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14 Mar 2003 : Column 597—continued

The Parliamentary Under-Secretary of State for Health (Mr. David Lammy): I congratulate the hon. Member for Romsey (Sandra Gidley) on securing this important debate. The allegations about the Ciproxin trial at Southampton general hospital that we have heard today have, as she knows, been the subject of previous—and ongoing—investigations. She will understand that, for that reason, it would be inappropriate for a Minister to comment substantially on the case. I understand that Lord Hunt also declined to comment on the case in responding to a letter from the hon. Lady in May 2001.

The case has now gone on for some considerable time—since the beginning of the last decade, in fact—and to comment might prejudice any current or future proceedings. I also understand from correspondence that some of the issues raised in this debate have previously been investigated by the police, the General Medical Council, the Southampton university hospitals trust and, of course, the Medicines Control Agency. Because those organisations are best suited to judging the scientific and ethical issues raised by the hon. Lady, I am not prepared to say any more about the Ciproxin trial. However, an important question that arises from this debate is whether patients volunteering for clinical trials are adequately protected by the procedures and guidance that is currently in place.

I respect the integrity and sincerity with which the hon. Lady put her argument, but she will understand that the matter involves a considerable history.

Sandra Gidley: I am aware that there have been investigations, but the problem is that the results are not in the public domain, so how can any member of the public be satisfied that due procedures were followed and that there was nothing fraudulent about the trial? I would be happy if someone showed me the information and said, "Here it is, Sandra. Go away and don't bother us any more." That has not happened, and we have come up against a brick wall.

Mr. Lammy: What I will say is that I will attempt, within the law and within the practice of the House, to answer some specific questions as far as I can, although I remind the hon. Lady that I am treading lightly because this is extremely delicate ground.

First, what are the outcomes of the various investigations? Information on the police and GMC investigations has not been made public, and the hon. Lady is right when she says that. Southampton university hospitals trust has completed a thorough investigation and concluded that there is no evidence to support the substantive allegations made by Mr. Karran on the Ciproxin trial. Professor John Primrose is a senior consultant who was involved in the trial. There was a minor breach of research protocol, which was raised with Professor Primrose, but no further action was required.

Sandra Gidley: Can the Minister say what the minor breach of research protocol is? If the breach is the fact that the wrong trial went ahead, I would not regard it as minor.

Mr. Lammy: I can undertake to ask officials and lawyers within the Department, after the debate, to take a close look at some of the issues raised. I may be able to elucidate in a letter to the hon. Lady, but I must tread lightly on what is established precedent.

The MCA reviewed its records in April 2001, finding that the information that Mr. Karran alleges was deliberately withheld had been provided in another context. The agency concluded that there was no intention to mislead and that no further action was necessary. Mr. Karran has been informed of that on several occasions.

The hon. Lady will also know that, within administrative law and other areas, such decisions can be subject to judicial review and other matters, so remedies are available should Mr. Karran take issue with the conclusions that people have reached. However, I am not sure, on some of those issues, that the House is the right place to conduct, as it were, a forensic retrial or that a Minister in the Department should be involved.

The hon. Lady asks why the MCA has refused to disclose information on the clinical trials of Ciproxin to Mr. Karran. I say in response that the MCA has complied with the code of practice on access to Government information and has advised Mr. Karran of the relevant exemptions. The code provides for an internal review if individuals are dissatisfied with the agency's decisions. In addition, recourse is available to the Parliamentary Commissioner for Administration, who may decide to investigate complaints that information has been unreasonably withheld under the code. So, it may be that avenues could be pursued, but that is as far as I can go on this occasion on those issues, which have continued for some considerable time.

I return to what is an important issue: patient safety in clinical trials of this nature. The United Kingdom has long been regarded as a good place to conduct research. It is right that I put that on the record. A number of factors, such as the presence of highly motivated and educated investigators, a strong academic base, a comprehensive health service committed to research and development, well organised and funded medical research organisations and strong networks of general practitioners, have historically resulted in an efficient infrastructure for the conduct of clinical research. Many facets of that infrastructure provide protection for clinical trial volunteers. That protection has been reinforced in a number of ways since the Ciproxin trial.

The Government want to ensure that volunteers who participate in clinical trials are safeguarded to avoid any unnecessary hazards. In the United Kingdom, there are a number of safeguards in the present regulatory system, which I will describe in turn.

Sandra Gidley: Does the Minister think that the 46 per cent. of patients who suffered post-operative infections in the trial were safeguarded?

Mr. Lammy: I have said that I am not going to be pressed on the specifics. We have various agencies that are well placed to look into these matters. There have been a number of investigations. The nature of any such trial is, of course, a delicate and difficult matter. What I cannot do today is unpick an individual trial on an individual occasion. The hon. Lady knows that a number of trials take place every year with varying results.

The current system of regulation under the Medicines Act 1968 requires that anyone who wishes to test a medicine in a clinical trial must obtain a clinical trial certificate or an exemption from holding a CTC. Most trials in the UK are conducted under one or other of those exemption schemes. The MCA receives applications from companies to supply about 250 different medicines for clinical trials each year. It authorises about 800 commercial clinical trials and 1,000 non-commercial clinical trials. Studies in healthy volunteers are self-regulated under guidance from the Association of the British Pharmaceutical Industry and the Royal College of Physicians, but are expected to be regulated under the EU clinical trials directive, which I would like to mention later.

The application to the MCA must provide information on the medicine to be used, any non-clinical tests of safety, any previous clinical trials or results, or other clinical information about the medicine. The MCA's professional assessors subject any application to a robust scientific evaluation.

Sandra Gidley: The Minister has just pointed out, rightly, that people applying for a trial must submit details of known problems. He said earlier that that clearly was not done in the Bayer case. Why is there not some sanction against drug companies that behave in that way?

Mr. Lammy: I have outlined that there is a code of conduct. There is a number of avenues. Of course, the ultimate sanction is the law and our legal courts, inquiry by the police, as happened in this case, inquiry by the individual trust, as happened in this case, and inquiry by the MCA itself, as happened in this case. I realise that the hon. Lady raises these issues with integrity and because she believes that there are facts that need to be penetrated further. As she may know, I used to be a lawyer, but even so I cannot conduct a trial from this Dispatch Box. I am limited in how far I can go in this chain of inquiry—a chain that has gone on, I believe, for some nine years.

If the hon. Lady has questions other than those that were raised on previous occasions, she can raise them with my Department. Our officials and legal advisers will look into the matter and we will attempt to do what we can. However, once there has been an investigation by the various agencies, there comes a time, I am afraid, when the matter has to rest—other than judicial review or some other process that she may be aware of, but which does not occur to me on this occasion. This matter has been looked into, and the integrity of Parliament's intention to protect patients—

The motion having been made at half-past Two o'clock, and the debate having continued for half an hour, Mr. Deputy Speaker adjourned the House without Question put, pursuant to the Standing Order.

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