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Peter Reynolds

The life and times of Peter Reynolds

Posts Tagged ‘GW Pharmaceuticals

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.

 

 

 

 

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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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oil-dropper-green-bg

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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cbd-molecule-spoon-oil

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.