Legal briefing: NICE rulings

Sometimes trusts have no choice but to follow the advice of the National Institute for Health and Clinical Excellence, says legal expert David Lock

A senior civil servant confessed to me last week that 'ministers must rue the day they ever created the National Institute for Health and Clinical Excellence'...

She made her comments as NICE came under repeated attack from both drug companies and patient groups. Both complained that the independent body was too restrictive in its approval of new drugs and treatments. It was said to be prejudicing Britain's position as a world leader in pharmaceuticals and leaving patients without life-saving treatment.

NICE robustly defends itself and, within the NHS, has many admirers as well as some detractors. It can take the heat off local NHS bodies and brings some objectivity to tough decisions by NHS bodies - mainly PCTs - on the funding of new treatments. It can give a PCT a reason to say 'sorry, but no'.

The legal process involved here is fairly straightforward. PCTs have block contracts with acute providers for all normal treatments, which are now mostly funded under a tariff fixed under payment by results. The PCT will also have policies on which treatments are rationed - IVF for example - and which are not provided at all, such as tattoo removal. If patients seek treatments not included in block contracts and are not subject to an existing policy, they are usually referred to a PCT panel for a decision under the relevant PCT procedure. The panel asks a variety of questions including:

• does the treatment deliver health benefits?
• is it suitable for this patient?
• does it provide value for money?.

NICE exists to try to iron out postcode lottery prescribing and guide the PCT in making these difficult decisions. It carries out assessments and then provides guidance for PCTs, which gives an objective and independent steer to assist them in formulating.policies and making.individual treatment decisions..

Advice you cannot ignore

There is one area, however, where NICE guidance becomes legally mandatory: technology appraisals. These.are NICE recommendations on the use of new and existing medicines and treatments in the NHS in England and Wales, such as medicines, medical devices, diagnostic techniques, surgical procedures and health promotion activities. The secretary of state has issued directions under the NHS Act which require PCTs to ensure that an intervention recommended by NICE in a technology appraisal guidance is 'normally available' not later than three months from the date of the guidance - unless the secretary of state grants an exemption.

Thus, if a new treatment is approved under the technology appraisal guidance procedure, PCTs have no choice. If the patient fits the profile in the guidance, the PCT is legally required to make funds available to pay for the treatment. Budgetary pressures and other higher priorities are no excuse. This becomes one of the very few categories in which the patient has a directly enforceable right to the treatment and a refusal can result in a judicial review against the PCT.

If NICE recommends that a drug or treatment is not effective or does not provide value for money then the PCT has fairly strong legal grounds in refusing the treatment. PCTs may still need to go through a process of considering the request but can have a policy only to grant funding in genuinely exceptional cases.

The problems arise with new drugs: PCTs can come under pressure to fund them before NICE has expressed an opinion. In those circumstances decision-making responsibility rests on the PCT's own policies and assessment..Our advice is usually to have a policy to refuse to fund emerging treatments except in exceptional circumstances, because such new developments should be directed into the local delivery plan process - but that's a whole new topic.

David Lock is head of healthcare at Mills & Reeve