On Thursday, the United Kingdom became the latest country to liberalize its cannabis laws, moving medical marijuana from a Schedule I to a Schedule II drug. Specialist physicians – doctors who focus on specific fields of medicine, such as neurology or paediatrics – are now allowed to prescribe cannabis in situations they deem medically appropriate.
The U.K. could become an important market for Canadian cannabis producers, who are already shipping medical-grade product to countries such as Australia and Germany. That said, the U.K.’s new approach to medical cannabis remains restrictive, with physicians being encouraged not to prescribe cannabis except as a last resort, and importers having to ship products based on individual patient demand.
Here are a few key takeaways from government guidance documents for would-be exporters to the U.K. to consider:
Physician buy-in may be limited
It’s unlikely that there will be an explosion of cannabis prescriptions due to the cautious stance being taken by U.K. health officials.
In a guidance note published on Wednesday, Dame Sally Davies, the U.K.’s chief medical officer, advised that “cannabis-based products for medicinal use should only be prescribed for indications where there is clear published evidence of benefit and in patients where there is a clinical need which cannot be met by a licensed medicine and where established treatment options have been exhausted.”
While there are some 80,000 specialist doctors now able to prescribe cannabis, very few are likely to do so at first. “I think we’re really just talking about a few dozen doctors, if that,” Dr. Michael Barnes, one of the U.K.’s leading cannabis experts, told Cannabis Professional in October.
GMP Certification needed
As is the case for imports to Germany, Canadian importers to the U.K. will need to have their facilities certified to European Good Manufacturing Practices standards. As it stands, only a handful Canadian companies have GMP certification: Aurora Cannabis Inc.; Tilray Inc.; Cronos Group Inc.; Canopy Growth Corp.; Aphria Inc.; and Wayland Group Corp. (formerly called Maricann Group Inc.).
Imports have to respond to individual need
Cannabis products won’t be shipped en masse the U.K. then distributed commercially. Products have to be formulated “in accordance with the specifications of a Specialist doctor, and for use by an individual patient under his direct personal responsibility,” according to the MHRA.
Before shipping a product to the U.K., a Canadian producer would need to receive an order from a special importer. The importer, in turn, needs to be acting on a request made by a pharmacy processing an actual prescription.
“MHRA expects that documentary evidence that the requested supply is for clinical need that cannot be met by an unlicensed medicine be obtained by manufacturers, importers or distributors… This may take the form of a prescriber’s letter, however an alternative fully documented audit trail through the supply chain confirming special need may be acceptable.”
Limits on advertising
Manufacturers of medical cannabis can advertise their services to doctors, but they’re not allowed to advertise specific products. In other words, a Canadian LP can’t do “anything designed to promote the prescription, supply, sale or use” of a given product, although they can provide price lists.