Cannabis is a genus of flowering plants which has been used for thousands of years for medicinal and recreational use as well as providing a source of fibre for textiles and providing seeds and oil which are used in food and cooking.
Three species of cannabis are commonly recognised; C. indica, C. sativa and C. ruderalis with sativa and indica being the most frequently referred to.
The cannabis plant has been found to contain more than 100 pharmacologically active compounds called cannabinoids and terpenes. The most important of these compounds are two cannabinoids; tetrahydrocannabinol (THC) and cannabidiol (CBD). THC is the principal psychoactive component of cannabis known for its euphoric effects whilst CBD is known for its calming effects. Terpenes in cannabis interact with the cannabinoids and are also responsible for the distinctive aroma of the plant.
Sativa generally has very low concentrations of THC and relatively high concentrations of CBD, whilst indica can contain up to 30% THC. In the United Kingdom THC and other cannabinoids are deemed controlled substances under the MDA 1971, while CBD is not deemed a controlled substance.
There are four distinct cannabis-related markets:
- Medical cannabis – plant based/derived products which are used to treat specific conditions and prescribed by a medical practitioner;
- Pharmaceutical cannabis – products based on cannabinoids which have received clinical approval and licensed as a medicine eg Sativex;
- CBD wellness – CDB infused products such as capsules and oils which contain no controlled substances and are regulated as food supplements;
- Recreational cannabis – cannabis used for non-medical purposes, illegal in many countries (including UK) and therefore obtained via black market sources.
In addition, there is a significant Hemp industry which yields four main products – fibres, shivs, pharmaceuticals and seeds. The cultivation of Hemp is regulated both in the UK (by the Home Office) and also by each of the governing bodies of the Member States. The varieties of Hemp which are allowed to be grown in Europe are those listed in the EU’s “Common Catalogue of Varieties of Agricultural Plant Species” where the THC content must not exceed 0.2% for industrial purposes.
Potential Medical Benefits of Cannabinoids
There is a growing movement globally to use cannabinoids to treat various conditions and this is reflected in the number of jurisdictions that have deregulated or are considering deregulating cannabinoid consumption.
The current Chief Medical Officer for England and Chief Medical Advisor to the UK Government, Professor Dame Sally Davies, and ADMR have reported that there is conclusive evidence of the therapeutic benefit of Cannabis-based medicinal products for certain medical conditions.
Patients have also reported numerous benefits from the use of cannabinoids including relieving insomnia, anxiety, spasticity and pain as well treating life-threatening conditions such as epilepsy. Chronic pain is seen as the segment which shall see the fastest growth within the next 5 years and there are many studies that have shown that Medicinal Cannabis is an effective way to treat chronic pain while being substantially safer than many other options.
The benefits of using cannabinoids to treat epilepsy symptoms were acknowledged by the Home Office in two high profile cases when it initially granted specific licences to two children before undertaking further deregulation on the 1st of November 2018 which now allows specialist doctors to prescribe Medicinal Cannabis for a number of conditions.
The Board believes its experience coupled with the substantial technical experience of the Technical Advisory Board will allow them to successfully identify and assess opportunities in line with the investment strategy of the Company as well as effectively navigate the dynamic regulatory nature of the market.
Summary of UK Legislation relating to Medicinal Cannabis
World High Life’s strategy is to conduct due diligence into Cannabis and Cannabis derivatives for medical and wellness purposes as well as to make investments into and acquisitions of businesses operating in the Medicinal Cannabis, Hemp and CBD wellness industries. These activities are subject to specific regulation under the MDA1971, the MDR 2001, the MDDO 2001 and the POCA 2002 in the UK.
Cannabis is a controlled drug and is assigned to Class B under the MDA 1971 based on the potential for harm, together with many of its derivatives. As noted CBD is not deemed a controlled substance, however, the Home Office has pointed out that CBD products are rarely devoid of other, controlled cannabinoids (such as THC). Class B is an intermediate category between Class A for the most harmful drugs and Class C for the least harmful drugs.
Under MDR 2001 and MDDO 2001, drugs can be imported, exported, produced, supplied and possessed under a licence issued by the Home Secretary. In mid-2018 the Home Secretary Sajid Javid exercised his authority by granting licence to allow medical teams to have access to Cannabis-based medicine to treat certain individuals with severe forms of epilepsy. The Home Secretary has also been given the necessary authority to make exceptions to the prohibition on the importation, exportation, supply, possession and cultivation of Cannabis by those without a licence. The Home Secretary’s actions followed a public outcry over two boys with severe epilepsy being denied access to Cannabis oil.
A two part review was undertaken by the UK government as a result of widespread support and campaigning for the legalisation of the distribution, supply possession and cultivation of Cannabis in the UK without a licence from the Home Office. Chief Medical Officer for England and Chief Medical Advisor to the UK Government, Professor Dame Sally Davies undertook the first part and considered the evidence available for the medical and therapeutic benefits of Cannabis-based medicines. In the review which was published in July 2018, it was reported there is conclusive evidence of the therapeutic benefit of Cannabis-based medicinal products for certain medical conditions and reasonable evidence of therapeutic benefit in several other medical conditions.
The second part of the review considered the appropriate schedule for Cannabis-derived medicinal products based on the balance of harms and public health requirements and was completed by the ACMD. The ACMD agreed with Professor Davies that there was evidence of the benefit of some Cannabis-derived medicinal products and that they have the potential to treat patients with certain medical conditions. The review concluded that the whole class of Cannabis-based medicinal products should be moved out of a Schedule 1 of the MDR 2001 classification which would allow them to be prescribed under controlled conditions by registered practitioners for medical benefit.
The two part reviews’ recommendations were heeded and since 1 November 2018, certain Cannabis based medicinal products are now placed in Schedule 2 of the MDR 2001 enabling them to be prescribed under controlled conditions by registered practitioners for medicinal benefit.
As previously noted the cultivation of Hemp is regulated both in the UK (by the Home Office) and by other Member States. There are a list of the varieties of Hemp which are allowed to be grown in Europe and this in found in the EU’s “Common Catalogue of Varieties of Agricultural Plant Species” where the THC content must not exceed 0.2%.