Guidance on cannabis-based medicinal products receives important clarification

28 April 2021

In September 2020 we reported in our blog on the First NHS Prescription for a Child’s Cannabis Medicine that a challenge to the National Institute for Health & Care Excellence (NICE) Guidelines on cannabis-based medicinal products (CBMPs) was being brought by way of judicial review (JR) by the family of Charlie Hughes. It was recently reported that the legal challenge has now been dropped, following an important ‘clarification’ of the NICE Guidelines.

Background
Charlie Hughes is a young sufferer of West Syndrome - a rare form of epilepsy which had caused Charlie to suffer up to 120 seizures a day. Charlie’s family had turned to treating his condition with medicinal cannabis as a last resort, after attempts to manage his condition with six different prescribed anti-epileptic drugs proved unsuccessful. However, two NHS clinicians had refused to prescribe CBMP’s to Charlie, leaving Charlie’s family with a £1,000-£3,000 a month bill for private prescriptions for cannabis oil. Charlie’s family reported that since taking the medicinal cannabis oil, his seizures had reduced by 85 percent, without side effects and his social and physical development improved significantly. Despite this, Charlie’s family were continuously unsuccessful in obtaining the CBMP on a prescription basis from the NHS.

Part of the NHS’s reluctance to prescribe CBMP’s was as a result of the NICE Guidelines, which stated that there was not enough evidence to recommend CBMP’s for severe and treatment-resistant epilepsy. Although the NICE Guidelines did not prohibit the prescription of CBMP’s per se, many medical practitioners interpreted the Guidance rigidly and used it as justification for not prescribing CBMP’s until further clinical trials were conducted.

As a result, Charlie’s family lodged an application for JR of the NICE Guidelines on the basis that the Guidelines were so restrictive that they prevented hundreds of children from accessing the treatment they required through the NHS. The family sought to amend the NICE Guidelines so that NHS clinicians consider CBMP’s for severe cases of treatment-resistant epilepsy.

In July 2020 permission was granted by the High Court on two grounds:

1.          Inadequate consultation; and

2.          Failure to take into account relevant considerations.

Charlie’s case was expected to be heard by the High Court in early 2021.

Clarification to the NICE Guidelines
It was reported on 28 March 2021, that Charlie’s family had decided to not proceed with the JR challenge following a ‘clarification’ to the NICE guidelines.

The clarification states:

The guideline made research recommendations for the use of unlicensed cannabis-based medicinal products for severe treatment-resistant epilepsy. The committee took the view, based on the evidence available at the time, that there was insufficient evidence of safety and effectiveness to support a population-wide practice recommendation (that is, a recommendation relating to the whole population of people with severe treatment-resistant epilepsy).”

“The fact that NICE made no such population-wide recommendation should not however be interpreted by healthcare professionals as meaning that they are prevented from considering the use of unlicensed cannabis-based medicinal products where that is clinically appropriate in an individual case. Patients in this population can be prescribed cannabis-based medicinal products if the healthcare professional considers that that would be appropriate on a balance of benefit and risk, and in consultation with the patient, and their families and carers or guardian.”

“There is no recommendation against the use of cannabis-based medicinal products.”

This clarification is significant. As stated, specialist practitioners working within the NHS are very reluctant to prescribe CBMP’s; the statement by NICE that unlicensed CBMP’s can be used in cases where it is clinically appropriate is likely to provide reassurance for practitioners. This is not to say, as we have commented previously, that the floodgates for prescription of CBMP’s will open, but there is certainly a shift to pave the way for tolerance and research in this area.  

FURTHER INFORMATION

If you require advice in relation to Judicial Review and/or medical cannabis licensing or investment our specialist team can assist. 

 

About the author 

Shannett Thompson is a Partner in the Regulatory Team having trained in the NHS and commenced her career exclusively defending doctors. She provides regulatory advice predominantly in the health and social care and education sectors. Shannett has vast experience advising  regulated individuals,  businesses such as clinics and care homes and students in respect of disciplinary investigations. She is a member of the private prosecutions team providing advice to individuals, business and charities in respect of prosecutions were traditional agencies are unwilling or unable to act. In addition Shannett has built up a significant niche in advising investors and businesses in the cannabis sector.

 

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