Posts Tagged ‘Department of Health’
Cannabis and CBD. UK and EU Bureaucrats -v- The People and Parliament.
For decades, public opinion and knowledge on cannabis has been way ahead of those in Parliament and civil servants in the Home Office and the Department of Health.
In other countries, governments have been more ready to update themselves on scientific knowledge and they are more speedily held to account through more effective democracies. At last, the UK Parliament has acted on access to cannabis for medical use as it should have 20 years ago. Both Canada and the Netherlands introduced legal access in 2001 and California even five years before that.
But the will of Parliament is being stifled and subverted by bureaucracts in the NHS and the Department of Health. As MPs are never shy to remind us, under our constitution, Parliament is supreme. That makes the conduct of these civil servants unlawful. They are being obstructive about the prescribing of cannabis. They need to be compliant with the law or they become guilty of maladminstration. We should have no more patience with this wilful misconduct. Their responsibility is to facilitate implementation of the law, not find ways to delay it because of their personal opinions.
The same goes for the Home Office which has done absolutely nothing to revise its cannabis licensing policy in accordance with the new regulations. Well-qualified, experienced, international corporations, willing to make multimillion pound investments in Britain to produce the cannabis-based products (CBPMs) which we need are being refused licences for no good reason. If the products are not available, how will they ever reach the patients who Parliament has decreed are entitled to access them?
For 50 years, the Home Office has run a systematic campaign of disinformation because it is institutionally opposed to cannabis. Until Sajid Javid, civil servants have thwarted the efforts of all minsters that have tried to introduce any drugs policy reform. Now he has to stand up against the subversive forces within his own department or someone has to fund judical review of the Home Office’s maladminstration of cannabis licensing. Just as in the Windrush Scandal, the Home Office maintains a ‘hostile environment’ based on senior civil servants’ personal prejudices rather than the best interests of Britain and now, the law.
CBD. Big Pharma Protectionism, Bureaucrat Box-Ticking or Both?
Many people are not yet aware of the meddling that is going on with CBD products. There is a real threat that they could be removed from sale within the next few months. This depsite their soaring popularity with the public and that hundreds, if not thousands of people are now employed in our burgeoning CBD industry.
CBD products are, in fact, whole plant extracts from low-THC cannabis which meet the criteria under drugs law to be exempt. They have become very popular because people were seeking a legal way of accessing the medicinal benefits of cannabis which have become widely understood, mainly as the internet has provided knowledge previously suppressed by government and media scaremongering.
Two years ago, the meddling began as civil servants from the MHRA, the medicines regulator, stepped in with heavy-handed threats to close the market down because of unlawful medicinal claims. To be fair, there was good justification for this. Medicines regulation is an essential function of government, otherwise we will have snake oil confidence tricksters selling coloured water as a cancer cure. So CLEAR acted and organised a response to the MHRA from the leading CBD companies. Now, the responsible and ethical companies have regulated themselves, stopped making medicinal claims and market their products as food supplements, just like vitamins and minerals than can help to maintain health and boost wellness.
So CBD companies have successfully negotiated their way through both drugs and medicines law but now the food police have stepped in with yet more problems. This time the civil servants objections are entirely unnecessary and unjustifiable but they are the most serious threat that CBD companies and consumers have faced.
The Food Standards Agency (FSA) from the UK and its opposite numbers in other EU countries have placed cannabis extracts in the EU Novel Foods Catalogue, which is for products that have not been consumed to a significant degree in the EU before 1997. This means that without going through a lengthy and very expensive authorisation process, all CBD products could become unlawful to sell.
Why? When I met with the FSA and its novel foods team just over a week ago, it acknowledged that the purpose of the novel foods regulations was to ensure that food products and supplements are safe. It also confirmed that it had no evidence that cannabis extracts or CBD products are unsafe. So, on the face of it, this seems to be simply a matter of bureaucrats who want their boxes ticked, for no other reason than that is what bureaucrats do.
But the widely-held opinion from those in the know, is that what is really behind this are the vested interests of painkiller companies who are seeing a big impact on sales of their products. Even the World Health Organization has recently given CBD an unequivocal endorsement as safe and effective, whereas the toxicity of paracetamol, ibuprofen, other NSAIDs and opioids is now well understood.
You see, however CBD products are sold, it is an indisputable fact that they are purchased for their medicinal benefit – and that they work. This is a big threat to pharmaceutical company profits and so they are wielding their big stick. They tried through the MHRA to close down CBD and now they are trying through the FSA.
Exactly the same thing is happening in the USA. The recent passage of the Farm Bill has removed CBD from the Controlled Substances Act but now the FDA (which combines the functions of our MHRA and FSA) has stepped in and said it is illegal to sell as a food supplement because it is the active ingredient in a licensed medicine.
We Will Overcome
So a battle royal is starting. What the outcome will be is uncertain. It is complex and multi-threaded. Different strategies are being developed and varying ideas are being put forward as to how to deal with this threat. Many people now rely on CBD for their health and the imminent threat of it not being available is a danger to individuals and so to our entire society.
Whatever happens, I am certain that commonsense and the people will prevail. For a century, the use of cannabis as medicine has continued despite every effort from governments and vested interests to stamp it out. The same will happen with CBD. Even it it disappears from the high street, it will continue to be available online and if it can’t be sold as a food supplement, it will move into a new category.
Once again, it will take politicians far too long to wake up and out-of-control civil servants will try to pursue their own agenda which, I am quite sure, is under the corrupt and improper influence of big business. It will be challenging and very difficult but the people have dealt with these dark forces before and we will continue to do so.
“The Settled View Of Ministers Is That The Medicinal Campaign Is Just An Excuse To Take Cannabis”.
These are the words of Sir Oliver Letwin, my MP, during a meeting with him just a few days ago.
To some this may be an astonishing revelation, to others it will be depressing confirmation that this bigoted and out-of-date view still persists. Anyone with even a modicum of knowledge will agree that it is deeply ignorant and in defiance of a vast quantity of scientific evidence.
This is the end point of my two and half years of discussion with Sir Oliver. He’s not currently a cabinet minster but through his 20 year parliamentary career he’s always been at the top of the Conservative Party: Shadow Home Secretary, Shadow Chancellor and then in government in 2010 elevated to the status of right hand man to David Cameron. As Minister for Government Policy and then Chancellor of The Duchy of Lancaster, he was been described as ‘the intellectual powerhouse of the Tory Party’ and as ‘number three in the government after Cameron and Osborne’.
So what goes through Oliver’s mind is a pretty good indication of how the Tory Party establishment thinks. I’m absolutely certain that what he has told me is exactly the present mindset of ministers from Theresa May down.
Back in 2015 Oliver wrote to George Freeman MP on my behalf, then the minister with responsibility for medicines. He’s also written to Jeremy Hunt, the Health Secretary and Amber Rudd, the Home Secretary. None of this correspondence has resulted in anything but the usual, anodyne words that are nothing but a brush off. I did think I was getting somewhere though when he told me he would establish with the Department of Health what its position was on the scientific evidence. Back came the answer that all the evidence had been considered, expert advice had been taken and the conclusion was that the risks of legalising for medicinal use would outweigh the benefits.
Now this didn’t make sense to me. I wanted to know what evidence and what experts. After half a dozen requests for this information and no response I submitted a Freedom of Information Request to the Department of Health. Eventually it was returned stating quite clearly that it had neither requested, received nor considered any evidence on medicinal cannabis. Coincidentally, just a few days later, Paul Flynn MP asked almost exactly the same question in Parliament and received the same answer. So I wrote to Oliver and said that either he had been misled or he was misleading me, which was it? It was at this point that he stopped replying to my emails.
After several months of repeated requests and no response I went direct to his parliamentary secretary and booked a surgery appointment to see him as a constituent. I was quite prepared to confront him face to face. I was amused to receive an email from Oliver the very same day in which he said that would reluctantly agree to see me on the subject “one last time”. So at the meeting his explanation was that it had all been a huge misunderstanding, he didn’t mean to suggest that any evidence had been examined, it was simply “the settled view of ministers is that the medicinal campaign is just an excuse to take cannabis”.
Such is the state of our so-called democracy and so-called evidence-based policy.
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.
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.
CLEAR’s Submission To The Parliamentary Inquiry Into Medicinal Cannabis
This was the response that CLEAR submitted to the APPG in February 2016. In March 2016, Roland Gyallay-Pap, then managing director of CLEAR and Peter Reynolds, president, were called to give oral evidence to the Inquiry.
A PDF copy of this document may be downloaded here.
Introduction
In June 2015 the All-Party Parliamentary Group for Drug Policy Reform (APPG) published a short report arguing for a rescheduling of cannabis to make it more widely available for medical use. Following the publication of that report there are a number of key questions remaining that it would like to address by means of a Short Inquiry.
CLEAR Cannabis Law Reform has been asked to submit evidence to the Inquiry in answer to these specific questions:
- Whether switching the medical status of cannabis from schedule 1 to a less restrictive schedule would be beneficial?
- What do you understand to be the range and extent of unofficial use of cannabis for medical purposes?
- What has been the impact of the current schedule 1 status on research into the medicinal uses of cannabis?
- Is there useful evidence emerging from the regulation of cannabis in over 20 US states and elsewhere and what does it tell us about the case for cannabis to be included in the UK pharmacopeia?
- What would be the implications of licencing cannabis for medicinal use following a change in Schedule?
- What role could EU regulations play in developing the potential for the medicinal use of cannabis?
We have also added a further response with additional information.
- Access to prescribed Bedrocan medicinal cannabis is already possible based on careful use of loopholes and errors in existing English law.
Whether switching the medical status of cannabis from schedule 1 to a less restrictive schedule would be beneficial?
Yes, we consider that switching cannabis from schedule 1 to a less restrictive schedule would be beneficial, both so that it could be prescribed by doctors as medicine and so that it could more easily be used in research into its use and effects.
Cannabis has been in schedule 1 of the Misuse of Drugs Regulations1 (MoDR) since the Misuse of Drugs Act 19712 (MoDA) came into force. Drugs in schedule 1 are specified as having no medicinal value. However, an inquiry by the House of Lords Science and Technology Committee published in 19983 recommended that doctors should be permitted to prescribe cannabis and that it should be moved to schedule 2. Strangely the government’s response to this recommendation was further to tighten restrictions by the Misuse of Drugs (Designation) Order 20014, which designates cannabis under section 7(4) of MoDA so that it is unlawful “for a doctor, dentist, veterinary practitioner or veterinary surgeon, acting in his capacity as such, to prescribe, administer, manufacture, compound or supply” it.
In fact, cannabis has already been re-scheduled into schedule 4 under the international non-proprietary name of nabiximols (Sativex)5. Although this is specified as being an extract of THC and CBD, it is clear from statements by the manufacturing company, GW Pharmaceuticals, that nabiximols is whole plant cannabis. Dr Geoffrey Guy, founder and chairman of GW, is on the record:
“Most people in our industry said it was impossible to turn cannabis into a prescription medicine. We had to rewrite the rule book. We have the first approval of a plant extract drug in modern history. It has 420 molecules, whereas every other drug has just one.”6
GW pharmaceuticals has confirmed that this quotation is accurate.7
The MHRA has chosen to issue a marketing authorisation8 for nabiximols (Sativex) by regarding it as only a two molecule medicine. The marketing authorisation is therefore at best inaccurate, at worst dishonest.
What do you understand to be the range and extent of unofficial use of cannabis for medical purposes?
In 2011, CLEAR commissioned independent, expert research from the Independent Drug Monitoring Unit (IDMU). The report, ‘Taxing the UK Cannabis Market’9, reveals there are three million people using cannabis in the UK regularly (at least once per month). Since then CLEAR has regularly polled its members and followers and consistently one in three of respondents claim at least some part of their use is for medicinal reasons. It is reasonable to estimate therefore that there are up to one million people using cannabis for medicinal purposes in the UK. It is certain that there are hundreds of thousands of medicinal users and previous estimates in the region of 30,000 are far too low.
The most common indications for medicinal use declared by our respondents are chronic pain, fibromyalgia, Crohn’s disease, multiple sclerosis and cancer.
Our interpretation of the responses we have received is that generally cannabis is used as a palliative agent. Some people find it so effective that they consider it to be a ‘cure’ as long as they keep using it. Others find it extremely helpful in reducing the amount of toxic and/or dangerous pharmaceutical medicines they are prescribed. Often the side effects of pharmaceutical medicines are severe and debilitating and cannabis offers a way of minimising these.
CLEAR maintains a Medicinal Users Panel10 which members join in order to gain support in lobbying their MPs and/or attempting to obtain prescribed Bedrocan medicinal cannabis. The active membership of the panel varies between 20 to 80 people. Panel members have also been involved in delegations to meet government ministers and other parliamentarians
What has been the impact of the current schedule 1 status on research into the medicinal uses of cannabis?
In the UK there is very little research into the medicinal uses of cannabis, except that undertaken by GW Pharmaceuticals11. There has been some research carried out into single cannabinoids but the evidence is that the therapeutic effects of cannabis depend on the whole plant ‘entourage effect’.
The allopathic, reductionist approach to medicine, which is reflected in the way that the MHRA regulates medicines, is the fundamental, establishment doctrine that impedes research into cannabis.
Sadly, one of the biggest trials of MS patients, the CUPID study at the University of Plymouth12, intended to look at the many anecdotal reports of benefit, used synthetic THC and consequently the results were disappointing and irrelevant to the claims it sought to test.
It is far easier to obtain funding for research into the harms of cannabis which is undertaken with an almost absurd degree of repetition, most notably by the Institute of Psychiatry at King’s College London (IOPPN).13 It is also worth noting that IOPPN regularly and consistently overstates the results of its research, encouraging the media to report causal effects between cannabis use and mental illness which its research does not support.14
There is a huge stigma around cannabis, largely due to inaccurate, misleading and hysterical press coverage. For instance, neither of the pre-eminent MS patient groups, the MS Society and the MS Trust, will take a stand in support of patients, despite the fact that many use cannabis. Similarly, despite extraordinary human clinical trial results on Crohn’s disease, none of the Crohn’s patient groups will engage with the campaign. Mention cannabis and calls are not returned, people are scared by the stigma. The immediate reaction from all such patient groups is to overlook evidence of benefit and refer to risks to mental health which, in fact, are very low compared to pharmaceutical products. The press, unchallenged by politicians in its disproportionate attention to these risks, bears a heavy responsibility for this stigma and the lack of research.
Unlike many within the reform movement, CLEAR recognises and values the expertise and achievements of GW Pharmaceuticals. However, any doctor or scientist that expresses any interest in medicinal cannabis in the UK is immediately retained or contracted by GW. We receive hundreds of reports of doctors, GPs and consultants, who tacitly and sometimes explicitly support their patients’ use of cannabis but it is impossible to find any doctor who is prepared to speak out publicly. In the few instances where doctors have spoken out on behalf of patients, they have been contacted by Home Office officials and warned. One GP reported that he felt “intimidated”. By contrast, there are tens of thousands of doctors across Europe, Israel and North America who advocate for the use of medicinal cannabis and further research into its applications.
The security and record-keeping requirements for cannabis as a schedule 1 drug15 are wildly disproportionate to the real potential for harm, requiring a high security safe for storage and an audit trail fit for Fort Knox.
In addition the fee for a high THC licence is currently £4700.00 per annum and applications can take more than a year to process. These requirements, delays and corresponding costs severely impede research into medicinal cannabis.
Recently, in response to two government e-petitions, the Home Office issued the following statement:
“In 2013 the Home Office undertook a scoping exercise targeted at a cross-section of the scientific community, including the main research bodies, in response to concerns from a limited number of research professionals that Schedule 1 status was generally impeding research into new drugs.
Our analysis of the responses confirmed a high level of interest, both generally and at institution level, in Schedule 1 research. However, the responses did not support the view that Schedule 1 controlled drug status impedes research in this area. While the responses confirmed Home Office licensing costs and requirements form part of a number of issues which influence decisions to undertake research in this area, ethics approval was identified as the key consideration, while the next most important consideration was the availability of funding.”
We consider this response to be disingenuous and misleading. Cannabis is a special case. It is a combination of hundreds of molecules, unlike other schedule 1 drugs, most of which are single molecules. Also, as is well established in written and archaeological evidence, cannabis has been used effectively for at least 5,000 years as medicine without any evidence of harm.
Furthermore. ethical approval and funding are difficult largely due to the evidence-free scaremongering about cannabis and the consequential stigma, in which the Home Office plays a leading role. Ethical approval and funding do not seem to be a problem in researching potential harms of cannabis. Indeed, as noted above, there is a massive amount of such research even though much of it is repetitive and inconclusive.
Until it is recognised that for many years, under successive governments, the Home Office has been systematically misleading and scaremongering about cannabis, it is difficult to see how an evidence-based decision can be reached. The Home Office regularly makes assertions about cannabis that are completely without evidential support. There is an established prejudice and determination to misinform and this must be tackled at root as it amounts to misconduct and corruption.
Is there useful evidence emerging from the regulation of cannabis in over 20 US states and elsewhere and what does it tell us about the case for cannabis to be included in the UK pharmacopeia?
There is a vast amount of peer-reviewed, published evidence of the safety and efficacy of cannabis as medicine. Much of this arises from research carried out in the USA, the Netherlands and Israel, where medicinal cannabis regulation has been in place for many years.
It is a populist myth, promoted by the Home Office, the press, the BBC and the prohibitionist lobby, that there is no evidence supporting the use of cannabis as medicine.
In February 2015, a delegation of medicinal cannabis users from CLEAR met with George Freeman MP, the life sciences minister, at the Department of Health who is largely responsible for medicines regulation. At the conclusion of the meeting, Mr Freeman requested CLEAR to produce a summary of the available evidence.
The result is the paper ‘Medicinal Cannabis:The Evidence’16 (MCTE) which has received international acclaim, so much so that in association with Centro de Investigaciones del Cannabis (CIC), a Colombian non profit association, a Spanish language version has been published.
MCTE was submitted to George Freeman MP in April 2015. Since then he has repeatedly refused to meet CLEAR again or respond to us directly, even after multiple requests from individual MPs representing CLEAR members. His only responses, received through third parties, fail to address the evidence at all. He simply refers to the legal status of cannabis, the theoretical availability of Sativex and the MHRA process for issuing marketing authorisations in respect of medicines.
This refusal to engage, acknowledge or properly consider the very large amount of evidence that is available is indicative of an inexplicable prejudice within government. Although conspiracy theories abound, it is difficult to understand why ministers adopt this position.
Cannabis was one of the most used medicines in the British pharmacopeia until only about 100 years ago. It could be restored immediately by a stroke of the Home Secretary’s pen to remove it from schedule 1. This would immediately make it possible for doctors to prescribe medicinal cannabis from Bedrocan17, the Netherlands government’s exclusive contractor.
Bedrocan cannabis is carefully regulated by the Netherlands government’s Office of Medicinal Cannabis. It is available in five different THC:CBD ratios. It is already exported to many countries in Europe and the company has established itself in Canada as well. It is less than a tenth the cost of Sativex for equivalent cannabinoid content and can be consumed either by a medical vapouriser or as an infusion.
No minister in this or any previous government has ever presented a coherent reason for the refusal to allow cannabis to be used as a medicine. Their only response is to fall back on largely spurious or exaggerated claims about the harms of recreational use.
What would be the implications of licencing cannabis for medicinal use following a change in Schedule?
Cannabis would not need to be ‘licenced’ for medicinal use following a change in schedule. As soon as it removed from schedule 1, doctors would be able to prescribe it and businesses interested to grow, process and develop cannabis medicines would be able to obtain cultivation/possession licences from the Home Office.
Medicines are no longer ‘licenced’ in the UK. The MHRA grants marketing authorisations. The initial fee, simply for filling in the application form is £103,000.00, thus prohibiting any but the very largest, established businesses from even considering such a venture. The very term ‘marketing authorisation’ reveals the mindset of medicines regulators which is now more about commercial interests than the evaluation of the safety and efficacy of medicines.
The MHRA does have a regulatory scheme for ‘Traditional Herbal Registration’ (THR) but it only applies “if the medicine is used for minor health conditions where medical supervision is not required.”. An application for a THR for cannabis could not be made while it remains in schedule 1 but, if granted, would not permit its use for many conditions where there is excellent evidence of its efficacy.
The MHRA is locked in an inflexible, unscientific and restrictive process which can only evaluate medicines which are either one or two molecules. Its process is designed for synthetic, potentially very dangerous molecules and is entirely unsuitable for a plant based medicine such as cannabis. This is why, as explained above, Sativex has been improperly regulated as containing only two molecules: THC and CBD.
When the Sativex (nabiximols) patent expires, independent analysis of the medicine would certainly demonstrate that it is whole plant cannabis oil. Presumably alternative and/or generic versions could then be produced. However, by any standards, for all parties, the regulation and scheduling of Sativex is inaccurate, if not dishonest, and needs revision.
If cannabis is removed from schedule 1, most appropriately to schedule 4 alongside Sativex, in our judgement there will be a large number of businesses applying for cultivation/possession licences for research which will eventually result in applications for marketing authorisations. In the meantime, it can only be described as cruel and evidence-free not to permit doctors to prescribe Bedrocan, a safe, effective medicine already regulated by another European government.
It is likely that enabling the prescription of Bedrocan would result in substantial savings to the NHS medicines budget. However, any idea that this could be quantified based on existing evidence is fanciful. Certainly, compared to existing prescription medicines and Sativex, Bedrocan is very inexpensive, probably less than 10 euros per patient per day. However, the complexity of calculating which medicines it could replace by individual, partly or wholly and for how long makes the exercise so hypothetical as to be meaningless.
It must be true that once local, UK-based cultivation of medicinal cannabis was permitted, prices would reduce even further.
What role could EU regulations play in developing the potential for the medicinal use of cannabis?
Aside from France and Ireland (which is moving rapidly towards drugs policy reform), every other EU country has a more intelligent, compassionate and evidence-based policy towards medicinal cannabis. Based on existing policy and its record, the UK government would simply refuse to comply with any EU regulation of medicinal cannabis.
Under the Schengen Acquis (of which UK is a signatory, though not to the full Schengen Agreement), if a medicine is prescribed to a resident of a member state, that resident may travel to other member states with up to three month’s supply under the protection of a Schengen certificate. The effect of this is that a resident of the Netherlands, Belgium, Finland, Germany, Italy, etc. can bring prescribed cannabis, likely Bedrocan, into the UK and use it without restriction.
The crucial test here is residency, so it is not possible for a UK resident to travel to another country, obtain a prescription and then return to the UK legally with cannabis. Presently, a Schengen certificate for a UK resident has to be issued by the Home Office. Strangely and in contravention of this explicit provision, Norway (Non EU but a signatory to Schengen) does permit its residents to obtain prescriptions, usually in the Netherlands, and return home with cannabis.
It is also likely that given the hostility towards EU regulation, adding cannabis into that debate would be counterproductive. It would be used as another stick with which to beat the EU.
Access to prescribed Bedrocan medicinal cannabis is already possible based on careful use of loopholes and errors in existing English law.
As some members of the APPG are aware, CLEAR has been involved in trying to obtain legal access to prescribed Bedrocan since 2012. We now have approximately a dozen members who regularly receive private prescriptions from their doctors (both consultants and GPs) and travel to the Netherlands to have them dispensed.
In all instances, these individuals have either declared their medicine at customs and/or have made prior arrangements with the Border Force, producing supporting documentation.
This is possible because of errors and inconsistencies in the MoDA and the MoDR. All English drugs legislation, including the recent Psychoactive Substances Act 2016, is badly drafted, contradictory and scientifically illiterate.
The principle active ingredients of cannabis are delta-9-THC and cannabidiol (CBD). Bedrocan products are specified with different ratios of these substances. While cannabis is classified in schedule 1, so is delta-9-THC but it is also in schedule 2 described as dronabinol, which is the international non-proprietary name (INN) for delta-9-THC. CBD is not a controlled drug.
Therefore, if a doctor is prepared to write a prescription e.g. dronabinol (Bedrocan 22%) or dronabinol (Bediol 7.5%), three month’s supply of the medicine may be legitimately imported as a schedule 2 drug.
In the past four years only one CLEAR member has been frustrated in this. He had his medicine seized but he was not prosecuted. An appeal against the seizure failed.
Clearly, the vital factor in this scheme is a doctor who understands the law and the science and is prepared to write the prescription.
References
1. Misuse of Drugs Regulations 2001 http://www.legislation.gov.uk/uksi/2001/3998/contents/made
2. Misuse of Drugs Act 1971 http://www.legislation.gov.uk/ukpga/1971/38/contents
3. House of Lords Science and Technology Committee report 1998 http://www.parliament.the-stationery-office.co.uk/pa/ld199798/ldselect/ldsctech/151/15101.htm
4. Misuse of Drugs (Designation) Order 2001 http://www.legislation.gov.uk/uksi/2001/3997/made
5. Nabiximols (Sativex) https://en.wikipedia.org/wiki/Nabiximols
6. Cambridge News, 24th Jan 2012 http://www.cambridge-news.co.uk/Cannabis-company-enjoys-major-growth/story-22509041-detail/story.html
7. Email corres with Marc Rogerson, GW Pharma, 160312. Attached.
8. Sativex (nabiximols) marketing authorisation, MHRA , 2010 http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con084961.pdf
9. Taxing the UK Cannabis Market, IDMU, 2011 http://clear-uk.org/media/uploads/2011/09/TaxUKCan.pdf
10. CLEAR Medicinal Users Panel http://clear-uk.org/pages/medicinal-panel/
11. GW Pharmaceuticals website http://www.gwpharm.com/
12. CUPID study, University of Plymouth, 2015 http://www.ncbi.nlm.nih.gov/pubmed/25676540
13. Institute of Psychiatry at King’s College London website http://www.kcl.ac.uk/ioppn/index.aspx
14. King’s College Confirms Institute of Psychiatry Misled Media On Cannabis Brain Study. CLEAR, 2015 http://clear-uk.org/kings-college-confirms-institute-of-psychiatry-misled-media-on-cannabis-brain-study/
15. Controlled Drugs (Supervision of management and use) Regulations 2013, Dept of Health https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/214915/15-02-2013-controlled-drugs-regulation-information.pdf
16. Medicinal Cannabis: the Evidence, CLEAR, 2015 http://clear-uk.org/static/media/PDFs/medicinal_cannabis_the_evidence.pdf Attached
17. Bedrocan BV website http://www.bedrocan.nl/
LibDems: Correct On Cannabis Policy, Wrong On Scaremongering.
The Liberal Democrats are doing great work on advancing the cause of cannabis law reform. Their policy proposals are sensible and their arguments for change are irrefutable but they are wrong to buy into and sustain the myths and scaremongering that have dominated the cannabis debate for so long.
Cannabis does not cause psychosis. Stronger strains do not present serious health risks. Memory loss is not a significant issue and no issue at all in comparison to the health harms of alcohol or tobacco. Cannabis cannot be described as dangerous unless you also apply that word to hay fever remedies, over-the-counter painkillers and energy drinks. There is not and never has been any scientific evidence to support these myths.
Of course, we must be sensitive to people’s fears and concerns. For more than 50 years the British people have been fed a stream of lies and exaggeration by the tabloid media. The Home Office, right up to today, is engaged in a systematic and deliberate policy to mislead and misinform on cannabis. Shocking though that fact is, this policy transcends successive governments and continues irrespective of ministers’ views. It clearly emanates from dishonest and corrupt officials who are determined to pursue their own agenda, irrespective of truth or concern for the massive harms and cost of cannabis prohibition.
Norman Lamb, the Liberal Democrat MP and health spokesperson, who is leading the party’s campaign, is a brave, sincere and conscientious politician. One of the few in Westminster that matches up to the high standards of probity and wisdom that we should be able to expect from all MPs. Similarly, Nick Clegg, former leader, and Tim Farron, current leader, have spoken out strongly on the need to reform the law. Now is the time for them also to start telling the truth about cannabis, about how its dangers have been vastly exaggerated, how for adults, in moderation, it can actually be very beneficial and far preferable as a choice of relaxant to alcohol. Indeed, if people substituted cannabis for some of their alcohol consumption, it would be a public health revolution. It would save the NHS billions and transform the health of our society.
The cannabis campaign will not succeed unless we tell the truth. We cannot compromise facts and evidence for the illusory belief that buying into the scare stories will somehow advance the cause. We need to push back at the scaremongering, acknowledge there are risks but that they are extremely small. They really only apply to use by children or to behaviour that is analogous to a ‘white cider drinker’. Consume anything to excess, regularly, without a break, without regard to other aspects of life and it will cause harm but even then, cannabis will cause less harm than any other substance.
As for children, one of the main aims of reform must be to minimise underage use. Even then, the scare story that cannabis is causing significant mental health problems amongst young people is untrue. The Department of Health’s own data shows that in the last five years, there has been an average of just 28 episodes per year of care for ‘cannabis psychosis’ in young people. 28 individual tragedies but an insignificant problem in public health terms.
The misuse of the term ‘skunk’ is also unhelpful. The Channel 4 ‘Drugs Live’ debacle last year was based on reckless, irresponsible overdosing of inexperienced users by a scientist who should know better. All the time calling the cannabis was called ‘skunk’ when it is a matter of fact that it was silver haze as grown by Bedrocan, the Netherlands’ government producer of medicinal cannabis. Skunk is actually the name of one particular cannabis strain and not an especially strong one. Cannabis is available in Britain that is twice, sometimes three times as potent as skunk but the word has been selected and promoted by the tabloid press because of its obvious, sensationalist, negative connotations.
Thank you to the Liberal Democrats for the fantastic work they are doing. All we need now is a little adjustment and focus on truth rather than scare stories.
