8 November 2018
Recent changes to the rules in the UK have raised some interesting possibilities and questions. Paul England explores.
Given the number of different varieties of cannabis plant that exist, the Medicines and Healthcare products Regulatory Agency (MHRA) needs to be clear in its definition of cannabis-derived products what exactly is being moved from Schedule 1 to Schedule 2. Cannabis plant varieties don't contain just one compound affecting to their properties, but over one hundred. These are called cannabinoids and most are also controlled under the Misuse of Drugs Regulations (MDR) 2001. The best known cannabinoids are tetrahydrocannabinol (THC) and cannabinol (CBN). It is THC that gives cannabis its psychoactive effect and is controlled. CBN, by contrast, has no such effect and is not controlled.
At one end of the scale, there is cannabis with most of the THC removed (hemp), and at the other, cannabis containing high proportions of THC (skunk). Once defined by the MHRA, it is expected that it will be possible to prescribe cannabis-derived products containing certain proportions of THC and other currently controlled cannabinoids. Indeed, there is one example of a cannabis derived medicine containing both CBD and THC in approximately a 1:1 ratio that is already licensed in the UK. This is Sativex, which is an oral spray containing cannabis extracts and was exceptionally licensed by the MHRA for prescription use in treating some of the symptoms of multiple sclerosis in adults. Sativex was exempted from the MDA 1971 and placed in Part I, Schedule 4 of the MDR 2001 in March 2013, on the basis that it has recognised medicinal or legitimate use.
Current guidance states that the re-scheduled products should only be made available to children with rare and severe forms of epilepsy, adults with vomiting or nausea caused by chemotherapy, and adults with muscle symptoms caused by multiple sclerosis. The list doesn’t include chronic pain, which is thought to be one of the main uses of medicinal cannabis.
The decision to prescribe under Schedule 2 must be made by a specialist doctor – not a GP.
MHRA has already advised manufacturers and retailers of CBD products that they should be regulated as medicines. This means obtaining marketing authorization under the procedures of Directive 2001/83. If so, it could take many years to authorise the many complex combinations of cannabinoids present in the different cannabis varieties.
The market in generic versions of traditional small molecule drugs already provides a thriving business model that relies on the absence (or expiry) of protection (specifically, patent protection). However, as with other new, innovative drugs, if investment is to be attracted to the research and development of entirely new cannabis-derived products, investors will want to see exclusivity protection so that their investment costs can be recouped with premium prices. This is more of a challenge for cannabis-derived products because:
by multiple authors
by multiple authors