What is the legal impact in England and Wales of guidance issued by the National Institute for Clinical Excellence? How can it separate itself from the politics of the NHS? Are health authorities, primary care trusts and GPs obliged to follow the guidance, or merely take it into account?
Is judicial review available against NICE itself?
NICE was created by the health secretary for a variety of purposes, one of which was to give authoritative and consistent advice on 'the promotion of clinical excellence and. . . the effective use of available resources in the health service'.
1What does this entail? Health secretary Alan Milburn outlined this duty to the Commons health select committee, making a distinction between one role, which is 'about assessing clinical and cost-effectiveness', and 'a quite separate set of decisions which are around affordability issues'.He said: 'In the end you would want affordability decisions to be located with an accountable politician who has to answer to the House of Commons and to Parliament.'
2What is the difference between 'the effective use of available resources in the health service' and 'affordability'? The first is much more about the need for hard choices between deserving cases - to an extent, politics.The second is limited to an impartial assessment of the clinical and economic merits of the treatment itself.Take the US example of the diagnostic test for bowel cancer that cost $47m for every case detected.
3Costs and benefits of this magnitude are relevant to any system of healthcare.This is not about the politics of affordability.
What about effective but expensive treatments - for example, new treatments for chronic, degenerative conditions? These treatments ought to be given very sympathetic consideration.NICE should certainly advise on their costs.At the same time, the question as to whether the NHS can afford them is for the health secretary.
The boundary between cost-effectiveness and affordability is far from watertight and there is always a danger that NICE will become embroiled in matters on the wrong side of the line.NICE's continued credibility depends on handling delicate cases on the boundary with extreme care.
NICE has to make judgements. Inevitably, this gives it a margin of discretion within which to work. Its recommendations may be subject to judicial review on the grounds that they are illegal, irrational, or procedurally improper.
But the courts often defer to the opinions of expert bodies, especially when the court has no relevant expertise of its own. The question for the court is not whether it agrees with the decision that has been taken. It is whether that decision was taken reasonably and within the framework of law imposed around it. For this reason, actions for judicial review against NICE will often present claimants with difficulty.
How should health authorities react to guidance from NICE? How should their priorities committees respond? The NHS Act 1977 imposes on each HA and primary care trust a specific statutory duty 'in respect of each financial year, to perform its functions so as to secure that the expenditure of the trust. . . does not exceed [its income].'Obviously, NICE guidance has financial implications, particularly as it accumulates. During 2000, it issued 15 pieces of guidance. A further 40 are expected by the end of 2001. This has the potential to distort the priorities identified at local level. Note, however, that NICE does not affect the duty of HAs and PCTs to remain within their annual allocations.
Also, especially in secondary care, HAs have broad discretion in the manner in which they allocate resources. The NHS Act places a duty on the secretary of state to promote 'a comprehensive health service'. But he is given discretion in the manner in which he does so.He is not obliged to fund every treatment that could benefit patients.
4Crucially, however, the actual performance of this duty is delegated to HAs, which 'shall exercise the specified health service functions on behalf of the secretary of state'.
5 So the broad discretion conferred on the health secretary is transferred to HAs. It is for them to determine how, within the framework of the NHS acts, resources should be allocated.
HAs may not 'fetter their discretion' by closing their minds to the special demands of their local health economy. This means that they do not have a duty to redirect local resources as an automatic response to NICE or the Commission for Health Improvement.
Local rationing decisions will still occur. Local decisions must be made reasonably, but the fact of delegation means that complete consistency across the country and an end to postcode rationing are impossible. Delegated discretion may be restricted by NHS directions issued by the secretary of state.
The NHS Act 1977 says that directions are binding (whereas circulars are merely discretionary). The distinction is one of intention, and is illustrated in ex parte Fisher, in which North Derbyshire HA refused to fund beta interferon to treat Mr Fisher's multiple sclerosis. Beta interferon had been recommended in HSC(95)97 which urged HAs to make the drug available to patients. The court said:
'If the circular provided no more than guidance, albeit in strong terms, then the only duty placed upon the HA was to take it into account.'
In judicial review the court held that the circular did not amount to a direction. But the authority had not properly taken the circular into account.
Thus, the court overturned the refusal to fund the treatment and remitted the matter back to the HA for it to pay proper regard to the circular.When it reconsidered the matter, the authority agreed to provide funding for beta interferon.
The case demonstrates the duty to take proper account of NHS circulars; NICE guidance should be treated with similar respect. Ideally, the clinical and economic content of its guidance will be authoritative and objective.
But the issue of affordability remains a matter for local judgement. It is one of the duties the secretary of state has delegated to HAs. NICE guidance does not have the status of a direction, which only the health secretary can issue, and is not mandatory.
Thus, NICE provides information, it does not make decisions on behalf of HAs.HAs retain the duty to allocate their resources reasonably and to stay within their budgets. This means that HAs may differ in their funding and priorities policies. If the secretary of state wishes to countermand their discretion, say to exclude treatments from the NHS, or to require others to be made available, he may do so by issuing directions.
This is not to devalue NICE. It will make a constructive contribution to the debate about equality and funding; its guidance ought to be held in high regard. No HA could ignore it. A decision to depart from it should only be taken after careful consideration and in the light of good, robust reasons for doing so.
Unlike hospital doctors, GPs are subject to specific duties imposed on them by their terms of service, regulations made under the NHS Act 1977 and contained in the general medical services regulations. In particular, a specific duty is imposed on a GP to provide 'all necessary and appropriate medical services' and to 'order any drugs or appliances that are needed for the treatment of any patient to whom he is providing treatment'. In the Viagra case of ex parte Pfizer, it was considered that these provisions placed duties on a GP to 'give such treatment as he considers necessary and appropriate'.
6A circular from the then health secretary Frank Dobson purporting to qualify this duty was, therefore, struck down in judicial review as unlawful.
Does guidance from NICE have any impact on the GMS duty to prescribe on the basis of need? The short answer is that it cannot.
Of course, medicines may be placed on the 'black', or 'grey' (banned or restricted) lists of the GMS regulations. But until action of this nature is taken, the terms of service require that GPs follow its very generous provisions.
Like HAs, GPs should find guidance from NICE helpful. It may provide support for a refusal to prescribe ineffective medicines. NICE guidance is likely to represent a responsible body of medical opinion and a defence to negligence.
Equally, it cannot be followed blindly. As the Pfizer case suggests, provided GPs wish to prescribe a medicine and have the support of a responsible body of clinical opinion, the terms of service appear to require that the treatment be provided.
NICE recommendations should make a significant contribution to quality and consistency in the NHS.However, HAs and doctors will not always be able to implement them.Hard choices and 'rationing' between competing treatments and deserving patients will still be needed. This is an inevitable part of the politics of the NHS. The credibility of NICE rests on its commitment to assessing treatments on their own merits and avoiding the politics of affordability.
NICE guidance should not overrule health authorities'discretion to allocate resources.
Complete consistency between HAs is not achievable.
Actions for judicial review of NICE guidance will often present claimants with difficulty.
GPs are required to prescribe on the basis of need and NICE guidance cannot have any impact on this.