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.

"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 also 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 also 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 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 under which a very small minority of 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.

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 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, 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.

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 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 naïve, 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 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.

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.

The wider package which has been announced today improves the timeliness of NHS appraisals, giving NICE greater flexibility and improving local decision-making. That reinforces the message that these new policies will reduce significantly the current circumstances in which a patient may seek to purchase a drug privately, but at the same time we are making an explicit statement that if a patient wishes to purchase a drug privately, their rights to NHS treatment should never be withdrawn.

The other issue that came up was the question of why other countries fund these drugs while we do not. We have to accept the fact that different countries have different healthcare systems and that the provision of drugs and other kinds of healthcare are funded in different ways. However, there is a growing recognition internationally that all healthcare systems face the same challenges and need ways of assessing both the clinical and the cost effectiveness of drugs so that decisions can be taken on how best to prioritise investment in health. We set up the National Institute for Clinical Excellence so that these difficult issues could be considered objectively and without political interference. While in general terms we use fewer cancer drugs than other countries, as highlighted by the noble Earl, that is not necessarily always the case. Perhaps I may give one example: the use of Herceptin for breast cancer is running at around 95 per cent of international average use. In many cases the level at which we use drugs runs close to the levels found in countries such as Australia, Canada and Norway. However, I acknowledge that we could do better, and that is the reason for these new policy announcements.

A further issue raised by the noble Baroness and the noble Earl is that of pharmaceutical companies exploiting patients at a very difficult point in their lives, a good example being as they approach the diagnosis of an advanced metastatic cancer. The revised guidance we have issued, which is out for public consultation, makes it clear that clinicians should exhaust all reasonable avenues for securing NHS funding before suggesting that a patient's only option is to fund the treatment for him or herself. One of the most important safeguards for patients is the transparency created by the revised guidance and Professor Richards's recommendations in regard to providing patients with clear, written information. In the EU and the UK, law prohibits the advertising to the public of prescription-only medicines. This means that the pharmaceutical industry may not promote such products directly to the public.

The noble Baroness also raised the issue of incentives. These policies do not in any way incentivise the pharmaceutical companies. The major policy announcement today about flexible pricing will incentivise pharmaceutical companies to introduce their drugs at a lower cost initially to get them through a NICE appraisal because the volume of patients using a drug once it is recognised by NICE will be significantly greater than the small number of patients who may decide to purchase the drug privately.

The noble Earl raised issues about clinical governance with which I agree. He will acknowledge that in many care pathways patients are transferred from different clinical teams throughout the journey. Whether it is a cancer pathway or a stroke pathway, we know that a large number of teams are involved in its delivery. Any effective team has clear policies for the transfer of a patient to the care of another team if that issue should arise.

On the issue of clinical governance from the perspective of the doctors involved in the delivery of such care, the revised guidance which has been issued today, and which will be open for consultation for a period of 12 weeks, establishes that if a patient seeks information about private services the NHS clinician should provide them with as full and accurate information as is available at that time—whether it is the evidence base, the side effects or other factors—in the same way as any other professional having a one-to-one discussion with the patient in front. Consultants, however, should not initiate discussions about providing private services from the NHS; the patient will instigate such discussions.

Professor Richards's review also recommends that doctors who are likely to have conversations with patients about treatments that are not routinely funded on the NHS should have the necessary knowledge and skills to communicate the information to patients in a balanced way. Another policy announcement today is that the Department of Health will commission communication skill programmes through royal colleges for clinical oncologists who will be involved in the counselling of their patients.

I could not agree more with the noble Baroness about the need to measure what we are doing. One of the recommendations in the report is to create a registry in which any drug a patient may wish to purchase privately will be registered. This is because we want to see whether the policy is working and, more importantly, we need to establish a benchmark. If a clinician advising patients in one part of the country shows an increase which is three-fold that of another clinician, the situation will need to be looked into. So the safeguards are in the guidance to ensure that there is no exploitation, as suggested earlier.

My Lords, the Minister's clear statement that a patient using any form of top-up drug will have their previous or current NHS care protected is enormously welcome. However, it raises a question about those who have suffered, not least since his colleague in this Chamber, in reply to a question that I raised on a previous occasion, said that it was the misinterpretation of advice that had created this situation. Some families will have suffered greatly: what kind of compensation will there be for them? Secondly, why is it not mandatory on a PCT to provide a drug that is approved by NICE?

My Lords, I am grateful to the noble Lord. With regard to the interpretation of the guidance, it is obvious from the Richards report that there has been a large variation in the interpretation of the guidance in different parts of the country. That is why we are where we are. Professor Richards's recommendation is to get rid of those variations across the country, and the clarity that we brought in today should do that.

The noble Lord asked about compensation. These are individual cases with unique circumstances, which I have no doubt should be taken up at a local level between the patients and the PCTs in discussions about their entitlement or otherwise to NHS treatment. From here on, though, we have brought in the clarity that no patient will ever lose their entitlement if they wish to purchase a drug privately.

PCTs should, if a drug is approved by NICE, be funding that drug. The next-stage review that I recently led, High Quality Care for All, can be met only if commissioners ensure on behalf of their patients that the best evidence that has an approval, whether for a drug, a medical technology or any other advance, should be available to any patients across the NHS in England.

My Lords, like other noble Lords, I greatly welcome the Statement and congratulate the Minister and Professor Richards. This creates a level playing field and regularises what in many ways has been happening in medicine for many years, with patients coming from private care possibly into A&E or ITU when things have gone wrong.

I want to ask more about registration. Will the register of those who have had additional drugs privately, based on clinical need, be held by the cancer registries? Will the data on that registry include data on outcomes that will be fed into NICE so that, where a drug has unexpectedly good or unexpectedly adverse outcomes when given to patients with multiple co-morbidities, that information can be fed into the NICE process and may alter the way that a drug is classified in the future?

It would be helpful to the House if the Minister could briefly outline how as a clinician he would explain the risk as well as the benefit to a patient who asked him whether he should go for an additional private and self-funded anti-cancer treatment.

My Lords, I am grateful for the noble Baroness's thoughts about the registry. She raised some important issues. We have not yet reached a conclusion on the exact details of what information should be on the registry or who should own it. I have no doubt that a registry of this kind should have not just the types of drugs but the conditions the patients are being treated for, the side effects of such treatments and their effectiveness. The purpose of the database is to use that information to empower NICE in the future to look at its appraisals based on the information available locally. One of the tasks following the review will be for Professor Richards to implement some of the recommendations in it. I would welcome the noble Baroness's expertise in helping him to decide where the registry should be and how it should be managed.

With regard to risks and benefits, she will also agree that one thing we learn in professional training is the ability to communicate with a patient about any treatment, whether it is a cancer drug or a straightforward day case procedure, the clinician might be carrying out. That is one of the basic principles of being a competent practitioner: to be able to sit in front of the patient and describe the risks and benefits. However, I appreciate that in certain circumstances, with terminally ill patients, such discussions might be much more challenging. We are talking about areas of drugs for which sufficient data may not be available. That is why I strongly believe that we should pursue the recommendation that the department should be commissioning the royal colleges specifically to target clinicians in specialised clinics, such as medical oncology clinics, who may have to have these difficult conversations—challenging conversations, in some instances—with their patients.

My Lords, there was widespread approval for what the Minister said, because he has listened to the hard evidence of cases put forward and submitted a change that will be met with gratitude on all sides. The Minister mentioned only drugs. Will the new rules apply also to some kinds of technical treatment? Can we assume, in this bright new day, that patients who have had cataract treatments may be fitted with the new implant lenses, for which they have always had to pay, without thereby being banned from further treatment for their eye condition? Will such patients be able to obtain those new lenses, which are an infinitely better treatment and give them far better vision than the previous lenses, eventually on the NHS?

My Lords, I am grateful for that question and delighted that the noble Baroness has accepted the policy announcement today. The answer to her question about cataracts is no. Cataract treatment is part of an operation that is funded by the NHS, so we cannot have two different proposals in that single treatment. The best example that I see in my own clinics is a patient coming in for a groin hernia repair who may request a tummy tuck on the side. The answer to that is no. However, if there are much more effective cataract treatments and there is an evidence base to support that, and if an appraisal could be carried out by NICE to conclude that that cataract treatment is significantly better, I cannot see why the NHS could not fund it across the country. However, there is no way we will provide for a patient purchasing a separate device during a single procedure.

My Lords—

My Lords, we are extremely grateful to the Minister for repeating an important Statement. It raises an important principle of care which I imagine will grow within the health service as our healthcare becomes increasingly complex and often quite expensive. One of the issues, however, is whether the principle might apply not merely to drugs but to other treatments. I think in particular of reproductive medicine. NICE has recommended that up to three cycles of in vitro fertilisation treatments might be offered, but in practice many primary care trusts refuse to treat any patients for IVF if they have already had a private cycle for which they have paid separately. As my noble friend knows, many NHS units quite properly offer private and public treatments in the same unit, accounting with proper governance, which we all respect and would wish to see.

Perhaps the Minister might opine on whether these kinds of treatments might also extend to pregnancy care; for example, to a patient who might go during pregnancy for an anomaly scan which is not available under the National Health Service but might do a great deal of good psychologically, if not medically, in dictating the course of her pregnancy care? I would be grateful for some preliminary evaluation and clarification of these points in general, although I understand that my noble friend may not be able to commit himself completely.

My Lords, the noble Lord, Lord Winston, spoke mostly about his area of expertise. If a patient has received IVF treatment privately and has never received the NHS-funded three cycles to which the noble Lord referred, they have every right to their three-cycle treatment. Having private treatment first does not take away your right to seek NICE-approved, three-cycle treatment. If a treatment is not approved by the NHS, such as an anomaly scan, as highlighted by my noble friend, the patient could purchase it privately if they wished to do so.

My Lords, does the noble Lord agree that much of the difficulty that has been expressed by, for example, the noble Earl comes from a failure to recognise that different people will take different views about the value of a treatment? If I am told that I could spend £20,000 on treatment that might keep me alive in some discomfort for another two months, I would say, "No thank you". However, a lot of people might say, "I want it regardless". The National Health Service cannot make individual judgments such as that; it makes a general judgment. If someone does not like the general judgment and wants to pay the difference, I can see no reason why they should not do so and every reason why the Government's Statement is greatly to be welcomed. The Opposition's cavilling is a failure to understand that some people will spend their money regardless, in the faint hope of keeping alive for just a little longer.

My Lords, the noble Viscount says that different people will value things in different ways. Indeed, it is our right to value different things in different ways, whether that is the money, the treatment or the risk of the treatment. That is one of our basic rights as patients or members of the public in seeking the opinion of an expert; we make the judgment based on that. However, on the second suggestion, I believe that paying the difference would create a two-tier system and erode one of the most fundamental principles of the NHS, which is 60 years old this year and in which care is provided for free at the point of need, irrespective of ability to pay. The Richards review received very negative vibes on that suggestion in its public consultation.

My Lords, it is clear that the flexibility and timeliness that will result from these welcome decisions will significantly reduce the occasions on which patients feel that they want to pay for private treatment. However, does the Minister agree that it is also important that we reduce confusion about this issue, particularly for patients? The advice of clinicians will be of the utmost importance, so I am delighted to hear that there will be training in communication skills for clinicians who have to convey these difficult messages. Will that training also include how patients can be involved in these difficult decisions, given the NHS's commitment to user and public involvement?

My Lords, absolutely. Communication skills are developed for talking to patients and should be based on what patients are telling us about these difficult conversations. The purpose of the communication skills is to meet the aspirations not just of the patients but also of their families and loved ones, who are usually involved in these difficult decisions.

My Lords, does the Minister think that the Statement will make postcode prescribing better or worse? Surely that is the real problem of a two-tier system.

My Lords, the purpose of this announcement by my right honourable friend in the other place is absolutely to reduce and tackle the postcode lottery in a dynamic NHS, which has constantly been challenged with new treatments and new drugs at a significant cost. Perhaps I may go into more detail on the two most important policies that we have announced. The first is flexible pricing, which will allow a pharmaceutical company to introduce a drug at a lower cost to get through the approvals system; if a larger pool of patients is using the drug, the company will obviously more easily recuperate R&D and other associated costs. The second policy is the announcement made by NICE today about rarer cancers. As the number of patients benefiting from these drugs is very small, the current appraisal processes make the cost per quality-adjusted life years greater than the benchmark, which has been between £20,000 and £30,000. NICE's announcement will significantly increase that level for these drugs for rarer conditions, which have given rise to many of the issues that the noble Baroness has been referring to over the past year or 18 months.

My Lords, I welcome the Minister's announcement. Has he looked at the interrelationship with the European health directive, currently under consideration, which raises similar difficulties? That is the directive whereby patients will be able to opt to go to Europe for their treatment and then claim the amount that the National Health Service would have spent had they stayed in this country. I declare an interest as chair of the European Union Committee, which is looking at the issue. I ask the noble Lord this because the Minister in the other place was unable to comment on the impact of top-up in this situation as this announcement was likely to be made.

One of the issues that concerns the committee, and it reflects the points made by the noble Earl, Lord Howe, is that it is clear that if you have more money—indeed if you have £20,000 to spend—you can travel, arrange accommodation and so on to avail yourself of some different kind of treatment. Does the Minister recognise that there will be greater complexities, even though we have a simplified system, that need to be considered when looking at both top-up and the capacity to travel to Europe? In addition, insurance schemes will develop to enable people to take up the healthcare they wish to have.

My Lords, the noble Baroness obviously has much greater expertise on the EU and the EU directive than I, but I shall attempt to answer the question. There are clear guidelines. If a patient wishes to receive a treatment in Europe, their reimbursement will be based on what the local health service pays in their home country. If there is a differential between the two, I would hope that any European country providing that treatment would make that clear to the patient prior to their receiving it.

I do not think that it is the Government's role to decide what patients or the public spend their money on. If patients wish to purchase a drug privately, the NHS will make it clear that we will help them in achieving that purpose, so long as that care is delivered in a separate setting. If they wish to have that treatment elsewhere, they have every right to do so.

My Lords, I apologise to the Minister for not being here at the beginning of his Statement, but I have read it thoroughly. One, perhaps small, point worries me. If a patient opts to pay for a drug privately that he or she thinks will help them and they get a complication or a reaction to that drug, which is directly related to the drug, will the patient then have to pay for treatment of that complication in the private sector, or will the health service accept them back into the NHS? Will it be made clear to the patient before they do so?

My Lords, if the complication or the side effect is related to the drug—and we are well aware of the side effects of most of these drugs—that patient will be counselled before, not only about the drug but also about the side effects, and they will be responsible for paying for the side effects of that specific drug. If a patient has or develops a complication related to their illness, which is nothing to do specifically with the drug, they will receive their full entitlement, which is free NHS care.

My Lords, I warmly applaud the Statement in general and particularly that part that deals with the purchase of additional drugs. I appreciate that administratively this matter has been transferred to the Welsh Assembly, but what discussions have taken place with the Assembly on the matter? My understanding is that this matter was already actively under consideration for some time by the Assembly. I uphold the right and responsibility of the Assembly to take its own independent decision on this matter, but is it possible that a common policy can be agreed—particularly since, as I understand it, some 30,000 patients each year cross the border in one direction or another, and it is therefore very much in the interests of all concerned that there should be commonality on this policy?

My Lords, this is a devolved issue, as the noble Lord has suggested, but I shall make two points in relation to Wales. First, Wales uses the NICE recommendations in its decision-making, unlike Scotland, which has its own system for appraising technologies; therefore, there are a lot of commonalities between England and Wales, and I have no doubt that officials in England are talking to officials in Wales.

Secondly—the noble Lord might view this positively—the flexible pricing which my right honourable friend in the other place is negotiating with the pharmaceutical companies is a UK-wide issue. If my right honourable friend is successful—the signals are that the Government and the pharmaceutical companies are both committed, but we are currently in discussions regarding the PPRS—many patients in Wales will benefit from one of these policies.