1. Rule relaxation
Mexico, Luxembourg, Canada and the majority of US states (33, plus the District of Columbia), now permit the medical use of cannabis.
In November 2018, the UK amended the Misuse of Drugs Regulations to move cannabis from schedule 1 – meaning it had no therapeutic value and researchers needed a Home Office licence to obtain and store it – to schedule 2 – a category for drugs which are still tightly controlled, but have a recognised medical use and can be prescribed in certain circumstances.
It is important to note that cannabis remains a controlled Class B drug, meaning it is illegal to possess without a legal prescription or licence.
Anyone found with the drug could be imprisoned for up to five years, while supplying it can be punished with a 14-year jail sentence or an unlimited fine.
2. CBD or CBPM?
The two main active ingredients in cannabis are cannabidiol (CBD) and tetrahydrocannabinol (THC).
THC is the psychoactive cannabinoid that gets recreational users "high". CBD does not have this effect.
CBD is a chemical that may come from cannabis. While some cannabinoids are controlled substances under the UK’s Misuse of Drugs Act, CBD is not, which is why many CBD products are already widely available.
Medicinal cannabis (or CBPM, referring to "cannabis-based products for medicinal use in humans") are currently unlicensed medicines – i.e., they do not have marketing authorisations in the UK – so doctors can only prescribe them if a patient has a "special" need that cannot be met by licensed medicines.
Under the new rules, GPs are not allowed to prescribe cannabis-derived medicines. Prescriptions can only be issued by a specialist doctor on the GMC's register – for example, a consultant in neurology or paediatrics.
A manufacturer looking to supply CBPM will need to engage with the Home Office and the UK's Medicines and Healthcare products Regulatory Agency (MHRA) to obtain the various necessary licences.
3. Updated WHO recommendation
Following consideration by the World Health Organization (WHO) Expert Committee on Drug Dependence (ECDD), on 24 January 2019, WHO recommended to the UN that cannabis and cannabis-related substances be rescheduled in the international drug control framework.
The ECDD proposed that preparations considered to be “pure” CBD should not be scheduled within the International Drug Control Conventions, by adding a footnote to the entry for “cannabis and cannabis resin” in Schedule 1 of the Single Convention on Narcotic Drugs (1961), stating:
“Preparations containing predominantly cannabidiol and not more than 0.2 percent of delta-9-tetrahydrocannabidiol are not under international control”.
In the UK, if a CBD product contains any controlled cannabinoids (e.g., THC), it is likely to be controlled under the Misuse of Drugs Act, unless it is either an "exempted product" under the Misuse of Drugs Regulations 2001, or is a CBPM. For any business intending to market or sell such products, it is sensible to obtain advice in this area.
4. Industrial hemp has legal but restricted uses
Industrial hemp may be grown under licence in the UK.
It is a strain of the cannabis plant that contains little or no THC, but does contain CBD.
Industrial hemp can be used in products such as building materials and clothing as well as for CBD oil.
5. CBD is available on the high street
CBD oil derived from cannabis and hemp plants has recently become much more widely available and is being proactively marketed.
Consumers may have noticed it appearing in everyday products including coffee, frozen yogurt, balms, drops, chocolate, flapjacks, cosmetics, dog treats and fizzy drinks.
As outlined above, the CBD used in these products has no psychoactive effects, but it has been linked with some health benefits, including relieving inflammation, pain and anxiety, although there have so far been no conclusive scientific studies to prove these claims.
Although CBD products appear widely in the UK market, there are a number of further regulatory considerations when selling and marketing them.
These include food labelling and food safety regulations, manufacturing legislation and advertising rules, on which legal advice should be sought.
Other regulatory issues may arise where CBD is used in cosmetics or vaping products, where EU Directives apply.
It is also worth keeping in mind that the Home Office is closely monitoring CBD products and whether the Misuse of Drugs Regulations' definition of "exempted product" is met in each case.
The MHRA (by its own admission) could, in the face of growing evidence of CBD's therapeutic effects, start to regard CBD products as medicinal by function (in the same way that aspirin cannot be marketed as a food supplement).
Therefore, there is some uncertainty as to whether any particular product, including products under development, will be classified as a medicinal product by the MHRA.
6. New "novel" food rules
When found in foods, all extracts of hemp and derived products containing cannabinoids (including CBD) are now regarded by the European Commission as "novel".
On 17 January 2019, a new entry was added to the European Commission's Novel Food Catalogue for generic “cannabinoids”, while the reference for CBD was also updated with a link to a new entry, stating:
“Products containing cannabinoids are considered novel foods as a history of consumption has not been demonstrated.”
This categorisation applies to the extracts themselves and also any products to which they are added as an ingredient (such as hemp seed oil).
Synthetically obtained cannabinoids are also considered to be novel.
The Novel Food Catalogue is not legally binding, but is used as a reference by many authorities in the EU for the purposes of the Novel Food Regulation ((EU) 2015/2283).
This change to the Catalogue may therefore mean authorities in EU Member States refuse to permit the supply of foods and food supplements containing cannabinoids, pending formal approval by the European Food Standards Agency (EFSA) under the Novel Food Regulation.
The Food Standards Agency (FSA), the regulatory authority responsible for food safety in the UK, has confirmed that it accepts the clarification from the EU that CBD-containing foods are considered as novel and is committed to finding a proportionate way forward by working with local authorities, businesses and consumers on how to achieve compliance in labelling and selling these products.
The first novel food application for CBD is currently under consideration by the EFSA to authorise the use of CBD in food supplements for adults, with a daily intake of up to 130mg.
7. Medical products require licences
In 2016, the MHRA said that CBD products, if advertised for medical purposes, need to be licensed.
Non-medical products can be sold (for example as food supplements) as long as no claims are made about their medical benefits.
It is prudent to take advice on advertising in this complex area.
8. Rescheduling was not a green light
The UK's Health Select Committee has been reviewing the issues around medicinal cannabis.
Its recent inquiry asked for evidence on:
The current evidence base for medicinal cannabis;
Plans and challenges for future research;
Current prescribing procedures;
Guidance and knowledge of practitioners regarding medicinal cannabis; and
Public opinion and behaviours in the UK.
The Committee reported on 3 July 2019 and noted that patient and families' expectations were raised by the rescheduling under the Misuse of Drugs Regulations, while in fact, very few prescriptions (possibly fewer than 20) have been issued for CBPMs in the UK since the change in the law.
The report recommended:
"The Home Office, Department of Health and Social Care and NHS England should consult relevant patient and professional organisations and form a communications plan to relay clear information to patients and the wider public about the availability of CBPMs and the need for further research."
9. Prescription rules remain extremely tight
Prescribing unlicensed products is often referred to as “off-licence”.
When prescribing unlicensed products, doctors have to:
(a) Be satisfied that there is sufficient evidence or experience of using the medicine to demonstrate its safety and efficacy;
(b) Take responsibility for prescribing the medicine and for overseeing the patient’s care, monitoring and any follow up treatment, or ensure that arrangements are made for another suitable doctor to do so; and
(c) Make a clear, accurate and legible records of all medicines prescribed and, where they are not following common practice, their reasons for prescribing an unlicensed medicine.
10. A NICE idea
By December 2019, the National Institute for Health and Care Excellence (NICE) intends to have published guidelines on CBD
The NHS will then use these to decide whether it will eventually fund the drug routinely for some patients.
On 30 July 2019, one of NICE's Technical Appraisal Committees will meet to consider evidence in relation to the clinical and cost effectiveness of GW Pharmaceuticals plc's product, Epidiolex, for adjuvant treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome.
Any resulting NICE Guidelines (which are anticipated in the autumn) will limit use to the drug’s awaited marketing authorisation.
Epidiolex, together with another of the company's products, Sativex, are currently undergoing clinical trials, the results of which are being reported to the authorities.
In February 2018 the European Medicines Agency (EMA) accepted for review GW Pharma's Marketing Authorization Application (MAA) for Epidiolex. This builds on the US Food and Drug Administration approval in June 2018.
The outcome of the MAA review by the EMA is expected in the second half of 2019.
The NICE and EMA decisions will make GW Pharma a bellwether for future marketing authorisations of medicinal cannabis in the UK and Europe.
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