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It is vital that the definition of crime remains the same across those pieces of legislation and in the Bill we are debating today. Such a uniform definition is fundamental to the efficient use of fingerprints and samples. As long as fingerprints and samples are obtained legally and retained legally, their subsequent use for the prevention and detection of serious crime must be of the utmost importance. As I have already said, samples are shared internationally only for the most serious crimes and where this definition has been in operation since 2001. The number of requests received from all other countries to check profiles from unsolved serious crimes or for the identification of an unknown deceased person believed to be a United Kingdom national for the year 2007-08 is 727.

It would be an anomaly for the definition in this legislation not to remain the same as that in other legislation concerning the retention and use of fingerprints and samples. What is more, given the nature of the samples held on this database, the ability to share them during investigation of the most serious crimes is likely to be of great utility to the United Kingdom as we work to build up a clearer picture of the criminal and terrorist networks which entwine and span the globe. It is important to remember that the number of samples covered by Clause 18 is very small. The number

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of officers who have access to those samples is limited and all are subject to stringent vetting processes. The samples subject to Clause 18 will be classified as secret and, as such, they will be closely guarded. Where these samples are shared internationally, it will be only for the most serious offences, in the very limited circumstances I have set out and subject to anonymisation.

We can all agree that it will be in the national interest to bring to justice those who have committed the most serious offences and we must do all we can to assist in that. I can state absolutely categorically to the noble Baroness, Lady Miller, that such material would not be with regard to drinking or other very minor crimes in this country. Historically, that has not been the case. I hope the noble Baroness is able to withdraw her amendment.

Baroness Miller of Chilthorne Domer: My Lords, I thank the Minister for that very helpful and full reply. He set out the guidelines, when they will be revised, how they will be applied and police attitudes generally to this legislation. I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Amendment No. 4 not moved.]

NHS: Access to Medicines

4.23 pm

The Parliamentary Under-Secretary of State, Department of Health (Lord Darzi of Denham): My Lords, with the leave of the House I shall repeat a Statement made by my right honourable friend the Secretary of State for Health in the other place. The Statement is as follows:

“With permission, I would like to make a Statement about Professor Mike Richards’s review of current policy concerning NHS patients who wish to pay for additional private drugs.

“I would like to begin by paying tribute to Professor Richards and his team for the diligence with which they have conducted this review. The report is informed by evidence from thousands of patients, carers and clinicians across the country, and was completed with necessary urgency, but without in any way compromising its thoroughness. The time scales I set were deliberately challenging because this is an issue that is causing great concern and distress to a number of patients and their families.

“The terms of reference for this review were to examine current policy relating to patients who choose to pay privately for drugs that are recommended by their clinician but not funded by the NHS and who, as a result, are required to pay for the NHS care that they would otherwise have received free of charge. I also asked Professor Richards to make recommendations on whether policy or guidance could be clarified or improved. Professor Richards quickly identified the underlying causes of the problem. His review starts from the fundamental principle that the NHS provides a universal and comprehensive service to all of its patients, free at the point of need.



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“During the Second Reading of the 1946 NHS Bill, Nye Bevan described the financial anxiety endured by people seeking medical help as the first evil that the NHS must vanquish. Yet Professor Richards’s report shows that access to certain treatments on the NHS, particularly drugs for the terminally ill, is inconsistent, and, as a result, a very small number of patients feel that they have to pay for additional treatment and are worried that in doing so they will jeopardise their entitlement to NHS care.

“The report makes recommendations not only to revise the guidance for these exceptional and rare circumstances, but to improve access to certain drugs on the NHS, reducing the need for such patients to resort to private care. His recommendations are accompanied by proposals put forward by Professor Sir Michael Rawlins, chair of the National Institute for Health and Clinical Excellence (NICE), to employ greater flexibility in the appraisal of certain treatments, specifically those relating to drugs for the terminally ill. I accept Professor Richards’s recommendations in full, and today I can announce two immediate developments to make more drugs available on the NHS to those who will benefit from them.

“Since it was established in 1999, the National Institute for Health and Clinical Excellence has ensured not only that many thousands of patients benefit from access to the latest treatments, but that the taxpayer gets value for money. NICE provides wholly independent and scientifically rigorous assessments of the latest medicines and treatments, and is widely admired across the world for its work. Its guidance on drugs and treatments is internationally respected, and many other countries are adopting similar models.

“The price of the drugs that NICE assesses is a matter for the manufacturers. I can also confirm today that I am working closely with the pharmaceutical industry on new and more flexible pricing arrangements that will increase patients’ access to new drugs. These arrangements will include enabling drug companies to supply drugs to the NHS at lower initial prices, with the option of higher prices if value is proven at a later date. The new arrangements will also build on patient access schemes already developed for particular drugs. This will help to ensure that patients can access medicines that would not otherwise have been deemed cost-effective by NICE. I expect to be able to say more about this shortly.

“In addition, NICE itself has for some time been concerned about its ability to take into account the premium that society places on helping those with terminal illnesses. Professor Sir Michael Rawlins has written to me to outline a new, more flexible approach to the appraisal process in order to address these concerns. NICE proposes to introduce more flexibility in the evaluation of higher-cost drugs, which have been shown to extend the lives of terminally ill patients, and where the less common nature of a particular condition may mean that the more flexible pricing arrangements we are discussing with the industry are not in themselves sufficient. The proposal

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will be implemented immediately while NICE holds a full consultation. These two measures will ensure that more treatments, which in the past patients may have been able to access only privately, will be available free on the NHS.

“The work of NICE is necessarily complex, but as we highlighted in the cancer reform strategy, it sometimes takes too long. Its appraisal guidance has often not been available for two years or more after a drug has been licensed. Steps have already been taken to address this with, for example, fast-track procedures to automatically appraise significant new cancer drugs. But the time it takes NICE to publish guidance can lead to a significant local variation.

“In response to Professor Richards’s report, I am today setting out a new timetable to speed up the appraisal process for all drugs evaluated by NICE. In 2009, draft or final guidance will be available within six months of licensing for about half of the drugs that are being appraised through the fast-track single technology appraisal programme. In 2010, draft or final guidance for all new cancer drugs will be available on average within six months of a drug being licensed. We will work with NICE to explore further ways of speeding up the appraisal process, with the intention of announcing the outcome of our work early in the new year.

“All these measures will dramatically reduce the instances where a drug is available on the market but primary care trusts have no guidance from NICE on which to base their decisions about funding a particular treatment. However, we cannot totally eliminate instances where primary care trusts have to make decisions in the absence of NICE guidance altogether. Professor Richards has found that patients and professionals often are not clear who is taking such decisions or how they are making them. Patients and their families are often left bewildered as to why a particular treatment has been denied, despite what they see as a clear clinical need. As we highlighted in the NHS constitution, we need to do more to improve the quality and consistency of these decisions, particularly during any interim period before NICE’s guidance is released.

“We will therefore publish a set of core principles to inform how primary care trusts make decisions on the funding of new drugs. It is essential that the process, as well as the decisions, is clear and accessible to patients and the public, so that if a patient is denied access to a particular treatment, the reasoning behind that decision is both transparent and consistent. We will be publishing detailed good practice guidance for PCTs about the processes they should have in place to make decisions about the funding of new drugs and their handling of exceptional cases.

“Better local decision-making, a faster appraisal process, fairer pricing and greater flexibility in the evaluation of certain treatments will address the main issues that have fuelled the demand from some patients for additional private treatment. However, it would be unreasonable to expect the NHS to fund every single new treatment, and we cannot guarantee that we will completely eradicate the circumstances in which a very small minority of

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patients wish to pay for a drug that the NHS does not provide. The vast majority of people Professor Richards spoke to during his review thought that, in these circumstances, it would be wrong to take away a patient’s entitlement to NHS care because he had purchased an additional treatment privately. Professor Richards recommends that this practice should end, and I agree with him. It will end with immediate effect.

“However, he is also clear that there must be tight controls to prevent the NHS becoming a two-tier system. Today, we will publish draft revised guidance to take immediate effect in order to ensure that the NHS is clear on how to deal with the rare occasions—which, with the implementation of the proposals already mentioned, will be even rarer—where patients opt to fund additional drugs privately. The guidance will make clear that in those circumstances NHS care should never be withdrawn and that administering private care should take place separately from NHS care to ensure that NHS funds are never used to subsidise private care. In short, there is no question of patients who are able to pay more being able to access a different and higher level of NHS treatment, but neither should any patient who has at some point paid for private treatment lose his entitlement to NHS care. Today’s draft revised guidance sets out that, in such circumstances, private treatment should be provided in a private facility so that it is always clear whether a particular treatment is NHS or private. This removes any confusion over what constitutes a single visit or a single episode of care. It will also remove any question of there being a two-tier system where those who pay for additional care are having their private care subsidised by the NHS.

“The NHS must by definition be continually evolving and improving to meet rising expectations and to offer the latest advances in medical care to all our citizens, irrespective of wealth, class, ethnicity or disability.

“This has been a debate of critical importance to the NHS and the values that underpin it. I believe that the measures that I have outlined today, in enabling the NHS to exercise its natural compassion, will actually help to secure these values for the future. We are fortunate in Britain to have a health system that provides a comprehensive service for all patients, based on clinical need, with public funds for healthcare devoted solely to the benefit of the people it serves. The report by Professor Richards enhances these principles, and I commend the Statement to the House”.

My Lords, that concludes the Statement.

4.35 pm

Earl Howe: My Lords, the House will be grateful to the noble Lord, Lord Darzi, for repeating the Statement. I am sure that I will not be alone among your Lordships in having mixed feelings about the announcement that he has made. On one level, the Government are to be congratulated, as is Professor Mike Richards, on having grasped a very difficult policy nettle and come up with a way forward that they believe is workable. I certainly

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welcome the announcements on NICE appraisals, flexible pricing for new drugs and the core principles to guide PCTs in their decision-making. On another level, we are left with the distinct impression, despite the noble Lord's assurances, that the way forward adumbrated today on top-ups amounts to nothing less than a two-tier NHS, something against which all political parties have hitherto set their faces.

We are also left asking whether the Government have focused sufficiently on the real issue, which is surely: why are NHS patients in England not able to receive clinically effective treatments that are routinely available in other European countries free at the point of need? Against that background, I have a simple query to level at the Minister: is he or is he not in favour of top-ups? Does he believe that top-ups will be good or bad for the NHS? Obviously, from the point of view of the patient, there can be no disagreement: patients in this country want to receive clinically effective treatments. If there are clinically effective treatments that the NHS is unwilling to supply, the NHS should not stand in the way of patients who want to access them. I would not for a minute argue with that. Equally, if a patient chooses to purchase a drug privately for which the NHS will not pay, it is wrong that he should then lose all entitlement to his other NHS care. The wonder is that the Government have allowed that to happen in those instances where it has been reported.

However, is creating a two-tier NHS the right way to address the issue? Do not top-ups in one important sense represent a defeat? Does the noble Lord think that by allowing an NHS patient in an NHS bed to top up his care with his own money we can successfully avoid blurring the line between private and NHS care? As he will know, to blur that line risks giving rise to enormous public resentment, as well as, for practical purposes, an abandonment of one of the founding principles of the NHS. Personally, I am fearful of that prospect in the light of today's announcement, because I do not think that the occasions on which the right to top-up is invoked will be as rare as the noble Lord suggests.

There is one thing about which we should all be clear. The announcement made today will not rid us of the postcode lottery. Unless the Government make the proposed core principles statutory and mandatory, PCTs will still be able to decide for themselves what exceptional cases they are prepared to fund and what cases they are not. That means that gross disparities in NHS-funded care are bound to remain around the country. What additional action are the Government going to take to address that issue?

I have a number of more detailed questions for the Minister. Once top-ups, in any form, are allowed, there must be a concern that patients may be at risk of exploitation. We must avoid a patient being led to invest their own money in treatments that do not deliver the clinical results that the patient expects, with the result that he spends in vain a great deal of money—money that he might not have. What does the Minister propose to do to prevent this kind of risk and to enable patients to make a genuinely informed choice? In so far as patients may be charged by the NHS for the cost of administering a drug purchased privately,

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what arrangements will be put into place to ensure that these charges are fair and transparent and genuinely represent only the marginal costs incurred?

On a related issue, how are patients to be protected from unjustifiably high prices for the medicines that they buy? Once pharmaceutical companies know that patients can purchase a drug privately, and that they do not have to justify their products to NICE, what is to deter them from raising their prices to a level that exploits the desperation of patients? Equally, what is to deter PCTs from deciding not to fund a particular treatment, knowing, as they will, that the patient can pay for them privately? How will the advent of top-ups not lead, slowly and quietly, to large numbers of treatments no longer being available on the NHS at a local level?

I could ask several detailed questions about how a top-up is to be defined, which is a fairly basic question, but I shall focus on more substantive practical issues. Where a privately purchased drug has been administered, who will be responsible for follow-up care, and where does the financial liability lie if the clinician is negligent or incompetent? What will happen if, half way through a treatment, the patient no longer has the money to pay for it? What happens if, having commenced a treatment privately, the patient finds that it prolongs his life for much longer than he had budgeted and that he is spending money that he has not got simply to keep the treatment going? What action will the Government take to ensure that patients are properly advised before they decide to top up their NHS care privately?

Today’s announcement will certainly come as a relief to patients who have been left in a state of uncertainty about whether they will be able to access certain drugs and still remain an NHS patient. To that extent, it is good news. Equally, however, we can surely no longer argue from today that treatment on the NHS is available based solely on need and not the ability to pay. Indeed, the Government have created a potentially awful muddle here. On the one hand, they think it right to exempt cancer patients from prescription charges. On the other, they know that the cost of that exemption—some £20 million—would be enough to fund all the requests that were turned down by exceptions panels in 2007 for drugs to treat rarer cancers, drugs that patients will in many instances find themselves paying for out of their own pockets and at considerable cost.

The Statement leaves unanswered as many questions as those that it purports to remedy. No doubt much of the detail will emerge, but the national debate on these questions is only just beginning.

4.43 pm

Baroness Barker: My Lords, I, too, thank the noble Lord, Lord Darzi, for repeating the Statement, and Professor Mike Richards for his report.

There is something inevitable about today’s Statement. There has been a build-up ever since one or two very high-profile cases came to light last year, and it was inevitable that this matter would unfold as it has. To a certain extent, neither the Government nor the opposition

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parties have any option but to go in principle with the position which the noble Lord has outlined. It is now inevitable that there should be a system that enables patients to pay for additional care without losing their entitlement to NHS care.

I welcome the Statement for one particular reason. I hope that it will signal the beginning of a much quicker process of NICE approval for drugs and remove one of the weapons that many people wield in order to bash NICE. A great deal of that bashing comes from the NHS. I believe that NICE is important and that we should do everything that we can to support it.

Like the noble Earl, Lord Howe, I believe that it is easy to agree with the principle, but it is essential to have clarity on the detail. Many issues have to be examined. One sentence in the middle of the Statement states:

“There is no question of patients who are able to pay more being able to access a ... higher level of NHS treatment”.

We have a duty to test that central assertion. I believe that this new system will bring inequities and inequalities; it is simply a question of how those will be managed. A key test will be whether patients receive the provision from the NHS that they need as opposed to the provision that they want, which may be very different.

I should like to give the Minister the opportunity to reply to some very specific questions, as I think that the answers will help people as they come to terms with the implications of the proposals. First, what will and will not be included? So far the discussion has been largely about cancer drugs. Are we going to talk about drugs for other conditions, including Alzheimer’s, and will the system extend to therapies such as hormone therapies? What steps will be taken to prevent drug companies manipulating patients? What sanctions will there be if drug companies are found to have manipulated patients or to have influenced or sought to influence the treatment decisions of health professionals?

Primary care trusts have to set an annual medicines budget. In the absence of any evidence about the number of people who could take advantage of the new top-up rules, what guidance to PCTs will there be on how to estimate the potential patient contribution in their area? When it sets PCT budgets, will the Department of Health take into account the difference in affluence among populations in different parts of the country? This question may be naive, but will the income generated go into the medicines budget of the NHS? Will it be ring-fenced or will it go elsewhere? Will patients pay the full cost of a drug that is not funded by the NHS, or will they pay merely the difference between the price of the requested drug and an existing drug with similar therapeutic qualities?

If drugs are effective and cost-effective for a significant number of people, NICE will recommend them for reimbursement by the NHS. But in terms of top-ups we must be talking about drugs that are marginally effective, or not cost-effective, though they may have a very high value to an individual in that they may prolong their life. In the Government’s new system, what is the incentive to pharmaceutical companies to make drugs cost-effective? It is inevitable that an insurance market covering drugs and people’s needs will develop. Have the Government estimated the cost to the NHS

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of a new insurance-funded market in medicines in which drug companies have no incentive to keep prices down? How is the system to be reviewed, and will any such review compare and contrast with the system being implemented in Scotland to see which works best in terms of patient benefit?

The proposal outlined in the Statement poses an interesting but severe challenge to clinicians, pharmaceutical companies and patients. The one thing that could damage it irreparably is any attempt to fudge or shy away from clarity about what is being proposed. I think that we are talking about the introduction of a private market into the NHS in terms of drug treatment. If it is going to be implemented in full, patients need to know at the beginning that they are in a private market. The worst thing the Government could do would be to present it otherwise.

4.50 pm

Lord Darzi of Denham: My Lords, I am grateful for the feedback from the noble Earl, Lord Howe, and the noble Baroness, Lady Barker. I shall start with the issues raised by the noble Earl on top-ups. The term “top-ups” has been used by different people to mean different things. There is no clear definition and I think that it is a confusing and sometimes unhelpful term. The Statement makes it clear that the Government are committed to not in any way allowing people to buy better care on the NHS. We are fundamentally committed to a comprehensive NHS free at the point of use, and the proposals we have announced today will widen access to drugs and treatments on the NHS. What we have said is that in very rare circumstances, ones that will become even rarer, where people choose to pay for additional care through drugs privately, they must receive that care separately. However, they will not have their entitlement to NHS care withdrawn. That was very strongly signalled in Professor Richards’s report, which involved consultation with more than 2,000 patients and members of the public, as well as a large number of clinicians.


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