Yesterday, 3rd November 2016, six delegates from the UK Cannabis Trade Association (UKCTA) met with Medicines and Health Products Regulatory Agency (MHRA) representatives at the agency’s headquarters in Victoria.
We were courteously received. The meeting was cordial, productive and enabled both sides to clarify their positions and better understand each other’s perspective.
In summary, in my opinion, there is no immediate threat to to CBD consumers or businesses. The MHRA has now extended until 31 December 2016 the date by which businesses should voluntarily comply with its opinion, either by withdrawing existing products from the market, or by complying with necessary regulation. Thereafter, the next step would be to begin the process of statutory enforcement. This would take a matter of some months and I believe, even were this to be started, we are looking at more than a year before any impact would be felt. More importantly, based on the meeting, I think the outcome is likely to be that we can negotiate a form of regulation that will work for everyone.
The MHRA team was led by Gerald Heddell, Director of Inspection, Enforcement and Standards. Also present were regulatory advisors David Olszowska and Chris Groutides; Dr Chris Jones, Manager of the Medicines Borderline Section; Greg Markey, Senior Medical Assessor and Malcolm Evans, Head of Patient, Public and Stakeholder Engagement. Mr Heddell opened the meeting by thanking us for bringing to the agency’s attention just how many people are using CBD, some for quite serious medical conditions.
The MHRA set out its reasons for its opinion that products containing CBD used for medical purposes are medicines. Greg Markey explained the mechanisms of action and pharmacology that had been considered and Dr Jones explained that the Borderline Section existed to deal specifically with products where it was difficult to determine whether they should be regarded as medicines or food supplements. The example was offered of vitamin C where if it was being used to treat scurvy then it was clearly a medicine, whereas if it was used to supplement a normal diet it could be regarded as a food supplement. We were able to explain that all so-called CBD products on the market, with the exception of crystals, are actually whole plant extracts from low-THC cannabis, usually industrial hemp. We pointed out that the growth in the CBD market had been driven by people seeking the therapeutic benefits of medicinal cannabis which until now had been denied by the British government.
The nub of the issue is really the nature of the condition for which CBD is used. The MHRA has already issued orphan designations for CBD for Dravet Syndrome, graft versus host disease and perinatal asphyxia. Orphan designations are granted where the benefit of a medicine can be recognised even though necessary regulatory processes have not yet been completed. It is important to understand that this is what has guided the MHRA’s opinion, viewing CBD as a medicine for very serious conditions.
We discussed a range of options whereby, at the lowest level, CBD products could continue to be marketed as a food supplement. For minor conditions, not requiring medical supervision, it may be possible to obtain a Traditional Herbal Registration (THR) at a cost of a few hundred pounds. A third option is a ‘Specials’ exemption where a doctor or prescriber has specified and taken responsibility for an unlicensed medicine for a particular patient. Finally, the highest level is a Marketing Authorisation (MA) where the costs including fees and clinical trials are probably a minimum of £250,000.
It is our view that CBD products should be regulated at all these different levels dependent on the purpose for which they are used and the concentration at which CBD is present. We have agreed that we will write formally setting out these proposals and the MHRA will respond accordingly.
The UKCTA and a number of individual companies have now obtained legal advice including counsel’s opinion. We have shared this with the MHRA and formal solicitors letters have already been served. In essence, the advice is that the MHRA has failed to comply with its own guidelines and requirements in issuing its opinion to CBD suppliers and that any requirement to comply with regulations would have to be addressed on an individual, product by product basis.
So, all in all, we believe the meeting was a success. We demonstrated that the new trade association is to be taken seriously and that we will work constructively with the agency. There was visible surprise at the level of professionalism we presented, particularly with the legal advice we had obtained. I believe we convinced the MHRA that we could establish a set of rules, guidelines and standards that would enable the industry to comply with its requirements.
The CBD market in the UK is presently worth several million pounds a year. If it is to continue to grow, provide safe, effective products for consumers and patients and job security for its workers, then we need to establish UKCTA so that it effectively represents the whole industry. We need to show that we are responsible, we care, we are professionals and we are ready to put our collective head above the parapet as a legal, ethical and regulated industry.
In advance of the meeting between the UK Cannabis Trade Association (UKCTA) and the MHRA on Thursday, there has been a flurry of activity which amounts to a climb down by the regulator.
This statement was published on the MHRA website at lunchtime today.
“Update 1 November 2016
An MHRA spokesperson said:
While MHRA has given its opinion that products containing cannabidiol (CBD) used for medical purposes are medicines, we have also carefully considered the needs of individuals using CBD products to treat or manage the symptoms of medical conditions.
Our primary concern is patient safety. In order to ensure that products remain available until individuals have the opportunity to discuss their treatment with their doctor, companies now have until 31 December 2016 to voluntarily operate within the law, by withdrawing their existing products from the market, or working with MHRA to satisfy the legal requirements of the Human Medicines Regulations 2012.
We have today written to the manufacturers of CBD to make them aware of the timeline for engagement.
It is vital that medicines meet safety, quality and efficacy standards to protect public health.”
Originally the MHRA wrote to CBD suppliers in threatening terms:
“You must cease to sell, supply, promote, advertise or process orders for the above products until appropriate authorisation has been granted for them. You must confirm this in writing within 28 days from the date of this letter that you have taken the above steps.”
So quite a change in tone. The MHRA seems to have recognised that contrary to its declared mission ‘to improve health’, its original statement actually endangered the health of tens of thousands of people.
Additionally, solicitors representing the UKCTA have now written to the MHRA seeking clarification of its intentions and making three crucial points:
- The letters to CBD suppliers and the MHRA’s original press statement have caused serious financial damage to the CBD industry.
- The MHRA has conducted no effective consultation with stakeholders.
- The MHRA’s own guidelines require it to consider each product on a case by case basis and a blanket ban on products containing CBD would be unlawful.
Professor Mike Barnes, scientific and medical advisor to CLEAR, commented:
“The MHRA’s new stance is an improvement from their previous position. However, I cannot see any value in delaying only a few months. Some patients might be able to find an alternative medicine from their doctor but many people will have already tried alternative medications and found that CBD is the only satisfactory treatment for their condition. This is the case, for example, for children with epilepsy who will have almost certainly have been under the care of a specialist and tried available anticonvulsants and found that CBD is the only treatment that works for them. The MHRA does not seem to realise the impact of this arbitrary and rushed decision which will clearly be detrimental and potentially have very serious (and in some cases life threatening) implications for some people. The MHRA need to work with the manufacturers and the medical profession to determine the best way forward that both recognises that cannabis based products have medicinal value, and as such need proper trials of efficacy and safety, yet on the other hand does not place existing users at risk of harm”.