Products used for medical purposes that contain cannabidiol (CBD) must now be licensed before they can legally be supplied in the UK, thanks to last year’s decision by the Medicines and Healthcare products Regulatory Agency (MHRA).
After issuing in October its initial opinion on the medicinal value of CBD products, the MHRA allowed businesses until December 31, 2016 to voluntarily remove their current stock of CBD products sold for medicinal purposes.
Now that the deadline has passed it is inevitable that the availability of CBD products in the UK will dry up whilst suppliers and manufacturers work towards obtaining the necessary market authorisation. If they ignore the licensing requirements and continue to dispense, they potentially face prosecution.
Release has remained fairly quiet on this issue since the MHRA’s October announcement, primarily because we wanted to analyse the legal implications of the decision coming into force. In the meantime there has been a significant amount of misinformation in the reporting of the law, and the legal position of CBD is still not straightforward.
Whilst a definitive legal position for individual cases cannot be provided in a blog, we can explore some of the issues raised as a result of the MHRA’s move, in particular what options and risks exist in the interim period of license approval for those currently using CBD-based products to relieve symptoms of ill health.
Importation of CBD products for personal use or use by a member of your household
The relevant legislation here is the Human Medicines Regulations 2012 (‘the Regulations’), which are concerned primarily with the regulatory framework for the production, supply and licensing of medicinal products. This is about controlling the mechanisms of a market and not, as the case is with the Misuse of Drugs Act 1971 (‘the 1971 Act’), predominantly prohibiting activities related to a whole class of drugs (although many controlled drugs are also medicines subject to the 2012 Regulations).
A breach of the Regulations can be a criminal offence carrying a maximum of two years’ imprisonment in some cases. There is clearly reason, therefore, to be concerned by the MHRA’s decision.
The 2012 Regulations are not concerned with individual use of a medicinal product, so personal possession of CBD, if it is considered as such, is not a criminal offence.
In terms of importation, of a medicinal product, Regulation 17 paragraph (1) states:
“A person may not, except in accordance with a licence (a ‘manufacturer’s licence’)—
(a) manufacture, assemble or import from a state other than an EEA State [European Economic Area] any medicinal product; or
(b) possess a medicinal product for the purpose of any activity in sub-paragraph (a).”
Regulation 17(6) states:
“Paragraph (1) does not apply to a person who imports a medicinal product for administration to himself or herself or to any other person who is a member of that person’s household.”
This would seem to provide legal protection for those who wish to import CBD either for their own use or to administer to their child if that child is part of their household.
The risk of criminalisation - you may not know what is in the bottle
The main risks faced in the circumstances described above is where the CBD imported contains tetrahydrocannabinol (THC), or where it is not considered a medicinal product and therefore may fall within the remit of the Psychoactive Substances Act 2016 (‘the 2016 Act’).
Traces of THC in a CBD product
In the first scenario, there has been some discussion in other reports on this subject that the EU permits CBD containing 0.2 per cent of THC or less. However, an initial review of the relevant regulations (Article 52 of Regulation (EC) No 1782/2003) appear to be concerned with hemp cultivation rather than products produced from the hemp so are unlikely to be applicable to CBD oil. The Misuse of Drugs Regulations 2001 (‘the 2001 Regulations’) have also been cited as a legislative source that permits small amounts of THC in a product; however, there is simply no basis for this assumption and the 2001 Regulations are silent on the issue.
If the CBD product possessed or imported for personal use contains trace amounts of THC this could then result in a prosecution under the 1971 Act, either under s5(1) where the offence is one of possession, or under s3(1) which prohibits the import of controlled drugs*.
In the case of a prosecution for possession, the defence of lack of knowledge of the existence of THC might be raised under s28 of the 1971 Act where the defendant can show that they “neither knew, nor suspected, nor had reason to suspect that the substance or product in question was the particular controlled drug alleged”. The defendant would have to show that they honestly believed that the substance contained no THC.
The difficulty in running this defence would be in relation to whether they could demonstrate they had no “reason to suspect”. If a defendant had clearly asked a producer whether the CBD oil contained traces of THC, had been assured that it did not, and could evidence this (perhaps through an email exchange) then this may be enough to establish the defence. However, failure to ask specifically when there is evidence that the CBD oil market usually contains trace amounts of THC might result in the defence of lack of knowledge falling short.
Importantly, the s28 defence of lack of knowledge does not apply to the offence of importation. Although, to prove the offence the prosecution would have to establish that the defendant knew, or should have reasonably known, about the existence of the THC, or more generally that the product being imported was subject to a restriction or prohibition on importation. Again, if the defendant can demonstrate they acted in the belief that the product they imported contained no controlled substances then this could assist in establishing that they lacked the intention to commit a crime.
It is also worth noting that the argument in relation to THC and prosecution under the 1971 Act could apply to cannabinol (CBN), which is also a controlled drug.
Prosecution under the 2016 Act
If the CBD oil is not considered to be a medicinal product – and the MHRA has advised that products containing CBD are ‘medicinal products’ and have not declared CBD itself to be a ‘medicinal product’ - then the 2016 Act could conceivably come into play. Equally, the decision by the MHRA could lead to products containing CBD being exempt from the Act, in which case it would not be applicable.
CBD is considered by many in the drugs field to be non-psychoactive, in which case the 2016 Act simply would not apply. If, however, the argument was made that it is psychoactive, there are a number of issues raised by this piece of legislation. Firstly, importation for personal use is an offence under s8 of the 2016 Act.
However, as Release has reported before, we believe that the legal test for establishing that a substance is psychoactive is likely unworkable.
In any of the above situations, if the police and the Crown Prosecution Service did bring proceedings, arguments could be submitted at any stage about whether it was in the public interest to pursue such cases. Arguably there could be persuasive points made in many cases where medical evidence can be submitted and questions raised about bringing people with an illness into the criminal justice system.
To sum up, the legal position is simply not that clear and without testing the various possible scenarios detailed above it is difficult to provide definitive advice on what people can do regarding CBD products for medicinal use. In addition, there is a possibility that doctors, or other prescribers, could prescribe CBD products as unlicensed medical products known as ‘specials’, something we will report on shortly.
We will continue to work on this, but with incomplete positions such as the one taken by the MHRA on CBD products used for medical purposes being considered medicines, or that trace elements of THC could potentially be found in CBD oil, or the question of whether CBD is psychoactive or not, it is difficult - and would be irresponsible - to provide legal opinion at this stage.
For those who have been using CBD for medical purposes, or have been administering it to a member of their household, it would appear that importation under the 2012 Regulations is possible, but a risk exists in relation to trace amounts of THC and a prosecution under the 1971 Act, or the potential for a case being brought under the 2016 Act.
What we really want to achieve in writing this piece is to demonstrate the complexities and lack of legal clarity to ensure that people are aware that it will be, at least for the time being, very hard to predict the legal situation for those wishing to secure CBD oil and other products from overseas. Once we know more we will let you know. Should you have any questions in the meantime, please call the helpline or email.
*The offence of importation is contained in the Customs and Excise Management Act 1979, which in combination with the 1971 Act create the criminal offences of importation and exportation).
The above is for guidance only and should not be treated as definitive advice or used in court proceedings. Anyone seeking specific legal advice, where there is a risk of prosecution or where they have been arrested for an offence, should contact the Release legal helpline or a solicitor.