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Peter Reynolds

The life and times of Peter Reynolds

Posts Tagged ‘Mike Harlington

Talking Cannabis With the MHRA

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MHRA Headquarters

In November 2016 I organised a meeting with the Medicines and Healthcare products Regulatory Agency (MHRA) and a number of key players in the CBD market.  It was in response to the MHRA seeking to clamp down on sales of CBD oil and related products.  That meeting led directly to the formation of the Cannabis Trades Association UK (CTAUK) which now represents more than 80% by turnover of all CBD suppliers in the UK.

Since that first meeting my friend and colleague Mike Harlington has taken on the leadership role at CTAUK and I give him great credit for what has been achieved.  We expect formal recognition by the MHRA is only a few weeks away and that is a tremendous coup.  For the first time ever, in the face of total intransigence by government, we have established to a significant degree a legally regulated cannabis market.  Clearly, it doesn’t yet go anywhere near far enough but this is the most concrete move ever towards long overdue cannabis law reform.

The first 18 months of CTAUK have not been easy.  Other than the MHRA, the other branches of government concerned are the Food Standards Agency (FSA) and the Home Office.  The FSA has also become a close working partner but, unsurprisingly, the Home Office remains difficult and our efforts to engage constructively with it have been characterised by responses that are inconsistent, irrational, contradictory and a realisation that it’s losing its grip on cannabis policy.  It is impossible to deal with.  In fact, I almost sympathise with the unfortunate civil servants charged with administering a policy that is itself irrational and contradictory and driven only by outdated prohibitionist values.  Maladministration of the Misuse of Drugs Act is now a persistent reality and several legal challenges to the Home Office’s conduct are imminent.  Soon the High Court will become involved in UK cannabis policy and then, in theory, facts and evidence should prevail rather than propaganda and government disinformation.

Dr Chris Jones

The CTAUK has been engaged in regular meetings with the MHRA and I was invited along for the most recent occasion.  The CTAUK team was Mike Harlington, Tom Whettem of Canabidol and myself.  The MHRA team was Dr Chris Jones, head of the Borderline Medicines section and Raj Gor. We discussed many administrative matters and gave a great deal of time again to discussing medicinal claims and how members could avoid mistakes.  It seems obvious that no claims of medicinal benefit can be made but there are many instances where it’s not clear cut.  A particular case we looked at was the use of ‘night’ and ‘day’ CBD products.  Eventually it was agreed that this description is acceptable but only just. This is an excellent example of how CTAUK works to represent its members’ interests and with goodwill on both sides how positive agreement can be reached.

On a continuing, day-to-day basis CTAUK and MHRA are in constant touch, ironing out problems, asking for and taking advice from each other.  I am impressed with the way the relationship has evolved and jointly we bring great benefit to the industry and consumers.

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Report Of Meeting With MHRA On Regulation of Cannabidiol (CBD).

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Tom Whettem, Cannabidol; Anthony Cohen, Elixinol UK; Tom Rowland, CBD Oils UK; Karl Spratt, Hempire; Peter Reynolds, CLEAR Cannabis Law Reform; Mike Harlington, GroGlo Research & Development

Tom Whettem, Canabidol; Anthony Cohen, Elixinol UK; Tom Rowland, CBD Oils UK; Karl Spratt, Hempire; Peter Reynolds, CLEAR Cannabis Law Reform; Mike Harlington, GroGlo Research & Development

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.

UK Cannabis Trade Association Meeting With MHRA This Week.

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MHRA Headquarters

MHRA Headquarters

After all the speculation, many misleading and false reports and a plethora of attempts to interpret the MHRA’s actions concerning cannabidiol (CBD), this week the chips are down.

On Thursday 3rd November, at MHRA headquarters in Victoria, six representatives of the UK Cannabis Trade Association (UKCTA) will sit down with those responsible for the agency’s statements on CBD.  We will be armed with counsel’s opinion on the legality of the MHRA’s action but most importantly we hope to secure clarification for those who rely on CBD as a food supplement.  We will publish details of the outcome of the meeting as soon as we can.

Those attending as UKCTA representatives are:

Anthony Cohen, Elixinol UK
Mike Harlington, GroGlo Horticultural Research & Development
Peter Reynolds, CLEAR Cannabis Law Reform
Tom Rowland, CBD Oils UK
Karl Spratt, Hempire
Tom Whettem, Canabidol

CLEAR and GroGlo Establish First UK Clinical Trials on Cannabis for Chronic Pain.

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groglo banner

CLEAR has formed a partnership with the research arm of GroGlo, a UK-based manufacturer of high power, LED, horticultural grow lighting.

The plan is to grow cannabis under a Home Office licence for the production of cannabis oil, both as a dietary supplement and for the development of medical products.  To begin with, a low-THC crop of industrial hemp will be planted.  We will be using the finola strain, originally developed in Finland and known for its short stature and early flowering. Unlike hemp grown for fibre, finola is usually grown for seed and only reaches a height of 160 – 180 cm but we will be removing male plants before they produce pollen and cultivating the female plants to produce the maximum yield of oil from their flowering tops.

Finola Industrial Hemp

Finola Industrial Hemp

The low-THC oil will be marketed as a dietary supplement, commonly known as CBD oil. There is already a burgeoning market in the UK for CBD products, all of which is currently imported from Europe or the USA.  In the USA, the CBD products market was said to be worth $85 million in 2015 so there is huge potential here at home. Aside from the benefit of being UK grown and processed, we anticipate achieving a CBD concentration of about 40%, which is higher than most products already on the market.

Cultivation will be in glasshouses supplemented with LED lighting.  GroGlo already has an established glasshouse facility in the east of England.  Initial trials will experiment with adjusting the LED technology to provide a changing blend of light wavelengths at different stages of plant growth.  This is GroGlo’s area of expertise -combining LED lighting and plant sciences, including existing relationships with some of Europe’s top universities. Professor Mick Fuller, GroGlo’s director of plant science, will lead this research and development process.

Professor Mick Fuller

Professor Mick Fuller

During the R&D phase, CO2 extraction of oil will be carried out under laboratory conditions at universities in York and Nottingham which already have extensive experience of the process. Each crop will be measured for yield, cannabinoid and terpene content using high pressure liquid chromatography (HPLC).  Safety testing will also look for the presence of heavy metals and other contaminants.  The results of testing will be fed back into cultivation and extraction processes to maximise yield and quality.

It is anticipated that the first batches of low-THC oil will be ready for market in six months.  We are already in discussions with potential distributors and wholesalers. The CBD market in the UK is ripe for an effective marketing campaign which could build a very substantial business for whoever gets it right.

Once we are successfully achieving our production goals with low-THC cannabis, the same testing and development process will begin with high-THC varieties of cannabis.  The aim will be to produce a range of oils extracted from single strains, selectively bred and stabilised for different THC:CBD ratios.

Professor Fuller says that GroGlo lighting products “are in use worldwide to grow a range of crops, but some 60% of sales currently come from overseas users growing cannabis for legitimate medical use.”  He explains that there is an emerging market for all sorts of nutritional and medicinal plant products but cannabis shows particular promise. GW Pharmaceuticals is the only UK company to enter this market and it has become a world leader, despite the current restrictive legislation.  He says:  “Together with CLEAR we believe we can help bring a range of safe, high quality UK-produced cannabis products to market within a matter of two to three years.”

A key issue in the development of a successful medicinal cannabis product is the method of delivery.  Smoking is not an acceptable solution as inhaling the products of combustion is an unhealthy practice but one of the great benefits of cannabis smoked as medicine is very accurate self-titration.  That is the effects of inhaled cannabis are felt almost instantly and so the patient knows when they have taken enough or when they need more to achieve the required analgesic effect.

The oral mucosal spray developed for Sativex is unpopular with patients, many complain of mouth sores from its use and it was developed at least as much with the objective of deterring ‘recreational’ use of the product as with delivering the medicine effectively. It strangles the therapeutic benefits of the cannabis oil of which Sativex is composed in order to comply with the concerns of the medicines regulators about ‘diversion’ of the product into what they would term ‘misuse’.  Absorption of the oil is quicker through the mucous membranes of the inside of the mouth than through the gastrointestinal system but, inevitably, some of the oil is swallowed and the pharmacology of cannabis when processed through the gut and the liver is very different.

We believe the best option is a vapouriser device and our intention is to source a ‘vape pen’ of sufficient quality to operate within clinical standards of consistency and safety. Vapourising cannabis oil avoids inhaling the products of combustion but still enables accurate self-titration of dose.  A vape pen would provide a handy, convenient and very effective method of consuming medicinal cannabis.  However, aside from the technology itself, initial research shows that vapour is more effectively produced when the oil is blended with either vegetable glycerin (VG) or propylene glycol (PG).  Establishing the correct ratio of VG or PG to the oil is another important task.

We anticipate that clinical trials for the use of cannabis oil in treating chronic pain could start within two years.  We want to compare different oils, ranging from high-CBD to equal ratios of THC:CBD and high-THC content. Prior to that we have to overcome the challenges of cultivation, oil extraction, vapouriser development and assemble the necessary research team and gain ethical approval for the trials.  Recruitment for the trials will start in about 18 months time.  If you wish to be considered please email ‘paintrials@clear-uk.org’ with brief details of your condition (no more than 100 words). Do not expect to hear anything for at least 12 months but your details will be passed to the research team as a potential candidate.

Mike Harlington, Managing Director of GroGlo

Mike Harlington, Managing Director of GroGlo

CLEAR is promoting this venture simply because someone needs to do something to make this happen. For all the campaigning and lobbying of MPs and ministers, at the end of the day, the plants have to be grown and the various legislative hoops have to be jumped through. We cannot wait any longer for a radical change in the law. We have to progress through the government’s regulatory regime if we want to bring real therapeutic benfit to patients.

This opportunity arises because of the vision of GroGlo’s managing director, Mike Harlington and the team of experts he has built around him. There is huge demand for legitimate medicinal cannabis products in the UK which is only going to increase with the inevitable progress towards law reform and increasing awareness of the benefits of cannabis. Together, CLEAR and GroGlo are bringing the great hope that medicinal cannabis offers closer to reality than ever before.