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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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.

We May Be Leaving The EU But The Soviet State Of Britain Is Already Here.

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policeman-on-keyboard

Email to my MP, Sir Oliver Letwin, concerning the Investigatory Powers Bill

From: Peter Reynolds
Sent: 25 November 2016 15:01
To: Oliver Letwin
Subject: The Investigatory Powers Bill

Dear Oliver,

Perhaps you can explain to me on what basis of reason, justice or liberty the following organisations will shortly have access at will to my (and your) internet browsing history?

This is an outrageous intrusion into my private life and completely unacceptable. I think it’s time we started a UK campaign for the right to bear arms. Every day it seems the government is becoming more and more of an oppressor. I reject this entirely and it does not have my consent.

Metropolitan Police Service
City of London Police
Police forces maintained under section 2 of the Police Act 1996
Police Service of Scotland
Police Service of Northern Ireland
British Transport Police
Ministry of Defence Police
Royal Navy Police
Royal Military Police
Royal Air Force Police
Security Service
Secret Intelligence Service
GCHQ
Ministry of Defence
Department of Health
Home Office
Ministry of Justice
National Crime Agency
HM Revenue & Customs
Department for Transport
Department for Work and Pensions
NHS trusts and foundation trusts in England that provide ambulance services
Common Services Agency for the Scottish Health Service
Competition and Markets Authority
Criminal Cases Review Commission
Department for Communities in Northern Ireland
Department for the Economy in Northern Ireland
Department of Justice in Northern Ireland
Financial Conduct Authority
Fire and rescue authorities under the Fire and Rescue Services Act 2004
Food Standards Agency
Food Standards Scotland
Gambling Commission
Gangmasters and Labour Abuse Authority
Health and Safety Executive
Independent Police Complaints Commissioner
Information Commissioner
NHS Business Services Authority
Northern Ireland Ambulance Service Health and Social Care Trust
Northern Ireland Fire and Rescue Service Board
Northern Ireland Health and Social Care Regional Business Services Organisation
Office of Communications
Office of the Police Ombudsman for Northern Ireland
Police Investigations and Review Commissioner
Scottish Ambulance Service Board
Scottish Criminal Cases Review Commission
Serious Fraud Office
Welsh Ambulance Services National Health Service Trust

Seriously, how can any MP with any integrity or honour vote for such Soviet-style government snooping?

Kind regards,

Peter Reynolds

Written by Peter Reynolds

November 27, 2016 at 8:28 am

Cruel And Irresponsible Response from UK Government To Parliamentary Report On Medicinal Cannabis.

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doctor-tips-bud-out-of-pot

Unsurprisingly perhaps, the response to the recent call from MPs and peers to legalise cannabis for medicinal use has come straight from the top.  Theresa May’s longstanding reputation as a denier of science and evidence on drugs policy is reinforced by her peremptory dismissal of the expert report.  It seems that, at least in the short term, the UK government is sticking by a policy that is discredited, ridiculous and deeply cruel.

It fell to Sarah Newton MP, minister of state at the Home Office, to respond to a parliamentary question from Roger Godsiff, Labour MP for Birmingham, Hall Green.

Roger Godsiff MP

Roger Godsiff MP

“To ask the Secretary of State for the Home Department, if she will respond to the recommendations of the report by the All-Party Parliamentary Group for Drug Policy Reform Accessing Medicinal Cannabis: Meeting Patients’ Needs, published in September 2016.”

 

Sarah Newton MP

Sarah Newton MP

“The Prime Minister responded to the All-Party Parliamentary Group for Drug Policy Reform’s report ‘Accessing Medicinal Cannabis: Meeting Patients’ Needs’ on the 27 October.

Cannabis is controlled as a Class B drug under the Misuse of Drugs Act 1971 and, in its raw form, currently has no recognised medicinal benefits in the UK. It is therefore listed as a Schedule 1 drug under the Misuse of Drugs Regulations 2001.

It is important that all medicines containing controlled drugs are thoroughly trialled to ensure they meet rigorous standards so that doctors and patients are sure of their efficacy and safety. To do otherwise for cannabis would amount to a circumvention of the clearly established and necessary regime for approving medicines in the UK.”

In other words, this is nothing more than a re-statement of the same position that the UK government has held since 1971 when legal access to medicinal cannabis was halted.  Quite clearly the government has given no consideration at all to the vast amount of scientific evidence and international experience that has accumulated over the last 45 years.  The latest report which took nine months to produce, took evidence from over 600 witnesses and included a review of over 20,000 scientific studies is simply cast aside.  To be honest, I doubt whether it has even been read by Ms May or anyone in the Home Office or Department of Health. This is the standard that now prevails in the UK – government of the people by an unaccountable, out-of-touch, unresponsive cabal of individuals elected by a deeply flawed system that gives democracy a bad name.

On the face of it, the claim that all medicines must be thoroughly trialled seems plausible – but it is not.  It is a misleading half-truth clearly intended to squash the call for access to medicinal cannabis by painting a false picture.

Doctors are allowed to prescribe any medicine, licensed or unlicensed, as they see fit, based on their own judgement. But prescribing of cannabis is specifically prohibited by Statutory Instrument despite the scientific consensus that it is far less dangerous than many, probably most commonly prescribed medicines.

So it’s not a level playing field.  It’s a policy that is based on prejudice and scaremongering about recreational use of cannabis.  Ms Newton’s answer is at best disingenuous but then she probably doesn’t even realise that herself.  For many years Home Office policy has been systematically to mislead and misinform on cannabis and evidently under Ms May’s successor, Amber Rudd MP, such dishonesty continues.

Theresa May MP

Theresa May MP

Something will eventually force the government’s hand to change its absurd position on cannabis. Sadly the very last consideration will be scientific evidence or the will of the people. Such factors hold no sway with  UK governments. Only when enough of the political elite open their eyes and examine their conscience, or some key individuals or their family members, experience the need for medicinal cannabis will change become possible.  Alternatively, political upheaval may present an opportunity. The Liberal Democrats were too cowardly, weak and concerned with building their personal careers when in coalition to advance the cause they now so bravely advocate.  Perhaps the SNP, with 56 MPs, all in favour of medicinal cannabis may be our best hope.

Sarah Newton is merely a puppet of the Home Office bureaucracy.  Theresa May’s mendacious position on all aspects of drugs policy is well established and she is as stubborn and bigoted as they come on such matters.  Only when she, in person, is subject to sufficient pressure will this cruel, ignorant and hateful policy change.

Guidelines On Cannabis For Medical Professionals.

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rcgp-external-hq

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

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.

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“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

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.