Medical Cannabis - the ABC of CBD

1 February 2019

Steph and Dom, known for their vibrant appearances on Gogglebox, appeared on Channel 4 on Monday night in relation to their son Max. The show was entitled: ‘Can Cannabis Save Our Son?’ #StephandDomCannabis. 

 

Max is 18 years old and suffers from a severe form of epilepsy. He suffers from up to 100 seizures a day. His seizures have caused permanent brain damage leaving him with a mental age of a 5/6 year old, along with other health concerns. None of the medications he has been prescribed since the age of 4 have been able to get his seizures under control. His consultant openly stated within the programme that as he gets older there is a real possibility that a seizure may sadly end his life. 

The programme followed Steph and Dom arming themselves with more knowledge about a treatment using cannabis oil; including speaking with the mothers of Billy Caldwell and Alfie Dingley. 

In June 2018, the Home Secretary, Sajid Javid, set up an expert panel to consider licence applications for the treatment in cases of exceptional need following cases involving children such as Billy Caldwell and Alfie Dingley. In fact, Alfie’s case was the catalyst for a change in the law such that patients can be prescribed with medical cannabis.

As commented on by my colleague Nicola Finnerty in her previous blog, the use of marijuana in products and for medicinal use is becoming more prevalent with the changes in legislation around the world, including the UK. If you are considering the process of applying for a licence, prescribing as a doctor, or the implications of investing in a company which produces and/or sells marijuana, continue reading.  

Let’s start with the basics

Cannabis is a controlled Class B drug under Part II, Schedule 2, of the Misuse of Drugs Act 1971. As such, it is unlawful to possess, supply, produce, and/or import a controlled drug except under a Home Office licence as stated section 5 of the Misuse of Drugs Regulations 2001 (MDR 2001) which states:
  5.  Where any person is authorised by a licence of the Secretary of State issued under this regulation and for the time being in force to produce, supply, offer to supply or have in his possession any controlled drug, it shall not by virtue of section 4(1) or 5(1) of the Act be unlawful for that person to produce, supply, offer to supply or have in his possession that drug in accordance with the terms of the licence and in compliance with any conditions attached to the licence.

Section 12 of the MDR 2001 expands on section 5, stating:

12.  Where any person is authorised by a licence of the Secretary of State issued under this regulation and for the time being in force to cultivate plants of the genus Cannabis, it shall not by virtue of section 6 of the Act be unlawful for that person to cultivate any such plant in accordance with the terms of the licence and in compliance with any conditions attached to the licence.

There are a number of Cannabidiols (CBD) found in the cannabis plant. CBD is a chemical substance found in cannabis. Tetrahydrocannabinol (THC) is the principal psychoactive constituent of cannabis. In terms of medical treatments, there is much debate around whether CBD on its own is effective, without an element of THC.

Licensing

Cultivation or possession of cannabis plants cannot lawfully be undertaken without a licence from the Home Office. Licenses are time-limited and there is a prescribed process which must be followed to obtain one. There are two separate licensing schemes depending on whether the cannabis is low or high in THC.  

Low THC 

A licence can be applied for:

  • to cover the production of hemp fibre for industrial purposes;
  • to obtain seeds which are then pressed for their oil.

Neither of the aforementioned allow for the use of the non-controlled parts of the plant i.e. the leaves and flowers. 

There must be a defined commercial use, and the Home Office will only issue a licence for cultivation of plants from approved seed types with a THC content not exceeding 0.2%.

A licence is required to cover both cultivation and possession, and will be valid for three growing seasons (three years) however; a grower must complete an ‘Annual Licence Review Statement’ each year by the 1st of May. As part of this process, details of the records for the previous growing season relating to cultivation areas, sowing details and yields must be provided to the Home Office. The factsheet can be accessed here.  

I am a doctor/patient, what do I need to know? 

“Cannabis-based products for medicinal use in humans” or CBPM is a defined category of cannabis, cannabis resin, CBD and CBD derivatives. These are listed in Schedule 2 to the MDR 2001. There is a three-limb test that a product must meet in Regulation 2 of the MDR to be defined as a CBPM:
“cannabis-based product for medicinal use in humans” means a preparation or other product, other than one to which paragraph 5 of part 1 of Schedule 4 applies, which— 

(a) is or contains cannabis, cannabis resin, cannabinol or a cannabinol derivative (not being dronabinol or its stereoisomers); 

(b) is produced for medicinal use in humans; and— 

(c) is— 

(i) a medicinal product, or 

(ii) a substance or preparation for use as an ingredient of, or in the production of an ingredient of, a medicinal product;”;

(The Misuse of Drugs (Amendments) (Cannabis and Licence Fees) (England, Wales and Scotland) Regulations 2018)

As of 1 November 2018, Specialist Doctors (i.e. those on a specialist register of the General Medical Council) can prescribe CBPMs without requiring a Home Office licence to lawfully write a prescription. The guidelines make clear that cannabis should only be prescribed where all other treatment options have been exhausted. As such, this does not open the floodgates for the use of medical cannabis in relation to all conditions, or make personal use lawful. 

The National Institute for Health and Care Excellence (NICE) has been asked by the Department of Health and Social Care to produce clinical guidelines on the prescribing of cannabis-based products for medicinal use. The guidelines are expected late this year, but in the meantime interim guidance is in place which can be viewed here.  

As a patient, even if CBPM is prescribed for you, accessing it in the UK is still very difficult despite the change in the law, and this is largely due to the issue of supply. 

In all, whilst the change to the law provides a gateway to treatment for patients who suffer with severe forms of epilepsy or the effects of chemotherapy, medical cannabis is not the ‘go-to’ treatment. Commercially, as commented on by Nicola in her previous blog, companies and investors must make sure that they have the appropriate licence and consider the implications of the Proceeds of Crime Act 2002 (POCA) in relation to the possession, supply, production, and/or importation of cannabis, and that’s where we can help.
 

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