Posts Tagged ‘THC’
The CBD Market Can Help Drive Cannabis Law Reform But Selling So-Called ‘CBD Flowers’ Could Take Us Backwards
Jim Weathers of Puff ‘n Stuff CBD shop, Cork, Ireland
Compliant businesses operating responsibly within the legal cannabis sector will help to drive reform. Blurring the lines between legal and illegal products will delay progress.
It seems that the crackdown on the open sale of cannabis flowers online and in high street stores is here. Both in the UK and Ireland, several shops have been raided in recent weeks and some people are facing potential charges of supplying a class B drug and a possible jail sentence.
These flowers, sold under meaningless pseudonyms such as ‘CBD buds’ or ‘hemp flowers’ are cannabis and cannabis is a controlled drug in both the UK and Ireland. As CLEAR has been warning for many months, there is no way that these can ever be ‘exempt products’ in the same way as CBD oil. Their THC content makes no difference. The penalty is the same for any type of cannabis whether it contains zero THC or 25% THC.
It’s unclear whether CBD oil is legal at all in Ireland. A more accurate description for these products is low-THC cannabis extracts and whereas the UK makes specific provision for exempt products in the Misuse of Drugs Regulations 2001, there does not seem to be any such provision in Irish law.
In other EU countries an even wider crackdown on CBD products is underway, fuelled also by the extraordinary and clearly unsustainable attempt to deem all cannabis extracts as ‘novel foods’.
Now it shouldn’t need to be said but CLEAR stands for an end to the prohibition of cannabis and all our work is directed towards that end. Some people seem very confused that our efforts to clarify the law mean that we are on the side of prohibition but this is not the case. Through our trade association, Cannabis Professionals (CannaPro) we refuse to certify businesses that sell cannabis flowers. They are cheating their customers by misleading them that these products are legal. They are also cheating all those other businesses operating within the legal cannabis sector who are working hard to remain compliant. They are undermining the very good work that the CBD industry is doing to drive wider cannabis law reform.
Of course, many of us are buying cannabis illegally already. Without our local dealers where would we all be under the oppressive and ridiculous regime under which we live? But our aim and the aim of all responsible cannabis campaigns is to ‘get the dealers off the street’ and move the trade into licensed, regulated outlets. The emergence of the CBD market and high street retailers selling CBD oil has shown how this could work and there is no doubt at all that it has been a very significant factor in increasing public acceptance of cannabis and the recent reforms for medical access.
The people selling cannabis flowers and claiming they are legal are not heroes, campaigners or warriors in the war on prohibition. They are confidence tricksters, seizing the opportunity to make a quick buck by cheating and endangering their customers. No one is going to go to jail for buying cannabis but if you’ve bought low THC flowers and get charged with possession that could ruin you future prospects of travel, a career, even of keeping your driving licence. If you’re going to take that risk you need to do so with your eyes open, with the honest trade of an illegal dealer rather than the dishonest trade of a shop or a website that is telling you lies.
Also, be very careful what you are buying. The ‘CBD flowers’ currently being advertised are most certainly not what they claim to be. The strain names are being misused. White Widow, Lemon Haze or Pineapple Express do not come with 20% CBD and only traces of THC. These products have been doctored. There simply aren’t any cannabis strains that contain these constituents in these proportions. What is probably happening is that they are being sprayed with CBD isolate and possibly terpene extracts to come with what are artificial cannabis buds. Buy these and you are being cheated on many levels and you really don’t know what you are actually inhaling.
We are making steady and accelerating progress towards a rational cannabis policy but this latest development is unwelcome and unhelpful. Trust your usual dealer. If you’re buying cannabis flower, it comes with THC. If you want added CBD take a little oil or vape some CBD crumble. This will give you a far better result than these fake flowers. It will enhance the therapeutic properties of your cannabis if you’re consuming for medical reasons. It will give you a far better buzz if you’re consuming for pleasure.
Nothing good will come from these fake flowers. Compliant businesses operating responsibly within the legal cannabis sector will help to drive reform. Blurring the lines between legal and illegal products will delay progress.
CBD Isolates Are NOT Becoming A Controlled Substance
Mike Harlington’s CTA has put out an announcement that CBD isolates are becoming a controlled substance. There is no truth in this at all, it is nothing but speculation and opinion.
Even if the speculation is correct that isolates will remain classified as a novel food, the terminology is wrong. ‘Controlled’ has a specific meaning in UK law and is applied to drugs classified and scheduled under the Misuse of Drugs Act 1971. There is no prospect whatsoever of this applying to CBD in any form.
It is correct that the FSA initially classified isolates as novel in January 2018 and no reasonable person can have any objection to this. Clearly, there cannot be any evidence of them having been consumed in the EU area prior to 1997. It’s a separate point that this is bureaucratic overkill. There’s no evidence that isolates are unsafe so there’s no reason to require them to go through an authorisation process except simply to comply with the letter of the law. It is bureaucracy for bureaucracy’s sake and a complete waste of the FSA’s time and taxpayers’ money.
Another, more pertinent point is that despite isolates being classified as novel for well over a year, the FSA has done absolutely nothing about enforcement. This whole rigmarole is pointless and doing little else other than keeping civil servants in work, making up rules which they then do nothing about.
What remains a far more worrying prospect, which has been entirely overlooked, is that in June 2018, the FSA also indicated that selective extracts would be regarded as novel. The argument for this is equally as strong and logical as it is for isolates and this poses a much more worrying prospect for the CBD industry.
Selective extracts are extracts in which the proportions of the component moleclues have been adjusted, most commonly by the elimination of THC. Making such adjustments, dialling up or down particular components is an inherent facility of supercritical CO2 extraction. But just as there can be no evidence of isolates having been consumed in the EU area prior to 1997, neither can there be any for selective extracts. Extracts consumed in the past will have been made by less sophisticated processes that do not permit such adjustments.
So the deep irony in this is that in order to avoid any infringement of drugs laws by removing the THC, such products will be in breach of food law.
Where the FSA is going with this no one knows. It has made major errors in its bungling and incompetent attempt to outlaw CBD products and its top priority now seems to be saving face. Similarly, having bragged about his mythical ‘close working relationship’ with the FSA, Harlington is also desperately trying to save face and make it look as if he is ahead of the game. It’s just more of his characteristic bluster and bullshit. Don’t be taken in.
Any predictions I will make about the future will also be speculation but I am quite confident that this time next year whole plant, low-THC cannabis extracts will still be on sale. In fact I am sure that the market will have continued to expand rapidly.
Sainsbury’s Now Stocking Legal Cannabis Products As UK Policy Looks Increasingly Shambolic.
In another demonstration of how fast attitudes are changing, Love Hemp water containing soluble CBD cannabis extract is now on sale in a number of Sainsbury’s stores.
This is a remarkable achievement by the team at Love Hemp who are remaining tight lipped about the terms of the deal. A store manager told me that the product is on test in about 100 stores.
Cannabis prohibition is crumbling and the Home Office seems increasingly our of touch with reality with its futile attempts to enforce a policy which nobody is taking any notice of. The real effect of the medical reforms should become clear within the next few weeks. The expert panel process has been revealed as little more than a farce. We still have an outstanding FOI Request on the issue but interim responses seem to confirm that not a single member of the panel, so-called ‘experts’ has any knowledge, experience or expertise in the use of cannabis as medicine.
We await the definition of a cannabis-based product which will determine which products will be re-scheduled and also a decision on who may prescribe. Initial overtures from the MHRA to both CLEAR and the CTA to consult on these issues have come to nothing. It seems that little if anything has been achieved over the summer break.
Home Office licensing policy is also looking increasingly ridiculous. It is refusing any licence application for low THC cultivation where any mention of CBD is made, while every other EU country is striding ahead and British CBD suppliers are having to import all their oil, which they do without any difficulty uner EU free movement rules.
A twist which reveals the absurdity of Home Office policy is that Love Hemp water, which is entirely THC free, is not the first cannabis product that Sainsbury’s has stocked. For many years it has been stocking Good Hemp hempseed oil. Recent lab tests have revealed that THC levels in Good Hemp oil exceed the 1mg limit in each bottle, meaning that it cannot be regarded as exempt under the Misuse of Drugs Regulations. In reality then Sainsbury’s is selling a product that is legally classified as a class B drug.
Reefer Madness 3.0 Is Here And It’s Being Promoted By Cannabis Law Reformers.
Reefer Madness started in 1930s America with the propaganda film of the same name.
Reefer Madness 2.0 was promoted by the Daily Mail from 2003 onwards after cannabis was classified downwards to a class C drug. It was strongly supported by the Labour Party through home secretaries Jacqui Smith, Alan Johnson and prime minister Gordon Brown.
Reefer Madness 3.0 is its latest incarnation but this time it’s promoted by reform groups Transform, which has been around as long as CLEAR and Volteface, which is a new group funded by Paul Birch’s personal fortune. (Birch was also the founder of the now defunct Cannabis Is Safer Than Alcohol (CISTA) political party.) Despite the overwhelming body of scientific evidence and the facts of healthcare records which show that cannabis is an insignificant health problem, both Transform and Volteface argue that ‘cannabis is dangerous so it must be regulated’.
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This is nonsense. Cannabis is not dangerous, in fact for most people it’s beneficial. It’s prohibition and enforcement of the law against cannabis that are dangerous. Prohibition has caused far more harm than cannabis ever has or ever could. Cannabis needs to be regulated because prohibition is dangerous.
I’m very disappointed by the new, much-hyped Volteface report ‘Street Lottery’. It offers nothing new, either in information or in proposed solutions. It takes us no further on from Transform’s work in 2009 or CLEAR’s proposals from 2011. What it does is ramp up the unjustified scaremongering and panic about high THC and low CBD levels. It panders slavishly to the exaggerated studies on psychosis from the Institute of Psychiatry and wildly overstates the health harms that, in fact, only occur in a very small number of people.
That’s not to say that we shouldn’t do all we can to protect those very few people for whom cannabis can be a problem and we should certainly educate about harm reduction. The most important message is that the most dangerous thing about cannabis is mixing it with tobacco.
It’s worth saying that in my opinion, cannabis is a better product when it has higher levels of CBD than usually found in what’s generally available today. When I say better, I mean more pleasant for recreational use and more effective for medicinal use and it is the ratio of THC:CBD that is more important than the absolute levels. 10:1 THC:CBD is plenty adequate enough to provide the benefits of CBD, any higher that 3:1 and it begins to wipe out the benefits of THC. It certainly is true that younger people and novice users are best with higher levels of CBD.
Of course I understand that arguing for regulation as a means of reducing harm should encourage politicians towards reform. I’m all for that but we don’t have to exaggerate the health harms and overlook the massive social harms in order to do that. However, it’s blindingly obvious that decisions on drugs policy are not made rationally, so what’s the point? Our politicians have failed to act on cannabis law reform, despite the solution to the harms of the criminal market being obvious for more than 30 years. Ministers are completely disinterested in effective drugs policy. The truth about their attitude is best illustrated by the Psychoactive Substances Act. This disastrous legislation is regarded as a success because it has taken the sale of NPS off the high street and driven it underground. This is all that ministers care about. They have been seen to do something and these drugs are no longer so obviously available. They really don’t give a damn that use has increased, harms have multiplied and deaths are becoming increasingly common.
Where the Volteface report actually takes us backwards is its pandering to renewed reefer madness and vast exaggeration of the harms of cannabis.
Correct, cannabis can be harmful to a tiny minority of consumers. All the speculative studies from Robin Murray and his team at the Institute of Psychiatry, all the scaremongering hyperbole in what is presented as ‘scientific’ evidence, all the esoteric, statistical tricks that create alarming headlines – none of these can change the hard facts of how infinitesimal is the number of people whose health is genuinely impaired by cannabis.
It’s ‘young people’ that all the concern is about but in the last five years there has been an average of just 28 cases per year of cannabis-induced psychosis – a tragedy for the individuals but a problem that is irrelevant in public health terms: https://www.theyworkforyou.com/wrans/?id=2015-03-17.227980.h&s=drug
For the entire population the total number of finished admission episodes (FAE) for ‘mental and behavioural problems due to use of cannabinoids’ in 2015 – 16 was 1606. A very long way from a problem of huge significance and you don’t be have to be an expert to realise that a very large proportion of those are due to ‘Spice’, suynthtrci cannabinoids which can have severe health effects.
For GP and community health treatment, Public Health England’s own data shows that 89% of under-18s in treatment are coerced into it, only in 11% of cases does the patient themselves or their families believe they need it: See table 2.4.1 http://www.nta.nhs.uk/uploads/young-peoples-statistics-from-the-ndtms-1-april-2015-to-31-march-2016.pdf
I welcome any new entrant to the drugs policy reform movement. We need all the help we can get but all Volteface has done since its inception is repeat the work already done by other groups. Now it is pursuing the same flawed and misguided route as Transform. It’s worth repeating – cannabis doesn’t need to be regulated because it is dangerous, it isn’t, cannabis needs to regulated because prohibition is dangerous.
US Surgeon General Joycelyn Elders
Note that this mythical ‘mental health crisis’ only seems to exist in the UK. It doesn’t exist in the rest of Europe, the USA, Israel or other jurisdictions where cannabis is legally avalable. Note also that former US Surgeon General Joycelyn Elders is published in the November edition of the American Journal of Public Health saying “The unjust prohibition of marijuana has done more damage to public health than has marijuana itself.”
The valuable contribution Volteface has made so far to cannabis law reform is the money it has spent on professional media relations. This has elevated the subject up the news agenda and that is a very good thing indeed. Everyone, cannabis consumers and those who don’t have the slightest interest, will benefit from legalisation. The sooner we get on with it the better. A legal, regulated market will help protect the few dozen children and few hundred adults who are vulnerable to possible health harms. Much, much more important it will halt the enormous harm that prohibition causes.
Why Is CLEAR Supporting Lord Monson In His Campaign Against So-Called ‘Skunk’?
Lord Nicholas Monson
CLEAR’s first and overriding objective is to end the prohibition of cannabis. The tragedies that have struck the Monson family demonstrate all too clearly that prohibition of cannabis is futile. Not only does it not protect people from harm, it actually maximises the harms and dangers of the cannabis market.
Nicholas Monson’s eldest son, Alexander, was arrested in Kenya in 2012. allegedly for smoking cannabis. Toxicology reports found no evidence of cannabis in his system. According to both a government and an independent pathologist he died from a fatal blow to the back of his head while in police custody. Clearly, it was the law against cannabis that led directly to Alexander’s death.
Nicholas Monson with his son Rupert
Just three months ago, Rupert, Nicholas Monson’s younger son, took his own life after a descent into depression and psychosis in which the excessive consumption of so-called ‘skunk’ was clearly a significant factor. Rupert himself said that he was addicted and there is good evidence to show that cannabis without CBD is more addictive. It is well established from research as far back as the early 1990s that approx 9% of regular users develop dependence which produces real physical withdrawal symptoms: insomnia, lack of appetite and irritability, sometimes a headache. For most people these are easily overcome within a week or so but not for everyone. Most importantly though, cannabis in the early 1990s contained, on average, half to a third as much THC as it does now and always a healthy buffer of CBD. The addictiveness of so-called ‘skunk’ with zero or very little CBD, is several times greater than the cannabis available 20 to 30 years ago.
It’s important to add that Rupert was also very badly failed by the dire state of mental health services. Surrey and Borders Partnership NHS Foundation Trust, a specialist provider of mental health and drug treatment services said that he needed to be admitted but a bed was not available. It was just a few days later that he committed suicide.
Nicholas Monson has called for so-called ‘skunk’ to be made a class A drug but also for lower potency cannabis, with a maximum THC:CBD ratio of 3:1 to be made legally available through a regulated system. Theresa May wrote to him after reading coverage of the story in the press. She expressed her sympathy and said how she shared his concerns. Importantly, she suggested that Lord Monson prepare a paper and a presentation to the Home Office on his proposals. This is a tremendous opportunity towards introducing measures that will better protect vulnerable people like Rupert and also for wider reform of the cannabis laws that will reduce all the harms presently caused by prohibition. Cannabis would be purchased from government licensed outlets just like alcohol and the aim would be to collapse the criminal market just like the market in dangerous, ‘moonshine’ whisky.
CLEAR does not agree that raising so-called ‘skunk’ to class A would be an effective measure. It would be virtually impossible to enforce, requiring a massive increase in laboratory testing of cannabis and the supply of high potency varieties would simply be pushed underground. The price will go up and all the harms of a criminal market will be increased. All the evidence is that drug classification or penalties have absolutely no effect whatsoever on consumption. However, Lord Monson suggests that all personal cannabis possession should be decriminalised and police would focus only on dealers in so-called ‘skunk’. There is a very strong argument that with high quality cannabis available legally, people would turn away from the black market.
Of course, we support the idea of legally available cannabis with a maximum THC:CBD ratio of 3:1. This could be the basis of a system that could work very successfully. The product would be available only through a limited number of licensed outlets to adults only. It would be supplied in appropriate packaging with detailed labelling of contents. Possession of any cannabis not in this packaging would be reasonable grounds for it to be seized and tested.
Lord Nicholas Monson, Peter Reynolds
This will, of course, provoke outrage amongst many cannabis consumers, particularly those who grow their own but it would be fantastic progress. It would usher in a far more rational, sensible regime where we could establish real data about harms and risks. If appropriate, this could lead to the regulation of higher potency varieties. Of course, we recognise that for medical use, a completely different approach to cannabinoid content is required and much higher potency may be necessary in some instances.
CLEAR is in the business of reform and this is the most likely path to reform that has ever emerged in the UK. We are not in the business of promoting a cannabis market which enthusiasts and connoisseurs would regard as some sort of utopia. The only purpose of any drugs policy must be to reduce harm and this proposal, if implemented, would massively reduce all the social harms caused by prohibition and reduce the risk of health harms.
Finally, it has to be said that, in typical fashion, a substantial part of the cannabis community has reacted in almost hysterical anger to Lord Monson’s proposals. The only effect of such behaviour is to hold back reform. We have been horrified and disgusted at the abuse directed at the Monson family. It has shown cannabis consumers in the very worst light and demonstrated that some are so stupid that they damage the very cause they seek to advocate. Nicholas Monson is a grieving father who, despite his agony, has seen the rational way forward and lent his energy and commitment towards reform that will benefit everyone. We stand alongside him and we urge all cannabis consumers to consider these ideas carefully – and please, lend us your support!
Lord Nicholas Monson adds:
“The motivation for my campaign is to protect the young and vulnerable in particular from ingesting any substance whose contents can have a deleterious short or long term effect on their minds. To watch one’s son spiral into psychosis from a heavy usage of skunk is distressing to behold. Rupert’s psychiatric team put his psychosis down to skunk. This is unequivocal. Yes there are other psychoactive drugs around but skunk is what did for Rupert. It so happens that the remedy for skunk is a legalised and regulated market in cannabis where clear information is available. This should be applauded by the recreational cannabis community. Separately I have long supported the medical community’s initiatives to prescribe variants of cannabis with high CBD for people suffering from a wide variety of conditions.”
Lord Monson and CLEAR to Campaign for a Regulated Cannabis Market.
Lord Nicholas Monson, Peter Reynolds
Lord Nicholas Monson, whose son Rupert committed suicide after he had become psychotic from ‘skunk’, has teamed up with CLEAR Cannabis Law Reform to campaign for a safer, regulated cannabis market.
‘Skunk’ is a form of cannabis with zero or very little CBD that can be harmful to young people and the vulnerable. The criminal market has driven the production of ‘skunk’ with high levels of THC, the psychoactive compound and low levels of CBD, the protective, anti-psychotic compound. The absence of regulation and control has also led to sales of highly dangerous products such as ‘Spice’ which contain an extremely potent, synthetic form of THC without any balancing CBD.
Lord Monson says:
“It is urgent that the government takes the historic step of legalising and regulating more traditional forms of cannabis and puts severe penalties in place for those dealing in skunk.”
CLEAR Cannabis Law Reform is the UK’s largest and longest established drugs policy reform group. It campaigns for medicinal cannabis on prescription by doctors and a regulated market for adults.
Peter Reynolds, president of CLEAR, says:
“We are honoured to work alongside Lord Monson towards a safer cannabis market that will reduce harm instead of the present policy that maximises all harms. Just like the policy that President Trudeau is introducing in Canada and already exists across much of the USA, we must rigorously restrict access by children and those with developing brains and ensure that safe, properly regulated cannabis with a good proportion of CBD is available for adults.”
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.
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/
Even The Guardian Is Now On The ‘Skunk Scaremongering’ Bandwagon.
Read The Guardian’s Editorial Here
In the last couple of years, even the Daily Mail has shifted its stance on cannabis as it sees opportunities to sensationalise ‘miracle cures’ from medicinal use – the epileptic child now smiling, the cancer patient whose tumour has disappeared. Truth and balance are irrelevant when a dramatic headline is all you’re after.
The Daily Telegraph has become the new home of ‘reefer madness’ with bad science, nasty prejudice and booze-fuelled fear of a safer recreational drug threatening the massive profits of the alcohol industry.
Now, even the Guardian jumps on the ‘skunk scaremongering’ bandwagon with the exaggerated claim that “the risks of heavy teenage cannabis consumption should frighten all of us”. In a backhanded editorial it suggests legalisation because cannabis is dangerous. It claims the consequences of cannabis “abuse are devastating. Psychotic breakdowns smash up lives and can lead to full-blown schizophrenia.” There is little evidence to support such hysteria. In reality, such effects are so rare as to be virtually unheard of and it’s impossible to prove they are caused by cannabis.
Of course we must protect young people, particularly from the high-THC/low-CBD ‘moonshine’ varieties that are a direct result of government policy. However, we cannot compromise facts and evidence for the illusory belief that buying into scare stories will somehow reduce harm. The only way to protect children is by legal regulation with mandatory age limits.
The Guardian makes much of Public Health England’s (PHE) figure that “there are more than 13,000 under-18s in treatment for the consequences of heavy cannabis use in England”. It neglects to mention that PHE also publishes more than 69% are referred by the criminal justice, education and social care systems while only 17% are referred from healthcare and just 11% by themselves or their family. Thus, more than two-thirds are receiving coercive treatment and only 11% actually consider they have a problem.
It is government propaganda that thousands of young people are suffering from mental health problems due to cannabis. Why is The Guardian promoting this myth? Last year, in answer to a Parliamentary question, Jane Ellison MP, minister of state at the Department of Health, revealed there have been average of just over 28 ‘finished admission episodes’ (FAE) for ‘cannabis-induced psychosis’ in young people for each of the past five years.
Of course, each of these 28 cases is a tragedy for the people involved and nothing must distract from that but it clearly shows that in public health terms, ‘cannabis psychosis’ is of negligible significance. To put it into perspective, there are an estimated 3,000 FAEs for peanut allergy each year but we don’t waste £500 million pa on futile law enforcement efforts to ban peanuts!
For 50 years, the Home Office has systematically misled and misinformed the British people about cannabis. Successive generations of young people know they have been lied to. Such dishonest health information is counterproductive. As a result, many children may think that heroin or crack are not as harmful as they have been told.
Cannabis is not harmless but neither is it ‘dangerous’. If you apply that description to it you also have to apply it to energy drinks, over-the-counter painkillers and hay fever remedies. Similarly, whatever scaremongering there is about ‘addiction’, the scientific evidence is that dependency amongst regular cannabis users is slightly less than caffeine dependency amongst regular coffee drinkers – and withdrawal symptoms are similar in nature and intensity.
What we need is evidence-based policy. Government needs to take responsibility for the £6 billion pa cannabis market instead of abandoning our young people and communities to street dealers and criminal gangs. The benefits to be gained from cannabis law reform are reduced health and social harms, massive public expenditure savings, increased tax revenue and proper protection for the vulnerable, including children.
References
Young people’s statistics from the National Drug Treatment Monitoring System (NDTMS), Public Health England, December 2015
Drugs: Young People. Department of Health written question – answered on 20th March 2015.
Relative Addictiveness of Drugs, Dr. Jack E. Henningfield, NIDA and Dr. Neal L. Benowitz, UCLA, 1994
