Angela Watkinson (Upminster): I am grateful for this opportunity to discuss an important subject that touches the lives of many different people: patients, their families, health professionals and managers and those in the pharmaceutical industry. The setting up of the National Institute for Clinical Excellence as a central body for the investigation, appraisal and recommendation of drugs, treatments and technologies was well intentioned and welcome. It offers an opportunity to obtain value for money in research through economies of scale and to make the best use of scarce national health service resources. Health authorities and primary care trusts can rely on the efficacy, safety and quality of NICE-appraised drugs and ensure that they are available to the patients who need them and who will benefit from them.
However, it is unclear who decides on the priorities for investigation and how much influence cost-effectiveness has on the institute's decisions. There is a general lack of openness and transparency about the process, methodology and criteria that are used to determine whether a treatment is effective. Realistically, the cost of the treatment should be set against the benefits of an individual restored to good health and able to work and lead a normal life. For example, it is estimated that rheumatoid arthritis costs the country £1.2 billion a year in benefits and lost income. Similarly, multiple sclerosis sufferers could be helped to lead a healthy life if beta interferon were available to them. Appraisal teams rarely include specialist clinicians in the particular field under investigation, yet such investigation would surely benefit from their detailed knowledge and experience. Perhaps the Minister would be kind enough to comment on those points in her summing up.
In theory, NICE should lead to faster take-up of clinically effective and cost-effective new treatments. There have already been many benefits. Since the institute was established less than three years ago, it has published clear and authoritative guidance on the use of more than 30 treatments, including new cancer drugs and treatments for coronary heart disease, asthma in children, diabetes and dementia. The duty of health authorities to implement NICE guidance within three months and make new treatments available should, in theory, eliminate the postcode lottery and make access more equitable. Regrettably, in practice, the variation in patient care that is so counter to the fundamental principles of the NHS persists, for two main reasons.
The second reason is delays. The process of appraisal is far too slow, and some health authorities are using NICE delays as a reason for not prescribing desperately needed treatments. That has become known as NICE blight. For example, following an appraisal process that started in August 2000, NICE has still not published guidance on the use of campto and other treatments for colorectal cancer. Negative NICE guidance would leave patients in Britain with no freedom of use of drug therapies. They would be in a similar position to those in Korea, Russia, Poland and the Czech Republic.
The United Kingdom lags behind many other countries in the uptake of innovative medicines, a situation exacerbated by a paucity of NHS drug funding. The NHS drugs budget allocation in 2000 for all anti-cancer drugs, for all cancers, was only 6.7 per cent. Only one in five eligible patients currently receives campto. The appraisal on its use in the first-line treatment of advanced colorectal cancer has taken far too long, which has serious implications for those already ill.
The condition is reaching epidemic proportions. The results of a second appeal against NICE refusal of camptoa drug of proven efficacybring into question the influence of cost on NICE decisions. There is similar concern over the availability of the breast cancer treatment herceptin, often the last resort for patients for whom other treatments have failed. Too many patients die while crucial decisions are awaited.
Implementation issues are causing difficulty with some areas of NICE guidance. Guidance on drugs for Alzheimer's published in January 2001 recommended that only specialists such as old-age psychiatrists and neurologists initiate and establish the maintenance dose for treatment. In many localities, there is a shortage of available specialists. A larger role for general practitioners who have specialist knowledge of not only the patient but the caring spouse would facilitate the wider availability of those treatments.
I recently received an answer from the Minister to a question about NICE guidance on fertility treatment. That is of concern to a group in my constituency, Couples Having Infertility Problems Solvedor CHIPSwhich is eagerly awaiting the outcome of the NICE investigation. The Minister said:
Although not a life-endangering condition, infertility causes extreme distress to couples. The delay has particular relevance because the biological clocks of the women concerned are ticking away; for some, it will be too late. Without the necessary treatment, those women could remain childless, with devastating results on their future emotional well-being.
Over the years, a plethora of health-related bodies has grown up, including NICE, the Commission for Health Improvement, the National Clinical Assessment Authority and the National Patient Safety Agency. On 10 January this year, the chief medical officer announced a new committee, the National Infection Control and Health Protection Agency. We await the establishment of a new council for quality health care. All those organisations have to work closely with the social services inspectorate, the National Care Standards Commission and the Audit Commission. We seem to be overburdened with bureaucratic bodies. There is an urgent need for greater co-ordination and the avoidance of duplication of effort in the provision of quality public health services in the NHS.
A formal review of NICE has been expected for some time and there has been much debate about how and by whom it should be carried out. It is essential that that review is not concerned only with issues important to the pharmaceutical industry, which contributes so much to medical research in the United Kingdom and to the Government. It must also take into account the views and experiences of a wide range of health professionals, patients and patient groups on how treatments are used and how they work in day-to-day circumstances. More emphasis should be placed on the cost-effectiveness of medicines in terms of outcomes for patients and the implications for other elements of Government spending.
The impact of medicines on patients' quality of life is frequently overlooked, and it is more difficult to measure than cost. Reassurance is needed that NICE is not a cost-containment body. Who makes decisions on the affordability as opposed to the cost effectiveness of treatment is paramount. The success of NICE depends on how its guidance is implemented. Evidence of continued, or eradicated, postcode prescribing following NICE guidance needs to be collated with evidence of health authority and GP compliance with NICE recommendations. Unacceptable variations in care could then be challenged and all patients, regardless of their geographical location, would have equal access to treatment that best meets their needs.
Mrs. Cheryl Gillan (Chesham and Amersham): I congratulate my hon. Friend the Member for Upminster (Angela Watkinson) on a fine presentation of the case against NICE, and on securing a debate on a topic that has concerned many hon. Members, and many of our constituents, over a number of years. I saw the Minister make a face, and I hope that that will not be reflected in her response because I come to this debate with some constructive suggestions from the Multiple Sclerosis Society.
To set the NICE investigation into beta interferon in context, I let the Minister know that I was receiving such papers in my office in 1998 and was passing them on to my constituents with multiple sclerosis. We started an investigation into the drug, and the Department of Health and the National Assembly for Wales asked NICE to appraise beta interferon on 6 August 1999. That appraisal did not happen in 2000, and it did not happen in 2001; it was not until 4 February 2002 that a final result came from NICE. That is an unacceptable length of time for anybody to wait for an investigation into a drug that has received the sort of reports that I have mentioned. Unfortunately, as the Minister knows, NICE was not able to recommend the drug.
At the same time that the Department of Health came out against the drug on the ground of cost-effectiveness, it leapt in to come up with a scheme to make the drug available to our constituents. I do not want to be curmudgeonly about that: we are extremely pleased that the scheme has been introduced, and many people are delighted to be included in it. However, it seems nonsensical that although NICE, which was set up by the Department of Health, opposed the use of the drug, the Department is spending its time finding ways around such decisions.
I agree with the Multiple Sclerosis Society, which has been absolutely fantastic throughout the debacle, supporting its members and providing information to Members of Parliament and other interested parties. The MSS wrote to me saying that it welcomes the Department's proposal but regrets
I want to reflect the concerns of the Multiple Sclerosis Society, which was involved in the appraisal of the disease-modifying drugs for MS for more than two yearstwice the standard length of technology appraisals.
There is no doubt that the appraisal of the drugs was a challenge for the institute. The appraisal of drugs for MS, which is a long-term and complex condition, has certainly tested the robustness of the institute's approach to drug appraisals, but it has thrown into
Mr. Oliver Heald (North-East Hertfordshire): Does my hon. Friend agree that NICE faces the problem of deciding cost-effectiveness according to available resources? The Treasury decides how much money is available, and what is clinically excellent or cost-effective is decided in that context. NICE is not really considering matters with a blank piece of paper; it is forced to look at things from the Treasury viewpoint.
Mrs. Gillan : My hon. Friend is right, and he makes a good point. There is a straitjacket enforced on NICE that is not good for its investigations and operations. I have had constituents who were put on the drug and continued to work and contribute to society. The NICE appraisal does not consider the whole economic picture of how people continue their lives and are productive in society.
There is a gap between the institute's rhetoric about openness, transparency and the patient's perspective, and the actual nature of its structures and practices. That gap undermines the credibility of guidance from the institute among patients and patient representative organisations. The institute's approach is dominated by health economics and is characterised by a heavy reliance on results from randomised control trials. Such trials are necessarily short-term and cannot provide concrete evidence for the drugs, which will be used in the long term. The institute has not yet developed a suitable methodology for assessing the cost-effectiveness of long-term interventions.
I should like to put to the Minister a series of recommendations from the Multiple Sclerosis Society. I hope that when she responds she will do me, and the society, the courtesy of addressing those points. The society believes that a cultural shift is needed so that the critical nature of the institute's decisions and the resulting need to command the respect of the public are reflected in its structures, processes, and the way in which it conducts its day-to-day business. The society thinks that appointments to the institute's partners council board and appraisals committee should be advertised and subject to open recruitment processes. It thinks that the deliberations of the appraisals committee should be opened up by allowing patient representative organisations to observe discussions and by posting detailed notes of the committee's meetings on the institute's website. Those are not difficult recommendations for the Minister to consider. The appeal panel should be replaced with a lawfully constituted, independent body. I do not expect a knee-jerk reaction from the Minister, but I hope that she will give that recommendation long-term consideration and tell me, perhaps in a letter, how it is received.
There should be a public review of the institute's approach to the use of health economics which should examine, for example, the threshold of cost-effectiveness that has been set by the institute, the value of relying on the evidence of randomised, controlled trials, the costs and savings taken into account in appraisals, and the difficulties of assessing cost-effectiveness in the long term. I hope that my hon. Friend the Member for North-East Hertfordshire (Mr. Heald) will accept from
In conclusion, many of my constituents have gone to hell and back over the appraisal. They have had their hopes raised; they have had their hopes dashed. Some have amazingly poignant stories of people who have been unable to afford the drug and whose friends have gathered to raise the money for it and seen results. The Minister will have seen in the newspapers at the weekend the wonderful story of the lady who was able to become a fitness instructor following a successful course of the drug. I hope that the Minister will take the recommendations from the Multiple Sclerosis Society seriously. There has been a lot of pain in the operation of NICE and I hope that she will now learn the lessons from the mistakes and give us the assurance about the institute that my constituents and the MS Society deserve.
Mr. Mark Hoban (Fareham): I congratulate my hon. Friend the Member for Upminster (Angela Watkinson) on securing this debate and opening it in such good style. NICE causes my constituents great concern in the prescribing of certain drugs and, in her opening comments, my hon. Friend referred to its lack of transparency. I want to illustrate that with two examples that I found on the NICE website.
One of the interesting features of the technology appraisal on NICE's website is that it states when the first, second and other appraisals committee meetings were held and the decisions reached, but it does not state when the appraisal process started. It states that assessment of the rheumatoid arthritis drugs etanercept and infliximab started before 6 February 2001, but not the firm date on which it started. It also states that the expected date of issue will be March 2002. One year seems a long time in which to appraise drugs that have already been assessed for effectiveness and safety and been approved and licensed. That is not the worst example of delays in the appraisal of drugs by NICE.
Asthma inhalers for older children are being assessed, and again no start date is published on the website, although those using the devices will be pleased to know that in March 2003, they will know which asthma inhalers are both cost and clinically effective. There has been a huge delay in reaching proper conclusions on drugs that have already been licensed as effective and safe. NICE's original remit was to speed up the availability of drugs and to assess clinical effectiveness, but the two examples that I cited fly in the face of that.
The area that causes me most concern is the change to NICE's remit in August 1999 to assess the cost-effectiveness of drugs within the Treasury's available resources. That sends a message to people awaiting evaluation of those drugs that once NICE has agreed that they are clinically and cost-effective, they will be available to those who need them. However, that is clearly not so, as an answer from the Department of Health suggested a few months ago. It stated that the Government will, in due course, announce plans to
I would like to mention a case, but do not expect the Minister to reply to my comments on it, as I am using it purely as an illustration. One of my constituents, Michael Cooper, is hoping to be prescribed etanercept, a drug that relieves rheumatoid arthritis. That drug is being assessed by NICE. Fareham and Gosport primary care groups sent me a letter to say that, even if NICE decides that the drug is effective, there is also a local process, led by clinicians, for evaluating the safety and effectiveness of new drugs. There is also a third layer of assessment, which takes advice issued by NICE into account. That is another delay in making the drug available to those in my constituency.
A further letter about Mr. Cooper's case was sent to me, and it raises the issue of what happens when NICE approves a drug, and how to fund the prescribing of it within the drug budget available to the local primary care group. I also have a letter from a consultant who works for Portsmouth City primary care trust, which says that we will have to consider carefully not just the benefits to patients from the drug, but what the rest of the population will have to do without in order to fund itthe drug is very expensive. Mr. Cooper hopes that it will deal with his condition effectively, but primary care groups say that they do not have the budget to enable the drug to be prescribed. That is remarkable, given that the Treasury laid down the basis on which the cost-effectiveness of the drug was to be assessed.
I worry about Mr. Cooper's condition. He has had many operations to replace joints and has taken a series of drugs, all of which have been rejected by his body. I spoke to him last night. He has been on morphine, and as his body did not accept the drug that he has tried most recently, he will have to go back on morphine. Etanercept has been licensed for use and is effective and safe, so why cannot his GP or consultant prescribe it privately while the NICE process is under way? That would be a sensible step. The drug must be safe and effective, as it has passed its licensing hurdles.
A consultant in secondary care cannot prescribe the drug unless Mr. Cooper goes private. That is an odd state of affairs for someone who cannot have a drug funded from the local drug budget. Why cannot Mr. Cooper use his resources to meet the cost of etanercept? The letter goes on to say:
We are in an odd situation. We have drugs that are licensed as safe and effective. They are being appraised by NICE and by a local PCG. It is not guaranteed that they will be made available to patients because of the limitations on the drugs budget. At the same time, NHS rules prevent the consultant or the general practitioner from providing those drugs.
That is the crux of the problem. The system adds layer upon layer of control on the prescription of drugs. NICE is acting as a gatekeeper for cost-effectiveness within available resources, but it is still the PCG's responsibility to determine whether it is able, from its restricted drugs budget, to prescribe what can be very expensive drugs. Members of the PCG in my areait is soon to become a primary care trustwill have to decide which drugs should be removed from the list and what changes in prescribing habits should be made in order to fund the availability of expensive drugs that have gone through the NICE process, which is intended to speed up the access and availability of drugs and to remove the postcode lottery.
Mr. David Tredinnick (Bosworth): I am grateful to be called to speak in this debate. It is astonishing that there is no Labour Member present beside the Minister. The Government's establishment of NICE has been attended by so much hope and expectation, and I cannot believe that they have received so little backing from their Back Benchers. My hon. Friends are nodding at that remark from our Back Bench, which is full, because the Conservative party recognises the seriousness of the subject under discussion. We wish to highlight some of the problems that we have encountered with NICE. I will not beat the Minister over the head about itmy hon. Friend the Member for Chesham and Amersham (Mrs. Gillan) has used the word curmudgeonlybut several serious issues must be raised.
NICE was introduced to appraise new therapies so that it can provide the NHS with information to help it to achieve optimum clinical and cost-effectiveness from medicines and other treatments. Therefore, the concept of NICE is positive; it is important that research is carried out into different treatment options to determine whether they should be provided by the NHS.
However, we have heard about the problems of beta interferon and renal cancers, and I want to highlight one of the glaring omissions of NICE's work at present: it has missed the plot with regard to integrated health care. There is a growing movement in favour of embracing what used to be thought of as complementary therapies, and of offering a wide range of them. Sadly, the majority of the technologies that NICE has examined are what might be termed conventional medicine. Little or no time and resources are spent on examining other treatment options, such as complementary medicine.
Dr. Evan Harris (Oxford, West and Abingdon): The hon. Gentleman has mentioned the shortage of high-quality research into some of the treatments that he is talking about, and he has stated that NICE is responsible for funding that, but I am unsure whether that is the case. I acknowledge that there is a call for such research. What role does he think the producers, manufacturers and prescribers of such treatments should play in providing the research base that is so urgently needed in that area of medicine?
Mr. Tredinnick : The hon. Gentleman has made a helpful contribution, as it is important to establish who will provide that research. We face a conundrum, because unless there is adequate research into a medicine, doctors such as the hon. Gentleman are not keen to prescribe it. I hope that I do not do him a disservice by saying that. Until we have a wide database of research, the medical profession will be somewhat sceptical. The Government must take the lead. I agree with him that there is an onus on the industrythose who produce pills and potionsto help, but the Department of Health has an overriding duty to provide information, which should be made available through NICE.
The issue must be examined in context. There are approximately 50,000 complementary practitioners in the United Kingdom. The Department of Health will not solve the health problems in the UK, with the exponential growth of demand on services that is in some part due to an ageing population, unless it brings in some of those 50,000 therapists.
The hon. Member for Oxford, West and Abingdon (Dr. Harris) may correct me, but I believe that there are approximately 30,000 health care professionals in the UKdepending on how they are added upand 50,000 complementary practitioners, most of whom work in the private sector, although some acupuncturists work in the health service. Until the Minister and her colleagues instigate wider use of complementary therapies in the health service, the supply of practitioners will be insufficient to deal with the demand for services. That is a fundamental point.
Complementary therapies are often a fraction of the cost of expensive drugs. I do not suggest that such drugs are unnecessary, but we should not ignore less expensive remediesa point that I will develop with regard to beta interferon.
Mr. Heald : Does my hon. Friend agree that in the treatment of mental health, a combination of treatments, such as the use of modern drugs with sport, reflexology massage or other such alternatives, provides the best way forward? Is he aware of MIND's "My Choice" campaign, which highlights the importance of the availability of a range of therapies to those with mental illness?
When the House was not sitting the week before last, I visited a high-security prison in Hollesley bay, Ipswich, where I saw how a range of therapies are used on prisoners who have received life sentencesI met one whose sentence was 20 years. Reiki, the Japanese system of using symbols to stimulate people to channel energy, is effective. Whether one believes that energy to be from God or the universe or whatever, some people can channel energy through their hands. I met 10 prisoners, and every single one said of their own volition that they had benefited from such treatment and that, when they were locked up in their cells at night, it was the one thing that they could practise themselves.
The use of Reiki is an example of what my hon. Friend the Member for North-East Hertfordshire (Mr. Heald) mentioned. It is effective for the treatment of mental health, especially in prisons. Most prisons in the midlands use a range of therapies to help reduce tension. Acupuncture is a key treatment. Indeed, I spoke to the deputy chair of the Hinckley magistrates bench on Friday about its effectiveness in prisons.
I remind the Minister that in mainstream complementary care there are approximately 2,000 acupuncturists, 7,000 aromatherapists, 16,000 healers, 800 herbal medicine practitioners, 2,000 homeopaths, 3,000 hypnotherapists, 8,000 massage specialists, 1,000 naturotherapists and nutritionists, 13,000 reflexologists, and 2,000 yoga practitioners. Will the Minister ask the management of NICE to investigate thoroughly such disciplines, which have existed for a long time? Traditional Chinese medicine and acupuncture have been around for 3,000 years.
In a Westminster Hall debate the other day, I pointed out that there are 60,000 hospitals in the People's Republic of China using Chinese medicine. We are told that we need more evidence to support such medicine, but it has existed for 3,000 years. Who are we kidding? The evidence is there, but the problem is that we have not looked for it. Much evidence that is published is often ignored. Masses of evidence exist about therapeutic touch and healing. Matthew Manning and others have written books and conducted surveys that are not considered. The Minister must consider such material.
Dr. Harris : I always listen to the hon. Gentleman with interest; sometimes he provokes me, although he does not mean to. Does he think that books on therapeutic touch and healing, which he described as research, meet the standards of research that pharmaceutical drugs must satisfy? Those drugs are tested by randomised, double-blind, placebo-based and long-term trials, in which many people are involved. Does he recognise that several of those qualities are required for research to be understandable, reproducible and valid?
The way in which the trials are set up is important and a matter on which the Government should expend time and energy. NICE may be able to interface with the database that was complied by the Research Council for Complementary Medicine. There are 75,000 research references for complementary and alternative medicine. I do not have the papers in front of me, but I am sure that I have written to the Minister, the Secretary of State or another Minister in the Department about the need for funding of that database. I have spoken in Parliament on behalf of the integrated health care movement for 15 years. The sums of money that would be required are small: £10,000 here and £100,000 there.
The Minister must address the regulation of complementary therapiesNICE may wish to take that on board. Osteopathy and chiropractic are in mainstream medicine. There was a big worry about the cost of regulation to the practitioners. That worry is approaching for traditional Chinese medicine and western herbal medicinephytotherapy. Professor Pittillo is on the new committee that the Department of Health set up to sort this thing out. The Minister should talk to him because his life will be much easier if the Government find £1 million to help people pay for the regulation.
If any of my colleagues think that I am taking up too much time, I hope that they will interrupt me, but I understand that I have a little leeway this morning. That is unusual because one is usually under considerable pressure in this Chamber.
The Minister's life would be easier if she considered the wheels of regulation, which doctors such as the hon. Member for Oxford, West and Abingdon are keen on because they like regulated complementary practices. If the Minister wants to reach that point, she must help people through the hoops by providing a few pounds to lubricate the wheels. I am not talking about multi-million pound trials, but £10,000 here and £100,000 there. We must bear that in mind in the context of the massive budgets of the Department of Health.
Mrs. Gillan : I am listening carefully to my hon. Friend. His argument comes down to the input to appraisals of voluntary organisations that represent a substantial transfer of funds from the charitable to the statutory sector, and that should be recognised by the Department. The institute should possibly extend to voluntary organisations that are involved in technology appraisals the practical support that it intends to offer to
Mr. Tredinnick : My hon. Friend has done tremendous work on multiple sclerosis with the Multiple Sclerosis Society. She speaks with eloquence and has great knowledge of the subject. She is right to look at other aspects. We are in a new health paradigm. People are going to doctors, such as the hon. Member for Oxford, West and Abingdon, saying, "Doctor, I want to try homeopathy." It is no good doctors saying that, although they do not know anything about that treatment, it will probably not do any harm. Patients now demand that doctors know about different therapies. My hon. Friend's point about the transfer of responsibility for such practices from voluntary organisations to the Government again illustrates the need for the Government to take the whole range of services very seriously. We are talking about service providers coming into the health service.
The Government need to focus on the fact that a vast number of doctors do not have much idea of how to refer patients to other practitioners such as those that my hon. Friend the Member for North-East Hertfordshire mentioned when he spoke about mental health. They must take on board the fact that many treatments are multi-treatments. Most of the people working in complementary, integrated medicine, which I understand best, are multi-discipline practitioners. Homeopaths are often experts in Bach flower remedies, which work at a mental level. They tend to help people with depression or those who have difficulties in managing their lives. For example, oak or olive may be taken to give strength to someone who is run down. The high levels of the bush and American flower essences are all valuable tools. However, far too few, if any, medical colleges offer courses for doctors so that they can understand how to interface with this world.
Many years ago, I did a masters degree in business administration, which some think makes people a master of absolutely nothing and an understander of little. I can see hon. Members smiling at that description. Hopefully, I gained some understanding from such studies. Having spent a few weeks studying a range of subjects, I did not necessarily become a great expert. However, that does not matter. What people need to know is where to look when they need help. I shall never be an expert on economics. I do not speak in the House about economics, but I know when to contact an economist.
Doctors need to be able to say, "We cannot fix this skin problem. We have tried steroids, but the patient has not responded." That certainly happens at the George Eliot hospital, a massive national health service hospital in Warwickshire. It has brought in a homeopath, who specialises in skin conditions. He is not getting the easy patients, but those whom no one else can treat. There are worries about steroid creams, but homeopathy and traditional Chinese medicine, in particular, deal effectively with skin conditions. I could give the Minister chapter and verse about such matters.
We must not get fogged by the terminology. We have intuition, which derives from the right side of the brain. The left side of the brain deals with thinking clearly. We have lost much of our right-side intuition, which can be observed in animals sensing fear. A very effective way of preventing deer from eating roses, if anyone ever has that problem, is to put lion dung in the beds. Deer, who have not seen lions in England for 1,000 years, know if they smell a lion that they have to get away. That is intuitive and instinctive. We have lost that and we need to return to it.
My hon. Friend the Member for Chesham and Amersham, who has carried out so much work on multiple sclerosis, referred to beta interferon, as did my hon. Friend the Member for Upminster (Angela Watkinson). NICE's decision on beta interferon is very controversial. What is just as controversial is the failure to investigate the effectiveness of acupuncture in relieving the condition. That is not some crazy moon therapy of which no one has heard. The therapy has been around for 3,000 years and is practised in 60,000 hospitals in a country that comprises a fifth of the world's population. We are not considering it, and we must.
We have referred to costs, which are crucial to the national health service. We have already been told that new Labour has blown it on its existing budget, and is returning to tax and spend. That is now Labour's policy. It cannot fix the health service. It has tried to, but will have to spend more of people's money. The Minister would not have to spend quite so much if she considered other treatments. Acupuncture treatment is incredibly cheap. All one needs is a set of 14 to 20 needles per patient. They are terribly cheap; one uses them once and then throws them away. The expense lies in training the practitioners, although even that is cheaper. NICE should consider that.
The cost-effectiveness of medicines and the outcomes for patients, to which my hon. Friend the Member for Upminster referred, represents another straw in the wind. The Government must consider the cost. I am minded to table questions to the Chancellor of the Exchequer asking whether he has investigated the cost comparisons of the different medicines. Perhaps the Public Accounts Committee should consider that. I may ask my right hon. Friend the Member for Haltemprice and Howden (David Davis), who chairs that Committee, to consider it. The costs are completely different, and out of line. We ignore that and we should consider it: it is terribly important.
Last week, we launched the parliamentary group on integrated and complementary health care, which replaces the one on complementary and alternative medicine that was set up in the 1970s by my hon. Friend the Member for Stone (Mr. Cash) with the former hon. Member for Erewash, Peter Rost, in order to create awareness. People are now very aware. A vast amount of the population is using such therapies and the Government are lagging. They need to wake up because we are undergoing a seismic change in health care in Britain as primary care trusts take over from the old health authorities. Many of the novel therapies offered under the old system have been done away with as the new system tries to bed in. More information provided through NICE and a greater number of inquiries would go a long way towards alleviating such problems.
It is rare that one gets a chance to say more than one hoped to in a debate. I hope that I have not monopolised the available time too much. I am grateful for the indulgence that my hon. Friends and hon. Members have shown in listening to me for so long.
Dr. Evan Harris (Oxford, West and Abingdon): It is a privilege to be here to discuss such an important issue. I see that the Minister is on her own on the Labour Benches, but she makes up for her isolation with her enthusiasm, and we look forward to her contribution.
It should be pointed out that the Select Committee on Health is, or has recently been, abroad. That is why many people who might otherwise be present, including Government Members, are not. My hon. Friend the Member for Romsey (Sandra Gidley) would almost certainly have been here and might have been speaking were it not for the Select Committee's travels. It is particularly appropriate that we have in the Chair a distinguished former Chairman of the Select Committee, the hon. Member for Macclesfield (Mr. Winterton). He can see that we are discussing things that that Committee has discussed over many years.
It is appropriate to put on record that I am an Industry and Parliament Trust fellow with what is now GlaxoSmithKlineit has gone back and forth through several name changes. I also went on a national health service study trip, funded by the company then called Rhône-Poulenc Rorer, to the American Society of Clinical Oncologists some years ago, to examine rationing of health care treatments.
We have had a fascinating debate. The number of treatments spoken about demonstrates the pressure on NHS budgets. We have heard calls for more spending on and funding for treatments for rheumatoid arthritis, multiple sclerosis, infertility and cancer, to name but a few. Those calls are all appropriate, but involve saying that greater priority should be given to those conditions. Politicians must realise that, when there is a limited budget, a call for priority to be given to certain treatments or alternative treatments is by definition also a call for less priority to be given to something else. We must be careful about falling into that trap.
Dr. Harris : Of course I accept the hon. Gentleman's point and shall deal with those issues when I discuss how to measure cost-effectiveness. However, it would be difficult, and a dangerous policy, to rely on increased spending on effective treatment and on the identifiable release of funds in order not to put pressure on the budget when more spending in one area is called for. The corollary of that would be that we could only spend more on certain drugs when they could be shown to release funds, although there might be arguments to spend more on treatments and drug therapies when that did not release funding elsewhere. Meeting unmet need is something that we do not do well. I suspect that much Government policy is designed to ensure that we do not identify unmet need in case that requires funding for which savings cannot be made from existing treatments because there are none.
Dr. Harris : I understand the hon. Gentleman's point that investing in modern treatments and early intervention can cause long-term savings. I do not dispute that. However, if he is saying that we should give extra resources only to areas, such as the one that he mentioned, where that might cause the release of funding not just in the health service but elsewhere, he is on tricky ground. It is often hard to prove that that release of funding will happen, and one should not have to go as far as that hurdle. I hope that he will recognise my point that increased priority for treatment for certain conditions within existing budgets will create pressure because health authorities cannot grab Home Office or Department for Work and Pensions budgets and the savings therein.
The other temptation that we must avoid is engaging in NICE bashing. A number of public submissions to the Health Committee inquiry into NICE said that it is a reasonably well run organisation, and those submissions came from people who might have had an axe to grind. I am certainly not going to indulge in NICE bashing; politicians' behaviour, and particularly Ministers' policies in that area, makes them far more eligible for bashing.
I congratulate the hon. Member for Upminster (Angela Watkinson) on her speech introducing the debate, and I thank her for bringing the issue before us. If she does not mind my saying so, she should be congratulated on identifying many key issues that we have toand want todiscuss, such as who appraises what goes forward, the lack of transparency on cost-
The hon. Member for Chesham and Amersham (Mrs. Gillan), who is no longer in her place, has done sterling work with the Multiple Sclerosis Society, to which I also pay tribute. It is a fantastic campaigning organisation which has kept the issue of the appraisal of beta interferon in the public domain to a greater extent, in terms at least of numbers, than might otherwise have been so, given competing priorities for media attention. That has put pressure on the Government, who responded with a quasi-trial, a quasi-subsidy and a quasi get-out arrangementa sort of sale or return scheme.
I should be grateful if the Minister answered the following question, and I should like an undertaking from her that she will do so either in her response or in correspondence. She announced a proposal to make beta interferon available, where it had been shown to be effective, on a reimbursement scheme. What negotiations had she had with the drugs companies that would supply the drugs, and had they reached a conclusion when she made that announcement just before the Friday on which the NICE verdict on beta interferon was announced? I question whether she was able to gain maximum value for money in subsequent negotiations if she had committed the Government to that policy.
I am glad to see the hon. Member for Chesham and Amersham back in her place. I was just appraising her contribution and asking whether the Minister can be sure that she got maximum value for money from the drugs suppliers given that she announced the scheme before it had been agreed with the pharmaceutical industry. Was the Minister not over a barrel having made that announcementwhich I suspect was made in order to pre-empt what she might have considered to be bad news on the NICE finding?
The hon. Member for Fareham (Mr. Hoban) gave a perfect example of NICE blight in the field of access to anti-rheumatoid arthritis drugs. That such drugs were under appraisal gave greater cover for those who look after tight budgets in resisting their wider prescription. Furthermore, because those treatments are available to the better off who can buy them privately if they have their whole treatment privatelya distinction that the hon. Gentleman was careful to makeand given that NICE has ruled that some drugs should not be available on the NHS or there is a policy not to prescribe such drugs until the information is available, there are issues of equity to consider.
The Government entitledI think satiricallythe White Paper in which they introduced the concept of NICE, "Faster Access to Modern Treatment". Whether it is a good thing or a bad thingI say that it is a bad thingmost people in the field recognise that, effectively, the Government have delivered slower access to modern and effective treatments, which they must recognise as a tool of rationing.
As I have said before, the placebo effect is important in medicine and worth buying. Indeed, much of what the NHS provides through what may be called the white-coat effect is a placebo. However, there are ethical difficulties in saying that something has a pseudo-scientific mode of working when all that one is generating is, in fact, a strong placebo effect. If one explains that the treatment is a placebo, one undermines its effectiveness but at least one is being honest. There is a difficulty with treatments that have an effect but for which the mode of working is, clearly, scientifically nonsensical. A balance must be found between achieving the effect that one wants and being honest with the patient, particularly if one is taking their money at rates that presumably support the industry. At some point, the hon. Gentleman must recognise and address the need for that balance. One could say much more on the subject; undoubtedly, we will return to it in future debates.
I should like to use my remaining limited time to discuss three issues: effectiveness, cost-effectiveness and affordability. The National Institute for Clinical Excellence was set up to consider the effectiveness of treatments. I do not question whether that is appropriate. It was also set up to consider cost effectiveness, which is a question of rationing. I am aware that the hon. Member for North-East Hertfordshire (Mr. Heald) is concerned about the time. I will finish soon, although I have taken several interventions, including his.
I do not think that there is any doubt that NICE should consider cost-effectiveness, as long as it looks at it in the round and not narrowly in terms of health budgets only. We must get a handle on some of the long-term measures of cost-effectiveness that the hon. Member for Chesham and Amersham mentioned, and drug companies have a duty to ensure that their trials consider long-term effects on health economics.
However, I disagree with the Government's imposition of an affordability test on NICE. I first raised the matter in 1999, when the Government snuck through an amendment during the recess to the statutory instrument that set up NICE. They argued that NICE had to take affordability into account. However, it is not for NICE but for politicians who raise taxes for and from the health service to say what is affordable. Unless the Government recognise that they are, effectively, approving a way of rationing, they cannot escape the charge of blame shifting, especially if they urge and force health authorities to fund treatments approved by NICE without providing sufficient funds. They are robbing Peter to pay Paul.
We may end up with a tyranny of the appraised, in which medicines and other treatments that have been appraised by NICE get all the funding at the expense of other effective and important treatments. Those are the key issues that we must address when discussing NICE. I look forward not only to the Minister's response but to what I expect will be the even more balanced approach of the Select Committee.
Mr. Oliver Heald (North-East Hertfordshire): I agree with the hon. Member for Oxford, West and Abingdon (Dr. Harris) that describing the work of NICE using the words "faster access to modern treatment" is ironic at best.
I congratulate my hon. Friend the Member for Upminster (Angela Watkinson) on securing this important debate. She launched it by referring to her constituents' concerns about the delays in introducing infertility treatment and colorectal cancer drugs. We have been waiting more than a year for determination of the appeals.
My hon. Friend the Member for Chesham and Amersham (Mrs. Gillan), who has a particular interest in multiple sclerosis and beta interferon, said that some of her constituents had been "to hell and back" over the issue.
My hon. Friend the Member for Fareham (Mr. Hoban) spoke about his constituent, Mr. Cooper, who has rheumatoid arthritis. He described the operations to replace joints that his constituent has had while waiting for drugs that should be available but are not because of NICE procedures. His constituent is frustrated that he cannot even pay privately to receive the treatment that would ease his condition.
My hon. Friend the Member for Bosworth (Mr. Tredinnick) described in his important contribution the benefits of integrated health care. Although it does not relate solely to NICE's work, it is important to note that in the treatment of mental health, as with other conditions, one treatment may not be the answer and a range of treatments may be necessary. A choice should be available. I make no apology for again mentioning the MIND campaign, "My Choice", which is making the very point that, in dealing with mental health, modern drugs coupled with sport and other treatments such as massage, reflexology and so on often make the difference for patients.
The starting point for our debate must be to examine why as the most innovative country in modern medicine in Europewe invent the most medicineswe are the slowest to allow patients to receive the benefits of those medicines. It is appalling that a country as innovative as Great Britain should be in that position.
We all agree that it is good to have a body that can describe excellence and that cost effectiveness should be part of that equation. However, as my hon. Friend the Member for Fareham said, when the Government decided that cost-effectiveness must be judged within available resources, as they did in August 1999, the pass
I agree with the hon. Member for Oxford, West and Abingdon that NICE's work should be praised. The Royal College of Psychiatrists described it as a well managed organisation with capable officialsI agree with thatand talented staff. It referred to it as an
The Government have stated recently, in the light of the Bristol royal infirmary report, that guidance will be issued without Secretary of State approval. That is supposed to suggest a new independence for NICE, but the fact remains that it decides what is clinically excellent on the basis of how much money the Chancellor will allow to be spent. It is a corruption of clinical excellence to require decisions to be made on the basis of Treasury-led concerns.
My hon. Friend the Member for Upminster referred to beta interferon, which NICE was forced to conclude was not a treatment that should be made available. During the trials in Europe, it became so obvious that it should be made available that the trial was stopped and the drug was given to those who had been receiving the placebo. In the face of such evidence, NICE was forced to state that that important therapy should not be available here because the Chancellor had not allowed enough money to make it available. Only when the Government were desperate owing to the publicitythat is what matters to this Governmentdid they manage to cobble together a compromise that, if the drug companies would treat its use as a trial and risk could be shared, they would allow beta interferon to be made available for a limited period to see whether it worked. The Government were hoist with their own petard. They had insisted that NICE be a rationing body, and when it did the rationing, they were so shocked by the effect that they had to scrabble around to find a solution through the back door to enable people to receive the drug to which they were entitled. It is all very well and good talking about guidance issued without the Secretary of State's approval, but that depends on what the Treasury can afford.
It has been said that there will be a statutory obligation to make funds available. However, as my hon. Friend the Member for Upminster pointed out, a mid-year determination can create a difficulty for the health bodies. Much criticism has been made of whether the NICE guidance, even if coupled with a statutory obligation to make funds available, will be followed, because there are competing bodies in the area. The NHS centre for reviews and dissemination and the "Drug and Therapeutics Bulletin" are in the public sector and are capable of giving different advice on drug therapiesand they do just that. For example, they gave different advice on relenza. Ultimately, the buck stops with the clinician. The law is clear that it is up to
Many health authorities or trusts have no procedure whereby they can monitor the implementation of the guidance. Recently, CancerBACUP undertook a study that showed that only 47.5 per cent. of health authoritiesas they then wereand primary care trusts have monitoring policy. Does the Minister accept that there is a need for a serious review of NICE? When I asked a parliamentary question about it in December, the answer was that the review that was promised in March 2001 would be considered in the light of the Bristol royal infirmary and Select Committee reports that were being undertaken. Will there be a full and proper review? If so, when?
Will the Minister confirm that the review will cover some of the important issues that have been outlined today? Will it deal with how cost effectiveness is quantified and measured? There is no doubt that, as the interim Wanless report made clear, a much wider assessment is required than that which is carried out by NICE at present. On mental health, the Wanless report estimates the cost of modern, world-class mental health services at £3.2 billion. It makes it clear that it is not unreasonable to set against that the
Will the Minister confirm that NICE simply considers the drugs budget and the quality of life for the individual patient on the basis of QALYsquality adjusted life years? If we can achieve from a treatment at a cost of less than £30,000 a quality adjusted life year, it passes the test. If it costs more than £30,000 a year, that is tough luck. Will she establish that that is how the system works at present and that it is as crude as that?
Will the review cover NICE blight and whether it should be merged with other bodies? Will it deal with the timing of appraisals? Who will decide when technologies will be up for appraisal? No one seems to know who makes such decisions. Will she comment on why her Department has published a report called "Faster Access to Modern Treatment" and has established NICE with the result, as I said at the start of my remarks, that patients in the most innovative country in Europe have the slowest access to modern medicines?
The Parliamentary Under-Secretary of State for Health (Ms Hazel Blears) : I shall do my best to respond to all the issues that hon. Members have raised in the time available to me. If I do not manage to respond to some of the important and interesting detailed issues raised, I undertake to do so in correspondence.
I congratulate the hon. Member for Upminster (Angela Watkinson) on securing the debate. All those who spoke raised important and complexnot to say difficultissues to be resolved. I am pleased that the debate is taking place in the context of the inquiry into
The hon. Lady said at the outset that the setting up of NICE was well intentioned and welcome. I was a little sceptical of the remark made by the hon. Member for Chesham and Amersham (Mrs. Gillan) that the hon. Member for Upminster had outlined the case against NICE; clearly, she had not. She voiced some reservations and concerns, but welcomed the establishment of NICE, and her comments were echoed by many other hon. Members who mentioned the way that NICE is run, the high quality of the people involved, and the way in which they are grappling with difficult issues.
The hon. Lady asked who decides the priorities and whether there are any specialists on the appraisal panels, before going on to discuss funding issues. The NICE process provides for expert views to be taken into account in many ways. The royal colleges and specialist associations make submissions to the NICE appraisal committee; those submissions provide the process with expert views. The appraisal committee also invites experts in technology to attend its meetings and give evidence. It is crucial that the best evidence is available to the appraisal committee during its consideration of such matters.
In the early days of NICE, concern was expressed about who decides the priorities and about the transparency of the selection process. That is one of the reasons for the launch tomorrow of a consultation paper on the processhow technologies are selected for appraisal, how they are considered, and who considers them. I urge the hon. Members who asked questions about the operation of the process to respond in detail to that consultation.
Ms Blears : My understanding is that that review, which was originally referred to in January last year, was proposed in the context of the pharmaceutical industry competitiveness taskforce. The industry had voiced concern about the way in which procedures were selected and about the process for appraising them. The consultation to be launched tomorrow will pick up many of those issues.
The Bristol royal infirmary report raised different issues. It dealt not with competitiveness or the way in which technologies were selected, but with the independence of NICE and the way in which it interacted with the rest of the health service. Those issues, too, have been raised by hon. Members today, and they are picked up in the response to the Kennedy report. The review will be about the selection process, how the topics are considered and the sorts of evidence submitted.
The hon. Member for Chesham and Amersham raised a series of Multiple Sclerosis Society recommendations on cultural shift, the membership of NICE and, in particular, the involvement of patients' representatives and the perspective of users on the
The hon. Member for Upminster expressed her worries about funding, and several hon. Members mentioned the possibility of mid-year determinations that could cause difficulty for primary care trusts and strategic health authorities when planning ahead within their allocations. Increases in the general allocations for health authorities and primary care trusts are occurring at a rate faster than any we have known before. Since 1997, health spending has increased by a third in real terms, and by 50 per cent. in cash terms. It is right that primary care trusts and health authorities that represent local communities are the bodies that plan ahead and decide how to meet the funding requirements for new treatments and technologies that emerge from the NICE process.
It is fair to say that mid-year determinations and items coming out of the blue will be very rare. The processes are generally long term, involving research, licensing and the development of ideas. Most people involved in health will receive pretty good notice of what is to come on stream, and they should plan how to fund that with their partners.
Several hon. Members mentioned so-called NICE blight. I assure them and the public that funding authorities are expected to use their existing prescribing arrangements and examine evidence of clinical effectiveness when considering the funding of any treatment being appraised by NICE, or of a treatment for which no appraisal has been commissioned. NICE should not be used as an excuse not to provide treatments. Health expenditure is rising significantly and procedures should be determined using the clinical views of GPs and those who are involved with their patients.
The hon. Member for Chesham and Amersham raised the issue of beta interferon. I am glad that she has welcomed the scheme that was set up to allow thousands of people to access beta interferon. The scheme is about creativity, imagination and taking an innovative and novel approach. That is in the best interests of patients in this country.
Turning to the comments made by the hon. Member for Oxford, West and Abingdon (Dr. Harris), I understand that negotiations with companies did not commence until after NICE had made its determination. That clearly answers the points that he raised.
The hon. Member for Fareham (Mr. Hoban) expressed concern about the three-month statutory period for the implementation of the decision set out in our manifesto to ensure that the system has teeth and that if NICE makes a decision, health authorities and primary health care trusts are obliged to implement it. I am delighted that that is now the subject of a direction
Generally, I tell hon. Members that deciding what can be afforded and assessing the cost-effectiveness and clinical effectiveness of procedures are complicated matters for mature discussion among all parties. We live in the real world in which there are some financial constraints on health expenditure, but I am happy to say that under the current Government those constraints are much smaller than they were.
I come now to the points made by the hon. Member for Bosworth (Mr. Tredinnick). In principle, NICE may consider complementary therapies, provided they satisfy the criteria. The technology advisory group considers proposals, and anybody may submit ideas to that group: if the hon. Gentleman or those he represents wish to submit projects for appraisal, they can do so. We want the consultation process that will be launched tomorrow to make the selection process more transparent and open, to allow more people in different fields to submit ideas to NICE. The hon. Gentleman said that just being around some people increases our sense of well-being. Unfortunately, the opposite is sometimes truebut not of him.
The hon. Member for North-East Hertfordshire (Mr. Heald) asked about rationing and the budget. He must acknowledge that under the Labour Government health expenditure is increasing faster than ever before. Unless his party is prepared to match our health expenditure, it is pretty contradictory and an example of wanting it both ways to say that everything should be implemented with no limit on expenditure.
I am delighted that the hon. Gentleman welcomes NICE. It is not about reducing expenditure, because approximately an extra £300 million will be spent this year as a result of implementing NICE guidelines: for example, 9,000 women will get drugs for breast and ovarian cancer, 10,000 people will get drugs for cancer, 77,000 patients will get drugs for coronary heart disease, and 72,000 will get drugs for diabetes