Medicinal products are defined in Article 1 of the European Parliament and Council Directive 2001/83/EEC. This has been incorporated into the 2012 Human Medicines Regulations statutory instrument of UK law. One provision of this act is that medicinal products that are placed on the market must have marketing authorisations. One consequence of this act is that the sale, supply, advertising of medicinal products, which do not have such marketing authorisation, constitutes an offence. Medicinal products have been carefully defined so that they include substances which have properties that include treatment and prevention of disease in human beings, in addition to the restoration, correction or modification of physiological functions by exerting a pharmacological, immunological, or metabolic action.
Furthermore, the Act also covers means of making a medical diagnosis. The MHRA has recently completed a review of Cannabidiol (The International Union of Pure and Applied Chemistry (IUPAC) nomenclature of this compound is: 2-[(1R,6R)-6-isopropenyl-3-methylcyclohex-2-en-1-yl]-5-pentylbenzene-1,3-diol) and has come to the opinion that it meets the second part of the definition of a medicinal product hence medicinal claims cannot be made for cannabidiol (CBD) in the absence of a marketing authorisation. Efficacy usually requires clinical trial evidence and in its absence products cannot be marketed. To this end, in early October this year the MHRA has been writing to 18 known vendors/distributors of CBD, which are believed to have made claims for medical effects arising from its ingestion by human beings. In essence the letter provides a brief summary of the legal status of products containing CBD in the UK. It is worthwhile examining the details of the subsequent statement made by the MHRA, via a spokesperson, published on their website.
“We have come to the opinion that products containing cannabidiol (CBD) used for medical purposes are a medicine. Medicinal products must have a product licence (marketing authorisation) before they can be legally sold, supplied or advertised in the UK, unless exempt. Licensed medicinal products have to meet safety, quality and efficacy standards to protect public health.”“If you use CBD and if you have any questions, speak to your GP or other healthcare professional.”
“We have written to UK CBD stockists and manufacturers to inform them of our view. We can provide regulatory guidance to any company who may wish to apply for a licence.”
An initial reaction to this statement is to question its relevance to hemp products, such as hemp seed oil, that are not intended for therapeutic use. Indeed, at the time of writing no correspondence from MHRA on this matter has been received by hemp producers. The sale and distribution of CBD as a food or foodstuff appear to be governed by regulation no. 178/2002. The Food Supplements Directive 2002/46/EC in outline defines a food supplement as ‘something which supplements a normal diet and is a concentrated sources of nutrients or other substances with a nutritional effect’. CBD can be categorised as an “other substance” and is therefore subject to national laws which must comply with this directive and in particular cannot be labelled, presented, nor advertised as preventing, treating, or curing a human disease. The precise legal issues are complicated and will require a detailed assessment of the claims made about each product. In truth, the MHRA has emphasised the fact that it assesses each product on a case by case basis rather than the application of a blanket ban. It would appear that food supplements can be classified separately from medicines and to date the MHRA has not made any determination in relation to their status. Clearly, this is a situation that requires very careful consideration of all the relevant factors and one would hope that the MHRA would respond positively to representations made to it by producers of CBD intended for use solely as a food supplement (with no claims being made for medical effect). Other issues among others which merit more detailed scrutiny include: CBD’s therapeutic effect and its value; the right to medicines under European Union (EU) law; the free movement of goods within the EU; a reasonable period of time being made available to companies operating in this space so that they can make formal representations to the MHRA; a list of existing licenses granted for the treatment of specific conditions such as arthritis, multiple sclerosis, childhood epilepsy, various forms of cancer and in particular pain management related to such conditions; the origin and nature of the clinical evidence (animal/human) to be provided in support of any application for a licence; the financial cost of applying for a licence.
It is clear that there will be a variety of opportunities available to the industry to enter into a constructive dialogue with the MHRA. The fact that an increasing number of countries and states are envisaging or are enacting legislation around the world to cover the wider use of cannabis for medical purposes adds further weight to the case for detailed discussion with the MHRA, which could usefully include a formal consultation process with all relevant stakeholders. It is to be hoped that such a process can be engaged before the end of the year.
E-H.O.DESFORGES © 2016
The UK Cannabis Trade Association (UKCTA) has a meeting scheduled with the MHRA on 3rd November 2016 specifically to address the issues you raise. Six representatives from UKCTA including CBD products suppliers and licensed, low-THC cannabis growers will be attending.
UKCTA has also instructed solicitors to advise on the legal position who have, in turn, sought counsel’s opinion. Although we cannot yet disclose the advice we have received, it will be used to inform our negotiations with the MHRA.