Mifepristone (RU486) (Hansard, 25 July 1991)

§ The Parliamentary Under-Secretary of State, Department of Health (Baroness Hooper)
My Lords, Mifepristone (RU486) was granted a licence in accordance with the Medicines Act 1968 on 1st July. That followed advice from the Committee on the Safety of Medicines. The use of Mifepristone is subject to the Abortion Act 1967. It will be available only in National Health Service hospitals and places approved by my right honourable friend the Secretary of State under Section 1(3) of the Act.

§ The Duke of Norfolk
My Lords, I thank my noble friend for that reply, although I find it incomplete. This drug is not authorised in Germany or the United States. It is an experimental drug. Is the noble Baroness aware that when the licensing authority in England looked at the drug, it spent only nine months before giving authorisation for it to be used, whereas the average length of time which a licensing authority takes is 20 months? I do not believe that there has been sufficient experimentation with the drug. It should not be given a general release. Will the noble Baroness comment on that?

§ Baroness Hooper
My Lords, the drug has been put through the standard strict regulatory assessment and has been fully reviewed by the Committee on the Safety of Medicines, which is the department's independent expert group. The noble Duke quoted average figures which take into account the two-stage appeal process in the United Kingdom. However, some 30 per cent. of applications for licences are approved within six to nine months.

§ Baroness Seear
My Lords, will the noble Baroness confirm that the drug is being used only under very careful medical supervision in that two doctors must sign the prescription and, indeed, it can be obtained only on prescription and not over the counter?

§ Baroness Hooper
My Lords, indeed. It must be administered in conformity with the rules of the Abortion Act. Furthermore, patients should be fully informed as to the effects of the treatment. Therefore, the company's data sheet used by the doctor makes that quite clear, and there is also a very full patient information leaflet.

§ Baroness Elles
My Lords, is my noble friend aware that the company making the drug has issued a warning that any woman who has an ectopic pregnancy is liable to die on taking that medicine? Is she further aware that in any case where that treatment is being given for termination of a pregnancy, it is essential that the woman has a scan prior to the application of this medical treatment? 881 Therefore, is she willing to accept that the National Health Service must provide such a scan if that form of treatment is to be given?

§ Baroness Hooper
My Lords, in any case the use of the drug will be a decision by the doctor and the patient on the basis of full information and the strict regulation which has been referred to. Its use has been approved by the Medicines Control Agency as safe and efficacious for use in terminations up to nine weeks of pregnancy. I have not been advised that other factors are appropriate in the case of ectopic pregnancies, which I understand are the formation of an embryo in the fallopian tube. If there is any other information on that issue, I shall write to my noble friend.

§ The Earl of Perth
My Lords, is the Minister aware that in a letter to The Times on 17th July Sir Bernard Braine and others expressed grave fears about the consequences which may arise from the drug, including the risk of congenital abnormality? I understand that a tragedy has occurred in France and I have in mind the sad case of the thalidomide children. In the case of a tragedy would the maker of the drug, the doctor, the hospital or the state be responsible? Who would have to compensate?

§ Baroness Hooper
My Lords, as I said, Mifepristone has been rigorously tested. More than 100,000 women worldwide have already received the drug and there is extensive experience in France where it has been administered to 90,000 women. Also, there have been clinical trials in Great Britain involving approximately 1,500 women. The evidence from all those studies was carefully evaluated by the Committee on the Safety of Medicines when it gave advice that the drug could be safely licensed. I understand that it carries fewer risks than other forms of abortion.
Clearly in the event of negligence the normal procedures would apply. Any person who wished to seek compensation would do so through the courts against one of the three bodies to which the noble Earl referred.

§ Lord Ennals
My Lords, perhaps I may say how much I welcome the clarity with which the Minister has answered these questions. Does she agree that RU486 is now in its 10th year of clinical use and that there is no evidence of any long-term health risk let alone a death, as has been referred to? Secondly, is she aware that there is now a large-scale British multicentre trial of RU486 which, as she said, began in 1987 with a recruitment of volunteers from 13 different NHS hospitals and gynaecological units in England and France? Every possible safety precaution seems to be taken according to the law and the procedures laid down by this Parliament.

§ Baroness Hooper
My Lords, yes. I happily agree with the noble Lord on this occasion. I draw attention also to the well documented studies in the British Journal of Obstetrics and Gynaecology of June 1990 on the subject. The death reported in France in April was 882 fully considered before the licence was granted in the UK. The woman who died had received a different prostaglandin preparation from that used in the UK and in any event the woman was believed to have an underlying heart disease. We feel that that is a separate example.

§ The Earl of Lauderdale
My Lords, is my noble friend aware that more than two years ago the Food and Drugs Administration in the United States banned the importation of this drug as being dangerous to those who took it?

§ Baroness Hooper
My Lords, I understand that clinical trials are taking place in the United States.

§ Lord Walton of Detchant
My Lords, in the light of the information that the Minister has so clearly given us, does she agree that the medical trials that are being extensively carried out involving over 100,000 women worldwide, including 90,000 in France, since the drug was first introduced in Switzerland in 1982, have demonstrated its complete safety? Does she further agree that there is no evidence to suggest that the drug has ever been responsible for foetal malformation? Does she also agree that the use of this drug to induce abortion in early pregnancy is associated with far less risk and much less distress and discomfort to the woman concerned than surgical methods of abortion?

§ Baroness Hooper
My Lords, yes. Whatever view we may take on the issue of abortion, I am sure that we all agree that any abortion which has to be performed should be carried out as early in the pregnancy as possible. Therefore any new safe and effective method of early termination which avoids the use of surgery and a general anaesthetic merits serious consideration. It is only right that doctors and patients should have the maximum choice of available methods and that there should be strict safeguards and controls.

§ Lord Ashbourne
My Lords, observing that RU486 is designed to kill a baby whose heart has started to beat and that in spite of what has been said no long term study has been carried out on the effects of the drug, are the Government aware that hundreds of thousands of voters have been deeply offended by the Government's failure to oppose the introduction of the drug which they regard as one of the more extreme and distasteful forms of child abuse?

§ Baroness Hooper
My Lords, as I said, all the normal strict rules for the licensing of a drug have been followed in this case. Indeed, over the past 10 years RU486 has been extensively studied in over 20 countries including France, the UK, Holland, Sweden, Switzerland, the USA, China, the USSR and India. Therefore there is considerable experience of the drug.

§ Lord Stallard
My Lords, before the noble Baroness receives further congratulations perhaps I may go in the opposite direction. Hundreds of thousands of women throughout the country will be appalled by the Minister's replies this morning on behalf of the Government to the Question tabled by 883 the noble Duke. Is the noble Baroness aware that people still remember the tragic events that followed the use of other insufficiently tried drugs? They are asking why the women of Britain should again be used as guinea pigs in premature experiments. The question will be asked as to who will be responsible for the tragic events that arise from the premature use of the drug.

§ Baroness Hooper
My Lords, the question of responsibility as a result of any negligence that is proved must be a decision for the courts. It would be open to anyone applying for damages to apply against either the company involved in the production or the medical advisers concerned if that is the area in which the negligence is presumed.

§ Lord Jenkins of Hillhead
My Lords, may I, on the contrary, congratulate the Minister on the clarity and firmness of her replies? As the exchange continues does it not appear to be increasingly the case that objection to the drug is not that it is dangerous but that it is efficient?

§ Baroness Hooper
My Lords, yes.

§ Lord Rea
My Lords, I congratulate the noble Duke and his friends on their persistence in pursuing the interests of the leader of their Church but not their congregation. Does the noble Baroness agree that, where a woman requires a legal abortion and has sought it, on health grounds it is far better that that should take place as early as possible in the pregnancy? Does not the existence of the drug Mifepristone, now fully endorsed by the Medicines Control Agency and the Committee on the Safety of Medicines, make it easier for that woman to obtain an early abortion?

§ Baroness Hooper
My Lords, again my answer must be yes.