The UK’s Medicines and Healthcare products Regulatory Agency has declared the cannabinoid cannabidiol (CBD) a medicine. The announcement is a double-edged sword.
” We have come to the opinion that products containing cannabidiol (CBD) used for medical purposes are a medicine,” says the agency in an official public statement posted earlier today.
” Medicinal products must have a product licence (marketing authorisation) before they can be legally sold, supplied or advertised in the UK, unless exempt. Licensed medicinal products have to meet safety, quality and efficacy standards to protect public health.”
MHRA is responsible for regulating all medicines and medical devices in the UK. Authorisation will involve clinical trials and facilities reviews for each product – just the same as any other pharmaceutical.
While the acknowledgement is positive and regulation can be a good thing when implemented correctly, this could effectively cut off supplies of cannabidiol for many UK patients very soon, as most products available do not have marketing authorisation.
A number of vendors have already been directed to cease sales in letters received from the MHRA a week ago. The vendors have been told they must end UK sales by the beginning of November and it appears some are attempting to shift as much product as they can by that date.
Currently, the only natural cannabis-based medicine licensed for medical prescription in the UK is Sativex. While Sativex contains CBD, it also contains tetrahydrocannabinol (THC), a psychoactive cannabinoid. Some patients prefer to avoid the effects of THC.
Sativex is also very expensive stuff – A 10ml vial costs around £125 in the UK and contains 2.5 mg of CBD per ml. CBD-only preparations that contain a much higher concentration cost a fraction of the price.
Additionally, patients face a lot more red tape in obtaining access to Sativex.
With no well-organised and resourced UK industry association to fight the changes and a CBD drought looming; the fear is many UK patients may feel the need to seek medication on the black market.
No doubt the race is now on to get approved CBD-only products into the UK market with MHRA’s blessing – something that could well be a lengthy and expensive process.
In other recent UK news, The nation’s All-Party Parliamentary Group for Drug Policy Reform published a report last month following its inquiry into medicinal cannabis.