Posts Tagged ‘medicinal cannabis’
UK Department of Health Has Neither Requested Nor Received Any Advice On Medicinal Cannabis.
“I know nothing. I ask nothing. I understand nothing.”
This is the astonishing reality of the way the UK government is responding to the national outcry for access to cannabis as medicine. They are doing absolutely nothing.
Across the world a revolution is taking place as more and more jurisdictions are introducing legal access to medical cannabis. Medical professionals and patients alike are realising the huge benefits to be gained from re-opening access to this most valuable of medicines. Scientific research is proving beyond doubt that cannabis is a safe and effective medicine for a wide range of conditions. Many pharmaceutical companies are investigating different cannabinoids, extracts and therapies. Most of all, citizens are demanding access to a medicine that has been denied to them for no good reason and that can improve, even save the lives of people of all ages, from the baby with severe epilepsy to the grandparent suffering the effects of aging, even dementia. Cannabis can help improve and maintain good health in all of us.
Yet the UK government is not considering the evidence. Despite even a year long Parliamentary inquiry which recommended permitting access, the Department of Health has not considered nor even asked for any expert advice. My Freedom of Information request has established this beyond doubt. See here: https://www.whatdotheyknow.com/request/395319/response/965315/attach/html/2/1078680%20Reynolds.pdf.html
I have been pressing my MP, Sir Oliver Letwin, on this issue ever since I became his constituent two years ago. Early on he was an extremely powerful cabinet minster, generally recognised as number three in the government after David Cameron and George Osborne but he was swiftly sacked when Theresa May became prime minister. He has already announced he will not stand for re-election to the next Parliament.
Meeting with Sir Oliver Letwin MP
To be fair, Oliver has always listened to me politely and attentively. We have met on about half a dozen occasions and we frequently exchange emails. He has been more responsive to me than I had hoped and to begin with he told me he was investigating what was happening in government about the subject. His answer was that the evidence has been considered, expert advisors have been consulted and ministers have concluded that there is not a good case for reform.
I have pressed him again and again, shown him reams of evidence, shared stories with him from across the world, both of scientific research and patient testimonies. While always courteous towards me he has remained resolutely opposed. I could have given up long ago. Indeed, when I asked him why can’t we simply leave it to the professional judgement of doctors whether to prescribe it or not, he gave me an answer straight out of a ‘Yes Minster’ script. He said: “But then they would prescribe it.”
At the beginning of this year I asked him once again for assistance in putting me before a minister to advance my case. He replied:
“We have discussed this issue before, but I am happy to set out the reason why I will not support your proposals. The Department of Health have, as you know, considered this issue, have taken advice on it from their professional public health advisors, and have concluded that the gains in healthcare arising from the legalisation of medicinal cannabis (as opposed to cannabinoids) would not be sufficiently great to outweigh the risk of abuse.”
It seems that, at best, Sir Oliver is mistaken. I have written to him again asking for comments on the FOI response.
Whatever reply I now receive, I urge everyone to get on to their MP about this. It is a scandal. There can be no doubt that it is irresponsible and negligent that the Department of Health is so clearly failing in its duty to the country. That’s not to say how very cruel and inhumane this failure is or how much money legal medical cannabis could save the NHS. Jeremy Hunt, the Secretary of State for Health, must be called to account for this.
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.
More Misguided Expenditure From The Monkeys At The BBC.
The BBC can mount a year-long investigation into the trade in baby chimpanzees and drown us all in heartbreaking, sentimental images for days on end.
But when it comes to the hundreds of thousands of people who live in pain, suffering and disability in the UK, in constant fear of a knock at the door because they use medicinal cannabis, the BBC are just stooges and slaves to government misinformation.
The only time the BBC covers the medicinal cannabis issue is when it’s forced to by proceedings in Parliament or when its promoting the work of cannabis oil scammers and rip off artists as it has done on BBC3 recently.
One properly funded documentary, interviewing patients, scientists, doctors and people involved in the genuine campaign could force our government to change its wicked and cruel policy. That wouldn’t suit the BBC’s paymasters though would it? They’re the same people as enforce the evil policy in the first place.
The UK Government’s Very Last Excuse For Denying Access To Medicinal Cannabis.
Essentially, UK government policy on cannabis hasn’t altered since 1971. Despite the vast amount of new evidence published since then and revolutionary change, particularly on medicinal use, all across the world, successive governments have stubbornly and obstinately refused to consider any sort of reform.
It doesn’t matter which party has been in power, Conservative, Labour or the coalition, it’s a subject that ministers and MPs simply refuse to engage with. It’s easier that way for them and be in no doubt: laziness, fear of a media backlash and deeply ingrained prejudice are the key factors in this impasse.
Grubby, Corrupt Deal Between Brown And Dacre
We had the downgrade to class C in 2003 and then back up to B in 2009 but this was a turgid and useless effort. No notice was taken of any evidence arising from this experiment. It was enacted to enable police to concentrate more on class A drugs and reversed based on Gordon Brown’s ‘Presbyterian conscience’ and a grubby, corrupt deal with Paul Dacre to win the Daily Mail’s political support. In fact, use went down while cannabis was class C and back up again when it was upgraded but governments have no interest in facts or evidence on this subject, only in political expediency and spinning advantage with the media.
The clamour for medicinal access has increased enormously, just as the evidence for its safety and efficacy has become overwhelming. The UK is now virtually isolated amongst first world countries with a cruel, inhumane and anti-evidence policy which makes us a laughing stock with all who are properly informed. It’s not a laughing matter for the victims though. For those persecuted by this nasty policy it is tears, pain, suffering, disability – all of which could be alleviated to at least some extent just by a stroke of the Home Secretary’s pen. It is sickening that all those who have held that office over the last 45 years escape without any shame or opprobrium on their character.
Home Secretaries Have A Lot To Answer For
CLEAR receives hundreds of letters and emails every year from people who have written to their MP about medicinal cannabis and it is astonishing that unlike almost every other policy, exactly the same words are used by all MPs. They slavishly repeat the Home Office line which is ruthlessly enforced across party lines.
There have been some subtle changes. The marketing authorisation issued for Sativex in 2010 has led to a minor change in the tired and inaccurate line ‘there is no medicinal value in cannabis’. It’s now become ‘there is no medicinal value in raw cannabis’. This is scientifically and factually incorrect. Pharmacologically, Sativex and the ‘raw’ plants from which it is made are identical. It is whole plant cannabis oil and its authorisation by the MHRA as an extract of THC and CBD is fundamentally dishonest. GW Pharmaceuticals reveals it contains more than 400 molecules, the MHRA says it only contains two and “unspecified impurities”.
More recently, and in the face of an explosion of supportive evidence, another line has been added. This states that ‘the UK has a well established process for the approval of medicines through the MHRA and that any company wishing to bring a medicinal cannabis product to market should follow this procedure. In fact, inside sources suggest that the government is very keen to see new cannabis-based medicines approved by the MHRA. It would take the wind out of the sails of the medical cannabis campaign
This is the very last excuse for denying access to medicinal cannabis. It is nothing but an excuse and one that is misleading and based on deception. If we can expose how weak, inappropriate and fake it is, the government will have nowhere else to hide.
Firstly, as demonstrated with Sativex, the MHRA process is incapable of dealing with a medicine that contains hundreds of molecules. It is designed by the pharmaceutical industry for regulating single molecule medicines, usually synthesised in a lab, which have the potential to be highly toxic. CLEAR rejects the tired, boring theory that ‘Big Pharma’ is engaged in a massive conspiracy to deny access to cannabis and to ‘keep people ill’ so it can continue to sell its products to the NHS. The MHRA isn’t engaged in such malevolent conduct, it’s simply incapable of 
properly evaluating a whole plant extract through its existing methods.
The bright, shining truth of this, that totally demolishes the government’s position, is that in every jusrisdiction throughout the world where medicinal cannabis has been legally regulated, it is through a special system outside pharmaceutical medicines regulation. Every other government that has recognised the enormous benefit that medicinal cannabis offers has come to the same conclusion: cannabis is a special case. It is far more complex but much, much safer than pharmaceutical products.
Of course, there is also the ludicrous status of cannabis as a schedule 1 drug, which prevents doctors from prescribing it. If it was moved to schedule 2, alongside heroin and cocaine, or to schedule 4 alongside Sativex (the logical choice), doctors could be prescribing it tomorrow and high-quality, GMP and EU regulated medicinal cannabis from Bedrocan would be immediately available.
So the MHRA is the final excuse, the last obstacle to a revolution in healthcare in the UK. We need an ‘Office of Medicinal Cannabis’ as there is in the Netherlands, or ‘Access to Cannabis for Medical Purposes Regulations’ as administered by Health Canada. Colorado has its ‘Medical Marijuana Registry Program’ and other US states have similar arrangements. Israel’s Ministry of Health has its ‘Medical Cannabis Unit’. In Australia, its equivalent of the MHRA, the Therapeutic Goods Administration, has established its own set of medical cannabis regulations.
This is now the most important factor in achieving medical cannabis law reform. Next time you contact your MP or in any advocacy or campaign work you do, this is where to focus your energy. Cannabis is a special case, it is not like other medicines. Once we can open the eyes to this truth the path ahead will be clear.
Cruel And Irresponsible Response from UK Government To Parliamentary Report On Medicinal Cannabis.
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
“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
“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
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.
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.
Home Secretary’s Refusal Of Orgreave Inquiry Is Brazen Cover-Up Of Police Corruption.
Amber Rudd is following faithfully in Theresa May’s footsteps by spurning evidence in her role as Home Secretary.
With such powerful prima facie evidence of organised police violence and systematic collusion over their witness statements, it is vital to justice and the rule of law that an inquiry is held. If Ms Rudd doesn’t have the courage to support this then she is not acting in accordance with the purpose of her office. That would mean she is corrupt, so I fervently hope she will do the right thing and reverse this dreadful decision.
Orgreave 1984
There is no doubt that in the 60s, 70s, and 80s, corruption was endemic within British police forces. Other than general trend in society towards more openness I’m not sure we can be certain there has been much improvement. My perception is that trust in the police is at an all time low and while there are many ‘good cops’, established practices, such as the police complaints system, are still deeply flawed and embed bias and cover-up. The number of deaths following ‘police contact’ and no officers ever held to account is a national scandal.
I remain very impressed with Theresa May’s leadership since she was appointed PM but it is a myth that this was after a successful period as Home Secretary. The only ‘success’ she achieved was to remain in post for six years but disasters with immigration, the Border Force, the Passport Office and virtually everything the Home Office touched tell a different story. Her drugs strategy has now been proven as a public health catastrophe with the highest rate of drug overdose deaths since records began and evidence-free bigotry defining policy, particularly on medicinal cannabis where the UK is now a third world country.
If the Home Office and the police are to regain the trust and respect of the British people, Amber Rudd needs to start making her own mark and not by following meekly in Theresa May’s kitten heels. Neither of them are pussy cats and that’s not what we want. We want strength, integrity, compassion and honour, that is what Ms Rudd must strive for.
The British Medical Journal (BMJ) Features The CLEAR Medicinal Cannabis Campaign.
By Nigel Hawkes
“Muddled thinking” over cannabis leaves patients in limbo, warn campaigners
BMJ 2016; 355 doi: http://dx.doi.org/10.1136/bmj.i5556 (Published 14 October 2016) Cite this as: BMJ 2016;355:i5556
Companies selling cannabis based products have been told to remove them from the market within 28 days, after a review by the Medicines and Healthcare Products Regulatory Agency (MHRA) determined that they were medicinal products.
Campaigners for cannabis law reform welcomed the recognition that cannabidiol (CBD) had medicinal properties but warned that the MHRA’s action would deprive thousands of users of a product they relied on. They said that it was impossible to obtain marketing authorisation in the timescale given and may never be possible given the high costs of clinical trials and lack of patent protection for a product that contained many components.
“In the long term, it’s a good thing,” said Peter Reynolds of the pressure group CLEAR Cannabis Law Reform. “But my immediate concern is for the tens of thousands of people who use CBD and have become reliant on it. We urgently need interim measures so that supplies can continue.”
The MHRA sent letters on 3 October to 18 companies that sold CBD, saying that it had concluded that CBD met the definition of a medicinal product as defined in the Human Medicines Regulations as “any substance or combination of substances which may be used or administered to human beings either with a view to restoring, correcting, or modifying physiological functions by exerting a pharmacological, immunological, or metabolic action or to making a medical diagnosis.”
This meant, the letter said, that CBD products required a marketing authorisation before they could be sold. Marketing authorisation for drugs requires lengthy clinical trials, only justifiable if the product has patent protection. An alternative route is under the traditional herbal medicines regulations, but that requires evidence that the product has 30 years of use and applies only to minor conditions, where medical supervision is not required. Reynolds said that he thought it unlikely that CBD could qualify by this route.
Mike Barnes, a neurologist and former NHS consultant and chief executive, is clinical adviser to CLEAR. He said, “The decision by the MRHA to treat CBD products as medicines has also been done without thought to the consequences for many thousands of people in the UK who currently benefit from the products. It will have very significant, and in many cases terminal, impact on the many legitimate businesses that provide high quality products.
“The government must now act to sort out their muddled thinking and try to help those people with long term and often painful conditions who benefit from the ready and hitherto legal availability of natural cannabis products. It is ironic that in acknowledging the therapeutic benefits of CBD, the MRHA is effectively suspending access to a product that has enhanced the lives of thousands for many years.”
Crispin Blunt, an MP and CLEAR supporter, has written to the MHRA saying that the decision to designate CBD as a medicine is directly contradicted by the Home Office’s position that cannabis has no medicinal value.
“It is vital that we do not let this anomaly in government policy cause harm to people’s health,” his letter said. He asked for details of how the decision was reached, the consultations undertaken, which specific regulatory regime MHRA proposed for these products, and whether the continued supply of these products, regulated as food supplements, could be ensured until such time that medicinal marketing authorisations could be obtained.
The MHRA has not yet posted details on its website about the decision. In a statement it said that people who used CBD should speak to their GP or other healthcare professional. “We can provide regulatory guidance to any company who may wish to apply for a licence,” the statement added.
Professor Mike Barnes Speaks Out On the CBD Ban.
Professor Mike Barnes, Scientific and Medical Advisor to CLEAR
Professor Mike Barnes, neurologist, scientific and medical advisor to CLEAR Cannabis Law Reform, has issued the following statement.
“It is encouraging that the MRHA is recognising that CBD has medicinal value but it is concerning that many people benefitting from CBD now will suffer in the short term as good quality manufacturers have to stop production pending MRHA approval”
A redacted copy of the letter now being sent to all CBD suppliers can be seen here.
For some weeks, rumours and half stories have been swirling around about the MHRA taking action on CBD.
Initially a number of suppliers were warned about making medicinal claims, even testimonials from satisfied customers were ruled as unlawful. Anything which suggested that CBD was a medicine or provided therapeutic effects was ruled out under UK medicines legislation.
Responsible CBD suppliers have known this for some time and were scrupulous in ensuring no such claims were made, even including disclaimers explicitly stating that their products were not for medical use. But as CLEAR has reported many times before, the CBD market is full of cowboys, get-rich-quick scam artists that tell bare faced lies about their products as well as making outlandish claims for the medicinal benefits. The crackdown from the MHRA was inevitable when these fools put their short term gain ahead of developing a responsible and self-regulating market in which CBD could continue to be sold as a food supplement.
We have seen every sort of bad practice it is possible to imagine. Some suppliers have attacked all of their competitors, stating that they are the only ‘ethical’ supplier and everyone else is telling lies. MediPen put all its resources and efforts into marketing and PR without providing proper information to customers about what its product contained. It achieved great coverage in tabloids like the Metro and the Mirror and even managed to spin a wholly misleading story that the NHS was “trialling” its product (In fact it was at last using an NHS accredited laboratory to test its product contents, that is all). Another supplier called Sacred Kana was rebranding cheap and nasty Romanian hemp extract and selling a bottle for just over £50, claiming it contained 10,000 mg of CBD. Testing showed that it actually contained less than 200 mg. Wrapped up in a warm, cuddly hippy-style marketing campaign, they were trying to pass themselves off as the Rick Simpson of CBD when all they are is conmen.
Responsible suppliers did include CBD information on their websites and often linked to scientific studies and research. Clearly, even this has become too much for the MHRA and now the market is being closed down. You can thank the greedy idiots, the conmen and the barrow boy salesmen trying to pretend they were scientists.
Of course the truth is that CBD is medicine, so the MHRA isn’t wrong. Most CBD products are, in fact, low-THC, whole plant extracts, so they were, effectively, a legal form of cannabis. The therapeutic benefits they offered were not just from CBD but from the ‘entourage effect’, recognised by science as the synergy between all the different components of cannabis. Unfortunately, we even had some companies promoting the fact that their so-called ‘CBD oil’ actually contained significant proportions of THC and CBN, both ‘controlled drugs’ under the Misuse of Drugs Act 1971.
The crackdown was inevitable but it may leave tens of thousands of people with real health problems as they are no longer able to obtain what they were legitimately using as a food supplement.
Crispin Blunt MP, Political Advisor to CLEAR
Of course, designating CBD as a medicine is inconsistent with the UK government’s position that cannabis has “no medicinal value” but it’s been common knowledge that this is untrue for many years. The only good news coming out of this debacle is that this could be the beginning of proper, honest regulation of cannabis as medicine. But if we’re looking at clinical trials before CBD can be marketed again, it could be many years away and that’s after someone or some company decides to invest the £250,000 or more that could cost.
CBD products will still be available offshore and you probably will be able to order online and have them delivered by post. The price is bound to go up and you will be committing a criminal offence by importing an unlicensed medicine but no doubt may will choose to take this risk.
CLEAR is working with the UK Cannabis Trade Association and our Advisory Board members Professor Mike Barnes and Crispin Blunt MP, to try and persuade the MHRA to enter a consultation process and allow CBD to remain available as a food supplement in the short term.
In the longer term, as we know far too well, the only solution is for a proper system of regulation for cannabis. including its use as medicine.
Fast Developing News On CBD And Medicinal Cannabis.
We learned today that the Medicines and Healthcare products Regulatory Agency (MHRA) has started issuing letters to CBD suppliers advising them that CBD is being designated as a medicine and that sale of CBD products must stop within 28 days.
This will be alarming news to many people. However, it is a complex situation which has some positive aspects to it. In the short term, if you are already using CBD products, you would be well advised to stock up as much as you can afford.
CLEAR has been aware of this possibility for several weeks and consequently we have been working with leading CBD suppliers and licensed producers of both low and high THC cannabis on establishing the UK Cannabis Trade Association (UKCTA). We are already in correspondence with the MHRA seeking to represent all stakeholders, to establish a consultation process on regulating CBD products and to protect the interests of producers, suppliers and consumers.
What these MHRA letters mean is that for CBD to be sold in future, suppliers will have to obtain either a ‘marketing authorisation’ or a ‘traditional herbal registration’ from the MHRA.
A marketing authorisation can be fantastically expensive, requiring an initial application fee of £103,000 and full scale clinical trials demonstrating safety and efficacy.
A traditional herbal registration is not as expensive, around £6,000 but relies on the product having been “traditionally used to treat the stated condition for a minimum of 30 years, 15 years of which must have been in the European Union (EU).” It also requires “scientific evidence relating to the safety, quality and traditional use of the herbal product”. It is far from certain that CBD will qualify for this scheme and in any event registration is only granted if the medicine is used for minor health conditions where medical supervision is not required.
CBD is not a ‘controlled drug’ and is not prohibited but most CBD products are in fact low-THC, whole plant extracts derived from industrial hemp, legally grown under licence. So yes, they are a legal form of cannabis and, of course, according to the Misuse of Drugs Act 1971, cannabis has ‘no medicinal value’. So, you may well ask, how can the MHRA classify it as a medicine?
MHRA Headquarters
This is just the first of many complications for the MHRA, the Home Office and the government. Potentially, it could be very positive as it could make the government acknowledge the medicinal value of cannabis and, in effect, force the beginning of cannabis regulation.
It has been certain for some time that many of the CBD products presently on the market are unlawful because they contain levels of THC and CBN which exceed the limits stated in the Misuse of Drugs Regulations 2001. Some CBD suppliers have taken a head in the sand attitude to this, even in some cases foolishly promoting the THC levels in their products. This led to CLEAR removing its endorsement of one supplier earlier this year and recommending CBD Oils UK instead.
The path ahead is uncertain. The UKCTA is pressing for an urgent meeting with the MHRA. Apart from the advice to consumers to stock up, these will be very worrying times for CBD suppliers and their employees. Another factor is that GW Pharmaceuticals is very close to applying for FDA approval in the USA and an MHRA marketing authorisation for its CBD epilepsy medicine, Epidiolex.
CLEAR, the UKCTA and leading CBD companies are working together to clarify and progress this situation. We will keep you closely informed of developments.
Peter Reynolds 