United Kingdom: an official definition of cannabis-based medicines

The United Kingdom has surprised everyone by the speed with which it has legalized medical cannabis this summer. After studying the’Advisory Council on the Misuse of Drugs (ACMD), the Ministry of the Interior has just announced the first official definition of cannabis-based medicines and the procedures by which they will become legal.

Home Secretary Sajid Javid saidAgreeing on this definition means that specialist doctors will be able to prescribe these drugs to patients who need them most this autumn«.

An extremely rapid procedure

Just two months earlier, Sajid David had pledged to return the medical marijuana available to patients through the public health system or by prescription. Medicines deemed suitable for prescription will be transferred from the schedule 1, which lists dangerous substances of no medical interest, at schedule 2 which lists substances of medical interest. The substances listed in the schedule 2 are always considered potentially dangerous and subject to detour, and are therefore strictly controlled.

In order to define which substances will be reprogrammed, and according to what criteria, the Ministry of the Interior has studied the ACMD's recommendations, most recently on September 11. Among the elements to be defined were: an official definition of cannabis-based medicines, routes of access to medicines, and appropriate guidance and support for healthcare professionals. Last Friday, Ministry of the Interior responds to ACMD by approving all the recommendations made.

How cannabis-based medicines will be defined

Since the pharmacological and scientific research on cannabis is still in its infancy, and the authorization of medicinal products will follow its evolution. The substances in question, to be considered as cannabis medicines, will have to meet the following three criteria: contain components of cannabis, be intended for medical use on humans, be a medical product or a substance used in its manufacture. This extremely broad definition must be considered alongside the following access routes:

• Prescription of a drug not yet licensed or authorized for sale in pharmacies by a specialist doctor (general practitioners are not authorized to prescribe cannabis).
• administration of an unlicensed substance as part of a clinical trial, i.e. in a controlled environment.
• prescribing a drug that has been approved for sale by the MHRA, the UK medicines regulator, and is therefore available in pharmacies.

The future legal cannabis-based medicines must have a transparent composition: the rates of CBD and THC as well as the route of administration must be clearly indicated on the label. In line with ACMD's recommendation, medical cannabis should never be dispensed in smokable form, because of the harmfulness of the smoke and to prevent recreational detour.

At the same time, the Ministry of Health and regional health systems must support and train practitioners. They will also coordinate and fund research programs to establish a clinical database on cannabis. Finally, a communication strategy aimed at the public, the medical world and law enforcement agencies will be put in place to spread a coherent message.

Drug approval is therefore not immediate, and will take place as and when clinical research evidence. Licenses to prescribe cannabis may still be issued to patients in exceptional cases through the usual procedure. Licenses are issued by the Ministry of Health on the advice of an independent panel of experts. Nevertheless, the procedure is reputed to be lengthy and costly.