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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.
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