In October, the MHRA announced its plans to regulate CBD containing products as medicines. We have been following the story as the situation has developed and more information has been made available. Yesterday Drugscience published a letter by the MHRA responding to questions asked by Prof David Nutt, founder of Drugscience, about the regulation of CBD.
The MHRA letter published yesterday in response to questions from Drugscience is unfortunately both helpful and confusing. While it provides clarification on some key questions regarding the MHRA opinion on Cannabidiol’s medical classification, at the same time the path forward following the 31st December deadline remains somewhat vague.
Although taken aback initially, I have been a supporter of the MHRA decision. While it may feel that the authorities are taking away a natural, plant-based therapeutically beneficial product that we should all be entitled to have access to, we must recognise that one of the key roles of the MHRA is to protect the more vulnerable members of our society. My experience in distributing CBD products over the last twelve months is that people do need to be protected from manufacturers and distributors with no conscience.
As the letter outlines, companies have been selling CBD products based on overtly medical claims, and for the most part without any advice or appropriate qualification with which to base their consumer advise on. However, where this really hits home is the interruption of other medicines processed through the liver, where CBD is prioritised over other compounds, including other medicines, many of which need to be processed by those same enzymes to become active.
Consider that any person, or parent, could potentially purchase a high strength CBD product online and administer it to themselves or their child, having read that CBD is non-toxic and has no adverse effects. If this person is on regular medication that is ingested and processed by the liver, CBD will hinder the breakdown and activation of those medicines.
You may think this is stretching, that the likelihood of this process leading to severe negative consequences are slim, nonetheless while the potential exists consumers must be protected. The reality is that the quality control and medical support around CBD products following regulation will ensure safe access to high quality medicinal grade products. We must also not ignore the significance of the acceptance by the medical authorities of CBD as a therapeutically beneficial compound, showing that patient and consumer persistence can drive change.
Going forward it is clear that there is a mechanism by which products can be made available to patients through the existing medical structure. Unlicensed medicines can be made available through pharmacies if their production complies with GMP standards, and they are distributed by an Authorised Pharmaceutical Wholesaler. Therefore, any current good quality producer of CBD product should in fact be able to match these standards.
Patients will need to consult a doctor to ask for a prescription, for which there should be products available early in 2017, and this process is designed to protect the patient. Doctors knowledgeable on the subject will be able to advise the patient on appropriate strength and mode of application, and prescribe a product that has been approved by the MHRA.
What is unfortunately vague is the nature of the intention of the products offered for sale, and the suggestion that where companies comply with the opinion, refrain from selling based on overt medical claims and complete a Borderline Advice form, they may be allowed to continue selling.
There are several problems with this; the first being that I can sell a high strength product with no medicinal claims that can still potentially cause an interruption effect; the second is that a consumer may buy this product against the advice of a doctor qualified in cannabinoid therapies, and the third is that this product is widely available on the market for patients to buy off the shelf which could be manufactured with absolutely no quality control. Ultimately part of the definition of a product’s medicinal value is whether a consumer is buying it to treat a specific medical condition, and I would suggest this is a significant portion of the people purchasing CBD products, therefore we must have products available to meet that purpose.
While a path forward has now been laid out for companies to potentially make products available in 2017 and ensure availability to patients that so desperately need it, it is yet to be confirmed definitively. No doubt a legal medical decision will be the final piece in this long running puzzle.
Liam McGreevy is Director of Elite Healthcare Distribution and founder of European Cannabinoid Therapy Association