In November 2018 a change in legislation saw the prescription of cannabis-based medicinal products, commonly known as medicinal cannabis, become legalised in the United Kingdom. Whilst this was a welcome change to those who had campaigned for the changes there were and still are barriers to the prescribing of medicinal cannabis, particularly on the NHS.
In some respects, whilst the law changes built public anticipation the medical community was taken off guard. Clinicians and pharmacists lacked the education, evidence, prescribing frameworks and support to prescribe appropriately. The law change was based on initial advice from the then Chief Medical Officer, Dame Sally Davies, and her team that medicinal cannabis displayed ‘conclusive evidence of therapeutic benefit for certain medical conditions’. However, she subsequently referred to these reforms as having opened ‘Pandora’s Box’ due to the large mismatch between patient expectations and the barriers to prescribing within the medical profession. This is highlighted in Paula Case’s recent article ‘The NICE Guideline on Medicinal Cannabis: Keeping Pandora’s Box Shut Tight’ in the Medical Law Review.
Prior to NICE issuing, it’s guidance on prescribing medicinal cannabis, NHS England and NHS Improvement published a document in August 2019 attempting to address the barriers to accessing medicinal cannabis on NHS prescription. Key themes identified in this document are the challenges to embracing data other than randomised controlled trials to support prescribing decisions, an absence of clinical guidance, and issues with cost and supply.
NICE’s guidance, eventually published in November 2019, represented a softening instance to that taken previously in draft documentation. However, the recommendations for use only covered four specific conditions and were largely restricted to already licensed medications. Whilst this undoubtedly will prove to be beneficial in improving prescribing for affected patients, the overall benefits are likely to be limited to a small cohort of patients who fit a narrow set of criteria.
A recent commentary by Sapphire Medical Clinics Managing Director Dr. Mikael Sodergren and colleague Dr. Simon Erridge highlighted legitimate criticisms of how NICE formed its decisions on medicinal cannabis. This particularly drew attention to how the models typically used by NICE for other medication categories are less appropriate for this wide spectrum of pharmaceutical products.
Dr. Paula Case in her article points to how NICE’s judgments may further restrict the prescribing of medicinal cannabis in the United Kingdom, particularly on NHS prescriptions. Deviation from guidelines, whilst accepted practice, can deter clinicians from prescribing for fear of potential litigation or allegations of negligence. The NICE guidance itself is keen to point out that guidelines do not replace clinical judgment and there is legal support to deviate from NICE guidance when clinically appropriate. From a clinical point of view, this is viewed within the bounds of innovative medical practice.
While NICE’s guidance has led to disappointment amongst patients it is important to recognise that NICE has to make difficult decisions across a population according to cost restriction. Clinicians, on the other hand, should continue to make evidence-based decisions to prescribe medicinal cannabis appropriately on an individual named-patient basis.
At Sapphire Medical Clinics, patients are assessed within a robust clinical governance structure that incorporates best evidence-based practices. We also have set up the UK Medical Cannabis Registry to capture real-world evidence to improve the evidence base upon which NICE can make future decisions.