kingdom marketing authorisation, it can only be manufactured under a manufacturer's licence granted under the Medicines Act which indicates that the licensing authority is satisfied as to the premises, equipment and other facilities of the manufacturer concerned and as to the qualifications of the staff undertaking the manufacturing operations. So there is always some guarantee of the quality of the product. Moreover, if it is of concern to them, it is open to foreign Governments to ask the United Kingdom whether particular drugs are sold on prescription only. Even further information is available to foreign Governments through the actions of the World Health Organisation.

My hon. Friend has referred to the work being carried out by the World Health Organisation. This organisation has now set up an action programme on essential drugs as part of its comprehensive effort towards the goal of health for all by the year 2000. The objective is to strengthen the national capabilities of developing countries in the selection, supply and proper use of drugs essential to meet their real health needs and in the local production and quality control, wherever feasible, of such drugs. The immediate aim of the action programme is to make basic drugs and vaccines available under favourable conditions to Governments of the less developed countries in order to extend essential health care and disease control to the vast majority of the population.

Initially, a study group drew up a list of some 200 drugs. The list is an indicative one not intended to be exclusive and restrictive. Individual countries or groups of countries need to draw up their own lists, which will probably be much shorter, of those drugs which are basic to their health needs and which they will therefore try to obtain under these favourable arrangements.

I understand that the programme was discussed only last week in the executive board of the World Health Organisation and the director-general has been instructed to proceed with consultations and negotiations with the pharmaceutical industries. I hope that the pharmaceutical industry in this country will be able to work with this very worthwhile programme to help the developing countries to obtain basic drugs of proved safety and efficacy on reasonable terms.

I think it has to be accepted, therefore, that the availability of information about the United Kingdom marketing status of products—and the clear use made of this information by many foreign Governments—in itself creates a formidable barrier for any unscrupulous company. But in any case let me say at this juncture that I am sure that the British drug industry is a responsible body. I am confident that it will have noted the public concern so ably voiced by my hon. Friend and will be considering whether any action is needed. If it is, I am sure it will take an enlightened view of its own economic interest. After all, an export-winning industry such as this depends on its reputation and its standards.

But now let us turn to a foreign Government's overriding right to decide for themselves what should or should not be imported. My hon. Friend will have noted the reply given to his recent written questions by the Secretary of State on 16 January in which the Government doubt whether it would be right that decisions taken in the light of circumstances prevailing in this country should deny other countries the opportunity of deciding for themselves what medicines are necessary or desirable, particularly where conditions such as the availability of medical services, endemic disease, climate and diet are quite different. As I have said earlier, decisions about the marketing of drugs in the United Kingdom rest with the licensing authority which is advised by expert bodies. Its present remit is to consider the safety, quality and efficacy of products for the United Kingdom market. The fact that a marketing authorisation for the United Kingdom may be sought simply to enable a company to export a drug to a foreign country which requires evidence of its United Kingdom marketing status is of no concern to these expert bodies. Their expertise is directed at conditions prevailing in this country.

That being so, we must consider the type of judgments that such bodies have to make. First, it is indisputable that any drug is potentially dangerous in that its use inevitably involves a balance of benefit and risk. If we are not talking about outright poisons, the medical decision whether to use a drug has to depend on the circumstances of the patient. A doctor might justifiably decide with a seriously ill patient to use a drug of known side effects which he would not consider for someone less ill. Scientifically, therefore, it is a question of weighing the benefits and risks and of taking a balanced judgment.

These expert bodies are confronted with the same decision except that—and it is important that I stress this point—they have to consider this same decision in relation to a drug's use in many varying circumstances. To restrict or prohibit its use simply because it is known that in one particular, perhaps very rare, situation its adverse side effects might consti- tute a greater risk than its potential benefit would be to deny its known benefits to many patients not in that particular situation. But, as I have said, these bodies must make such judgment in the light of circumstances in this country which may differ considerably from those in other countries.

Is it not reasonable, therefore, to question whether we have the right to deny a foreign Government the right to make their own decision on the basis of their own expertise on the circumstances prevailing in that country? To deny this right might be to deny exportation of a drug which, in the particular circumstances of that country, has greater potential benefit than risk. Moreover, it must be emphasised that it is not simply a question of medical science, but it might well be a question of economics also. The availability of medical services, the quality of those services and the nutritional state of the population are clearly all factors which bear on such decisions and therefore they can be taken only by that Government. I cannot believe that my hon. Friend would seriously consider it the duty of our licensing authority and its expert bodies to take such factors into account since they are clearly not equipped to do so.

In setting out some of the fundamental considerations involved in the problem, I hope I have assured my hon. Friend that, although the Government fully appreciate his concern in the matter, there is no simple answer. Indeed, I hope to some extent I have been able to assure him that, even without further Government intervention, there are already a number of barriers to the promotion of drugs for export in ways which he, and indeed the Government, might consider undesirable. I regard as important our willingness to encourage further discussion within the WHO. In this forum not only can the major exporting nations present their views but it will be of particular importance to hear the views of the developing countries as to how far they would wish exporting nations to limit their right to make their own decisions on what they should or should not import.

I realise of course that merely explaining that a problem is a complex one will not make it go away; and since my hon. Friend has specific examples of difficulty in mind, neither the Government nor, I am sure, the industry would wish to wash their hands and stand cynically by. However, bearing in mind what I have already said, I feel that the most useful first steps should rest with the industry associations. I am sure that they will consider whether guidance should be given to their member companies in the light of the particular examples which my hon. Friend has given and any others which are brought to his attention.

Question put and agreed to.

Adjourned accordingly at twenty-five minutes past One o'clock.