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However, all these grounds are quite broad in nature. Given that PCTs are not allowed to issue blanket refusals on the funding of treatments, all PCTs are obliged to consider whether to provide funding whenever a request for an exceptional treatment is received. For this reason many PCTs, though by no means all, have established what can loosely be termed “exceptional

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requests panels”. Where such panels exist, they tend to operate to certain protocols in assessing individual requests for treatment. The problem here is that there is no requirement for a PCT to publish its criteria for judging exceptional cases. In the absence of that requirement, members of the public do not know anything at all about the decision-making process. They cannot scrutinise it. That inability to scrutinise is often serious because, in reaching a decision on whether to fund a treatment, it is not uncommon for a PCT to rely on social criteria which, of necessity, involves making value judgments. Once you start doing that, you enter territory that is fraught with difficulty. For example, if a treatment is given to a patient who has young children over and above a patient who is childless, this involves a social value judgment which favours a lifestyle choice to have children.

It is known that judgments of this sort are made, but without a request under the Freedom of Information Act about whether there is a panel—and that is sometimes not manifest—and what sort of social criteria are used, a patient cannot find out how he might be able to build up a convincing argument for why he should be able to receive a particular treatment. There is also a possibility that taking a decision on the basis of social factors could fall foul of the requirements of the Equality Act 2006, which outlaws discrimination on the basis of age and sex. The amendment is needed, therefore, to empower patients. It is needed to ensure that there is transparency in the way that PCTs make decisions to fund, or not to fund, exceptional cases, and it is needed to expose geographical variations in the way that requests for exceptional treatments are assessed. We know that in some PCTs there is a 50:50 success rate in exceptional applications whereas in other areas the success rate is virtually 100 per cent. So where differing criteria and procedures are used in different areas of the country, the postcode lottery that this creates would be made apparent.

I hope the Minister will accept that there is a very real issue here which needs to be addressed. It would be most helpful if she were able to say something about the problems I have outlined and indicate whether she accepts that secrecy about the processes used to make decisions on the use of public money should be viewed as unacceptable in both principle and practice. I beg to move.

Baroness Thornton: My Lords, I fully appreciate the intention behind this amendment to achieve maximum transparency about the decision to fund treatments beyond PCTs’ stated commissioning policies and I agree with the noble Earl that transparency is key. In the commissioning cycle, PCTs will need to effectively engage patients and the public, assess needs and prioritise investment. They will have to be proactive in seeking out the views and experiences of the public, patients and other stakeholders and they will need to demonstrate clearly how they are discharging their responsibilities. In addition, they will need to have the capacity to consider applications from clinicians and patients who believe that genuinely exceptional circumstances apply in their particular case. The assessment of such cases requires a delicate balance to be struck between the genuine desire to give an individual patient care that

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may benefit them and the PCT’s wider responsibility to commission services that deliver the best results in terms of gain for the whole population.

The Government expect PCTs to have in place appropriate processes for reaching decisions on applications for treatments that are not normally funded, but the details and operation of such processes are for local determination. I understand the concerns that have been expressed about the accessibility and transparency of individual PCT arrangements and I agree that it is desirable that PCTs should publish information on those arrangements. I believe that many already make such information available and I am told by my noble friend—without giving any secrets away—that the next-stage review addresses this issue.

We are, I believe, in agreement on the good practice that PCTs should follow in making available this kind of information to patients and clinicians, but we think that it is inappropriate to set such a requirement in primary legislation, particularly as there are already systems in place to ensure that PCTs are accountable to their local population for their commissioning policies. I hope that this will provide enough reassurance for the noble Earl to withdraw his amendment.

Earl Howe: My Lords, that was a helpful reply. I am grateful to the Minister for saying that transparency is key in this area. In a way, the amendment relates to our earlier debates on the ability of the CQC to assess how well or badly a PCT is commissioning services or meeting the health needs of an area. It would be helpful if the CQC were to encourage PCTs to maximise transparency on requests of this kind and in their general approach to considering requests for exceptional treatment. It is heartening to hear that this is not a subject that has been lost on the noble Lord, Lord Darzi, in his next-stage review. That leads me to look forward even more to reading the review when it is published. For now, I thank the Minister for her reply. I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Earl Howe moved Amendment No. 70:

(a) must consult any body appearing to him to be representative of persons to whose remuneration the direction would relate;(b) must have regard to any advice given to him by the relevant advisory body; and(c) may consult such other persons as he considers appropriate.”

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The noble Earl said: My Lords, this amendment is about the quality and outcomes framework—QOF—which is a voluntary annual reward and incentive scheme introduced as part of the new GP contract in April 2004. In 2007-08 under the scheme, GPs were awarded 1,000 achievement points for managing common chronic conditions, how well the practice is organised, how patients view the care that they receive and the amount of extra services that are offered. When the new GP contract was introduced, it was agreed that the QOF would be subject to ongoing review and development to ensure that it accurately reflected changing clinical practice and new therapeutic areas. It was agreed that an independent expert group would consider the latest available evidence and make recommendations to the four health departments of the UK and that it would then be up to the negotiating parties to agree any changes to the quality framework.

Since the GP contract came into force, the QOF has been renegotiated twice: once for the 2006-07 contract and once for the 2008-09 contract. Each renegotiation has involved a robust, evidence-based process. For example, in 2006-07, the QOF renegotiation was informed by a review panel comprising the University of Birmingham, the Society for Academic Primary Care and the Royal College of General Practitioners. Following the receipt of 514 submissions, the review panel made recommendations to NHS Employers and the GPC. During the negotiations between the GPC and NHS Employers, the review panel was available to clarify questions of evidence for the negotiating parties.

The 2006-07 renegotiation resulted in a number of small but significant changes; for example, 15 new evidence-based indicators in seven new clinical areas were introduced. This was not in any way a cursory process. The success of those negotiations laid the foundations for the review panel to be placed on a more formal footing. In August 2006, the University of Birmingham was awarded a three-year contract to inform the ongoing review and development of the QOF. A new review panel was constituted, comprising over 40 senior academics who were expert in the field of general practice. The cost to the taxpayer of this three-year contract was nearly £800,000, excluding VAT.

The review panel began its work reviewing the QOF for 2008-09 after receiving 153 completed questionnaires from national societies, patient groups, individuals, pharmaceutical companies, primary care organisations and others. The review panel considered the written questionnaires and then held oral evidence sessions with a number of the groups that had submitted evidence. The QOF negotiations then commenced, informed by the findings of the panel. We know from the BMA that the recommendations submitted by the review panel included two new clinical areas with respect to the management of osteoporosis and peripheral arterial disease, an expansion of the scope of ethnicity monitoring, a new indicator in the area of heart failure and enhancing the points value in the QOF of chronic kidney disease.

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What happened? The recommendations of the expert panel, prepared at great trouble and not inconsiderable expense, were effectively overturned. In their place, the

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GPC was presented with a Hobson’s choice, the effect of which was the hijacking of the QOF by a set of objectives that owed more to the pledges made by the Prime Minister during his campaign for the leadership of the Labour Party than they did to clinical need. The focus was suddenly on supporting improved access to GPs and, in the final agreement, no points at all were allocated to support the areas recommended by the expert panel.

In ignoring the detailed conclusions of the review panel, the Government drew a large amount of criticism from professional and patient groups. Dr Laurence Buckman of the GPC called the Government’s plans,

A letter published in the Times on 14 January 2008 and signed by, among others, the British Society for Rheumatology, the Royal College of Nursing, the British Orthopaedic Association, Help the Aged, the British Geriatrics Society, the Royal College of Surgeons and the National Osteoporosis Society, stated that many osteoporotic fractures,

The letter said:

The good will of those organisations and individuals who took time to make submissions to the QOF review has been sorely tested. Without some way of ensuring that evidence-based recommendations made by the expert panel are guaranteed some standing in the QOF review process, it is doubtful whether public and professional involvement in attempting to formulate sensible proposals can be maintained at the level that we have seen.

The rationale for the amendment is therefore to ensure that the recommendations of the review panel cannot simply be ignored. This is not just my own idea. The National Audit Office, in its report of 28 February, NHS Pay Modernisation: New Contracts for General PracticeServices in England, said that,

I am aware that the noble Lord, Lord Darzi, is considering the QOF as part of his next-stage review. I very much hope that he will understand what has prompted me to raise these matters and why I believe that they merit the closest attention. I hope that the noble Baroness will be able to indicate in her reply that, if the QOF is to work as originally intended, we simply cannot have a repeat of what happened this year and that safeguards of the kind that I am proposing are in everyone’s interests. I beg to move.

Baroness Thornton: My Lords, Amendment No. 70 would establish a quality and outcomes framework review panel to advise on the payments made as part of the QOF. I note that the amendment, as drafted,

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would require the Secretary of State to have regard to the advice of this review panel in respect of any directions on payments to be made under a general medical services contract.

The current QOF independent expert panel already has the function of advising the negotiating parties on the evidence base for indicators in the QOF. However, the expert panel has no remit to advise on the level of payment for achieving QOF indicators, payments to GPs in general or the directions that give effect to those payments. As regards the level of payments that GPs receive for the QOF, or any part of the general medical services contract, the Secretary of State is already required, before giving any directions as to payments to be made under such a contract, to consult any body that is representative of the persons to whose remuneration the directions would relate. It is also open to the Secretary of State to consult any other person whom he might think appropriate.

In addition, the doctors’ and dentists’ review body can make recommendations on GP pay when invited by either of the negotiating parties, NHS Employers and the General Practitioners Committee of the British Medical Association. Therefore, we believe that the process has many safeguards in place already and that there is no need to set up a new statutory body to advise on payments to GPs, although I thought that the noble Earl made an eloquent case.

I can inform the House that the primary and community care strategy, which is being developed as part of my noble friend Lord Darzi’s next-stage review, is considering the case for developing a more independent process for setting and reviewing quality indicators in the QOF and giving more flexibility for PCTs to address local needs and priorities. It is not necessary to make any statutory change to introduce a more independent process for setting indicators and this would not concern decisions on the levels of payment made for achieving the indicators. I am aware that I may not have addressed the specific points raised by the noble Earl and I will see whether I can write to him about them, but I ask him to withdraw the amendment.

Earl Howe: My Lords, I am grateful to the Minister for her reply and for her offer to write to me. That would be helpful. I am sure that she appreciates that my concern lies almost exclusively with the QOF process and the integrity of that process. There is something very wrong if we have, at great expense and trouble, an expert panel that takes evidence from all over the place and considers it carefully, only to find that its recommendations are almost completely ignored, so that the QOF that emerges takes no account of the clinical recommendations. We need a more robust mechanism if the system is to work as originally intended. However, I take heart from the fact that the noble Lord, Lord Darzi, is looking at this whole area in the next-stage review, as with the previous amendment. Once again, I look forward to what he has to say. If the noble Baroness is able to give me any words of comfort in the mean time when she writes to me, I shall be extremely grateful. I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

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Schedule 12 [Funding of expenditure in connection with provision of pharmaceutical services]:

Earl Howe moved Amendment No. 71:

The noble Earl said: My Lords, this amendment concerns arrangements for the NHS remuneration of community pharmacy contractors. As a member of the All-Party Parliamentary Group on Pharmacy, I very much believe in the importance and value of pharmacy services in local communities and I am encouraged by the Government’s recent White Paper, Pharmacy in England:Building on Strengths—Delivering the Future, which sets out a range of new services that patients and the wider public will be able to access from community pharmacies. The White Paper is based on a report published by the all-party group last year and reflects many of our recommendations.

The House may not be aware that, on average, community pharmacies derive around 90 per cent of their income from the NHS services that they provide. This means that arrangements for remuneration by the NHS are crucial. Community pharmacists need certainty and stability in those arrangements. That stability enables them to plan and invest with confidence. As it stands, the Bill unnecessarily—and perhaps unintentionally—casts doubt over the nationally agreed arrangements for community pharmacy remuneration and therefore jeopardises plans for investment in existing and new pharmacy services.

Amendment No. 71 would address that by inserting what I hope the Minister will see as a modest new provision in Section 164 of the National Health Service Act 2006. That Act sets out the arrangements for remunerating community pharmacy contractors. Remuneration is determined by so-called “determining authorities”—either the Secretary of State, primary care trusts or other persons appointed by the Secretary of State. Pharmacy owners need to know the remuneration that they will receive for those substantive parts of the contractual framework so that they will have the confidence to continue to invest in their businesses.

In Grand Committee, the noble Baroness, Lady Thornton, confirmed that,

However, she did not accept the amendment tabled by the noble Baroness, Lady Barker.

Section 164(3) of the NHS Act 2006 allows the Secretary of State to authorise a PCT to exercise the functions of a determining authority by issuing an instrument of appointment. Section 164(5) allows him to set out in that instrument of appointment the requirements with which a determining authority must comply in making determinations. However, although

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Section 164(5)(b) allows an instrument of appointment to be contained in regulations, there is no statutory requirement for any particular instrument of appointment to be contained in regulations.

The Government, I know, recognise the importance to pharmacies and to PCTs of setting some fees and allowances nationally and have given assurances of their intention to continue to do so. However, this is of such importance that any instrument of appointment that seeks to delegate to PCTs the determination of fees and allowances for the national elements of the pharmacy service should be contained in regulations. Section 164(5)(b) already provides that some instruments of appointment “may” be contained in regulations. Amendment No. 71 seeks only that, in relation to these important nationally specified pharmaceutical services, the instrument of appointment must be contained in regulations.

This is of great importance to community pharmacists and to the public who rely on pharmacy services. The amendment would simply put in the Bill the intentions expressed by the noble Baroness, Lady Thornton, in Grand Committee. I therefore hope that it will prove acceptable to her today or at least that she will undertake to consider the matter before Third Reading. I beg to move.

Baroness Barker: My Lords, I support the noble Earl in his attempts to join our ongoing campaign to secure the future of community pharmacists. He is right that community pharmacists rely on the NHS element of what they do for the bulk of their business. That is what makes their businesses viable. It is also true to say that community pharmacies deliver to the NHS a level of service that is way above what they are contracted to do.

Those of us with friends who are pharmacists know, having discussed these matters with them, that lots of studies show that, to be viable, a parade of shops must have a shop to buy newspapers, somewhere to buy food and a pharmacy. Community pharmacies provide a huge amount of preventive healthcare information, but they are struggling. The amendment, which the Government could easily accept, would guarantee pharmacists some stability with which to underpin their businesses. If the Government were to do so, that investment would pay for itself in the additional services that community pharmacies would offer in areas with the greatest health poverty. I strongly support the amendment.

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