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Julia Goldsworthy (Falmouth and Camborne) (LD): I should like to declare an interest in that I have a slight cold at the moment, so I am probably benefiting from some pharmaceutical products.
Today's debate comes off the back of a report from the Health Committee that was released in 2005—just ahead of the general election, but before the right hon. Member for Rother Valley (Mr. Barron) became Chairman of the Select Committee and before my time in Parliament. Although the report listed a series of concerns and made a series of recommendations, it carefully highlighted the importance of the pharmaceutical industry to our economy. That importance is well understood by Members, because, in some cases, literally thousands of their constituents are employed by that industry. We know that the pharmaceutical industry's contribution to the nation's economy is ranked third only to tourism and finance. We also know that investment made by UK pharmaceutical companies represents 65 per cent. of health-related research and development in the UK, and 10 per cent. of global research and development expenditure.
The industry makes such a marked contribution to the economy because the development and production of drugs has truly revolutionised our lives. The discovery, development and use of drugs has had a revolutionary effect on our lifestyle, life expectancy and our ability to cure and to cope with illness. About 650 million prescriptions are issued each year at a cost of £7 billion to the NHS. Today, it is increasingly believed—I share that belief—that for every ill we suffer, there is a pill that we can pop to cure it.
Despite recognising the important and revolutionary contribution of the pharmaceutical industry, the report highlighted a series of concerns that ultimately stem from the fact that certain issues have been ignored for nearly 100 years and from the imbalanced approach that the Government have adopted to the pharmaceutical industry on the one side and the patient on the other.
As we have already heard, allegations were made about badly designed and biased clinical trials—trials biased towards showing drugs in the best possible light. There is evidence of selective publication of evidence relating to those trials, in which the negative evidence was not made public or full data sets were not published. Allegations were also made about ghost-writing, with
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the names of third-party so-called "independent" academics being added to papers not authored by them. Sometimes their names were added, but they did not have full access to the full data sets on which the reports were based.
Finally, the report highlighted the ever-increasing intensity of the promotion of new drugs that provides incentives for prescribers that are totally unrelated to health outcomes. Press coverage referred to incentives that ranged from winning an iPod if a drug is prescribed to entertaining nurses and doctors at very nice hotels or restaurants. There were justifiable concerns that such practices could end up having a negative impact on patient outcomes.
One problem is the fact that NICE licensing relies on published evidence, but we have already seen that the full data sets are not always published. If negative evidence is not made available, surely NICE is being constrained in its ability to make evidence-based decisions. There are concerns that the lack of an evidence base could lead to the unsafe use of drugs, and that the level of brand awareness has resulted in extension beyond appropriate prescription because of pressures from patients and prescribers.
In response to these concerns, the Select Committee recommendations centred around the need for transparency in the licensing process, for greater independence of assessment, and for greater research into the potentially adverse effects of prescribed drugs, given that up to 5 per cent. of hospital admissions are the result of adverse reaction to drugs. Its final recommendation was as follows:
"In view of the failings of the MHRA, we recommend a fundamental review of the organisation in order to ensure that safe and effective medicines, with necessary prescribing constraints, are licensed."
So the Committee felt that there needs to be much greater balance between promoting the interests of the pharmaceutical industry, and promoting the health of the public and the effectiveness of the NHS. It was felt that those recommendations would help to redress that imbalance.
Unfortunately, in many respects the Government's response, published in September this year, reflects the perpetuation of this imbalance. Many of the recommendations were not acted on, and in many cases the justification given was that the Government did not recognise or acknowledge the problem identified by the Health Committee report. They said that current guidelines and measures are already, or are about to be put, in place to deal with these problems. The result is that the fundamental balance between the patient and the industry has not shifted, although some welcome concessions have been made to improve the MRHA's marketing material.
The industry itself has also sought to improve its practices. The Association of the British Pharmaceutical Industry recently issued new guidelines to help encourage best practice. These are voluntary guidelines that represent a gold standard; they are not backed up by the law. While the ultimate sanction for breaking the code is expulsion from the ABPI, that has never
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happened. The board has never required a company to publish a corrective statement for a breach of those guidelines.
Some of these guidelines are rather vague. For example, although delegates sponsored by companies to attend meetings can travel there and back only on economy flights and must not stay in "lavish" accommodation, it is not clear what is meant by that or what the extent of their stay will be. Of course, many companies will follow these guidelines for reasons of reputation, but the fact is that if they are voluntary, they ultimately lack teeth.
Recent evidence in the press indicates that such problems are still arising. However, they are being dealt with by the MRHA on a case-by-case basis, without any significant strategic or systemic changes being made. A piece in last Sunday's edition of The Observer refers to allegations of ghost-writing; the academic concerned apparently did not have full access to the data sets that the report put his name to. As I have said before, evidence emerged last month of perks for prescribers. They could win an iPod if they prescribed gum disease medication, and some doctors and nurses were entertained at the Groucho club.
Mr. Charles Walker (Broxbourne) (Con): Am I not right in thinking that the new ABPI code of conduct specifically limits the maximum value of these awards and gifts to £6 excluding VAT?
Julia Goldsworthy: I was not aware of that. I am not sure how the ABPI could provide flights to and from seminars at that low value, even given the existence of some very low-cost carriers. There may still be some devil in the detail and of course this code remains voluntary.
Paul Flynn : The new code of practice is entirely cosmetic and has been described by the British Medical Association as lacking teeth. The Drug and Therapeutics Bulletin describes it as fundamentally weak in all respects. It is purely window-dressing to hide the drugs industry's continuing close collaboration with the MHRA, which has been so detrimental to patients.
Julia Goldsworthy: I recognise the hon. Gentleman's concerns, but of course, although the problems associated with patient safety and access to drugs can in some respects be dealt with through improved regulation of the pharmaceutical industry, that is not the sole determinant. It is clear that the Government's behaviour has had a significant impact, and stories in the media have a fundamental impact on the public's awareness of drugs. Moreover, the Government have a major influence on the ability to get new drugs to patients quickly.
We have heard much this afternoon about NICE blight and the delays in the licensing programme, but to what extent are those delays due to NICE? My hon. Friend the Member for Sutton and Cheam (Mr. Burstow) recently tabled written parliamentary questions on this issue, and the answers show that it takes the Government nine to 10 months to produce the list of drugs that is subsequently sent to NICE for licensing approval. That is another part
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of the delay in getting drugs to patients who may need them as quickly as possible. I should be grateful if the Minister explained the reasons for this delay and what measures his Department are implementing to speed up the process.
There is also the apparently contradictory position whereby drugs need to be licensed by NICE before they become widely available, yet in some cases—such as the recent and well-known one involving Herceptin—statements have been made implying that there should be widespread uptake before the licensing process has been completed. What assessment has the Minister's Department made of the immediate and long-term financial implications of making such drugs available? On Herceptin, we know that it is not a question simply of the cost of the drug; there are also costs associated with echocardiograms and ongoing monitoring. Herceptin will of course make a huge difference to some women with early-stage breast cancer, but how do the Government envisage that these costs should be met, given the existing pressures on many budgets? The cost of such drugs is only rising, so what is the long-term sustainability of their prescription? There is a real concern that post-2008, when the increase in NHS funding tails off, funding for many such drugs will experience a hard landing.
Finally, in contrast to moves to increase the transparency of the data—
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