Posts Tagged ‘Medicines and Healthcare Products Regulatory Agency’
Cannabis Trades Association Receives Official Endorsement From the MHRA.
For nearly two years the Cannabis Trades Association (CTA) has been working with the Medicines and Healthcare products Regulatory Agency (MHRA), the Food Standards Agency (FSA), the Home Office, Trading Standards and other UK authorities to bring order and professional standards to the growing market in legal cannabis and CBD products.
The MHRA has now officially recognised CTA by inclusion in its Guidance Note 8 ‘A guide to what is a medicinal product’.
This is long overdue recognition for the CTA’s work which includes regular liaison with the authorities, providing guidance to businesses operating within the market on the law, regulations, professional and quality standards. The CTA with the MHRA and FSA is also in the process of developing the Cannabis Products Directive (CPD), a framework for regulation and licensing of all cannabis and cannabinoid products. CPD has been translated and submitted to all 28 member states of the EU by the European Food Safety Agency (EFSA). It is anticipated that CPD will become UK law within the next two years and will relieve the Home Office of the burden of the cannabis regulation and licensing process, placing it in expert hands.
The CTA was initially conceived at a meeting in Manchester Airport in September 2016. In November 2016, with the assistance of Crispin Blunt MP, then a member of the CLEAR Advisory Board, it was invited to an initial meeting with the MHRA to represent the emerging CBD industry. The market for legal, low-THC cannabis products derived from industrial hemp had grown rapidly within just a few months but was becoming out of control with a multitude of new companies making unlawful medical claims for their products, which themselves were totally unregulated and of inconsistent quality and unknown provenance.
Through negotiation and a growing relationship with the authorities, CTA was instrumental in bringing the market back from the brink of a serious clampdown. Now, with over 300 full members and more than 1200 registered sellers, CTA encompasses not just CBD suppliers but also licensed growers and producers of cannabis and businesses involved in the long term development of cannabis products.
CTA is closely involved in the rapidly developing reform of the laws around medical use of cannabis and will be working with the authorities to manage development of the products and systems required for what is expected to be a huge new market.
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.
Talking Cannabis With the MHRA
MHRA Headquarters
In November 2016 I organised a meeting with the Medicines and Healthcare products Regulatory Agency (MHRA) and a number of key players in the CBD market. It was in response to the MHRA seeking to clamp down on sales of CBD oil and related products. That meeting led directly to the formation of the Cannabis Trades Association UK (CTAUK) which now represents more than 80% by turnover of all CBD suppliers in the UK.
Since that first meeting my friend and colleague Mike Harlington has taken on the leadership role at CTAUK and I give him great credit for what has been achieved. We expect formal recognition by the MHRA is only a few weeks away and that is a tremendous coup. For the first time ever, in the face of total intransigence by government, we have established to a significant degree a legally regulated cannabis market. Clearly, it doesn’t yet go anywhere near far enough but this is the most concrete move ever towards long overdue cannabis law reform.
The first 18 months of CTAUK have not been easy. Other than the MHRA, the other branches of government concerned are the Food Standards Agency (FSA) and the Home Office. The FSA has also become a close working partner but, unsurprisingly, the Home Office remains difficult and our efforts to engage constructively with it have been characterised by responses that are inconsistent, irrational, contradictory and a realisation that it’s losing its grip on cannabis policy. It is impossible to deal with. In fact, I almost sympathise with the unfortunate civil servants charged with administering a policy that is itself irrational and contradictory and driven only by outdated prohibitionist values. Maladministration of the Misuse of Drugs Act is now a persistent reality and several legal challenges to the Home Office’s conduct are imminent. Soon the High Court will become involved in UK cannabis policy and then, in theory, facts and evidence should prevail rather than propaganda and government disinformation.
Dr Chris Jones
The CTAUK has been engaged in regular meetings with the MHRA and I was invited along for the most recent occasion. The CTAUK team was Mike Harlington, Tom Whettem of Canabidol and myself. The MHRA team was Dr Chris Jones, head of the Borderline Medicines section and Raj Gor. We discussed many administrative matters and gave a great deal of time again to discussing medicinal claims and how members could avoid mistakes. It seems obvious that no claims of medicinal benefit can be made but there are many instances where it’s not clear cut. A particular case we looked at was the use of ‘night’ and ‘day’ CBD products. Eventually it was agreed that this description is acceptable but only just. This is an excellent example of how CTAUK works to represent its members’ interests and with goodwill on both sides how positive agreement can be reached.
On a continuing, day-to-day basis CTAUK and MHRA are in constant touch, ironing out problems, asking for and taking advice from each other. I am impressed with the way the relationship has evolved and jointly we bring great benefit to the industry and consumers.
Misleading Parliament Again. Victoria Atkins, The Drugs Minister With A Family Cannabis Farm.
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.
The Facts About CBD In The UK. December 2016.
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.
CLEAR 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.
Crispin Blunt Asks Parliamentary Question On Medicinal Cannabis, 22nd November 2016.
Crispin Blunt MP
Q. To ask the Secretary of State for Health, whether (a) his Department and (b) the Medicine and Healthcare Products Regulatory Agency has reviewed the latest evidence, including evidence on different regulatory approaches in other jurisdictions, for the use of medical cannabis.
Nicola Blackwood MP. Minister Of State For Health
A. The Medicines and Healthcare products Regulatory Agency (MHRA) reviews evidence submitted by a company seeking a marketing authorisation for a medicinal product in the United Kingdom. One product containing extracts of cannabis, Sativex, has been licensed as a medicinal product by the MHRA. However, no such application has been received in respect of herbal cannabis, and therefore the MHRA has undertaken no review of the evidence for its medicinal use. Outwith the MHRA licensing process, the Department has not conducted or commissioned a review of herbal cannabis or its regulation in other jurisdictions.
MHRA Backtracking Super Fast On CBD Ban.
In advance of the meeting between the UK Cannabis Trade Association (UKCTA) and the MHRA on Thursday, there has been a flurry of activity which amounts to a climb down by the regulator.
This statement was published on the MHRA website at lunchtime today.
“Update 1 November 2016
An MHRA spokesperson said:
While MHRA has given its opinion that products containing cannabidiol (CBD) used for medical purposes are medicines, we have also carefully considered the needs of individuals using CBD products to treat or manage the symptoms of medical conditions.
Our primary concern is patient safety. In order to ensure that products remain available until individuals have the opportunity to discuss their treatment with their doctor, companies now have until 31 December 2016 to voluntarily operate within the law, by withdrawing their existing products from the market, or working with MHRA to satisfy the legal requirements of the Human Medicines Regulations 2012.
We have today written to the manufacturers of CBD to make them aware of the timeline for engagement.
It is vital that medicines meet safety, quality and efficacy standards to protect public health.”
Originally the MHRA wrote to CBD suppliers in threatening terms:
“You must cease to sell, supply, promote, advertise or process orders for the above products until appropriate authorisation has been granted for them. You must confirm this in writing within 28 days from the date of this letter that you have taken the above steps.”
So quite a change in tone. The MHRA seems to have recognised that contrary to its declared mission ‘to improve health’, its original statement actually endangered the health of tens of thousands of people.
Additionally, solicitors representing the UKCTA have now written to the MHRA seeking clarification of its intentions and making three crucial points:
- The letters to CBD suppliers and the MHRA’s original press statement have caused serious financial damage to the CBD industry.
- The MHRA has conducted no effective consultation with stakeholders.
- The MHRA’s own guidelines require it to consider each product on a case by case basis and a blanket ban on products containing CBD would be unlawful.
Professor Mike Barnes
Professor Mike Barnes, scientific and medical advisor to CLEAR, commented:
“The MHRA’s new stance is an improvement from their previous position. However, I cannot see any value in delaying only a few months. Some patients might be able to find an alternative medicine from their doctor but many people will have already tried alternative medications and found that CBD is the only satisfactory treatment for their condition. This is the case, for example, for children with epilepsy who will have almost certainly have been under the care of a specialist and tried available anticonvulsants and found that CBD is the only treatment that works for them. The MHRA does not seem to realise the impact of this arbitrary and rushed decision which will clearly be detrimental and potentially have very serious (and in some cases life threatening) implications for some people. The MHRA need to work with the manufacturers and the medical profession to determine the best way forward that both recognises that cannabis based products have medicinal value, and as such need proper trials of efficacy and safety, yet on the other hand does not place existing users at risk of harm”.
