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Mr. Kevin Barron (Rother Valley) (Lab): First, I declare an interest in that I am currently a lay member of the General Medical Council and it is mentioned with other regulatory bodies and related associate bodies once in the report. I should put that on the record. This is my maiden speech as Chair of the Health Committee and the attendance resembles that for my maiden speech in 1983.
The Committee's report on the influence of the pharmaceutical industry raised questions about how it is regulated and how it regulates itself. As hon. Members know, the pharmaceutical industry is the third most important United Kingdom industry economically after tourism and finance. The report acknowledged its valuable contribution to patient health and the economy. Although I shall mention some problems and some hon. Members might view the industry negatively, I shall put the debate in context by reminding hon. Members of the Health Committee's first conclusion in its report. Paragraph 336 states:
"The UK-based pharmaceutical industry is large, profitable and highly competitive; it has understandably been described as 'world class and a jewel in the crown of the UK economy'. The industry has an outstanding record in developing new medicines, and is a major source of funding of medical research. The industry's products include many life-saving and important drugs which greatly benefit many people and contribute substantially to national health."
However, the Committee had several concerns about medical research, the conduct of clinical trials, medicines marketing, the information provided to patients and prescribers and the independence of the regulatory system. Overriding themes of the report included the lack of transparency in medicines research and regulation, and the potential effect of that on patient safety.
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Mr. Philip Hollobone (Kettering) (Con): I congratulate the right hon. Gentleman on his introductory remarks. He is absolutely right to place the debate in the context of the world-wide demand for pharmaceutical produces. Is not it the case that Britain can hold its head up and be proud of its contribution to improving people's health around the world?
Patient safety is paramount in the use of drugs in this country and it goes to the heart of the Committee's report. If a patient is prescribed one drug rather than another, similar drug, the negative effect on the patient is likely to be minimal. If, however, a patient is prescribed a drug that is linked with negative physical effects of which the doctor is not aware, the results may be far more serious. The regulators, industry and health care professionals have a role to play in ensuring that potential side effects are picked up early in drug testing, made known to doctors and monitored after licensing.
The Committee highlighted the need for better reporting of adverse drug reactions or ADRs. I am pleased that the Department is addressing that. The yellow card system of reporting ADRs is now being rolled out to include patients and all health care professionals, such as nurses, pharmacists, health visitors etc. Previously, only doctors could report suspected drug side effects. Pilot schemes were already running at the time the report was published and final systems will be in place by 2006. A new IT system will improve the detection of signals of a problem with a particular medicine.
Drug-induced illness was recognised by the Government as a serious issue in human and economic terms. The Department of Health and the Medicines and Healthcare products Regulatory Agency have commissioned research to determine the "frequency of medical errors". According to a recent National Audit Office study, medication errors are the second most common patient incident in the national health service.
Mr. Peter Bone (Wellingborough) (Con): It has come to light that one of the problems is repeat prescription provision, especially in the care of the elderly, particularly those with dementia. Although they initially get the right drugs, the repeat prescriptions do not necessarily help them and, indeed, have a negative effect. There is no proper procedure for reviewing those prescriptions at least every six months.
Repeat prescriptions are sometimes numerically limited so that one has one, four or five out of six. After that, it is doctors' clinical responsibility to ensure that they see the patient before any further prescribing of the drug. However, what happens in the real world is not always consistent with that. Occasionally, that is at great cost to the individual concerned, but it is always at great cost to everyone because safety incidents cost the NHS approximately £2 billion a year in bed days in our acute sector. They are problems for clinicians and everyone.
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Paul Flynn (Newport, West) (Lab): The university of Liverpool recently reported that there are at least 10,000 fatal adverse reactions to drugs in this country. Is not it therefore extraordinary that the Government's response to the report does not mention Vioxxthe most recent scandalor Seroxat?
Mr. Barron: I am not aware of the Liverpool report, but my hon. Friend is right about what the Government mention. However, they have been examining the mechanisms around the issues, and I shall consider that later.
The Committee recommended improved post-marketing surveillance beyond ADR reporting. It suggested that more trials of licensed drugs be conducted in real-life situations, but that is not mentioned in the Government's response.
Post-marketing surveillance by the MHRA will be strengthened under a planned reorganisation of the agency. The Government reject the recommendation that drug surveillance be carried out independently of the agency. They say that such a system would
of the marketed drug. I am sure that the Under-Secretary of State for Health, my hon. Friend the Member for Birmingham, Hodge Hill (Mr. Byrne), knows that members of the Health Committee will be watching what takes place.
Dr. Brian Iddon (Bolton, South-East) (Lab): Does my right hon. Friend agree that counterfeit drugs are an increasing problem and that many counterfeit drugs are introduced into our country via parallel trading? Does he also agree that legislation is needed to combat the introduction of counterfeit drugs into the market? Unfortunately the drugs that are being counterfeited are those that are most commonly usedobviously, they are the best sellers, which give the most profit to the counterfeiter.
Mr. Barron: I agree with my hon. Friend. Although the report did not look into the matter in detail, parallel trade and counterfeiting is a problem, not only for the market but for safety and efficacy. It is important that those issues are considered.
Mr. Andrew Lansley (South Cambridgeshire) (Con): Does the right hon. Gentleman agree that we should not assume that randomised control trials designed to establish the efficacy of drugs can always provide the same degree of assurance on a drug's safety? Should not particular importance therefore be attached to the capture of data from whole populations after licensing, to establish the safety of the drug? It would be impractical to undertake that kind of evidence gathering from a substantial population before licensing.
I agree with the hon. Gentleman. There should be more ongoing studies to establish what happens after a drug enters the marketplace, and to determine which drugs are being used. Over the past two weeks, the Health Committee has been looking into expenditure levels in the national health service. The Secretary of State and various civil servants have given
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evidence to the Committee, and we discovered that we often do not know which families of drugs are being prescribed. We need that information to determine certain interactions, perhaps with public health promotion or with people getting assistance in the acute sector. We need to determine whether any great changes have taken place in the level of use of certain families of drugs over the years. We need a big national picture of the use of those drugs in society, because this relates to the money that we, as taxpayers, spendand the taxpayers' money that the Department of Health spendsto try to improve the nation's health. I do not know whether there are any simple correlations in this regard, but when we were taking evidence the other week, we felt that we ought to be able to get an answer to that question.
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