Select Committee on Health Minutes of Evidence

Supplementary memorandum by Mr Christopher Newdick (NC 64A)

  1.  I gave evidence to the Health Committee on 16 January. Dr Naysmith MP asked me to clarify one further matter. I understand his question to be: since the introduction of the NICE directions on 1 January 2002, could a health authority/PCT advise doctors not to adhere to NICE guidance?

  2.  There are, I think, two reasons why an authority might advise in this way.

    (a)  First, the authority might have legitimate and well-founded reasons to think that the guidance is mistaken. For example, subsequent research might demonstrate that it should not be used in respect of a certain category of patients, or there may be legitimate doubt as to the veracity of NICE's own guidance (following, say, research from the Drugs and Therapeutics Bulletin).

    (b)  The second reason is that the HA/PCT say that it has insufficient funds to accommodate NICE guidance. Perhaps it does not want to divert resources away from its own projects. In other words, it says its own health strategy should command priority. Alternatively, it may be content to implement the guidance but it has insufficient resources to do so.

  3.  Law on directions is as follows: Section 126(3)(c) of the National Health Service Act 1977 provides:

        Any person or body to whom directions are given in pursuance of any provision of this Act or Part I of the National Health Service and Community Care Act 1990 shall comply with the directions.

  The direction on the authority of NICE guidance applies to health authorities, PCTs and NHS trusts in England. It provides:

        A Health Authority shall, in exercising those functions that it has been directed to exercise by the Secretary of State, apply such of the sums paid to it under section 97(3) of the [1977] Act as may be required so as to ensure that a health care intervention that is recommended by the Institute in a Technology Appraisal Guidance is, from a date not later than three months from the date of the Technology Appraisal Guidance, normally available:

    (a)  to be prescribed for any patient on a prescription form for the purpose of his NHS treatment, or

    (b)  to be supplied or administered to any patient for the purpose of his NHS treatment.

  This requires authorities to put aside sufficient sums to ensure that NICE guidance is "normally available". It gives a strong presumption that the treatment should be available. However, it also permits authorities not to set funds aside in abnormal circumstances. The nature of these circumstances is not specified, but the reasons would need to be persuasive.

  4.  Arguably, a legitimate and well-founded concern as to the safety of NICE guidance would enable authorities to discuss their concerns with doctors and other prescribers. The interests of patient safety would enable them to advise against use of the treatment. Indeed, there may be a duty to do so. There is no reason to stifle such advice and the words "normally available" in the direction permit it. Reasonable doubts as to the veracity of NICE guidance should permit a similar response. Thus, provided the authority's concerns are legitimate, bona fide and well-founded, and raised as advice intended to leave the decision to prescribe to the doctor, such advice would be lawful. Of course, the final decision to prescribe, or not, rests with the responsible doctor. This was the case before 2002 and remains so now.

  5.  The second reason for advising against use of NICE guidance is that an authority cannot afford to do so. The reason may be that it considers its own priorities to be more important to the local community. However, a general policy to fund local priorities in preference to NICE guidance is, I think, not lawful. The direction requires monies to be set aside to accommodate NICE guidance. It does not permit authorities a general discretion to refuse to do so on resource grounds.

  6.  On the other hand, the words "normally available" in the direction permit some flexibility. For example, nothing in the new directions changes the statutory duty on HA/PCTs to remain within their annual budgets. Sometimes, the costs of NICE guidance may be such that the HA/PCT cannot stay within budget and provide funding for NICE guidance within the three month period. In this case, it would be permissible, indeed, it would be obligatory, to postpone funding of the guidance until additional resources became available.

  7.  Similarly, NICE guidance may depend upon investment in additional specialist staff, without whom the new service cannot be provided. We are familiar with the difficulties of recruitment in the NHS. It may be that, despite the reasonable efforts of the HA/PCT, specialist staff are unavailable to supervise the treatment. In these circumstances too, the implementation of the guidance outside the three month period would be permitted by the words "normally available".

  8.  In general, however, this restriction on HA/PCT decisions as to resource priorities is difficult to justify. When demand for health care exceeds supply, evidence of efficacy says nothing about the need to prioritise claims to health care. Some of the treatments recommended by NICE, though effective, are of marginal benefit to local communities. They do not merit priority access to scarce resources. Either NICE should direct its attention to more central health concerns, or the blanket obligation to fund all NICE's recommendations should be reconsidered so as to preserve local discretion in certain cases.

28 February 2002

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