UK Government Announces Definition For Cannabis-Based Medicines
Last week, the UK government announced how it will define cannabis-based products for medicinal use. Following the conclusion of the two-part review by the Chief Medical Officer and the ACMD on July 25th, Home Secretary Sajid Javid committed to swift action on the matter, and promised that these products would be lawful by autumn.
Following the Chief Medical Officer’s July report which recommended that the whole class of cannabis based medicinal products (CBMPs) be moved out of Schedule 1, the Home Secretary and Health and Social Care Secretary stated that it was ‘critical that we do not hinder the use of cannabis-based products for medicinal use for the relief of pain and suffering where medically appropriate and there is evidence.’
Commenting on the announcement CEO of Hanway Associates, George McBride said:
“There is not much new information in this announcement but the one important new piece of information is cause for concern - ‘Patients will not be able to get cannabis-based medicinal products from their general practitioner.’
”This fetter of the broad right for GPs in the UK to prescribe any drugs that they feel are needed for their patients’ medical care is likely to restrict patient access. An obsession over the risk of diversion of tested medical products onto the black market risks leaving hundreds of thousands of UK patients procuring untested cannabis from the black market.”
The definition, created by the Home Office, ACMD, Department of Health and Social Care (DHSC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) outlines three requirements for the products:
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
The definition specifically mentions cannabinol, "which stems from the legal description of cannabis and cannabis products in the Misuse of Drugs Act 1971,” Hanway CSO, Dr Henry Fisher explains. “The Act explicitly includes 'cannabinol and cannabinol derivatives' alongside cannabis and cannabis resin - this was done at the time to ensure the Act covered all compounds detailed in the UN Convention on Psychotropic Substances 1971. The Act also gives a specific legal definition of 'cannabinol derivatives', which states which compounds are covered."
The announcement came in the form of a response to the ACMD’s letter last week, responding to each of the 11 recommendations. Some key takeaways from the government’s announcement:
CBMPs will be moved from Schedule 1 to Schedule 2.
The medicines will be able to be prescribed by specialist doctors (on the Specialist Register of the General Medical Council) only, not general practitioners.
Smoking will remain prohibited. No direction was given on vaporising.
There will be a long-term review of CBMPs, which may lead to certain products being moved back into Schedule 1 or into other schedules.
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.
Until products have gone through MHRA marketing authorisation, they will be regulated as unlicensed medicines for human consumption.
The MHRA is updating their guidance on medicines specifically to support the rescheduling of CBMPs. The guidance will be available when the legislation is laid.
NICE guidance on prescription of cannabis-based products for medicinal use is expected by October 2019.
For more information on these developments, please contact Hanway Associates.