Peter Reynolds

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The UK’s First Licensed Cannabis Dispensary.

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Mike Dobson

Mike Dobson

When Mike Dobson first called me a few months ago and told me he had an idea for gaining legal access to cannabis in the UK, I was, of course, sceptical. CLEAR has frequently been approached with hare-brained and convoluted plans for avoiding the law that prohibits cannabis.  Without exception they have all been bonkers.

Within a few minutes though, I could see this one was different.  In the past, most of these ideas have been around sidestepping the law by claiming ‘freeman’ status, the suggestion being that statutes, laws made by Parliament, are only enforceable if you have consented to them in the first place.  Some claim to have succeeded in using this to defeat charges for growing cannabis, even having their harvest returned to them by police.  I can’t verify any of these stories but I’m quite sure the courts are littered with the broken dreams and delusions of those who have tried to go down this path.

The big difference with Mike’s plan, his ‘scheme’ as I like to call it, is that instead of evading, avoiding or dodging the law, it actually uses the law itself to provide legal rights to grow and possess cannabis.

Preston Cannabis Club Website.  Click To Enter.

Preston Cannabis Club Website. Click To Enter.

The Misuse of Drugs Act 1971 empowers the Home Secretary to issue licences in respect of cannabis. These could be for cultivation, production, possession, supply or any other activity such as import or export.

This scheme involves setting up a company to cultivate cannabis and produce cannabis products under licence from the Home Office – the ‘Licensed Supplier’. Providing the various licence conditions are complied with, the Home Office cannot unreasonably refuse such a licence.  If it does then it will be subject to judicial review.  The licence conditions that need to be met are security and the prevention of ‘diversion’ of the cannabis into illicit or unlicensed hands.

The next step is to set up another company where it and its shareholders, guarantors and/or members are licensed to possess cannabis – the ‘Membership Company’.  Again, providing the licence conditions are complied with, the Home Office must issue a licence and if it refuses judicial review proceedings can be brought.  Sensible and responsible rules must be put in place so that members only consume cannabis in private with necessary security precautions.

The genius of Mike’s scheme, now coming to reality with the first Membership Company, the Preston Cannabis Club, is that it uses the law exactly as it is intended, to ensure that the only people cultivating, producing, supplying or possessing cannabis are licensed to do so.

I have consulted informally with several lawyers and there is no doubt that this scheme holds promise. Whether it works out remains to be seen.  CLEAR is putting its weight and support right behind the scheme as a responsible and lawful way to enable legal access to cannabis.  I would expect initial resistance from the authorities but if we are right, it would mean Parliament would have to pass a new law to prevent this happening.  In my judgement that is unlikely and, in fact, the demonstration of such a legitimate route to cannabis would get the government off the hook of its present, unsustainable policy.

Watch this space.  CLEAR is now actively involved in supporting this venture and we will keep you fully informed.

The Facts About CBD In The UK. December 2016.

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oil-dropper-green-bg

On 3rd October 2016 the Medicines and Healthcare products Regulatory Agency (MHRA)  issued notices to a number of CBD suppliers stating that cannabidiol (CBD) was being designated as a medicine and that sale of all CBD products must stop within 28 days, ostensibly by the 1st November.

A lot has happened since.  Most importantly, the Cannabis Trades Association UK (CTAUK) has been established to represent the industry and protect the interests of CBD consumers but there remains great confusion as to the legal status of CBD and whether these products will still be available.  This article sets out the facts and explains how the market is likely to develop. The most important point is that there is no need for panic.  There will be some changes but no one will lose access to CBD for the foreseeable future.

Background

Through the summer of 2016, rumours and half stories had been swirling around about the MHRA taking action on CBD. When the news broke it caused real panic, both for the thousands of people using CBD products and for those working in CBD businesses.  It looked like a real disaster for everyone. On the one hand the government, through the MHRA, was finally recognising the truth that CBD and cannabis are medicine.  On the other, it seemed that the whole industry was going to be shut down, businesses would close, people would lose their jobs and, most importantly, those who rely on CBD products for maintaining their health were going to suffer real harm.  If CBD was going to be regulated as a medicine it would require the investment of hundreds of thousands of pounds to obtain the necessary authorisation to put any products on the market.

It quickly became clear that the MHRA was unprepared for the reaction it received. Its switchboard was swamped by worried callers.  Social media exploded with the inevitable Big Pharma conspiracy theories and even the national press covered the story demonstrating that medicinal cannabis is now an issue of mainstream interest.

ctauk-logoCLEAR took action to rally our friends and colleagues in the legitimate cannabis business and this led to the creation of CTAUK.  The same day the news broke we wrote to the MHRA notifying it of the formation of the trade association and seeking a meeting.

On 13th October, the MHRA issued a statement on its website explaining its actions.

CLEAR’s advisory board members, Professor Mike Barnes issued a statement to the media and Crispin Blunt MP wrote to Dr Ian Hudson, the chief executive of the MHRA.  Even the British Medical Journal covered the story.

On 19th October the MHRA finally confirmed a meeting with the CTAUK to take place on 3rd November.  On 21st October, Dr Ian Hudson replied to Crispin Blunt’s letter.  CTAUK appointed solicitors who in turn obtained counsel’s opinion and on 28th October a solicitor’s letter was sent to the MHRA formally objecting to its action. On 1st November the MHRA updated its statement on its website softening its position by claiming that its notices to CBD suppliers were merely its “opinion” that it should be designated as a medicine.

The meeting took place at MHRA headquarters on 3rd November.  It was cordial and constructive and on 16th November CTAUK wrote to the MHRA formally proposing a system for the regulation of CBD.  Essentially this suggests that CBD products with daily adult dosage of up to 200mg should continue to be marketed as a food supplement.  Products with a daily adult dosage of up to 600mg would require a Traditional Herbal Registration and higher dosage products would require a full Marketing Authorisation.  We await the MHRA’s response.

The MHRA has since written to CBD suppliers requiring them within seven days to provide samples of their products along with various information about them.  However, CTAUK has been able to negotiate that our members have until the end of January to comply.  This is excellent news and demonstrates recognition of the association by the MHRA.

Is CBD Legal In The UK?

Yes, CBD is not a controlled drug under the Misuse of Drugs Act 1971, neither is it covered by the Psychoactive Substances Act 2016.  As long as it is marketed as a food supplement without any medicinal claims it is perfectly legal to sell and to buy.

Is The MHRA Going To Ban CBD?

No, the MHRA will have to assess each product on its own merits, particularly taking into account how it is marketed and whether any claims of medicinal benefit have been made.

What Will Happen In the Future?

We hope that the MHRA will accept our proposals for a system of regulation, meaning that only the highest dose products, such as GW Pharma’s soon-to-be- released ‘Epidiolex’ will require a full Marketing Authorisation.  However, even if the MHRA tries to take formal action about any other products, this is going to take many months and probably a much as a year before anything changes.  We remain confident that we will come to an agreement that will enable everyone to continue to access CBD products.

CLEAR Cannabis Law Reform Accounts 2015.

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Income

Compared to the previous year, CLEAR’s regular income in 2015 was up 79% to £17,074. The majority of income continues to come from memberships, with the remainder coming from donations, merchandise and Google advertising.

Regular income: £17,074

clear-income-2015

Expenditure

CLEAR spent a total of £12,023, a decrease of 11% on the previous year.

Total expenditure: £12,023

clear-expenditure-2015

Administration: membership administration, stationery, postage, telephone & internet, meeting expenses, etc. Administration costs have increased as an overall proportion of expenditure as there were no dedicated campaigns during the year.

Travel: expenses incurred meeting government ministers, MPs, agency representatives, media engagements, boards meetings, also re-imbursement of travel costs for Medicinal Use Panel members

Fundraising costs: PayPal fees and other fundraising costs

Promotion: Facebook advertising, printing of leaflets, design work, etc.

Written by Peter Reynolds

November 8, 2016 at 11:00 am

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.

MHRA Backtracking Super Fast On CBD Ban.

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mhra_logo_600In 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

Professor Mike Barnes

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”.

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

MHRA Confirms Meeting With CBD Industry Representatives.

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cbd-molecule-over-plant

Today, the Medicines and Healthcare products Regulatory Agency (MHRA), has arranged a meeting with representatives from the UK Cannabis Trade Association (UKCTA) to discuss its designation of cannabidiol (CBD) as a medicine.

mhra-logoA request for a meeting was was first made in writing on 20th September 2016, when the possibility of the MHRA’s action was still little more than a rumour.  Nearly six weeks later, after repeated requests, complaints and lobbying from many companies, individuals and MPs, the meeting has been fixed for 3rd November 2016.

The main aim of the meeting will be to discuss interim arrangements for people currently using CBD as a food supplement.  Clearly, we will also address concerns over the impact of this decision on many small businesses and the people they employ.

Written by Peter Reynolds

October 19, 2016 at 5:08 pm