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.
This is good news as there's good evidence it’s an effective treatment for some severe forms epilepsy in children. However, once the R&D costs have been written in and given the effective monopoly now held by GW means that it is very expensive, especially when compared to very similar unlicensed CBD products currently sold as food supplements in the UK because they cannot be sold as medicines without the MHRA’s approval. GW's share price has naturally surged on this announcement
Among those who may be pleased at this news is UK Home Office drugs minister, Victoria Atkins. British Sugar, of which Atkins' husband Paul Kenward is managing director, grows 45 acres of raw cannabis to supply GW to manufacture Epidiolex.
Also pleased will be UK Prime Minister Theresa May. May's husband, Philip May works for Capital group, which has a 19% holding in GW through its subsidiary, Capital Research Management Company.
Whilst not wishing to suggest anything corrupt going on, what this most certainly represents is blatant hypocrisy:
The Government maintains cannabis has 'no medical uses' through keeping it in Schedule 1 but then licenses the world’s biggest medical cannabis industry!
In addition, the two UK politicians, indeed ministers, best placed to reform our failed & archaic cannabis laws, both potentially stand to benefit financially from our booming legal cannabis industry.
Meanwhile, along with an estimated 1.1m medical cannabis users who face the risk of arrest and prosecution every day, whilst dealing simultaneously with chronic illnesses, poor Alfie Dingly STILL can’t get the medicine he needs for his condition even after a petition exceeding 300k signatures and many months of appealing directly to the Home Office with the support of pretty much every MP in the Commons.
Surely this hypocrisy cannot be maintained for much longer and United Patients Alliance will be asking questions of the Home Office directly.
Jon Liebling - Political Director - United Patients Alliance
United Patients Alliance are not-for-profit. We are volunteer patients with chronic illnesses fighting for legal access to cannabis therapeutics. We act as advocate for and support 1000s of medical cannabis patients in the UK.