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.
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  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
28 February 2002