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Mr. Lansley: This is an interesting point, and I hope that the Minister will tell us more about electronic prescribing and about the conversion of the Prescription Pricing Authority on to an electronic basis. That should, in theory, allow us to extract much more of the data that the right hon. Gentleman describes. However, although the transfer to electronic prescribing has increased, we are still achieving only a tiny fraction of the amount that was intended. By this stage, we were expecting to have pretty much an entirely electronic system, from the doctor's screen right through to reimbursement through the PPA.
Mr. Barron: I do not disagree with the hon. Gentleman, but I shall not be tempted to discuss information technology in any part of the public sector—or the private sector, for that matter—because it has its own history. We have debated the issue in the past, and we will no doubt do so again.
Paul Flynn: A serious situation has just been revealed in a report by the university of Sussex, which shows that we have been much too ready to license drugs in this country, compared with the United States. Between 1971 and 1992, nine drugs were withdrawn in the United States because they had serious adverse effects, whereas the figure in this country was 24. In our rush to put drugs on to the market for the benefit of the pharmaceutical companies, we are conducting experiments with those drugs and using the public as guinea pigs, and those guinea pigs often do not survive the experiments.
Mr. Barron: My hon. Friend will have to forgive me, because I disagree with parts of what he has just said. I know that he has taken a great interest in the pharmaceutical industry for many years, but I do not agree with him on this issue. Proper licensing arrangements are in place. Yes, it is true that issues such as the withdrawal of Vioxx come around now and again, but patient safety was one of the first subjects emanating from the report that I raised in this debate. The House must understand that I was not on the Health Committee when the investigation took place or when the report was published, although I did play a role in trying to get the Government's response a bit earlier, in view of their delay in providing it.
Paul Flynn:
I want to give the House a clear example of the disastrous failure of our regulatory system.
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The Food and Drug Administration in America has claimed that there were 144,000 cases of heart attacks and strokes due to the use of Vioxx. However, in answer to a parliamentary question asking how many bad reactions had been discovered here under the yellow card system, I was told that there were never more than half a dozen a year, and that they amounted to no more than 12. There is evidence of 4 million prescriptions for medicines of this type being prescribed, and if America had not discovered the terrible, fatal side-effects of Vioxx, we would still be using it, and British patients would still be being killed by it.
Mr. Barron: Vioxx is an issue for everyone here, and the Health Committee asked for a public inquiry into the matter, saying that when a drug is withdrawn in the way that Vioxx was, there should be a public inquiry. The Government did not agree, and I have to say that I have some sympathy with the Government on that. However, the public should have more information on the way in which the drug was licensed and came into use, so that they can be satisfied that we understand the issues surrounding it. My hon. Friend mentioned half a dozen cases. He will be aware that there is the potential for litigation on this matter either in this country or the United States. Reports in The Lancet have put the number of cases in this country of people who have been affected long-term in relation to taking Vioxx at far higher than half a dozen. Perhaps my hon. Friend the Minister will comment on this when he speaks later in the debate.
The lack of transparency in the MHRA and the industry means that health care professionals do not always have all the information that they need to make appropriate prescribing decisions. The report welcomed the introduction of a register for clinical trials, which will allow professionals and the general public to access information about the development of drugs. The Committee's proposal for maintenance of the register by an entirely independent body was rejected, as was the recommendation that information regarding clinical trials be available at drug launch, so that prescribers could access information during the period when the promotion of a new medicine was at its most concentrated. The Government believe that the publication of such trials within one year of launch is appropriate.
The Government's response reiterates the importance of a close relationship between the Government and the pharmaceutical industry, citing as a reason the need to ensure transparency in the way in which medicines are brought to the public. The response stresses the role of the ministerial industry strategy group—the MISG—in this respect. Importantly, the response agrees that
and this is one of the aspects that will be considered by the MISG. I hope that, in doing so, it will consider the issues around Vioxx that my hon. Friend mentioned.
Corrective statements will not be issued in every case of a breach of legislation, as was recommended by the Committee. However, the MHRA is considering publishing the correspondence with companies relating to the promotion of medicines. The agency will also publish an annual advertising regulations outcome report. Contrary to the Committee's recommendation,
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information received by the MHRA will remain confidential until a licensing decision has been made. However, upcoming legislation will require a public assessment report of a medicine's licensing history to be published shortly after a licence is granted. The MHRA has undertaken to publish assessment reports for licence renewals and safety update reports. Such safety reports will also be issued more frequently.
One of the Committee's main recommendations was for a large-scale, independent review of the MHRA to be conducted. The suggested governing principles included the agency's need for independence from the Government and the industry, greater transparency, greater proactiveness in post-marketing surveillance, the prioritisation of new marketing applications, and the inclusion of lay members in policy-making decisions.
That recommendation was rejected by the Government, although they stated, on page 18 of their response, that perhaps a four-yearly review of the operations of the MHRA should take place. If that were to happen, the terms of reference would remain to be decided. I remind the House that the terms of reference should consider methodology, timing and other issues. If the Government adopt that approach, as I think they should, it would be useful if there were a parliamentary input into exactly what the terms of reference should be, either on the Floor of the House or at least from the Health Committee. I am sure that members of the Committee would be more than happy to consider the issue.
Both the report and the response stressed the importance of research and development for patients and the economy, and the need to maintain levels of investment by drug companies in the United Kingdom. However, the Government agreed with the Committee that there were occasional deficiencies in the design and conduct of clinical trials. Poorly designed trials have significant consequences for patient safety, as is shown by the tragic consequences of widespread prescription of the anti-arthritis drug Vioxx, mentioned by my hon. Friend the Member for Newport, West (Paul Flynn).
Adam Afriyie (Windsor) (Con): I thank the right hon. Gentleman for being so generous in giving way.
It seems that the National Institute for Health and Clinical Excellence must rely on published evidence. In many cases, evidence of a faulty trial or certain sets of data are not published. Does that cause the right hon. Gentleman as much concern as it causes me?
Mr. Barron: Yes, it does. It should concern us all, and it should concern the pharmaceutical industry more than any of us, because it is directly responsible for ensuring that we have as much information as is necessary.
The Committee recommended closer working between the MHRA and the industry to ensure that trial design benefits patients. No changes or additional work by the MHRA to improve the design of trials to reflect clinical improvements is suggested in the report, which I think is a shame. Guidance on
is said to be already in place, but that does not apply to guidance on the types of trial likely to prove therapeutic gain. That is one of the issues raised by the hon. Member
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for Windsor (Adam Afriyie). No additional funding for NICE to address the issue has been agreed, and the report does not mention changes in the way in which research ethics committees review and approve clinical trials. I think that that is wrong. As I have said, the issues should concern us all. On the few occasions that such matters do come into the public domain and drugs are removed from the market, we should establish why that has happened. When drugs come on to the market, we should do our best to ensure that that is dealt with as safely as possible.
The report highlights the problem of "me-too" drugs—medicines that add little to the clinical effects of chemically similar drugs that are already on the market. The Government recognise the problem, and the response states that additional work by the National Prescribing Centre may be considered to address it. The Government agree with the Committee that impediments to generic drugs entering the market should be prevented, and will consider an initiative to investigate the problem.
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