Two government departments seem to disagree about whether cannabis products have a medicinal value.
Vendors of a product called cannabidiol, or CBD, an oil derived from cannabis plants, have received letters from the Medicines and Healthcare Products Regulatory Agency (MHRA), a Department of Health-sponsored agency, saying that they have to stop selling it in the next 28 days, because it has been designated as a medicine.
That means that they will probably have to undergo clinical trials, and demonstrate that they are safe and effective treatments for specific conditions, before they can be sold.
However, the Home Office considers cannabis a “schedule 1” drug, under the Misuse of Drugs Regulations 2001. That means that they consider it to have no therapeutic or medicinal value. It is possible to carry out medical research using schedule 1 drugs, but researchers must apply for special dispensation to do so, making it significantly harder to do.
CBD is one of 113 different “cannabinoid” substances found in cannabis. It has no psychoactive effects. It is commonly taken by people with multiple sclerosis, and there is evidence from preliminary trials that it has some effect. There is also limited evidence that it has a protective effect against psychosis, and a stronger suggestion that it helps treat certain kinds of childhood epilepsy.
However, to meet MHRA standards, it will have to undergo full, double-blind, randomised clinical trials with hundreds of subjects, which take several years. Applying for a licence costs tens of thousands of pounds, before the cost of running the clinical trials themselves, which can run into the millions.
One major pharmaceutical company, GW Pharmaceuticals, is already doing a trial into the treatment of Dravet syndrome, a rare form of childhood epilepsy, using CBD. However, it is unlikely that smaller vendors will be able to afford those costs. A spokesperson for VolteFace, a drug policy campaign group, told BuzzFeed News that “smaller companies will be shut down, leaving the whole field to big pharma”.
He went on: “It’s an innocuous product, and it’s widely available elsewhere around the world. There’s no sense that the MHRA are doing this on a public health basis.”
A spokesperson for the MHRA said: “We have determined that products containing cannabidiol (CBD) are a medicine. This means that these products must have a medicines’ licence before they can be legally sold or supplied in the UK. The products will have to meet safety, quality and effectiveness standards to protect public health.
“If you use CBD and if you have any questions, speak to your GP or other healthcare professional.
“We have written to UK CBD stockists and manufacturers to inform them. These products must not be made and sold without a licence.
“We can provide regulatory guidance to any company who may wish to apply for a licence.”