Currently in the UK, cannabis in its raw form, which is a comparatively recent amendment in the wording, sits in Schedule 1 of the Misuse of Drugs Act 1971 (MODA) which defines it as having no therapeutic benefit and high potential for abuse.
At the same time GW Pharmaceuticals have had a medicine extracted from the raw cannabis plant, Sativex, approved in 2011 by the Medicines & Healthcare products Regulatory Agency (MHRA) for Multiple Sclerosis patients. The next product in their pipeline, Epidiolex, which consists of purified cannabinoid CBD (Cannabidiol) (99.1%) along with traces of other cannabinoids also extracted directly from the raw plant material has recently been granted pre-approval by the FDA in the US, to be fully confirmed in June 2018. It has been submitted for approval in Europe and will be in the UK shortly as a medicine for children with severe forms of epilepsy.
As no substance named in Schedule 1 can be legally prescribed as a medicine and even though it is an extract from raw cannabis, Sativex was initially placed in Schedule 2 of the MODA which required some clever tweaks to existing policies and careful wording in order to make it distinct from the illegal stuff that it was extracted from so that “raw cannabis” could remain in Schedule 1. Two things had to happen to allow this:
Firstly, as the MHRA have a policy forbidding full plant extracts from being approved as medicines, Sativex was submitted to the Medicines and Healthcare Regulatory Authority (MHRA) as;
“a combination of 2 cannabinoids, THC and CBD in a 1-1 formulation with other inactive impurities”
Of course, what the MHRA didn’t know/weren’t told/ignored? was that the other inactive impurities are all the other cannabinoids, terpenes and flavonoids from the raw cannabis plant, as it is, in fact, a mixture of 2 full plant extracts manufactured into a tincture which can be sprayed under the tongue.
Secondly, to make sure that Sativex remained distinct in law from anyone else’s cannabis the wording in schedule 1 of the MODA was changed from “cannabis” to “raw cannabis” – Do you see what they did there?
Unfortunately, even its Schedule 2 status seriously impacted the adoption of Sativex by doctors due to all the additional licenses, approvals, checks and balances required to prescribe medicines in that Schedule, so the Home Office agreed to change it to Schedule 4(i) which makes it easier for doctors to prescribe to patients but still illegal to possess without a valid prescription, just like it was in Schedule 2.
Practically, this now means that if you have a bottle of Sativex and a valid prescription, the contents are a Schedule 4 substance, but if you didn’t have or could not produce a valid prescription the contents were now treated as a Schedule 2 substance, but if you then decanted it into any other container, or damaged/removed the label it would magically become a Schedule 1 substance, as through testing it would be impossible to differentiate chemically from a plant extract from “raw cannabis” with no medical benefits?
This really does seem like an awful lot of effort to make sure that GW Pharmaceutical’s cannabis remains readily available for patients and for sale around the world, whilst keeping everyone else’s cannabis strictly controlled. You’d think with all this messing around with policies and schedules, it would have been so much easier just to accept that cannabis has medical benefits and move the whole lot out of Schedule 1?
Why go to all these lengths? Surely the additional penalties for illegal cannabis consumption, possession and production that this Schedule affords is not enough on its own to justify it? This begs the question: Are there other motivations?
As mentioned above, GW Pharmaceutical’s Epidiolex is about to become the first licensed CBD product to negotiate the medical regulatory system and win FDA approval.