Posts Tagged ‘CLEAR Cannabis Law Reform’
Probably The Biggest Breakthrough Yet For Medicinal Cannabis In The UK.
Peter Reynolds, President, CLEAR Cannabis Law Reform
Since the beginning of 2017, Peter Reynolds and Professor Mike Barnes of CLEAR Cannabis Law Reform have been working on a project that is about to come to fruition. The Council of the Royal College of General Practitioners (RCGP) meets tomorrow, 22nd September 2017, to consider our proposal to issue guidelines to doctors on the use of medicinal cannabis.
Professor Mike Barnes, Scientific & Medical Advisor, CLEAR Cannabis Law Reform
As ever, the UK’s stubborn, anti-evidence government remains intransigent on permitting legal access to cannabis, even for medicinal use. This despite an overwhelming tide of reform across the world and the reality that perhaps one million people in the UK are criminalised and persecuted for using a medicine that has been known to be safe and effective for many centuries, facts which modern science now proves beyond doubt.
However irresponsible and pig-headed government ministers may be, doctors have a responsibility to their patients, an ethical duty that transcends the grubby and corrupt politics that ministers subscribe to. Professor Nigel Mathers, Honorary Secretary of the RCGP with responsibility for its governance, has championed CLEAR’s proposal. He recognises that while doctors cannot be advising their patients to use an illegal drug, the reality is many people already are.
Professor Nigel Mathers, Honorary Secretary, Royal College of GPs
So this is not just another report or a conference. This is practical action at the point of delivery of healthcare. If the proposal is approved by the RCGP Council, the guidelines will be drafted by Professor Mike Barnes, assisted by Peter Reynolds, with additional input from the MS Society and Newcastle University.
In due course, probably by the end of the year, a booklet will be available for download by all GPs from the RCGP website. It will set out balanced and reasonable advice on the appropriate use of cannabis for specific medical indications. The guidelines will also cover harm reduction advice and provide a basic grounding in the scientific evidence and the endocannabinoid system.
If our government refuses to take such sensible steps to improve healthcare and protect patients, then we, campaigners and medical professionals, must do it for them.
Lord Monson and CLEAR to Campaign for a Regulated Cannabis Market.
Lord Nicholas Monson, Peter Reynolds
Lord Nicholas Monson, whose son Rupert committed suicide after he had become psychotic from ‘skunk’, has teamed up with CLEAR Cannabis Law Reform to campaign for a safer, regulated cannabis market.
‘Skunk’ is a form of cannabis with zero or very little CBD that can be harmful to young people and the vulnerable. The criminal market has driven the production of ‘skunk’ with high levels of THC, the psychoactive compound and low levels of CBD, the protective, anti-psychotic compound. The absence of regulation and control has also led to sales of highly dangerous products such as ‘Spice’ which contain an extremely potent, synthetic form of THC without any balancing CBD.
Lord Monson says:
“It is urgent that the government takes the historic step of legalising and regulating more traditional forms of cannabis and puts severe penalties in place for those dealing in skunk.”
CLEAR Cannabis Law Reform is the UK’s largest and longest established drugs policy reform group. It campaigns for medicinal cannabis on prescription by doctors and a regulated market for adults.
Peter Reynolds, president of CLEAR, says:
“We are honoured to work alongside Lord Monson towards a safer cannabis market that will reduce harm instead of the present policy that maximises all harms. Just like the policy that President Trudeau is introducing in Canada and already exists across much of the USA, we must rigorously restrict access by children and those with developing brains and ensure that safe, properly regulated cannabis with a good proportion of CBD is available for adults.”
How To Campaign For Cannabis Law Reform Under A Theresa May Government.
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Lobbying Parliament
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If the Government Won’t Regulate Cannabis Then We’ll Do It For Them
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The CBD Market
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Medical Cannabis
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Educating And Influencing Researchers
For cannabis and drugs policy reform, out of 650 MPs, there could not have been a worse person to seize power than Theresa May. There are a few who come close on both Tory and Labour benches but no one who has such a long record of bigotry, denial of evidence and refusal even to consider the subject.
Senior Tory MPs For Cannabis Law Reform
To be fair, I am a member of the Conservative Party, which to many people involved in the cannabis campaign is a mortal sin but my advocacy is based on science and evidence, not tribalism or wider politics. In any case, though many find this fact hard to accept, there has always been more support from Tory MPs than Labour. Highly influential and senior Tory MPs such as Crispin Blunt, Peter Lilley and Dr Dan Poulter are powerful advocates for reform. I firmly believe that the only sustainable route to legalisation is commercialisation and the left wing, nanny state, anti-business types are already pushing the ‘Big Cannabis’ scare stories.
So what can we do and what are we doing to advance our cause in these dark days? Theresa May always has been secretive, inaccessible, unresponsive and entirely disinterested in any opinion except her own. How can we possibly make any progress with a PM who has already shown she is prepared to cover up or falsify evidence and defines herself by her belief in a supernatural power?
There is more support for cannabis law reform in Parliament than ever before. It is now official policy of both the Liberal Democrats and the Scottish National Party. The support from Scotland is far more valuable than that from the discredited LibDems. With the added factors of Brexit and Scottish Independence, the SNP is in a powerful position to advance its policies. Also, in Ireland, both north and south, public support for medical cannabis reform is exploding. Michelle O’Neill, SinnFein’s new leader, has pledged medical cannabis reform if she is re-elected (though she has no power to do so!). Her negotiating position is immensely strong now that the problems at Stormont, the rise of Sinn Fein and the Brexit factor all combine to make a united Ireland a real possibility.
During the coalition government from 2010 to 2015, few doors were closed to us. Over that period, CLEAR conducted more meetings with ministers and senior politicians than the entire UK campaign had achieved in 50 years. Because we had support from the LibDems, and introductions from the Deputy Prime Minister, even Tory ministers were ready to see us, even if they were merely paying lip service. That all stopped with the election of a majority Conservative government and after Cameron stepped down the doors were slammed in our faces, bolted and double-locked. The campaign has been in the doldrums ever since. Or has it?
The last major achievement of the last few year’s campaigning was the release of the APPG report on medical cannabis in September 2016. Alongside it, Professor Mike Barnes, CLEAR advisory board member, published his review ‘Cannabis: The Evidence for Medical Use‘. To all impartial and reasonable observers, these documents should have initiated positive government action towards reform, even if it was only very limited in scope. But no, Theresa May didn’t leave it to Amber Rudd, her successor as home secretary, she stepped straight in herself on the day of publication, before she could even have read it and dismissed the report out of hand. This echoes the apocryphal story of James Callaghan, then PM, throwing the 1969 Wooton Report in the bin without even opening it. Such is the inertia and prejudice that has not softened at all amongst the bigots despite 45 years of science and research proving that there are better, safer, more beneficial options available on cannabis.
Lobbying Parliament
For now, individual lobbying of MPs is our only route to power. Over the years we have refined our approach to this and we know what works. Getting into ping pong correspondence with an MP is a waste of time. An initial letter or email needs to be followed up with a face-to-face meeting and a determined focus on getting a tangible result. What sort of result you should look for depends on your circumstances but getting your MP to arrange a meeting with a government minister should be your goal.
If you’re a medical user then you’ll want to meet a health minister, preferably the Secretary of State, if not a junior minister or perhaps an advisor to the Department of Health. Work with your MP to achieve the best result you can. Your MP doesn’t necessarily have to agree with you about cannabis but they should facilitate your communication with government, that’s their job. If you’re more interested in the economic or social benefits to be gained from reform, you could ask for an introduction to the Chancellor, a treasury or business minister, or someone at the Cabinet Office who is involved in policy development. CLEAR can usually provide someone to accompany you on meetings but this must be arranged in advance and agreed with your MP or whoever your appointment is with. Alternatively, we can provide advice over the telephone on how to approach the meeting, what to ask for and what evidence or supporting material to take with you.
If the Government Won’t Regulate Cannabis Then We’ll Do It For Them
With an intransigent government that does it all it can to evade engagement on this issue, there is more that CLEAR is already doing. If the government won’t take responsibility and regulate cannabis, then step by step we are going to do it for them. Someone has to, there is far too much harm and suffering caused by present policy.
The CBD Market
Through 2016 the CBD market in the UK really began to take off. These are products derived from industrial hemp, grown legally under licence that offer many of the therapeutic benefits of cannabis. They should, in fact, be more accurately termed low-THC cannabis as apart from crystals and a few, rare examples of isolated CBD, they are whole plant extracts and contain all the cannabinoids, terpenes, flavonoids and other compounds found in the plants from which they are made. Therefore they offer many of the ‘entourage effect’ benefits but with very low levels of THC. It was obvious though that this market was heading for problems. More and more dubious suppliers were starting up, many making brazen claims for the medical effects and benefits of their products and many without any product testing, quality assurance or honest customer service. The law was then and always has been crystal clear, you cannot make medical claims for a product without it being properly licensed or regulated. Inevitably, in June 2016 the MHRA stepped in and sent threatening letters to a number of CBD suppliers.
CLEAR took the initiative. We wrote to the MHRA requesting a meeting. We engaged with the leading CBD suppliers and our advisory board members Professor Mike Barnes and Crispin Blunt MP were quickly on the case. The story has already been extensively reported but now, nearly a year on, our efforts are coming to fruition. We led the approach to the MHRA and in the process created what is now the Cannabis Trades Association UK (CTAUK). It is now recognised by the MHRA, it has established a code of conduct and it is now the gold standard of quality, ethics and legality that can give anyone buying CBD products real peace of mind. There are still cowboys out there, making false claims, selling products that offer no real benefit and even endangering their customers with products that are illegal under the Misuse of Drugs Act 1971 or the Psychoactive Substances Act 2016. Now though, customers can go to the CTAUK website and choose a supplier that is operating legally, ethically and within the regulations that the industry itself has established. We expect the MHRA very shortly formally to endorse CTAUK members as legitimate suppliers of CBD products as food supplements.
Medical Cannabis
Professor Nigel Mathers, Honorary Secretary, Royal College of GPs
Neither can we accept the government’s irresponsible and cruel policy towards people who need cannabis as medicine. So CLEAR has taken a further initiative. After Theresa May’s dismissal of the APPG report, we approached the Royal Colleges of medicine. We pointed out that whatever the government might say, around one million people are using cannabis as medicine. Doctors have a duty and an ethical responsibility to educate themselves on the subject and be able to provide properly informed care to their patients. Our efforts have borne fruit. Professor Mike Barnes and I have worked with Professor Nigel Mathers of the Royal College of GPs (RCGP). We will be producing a draft set of guidelines on medicinal cannabis for GPs which will go the next meeting of the RCGP Council and is planned for publication in June 2017. If the government won’t do it, we will and the medical profession agrees with us. This will be the greatest practical advance ever made in medical cannabis in the UK.
Educating And Influencing Researchers
Dr Musa Sami, Peter Reynolds
The UK is the most prolific source of research into the harms of cannabis, particularly the tenuous links between cannabis and psychosis. Despite dozens of studies, mainly from the Institute of Psychiatry at King’s College Hospital, this has never been shown to be any more than statistical correlation. Most of these studies are confounded by tobacco use but the latest work from Professor Sir Robin Murray and his team shows an even stronger correlation between tobacco and psychosis than cannabis.
Across the world, UK scientists have become notorious for this scaremongering which seems little different from the ‘reefer madness’ hysteria. To be fair, much of this is down to the UK media which has barely advanced since the 1930s in its reporting. It provides the environment in which researchers are able to gain funding for research into cannabis harms but hardly ever for cannabis benefits.
CLEAR is now working with the Institute of Psychiatry to develop a new and more balanced way of surveying the effects of cannabis. Dr Musa Sami has asked us to advise on the construction of a questionnaire on which the Institute will base its future work.
Bad Behaviour On Both Sides Of The Cannabis Debate.
Is Mr Angry For Or Against?
Cannabis evangelists, with their conspiracy theories and religious ‘belief’ that cannabis is totally harmless and cures everything, are every bit as delusional as those who subscribe to ‘reefer madness’.
We see this every day on the CLEAR Facebook page. Anything we share that is even slightly negative about cannabis or that suggests some people might be vulnerable to some harm from using it, produces a hostile, often hysterical reaction.
100% Fake News
Actually, the evangelists play straight into the hands of prohibitionists. They make fools of themselves by behaving as if we have committed the most heinous blasphemy by daring to criticise their favourite plant. Particularly amongst our American followers, many cannot distinguish between sharing something and endorsing it. We share many news items we disagree with but when it comes to science we neither agree nor disagree, it’s all part of the body of evidence that needs to be considered and balanced.
Of course, the reality of social media is that those who shout loudest or comment most frequently are not necessarily representative of the whole audience. We put a lot of effort into moderating our page to make it as informative as possible. We have a very strict policy on bad language. We won’t tolerate commenters abusing each other or launching vicious personal attacks (even if they are against Donald Trump or Theresa May). All single word comments are deleted. No one wants to read an endless string of “bullshit”, “BS” or worse. Far too often we have to ban some commenters immediately. We simply don’t want people who can express themselves only through a string of obscenities getting in the way of our newsfeed.
A few days ago we shared the study presented at the American College of Cardiology’s 66th Annual Scientific Session, held in Washington, D.C. It suggests that cannabis use can raise the risk of stroke and cardiac failure. The furore and firestorm of abuse that erupted is quite ridiculous and only serves to make the cannabis campaign look completely ridiculous. There are clearly limitations in the study. Firstly, it doesn’t show causation, merely statistical correlation. Secondly, all the subjects had been discharged from hospital so clearly had suffered some serious health problem.
It is a ridiculous way to behave for anyone who wants to advance the cause of cannabis law reform. It’s also utterly stupid constantly to accuse scientists, researchers or indeed CLEAR of being corrupt, dishonest, ‘in the pocket of Big Pharma’ or often far, far worse.
It is true that the history of cannabis prohibition is all about lies, deceit, misinformation and propaganda. There are still some people, even in elevated positions such as UK prime minister Theresa May, who wish to continue with this form of repression but wiser counsel is prevailing in most parts of the world.
More and more scientists, researchers and doctors are studying the effects of cannabis and rarely does a day pass without a cannabis report being published somewhere in the world. What were almost accepted prejudices such as the ‘gateway theory’ and that ‘cannabis causes psychosis’ are being debunked more and more often.
Of course, scientists, researchers and doctors, just like everyone else, have been subject to all the propaganda for the past 100 years, so there is still much prejudice and confusion to dispel but we should respect and value the work of such people even if we don’t like all their conclusions.
On any subject, truth lies in assessing and balancing all the evidence that is available. CLEAR will continue to share all significant evidence published about cannabis whether it is positive or negative. Similarly, we will continue to share stories from the tabloid media that seek to demonise or scaremonger about cannabis. It is important that people see the propaganda that is being published and the way that public opinion is formed.
The UK’s First Licensed Cannabis Dispensary.
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.
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.
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.
CLEAR 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.
Guidelines On Cannabis For Medical Professionals.
In a new initiative, CLEAR’s scientific and medical advisor, Professor Mike Barnes, has written to the presidents of several Royal Colleges proposing the development of guidelines around the use of cannabis as medicine.
Professor Mike Barnes
This is a tricky situation for doctors. Surveys and individual reports from CLEAR members indicate that many doctors tacitly endorse their patients’ use of cannabis but clearly cannot recommend the illegal use of cannabis, however safe and effective it may be.
Professor Barnes’ letter refers to the recent APPG report, his own paper ‘Cannabis: The Evidence for Medical Use’ and says:
“…cannabis now has a reasonable evidence base for the management of chronic pain, including neuropathic pain, and the management of spasticity as well as in the management of anxiety and a use in nausea and vomiting in the context of chemotherapy.”
In conjunction with CLEAR, Professor Barnes has written to:
Royal College of Anaesthetists
Royal College of General Practitioners
Royal College of Paediatrics and Child Health
Royal College of Physicians
Royal College of Psychiatrists
His letter goes on to explain that about one million people are using cannabis as medicine:
“I do feel that doctors need guidelines to assist them when patients request advice on the use of cannabis…doctors should be properly informed about harm reduction advice and should be aware of the clinical evidence that is now guiding medicinal use in several other countries around the world.”
Our proposal is for an initial meeting to discuss the idea. If one or more of the Royal Colleges is prepared to back this initiative, CLEAR will set up and fund a working group of clinicians and medical education specialists to develop a set of guidelines.
CLEAR Statement Concerning Cannabis Legalisation Measures In US Election.
“This is marvellous news for liberty, health and human rights. The USA, unlike Britain, has a functioning democracy where the will of the people prevails rather than the bigotry and self-interest of politicians. It is wonderful to see that truth, justice and evidence is winning out over the lies and misinformation we have been fed about cannabis for almost 100 years.
In 1971, the British government abdicated all responsibility on cannabis and abandoned our communities and our children to criminal gangs. Since then all the harms have multiplied exponentially. The laws against cannabis fund organised crime, promote dangerous hidden farms which are fire risks, the destruction of rental property, selling to children, contaminated ‘moonshine’ cannabis, gang violence, lives ruined by criminal records and the cruel denial of safe, effective medicine that can relieve pain, suffering and disability.
Donald Trump has supported access to medicinal cannabis all along. Many British politicians who consider him to be an unreasonable person should now look to themselves and ask whether they are being reasonable by supporting prohibition, even for medical use.
It is time for Theresa May, Amber Rudd and the UK government to take responsibility for the £6 billion pa cannabis market. The tide of legalisation is now unstoppable and it would be deeply irresponsible for them to fail to act. They must grasp this nettle now!”
Peter Reynolds, president of CLEAR Cannabis Law Reform
CLEAR Cannabis Law Reform Accounts 2015.
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
Expenditure
CLEAR spent a total of £12,023, a decrease of 11% on the previous year.
Total expenditure: £12,023
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.
Report Of Meeting With MHRA On Regulation of Cannabidiol (CBD).
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.
