HC Deb 22 July 1991 vol 195 cc884-902

12.3 am

Mr. Kenneth Hind (Lancashire, West)

I am grateful to Mr. Speaker for this opportunity to talk about the drug RU486. The purpose of the debate is to call the attention of the House and the country to this abortifacient drug, which is manufactured by Roussel Uclaf, a subsidiary of the international company, Hoechst, which is based in Germany. As an active campaigner on pro-life issues, I took an interest in the drug mainly because it was one of the first drugs developed purely and simply to kill—and against that background we should consider it very seriously. I am sure that hon. Members will listen carefully to the objections to the drug.

The purpose of the debate is to call for the withdrawal of the drug, which was licensed on 1 July by my right hon. Friend the Secretary of State for Health. It is planned to introduce it into the national health service in the near future. I do not want to concentrate on the pro-life arguments this evening—they are perfectly clear. I want to discuss the other factors that are being ignored by many of the people who are considering this matter.

The first is the insufficiency of the research into RU486, which is a danger to the health of the women who take it. The long-term costs of the NHS could be vast because the chances are that the drug will produce deformed and damaged children. Britain is being used as a guinea pig by the manufacturer to set an example to the rest of the world, and especially the third world, where it could be used with disastrous consequences. Only two countries currently license RU486. One is France, where the drug is manufactured and the French Government have 40 per cent. of the shares in the manufacturer.

On the question of insufficient research, Dr Turchen —a member of the United States Public Health Association and a well-known pro-abortionist—has claimed that all but one of the studies on the drug have been financed by the manufacturer. In answer to a written question two weeks ago, the Minister of State, Department of Health, said that no independent studies had been carried out in the United Kingdom by the Medicines Control Agency. By implication, that must mean that all the research programmes on the drug that were considered by the agency were carried out and paid for by the manufacturer.

As a consequence of the lack of independent research, there is no evidence to show what the long-term effects will be for women who use RU486. It has been described as a powerful steroid. It has neoplastic qualities, so in simple terms it is cancer-causing. In a recent study on 11 normal, healthy male volunteers who took the drug twice a day for seven to 14 days, one developed adrenal insufficiency, which is potentially fatal, and a further eight developed widespread, unpleasant skin rashes. In another study, four women developed hirsutism, a male pattern of baldness or menstrual irregularity. That was after only a short period taking the drug.

Tests on animals in the United Kingdom have shown that the drug is cancer-causing. The chemical cocktail of the drug works away in the body of the woman. The long-term effects are not known, as is admitted by the drug's supporters. This House, the Medicines Control Agency and the other agencies throughout the world with responsibility for licensing RU486 all agree that we cannot predict the long-term effects of the drug.

According to an answer to a written question by my hon. Friend the Member for Hexham (Mr. Amos), drug licences are granted in this country within, on average, 19 months, and only when the matter is not referred for examination to the drug committee of the Department of Health. RU486 was fast-tracked—it was licensed within 10 months. The only reason given is that it will save money for the national health service.

The Chinese carried out a study into RU486 involving 3,000 patients. The conclusion was that the drug was three times more expensive than a clinical abortion. The Chinese totally reject the argument that it will be cheaper. No doubt my hon. Friend the Minister will tell us that a clinical abortion will cost the NHS £270, whereas the use of RU486 will cost £182. I do not believe that four appointments at a hospital, four lots of treatment—involving taking RU486 and then taking prostaglandin, the second process in 15 per cent. of cases—will cost the NHS only £182.

Many more tests have been carried out in the United States than in the United Kingdom. The United States has banned the import of RU486. The Food and Drug Administration warned that the drug could pose a risk to the safety of the user. The FDA refused to license Opren. We did so, and are experiencing the consequences.

Recently, representatives of the Pro-Life medical committee, which advised a group of hon. Members, went to Germany and talked to Hoechst, the holding company for Roussel Uclaf, and asked whether it would seek to license RU486 in Germany. The company did not suggest that it would attempt to do so.

I recently had a debate at the Oxford Union with Professor Baird from Edinburgh university, who has carried out research into RU486. He claimed all sorts of wonderful side effects. I refer him and the House to Dr. John Seward of the American Medical Association Trust, who said that published conjecture that RU486 might be an effective treatment for a variety of illnesses was not based on any substantial test of the drug.

RU486 is certainly not a contraceptive. It does not do anything to treat cancer. It cuts progesterone and probably stimulates the growth of breast cancer. It is of use only for strangling and killing a child in the womb. It is useful only as an abortifacient. No doubt my hon. Friend the Minister will say that it has only been licensed as such in the United Kingdom.

My major concern is the danger to women's health. In March this year, a woman died in Lens, in France, from taking RU486 followed by an injection of prostaglandin. The drug licensed in France is called Nallodor. There is evidence that two women in France had serious heart attacks as a consequence of taking it. It is clear that RU486 stimulates some types of breast cancer, although it is fair to say that it puts others into remission. We must seriously consider that factor.

It would be wrong of me not to examine the French experience of taking RU486. If I correctly read the notes attached to the licence, it is proposed to replicate in the United Kingdom the clinical usage in France. In France, there are four visits to the hospital or the clinic where the drug is taken. On the first occasion, the blood count is taken. If the patient is anaemic or a heavy smoker, she is rejected. The child is examined by ultrasound. In France, the woman who is to take the drug signs an eight-page document, a waiver which absolves the manufacturer, Roussel Uclaf, from liability if the woman refuses to continue with the full treatment and goes on to have a deformed child.

The woman returns one week later and takes RU486. She returns a third time, 48 hours later. If the child has been aborted she has to bring the remains with her. If she does not return, she is fetched. If I read my hon. Friend's notes on the licence correctly, in Britain the patient will not be brought back—she will be lost in the community, irrespective of any medical complications that may arise.

In 75 to 85 per cent. of cases, RU486 works, but that leaves between 15 and 25 per cent. Those patients need to take prostaglandin. In the United Kingdom, that will be taken by way of vaginal suppository. In France, if the child is not aborted by late afternoon, the women is taken into theatre and a surgical abortion is carried out.

There is some dispute about how effective the drug is. Dr. Turchen of the United States says that the drug is only 90 per cent. effective, and that in 10 per cent. of cases surgical abortions will be required. Roussel objects to that and says that it is 95 per cent. effective. But its data depend on the duration of the pregnancy. The longer the pregnancy, the less effective is RU486 and the greater the number of failures.

We must also consider bleeding. Professor Baird at Edinburgh came to the conclusion that women could bleed for up to 44 days. The average is 13 days. In a study in the New England Journal of Medicine of a large number of women who took RU486, one in 1,000 needed a blood transfusion and, more importantly, one in 100 needed a surgical dilation and curettage to stop the bleeding. One can imagine what that involves. It has been described by Mr. Sakiz, chief executive of Roussel, as an appalling psychological ordeal". Roussel is using Britain as a springboard to the third world. If a woman is anaemic, or suffering from some other disease, and she bleeds for up to 13 days, where will she find a clinic or hospital in the outback of Zimbabwe or the uphills of Ethiopia to provide the necessary treatment? She will bleed to death. There will be many fatalities in certain parts of the world if the drug is licensed there. Those people look to us, and we shall carry the responsibility. They do not have the sophisticated licensing facilities that we have. They will follow our lead, and we shall be responsible if people die as a result.

Unlike a surgical abortion, the user of RU486 removes the remains of the child herself after the abortion. It is not like a clinical abortion where the foetus is removed under a general anaesthetic. The woman has to take part in the abortion. We cannot underestimate the long-term psychiatric effects, particularly when we consider the guilt that women may suffer, as has been shown in psychiatric research which proves that post-abortion syndrome is very much a reality. Professor Alan Templeton of the university of Aberdeen has found that women are distressed at the sight of their aborted babies. We should not underestimate the long-term psychiatric troubles that will come to many of these women as a result of post-abortion syndrome.

Most important of all are the deformities that may result if women start the process of taking RU486 and then change their minds and do not take prostaglandin, Their children will be born with congenital abnormalities. Tests on rabbits have shown that the drug can give rise to a condition known as sirenomelia, in which the legs are fused together. There may also be effects on the skull and head. If such children are born here, they will not be the subject of signed waivers as they would be in France. Their relatives will sue the NHS, and out of its budget will have to flow the hundreds of thousands of pounds necessary to provide those children with the lifelong treatment that they will require.

We have seen the same happen after mothers have taken other types of drug. This means that money will not be spent on treating other people but will go to meet the needs of children whose deformities could have been avoided. The drug should be withdrawn now. Already an example of this syndrome has been noted in France. The child in question was so badly deformed that it was aborted after 19 weeks. Before this goes any further, it should be stopped, thereby preventing the vast costs to the people of this country that will ensue if it is not.

When a drug is approved in the United States, those involved in the Food and Drugs Administration produce a summary of their findings on the drug, detailing why it has been approved, for the public to see. All that happened here was an answer to a written parliamentary question and nothing more. We have been given no details of clinical research into the drug or into past-abortion syndrome occasioned by it. The United States has a much tougher regime and is more careful about licensing drugs. We need the same in this country in order to know where we stand.

We know too little about this drug, and it is too dangerous. The risks involved are too great. Now is the time to draw back and recognise that we should examine the matter further before British women are used as guinea pigs in trials of the drug.

12.23 am
Sir Bernard Braine (Castle Point)

I congratulate my hon. Friend the Member for Lancashire, West (Mr. Hind) on his tenacity during the past few weeks in persistently bringing this matter before the House, and now on successfully enabling what I am sure will turn out o be a major debate o take place.

I am sure that every hon. Member knows my views on abortion. Everybody also knows that, for a quarter of a century, I have fought unceasingly for the protection of the unborn child, the most defenceless of all members of the human family. However, during that time, nobody has ever heard me single out any abortion technique and demand its withdrawal. The reason for that is simple. I am concerned about the destruction of human life, not the means of bringing about that destruction.

However repugnant I feel abortion to be, the House made it legal, and some technique has to be used. Some techniques are quite revolting, but at least we know something about the long-term effects on the mother. RU486 is totally different. It is the first drug to be produced with the single aim of killing, and we have no idea whatever of its long-term effects on children in cases where the abortion fails or upon the women to whom the drug has been given.

One of the most worrying aspects of the matter is that the drug was supposedly examined and evaluated by the Medicines Control Agency, a body governed by the Medicines Act passed as a result of the thalidomide tragedy, when Parliament and public opinion were unanimous that we should never allow such a disaster to happen again. But here we have a drug that was approved behind closed doors and of which the manufacturers have had to admit that they have no idea of the possible long-term effects.

How many hon. Members have noticed a singular lack of enthusiasm demonstrated by the National Abortion Campaign, which since its inception has fought for abortion on demand up to birth? its supporters are not opposed to the principle of abortion, but they are quite categorical that the purpose of treatment is to benefit the woman. On that at any rate we can respect the views of people who say that in certain circumstances, abortion is justifiable.

Nobody knows what the long-term effects of RU486 might be on women. One would think that the fact that the manufacturers admit the possibility of sequelae which could be absolutely disastrous to those who were afflicted, would have encouraged the Medicines Control Agency and the Department of Health to proceed with caution. I very much regret that the Secretary of State for Health is not here to reply to the debate. If he were, he would be left in no doubt about how some of us feel about the way in which this matter has been managed.

Such has been the unseemly haste in giving approval that one might almost think that our Government, like the French Government, had 40 per cent. of the shares in the manufacturing company Roussel Uclaf or in its parent company, Hoechset. I hope that we shall be told that there is no such connection here as there was in France.

The Parliamentary Under-Secretary of State for Health (Mr. Stephen Dorrell)

indicated dissent.

Sir Bernard Braine

At least we have gained one admission right at the beginning of the debate.

Since Roussel Uclaf applied for a licence to market the drug in September, stories have been leaked to the press that the Department of Health was "fast tracking"—that is the term that was used—its progress to ensure that it would reach the marketplace with such speed that one would hardly notice its arrival.

On Thursday, my hon. Friend the Member for Hexham (Mr. Amos) tabled a question asking the Minister how many drugs had received product licences in the United Kingdom in the last year, and how long each took to receive its licence. The answer is interesting: it showed that new drugs took 19 months, and that established drugs also took 19 months, unless referred to a committee established under the Medicines Act, in which case the period was 23 months. That is surprising, because the process took only 10 months in the case of RU486.

By the most remarkable of coincidences, the company just happened to have organised, for the second half of July and the beginning of August, a series of seminars to take place all over the country, to promote the use of the drug. As a former Minister in the Department of Health, I know that seminars take a great deal of organisation, requiring considerable advance planning. However, the company was able to send out letters to every gynaecologist in Britain, on the very day that the licence was issued, inviting them to seminars, the first of which was to take place within days of the letter being posted.

Neither the Secretary of State nor the Minister saw fit to inform the House. They both know that there is a joint committee of both Houses of Parliament that holds a watching brief in pro-life matters. They know, especially from the debates last year, that there is considerable interest in the subject on both sides of the House. But all this was done in secret. No sooner was the licence granted than the company moved. The seminars had been organised, and everything was ready to go ahead.

Such is the scenario that a fair-minded person would wonder whether the company could assume in advance that a licence would be issued. We insist on having a clear answer on whether the company was told this in advance. If we do not have the answer tonight, we must have it from the Secretary of State. If the answer is no, my right hon. Friend the Secretary of State will have to draw up new rules to ensure that there is no repetition of such indecent haste in introducing a drug that it known to be dangerous, and is banned in other countries such as the United States and Germany. We are being used as a guinea pig for the vaster markets in countries which have a policy of restricting population growth.

What is more, as the Secretary of State knows, the drug has long aroused deep suspicion in the minds of parliamentarians and leading medical authorities. We were finally informed that the licence had been issued only because of the persistent questioning of my hon. Friend the Member for Lancashire, West. By the time that the question was answered, the licence had been issued. Such indecent haste demands an explanation, especially when one looks at the data sheet to examine the admissions that both the company and the licensing authority deigned to make.

As I have said, the Medicines Act was passed to ensure that never again would we experience another tragedy such as that caused by thalidomide, yet this drug was licensed behind closed doors, in record time, when, as we learn from the company's data sheet, it could result in the child being handicapped in the case of a failed abortion.

The data sheet says that, in such cases, the woman should be informed of the dangers, and it stresses that it is essential that the termination is carried out by another method. The manufacturers do not explain just how dreadful these abnormalities might be. My hon. Friend the Member for Lancashire, West has said that rabbits treated with RU486 developed sirenomelia—in plain English. mermaid syndrome—where the child's legs are fused together, quite apart from other gross deformities of the organs.

Let us be clear about this grave matter. Let us weigh carefully what the Department of Health has done. It may be said that the Department proceeded to license the drug in a fit of absent-mindedness, but I do not believe that for a moment.

We know that, in France, at least one baby exposed to RU486 was aborted at 19 weeks because its legs were fused. Its mother had changed her mind about having an abortion, but then the child developed such horrendous abnormalities that she clearly felt compelled to end the pregnancy. I use the phrase "at least one baby" advisedly. The case was cloaked in such secrecy that, when the story leaked out from the hospital, it took months for any real details to filter through. We have no idea whether information about similar cases has been successfully suppressed or not.

We need to know exactly what independent investigations, if any, were carried out by the Department of Health before it granted the licence. Both the manufacturers and the licensing authority have left unsaid things that most people would consider they ought to have said in explaining the possible handicaps that children who survived exposure to the drug might develop. They have also failed to make any reference to other abnormalities that could be just as dangerous, or even more so, since they could be passed down from generation to generation.

I should explain that I have been advised on such matters for some years by a committee whose membership includes some of the most distinguished medical figures not only in this country but in the world. RU486 is not dissimilar to another drug—DES, or diethylstilboelstrol —which was originally produced with the laudable aim of preventing miscarriage. In this country, it was given to some 10,000 pregnant women between 1940 and 1970.

Apart from the fact that it was not effective in preventing spontaneous abortion, the drug was finally withdrawn from the market when it was discovered that teenage girls who had been exposed to it in utero had developed cancer of the vagina. It was also discovered that 25 per cent. of males and 40 per cent. of females who had been exposed to it had developed abnormalities of the reproductive tract, none of which had been apparent at birth.

As if that were not tragic enough, it has been discovered in the past few years that the third generation may also have been affected. People who had been exposed to the drug in utero, but were apparently normal, have now produced children with urinogenital tract deformities, or children who have developed cancer in their teens or twenties. As a distinguished embryologist told me recently, the chemical time bomb ticks on; we can have no idea whether a fourth generation will be affected, or how.

Having considered the children who may be affected by RU486, let me now turn to women who, in their dilemma, may now be subjected to it. Admittedly, the manufacturers warn that women taking the drug could have heart attacks. At least one unfortunate patient has died in France from a heart attack, and at least two more have suffered severe cardiac trauma. The manufacturers have persistently stated that the drug should never be used in cases of ectopic pregnancy; that is also one of the contra-indications of the licence.

When a woman is being considered for an abortion by RU486, it should be mandatory for her to be given a scan to confirm an intra-uterine pregnancy; otherwise, her life will be in danger. As a number of our medical advisers—including gynaecologists—have pointed out, a woman suffering from pain and bleeding after taking the drug might well believe that the symptoms were related to her abortion, rather than being the early signs of a rupturing ectopic pregnancy, which could be fatal.

In this connection, it is of supreme importance to note that ectopic pregnancies have increased. I hope that the Under-Secretary of State will confirm that they have increased and are a significant cause of maternal deaths, yet nowhere in the Department of Health circulars on the subject of RU486 is scanning considered to be mandatory. We consider that to be absolutely scandalous. I hope therefore that we shall hear that there are plans to rectify that omission quickly. I require a precise answer to that.

I have been an opponent of abortion for a quarter of a century, but this is the first time that I have ever called for the withdrawal of a drug or for the banning of a technique to terminate a pregnancy. I do so now for one reason only. Far from being a simple, easy, new method of abortion, this drug, introduced by ministerial decree, is potentially very hazardous, and there has been almost no independent research on it.

I call upon the Secretary of State for Health to withdraw the licence and to order a proper scientific and wholly independent investigation that is not financed by the manufacturers. I should have preferred to say that to my right hon. Friend the Secretary of State for Health. I expected him to be here, since this is the most important subject that we have debated today. It relates not only to the health of women but to our children's futures. The Department is represented by the Under-Secretary of State. I hope that he has been fully briefed on the subject, for he will have to answer a great many questions. I hope too that he will pass on the message that I should have preferred to see my right hon. Friend on the Treasury Bench.

It will take great courage by my right hon. Friend to withdraw the licence, but for him to admit the possible dangers and to do what, in the circumstances, is right will enhance, not weaken, his reputation.

12.42 am
Ms. Jo Richardson (Barking)

I intervene early in the debate because a number of Conservative Members want to speak. If I do not do so now, I may be squeezed out.

The hon. Member for Lancashire, West (Mr. Hind) and my old adversary, if I may so describe him, the right hon. Member for Castle Point (Sir B. Braine), the Father of the House, have spoken against RU486. The right hon. Member for Castle Point made his usual somewhat exaggerated condemnation of this very important development. Both of them—and doubtless those hon. Members who will speak later in the debate—are obsessed anti-abortionists. They have made a number of very misleading statements and—I was going to say half-truths, but I do not want to be ruled out of order.

Mr. Hind

indicated dissent.

Ms. Richardson

The hon. Member for Lancashire, West shakes his head. I want to try to put the record straight.

I am glad that the Government have decided, after the most rigorous checks, to grant a product licence. I am sure that the Under-Secretary of State will explain those checks. It is unusual for the Under-Secretary and me to be on the same side, but in this case I fully support the Government's licensing of this product.

We believe that RU486 is a step forward. It is the culmination of a research programme that was initiated in 1975 by Roussel. In 1982, the first clinical trials were carried out in Switzerland, since when it has been used by more than 100,000 women in more than 20 countries. In France, about which so much has been said, it was introduced in January 1989 as an integrated part of the women's health care programme. More than 90,000 RU486-induced trimester abortions have taken place.

A large-scale British multicentre trial of RU486 began in 1987 with the recruitment of volunteers from 13 NHS hospital gynaecological units in Scotland and England. The findings, which were published in 1990, confirmed the effectiveness of the sequential use of oral mifespristone and vaginal prostaglandins in inducing pregnancy up to the 63rd day of the pregnancy. That is the limit to which it can be used.

British-based Roussel Laboratories applied to the Department of Health for a product licence in September 1990. It was granted on 1 July 1991, nine months later—that magical figure of nine months.

Roussel Laboratories is running a series of seminars—the right hon. Member for Castle Point referred to the seminars; I presume that he means the same thing—in Leeds, Bristol, Nottingham, Glasgow and London to ensure that gynaecologists are familiar with the drug before it becomes available. It is doing so under conditions of the tightest possible control within the NHS and in other places approved by the amended Abortion Act 1967.

RU486 is not a morning-after pill, as so many people have said in the run-up to the debate; it is an abortifacient. It will be available under the terms of the 1967 Act. Its use will be confined to approved places and, as with other methods of abortion, will require the agreement of two doctors who will have to give their signature in good faith. It is not abortion on request. A leader in the Daily Telegraph today—other hon. Members doubtless will refer to it—said that it is, but it should get its facts right.

Despite what the hon. Member for Lancashire, West said, no deaths have been recorded that were attributable to RU486, and more than 100,000 women have used it since 1982. One woman died in France earlier this year during the course of a medically induced abortion shortly after receiving an injection of sulprostone, which is an injectable form of prostaglandins. She was an exceptional case. She had had 12 previous pregnancies and was a heavy smoker. In this country, the injectable form is not used. The prostaglandins analogue is given in pessary form.

RU486 is now in its 10th year of clinical use.

Mrs. Ann Winterton (Congleton)

rose—

Ms. Richardson

I do not propose to give way, as there is so little time for this debate.

There is no evidence of any long-term health risk. We have heard many scare stories this evening, but we should stick to the facts. The drug is taken as a single dose, perhaps once in a woman's lifetime. It goes through the metabolism quickly and is eliminated quickly from the body. Nothing could be simpler and safer than that.

Women in this country can obtain legal abortion despite the vigorous attempts by some hon. Members to close that option. We have never debated what methods of abortion should be legal—should women be entitled only to vacuum aspiration abortions, or would D and Cs be the most appropriate? It is right that we have not debated that, because we need to leave the decision on the safest and most appropriate method to doctors and women to decide between them case by case.

I welcome the product licence for RU486 in Britain, because it extends the choice to women and to doctors. It has proved safe in clinical trials, despite what the hon. Member for Lancashire, West has said, and I believe that many women will prefer it. Of course it is not without risk—no drug is. Conventional methods of abortion are not without risk either, but they are all safer than a pregnancy which carries quite a lot of risk, as I am sure hon. Members will recognise.

In 1988, Roussel announced in France that the distribution of RU486 would be suspended. We now know that that was as a result of pressure and threats from the anti-choice movement against both Roussel and its parent company Hoechst, which is based in Germany and in the United States. It is to the very great credit of the French Government that they responded with the now famous phrase: RU486 is the moral property of women. More than 100,000 French women are very grateful.

I am delighted that the forces of ignorance and fear have not been successful in Britain either and that Roussel has been granted its licence. RU486 is not a wonder drug. There will always be some women who prefer an abortion under an anaesthetic. Although I would like abortions to be carried out as early as possible, I recognise that some second trimester abortions are necessary. RU486 is not available for use in later abortions; it is simply for the first three months.

RU486 has the potential to improve national health service abortion facilities, which are currently inadequate and have too great a regional variation. The drug has the potential to cut delay because the woman does not need to be scheduled for surgery and because the prostaglandins which accompany RU486 can be administered on the ward.

The drug will save theatre time and theatre staff. It will save the surgeon's time. It will save anaesthetists, theatre nurses and anaesthetic nurses. It will save porters, equipment and anaesthetic agents. I hope that that considerable saving of resources and the freeing of resources will be redirected into providing a comprehensive national health service for abortion, with less delay for women. I have heard some Conservative Members talk at length in previous debates about the difficulties. I accept that delays cause great problems for women.

Here we have something that is safe, or it would not have been licensed. It has been properly tested, or it would not have been licensed. Yet those hon. Members resist the drug because of their obsession with their anti-abortion feelings. Far too many women are forced out of the NHS and have to go privately because the NHS is not good enough. I want the NHS to become good enough. I believe that RU486 will liberate a number of women.

I support self-referral for abortion in the first three months of pregnancy. I realise that that view is not shared by everyone. That practice would ease NHS delays and, for the first time, would give women rights to decide whether to continue with a pregnancy. That would be in line with public opinion, as a recent Harris poll showed that 81 per cent. of adults support that proposal. In that context, RU486 would mean that women who wanted abortions could get them very quickly.

Do not let us be deflected from making progress along this difficult and sometimes muddled path by the scare stories and the myths that are constantly put about by those who are anti-abortion anyway. Whatever the developments in the next decade, those anti-abortionists will be there to argue that such developments are unsafe and unwelcome. I believe that they will be wrong, as they have been in the past.

On this occasion, the anti-abortionists are using the potential benefits of RU486 to so many women to throw a cloak over their real intention of outlawing abortion altogether. The right hon. Member for Castle Point admitted that he was anti-abortion. I am sure that hon. Members will not be deluded by the comments of the anti-abortionists. Hon. Members have not been so deluded in the past, when they voted decisively for the improvements to the Abortion Act 1967.

It is not often that I agree with the Government, but I welcome their decision to grant the product licence. I am sure that women will also welcome that decision and the additional choice that RU486 will bring.

12.57 am
Mrs. Ann Winterton (Congleton)

I shall try to be brief, because I know that many hon. Members who are against the product licence want to talk about this important issue.

It is always a pleasure to follow my right hon. Friend the Member for Castle Point (Sir B. Braine), and I am grateful to my hon. Friend the Member for Lancashire, West (Mr. Hind) for introducing this important debate. It is difficult to follow the hon. Member for Barking (Ms. Richardson) as we always seem to be totally opposed. The hon. Lady has said that, in her opinion, the drug is perfectly safe for the women of this country to use. In 10 years' time I hope that the hon. Lady will not have to eat those words, which are now on record. The hon. Lady believes that the drug is safe—I do not, and I believe that the medical evidence will prove me right.

I am amazed that the drug has been licensed in such record time, almost with unseemly haste. All the excellent pharmaceutical companies associated with my constituency—ICI, Wellcome, Fisons and Ciba-Geigy—would love to know the magic formula to put the product licences that they want on the fast track for acceptance. What do they have to do to make that happen? The House should consider the speed with which the licence has been granted.

Tonight we have the opportunity to register our concerns. The hon. Member for Barking made great play of the fact that Conservative Members are opposed to abortion. I am opposed to social abortion. It is regrettable that in this day and age, with better education, better living standards, and free contraception through the national health service, the lives of unborn children are taken away merely because they happen to be a social inconvenience. Rather than discussing women's rights, I wish that hon. Members would say more about their responsibilities and, for that matter, about men's responsibilities for the children that they father.

Initially, family planning was introduced to plan families, not to destroy life. So-called family planning has been abused and there is abortion on demand in this country. We have the most liberal abortion laws in Europe and I am thoroughly ashamed of them.

The drug has been marketed very cleverly as a wonder drug—a morning-after pill—which is easy to take and will solve the dilemma of young women who find themselves pregnant and want to do something about the matter. The drug has been promoted as a cheap alternative to surgical abortion. I was dismayed to hear the hon. Member for Barking (Ms. Richardson) advocate that it was so good and cheap and would save surgeons' time. She was really advocating the cheapest possible method of ensuring that women have abortions. That is an insult to women and I am appalled to have heard those words spoken in this House.

RU486 will not be cheap. It has been promoted on the ground, for example, that it will save the national health service between £15 million and £23 million. Why has the Birth Control Trust, which actively promotes the drug, subsequently revised the figure down from £15 million to zero? I suggest that it is because there must be at least three appointments with the doctor who will prescribe the drug. At the beginning there will be no scan, which would immediately put up the cost. I believe that a scan is essential. Neither is there a costing of the pathological assessment for anaemia and other illnesses. Furthermore, the costs of the drug itself, the prostagladins and the surgical abortion when the drug fails in its purpose have not been taken into account. There are hidden long-term costs of treatment for, for example, post-abortion syndrome, the possible cancers that the women may develop in the long term and the cost of a child who is damaged if a woman has a change of heart halfway through the treatment.

The licensing of the drug shows a cavalier attituded towards women's health, and ignores the possible long-term damage, both psychological and physical which may be inflicted. There is no doubt that insufficient independent research has been done on the long-term effects. Most countries have rejected the drug, and it is licensed for use only in France and Britain. France has a vested interest because the drug was developed there, and at that time the French Government had a 40 per cent. holding in the company, but Roussel needs the United Kingdom licence to promote and market the drug elsewhere and to give it credibility. Women in this country are therefore to be used as guinea pigs to help market the drug. People reject research on animals—yet this drug involves research on women, and the Government are backing it and introducing it as fast as they can.

We must get the message across to women that, due to insufficient research, no one knows whether the use of the drug will cause cancers in the future. No one can predict the side effects that patients may experience. Opren was introduced and licensed and, in the majority of cases, it did what it was claimed that it would do—but in a minority of cases it reacted adversely, ruining the lives of several of my constituents. So an example already exists.

It cannot be predicted whether the woman will abort quickly or easily, or whether she will suffer much pain alone and unsupervised when the abortion takes place. She may—more often than not, she does—suffer considerable bleeding. On top of that, the drug may not work—if it is not administered early on, the maker's claim for a failure rate of only 5 per cent. does not apply. If the pregnancy runs to 63 days, as it will be allowed to in the United Kingdom, the failure rate rises steeply to 20 per cent., so 20 per cent. of cases could be presented for surgical abortions, thus increasing the cost.

I am possibly the only woman who has had children to speak in the debate, other than the hon. Member for Barking. At the beginning of pregnancy, most women have ambivalent feelings about the baby. A young, unmarried woman who finds herself pregnant and is horrified at the prospect may go to her local doctor or to one of the clinics advertised on the tube for what is commonly known as counselling, which is absolutely worthless because it is not independent. There will, however, be some discussion of the woman's dilemma, and she may then decide to have a medical termination.

The woman will go to a doctor to be given RU486, be told to go home, and to return in 48 hours. In that time, she may change her mind and decide not to return for the prostaglandin. What will happen then? It is perfectly true that the baby that she is carrying will most likely be severely damaged by the RU486 that she has already taken. In addition to the physical damage done to the women, she may suffer psychological damage. Post-abortion syndrome is well chronicled and recognised by the medical establishment, but there will be additional trauma for a woman who undergoes a medical termination and has to deal with the products of her conception and then return with that to her doctor.

If a woman has a surgical abortion, at least it is quick. She is admitted to hospital, is given an anaesthetic and does not see the baby, and the trauma is kept to a minimum. The same is not true of a medical termination, when she may be left alone and totally unsupervised for a considerable time. How on earth is she supposed to cope with that while working or carrying on her normal life? It seems quite intolerable.

I do not know why the information that my hon. Friend the Minister has laid down for general practitioners does not state that a scan is essential before the treatment is administered. No young woman keeps the date of her last period regularly, which is the only way to work out by how many weeks she is pregnant. Unless a scan is undertaken to ensure that the baby is not more than nine weeks and that there is no ectopic pregnancy—which can kill the woman—it is disgraceful to allow the drug to be administered.

The hon. Minister for Barking spoke of the rigorous checks made by the committee which licensed the drug and the way in which it was introduced in France, where restrictions were put on its use. Is she happy that in France people who smoke heavily, whatever that may mean, or have a heart condition will not be allowed to have that drug, but that in this country no such restrictions are placed on its use? It seems appalling that women in this country should be allowed to take the drug without meeting the conditions that apply elsewhere.

I genuinely believe that the drug is being introduced at far too great a pace. We need much more independent research. Despite the fact that, as was said by the hon. Member for Barking, I do not believe in social abortion, I am concerned about the long-term health of women, I believe that we shall rue the day that RU486 was introduced into this country.

1.8 am

Mr. Peter Thurnham (Bolton, North-East)

I congratulate my hon. Friend the Member for Lancashire, West (Mr. Hind) on being called at a comparatively reasonable hour, but I find it difficult to agree with him, with my right hon. Friend the Member for Castle Point (Sir B. Braine), or with my hon. Friend the Member for Congleton (Mrs. Winterton), all of whom expressed concern about women's health and said that RU486 should be withdrawn because it is not safe. I suspect, however, that they feel that drug will make abortion too easy, and that they want RU486 to be withdrawn because they oppose abortion.

I am surprised that lay persons should so question the work of the Medicines Control Agency, which is held in the highest regard and undertook proper testing. The drug has been available for some 10 years, so I do not accept that it has been on any fast track. My right hon. and hon. Friends want its more widespread use delayed because they oppose abortion—not because they are really interested in the woman's point of view.

I found myself in agreement with my hon. Friend the Member for Congleton when she spoke of the need for parental responsibility. No one wants abortions in the first place. Surveys in this country have shown that 1 million women are at risk of unplanned pregnancy, and that in the course of a year one third of them become pregnant. More than one half of unplanned pregnancies end in abortion, and the remainder in the birth of a child that was not planned. No doubt some of those children are unwanted.

Mrs. Winterton

My hon. Friend says that such children are unwanted, but that is not so. Many childless couples in this country would love to adopt them. Surely it is much better to do the honourable thing and to give birth to one's child, even if one cannot bring it up oneself.

Mr. Thurnham

My hon. Friend knows that few children are given up for adoption. I am sure that people do not want to see children born who are not wanted in the first place, and who might then become the victims of abuse.

There needs to be more and better family planning, and improved sex education in our schools—and that should begin at an even earlier age than now. We are all aware of the phenomenon of gymslip mothers. Only the other day, The Sun published a picture of a 14-year-old mother of two children. It seems as though sex education ought to be introduced in our primary schools, if we are to bring home to children what are the real choices in this world.

It seems to me that RU486 is a safe drug and that its use ought to be considered on that ground and not rejected. The drug's provision by the health service ought to be considered in the light of today's statement by my right hon. Friend the Prime Minister on a citizens charter. On the subject of the principles of public service and choice, it states on page 5 of the charter: The public sector should provide choice wherever practicable. The people affected by services should be consulted. Their views about the services they use should be sought regularly and systematically to inform decisions about what services should be provided. It follows that women ought to be given the choice of using a drug that I am satisfied is safe. I am sure that my hon. Friend the Minister will confirm that that is so, and that RU486 should be made available to women under the terms of the Abortion Act 1967—that is, when two doctors agree that it should be used.

1.13 am
Mr. David Amess (Basildon)

I congratulate my hon. Friend the Member for Lancashire, West (Mr. Hind) on initiating this debate, but I wish that it had been held before RU486 was licensed. I am delighted to see my hon. Friend the Member for Maidstone (Miss Widdecombe) in her place, and also my hon. Friend the Member for Hyndburn (Mr. Hargreaves), because I know that he, too, has strong feelings on this matter.

I was appalled by the speech of hon. Member for Barking (Ms. Richardson). I do not know why anyone who regards life so cheaply should serve as a Member of Parliament. She spoke about life in a way that I found deeply offensive.

I congratulate my right hon. Friend the Prime Minister on initiating the citizens charter today, and I hope that as it develops we shall learn what price is placed on the unborn citizen.

Like an increasing number of my colleagues, I am appalled at the manner in which the Medicines Control Agency is allowed to reach its decisions on drugs behind closed doors. I am well aware that much of the material must remain confidential because of pirating, but the United States Food and Drug Administration is required to publish the summary basis for approval, which any member of the public, not to mention parliamentarians, can scrutinise.

I call on the Government to withdraw the licence allowing the marketing of Mifeggne until it has undergone substantial independent clinical trials, rather than allowing the women of this country to be used as guinea pigs. I and other colleagues intend to campaign for a change in the law to make it mandatory for the Medicines Control Agency to publish the summary basis of approval each time it licences a drug, and for that summary to be available for public scrutiny.

1.16 am
Mr. D. N. Campbell-Savours (Workington)

With the leave of the House, I should like to contribute a few words to the debate.

The hon. Member for Basildon (Mr. Amess) was perhaps ill advised to attack my hon. Friend the Member for Barking (Ms. Richardson), as the argument about RU486 is far more complicated than he suggests. Four years ago—I remind the House that my maiden speech was on abortion and that I have always been in the life lobby in the House—I addressed a conference of about 2,000 people in Central hall, Westminster. I believe that the right hon. Member for Castle Point (Sir B. Braine) was there. I told him then, and all the others who were present, that I believed that the drug would divide the life lobby.

The drug raises a huge principle, and it was one that the right hon. Member for Castle Point and I had to examine in the debate in which we were involved. If we are devoted to ending the practice of late abortion but recognise that there are millions of women who, however much we object, will demand abortion, we must find a way around the dilemma that they as women face. The principle of a morning-after pill, while it may be unpalatable to many in our lobby, may to some extent appease our consciences. I know that that is not the purists' position, but we must deal in the world of reality.

I understand the concern about the placing on the market of a drug which seems to me to be untested, and I understand also that much evidence has been produced in the debate to suggest that that is the position. We should be careful, however, about how we deploy our arguments. There is an argument for delay, but in the longer term this drug—or one of this nature—may well resolve the great dilemma confronting the right hon. Member for Castle Point and me, and all in this place who are part of the great life movement of which he is a member.

1.18 am
The Parliamentary Under-Secretary of State for Health (Mr. Stephen Dorrell)

It is common ground among all those who have participated in the debate that my hon. Friend the Member for Lancashire, West (Mr. Hind) has raised a major issue by talking about the licensing of RU486. I regret that my presence in the place of my right hon. Friend the Secretary of State for Health has been interpreted by some as signifying a downgrading of the importance that the Government attach to the drug. I can assure my right hon. Friend the Member for Castle Point (Sir B. Braine) and the House in general that that would not be a correct interpretation of the view of the Government or of my right hon. Friend the Secretary of State. There is no argument about the importance of the issues that are raised by the licensing of the drug.

I shall begin my substantive reply by briefly sketching the background against which I approach the problem. I do not agree with the hon. Member for Workington (Mr. Campbell-Savours) that we are talking in any sense about a morning-after pill. We are discussing a method of abortion. As it should be seen clearly as an abortion method, its use must be governed by the provisions of abortion legislation, and principally the Abortion Act.

My right hon. Friend the Secretary of State has made it clear that he is licensing the drug only for use in conditions that are clearly set out in law—that is to say, that the prospect of an abortion must be agreed to by two doctors. It must be on defined grounds within the terms of the Act, it must be in licensed establishments—there is no question of it being available for use in unlicensed establishments by general practitioners—and it will be available for use only where a pregnancy has run for a maximum of nine weeks.

Mrs. Ann Winterton

How does my hon. Friend intend the length of pregnancy to be confirmed, unless a scan is carried out? Will he give an assurance that a scan will be carried out on every woman before the drug is administered?

Mr. Dorrell

My hon. Friend earlier asked me to answer that specific question, and I shall do so now. If a clinician is to use RU486, the conditions of the licence require him to be satisfied that the pregnancy has not run for more than nine weeks. In those circumstances, the clinician may be satisfied by the woman giving details of her normal menstrual cycle. However, if the woman does not know the details with sufficient accuracy, clearly the clinician would have to satisfy himself by some other means that the conditions of the licence were being fulfilled. The conditions are clear and unambiguous, and the drug is licensed for use only for abortions before the expiry of nine weeks of pregnancy.

In the Government's view, the drug is an alternative method of carrying out an abortion, and we leave the choice of the method principally in the hands of the clinician, although, as with all clinical choices, the clinician will use the discretion vested in him in consultation with the patient. I emphasise that we do not envisage the use of RU486 as a cost-saving exercise. Even if we did, it would be arguable whether it would be an effective cost-saving approach.

I wish to distance myself from one of the comments of the hon. Member for Barking (Ms. Richardson), although I was grateful for her support on some matters. There is certainly no commitment by the Government that any savings that did accrue from the use of RU486 would be made available to increase the availability of NHS abortions. That is a matter to be decided by individual district health authorities against the background of their own choices and decisions about health priorities in their districts.

In considering whether a clinician should use that method of abortion or any other, the primary concern must be the welfare of the patient. One of the considerations that was not given as much weight by some of my hon. Friends as I had anticipated is the relative risks for the woman of an abortion by taking a drug or an abortion requiring general anaesthesia. Neither routine is risk-free, but it is a legitimate exercise of clinical judgment to make the choice between those two methods of carrying out the legal act of procuring an abortion.

Dr. John G. Blackburn (Dudley, West)

My hon. Friend referred to the clinical welfare of the woman. As has been said, some 588 cases were reviewed. Is my hon. Friend aware that 37 of those women required surgical evacuation as a result of taking the drug?

Mr. Dorrell

I cannot confirm that statistic, but it is true that, if a woman changes her mind halfway through the course of treatment with RU486, or if its use is found to be ineffective, the guidance from the manufacturer is that there is an appreciable risk of a foetal deformity and that an alternative method of abortion should be considered. That is clearly stated as part of the supporting literature on the licensing of the drug.

Sir Bernard Braine

My hon. Friend has just made an important statement. Is he saying that weight is given to what the manufacturers say? Has my hon. Friend grasped the main point—which has been made by all Conservative Members who have spoken, save one—that independent research is needed before we are committed to a method that is largely, if not wholly, unproven?

Mr. Dorrell

If I may, I shall come later to my right hon. Friend's point about independent research. I was trying to establish common ground between Health Ministers as the licensing authorities and those who are worried about the use of the drug. If an abortion is not completed as a result of the drug being administered, there is acknowledged to be a risk of foetal deformity, which must lead the clinician and the woman to consider what further steps should be taken to complete what I emphasise is a legal abortion routine.

I know that my right hon. Friend the Member for Castle Point and many of my hon. Friends fundamentally disapprove of the procurement of the abortion in the first place, but if the law allows the woman and the clinician to contemplate that action, and the initial steps taken in using the drug were ineffective but rendered the foetus liable to deformity, it is clearly legitimate for them to consider alternative ways of bringing the contemplated abortion to a successful conclusion.

My hon. Friend the Member for Lancashire, West said that there had been insufficient research into the drug. In responding to that point, I shall answer the point made by my right hon. Friend the Member for Castle Point about independent assessment of the evidence used in the licensing process. Under the licensing system, it is for the applicant in the case of any drug to substantiate the application against the tests of safety, efficacy and quality that are laid down in statute. It is not for the taxpayer but for the drug company to pay for research into a new drug and to demonstrate to the Independent Licensing Authority—the Committee on Safety of Medicines and the Medicines Control Agency, giving advice to Ministers—that the proposed new drug passes those tests.

As my right hon. Friend the Member for Castle Point correctly pointed out, that was the system set up as a result of earlier failures of medicines licensing. That system, seeking to learn the lessons of those earlier failures, gave my right hon. Friend the Secretary of State unambiguous advice that this drug should be licensed for the purpose, and on the condition, set out in the licence.

I assure the House that there was no fast-tracking of the application; it was considered according to the normal processes laid down in statute and it passed the tests, set out by Parliament, of safety, efficacy and quality.

Sir Bernard Braine

Did the Government inquire into why the drug is banned in the United States and Germany, two highly civilised countries with established medical professions, from whose ranks have come some of the greatest medical scientists in the world?

Mr. Dorrell

No, the Government did not inquire into that, because, if we had done so, we would have been acting outside the Medicines Act. Parliament sets out the test that a new medicine must pass in order to secure a licence.

Sir Bernard Braine

Why not come to Parliament in the first place?

Mr. Dorrell

The Medicines Act sets out the tests of efficacy, quality and safety which the producers of a new drug must pass.

My right hon. Friend asked me whether the company had had notice of the issuing of the licence. I am advised that the company had no such notice. The seminars, which my right hon. Friend correctly said would have been prepared before the licence, were organised by the company at its own risk.

My right hon. Friend also asked me about the investigation of mermaid syndrome, and I will, if I may, write to him on that.

Mr. Hind

Was any research carried out by Roussel Uclaf and submitted to the Medicines Control Agency on post-abortion syndrome?

Mr. Dorrell

The information that is tendered by a company to the MCA is, as my hon. Friend knows—not least because my hon. Friend the Minister for Health has responded to him on the specific point during parliamentary questions—confidential within the MCA and the published information on the drug, as was also referred to during parliamentary questions, appeared in the British Journal of Obstetrics and Gynaecology and in the New England Journal of Medicine, both of them containing scientific papers on the background to the drug.

My hon. Friend the Member for Congleton (Mrs. Winterton) asked about the supervision of a woman, particularly if she changed her mind or if there were problems associated with the use of the drug. It is clearly true, and unavoidable, that, with a drug which involves the use of several stages some days apart, there is the risk that the woman will change her mind during the course of the treatment. I have already acknowledged that a half-completed use of the drug leads to a risk of foetal abnormality, and I have dealt with the consequences that flow from that.

The guidance that has been issued makes it clear that, if an abortion has not occurred in the expected time and if the patient leaves the treatment centre, she must be given a specific contact name and told where to go in the event of any problems. A follow-up visit must always take place within eight to 12 days after the administering of the drug to verify that the abortion has been completed and that vaginal bleeding has stopped or substantially reduced. Persistence of moderate vaginal bleeding at that point or later could signify an incomplete abortion, and appropriate investigation and treatment would therefore have to be considered.

But we must remember that it is always true that any treatment of this nature is voluntary. We have no power, nor should we have, to compel a woman to return. We should make it as easy as possible and stress to her the clinical need for her to ensure that such signs are followed up in her own interests.

Madam Deputy Speaker

Order.

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