Medicinal Cannabis Defined: UK Home Office sets out rules for products
On 21 September, the Government formally announced its definition of what qualifies as ‘cannabis-based’ products for medicinal use ahead of a proposed law change this autumn, including in Northern Ireland.
But it said that only doctors on the Specialist Register of the General Medical Council will be able to prescribe medicinal cannabis, not GPs.
The government has agreed:
- Prescribing licensed medicines must be considered first.
- NHS England and others will develop prescribing guidance.
- THC and CBD content of all CDMPs must be specified and verified.
- Medicinal use of cannabis by smoking will remain prohibited.
- Steps will be taken to stimulate and encourage research and clinical trials.
A Government press release explained: “Together with the Health and Social Care Secretary, the Home Secretary has now set out how cannabis-based products for medicinal use will be defined in order to make it lawful for them to be prescribed when specialist doctors believe this is appropriate.
“Specialist doctors specialise in one field of medicine such as neurology or paediatrics. In the UK, specialist doctors are listed on the General Medical Council’s (GMC) specialist register.
“The Home Secretary’s decision takes into account recommendations made by the Advisory
Council on the Misuse of Drugs (ACMD) and the UK’s Chief Medical Adviser.”
The Government of course reiterated that is has “no intention of legalising the recreational use of cannabis. Due to the known harms of smoking and the potential operational impact on misuse and diversion, smoking will remain prohibited.”
The decision as to which products will be made available is the result of work between the Home Office, ACMD, Department of Health and Social Care (DHSC) and the Medicines and Healthcare Products Regulatory Agency (MHRA).
There are three broad requirements for products before they can be prescribed:
- the product is or contains cannabis, cannabis resin, cannabinol or cannabinol derivatives
- the product must be produced for medicinal use in humans
- it must be a product that is regulated as a medicinal product or an ingredient of a medicinal product
Until the autumn, specialist doctors will still be able to apply to the independent expert panel on behalf of patients wishing to access these products.
The Home Secretary Javid Sajid Javid committed in July to “swift action” on behalf of those whose medical conditions could potentially be eased by cannabis-based products. In June the Home Office had backed down over its refusal to release medicinal cannabis oil that it had confiscated from Billy Caldwell, 13, from Castlederg, who is severely epileptic. Mr Javid said he had used an exceptional power as Home Secretary to issue a licence for Billy to be treated with the oil as a matter of urgency.
UKCSC chairman Greg de Hoedt commented: “The progress we have seen in the past few months is a significant victory for everyone campaigning for the medicinal use of cannabis – we have forced the Government to act.
“However, it remains only a partial victory. This announcement is another positive step given that patients will be able to go to specialist doctors instead of the so-called ‘expert panel’ who have so far only given permission for a handful of cases. Hopefully this will take away one level of bureaucracy.
“But it is extremely disappointing that GPs will not be given the same authority. This means it will remain difficult for most patients to get access to the medicine they need and they will still be at risk of criminalisation, not to mention that the costs will remain prohibitively high which effectively keeps people either breaking the law growing their own, or – more likely – buying it off a street dealer.
“GW Pharmaceuticals has already set the cost of Epidiolex at £32,500 a year – a barbaric price enabled by the monopoly licence granted by the Home Office – to ‘keep it in line with other AEDs’. Prices like these deter an underfunded NHS from prescribing it.”
Greg concluded: “On top of these problems, the UK Government continues to stand by prohibition while the rest of the world is progressing beyond it. Patients should have the right to grow their own cannabis without fear of being criminalised while the Home Office finalises all the rules, but again this would undermine the profits of GW Pharma or any other companies looking to import their licenced cannabis products already available in other legal countries.”
UKCSC has now been contacted by NICE about the Medicinal Cannabis Guidelines Committee which we look forward to engaging with to help try and further develop an understanding of what patients’ direct needs are.
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