Peter Reynolds

The life and times of Peter Reynolds

Posts Tagged ‘GW Pharmaceuticals

Cannabis Advocates Really Need To Stop Accusing Doctors of Being Bribed By Pharmaceutical Companies.

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There may well be some doctors who are corrupt and there are still, despite much improvement, serious questions over the relationship between pharma companies and doctors but the idea that every member of the Faculty of Pain Medicine who signed that letter to the Times is taking bribes is ridiculous.

The real reason is ignorance and that’s not an attack on doctors, it’s a reason.  They have been subject to the same relentless torrent of reefer madness propaganda from government and media as the rest of society.  They have been prevented even from learning about the endocannabinoid system by the authoritarian policy of prohibition and any doctor in the UK who has any experience of cannabis as medicine will have been in breach of professional ethics as well as the law.

CLEAR has been working with some of the very few enlightened doctors since way before the cause of cannabis as medicine became fashionable.  Working with members, their MPs and doctors, we have organised lobbying of ministers and MPs over more than the past 10 years. In several instances we had doctors, both GPs and consultants, contact the Home Office to enquire about obtaining a licence for a specific patient.  In at least three instances these doctors were then contacted by Home Office officials who warned them off using threats and intimidation.  Shocking but completely true.

It is and it always has been government – stupid, prejudiced, bigoted and self-opinionated politicians – who have prevented access to cannabis, even in the face of overwhelming evidence.  This means that there has been no education at all and doctors are as poorly informed as everyone else. They’re also, and understandably, worried, even scared.  They don’t understand cannabis, many will not even have heard of the endocannabinoid system and they are concerned about being sued, professionally disgraced, losing their job and now of being swamped by patients demanding cannabis about which they know nothing.

Of course, it was thoroughly stupid to assert in the letter that “the evidence suggests that the prescribing of cannabis (containing the psychoactive and addictive tetrahydrocannabinol component) will provide little or no long-term benefit in improving pain and may be associated with significant long-term adverse cognitive and mental-health detriment.”

There is no reasonable interpretation of the evidence that supports this. THC can be addictive in a very modest sense but the withdrawal symptoms and negative effects are trivial compared to those from opioids which doctors prescribe readily and frequently.  There is excellent evidence from many sources that cannabis containing THC and CBD benefits pain and while there may be some cognitive and mental health effects, to suggest they are significant or even come remotely close to those from opioids is false and in opposition to the evidence.

I repeat, doctors aren’t saying this because they are bribed by pharmaceutical companies, it’s because they have no idea what they are talking about.

The urgent requirement now is medical education.  It is amazing how radical the new regulations are and many people still don’t seem to realise how far the government has gone.  They go much further than we at CLEAR had even dared to dream and the definition of cannabis-derived medicinal product (CDMP) is very broad.  When we were consulted on it by the Department of Health and MHRA we never thought they would accept all our recommendations.  They enable the prescription of every form of cannabis, including flower, oil and concentrate, provided they meet quality standards.

So the problem with the law is gone. Literally, it is all over. It is absolute and total victory. Now two big problems remain. Education is the first but this is being addressed.  NICE has acted commendably fast to start recruiting a panel to advise on prescribing guidelines and Professor Mike Barnes, CLEAR’s scientific and medical advisor has already developed a series of introductory online training modules. Early in November his Medical Cannabis Clinicians Society launches and this will be an important forum for the future.

The second big problem is supply.  Where are the CDMPs to come from?  Sativex falls into the definition and this was GW Pharma’s big opportunity to act responsibly and imaginatively.  The possibility still exists that it will substantially reduce the absurd, rip-off price that it has been charging for Sativex since 2010.  If it had the imagination it could very easily turn over some of its production to unlicensed CDMPs for which there is now a ready market. I fear that it is wedded to licensed products only, hugely expensive and, in my judgement, unnecessary clinical trials and very high prices for its end products.  If so, then I will be selling my shares.  I admire the company for its courage, innovation and high standards but if it does not seize this opportunity then I believe it is failing in its duty to shareholders and also to Britain, which let’s remember has gifted it a privileged and unique opportunity in the world.  Fail now to provide for the needs of UK patients and that amounts to betrayal.

So for now the only possible sources of supply that meet the definition will be Bedrocan in the Netherlands and some of the Canadian licensed producers. US companies cannot export.  Neither can the Israeli companies and they would also face a thoroughly deserved boycott of their products even if Netanyahu was to issue export licences.  Bedrocan can barely meet demand from its existing customers and there is talk of it having difficulties with a ceiling on its export licenses. Only some Canadian producers meet the required GMP quality standards and they too are facing shortages as they also supply the recently legalised recreational market which is seriously short of product.

So the Home Office has to act and start issuing domestic production licences and it has to do so immediately.  Whether it will, remains to be seen.  Its drugs licensing department is a shambles, staffed by officials who do not even understand the law they are supposed to administrate, who regularly give different, contradictory answers on different days and exceed their lawful authority as a matter of course.  If there is a ‘hostile environment’ for immigration in the Home Office, for drugs licensing and cannabis production it has been hostile but also aggressive, paranoid and stupid ever since the Misuse of Drugs Act 1971.

The urgent need is for prospective British cannabis producers to mobilise their MPs and for immediate pressure to be brought on the Home Office at the highest level.  Sajid Javid has shown he can act decisively.  Expanding domestic cannabis production is the inevitable next step in what he has already achieved.  He must act now.

So the future in the UK for those who need cannabis as medicine is brighter than could ever have been imagined.  The next steps are challenging but nowhere near as difficult as the campaign to reform the law that CLEAR has fought for nearly 20 years.  Don’t blame doctors, continue to blame the government and hold their feet to the fire until they act on medical education and cannabis production as they must.

The Definition Of A Cannabis-Derived Medicinal Product Must Include Standardised Herbal Cannabis Or Sajid Javid’s Reform Will Fail.

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Bedrocan, the Netherlands government’s official producer, grows cannabis in which the cannabinoid and terpene content is standardised and consistent. It does this by very careful cultivation techniques which include clonal propagation, continuous analysis and gamma irradiation to eliminate contamination with potentially harmful microbes. Its production facility is Good Manufacturing Practice (GMP) certified.

With the exception of Sativex, which NICE has declared as not cost effective, the Bedrocan range offers the only medicinal cannabis products which could be readily available in the UK.  They are also available as oils extracted directly from the raw herbal flowers.

It’s very simple, unless Bedrocan products come within the definition of a ‘cannabis-derived medicinal product’, the very welcome reform announced today by Sajid Javid will fail and most people will have no option but to continue sourcing their medicine from the illegal market.

There is no doubt that the gold standard in safety, efficacy and self-titration is vaporised herbal cannabis of Bedrocan-standard quality.  Cannabis that is ingested as oil, either sub-lingually or through the gastrointestinal system, has a substantially different pharmacology and is very difficult to titrate accurately or to deliver its beneficial effects promptly.

Bedrocan provides an immediate solution.  GW Pharmaceuticals could also easily turn to providing a similar range of products.  One hopes that it could also be prevailed upon to reconsider its pricing of Sativex. It is essential however that new, domestic production facilities are established quickly.  Up to now the Home Office has rejected all efforts to set up such facilities, even applications from extremely reputable international businesses that already have licences elsewhere.  This policy must be immediately revised.

Dame Sally Davies advised that “only cannabis or derivatives produced for medical use can be assumed to have the correct concentrations and ratios”. The ACMD agreed with this, stating that “raw cannabis (including cannabis-based preparations) of unknown composition should not be given the status of medication.”  Bedrocan products fully comply with these requirements and it is essential that they are re-scheduled and made available on prescription.

Written by Peter Reynolds

July 26, 2018 at 5:57 pm

The Facts About CBD In The UK. April 2018.

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This article is an update to ‘The Facts About CBD In The UK. December 2016.

The past three years have seen a true phenomenon develop around the cannabis law reform movement which has quickly crossed into mainstream society, commerce and general awareness.  It’s the explosion of the CBD market, a trade that has grown from zero to £50 million per annum in the UK in this very short period.

There has been a great deal of nonsense published about the market, the products and their legality both under drugs laws, food and medicines regulation. The facts that are set out in this article are established from close involvement with the developing market on a daily basis as well as consultation with a number of lawyers of all types and levels of experience as well as direct contact with the Home Office, the Medicines and Healthcare products Regulatory Agency (MHRA), the Food Standards Agency (FSA) and other authorities.

The market has been driven initially because of growing interest in the medical benefits of cannabis and the recognition that, within certain constraints, products derived from low-THC cannabis, legally grown under licence as industrial hemp, are a legal alternative.  An important factor has been that CBD is most often consumed by placing a few drops of oil under the tongue. This has avoided the stigma of smoking a joint and is more in line with the way people perceive a medicine or health food.

The CBD market has also exposed the contradictions, inconsistencies and errors in the Misuse of Drugs legislation and particularly in the confused and inconsistent way in which the Home Office attempts to administer it. For instance, currently there are CBD products produced legally in other EU countries and the USA which can legally be sold in the UK but which the Home Office will not permit UK companies to produce.

Ironically, the most significant development has been that responsible CBD suppliers have moved away from claiming the sort of medical benefits that are, in fact, the reason for the market’s existence.  Although everyone knows this is why people are buying CBD, if you’re in the business of supplying the products you can’t say a thing, not even indirectly, about the medical benefits it offers.

18 months ago, all the leading and responsible suppliers of CBD products in the UK joined together to create their own trade association.  The Cannabis Trades Association UK (CTA UK) now represents 80% by turnover of all the CBD suppliers in the UK. It is governed by its members who have established a set of standards on products, labelling and marketing which all abide by.  These standards are designed to protect and inform consumers and to ensure that all CTA UK members are compliant with the law.

The formation of CTA UK was prompted by the MHRA issuing warnings to some suppliers about making medical claims for their products. To remain within the law, CBD products must be sold as food supplements and the most that can be said about them is that they help to improve and maintain health and wellbeing.  Before any product can be marketed with medicinal claims it must have a marketing authorisation from the MHRA. Food supplements must also comply with certain laws and regulations administered by the FSA.

CTA UK is now engaged in a continuous dialogue with both the MHRA and FSA.  Regular meetings are held to consider new suppliers and products entering the market to ensure they comply with the law, regulations and CTA UK standards.

When supplied by a CTA UK member, consumers can be certain that the product they are buying is 100% legal and is accurately labelled and described.  CBD is not a ’controlled drug’.  It does not appear in any of the classifications or schedules to the Misuse of Drugs Act 1971.

There is widespread misunderstanding about the 0.2% THC limit in industrial hemp.  This is the limit in the growing plant and is not relevant to CBD products.  Clearly what may be under 0.2% in the growing plant would be far higher in an extract which is, by definition, concentrated. The Misuse of Drugs Regulations 2001 make it clear that any product derived from low-THC cannabis grown legally under licence as industrial hemp is “exempt” provided it contains “not more than one milligram” of THC or CBN. This is the limit that matters. See The Misuse of Drugs Regulations 2001 ‘Interpretation’ 2-(1) (a)(b)(c)

Contrary to suggestions that the market is “in chaos”, “half-legal”, “a bit of a mess” and other spurious claims, in fact, it is a model of self-regulation where the industry itself has put aside its competitive instincts to co-operate for the benefit of consumers and in its own long term self-interest.

No suppliers will be admitted to membership of CTAUK unless they cease making medicinal claims, stop selling illegal products (for instance with high levels of THC, described as ‘indica’ or intended for pets or veterinary purposes).  Indeed, any suppliers that continue such conduct are likely to be subject to enforcement action by the MHRA and Trading Standards.

There are further changes or clarifications in the law relating to some CBD products which have emerged in the last few weeks.  These arise out of regulations from the FSA.  Isolates or pure CBD are now no longer permitted as they have been classified as ‘novel foods’.  This could mean a prison sentence of up to two years for anyone selling them.

It’s a myth, although regularly reported in the press, that there has been any change in the law or that CBD has been made legal or classified as a medicine. CBD products can already be prescribed by doctors without any restriction, just as any other food supplement. When the inevitable cannabis law reform takes place it will still be unlawful to make medicinal claims about any CBD or cannabis product without a marketing authorisation from the MHRA.

Within the next few months, the first CBD medicine will receive a marketing authorisation from the MHRA. Epidiolex, a whole plant extract, refined to deliver 98% CBD, is GW Pharmaceuticals’ second cannabis-derived prescription medicine which is intended for severe forms of paediatric epilepsy. It is not derived from industrial hemp but from high CBD strains of cannabis grown specifically for the purpose. It should be noted that this is to be administered in massive doses of up to 20 mg per day per kg of body weight,  CBD as a food supplement for adults has a maximum recommended dose of 200mg per day.

The CBD food supplement market will continue to grow.  Other medicines may be authorised in the near future, most likely under the MHRA’s Traditional Herbal Registration scheme, which will permit them to be described as medicines for minor ailments not requiring the supervision of a doctor.

Clearly, it remains urgent that our government gets to grips with the reality of the need and benefits of cannabis for medical use in the wider sense. However, even as we begin to make progress the CBD market in its present form will continue to fulfil an important need for many years to come.

 

 

 

 

Home Office Denies FOI Request In Cover-Up Of All Information On Cannabis Production Licences

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On 6th March 2018 CLEAR submitted a Freedom of Information Request to the Home Office asking for full details of the licences accounting for the legal production of cannabis in the UK.  This arose from the story which we broke on 4th March revealing that the UK is the world’s largest producer and exporter of legal cannabis, this according to data provided to the International Narcotics Control Board (INCB) by the government.

The Home Office has refused the request.  Its grounds for refusal are that disclosure “would, or would be likely to, prejudice the commercial interests of any person or would be likely to prejudice the prevention or detection of crime“.

Presumably this means that the commercial interest of GW Pharmaceuticals and whoever else has been granted such licences would be prejudiced and that they would risk robbery or other crime at their places of business.

INCB Production of Cannabis 2015-2016

We consider this to be false and without any merit whatsoever. How would it prejudice anyone’s commercial interest?  We would not expect any detail that goes behind the licence holder’s normal commercial confidence and it must be right that the identity of those companies or individuals licenced to produce cannabis should be on the public record together with outline information about the terms of the licence – what is it for, for what period, in what quantities.  Furthermore, with the security precautions required for such a licence, any attempt at crime would be foolhardy and utterly stupid.  It would be much easier either to import or produce your own cannabis.  The sort of criminal enterprise that would be required to raid, for instance, one of GW’s grows would be on a grand scale, incredibly risky and with sentences probably higher than for production of cannabis.

Clearly, disclosure of the information around these licences could, in any case, be limited to redact any specific information which should be kept confidential

It’s quite clear that this refusal is simply an excuse, probably to cover-up not only the extent of the licences but also the basis on which they have been issued.

Of course, the Home Office has pre-empted the next step in a FOI request and states that “the public interest falls in favour” of not providing this information.  We consider this to be nonsense.  It is clear that the public interest (not just the interest of the public) is very much that the issue of such licences should be a matter of public record.  It is outrageous that this information is being kept secret.

The answer to the second part of our FOI Request provides further insight into how little trust can be placed in the Home Office and demonstrates that its answers are dishonest.  In answer to a written question in Parliament on 1st March 2018, Home Office minster Nick Hurd MP said “No licences for pharmaceutical companies to grow and process medicinal cannabis for exportation to other countries have been issued.”  However the INCB report, which information can only have come from the Home Office, shows that in 2015/16 the UK exported 2.1 tons of medical cannabis.  We asked for an explanation of how Mr Hurd’s answer is consistent with the facts reported.

Nick Hurd MP, Home Office Minister

The Home Office’s answer is that “these figures could include any plant material exported for pharmaceutical purposes or pharmaceutical products containing cannabinoids that are manufactured in the UK and exported, such as Sativex.” and that it takes ‘medicinal cannabis’ to mean “substances produced to be consumed, be that smoked or ingested in any way.”

It is clear therefore that the Home Office has given two different answers to the same question and that the answer given to the INCB is correct whereas the answer given by Mr Hurd is without doubt intended to mislead Parliament.  It also seeks falsely to create a distinction between Sativex and other forms of cannabis which is manifestly and beyond doubt another deception, based on information published by GW Pharmaceuticals which CLEAR revealed in 2016.

In summary therefore, the Home Office has refused to answer the FOI Request in relation to licensing on grounds which are entirely spurious and has demonstrated that it is actively engaged in deceiving both Parliament and the public on the export of medicinal cannabis from the UK.

Following the required procedure, we have now requested an internal review of the Home Office’s handling of the FOI Request.  We argue that: “It goes directly to the question of the massive public demand for legal access to cannabis for medical use and the total denial of this by government. This policy is itself irrational and against the public interest and the refusal to disclose the information requested is a political cover-up.”

We anticipate this will be a whitewash and further attempt at a cover-up. Thereafter we have a right to complain to the Infomation Commissioner.  At this stage we would also seek to mobilise support from MPs with an interest in this area.  Ultimately, we may be able to apply to the High Court for judical review of the Home Office’s decision and we will consider mounting a crowdfunding campaign to enable this.

This is Paul Kenward, husband of Victoria Atkins MP who is the UK drugs minister. He grows cannabis for a living.

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Mr Kenward is managing director of British Sugar which grows cannabis under contract to GW Pharmaceuticals at its 45 acre greenhouse in Wissington, Norfolk.  As confirmed by British Sugar, the cannabis is for production of Epidiolex, GW’s epilepsy medicine which is understood to be 98% cannabidiol (CBD).

British Sugar website

Epidiolex is not yet licensed as a medicine although it is currently with the FDA for US approval and the European Medicines Agency for approval within the EU including the UK.  It’s unclear how the British Sugar operation can be legal as according to the Home Office it only issues licences for research purposes.  Only after the medicine has received a marketing authorisation could it be legally grown for commercial purposes.

This is Mrs Kenward, who prefers to be known by her maiden name of Atkins, in a recorded discussion with Kevin Sabet, America’s most notorious anti-cannabis campaigner who is fighting desperately to see the wave of legalisation in the USA reversed.

Victoria Atkins MP is now a junior Home Office minister with responsibility for drugs policy.  She has spoken out forcefully against any form of legalisation or regulation of cannabis in the UK.  She also rigidly maintains the government’s line that there is ‘no therapeutic value’ in cannabis.  Of course, when it comes to her husband she takes a different view and, of course, she has authority to see licences issued entirely on her own discretion.

Ms Atkins spoke about drugs regulation in Parliament in July 2017:

“We are talking about gun-toting criminals, who think nothing of shooting each other and the people who carry their drugs for them. What on earth does my hon. Friend think their reaction will be to the idea of drugs being regulated? Does he really think that these awful people are suddenly going to become law-abiding citizens?”

Isn’t it is her husband who is exactly the person she is talking about? He seems to be doing just fine as a “law-abiding citizen”.

Together with the Home Secretary, Amber Rudd MP, other cabinet minsters, including prime minister Theresa May, who was the previous Home Secretary, Ms Atkins is running a giant cannabis cartel.  As shown by the International Narcotics Control Board, the UK is in fact the world’s largest producer, stockist and exporter of ‘legal’ medical cannabis.

UK citizens are denied any access to medical cannabis at all, except in the form of another licensed GW product known as Sativex.  However, in practice, Sativex is virtually impossible to obtain.  It is believed that about one million UK citizens use cannabis illegally for medical purposes.

No, this is not a spoof article.  This story is so incredible and outrageous that you really couldn’t make it up.  Yes, the picture of Paul Kenward is photoshopped but all these facts are easily verifiable.

Misleading Parliament Again. Victoria Atkins, The Drugs Minister With A Family Cannabis Farm.

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She’s back!  Victoria Atkins MP is again engaged in answering parliamentary questions on cannabis for the UK government.  Clearly this is wholly improper when she directly benefits from commercial production of cannabis.

Ms Atkins disappeared from public view for a few weeks after CLEAR revealed that her husband is growing 45 acres of cannabis under government licence while she argues against drugs regulation in Parliament. It was particularly notable that she was absent from the House of Commons during the recent urgent question debate on a medical cannabis licence for Alfie Dingley.  Instead, her colleague Nick Hurd MP, ostensibly the Police Minister, was required to answer a question on drugs.  Similarly, she was nowhere to be seen as Paul Flynn MP’s bill came up for debate, which sadly, as CLEAR had predicted, never took place.

It is simply extraordinary that the so-called Drugs Minister should duck and dive out of view when such issues of massive public interest hit the headlines.  She has a massive conflict of interest and it is completely unacceptable for her to continue in her present role.

Yesterday, 7th March 2018, she answered a written question from Roger Godsiff, the Labour MP for Birmingham Hall Green.

“To ask the Secretary of State for the Home Department, if she will assess the health and economic benefits of legalising cannabis for medical use.”

Ms Atkins answered:

“The World Health Organization’s Expert Committee on Drug Dependence has committed to reviewing the scheduling of cannabis under the United Nation’s 1961 Convention. This is due to consider the therapeutic use, as well as dependence and the potential to abuse constituent parts of cannabis. This is due in 2019 and we will await the outcome of this report before considering the next steps.”

This answer is at best disingenuous and misleading.  Once the full facts are understood it is clear that it is deceptive and mendacious.

British Sugar’s giant greenhouse in Wissington, Norfolk where Victoria Atkins husband, Paul Kenward, grows cannabis

Ms Atkins husband, Paul Kenward, managing director of British Sugar, grows cannabis under contract to GW Pharmaceuticals for the production of medicine.  Ms Atkins deceit is predicated on another deception promoted by the UK government that is some way or another, Sativex, GW’s cannabis medicine is not cannabis.  GW is perfectly straightforward about this.  Sativex is a whole plant cannabis extract adjusted by simple blending of two different strains to deliver 1:1 ratio of THC:CBD.  It contains all the other cannabinoids, terpenes, flavonoids and other compounds present in the plants from which it is made.  The government deception is to justify the issue of a marketing authorisation (MA) for Sativex by the Medicines and Healthcare products Regulatory Agency (MHRA) which is itself a deception.  The MA was issued on the basis that Sativex is THC and CBD alone.  The MHRA conveniently overlooks the hundreds of other ingredients and calls them “unspecified impurities”. The consequence of this is that, ludicrously, Sativex is a schedule 4 drug whilst any other form of cannabis remains schedule 1 and may not be prescribed

But the plot thickens.  The deceit goes even deeper.  It has been widely reported and British Sugar confirms that its grow is not for Sativex but for production of Epidiolex, the 98% cannabidiol (CBD) medicine that has not yet received an MA.  If, as appears certain, this is the case then the British Sugar grow is unlawful under the declared policy of the government.  Cannabis production licences (other than low-THC industrial hemp) can only be issued for “research or other special purposes“. They most certainly cannot be issued for the production of a medicine that is not yet authorised.  Even if the British Sugar cannabis is low-THC, it is definitely not an approved EU industrial hemp strain and the purpose of its production is presently unlawful.

Ms Atkins through her husband is therefore engaged in the unlawful production of cannabis and is directly engaged in misleading Parliament as to government policy, the law and the medical value of cannabis.  The World Health Organization story is a trick, a distraction, an excuse to divert Parliament from understanding the truth.

Ms Atkins conduct cannot be described in any other way except as corrupt.  She is a disgrace as a minister of the Crown, to Parliament, to her profession as a barrister, to the Conservative Party, to her constituents in Louth and Horncastle and to the United Kingdom as a whole and all of its citizens.  She is manifestly unfit for any public office.

 

Victoria Atkins MP, The UK Drugs Minister, Opposes Drugs Regulation While Her Husband Grows 45 Acres of Cannabis Under Government Licence.

The UK’s New Princess Of Prohibition: Dishonesty, Hypocrisy, Corruption And Cruelty Behind A Pretty Face.

There are many examples of wilful ignorance, blind prejudice and bare faced dishonesty on drugs policy from many former and current MPs.  There is no one though who plumbs the depths of deception and hypocrisy as the new drugs minister Victoria Atkins.

Her recent performance in the Westminster Hall debate on drug consumption rooms (DCR) was riddled with inaccuracies, distorted information and downright falsehood about the success of such facilities throughout the world.  She simply told brazen untruths in order to support her rejection of the clamour from other MPs to introduce DCRs because they are proven to save lives.  I can do no better than Transform in explaining her behaviour. Its press release sets out her lies in detail.  Ronnie Cowan MP even raised a point of order and then a Home Office question about her scandalous dishonesty but as usual the government just brushed aside any criticism.

Victoria Atkins: Barrister, MP, Home Office Minister, Dishonest And Corrupt To The Core

Ms Atkins is the daughter of Sir Robert Atkins, a former Conservative MP and MEP.  She studied law at Cambridge and was called to the bar at Middle Temple in 1998. She has practised as a barrister and was formerly listed as a member of Red Lion Chambers.  She has been appointed to the Attorney General’s Regulators Panel and the Serious Fraud Office’s List of specialist fraud prosecutors.  She claims to have been involved in the prosecution of major, international, drugs gangs and that this, somehow or another, qualifies her as an expert in drugs policy.

I relate her background because it is clear that she is a highly intelligent, clever and well informed woman.  This makes her dishonesty, hypocrisy and corruption all the more serious and completely inexcusable.

Ms Atkins has replaced Sarah Newton as drugs minister.  Ms Newton didn’t last long, perhaps because she couldn’t stand the ridicule that she was subjected to for trying to hold the line on the government’s ridiculous drugs policy.  When she tried to claim that alcohol isn’t really that damaging compared to illicit drugs, she had MPs either gasping in amazement or chuckling in amusement.  Ms Atkins was clearly spotted for the job because she is one of the few MPs still enthusiastic about prohibition.

Paul Kenward, Victoria Atkins’s husband, grows cannabis under government licence

But of course, it’s specifically on cannabis that I must call Ms Atkins to account. Aside from the usual, hysterical and evidence-free claims that so-called ‘skunk’ cannabis is causing an enormous increase in mental illness, which she trots out repeatedly, she rejects any idea of regulation in drugs policy as a means of reducing harm.  In the drugs policy debate on 18th July 2017 (before she was appointed drugs minister) she said:

“We are talking about gun-toting criminals, who think nothing of shooting each other and the people who carry their drugs for them. What on earth does my hon. Friend think their reaction will be to the idea of drugs being regulated? Does he really think that these awful people are suddenly going to become law-abiding citizens?”

and “I do not share the optimism of others about tackling the problem through regulation.”

Paul Kenward’s Cannabis Greenhouse

However, in what must be the most blatant hypocrisy ever from a government minister, Ms Atkins benefits directly from regulation of drugs.  She is married to Paul Kenward, managing director of British Sugar which is growing 45 acres of cannabis under licence in its mammoth Norfolk greenhouse.  Mr Kenward is producing high CBD cannabis for use in Epidiolex, GW Pharma’s cannabis extract epilepsy medicine.  Ms Atkins has tried to brush this off calling it “…a very different substance (from the) psychoactive version of cannabis.”   Of course, anyone with even the most basic knowledge of plant science will know this is nonsense.  The difference between different strains of cannabis is the same as the difference between different varieties of tomatoes.  Whether they’re Ailsa Craig or Alicante, they’re all tomatoes.

With this latest scandal the shameful truth about UK drugs policy and the corrupt nature of this Conservative government is highlighted once again.  It is difficult to believe this bare faced dishonesty can prevail in a country that was once held up as an example of honour and decency but as with so much that Theresa May has been responsible for since she entered government in 2010, we are disgraced, shamed and the electorate is treated with absolute contempt.

 

The Facts About CBD In The UK. December 2016.

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On 3rd October 2016 the Medicines and Healthcare products Regulatory Agency (MHRA)  issued notices to a number of CBD suppliers stating that cannabidiol (CBD) was being designated as a medicine and that sale of all CBD products must stop within 28 days, ostensibly by the 1st November.

A lot has happened since.  Most importantly, the Cannabis Trades Association UK (CTAUK) has been established to represent the industry and protect the interests of CBD consumers but there remains great confusion as to the legal status of CBD and whether these products will still be available.  This article sets out the facts and explains how the market is likely to develop. The most important point is that there is no need for panic.  There will be some changes but no one will lose access to CBD for the foreseeable future.

Background

Through the summer of 2016, rumours and half stories had been swirling around about the MHRA taking action on CBD. When the news broke it caused real panic, both for the thousands of people using CBD products and for those working in CBD businesses.  It looked like a real disaster for everyone. On the one hand the government, through the MHRA, was finally recognising the truth that CBD and cannabis are medicine.  On the other, it seemed that the whole industry was going to be shut down, businesses would close, people would lose their jobs and, most importantly, those who rely on CBD products for maintaining their health were going to suffer real harm.  If CBD was going to be regulated as a medicine it would require the investment of hundreds of thousands of pounds to obtain the necessary authorisation to put any products on the market.

It quickly became clear that the MHRA was unprepared for the reaction it received. Its switchboard was swamped by worried callers.  Social media exploded with the inevitable Big Pharma conspiracy theories and even the national press covered the story demonstrating that medicinal cannabis is now an issue of mainstream interest.

ctauk-logoCLEAR took action to rally our friends and colleagues in the legitimate cannabis business and this led to the creation of CTAUK.  The same day the news broke we wrote to the MHRA notifying it of the formation of the trade association and seeking a meeting.

On 13th October, the MHRA issued a statement on its website explaining its actions.

CLEAR’s advisory board members, Professor Mike Barnes issued a statement to the media and Crispin Blunt MP wrote to Dr Ian Hudson, the chief executive of the MHRA.  Even the British Medical Journal covered the story.

On 19th October the MHRA finally confirmed a meeting with the CTAUK to take place on 3rd November.  On 21st October, Dr Ian Hudson replied to Crispin Blunt’s letter.  CTAUK appointed solicitors who in turn obtained counsel’s opinion and on 28th October a solicitor’s letter was sent to the MHRA formally objecting to its action. On 1st November the MHRA updated its statement on its website softening its position by claiming that its notices to CBD suppliers were merely its “opinion” that it should be designated as a medicine.

The meeting took place at MHRA headquarters on 3rd November.  It was cordial and constructive and on 16th November CTAUK wrote to the MHRA formally proposing a system for the regulation of CBD.  Essentially this suggests that CBD products with daily adult dosage of up to 200mg should continue to be marketed as a food supplement.  Products with a daily adult dosage of up to 600mg would require a Traditional Herbal Registration and higher dosage products would require a full Marketing Authorisation.  We await the MHRA’s response.

The MHRA has since written to CBD suppliers requiring them within seven days to provide samples of their products along with various information about them.  However, CTAUK has been able to negotiate that our members have until the end of January to comply.  This is excellent news and demonstrates recognition of the association by the MHRA.

Is CBD Legal In The UK?

Yes, CBD is not a controlled drug under the Misuse of Drugs Act 1971, neither is it covered by the Psychoactive Substances Act 2016.  As long as it is marketed as a food supplement without any medicinal claims it is perfectly legal to sell and to buy.

Is The MHRA Going To Ban CBD?

No, the MHRA will have to assess each product on its own merits, particularly taking into account how it is marketed and whether any claims of medicinal benefit have been made.

What Will Happen In the Future?

We hope that the MHRA will accept our proposals for a system of regulation, meaning that only the highest dose products, such as GW Pharma’s soon-to-be- released ‘Epidiolex’ will require a full Marketing Authorisation.  However, even if the MHRA tries to take formal action about any other products, this is going to take many months and probably a much as a year before anything changes.  We remain confident that we will come to an agreement that will enable everyone to continue to access CBD products.

Fast Developing News On CBD And Medicinal Cannabis.

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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.

lovehemp-oilWhat 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

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.

epidiolexThe 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

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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.

A copy of the Powerpoint presentation delivered by CLEAR at the oral evidence hearing can 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/