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I come back to where the noble Earl came in. There is no coherent framework of provision for these things at the moment, and this needs to be attended to. There is also a really urgent need for accurate and comprehensive information about off-limit prescriptions and treatments in future. It is not safe to leave the situation as it is, and I congratulate the noble Earl again on spotting this. It is a really important subject, and I hope that the Government agree.

2.34 pm

Baroness Thornton: My Lords, I am grateful to the noble Earl for calling this debate. Although we may be few in number, we make up for that in the quality of our contributions. Precious things come in small packages.

I know that the noble Earl takes a keen interest in the Government's medicines policy; this is not the first time that we have looked at this complex issue. I will take a moment to set out its background. A marketing authorisation, or product licence as it is often known, defines a medicine's terms of use. The licensing system ensures that medicines are effective, safe and of good quality. As both noble Lords have said, however, there will always be clinical situations in which a prescriber may judge that the use of a medicine outside the terms of its licence is in the best interests of a patient based on the available evidence. This, as has been remarked, is known as off-label or off-licence use. Such practice is relatively common in the treatment of some cancers and other conditions, and decisions are normally taken by hospital doctors. They need to be taken in discussion with the patient concerned, and funding may sometimes need to be agreed with the patient's primary care trust.

The use of off-label treatments in cancer presents a particular challenge because treatments are not licensed for cancer but for a specific type and stage of a cancer. The Rarer Cancers Forum-I have looked at its excellent report-has coined the term "near-label" to describe the situation in which such drugs are used off-label but in an indication that is near, or similar, to the licensed indication. However, because these near-label treatments are not licensed for such a use, they cannot usually be appraised in England by NICE, because NICE generally issues mandatory guidance on the use of a medicine within its licensed indication. To do otherwise risks undermining the licensing process, which exists to protect patients. This means that PCTs have to use their own processes for determining whether to fund these off-label or near-label treatments. In a way, how this operates is the nub of both noble Lords' contributions.

The issue of patients' access to off-label treatments was dealt with by Professor Mike Richards in his report, Improving Access to Medicines for NHS Patients, which was published last November. Professor Richards reported that there are particular challenges for PCTs in taking such decisions, as the noble Earl described very adequately. He commented that better collaboration

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by PCTs would help better quality decisions to be taken on applications for funding, although, as the noble Lord, Lord Kirkwood, quite rightly said, funding is not always the only issue; how decisions are taken is also important.

Mike Richards made a number of linked recommendations that focus on the manner and processes by which PCTs take decisions on new medicines and that, where there is no guidance from NICE, stress the need for PCTs to be proactive, transparent and rational in their commissioning decisions, to work collaboratively and to be better supported.

Again, the noble Earl is completely correct when he says that the NHS Constitution includes the right to expect rational PCT funding decisions on drugs. He asked about the illegality of barring funding for treatments. PCTs must have arrangements in place to consider all requests. A blanket ban would leave them open to challenge in the courts.

To help PCTs improve the quality of their decision-making so that patients can have confidence in these arrangements and therefore deal with the issue of postcode lotteries and unevenness of decision-making, we have commissioned a number of measures to support the introduction of improved local processes. We have produced a set of public-facing principles to inform PCT decision-making, which is about governance arrangements and procedures; a set of directions to PCTs making explicit their public law responsibilities to put in place processes for making decisions on new drugs and treatments, which should address the issue raised by the noble Earl; and, most importantly, a handbook of detailed good practice guidance for the NHS, covering funding policies on new drugs and processes for considering individual funding requests, which is a very important document. The National Prescribing Centre has embarked on a major programme of work to provide a bespoke and continuing training package for key PCT staff to help ensure that local processes are able to develop in the way that we, and our policy, believe that they should.

The NHS chief executive wrote to strategic health authorities on 4 November 2008 asking them to review the way in which PCTs in their area collaborate to support effective decision-making on new drugs. Although this work is not specific to off-label use of drugs, it is very relevant to that issue as the same general principles should apply. The key part of this package is the handbook of good practice guidance, which was issued to the NHS in March 2009. It provides tools to help PCTs review their current decision-making processes about the funding of medicines.

PCTs are likely to be faced with decisions about a range of medicines and treatments for rarer conditions where they and their local providers cannot reasonably be expected to have the full range of expertise. It is our view that PCTs must consider collaborating in these circumstances and collaborative arrangements already exist for many cancer medicines. Funding the off-label use of drugs is an area that might trigger collaborative decision-making and we would expect the good practice guidance to inform such decisions.

I understand the concern of the noble Earl and the noble Lord, Lord Kirkwood, about the report from the Rarer Cancers Forum, which alleged that, over the

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past three years, almost 3,200 cancer patients were forced to apply for funding from the NHS for near-label treatments. From what I have said, noble Lords will appreciate that the Government have a great sympathy with these concerns. It is difficult and complex to see how all PCTs and their provider trusts can be reasonably expected to have the full expertise or resources to make the full range of decisions on rarer and more complex cases. It is possible that the noble Earl's proposal may go some way to addressing that issue and I intend to take this question back to the department. I will let noble Lords know the answer.

The National Prescribing Centre is engaged in developing ongoing support for PCT decision-making and, as part of this work, it has established that most SHA areas now have some supra-PCT activities to support local decision-making. However, I appreciate that that is not quite the point being made by the noble Earl.

The noble Earl asked about antipsychotic drugs, which is an important and complex issue affecting people with dementia in all care settings. That is why we have commissioned the independent review on antipsychotic drugs, which we will publish next month. I will take the issues raised about collaborative commissioning back to the department and will explore them.

The noble Lord, Lord Kirkwood, mentioned overprescribing. We are attempting to tackle this again through our quality and productivity challenges. Controlling the growth of the drugs bill is permanently on the agenda. The noble Lord also asked about Scotland. Every time I answer a question about NICE, I also have a note about how closely we work with Scotland and how much easier it is for it to be fleet of foot, to paraphrase what my brief usually says. The dialogue is ongoing and there is a lot of co-operation and collaboration between the teams.

The noble Lord also asked about local decision-making. The department has always taken a cautious approach to mandating or encouraging the use of drugs outside licensed indications. Aside from obvious liability issues if there is an adverse incident, there is a real risk that national advice to use a drug outside its licence could undermine the established licensing process. While some off-label cases may be obvious, others may be far more complex, so it is difficult to draw a clear line about what the national level should be. Although not specifically intended for the small volume of off-label prescribing that takes place in the NHS, the measures that we are putting in place to strengthen and support local decision-making will be relevant to such prescribing as well.

Finally, while a good deal of progress has been made, we are not complacent. With the development of new drugs, more complex drugs and the applications of many different drugs, it becomes more important that these procedures and processes are transparent and in the best interests of the patient. We will continue to promote and encourage collaboration through the strategic health authorities. We will also continue to consider whether there is a need to provide further support to PCTs to enable them to effectively discharge their responsibilities in this area.

House adjourned at 2.45 pm.

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