HC Deb 12 June 1996 vol 279 cc250-72 10.59 am
Dr. Jeremy Bray (Motherwell, South)

The House has given a good deal of attention to the warning given by the Committee on Safety of Medicines on third generation oral contraceptives last October. The committee was right to hold the views and take the actions that it did, given the evidence available at that time. Certainly, there was, and is, a need to review the announcement procedure. Owing to the immediate public reaction, there was a deplorable jump in the number of unwanted pregnancies and abortions. Sadly, some women ignored the committee's advice that no one need stop taking oral contraceptives and that women taking the third generation pill should see their doctors.

This morning, I wish to talk about the lessons to be learnt about the general arrangements for monitoring the safety of drugs. The second generation pill, which was introduced from 1970, greatly reduced the risk of a blood clot forming in the veins of the legs and moving to the lungs—a pulmonary embolism—with sometimes fatal consequences. Second generation pills are still in use today and the Committee on Safety of Medicines' letter of 18 October reported even lower risks in their use than had previously been observed.

During the 1970s, there began to be concern about other circulatory side effects. Large cohort studies by the Royal College of General Practitioners and the Oxford Family Planning Association found a slightly increased mortality from heart attacks and strokes, and found factors in those cases that increased the risk of the pill. With appropriate prescribing and lower dosage, the incidence of circulatory side effects and mortality were reduced to very low levels.

There is a large—and what was a profitable—market for the pill in the United Kingdom, but the patents and trade agreements in the second generation pills held by Schering and Wyeth and by Janssen-Cilag and Syntex began to run out in the 1980s and 1990s. The search was on for new patentable products aimed at further reducing risks and side effects. The risks had become too low to be picked up by the public cohort studies and public funds were not available for a wider form of monitoring of a research standard.

Researchers began to pay more attention to surrogate or proxy bio-chemical markers to represent the side effects of the pill. At the same time, there was a great deal of research on fats and cholesterol, and their effects on the circulatory system. The relationship of those effects to the use of oral contraceptive pills is somewhat distant: it depends on a connection between the effect of the pill on cholesterol and the effect of cholesterol on arterial disease. Most of the studies of cholesterol changes have been on middle-aged and elderly men, not many of whom are on the pill.

Before they experience the menopause, women have a particularly low rate of coronary heart disease. Pharmaceutical companies came up with third generation pills with new progestogens that are claimed to protect women against coronary heart disease and strokes. The three firms that hold the third generation patents are Organon, Wyeth-with-Schering and Janssen-Cilag. The latter two had held second generation patents that were running out. Third generation pills were vigorously marketed and about 1.5 million women in the United Kingdom—out of a total of 3 million pill users in the country—were using them last October. Half the pill users were taking third generation pills.

It was against that background that the Committee on Safety of Medicines had to issue its warning on 18 October last year that three independent new studies showed that the third generation pills, on a pooled estimate, doubled the risk of the old problem of blood clotting in the legs, leading to pulmonary embolism. It is a good idea to keep a sense of proportion and to bear the numbers in mind. The background risk of pulmonary embolism was five cases per 100,000 women per year not taking the pill, 15 cases per 100,000 women per year taking second generation pills and 30 cases per 100,000 women per year taking third generation pills. The 50 per cent. of young, pill-taking women, probably raising their families, using third generation pills, were therefore suffering 75 to 150 more thromboembolisms, and each year one to two more of them were dying.

It was not a major disaster by serious epidemic or public health disaster standards, but even those numbers should not be on the conscience of any firm or group of workers. Following the warning in October, sales of third generation pills have dropped drastically. One of the firms affected, Organon, has a factory in Newhouse next to my constituency, so I am acutely aware of the industrial effects. At the time of the announcement, the lay media did an excellent job of accurately reporting the relevant brands and passing on the committee's message that no one need stop taking oral contraceptives, but the scientific press made an ass of itself.

On 18 October, Schering, one of the three patent holders, flew over from Montreal Professor Spitzer, the author of one of the studies. He gave a press conference at Heathrow criticising the Committee on Safety of Medicines, based partly on his own work—possibly without knowing the other two study results.

Organon, another of the patent holders, paid for a conference in London for 400 family planning doctors in order to argue its case. Both the British Medical Journal and Nature managed to get their reporting of the facts wrong. For comic relief, the hon. Member for Southwark and Bermondsey (Mr. Hughes)—who I see is in his place and who is the Liberal Democrats' spokesperson on health—persisted in suggesting that the committee's announcement was a Government conspiracy to divert attention from the Home Secretary's troubles with Derek Lewis. I do not think that the Secretary of State for Health is that stupid, but the hon. Gentleman should not attack the independence and integrity of scientists doing their public duty.

The Committee on Safety of Medicines' announcement was not rushed: data for the two case control studies were collected between 1989 and 1993. The general nature of the results was known to those involved in the industry and in the regulatory agencies in advance of the announcement by the Committee on Safety of Medicines. Owing to the nature of its work, the committee has to base its findings on mostly unpublished work, and when the three studies were published, it was generally agreed on reflection that the committee was right to act as it did.

In one way, the episode has demonstrated the effectiveness of modern pharmaceutical research and monitoring. Yet, and yet, and yet—was it necessary for that decade of commercial research to be wasted on the blind alley of the third generation pills? More fundamental medical research might have come up with real advances in contraception, but instead contraceptive research was run down by the Medical Research Council. Had the United Kingdom publicly funded cohort studies been extended and had new research methods been adopted, could not the epidemiology of pulmonary thromboses, cholesterol levels, heart attacks and strokes have been properly measured in women at a much earlier stage and at much reduced cost?

What about the use of the United Kingdom general practice research database? American drug companies often say that the United Kingdom is a good place to do pharmaceutical research, because the national health service provides such a coherent and well-ordered source of data. The general practice research database is a good case in point. It is a computerised record by general practitioners of all the medical events affecting some 3 million or 4 million people and accumulating in the past five or six years. It is a record that could not have been built up in the United States without a general practitioner system. It is a development of the VAMP—value added medical products—system which this privatising Tory Government nationalised absentmindedly when Reuters decided that it could not afford to develop it. It is now run by the Office of Population Censuses and Surveys which has now been merged into the new Office of National Statistics. The software is archaic and the only person who seems to be able to wring real results out of the database is Hershel Jick, an American in Boston who is 70 years old and operates on his own with half a dozen assistants. It was to him that the Committee on Safety of Medicines had to go for a database study on third generation pills.

Open access to the general practitioner research database costs £250,000 a year, which puts it out of the reach of academic researchers. It is a neglected gem of a resource. There are two United Kingdom efforts at exploitation of the database. One is by Dr. Alan Dean, the remarkable medical practitioner who pioneered the database. The other, which is apparently inadequately resourced, is by the Office of Population Censuses and Surveys. Contrast that with the sophistication of the human genome databases. Three independent versions are emerging, two of them with free access and two of them privately financed.

Let us suppose that the Committee on Safety of Medicines wanted a pharmaceutical company to carry out a study on a licensed drug, as it could have done using the general practitioner research database. The Committee on Safety of Medicines has no powers to require a pharmaceutical company to do that. In the trials before licensing, the CSM has the obvious sanction of refusing the licence until the study is done, but afterwards it has no sanction. It could withdraw the licence, but often that is not desirable because there may be cases in which the drugs are useful, as with third generation pills for older women who persist in smoking while taking the pill. The CSM can ask for new studies on a licensed product, but only if it has new evidence rather than a new judgment on existing evidence.

The Medicines Control Agency, the CSM, the Royal College of General Practitioners, the British Medical Association and the Association of the British Pharmaceutical Industry have issued agreed guidelines for company-sponsored safety assessment of marketed medicines. That is an admirable example of the way in which progress is made by agreement in the United Kingdom, but the so-called SAMM guidelines do not cover database methods, nor does the CSM have powers to require such studies. Drug companies can be recalcitrant and tough, as the third generation pill affair showed. Could not the CSM have powers to require companies to carry out specified studies on licensed drugs or pay for others to do so?

In discussing these issues, members and staff from all the organisations concerned, pharmaceutical companies included, have been very helpful, especially John McEwan, a consultant at King's College hospital who alerted me to the broader issues; Michael Rawlins, the chairman of the CSM; Susan Wood, a director of the Medicines Control Agency; and Frances Charlesworth, a director of the Association of the British Pharmaceutical Industry. The views that I have expressed and any mistakes that I have made are, of course, entirely my own.

I think that the practice in the United Kingdom of seeking informal agreement is more healthy and productive than the lawyer and litigation-ridden world in the United States and the regulated, directive-laden world of the European Union, but we have to live with those worlds and they have great strengths, including the enterprise of the American and the thoroughness of the European. We go too far in our passion for informality and agreement if we let things slip.

Safety is not the only aspect of medicines that has to be considered. Important issues arise in patenting, research and pricing. Safety must not be compromised by those or any other considerations, yet there are interactions. An enhanced pharmaco-vigilance system would increase the price of medicines. Firms will not do research that does not offer the prospect of a commercial return, yet the prospect of a valuable patent can unlock resources for research quite beyond the reach of the basic research funding bodies, whether charitable or public. The CSM and the Medicines Control Agency must not be diverted by interesting research questions, by difficult patent issues, by tough commercial pressure or by political pressures. They must have the uncompromising support of Parliament in discharging their responsibilities for safety, but Parliament must likewise provide other ways in which the interactions can be explored and reviewed.

Medicines have a long history. The existence of the overarching Medicines Commission was a factor that led the Select Committee on Science and Technology recently to recommend the setting up of a human genetics commission to keep an overview on that rapidly developing field. The Government seem about to accept the principle of that recommendation. A similar breadth of view needs to be, and could be, taken for medicines generally by the existing Medicines Commission without in any way compromising the independence and integrity of the CSM and the Medicines Control Agency.

The integration of national pharmaco-vigilance in a European framework, which is an important current development, will of course continue, and that offers great advantages if it operates well. We should certainly play our full part in its development. But it will increase the complexity of the interactions with the other considerations—for example, patenting and research—that have to be watched. I hope that the Minister will be able to show the House that the Government have learnt the broader lessons from the third generation pill story.

11.18 am
Mr. Simon Hughes (Southwark and Bermondsey)

I am grateful to the hon. Member for Motherwell, South (Dr. Bray) for introducing the debate, but I take a fundamentally different view of the lessons to be learnt and I shall set out why. For the record, I must say that, last October—the time that is most relevant to the debate—I was not doing my current job on health for my party, and I was therefore not directly involved at the time.

I was appointed to my current job later in the autumn and, by doing by my own research and investigation, I have come to the conclusion that several severe questions have yet to be answered by Ministers and that they have not yet come clean. Something appears to be rotten in the state of the advisory system on the safety of drugs. I am not a conspiracy theorist, but I remain to be persuaded that politics and medical advice were not intermixed in this instance, with the serious result that the health of a considerable number of women was adversely affected—in one case, potentially, fatally.

About 1.5 million women were using third generation oral contraceptives during the second half of last year and, as the hon. Member for Motherwell, South said, a preponderance of them were young. They were much more likely to be prescribed what are called third generation oral contraceptives, the clearest definition of which, as I understand it, is those that contain one of two chemicals—desogestrel or gestodene. They are the type of products affected.

I want, first, to put on record what I understand to be the sequence of events surrounding the Government's announcement on birth control pills, and a letter sent to general practitioners, last October, which had the same sort of effect as their subsequent announcement on bovine spongiform encephalopathy—namely, that they caused people to change their habits. It is clear that, as a result of the announcement in October, a considerable number of women stopped taking a particular pill, or any pill. The result was that many women had either abortions or unwanted pregnancies.

No later than July last year, interim results of a World Health Organisation study into second and third generation oral contraceptives were issued. The results were sent to the Medicines Control Agency, the body with responsibility for regulation in Britain. On 19 September, the MCA requested a meeting with Professor Spitzer, one of the three academics referred to by the hon. Member for Motherwell, South. Spitzer is the author of the transnational report. The meeting took place on 9 and 10 October, and those who attended were given tables from the expedited analysis of the study. On 10 October, Professor Spitzer met the MCA and the Committee on Safety of Medicines sub-group, which specifically comprises the people who make the decisions and recommendations.

The very next day—11 October—the MCA called a special meeting of the Committee on Safety of Medicines for 13 October. On the same day, it referred the matter to the European Committee for Proprietary Medicinal Products, the CPMP. Papers were sent on 11 October to CSM members who, on the same day, received the final manuscript from one of the other academics referred to by the hon. Member for Motherwell, North, Professor Jick.

CSM members received the papers—about 150 pages each—on 12 October. On the same day, the MCA met the producer companies, Organon, Schering and Wyeth. On 13 October, with only two days' notice, the CSM met. I hope that the Minister will tell us what it decided and specifically what it recommended, because it would be very helpful if its decision and recommendations were put in the public domain.

On 16 October, the hon. Member for Bolton, West (Mr. Sackville), who was then an Under-Secretary of State for Health, approved the sending of what has come to be known as the "Dear Doctor" letter, to be issued on 18 October. On 17 October, the European Committee met to consider the safety of oral contraceptives and that meeting went on until 18 October. On the afternoon of 18 October, the "Dear Doctor" letter was sent to about 27,000 GPs across the country. I shall deal later with whether it actually reached all those whom it was intended to reach.

On 19 October, there was a press conference to announce what was going on and that the letter had been issued. A press release was also issued. The press release is material because it gave doctors advice on what to say to patients but it also specifically made it clear that some women should be advised to change their contraceptive. In the press release, the chairman of the CSM stated: I have written to all doctors and pharmacists to provide them with detailed advice … We realise that our advice will place a burden on doctors and pharmacists … Doctors should discuss the CSM's advice with patients taking the pills listed in order to determine whether a change in brand is necessary. In general, women taking a pill containing gestodene or desogestrel should be advised to change to another brand, unless they are intolerant of other oral contraceptives. The salient part of the press release is that advice should be given to change from an otherwise commonly used third generation oral contraceptive.

The very same afternoon—the public and the House can draw their own conclusions about this—and a matter of four hours after the press conference, there was a debate in the House on the Learmont report, during which the Home Secretary, more than ever before or since in his career at the Home Office, had his back to the wall. The Government were in considerable difficulty. On Friday—the following day—the Department of Health issued a press release refuting the claim that its analysis of the three independent studies was not the final one.

Mr. John Marshall (Hendon, South)

The hon. Gentleman is obviously trying to create the conspiracy view of history, but on that particular day the Home Secretary gave the shadow Home Secretary such a beating and won such a parliamentary victory that the Government would have wanted it to make the headlines.

Mr. Hughes

I accept that, but nobody was to know in advance that the Home Secretary would come out on top, not least the Home Secretary.

Mr. Marshall

The Home Secretary wins against the shadow Home Secretary in every debate. The shadow Home Secretary is an embarrassment even to members of his own Front Bench.

Mr. Hughes

I am not going to respond to that. I have my own views on those particular battles, but this is a debate on another matter which appears to have become intertwined with the Government's agenda of defending themselves against a serious report on the conduct of the Prison Service.

On Monday 23 October, the Secretary of State for Health made a statement to the House. In that statement, he did not reveal, although he knew it, that the "Dear Doctor" letter was going to be supplemented by a further letter intended to limit the damage caused by the first. The second letter was being prepared, and was sent on 26 October. It clarified and, in a sense, sought to allay the alarm caused by the first letter that had been sent only a few days earlier. Both letters came, in effect, from the Committee on Safety of Medicines.

To complete the series of events, in November, the hon. Member for Bolton, West was moved to the Home Office but, most materially, in April this year, the CPMP recommended that no action needed to be taken. On 1 May, however, the CSM sent a letter, which also is not yet in the public domain, to the manufacturers stating that it, the CSM, had advised the licensing authorities that regulatory action should now be taken. I understand that manufacturers are now considering appealing against that.

Dr. Bray

At this point in the hon. Gentleman's account of events, might it be relevant for him to say that, although the European committee did not recommend action, the German committee took action in amending the licence and, furthermore, since then I understand from a pharmaceutical company that the CSM has written to it proposing a change in the licence?

Mr. Hughes

I accept the hon. Gentleman's first point, although I am not in a position formally to agree it. On his second point, I said that my understanding was that the CSM had written on 1 May, and that and it is against its position that there will be some regulation that the producers are now considering appealing.

I contend—it is a belief that is also widely held in relevant professions—that there was great haste in rushing the issue through the CSM, in literally two days, and then on into the public domain, that that great haste was unjustified and that it cannot be adequately explained either by the scientific evidence or by the supposedly increased risk faced by women.

That view is supported by eminent people. For example, the Government's chief medical officer in Scotland, writing in the January 1996 edition of his official publication, "Health Bulletin", said: Last October's decision to publicise the CSM's warning to all doctors … was taken too hurriedly. He refers to it as "an error of judgment". He goes on to say: The Health Departments owe general practitioners an apology for what he then called the fiasco over oral contraceptives. That is the view of the Government's chief medical officer in Scotland, and I should be grateful to know whether the Minister agrees with it, and if not, why not.

Secondly, the chairman of the family planning faculty of the Royal College of Obstetricians and Gynaecologists, David Bromham, who I understand was present at the CSM meeting on 13 October as an outside adviser, has said: one is forced to wonder whether the haste in disseminating the CSM letter was justified. I shall come back to him in a minute.

Why was there such urgency to get the CSM advice on supposedly new information relating to third generation oral contraceptives on 11 October? Again, to pick up a point made by the hon. Member for Motherwell, South, the issue was not considered by the sub-committee on pharmaco-vigilance, on the ground of the urgency of the matter, on any date before 13 October, even though it is the normal practice for safety issues to go to that committee for prior consideration.

The Minister, in an answer to me on 19 December, said that it is normal practice for urgent safety issues to be considered without prior consideration when there are time constraints, but here there were no necessary time constraints. The evidence had been around at least for weeks, if not for months. I say that for this reason. The regulatory bodies had information and did nothing about it from May last year until October. It is clear that the sub-committee met on 5 September and 3 October. We know that oral contraceptives were placed high on the agenda of the European working party in August last year. Therefore, it was already known that there was a problem.

The question is, why was the matter not on the agenda of either of the two meetings of the relevant sub-committee of the CSM in the UK, which had the principal responsibility for considering these issues, when it could have considered the matter on either of those dates last summer. A full committee meeting was called, at two days' notice, in October, the sub-committee was by-passed, and members were given 24 hours to read all the papers.

Next, I have a set of questions about the regulatory action. Why, if there was such an urgent need for people to know about the increased dangers, was no regulatory action taken from last October until 1 May this year? If the pills were dangerous, why was it perfectly permissible for them to go on being prescribed? The MCA specifically asked the CSM to consider at its meeting the regulatory implications and whether there should be withdrawal or warnings. Nothing happened for more than six months.

To make it clear, the word "warning" is, I am advised, a synonym of the technical term "variation"—a variation that applies to the regulations which govern the use of pills such as these.

The CSM was specifically asked about regulatory action in October. What we have not heard, and what the Minister has so far refused to reveal in any parliamentary answers, is whether the CSM recommended any regulatory action. I ask the Minister to make sure that he tells the House that in his answer today.

With regard to the regulatory issues, as far as I can judge, and as far as I have been able to research and am advised, it is unprecedented to make an announcement, as the Government did and always planned to do, and then not to take regulatory action within a short period thereafter.

There was always going to be a public statement. It would have created as much of a scare as did the one issued at midday by the Department of Health. We know that because the Secretary of State said, in his statement to the House on 23 October, that the MCA planned a public announcement on Thursday afternoon. The Minister has twice refused to answer parliamentary questions from me asking him on which other occasions, if any, such a warning letter has been issued without follow-up action.

For fear that the Minister might interpret that as an unqualified criticism, I should say that I am grateful to him and to his officials, although they may not love me for it, for the many answers to my many questions that I have received. I do not want anyone to assume that a large amount of information has not been revealed. However, some of the key questions have not been answered and I do not want the Minister to believe that he is yet off the hook, because I do not think that he should be. I hope that he will answer today the questions that I pose today. If he does not, I give him warning that they will certainly be pursued. Has there been any warning letter in the past to doctors without regulatory action linked to it?

The only reason that I have been given for our not having the answer so far is that it would be disproportionately costly. That is a normal let-out of the Government, but compared with the consequences of this action, it could be argued that the costs would be worth paying. Perhaps the answer would be unhelpful to the Government.

Can the Minister be clear in his answer whether the pharmaceutical companies have a right of appeal? Were the regulatory authorities right to behave as they did? My advice is that, although they were given early advice that they were acting within their power to take the action, or inaction, that they took, they were subsequently told that they were not. We need to be told.

The fact that such issues have not been addressed and that answers have not been given is ground for suspicion about what the Government were playing at through those crucial days in mid-October last year. What was the outcome? Nothing happened in October, but on 1 May this year, more than six months later, the committee sent a letter to companies stating that it had advised the licensing authority that regulatory action should now be taken.

The only thing that had happened, apart from, if the hon. Member for Motherwell, South is right, the change in the German regulatory body's view, was that the European body, meeting on 16 and 18 April, decided that there was no decisive evidence of any increased risk from oral contraceptives, and had declined to recommend any regulatory action. Indeed, the chairman of the European body, Professor Alexandre, said last month that it would be "absurd" to take any regulatory action against any of the pills, given the uncertainty of the data.

If the Government did not take any action until May—they have now, apparently, taken action—because they were waiting for pan-European advice or action, why have they now proceeded to propose regulations through their agency, the CSM, against the recommendation of the European body?

In any event, the Minister for Health at the time said: it is a matter for individual states to deal with"—[Official Report, 7 November 1995; Vol. 265, c. 681.] In his statement, the Secretary of State for Health said: The responsibility for reaching clinical judgments about which contraceptives satisfy the standards required by law rests on me, subject to the advice from the Committee on Safety of Medicines."—[Official Report, 23 October 1995; Vol. 264, c. 704.] I assume, therefore, that that means that the Secretary of State takes responsibility for the regulatory action that the regulatory authorities have the power to take. The conclusion to be drawn must be either that the oral contraceptives concerned did not satisfy the standards required by law, in which case regulatory action should have been taken, normally on the same day, or they satisfied the standards, which we must assume was the case given that nothing happened for six months. If that was the case, why on earth did we have such an alarmist announcement in October?

Dr. Bray

Does the hon. Gentleman consider that he is advancing the cause of safety of medicines if he asks for watertight, cast-iron judgments on whether a product is safe? To insist on a reply to such a question would force Ministers and the system into a quite impossible position. The Minister must ensure that agencies spell out the facts and that a judgment is given, but we must recognise that it is a judgment. Now that all the material has been published, is the hon. Gentleman saying that the general view of the medical profession is that they should prescribe third generation drugs in preference to second generation drugs in the ordinary case?

Mr. Hughes

The hon. Gentleman asks a perfectly proper and profound central question. I share his view. On this issue, I have been supportive of the Government, such as when the Secretary of State for Health made a statement about bovine spongiform encephalopathy. It is not my case that the Government should always reach conclusions on the basis of scientific evidence, and I hope that the hon. Gentleman accepts that. My case is that the letter and the press release that went out in this instance made it clear that the advice that should be given to general practitioners, and which it was suggested they should give to their patients, was that women on the third generation pill should change their prescription. That was the balance of view that was taken. I do not argue that the Government should substitute their view for that professional one.

The hon. Member for Motherwell, South is a scientist, and I am not, but I have done enough science to understand the issue. My case is that we should give people the evidence and the facts and that, from it, different conclusions can be drawn. I hope that the hon. Gentleman will accept that it is not the burden of my case that the Government should always have a definitive view, and I would not wish to push this or any other Government into that position. It is important that we do not spoon feed, or pretend to spoon feed, the public when evidence is often contradictory and difficult to draw conclusions from.

I shall move on to my final remarks, as I know that the hon. Member for Fife, Central (Mr. McLeish) wishes to speak from the Labour Front Bench, and I am keen to give the Minister plenty of time to answer the questions that remain to be answered. I have given the Minister notice of three specific questions.

First, the Secretary of State stated on 23 October 1995 that the concerns relating to oral contraceptives arising from the World Health Organisation study were brought to the attention of the Medicines Control Agency in July. Will the Minister confirm that that is not correct and that the MCA had the information in May, not July, as the evidence shows that it had a further two months' notice, which the Government have so far not admitted?

Secondly, in his statement, the Secretary of State indicated that adequate information had been made available to doctors to allow them to make informed decisions. That point was made by the hon. Member for Motherwell, South. When the Secretary of State made that assertion, the MCA was working with the Family Planning Association to sponsor a letter to correct some of the deficiencies of the 18 October "Dear Doctor" letter. The chief medical officer in Scotland made it clear that the "Dear Doctor" letter did not get through to all doctors, and he has severe concerns about the fax system, however good it might be in theory. The MCA spent in excess of £90,000 to sponsor the second letter, which was, in effect, a correction of the first. One of the Minister's written answers describes the second letter as having been issued because of a clear need to provide health professionals with additional advice and guidance on the practical management issues arising from the advice issued by the CSM. I hope that the Minister will issue a correction to the statement of 23 October, and confirm that the Government accepted that the information issued on 18 October was inadequate and flawed and that they knew that by the time the Secretary of State came to the House on 23 October.

Thirdly, in a written answer on 19 December 1995, the Minister stated that the final report of the WHO study had been received by the MCA on 6 October. A further question, on 30 April, elicited the information that the final WHO report was dated 13 October. Any document received on 6 October cannot therefore have been the final report, which must mean that the answer given to the House on 19 December was inaccurate.

We are told, in "Questions of Procedure for Ministers": Ministers must not knowingly mislead Parliament and the public and should correct any inadvertent errors at the earliest opportunity. I hope that the Minister will correct today what I am still perfectly happy at the moment to accept were inadvertent errors.

Finally—this is a scientific point—why was an announcement made when there was no new evidence of increased risk? I have taken the advice that is available to all of us, and it has always been known that there is a small risk of blood clots—thromboembolism—from all oral contraceptives. It has generally been supposed that the risk was to about 30 cases per 100,000 women each year. All that the new evidence revealed was that the risk continues with third generation oral contraceptives, while for those containing second generation drugs it is lower than was previously supposed. The news was, therefore, good news. It was that there is no greater risk and, therefore, there was no need for any alarming announcement.

Dr. Bray

There were new data—I am sure that the hon. Gentleman accepts that—on second and third generation drugs. The new data showed that the risks from second generation drugs were lower than was thought and that the risks from third generation drugs were twice those of the second generation ones. The absolute level of risk depends on the denominator. A notorious problem in testing is that it is very difficult to know with what a comparison is being made, but in this case it is quite clear: it was between second generation and third generation drugs. I think that there is no dispute about the evidence.

Mr. Hughes

I am happy to tell the House that, on those facts, there is no dispute between the hon. Gentleman and me, but I draw the same conclusion as I drew before: what went out was a warning. I think that he will accept that it was stated in the letter that GPs should advise women on third generation pills to change their prescription—but there was no evidence of greater risk. It was greater than with second generation drugs, but there was no evidence of greater risk than was known before. I shall conclude with what the professionals say about that.

The family planning faculty of the Royal College of Obstetricians and Gynaecologists advised GPs this January that it is safe for them to continue to prescribe third generation oral contraceptives. The chairman, who was present at the meeting of 13 October, said: The surprise is that the older Pills carry a lower risk than previously supposed. As this emerges as the true situation, one is forced to wonder whether the haste in disseminating the CSM letter was justified. On 23 October, the Secretary of State said: the evidence is that … women do not find it"— the advice— confusing."—[Official Report, 23 October 1995; Vol. 264, c. 706.] I do not think that that is true. A survey of 1,300 third generation pill users carried out in November by Exeter university found that half had had their confidence shaken and that teenagers were particularly confused about the level of increased risk.

A separate survey by a family doctor in Oxfordshire found that 12 per cent. of users at her practice had stopped taking the pill on the day of the warning. A family planning expert, Dr. Horrocks, at Frenchay hospital in Bristol, said that at least 56 women were known to have had a termination in the past three months because fear had prompted them to stop taking the pill. She said: This is probably an underestimate. In February, we could barely cope with the numbers coming in. Instead of having 70 waiting at one time, there were 170. The waiting list was much longer. Sometimes it was difficult getting women seen before 12 weeks. There was widespread confusion and there was panic. Some doctors advised women to stop taking the pill immediately, even if they were in mid cycle. Others advised an immediate change to second generation pills and it has been professionally argued—I say this carefully because I do not want to be alarmist—that there has been one death of a woman who suffered a massive blood clot as a direct result of being switched from a third-generation pill to another.

There was a public health "fiasco", to use the word of the chief medical officer in Scotland. There are no clear answers to some of the crucial questions, the most important of which is what the advice of the CSM was in October. It is, therefore, difficult to escape the conclusion that there is something as yet not revealed by the Government, and possibly something that they still wish to hide about why there was a rushed announcement in October.

Why did we get such a slow set of events between May and October last year and then another slow set of reactions between October and May this year? Why did we have a public health warning and no regulatory action, despite the fact that advisers were asked specifically to consider it? Why have we had a further six-month delay before any regulatory action has been taken? Why was regulatory action taken two weeks after the European advice that we did not need to take regulatory action? If this is not a serious set of questions about the control of medicines, I do not know what is.

11.51 am
Mr. Henry McLeish (Fife, Central)

I congratulate my hon. Friend the Member for Motherwell, South (Dr. Bray) on bringing this debate to the Floor of the House. It is an important debate in many respects, the first being the recent health scares—the most notable being the BSE scare. We need to have a debate on the safety of medicines and on the way in which the Government handle the issue.

Secondly, very sophisticated electronic news-gathering now exists, and increasingly the Government do not appear to be aware of that. Scares can develop very quickly. Thirdly, with the advances in research in science and technology we are in a much better position to identify adverse reactions to drugs, which is much to be welcomed. Fourthly—this is really the background to the debate—we need to have a wider public who are more informed and educated on health matters. It is ludicrous that in 1996 a scare can develop so quickly. One of the reasons for that is the Government's lack of trust in the public and the lack of information that the public have on which to make informed choices about their health and the health of members of their families.

Above all, there is the question of public confidence in the scientific community, and in the ability of Government to disseminate information, which is a matter that we have to take extremely seriously. It is obviously an issue of public interest, but it is also an issue for manufacturers, who use sophisticated processes to produce excellent products and have a great interest in how we deal with the safety of drugs.

As my hon. Friend the Member for Motherwell, South suggested, we owe it to our scientific community to take them seriously. Scientists do an excellent job of advising Government, but they are often dragged into a debate and treated very unsympathetically. The issue is also vital for the medical profession, especially general practitioners, who are often at the sharp end of receiving information from Government and from the Committee on Safety of Medicines. They are also at the sharp end of public reaction, as we have seen with the scare about the oral contraceptive pill. The issue is of enormous interest for all concerned.

There are, however, no easy solutions. The hon. Member for Southwark and Bermondsey (Mr. Hughes) rightly made the point that there is no quick fix for some of the serious concerns. Nevertheless, it is incumbent on parliamentarians and on all the organisations that I have mentioned to try always to improve communications techniques so that the public have information on which to make sound choices.

I will concentrate on two areas. The first is informing the public and the professionals when there is a safety alert involving drugs and medicine. Secondly, I will refer briefly to pharmaco-vigilance and the post-market surveillance of medicines as that is clearly an important issue for those in the field who seek to monitor what is happening in relation to prescribed drugs.

Today's debate has largely, and rightly, been taken up with last October's scare about contraceptive pills. That has been well documented and I do not intend to go much further into the details. However, important lessons can be learnt from the substance of that issue. It is important to stress that Government can learn lessons. Clearly, we have become immune to the Government's indifference in recent years in relation to certain issues. However, it is vital that they take seriously criticisms that are intended to help the public and not merely to be another debating point in the Chamber.

An article in The Times on 20 April this year was headlined: Britain is criticised over pill scare". It talked about the alert which, as the hon. Member for Southwark and Bermondsey said, is likely to lead to several thousand unwanted pregnancies or abortions. We should not underestimate the importance of that. The Times article then said: The announcement leaves Britain isolated over its stand on so-called third-generation Pills. We are well used to the scepticism and exaggeration that can accompany press articles, but The Times makes an important point. The article continues: But the European agency said that there were too many uncertainties in the three studies used by the Government to justify its alert … The European agency said it was calling for more research. The article highlights the concerns about why the Government took action and when they took action. It is now important to look further at some of the lessons that can be learnt from the way in which the matter was dealt with.

Crucially—I have made this point before, but I will make it again because it is worth repeating—the public deserve to have proper guidance and proper information. In many respects, the BSE scare highlighted a real crisis of communication from Government to people. There was no attack on the scientific community, but the initial scare was the basis of the subsequent scares, for which everyone is now paying the price. Information is important.

An article in the British Medical Journal of Saturday 28 October advising women about which pill to take was a constructive piece. However, the article said that legitimate questions may be asked about the timing of the announcement, procedures for circulating information to doctors, and the detailed content of the committee's letter". Again, that illustrates the basic problem of communication between a Government who have absorbed information given to them and the professionals and the public to whom they give information.

It is also important to consider an article in The Lancet of 27 January 1996, which states: The UK and German regulatory agencies have erred and their respective governments must ensure that such intemperate action does not happen again. The European Union's regulatory authority and regulatory agencies in other countries, including the US Food and Drug Administration, have waited for the opportunity to examine in detail the published, peer-reviewed … studies. That is another example of the wide-ranging criticism of the Government's handling of the matter. Articles in distinguished periodicals, the British Medical Association and many consumer organisations have also criticised the Government.

It is crucial that we have safety margins, but monitoring must not create medical scares. I stress that point and I hope that the Government will respond to it. I have spoken mainly about the public, but in that particular scare, GPs, who are in the front line in terms of patient in care, were given only perfunctory notice of what was happening. Again, they were reading about it in the press while information was filtering through to their surgeries as to what they could tell patients who telephoned them. That smacks of a fundamental weakness in the process.

If the Government learn nothing more from today's debate than that they must continuously give information to the professionals to pass on to the public, we shall have done the nation a favour. That said, it strikes me that the Government are often unwilling to take lessons.

Let me summarise the serious issues. First, the quantity, quality and consistency of scientific evidence must be taken seriously. Secondly, although I do not want to join in the attack on the Government in respect of the announcement regarding the contraceptive pill, it is obvious that timing is crucial. Professionals must be informed and the Government must follow up initial health alerts with positive helpful guidance. It did not happen with BSE; we nearly had another crisis on the phthalate in powdered baby milk; and then, of course, there was the oral contraceptive scare last year. There are too many scares. Ultimately, the Government must bear responsibility for improving the handling of information.

Thirdly, the Government should review the process of circulating information to doctors. Fourthly, we need to examine the process of informing the public. Fifthly, there is concern about the detailed contents of letters and advice as there have been many criticisms in the past that, to use the old adage from one of the adverts, one should never make a drama out of a crisis. Clearly, we should be cognisant of wording and keep it very simple.

My final point relates to transparency and secrecy. It is not a particular attack on the present Government, but on all Governments. We simply do not take the public into our confidence in the way that we should. There is always reluctance to provide information when we feel more comfortable hanging on to it. It is clear from the medical press and consumer groups generally that there is too much secrecy about health matters. I hope that the establishment of the European agency will provide new opportunities to make issues more transparent.

I acknowledge that companies need to have an eye on commercial confidentiality and that sophisticated processes are at work, but none of those issues should be subservient to the need for the public to know and to make informed choices on the knowledge that they have. It is a difficult balance to strike. Nevertheless, we should be making greater efforts towards it.

I have outlined the issues to which the Government should respond, which involve their attitude as well as the implementation of practical policies. They have demonstrated more than a hint of arrogance and complacency in dealing with issues involving the public. We should remember that we are elected by the public and the Government are selected from a group of elected representatives. Therefore, the public should always be the overwhelmingly important factor.

Finally, so that the Minister, who is desperate to get to his feet, can have adequate time, I turn briefly to pharmaco-vigilance and surveillance in the marketplace. The system in operation is known as the "yellow card" system. It is a basic procedure whereby adverse drug reactions are recorded and forms are submitted to the authorities monitoring drug safety. The system is working well, but the BMA has raised two issues that I should like to put to the House.

First, it is clear that there are fluctuations in the reporting of adverse drug reactions. There could be good reasons for that, but the BMA suggests that there should be further research into how the system is operating. It could be that there are fewer adverse drug reactions, which would be warmly welcomed by all concerned. Secondly, there is a possibility that the time involved in filling in forms could be a disincentive to some GPs properly to report adverse drug reactions. There may be problems that require investigation.

The second issue raised by the BMA concerns the confusing terminology used in reporting adverse drug reactions. According to the BMA: For example the British Natural Formulary uses the terms `cautions', 'contradictions' and `side-effects', while MIMS (the monthly index of medical specialties) uses 'special precautions',`drug interactions' and 'adverse drug reactions'. There is a European Union definition of what is an adverse drug reaction. It suggests that a standardised definition might be helpful, but acknowledges the complexity of these matters. Nevertheless, the BMA has contributed two positive ideas to the debate and I hope that the Minister will consider them.

My hon. Friend the Member for Motherwell, South and the hon. Member for Southwark and Bermondsey have made the issues quite clear. We have had a scientific and technical discussion, but at the end of the day I return to the point on which I started. We must always reassure the public that their drugs are safe in the hands of the Government and the experts who are dealing with them.

Finally, I call on the Government to review the way in which they handle health issues. It seems to me that we have built up a catalogue of scares. On reflection, some of them might not have been avoidable—perhaps the complex process of society means that it is impossible to get it completely right or wrong.

The Minister for Health (Mr. Gerald Malone)

indicated assent.

Mr. McLeish

The Minister agrees with me. When we have three or four such scares in a row, however, Oscar Wilde's comment about carelessness comes to mind. It would be worth while for the Government to review the way in which they handle the interface with the public on health issues. I hope that the Minister will consider that point. It is not only germane to the Health Department: Ministers at the Ministry of Agriculture, Fisheries and Food could use a significant dose of reality to knock some of them out of their complacency, particularly Ministers dealing with the BSE crisis. However, I will not spoil a speech in which I have tried to be constructive by making any further attacks on the Government. That can wait until another day.

12.7 pm

The Minister for Health (Mr. Gerald Malone)

I welcome the opportunity to respond to the important debate that the hon. Member for Motherwell, South (Dr. Bray) has been successful in securing. In the time that remains, it may be helpful if I address the specific points that the hon. Gentleman made in his speech and then turn to wider issues and set them in the context of the Government's policy in these matters. I am sure that the hon. Gentleman will not take it amiss if I begin with the points raised by the hon. Member for Southwark and Bermondsey (Mr. Hughes), with the intention of getting them out of the way before dealing with the substance of the debate.

With typical courtesy, the hon. Member for Southwark and Bermondsey gave me notice of the specific questions that he wished to raise. I shall deal with those before explaining how I intend to deal with the range of eclectic points that he made and I shall set out my reasons for dealing with them in that way.

First, the hon. Gentleman asked when the Medicines Control Agency first became aware of the World Health Organisation study. The MCA first became aware of the likelihood that information would become available from the WHO study in May, but it was not until July that information from the study was provided suggesting that there was concern as to the safety of some oral contraceptives.

The hon. Gentleman also suggested that the advice of the Committee on Safety of Medicines was not adequate. He has questioned the value of the committee's information on other occasions as well, although in fact it has given doctors extremely clear advice on the use of the relevant oral contraceptives. He then tied that in with the guidance of the Family Planning Association. I remind him that the purpose of that guidance was to place the CSM's advice in the context of family planning practice, which can be different.

There is no point in the hon. Gentleman's pointing out that the two are different in substance. Of course they are: they are specifically designed to be. The hon. Gentleman, however, seems to take a perverse delight in refusing to recognise what are often simple facts. It is the role of the FPA, not the CSM, to give guidance on the practicalities of management of the care of women. I hope that he will now accept that distinction.

The hon. Gentleman has often repeated his serious accusation that Parliament was misled about the date of the final World Health Organisation study. I have answered that question at least once, and I do not intend to go over the same ground again; but I must tell the hon. Gentleman that he has made some serious accusations. I am not sure whether he thinks that they are part of the cut and thrust of politics, and that that enables him to make his point. I am much less concerned about his accusation that I have misled the House—important though that may be—than about the accusation that he levelled, at least by implication, against both officials and professionals who advise the Government on issues relating to the safety of medicines. He suggested that they were involved in some complex and incomprehensible conspiracy connected with the way in which the matter was brought to the public's attention.

It is disgraceful that, notwithstanding the evidence that I have provided in answer to more than 200 written questions tabled by him, the hon. Gentleman persists in the accusation that a conspiracy has taken place. It is time that he abandoned that false trail, and concentrated on the substance of the issues—which he pretends to do, while using that as a smokescreen for what is simply a political campaign.

I will check the points made by the hon. Gentleman with the questions and answers that are already in Hansard, and if there are any blank spaces I will write to him. I must deal with this complex subject in that way because I was not able to flick through the answers that had already been provided while listening to the hon. Gentleman's speech in order to establish whether I had answered all his questions. When providing him with written answers, I have often found that answers have already been given to questions which, if not asked by the hon. Member for Southwark and Bermondsey, have been asked by his hon. Friend the Member for Gordon (Mr. Bruce), who ran around the race track about six times before handing the baton on to his hon. Friend to run around again in ever-decreasing circles and at ever-increasing speed. I will check carefully what he has said, and, if the House allows me, I will leave this part of the debate at that.

I will now deal with the serious points made by the hon. Members for Motherwell, South and for Fife, Central (Mr. McLeish). Having listened with great attention to what was said by the hon. Member for Motherwell, South, I will explain the purpose of controls on medicines and the way in which we try to provide medicines where they can be effective while still maximising the benefits and minimising the risks. That is the general objective of the policy.

A focal point for the debate must be the recognition of the enormous benefits conferred by modern medicines. They certainly prevent far more adverse events than they cause. The appropriate use of medicines relieves human suffering, and cures or alters the course of many life-threatening diseases. They also provide a cost-effective form of treatment. For example, modern antibiotics and vaccines have markedly reduced the impact of infectious diseases in the past 50 years. Developments in biotechnology and molecular biology are bringing about a further revolution in treatment. That is expected to have an equally dramatic impact on diseases such as cystic fibrosis, which has been extremely difficult to treat hitherto.

The hon. Member for Motherwell, South struck the right note when he spoke of finding the appropriate balance between what medicines can achieve and the possible risks. In a powerful intervention on the speech of the hon. Member for Southwark and Bermondsey, he pointed out that value judgments must often be made, and that finding the right balance was the answer. Mechanisms must be designed to find that balance, and when it is found, if it is on the side of risk, the mechanisms must deliver that information at the earliest opportunity, not only to the health care professionals who administer the medicines but to the public who consume them. The truth is that no medicine is entirely risk-free.

There is a well-defined framework for the control of medicines. As the hon. Gentleman said, in a sense the definition of that framework and its development is never completed; there is a continuing debate about how mechanisms can be improved and advanced. The hon. Member for Fife, Central asked whether, in the light of circumstances, the Government would conduct a review. There would be no specific review, but these matters are always open to debate. Better information leads to change. There is, in fact, a constant review of progress, and the hon. Gentleman will know—especially in the light of recent events—that the Government have made clear through the chief medical officer that the dissemination of information to professionals in particular is a process that we think we can improve. That is being examined, and much of it ties in with the development of technology within the national health service.

The framework for medicines control in the United Kingdom is provided by the Medicines Act 1968, and by a series of EC directives dating back to 1965. It is a comprehensive system of standards, used as the basis for authorisation, marketing and monitoring of medicines in the UK. Those standards are incorporated into the EC licensing system that came into force in January 1995. The system requires all medicines used by the public—either prescribed by doctors or purchased by consumers—to be licensed, with only a few closely controlled exemptions. Licensing is based solely on a scientific assessment of safety, quality and efficacy; other factors, such as costs, do not affect licensing decisions.

The licensing process involves rigorous assessment, including toxicity tests on a variety of animal species before any medicine is tested on humans. Prior to marketing, clinical trials of efficacy and safety are conducted in between 1,000 and 2,000 patients. As part of that assessment, the Government receive advice from independent experts—I stress the word "independent"—and from those working in the Medicines Control Agency.

Pharmaceutical companies also have responsibility for the safety of the medicines that they sell, and must meet statutory pre-marketing and post-marketing obligations. I emphasise that aspect because it relates to what seemed to be the burden of the speeches of the hon. Members for Motherwell, South and for Fife, Central: what happens at the post-marketing stage. Those obligations are to provide the licensing authority with information on safety, quality and efficacy. Extensive guidance on those requirements is available, and in general the industry complies well. if it does not, the Medicines Control Agency has power to deal with that and to ensure that it complies in future.

Pharmaco-vigilance has been referred to by all hon. Members who have spoken in the debate, and I shall set out the procedures, the powers and the recent developments which ensure that pharmaco-vigilance is as effective as possible. Once a medicine is licensed, the Government monitor its adverse effects closely to ensure that it is safe in widespread use. The UK is respected world wide in this area, and the MCA also has an excellent record.

There are a number of key elements in the pharmaco-vigilance system. Access to the best advice, prompt action and effective dissemination of information about the safe use of medicines are the foundation stones on which the system is built. The licensing authority has powers to suspend, revoke or vary marketing authorisations in response to concerns about safety or efficacy, and there is an appellate process involving expert bodies before final decisions are made. The system has a clearly defined process, and has teeth to make things happen.

I pay tribute to the independent critical review provided by the Committee on Safety of Medicines. Ministers— especially the Minister for Health, in the role of licensing authority—know from direct experience that its advice is sound and can be relied upon. I shall return to how the information is disseminated, but we should consider the means by which possible safety issues with medicines are identified and investigated.

The first question is that of monitoring. The yellow card scheme, which encourages doctors to report adverse effects of medicines to the MCA, is one of the best-supported reporting schemes in the world. It is underpinned by a purpose-designed, state-of-the-art computer database that enables the MCA to identify important hazards as early as possible. The scheme has a proven track record in identifying drug safety problems promptly. The agency also has access to reports of adverse effects occurring abroad so that it can benefit from worldwide drug safety experience. Wherever possible, the scheme plugs into a wider network.

Formal post-marketing studies are an important part of the process, and a range of other methods to assess the safety of medicines are also used. The UK has taken the lead in this area by developing guidelines for those studies that are sponsored by pharmaceutical companies. The hon. Member for Motherwell, South asked whether we were running down studies in these areas in a formal sense, whether enough was being spent on research and how that tied in with what happens to the commercial studies carried out by pharmaceutical companies.

The guidelines were a first for the industry, and have been followed elsewhere. They were agreed in 1993 with representatives of the industry and the medical profession. They are important because they provide for independent advisory groups to oversee the studies and for the MCA to comment on their design and receive regular reports on the findings. They are the basis upon which European Union guidelines are drawn up, and they have been incorporated into them. That is sufficient testimony to their robustness.

The hon. Member for Motherwell, South knows that not all the funding of clinical studies that assess drug safety comes from the companies. Many relevant studies use direct or indirect public funding, including some commissioned by the Department's NHS research and development division—which now has an annual research budget of £21 million—and others funded by the Medical Research Council. The Government also fund the UK Cochrane centre. The hon. Gentleman, who takes a keen interest in these matters, will know that the centre plays a vital role in the dissemination of information about a range of drugs and procedures, not just in this country but world wide.

The hon. Member for Motherwell, South referred to the general practice research database, and described the present situation as a kind of reverse privatisation. I can tell him that the Department of Health knows a bargain when it sees one, and we were delighted to seize the opportunity when the GPRD became available. Since then, there have been important opportunities to develop the use of this important resource for pharmaco-vigilance purposes. This has been pursued vigorously by the MCA, which has set up an epidemiology unit directed by a leading professor of medical statistics. The goals of the unit are to make the best use of recorded linkage databases in the UK and abroad and to develop other approaches to investigating drug safety.

Dr. Bray

Will the Minister look further at the arrangements made for the exploitation of the GPRD, because a good deal more could be done?

Mr. Malone

I was going to give an undertaking that I would look carefully at the hon. Gentleman's remarks. Clearly if there are ways in which greater use can be made of this asset, we would wish to use them. I will take his remarks on board and look at ways in which we might take the matter forward. The MCA has used the GPRD on, I believe, 14 occasions until now. The database is important, and its value is clearly recognised by the Government.

The provision of information is vital, as hon. Members will recognise. Without it, collecting the information is valueless. Often information arrives that must be made available to the public rapidly because of public safety issues. Value judgments must be made, and I make no bones about the fact that—with the benefit of hindsight— better methods could have been used or further investigations carried out. The Government take responsibility for drawing to the public's attention as early as possible any information affecting public safety. If the hon. Member for Southwark and Bermondsey can create a conspiracy theory from Ministers coming to the House to provide information, I wonder what theory he would have concocted had the decision been not to do so.

There is a range of ways in which information is made available to the professions and the public, including the British National Formulary. Other regular publications bring the information up to date and draw it to the attention of the profession. Perhaps the best known is the bulletin, "Current Problems in Pharmacovigilance", which provides more detailed and technical information on specific drug safety issues. In addition, if an important new hazard is identified, the chairman of the Committee on Safety of Medicines writes to all doctors and pharmacists as a matter of urgency. We also make use of electronic communication networks to get important information to health professionals more quickly. That is a rapidly developing field.

The MCA is playing a key role in initiatives—both within the EC and more widely, involving the USA and Japan—through the International Conference of Harmonisation to develop standards to support electronic transmission of pharmaco-vigilance information. It is important that the network spreads and that information can be made available in a comprehensible way so that it can be brought to the public's attention and to the attention of health care professionals as quickly as possible.

This has been an extremely useful debate that the Government very much welcome. Everyone recognises that medicines sometimes have adverse effects. I accept the point made by the hon. Member for Motherwell, South that we must develop the systems that inform us and improve, where we can, the research that is undertaken. We must always get the balance right but never, as Ministers and as the licensing authority, be afraid to go to the public with information as and when it becomes available.

Dr. Bray

In half a minute, will the Minister say what is the machinery for examining the interactions between safety and other matters?

Mr. Malone

I am not certain that I shall be able to deal with that point in the 30 seconds available. I have listened carefully to what the hon. Gentleman has said and I will write to him in detail on that.

In conclusion, we take our obligations very seriously. This has been a useful opportunity to air the Government's policy and I am grateful to the hon. Gentleman for choosing this subject.