The “right” to NICE-recommended drugs - fact or…

NHS England and the National Institute for Health and Care Excellence (NICE) have recently consulted and approved plans to delay the availability of NICE-approved drugs if the total cost to the NHS is more than £20m a year.

As reported recently in The Times, it is expected that 20% of newly approved drugs may fall into that category.

This is part of a general trend commonly referred to as ‘rationing’ and is part of a broader quest by the NHS to make costs savings. It is suggested that these proposals are rooted in a fear that a ground-breaking treatment for a widespread condition, such as Alzheimer’s, may become available on the market. Although this treatment may not be particularly expensive, the large number of potential recipients of such a drug would likely represent a huge cost to the NHS.

Is this lawful?

Various stakeholders and consultees have criticised these reforms, citing the “right” to NICE-recommended drugs as set out in the NHS Constitution. However, the NHS Constitution does not make law; it is a declaratory document setting out pre-existing legal rights and duties, which arise from several disparate sources.

So, where does this “right” come from?

Under the National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013, SI 2013/259, health bodies including clinical commissioning groups (CCGs) and NHS England must comply with any recommendation made about drugs by NICE (regulation 7).

The usual period for compliance is three months from the date the recommendation is published. However, the Regulations do in fact allow for NICE to specify a longer period if it considers it ‘appropriate’ in accordance with certain criteria.

As set out in the consultation, one of these criteria is that ‘the health technology cannot be appropriately administered until other appropriate health services resources, including staff are in place’. NHS England and NICE are proceeding on the basis that ‘resources’ here includes financial resources.

Reflecting the duty on CCGs and NHS England to comply with NICE recommendations, the NHS constitution explains to patients that:

‘You have the right to drugs and treatments that have been recommended by NICE for use in the NHS, if your doctor says they are clinically appropriate for you.’

So what will these reforms mean for patients?

Patients’ rights to clinically appropriate NICE-approved treatments for which the compliance period has already expired will be protected. This is subject to the caveat that the Regulations do impose a duty on NICE to keep under review and revise its recommendations when appropriate.

However, for new drugs, NICE will now be able to delay the point at which compliance is required. Until this point, the “legal right” set out above does not crystallise and patients may be denied potential new treatments.

Unfortunately for patients, there is a clear theme running through case law that recognises that limits on financial resources are key to commissioning decisions and that patients do not have an unfettered right to medical treatment (see Lancashire HA ex parte A [1999] 1 WLR 977, Coughlan[2001] QB 123, Thanet [2014] EWHC 1182). It is likely, therefore, that it will be difficult for individuals to found successful human rights claims in respect of unavailable or delayed treatments.

There may be more scope for patients to make claims on equality grounds. Public bodies must act in accordance with the public sector equality duty under section 149 of the Equality Act 2010. There are also specific equality duties on NHS England under section 13G of the National Health Service Act 2006 (see for an exampleof their application R (National Aids Trust)[2016] EWHC 2005 where the claimant alleged that NHS England’s refusal to commission an anti-retroviral drug, PrEP, to be used on a preventative basis for those at high risk of HIV and AIDS, was a breach of the section 149 and 13G duties).