The ACMD has published its advice to the Home Secretary regarding the scheduling of cannabis-derived medicinal products [link]. As stated in my earlier blog, in order to make certain cannabis related products available on prescription, it is not enough merely to move cannabis from schedule 1 to the Misuse of Drugs Regulations 2001 to another schedule. The complex provisions of the UK/EU medicines legislation must also be considered. It is therefore significant that the ACMD has stated:
Defining Cannabis-derived medicinal products
The CMO’s report states that “using other forms, such as grown or street Cannabis, as a medicine for therapeutic benefit is potentially dangerous”. The ACMD agrees that raw Cannabis (including Cannabis-based preparations) of unknown composition should not be given the status of medication.
Prescribers, patients, regulators and policy-makers must have confidence in the effectiveness, composition and consistency of Cannabis-derived medicinal products to ensure patient safety. Cannabis-derived medicinal products should meet defined safety and quality assurance standards to ensure that they do not put patients at risk of harm. Risks to patients may arise from impurities and adulterants, and variability in the composition of active constituents.
One of the complexities of this area is the lack of clarity of what Cannabis-derived medicinal products are. The ACMD has identified this as a problem that needs addressing with clear definitions. The Department of Health and Social Care (DHSC) and the Medicines and Healthcare products Regulatory Agency (MHRA) should agree on appropriate definitions and medicinal standards following appropriate consultation. The ACMD requests the development of appropriate definitions to be completed in a timely manner, so that it does not introduce unnecessary delays to the ACMD’s ‘longer term’ review, or prevents doctors prescribing Cannabis-derived medicinal products to patients where there is an identified need and likelihood of benefit.
Quite apart from the fact that (controversially) raw herbal cannabis would remain in schedule 1, the statement that “Cannabis-derived medicinal products should meet defined safety and quality assurance standards to ensure that they do not put patients at risk of harm” is an oblique reference to the rules relating to medicinal products. Which cannabis-related products – and how many – would meet those standards? How many of those products would be available on prescription either on a named-patient basis (restrictive) or because they receive a UK MHRA “marketing authorisation” and are designated “Prescription Only Medicines”?
Reality may not match much of the anticipation and hype that has surrounded this topic.