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Dr. Ian Gibson (Norwich, North) (Lab): Is the hon. Gentleman aware that a Sheffield university lecturer was sacked because, although he was not quite a whistleblower, he queried a decision? He began some work, the results of which were sent to Proctor and Gamble. He queried the company's decision to allow a drug on to the market, and he was sacked. Is that ethical and is it good practice, or is it a one-off event?
Mr. Amess: The House will have heard what the hon. Gentleman said. It is a valuable intervention, which I know the Minister heard. I hope that the case was a one-off, but I suspect not. We should reflect on it, and perhaps the Minister will respond.
It is gratifying that the industry is being forced to look seriously at the concerns that we raised in the report about its professional practices. It should be stressed, however, that the code is voluntary, without the backing of law. The code promises reforms to speed up the complaints procedure, with tougher measures to withdraw products during investigations, but on close examination, the sanctions for companies that break the code are lightweight in relation to the serious implications of such failings, with naming and shaming taking preference over financial penalties.
I shall not attempt to pronounce the name of the editor of the Drug and Therapeutics Bulletin. He was quoted in the British Medical Journal on 26 November as saying:
"This has been heralded as a new dawn in the promotion of prescription medicines and allied activities. But the problem is that the code is fundamentally weak because the ultimate sanction a company faces for breaking it is very limited."
Indeed, the ultimate sanction that a pharmaceutical company can face for breaking the code is expulsion from the Association of the British Pharmaceutical Industry. As the House has heard, that has never happened. What we should be striving towards instead, as the Select Committee report suggested, is the strengthening of the MHRA, the statutory regulator that exists purely to protect the public interest, independently of the industry.
I am not suggesting that the Department is naive enough to assume that the interests of the health sector and of the pharmaceuticals industry are synonymous. Clearly, although there is an overlap, the former is driven primarily by patient care and the public interest, whereas the latter must also weigh medical need against the returns that it will get from its investment. This is why, quite wisely, the Committee concluded that a key recommendation of its report would be that the sponsorship of the industry be passed from the Department of Health to the Department of Trade and Industry, so as to avoid that conflict of interest. I very much regret that this recommendation was rejected by the Government in their response to our report. I hope the Minister will comment on that.
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Overall, the tone of the Government's response was complacent. We have heard from the Chairman of the Select Committee that he was responsible for geeing up the response. Whether it was prepared too quickly I do not know. In reply to a number of the Committee's concluding recommendations, the Department of Health stated that the current guidelines or measures were sufficient to deal with the concerns raised. The Committee does not accept that. For example, the Government did not strongly support the Committee's proposals to subject the MHRA to an independent review that would examine the regulation process with a view to making it more transparent. I much regret that.
The need for more transparency in the industry was another ongoing theme throughout our inquiry, not only so that medical practitioners and the public can make informed judgments about the evidence they are presented with by the pharmaceutical companies, but so that they are more informed about the materials considered by the MHRA in its inquiries. It was disappointing that in their response, the Government committed only to a suitably planned review of the MHRA
without giving a start date for the review cycle, which leaves us unclear as to whether the process will go ahead. A four-year cycle is too loose and not realistic enough.
The issue of independent regulation is given added salience when we consider a series of controversial treatments that have hit our headlines in recent months. The hon. Member for Newport, West mentioned that following the death of a patient who had been taking the painkiller Vioxx, which, as he rightly said, has been shown to increase the risk of heart attacks and strokes, a US court found against the responsible company, Merck. During the case, it emerged that Merck had deliberately hidden its reservations about the treatment, which was a worrying discovery.
Here in Britain, the Minister announced at the end of October that primary care trusts should fund the treatment of Herceptin for the early stages of breast cancer, if it is clinically appropriate. He has probably not had time to read his boss's comments to the Health Committee on Tuesday, when the Secretary of State for Health was involved in an interesting exchange with a Labour Member. Herceptin has not yet been licensed for treatment in early cases, and to allow a politician to bypass all the licensing safeguards to demand that a treatment should be made available on the NHS is surely not a precedent that we should set.
Two weeks ago, I asked the chief medical officer about inoculation against tuberculosis. The old product ceased to be used when Parliament broke up for the summer recess, so there was no chance to challenge the decision in Parliament, and the new product is unlicensed. I do not want to start scaremongering among the general public, but I am concerned about the message that is being sent out. The House has probably forgotten that change, although I do not bear the scar of a TB inoculation.
Mr. Lansley:
Does my hon. Friend agree that although this matter is not covered in the Health Committee report, the mechanism for the approval of vaccinations and immunisations is still within the hands
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of the Department of Health and does not rest with National Institute for Health and Clinical Excellence? On TB testing, there is a very good case for examining the efficacy of the old technology for skin tests compared with new blood-testing technologies, and I have asked questions about that matter. At the moment, the mechanism sits inside the DOH and vaccinations and immunisations are not exposed to an evidence-based appraisal by NICE.
Mr. Amess: I like where my hon. Friend is leading me and am aware of his interest in the matter. The Minister has heard our exchange, and I am sure that the general public will become increasingly interested in what is going on. We certainly need to clarify the matter.
It is vital that new drugs are proven to be of real therapeutic benefit to patients, and clinical trials should therefore aim to produce health outcomes that are relevant to patient care rather than relevant to the profits made by pharmaceutical companies. That is why the Health Committee made the sensible recommendation that better communications should be established between the Medicines and Healthcare products Regulatory Agency and the pharmaceutical companies in the early development stages of a drug. There should be more post-licensing monitoring of medicines, which requires systematic appraisals of drugs on the market. I hope that the Minister will comment on that point in order to reassure the Committee.
There is no doubt that medicines contribute enormously to the health of the nation. The hon. Member for Newport, West is not present, but I was concerned by his remarks about drugs to assist people who are depressed or who have other mental health problems, because I think that he overstated the case against those drugs. For many people, they are the source of a better quality of life, negating the need for surgery or other invasive treatments.
Economically speaking, the production of pharmaceuticals is the third most profitable activity in the United Kingdom after tourism and finance. The UK should be very proud of the many achievements of its domestic pharmaceutical industry, as it has an excellent global reputation for scientific research, accounting for 10 per cent. of global research and development expenditure.
In order to maintain that wonderful reputation, the Government must act to protect the public, especially the elderly and less well-off, who are the biggest users of prescription-only treatments but also the most vulnerable people in society. It would be unrealistic to rely on the pharmaceutical industry to protect the public interest through self-regulation, but neither must we over-regulate through the statutory body. All restrictions on pharmaceutical companies must be targeted, and they must have a clear purpose in the promotion of public safety.
I believe that the United Kingdom's pharmaceutical industry is a respected and highly lucrative business, but I also believe that it is the Government's responsibility to ensure that it remains so.
2.51 pm
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