Posts Tagged ‘Epidiolex’
The Facts About CBD In The UK. April 2018.
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.
This is Paul Kenward, husband of Victoria Atkins MP who is the UK drugs minister. He grows cannabis for a living.
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:
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.
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.
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:
and “I do not share the optimism of others about tackling the problem through regulation.”
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 Man Who Smashed UK Cannabis Prohibition – And Looks Set To Do The Same In America.
Across social media, it’s ‘on message’ to despise Big Pharma and to promote the idea that government and pharmaceutical companies are engaged in the business of making people ill and feeding them with drugs in the pursuit of profit.
In the cannabis campaign, it’s virtually compulsory to abuse, defame and promote conspiracy theories about GW Pharmaceuticals, the world’s leading developer of cannabis-based medicines.
Now GW Pharma is hardly ‘Big Pharma’. It’s annual revenues for 2014 were £30 million. By contrast, Pfizer’s 2014 revenue was $50 billion. But such trifling facts are of no concern to the keyboard warriors and trolls that plague the cannabis campaign and bring it into disrepute every day.
In any case, I’m not sure whose message this is and why anyone buys into this hate-filled invective and unjust condemnation of an industry that has saved so many lives. Antibiotics, vaccines and, yes, chemotherapy products have saved or extended millions of lives. The most profitable pharmaceutical product of all time, Zantac (ranitidine), cures or prevents stomach ulcers and has prevented millions from having to undergo major surgery. Certainly, as in any industry, there have been mistakes, things have gone wrong and much could be improved but overall, the pharmaceutical industry is a huge force for good in our world.
Those engaged in these bitter, vindictive, online campaigns are largely sheep, ignorant of the facts and simply jumping on another hysterical bandwagon that they understand nothing about. They complain about the pursuit of profit and that money is being made from medicines and healthcare. It’s a strangely socialist and anti-business attitude, particularly as so much of it comes from America, supposedly the home of free enterprise where the maverick and outsider who triumphs against all the odds is usually revered.
Dr Geoffrey Guy, who founded GW Pharmaceuticals in 1998, is such a man. He has broken the UK government’s prohibition of cannabis by outwitting a regulatory process run by the Home Office and the Medicines and Healthcare Products Regulatory Agency (MHRA) that is corrupt, dishonest and denies scientific evidence. In my view, he deserves great admiration and should be seen as a hero by cannabis campaigners, not as the villain that he is often portrayed.
Now, both GW’s lead products, Sativex and Epidiolex, look set to gain FDA approval in the US. This will be a fantastic achievement for Dr Guy and all his colleagues. It’s also something that we Britons should be immensely proud about. Even though America is a very long way ahead of us in understanding and using cannabis as medicine, it is British science and expertise that is breaking down US federal prohibition. Soon most Americans will have state sanctioned access to medical marijuana but also the option for doctor-prescribed cannabinoid medicine of unparalleled quality and consistency.
Of course, for now GW Pharma stands against the use of raw herbal cannabis and at present that’s a rational business decision but I won’t be at all surprised if in future it moves into that market too. There are already unconfirmed rumours that GW is considering entering the CBD market.
This is a story of enormous courage, innovation and triumph against all the odds. It is in the finest tradition of British ingenuity and business skill. Since the Middle Ages we have led the world in engineering, science and technology. Geoffrey Guy is another world leader from Britain, this small island that has given birth to so many. Surely, at least a knighthood, possibly a Nobel prize must be coming his way soon. Even if the curmudgeonly, loud mouthed critics of today attack him, in future years he will be seen as a great pioneer of medicine and he will deserve his place in history.
UK’s ‘Cruel and Corrupt’ Medicinal Cannabis Policy Exposed By CNN’s Dr Sanjay Gupta.
This clip is from ‘Sanjay Gupta MD’, CNN’s regular medical affairs programme. It was broadcast on Saturday, 16th November 2013.
An hour-long documentary is to follow, probably in March 2014, when Dr Gupta will expose the terrible cruelty, hypocrisy, dishonesty and corruption which is UK policy on medicinal cannabis. The programme will investigate GW Pharmaceuticals and its cannabis medicines Sativex and Epidiolex. It will also feature Bedrocan and its grow facility in Holland and look in detail at the process CLEAR has developed which has so far enabled five members successfully to import medicinal cannabis to the UK.
Although the UK government claims that cannabis has“no medicinal value”, it has licensed GW Pharmaceuticals to grow massive quantities of the plant which it then processes into its hugely expensive medicines. The license, which was issued for research purposes only, was operated unlawfully between 2003, when Sativex became a commercial product, until March 2013 when the Home Secretary retrospectively legalised it.
Most CCGs refuse to provide Sativex because it is so expensive. A month’s prescription of Sativex costs the NHS £560.00. The equivalent from Bedrocan costs between £35.00 and £105.00 depending on which product is prescribed.
Successive governments have failed to act in the interests of British citizens. Ministers have refused even to consider a change in policy and have ignored or rejected all the efforts of CLEAR and other groups to present evidence and make a case on behalf of those who need cannabis as medicine.
Even though medicinal cannabis was the subject most often mentioned in the written evidence to the recent Home Affairs select committee drugs inquiry, it was ignored. No evidence was heard on the subject and no questions were asked.
Peter Reynolds, president and elected leader of CLEAR, commented:
“UK policy on medicinal cannabis is cruel and corrupt. While ministers refuse even to consider reform despite overwhelming scientific evidence, hundreds of thousands of British people persist in pain, suffering and disability which could be relieved by cannabis. The police are used as armed enforcers of GW Pharmaceuticals’ unlawful monopoly, arresting and even imprisoning sick people who are merely trying to improve their health. I want to thank Dr Gupta for his work. While he has travelled thousands of miles to tell this story, UK government ministers hide in their offices with their fingers in their ears.”















