NICE guidelines: not just the gold standard practice

When the National Institute for Health and Care Excellence (NICE) guidelines were introduced in 1999, they were intended to provide ‘evidence-based guidance’ for health practitioners. Since April 2013 the guidelines have extended to social care practitioners. NICE’s website credits the guidelines for improving the outcomes for people using the NHS and other public health and social care services. However, with a recent poll by Pulse Today showing that 76% of 515 English and Welsh GPs, believe NICE guidelines are only at least ‘somewhat relevant’ to their practice; the guidelines’ relevance and importance appears to be being questioned. The same survey revealed that more than 70% of GPs in England and Wales were departing from NICE guidance at least once a month, with one in ten ignoring it daily.

Whilst NICE guidelines are not at present legally binding, it is well established that Regulation 7 technology recommendations and Regulation 8 specialized technology recommendations, must be complied with. The general guidance and recommendations under Regulation 5 have been considered open to interpretation and implementation. Case law is now turning this proposition on its head as NICE guidelines become legally binding through case law.

Implications of avoiding the guidance  

Whilst the word ‘guidelines’ may conjure the impression of discretionary and optional advice, this is far from the case. Following the landmark case of Montgomery -v- Lanarkshire (2015) the way that practitioners dealt with consenting patients for operations significantly altered. Legal principles established through case law are binding and they cannot be ignored. The case law on NICE guidelines is likely to have the same effect. When making a decision about how to treat a patient, ignoring and failing to adhere to the NICE guidelines is likely to lead to legal consequences.

Case law

An important case of interest is that of R (Elizabeth Rose) -v- Thanet Clinical Commissioning Group (2014). The case concerned a woman who was undergoing chemotherapy due to a severe form of Crohn’s disease. The treatment would in all likelihood leave her infertile. The claimant wanted to undergo oocyte cryopreservation (OC) to preserve her eggs in order to allow her to have her own genetic children in the future. NICE guidelines state that OC should be given to women of reproductive age who are preparing to undergo medical treatment for cancer which may make them infertile. The claimant was an appropriate candidate under the guidelines. However, the CCG’s policy was to allow the treatment in clinically exceptional circumstances only, for which they did not consider that the claimant qualified. The CCG also refused to fund the OC due to insufficient evidence demonstrating its effectiveness. When the claim came before Justice Jay, it was held that the CCG was not able to choose not to follow NICE guidance because they disagreed with it.

The general rule in respect of following national policy and state guidance, was established in the case of R -v- North Derbyshire Health Authority, ex parte Fisher (1997) a case prior to the introduction of the NICE guidelines. In this case the Defendant was permitted to depart from the national policy by way of guidance from the secretary of state, only if there was a ‘special factor’ that meant there was an ‘exceptionally justified departure’. In the case of R (Elizabeth Rose) the CCG’s disagreement with OC treatment was not considered a special factor which would enable them to depart from NICE guidance. Furthermore, Justice Jay found that the CCG had not put forward a significant case which exceptionally justified departure from the guidance in respect of the R -v- North Derbyshire Health Authority criteria. Disagreement with the OC guidance was not sufficient to justify not following the guidance. This further advocates how the NICE guidelines do not just provide guidance but are increasingly becoming mandatory rules which must be followed.

Dr Naylor, barrister at Exchange Chambers and former general practitioner considers that in the context of a legal claim if the practitioner has failed to consider or apply the guidelines they are likely to be found negligent. ‘Clinical practice is being increasingly influenced and some would say dictated by the NICE guidelines. The guidelines are becoming increasingly detailed and prescriptive. There is a perceived disconnect between the world seemingly inhabited by the academics who draft the guidelines and the clinicians working at the coal-face, doing their best in a busy and under-resourced health service. It may be argued that the clinicians should be afforded flexibility in deciding which guidelines to follow. In reality, however, where a claim is based upon a failure to follow the guidelines, that failure is likely to prove fatal in any attempt to defend the claim. The guidelines are, by their very nature, evidence-based and increasingly they are drafted in clear, unambiguous and prescriptive terms. Any decision to depart from the guidelines will usually require full discussion with the patient and in some cases, specialist advice. The quality of the consultation and the standard of record keeping are key factors, when determining whether departure from the guidelines can be justified as being reasonable and rational.’

NICE’s website does not refer to the guidance as mandatory but rather they advise that organisations and practitioners delivering services should take NICE guidelines into consideration when treating patients. Yet in the case of R (Elizabeth Rose) Thanet CCG did consider the guidelines but chose not to apply them because they disagreed with them. Therefore even if practitioners can show they considered the guidance they are unlikely to escape liability in the civil courts for failing to apply them.  

Reasonable practice

In the courtroom it is independent expert evidence which is used to determine what constitutes ‘reasonable practice.’ Expert witnesses frequently refer to the guidelines when determining if a practitioner’s actions have fallen short of the appropriate standard. However, long before the NICE guidelines it was the case of Bolam -v- Friern Hospital Management Committee (1957) which set the appropriate standard for determining reasonable practice. The so-called ‘Bolam test’ establishes whether  a medical professional has breached their duty of care to a patient and confirms that negligence is not established if the doctor has acted in accordance with a practice accepted as proper by a responsible body of opinion.

Likewise in respect of the NICE guidelines, if it can be shown that the practitioner did not follow the guidelines for a justifiable reason, which is supported by a reasonable body of experts, then the practitioner should not be found negligent. Once again the R (Elizabeth Rose) case appears a stark contrast to this. The CCG considered that they had a justifiable reason for departing from the guidelines and presumably considered the impact of the guidelines when choosing to not adopt them. Yet their reasoning and justification for not adopting the guidelines was insufficient to persuade the judge that the NICE guidelines should not apply.

Guidance in practice

The guidance is prescriptive and in some cases, such as the above, it will provide a clear course of action. Miss Rose was a woman of childbearing age who was undergoing medical treatment which may result in her being left infertile. Therefore, she fell within the criteria for the guidelines and their prescriptive instructions had to be applied.

Not all patients will present in the same way or fall neatly into the criteria for a particular guideline. Determining which guideline to apply appears to be a balancing act of identifying symptoms and acting quickly to eliminate possible causes. Ultimately, the aim of the guidance is to provide an evidential basis for treating a patient in a certain matter. A turning point case will no doubt soon come before the courts to establish whether or not following one guideline over the other will result in a practitioner being found negligent.