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Peter Reynolds

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CLEAR Advises Department of Health and MHRA on Definition of Cannabis-Derived Medicinal Products.

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Last week, CLEAR was invited to participate in a teleconference with representatives of the Department of Health and Social Care (DHSC) and the Medicines and Healthcare products Regulatory Agency (MHRA).  This followed our written submissions made over the last few weeks.

The teleconference included two representatives from each party. The DHSC was represented by the Medicines Pharmacy and Industry section. The MHRA was represented by the Licensing Division.

CLEAR has now submitted a summary of all the advice offered which is reproduced below.

1. The definition of cannabis-derived medicinal products (CDMP) is for products that will be re-scheduled in the Misuse of Drugs Regulations out of schedule 1 and ostensibly into schedule 2.  These products will be available for prescription by doctors.

2. With the exception of Sativex, a whole plant cannabis extract with a THC:CBD ratio of 1:1, there are no cannabis-derived medicinal products available in the UK which have been licensed by the granting of a marketing authorisation (MA) or a Traditional Herbal Registration (THR). THR licensing is for minor ailments only that do not require the supervision of a doctor. MA licensing would be required for any CDMP aiming to treat most of the conditions for which cannabis is currently being used illicitly unless such CDMPs are prescribed as an unlicensed medicine.

3. In every other jurisdiction in the world where CDMPs are legally available, governments have recognised that licensing regimes designed to regulate single molecule pharmaceutical medicines synthesised in a lab are not suitable for regulating CDMPs. All such governments have either established entirely new cannabis regulators or created a specialist division within the existing medicines regulator.  If there is a genuine intent to enable legal access to CDMPs by the estimated one million people currently using illicit cannabis as medicine, this is the only practical route forwards. The cost and length of time involved in obtaining an MA makes them prohibitive for a plant-based medicine. Given the experience of using cannabis as medicine over many millennia, its non-toxic nature and very low risk profile, the rigorous approach of an MA is unnecessary.

Recommendation 1. A CDMP regulator should be established encompassing genuine expertise in the use of cannabis as medicine. The Cannabis Trades Association UK (CTA) is already in the process of developing the Cannabis Products Directive (CPD) in co-operation with the MHRA and FSA.

4. There is no justification or evidence that can support cannabis being in such a restrictive schedule as schedule 2 alongside opioids and cocaine.  The potential for causing social harm, which is the criterion used to determine the correct schedule, is several orders of magnitude greater with all existing schedule 2 drugs. They are all demonstrated to produce far higher levels of problematic dependence and long-term health harms than cannabis.

Recommendation 2. CDMPs should be re-scheduled into schedule 4 alongside Sativex.

5. The primary objective of the definition should be to ensure that the products are safe. Cannabis is non-toxic with no practical lethal dose and any harmful health or social effects are only likely with sustained and abusive use. In normal, moderate and especially medical use the potential for any harm is extremely low, certainly no higher than with common over-the-counter medicines. The main safety considerations are therefore the risk of contamination during cultivation and in subsequent processes such as extraction and refinement of oils, arising from the use of pesticides, herbicides, nutrients and solvents.

6. The definition should be wide enough to encompass all cannabis products that are produced to specified quality standards. It should not be so narrow as to prohibit high THC and/or low CBD products that may well be appropriate in individual circumstances. Prescribing guidelines should be issued to enable doctors to make appropriate clinical judgements on appropriate THC:CBD ratios for different conditions. These guidelines must be compiled by experts in the use of cannabis as medicine, not by the ‘non-experts’ who have been appointed to the expert panel on cannabis-derived medicine.  FOI Requests have revealed that none of the members of the panel have any knowledge, experience or expertise in the use of cannabis as medicine.

7. The definition should be wide enough to provide for a future in which doctors can vary THC:CBD ratios and terpene content in accordance with evidence for therapeutic effect. For example, in paediatric epilepsy, CBD has been shown to be the most important compound but some children require a small percentage of THC for it to become effective.  Doctors should be free to vary dosage in the same way as they do with many licensed medicines in accordance with the way the patient responds.

8. Regulators/authorities will properly require some independent assessment of the safety of products as defined above. The only such assessments currently available are Good Manufacturing Practice (GMP) and certification by the Cannabis Trades Association UK (CTA). By definition, these certifications are only available for products that are legally available and CTA only operates within the UK where only exempt, low-THC products (known as CBD products) are legally available. GMP certification is available on some cannabis products legally available outside the UK.

9. Cannabis consists of around 500 molecules including approx. 110 cannabinoids, 120 terpenes and 20 flavonoids which provide the important therapeutic effects, most effectively, when working together in what is known as ‘the entourage effect’. The most significant cannabinoids are believed to be THC and CBD. THC has long been demonised as the principal psychoactive component but it has very important therapeutic effects, notably as an analgesic, an anti-spasmodic and an appetite stimulant. CBD works as an analgesic, anti-inflammatory, anxiolytic and anti-psychotic.  It is beyond doubt that they work best together as they enhance each other’s positive effects and ameliorate any side effects. It is vital that cannabis for medical use contains a balance of both.  In some conditions, THC is more important than CBD and in others the reverse will be the case. We recommend that for medical use the ratio of THC:CBD should ideally not be less than 10:1.  This will protect against any negative effects of THC which a very small proportion of patients may be vulnerable to. In most instances, for medical use, the ideal THC:CBD ratio will be 1:1. Doctors should however be free to prescribe outside these parameters including high THC and high CBD products, subject to prescribing guidelines.

Recommendation 3. The definition of CDMPs should be primarily concerned with safety in the production process. CDMPs should have either a. GMP certification b. CTA certification c. an existing MA d. an existing THR. The composition and cannabinoid ratios of CDMPs should be a matter for determination by doctors in accordance with prescribing guidelines.

Recommendation 4. Prescribing guidelines for CDMPs should be developed by experts in the use of cannabis as medicine, not by the ‘non-experts’ who have been appointed to the expert panel on cannabis-derived medicine. 

10. Cannabis has traditionally been smoked and millions of people have gained great benefit from it over many centuries. The principal benefits of smoking, which are extremely important, without any of the negative effects, can now be achieved through vaporising. The benefits are rapid onset of therapeutic effect and accurate self-titration of dose.  When ingested, either through the GI system or absorbed through the mucus membranes, onset is much slower, the effect is prolonged and accurate titration is very difficult to achieve. Vaporisers are already in widespread use and a variety of different types are available.  The Storz and Bickel ‘Volcano’ has a CE mark and is a licensed medical device in Canada and Israel. The Teva Pharma ‘Syqe’  has completed three clinical trials with positive outcomes for safety and efficacy.

11. Vaporised, pharmaceutical-quality, standardised herbal cannabis with consistent cannabinoid and terpene levels is the gold standard in the use of cannabis as medicine.  Presently the only way to achieve this in Europe is with GMP-certified cannabis produced by Bedrocan BV, the Netherlands government officially contracted producer.  Some Canadian producers are also GMP certified.

Recommendation 5. Vaporisers should be made available on loan, for subsidised purchase or free-of-charge in accordance with existing provision for those in receipt of benefits.

12. The DHSC should prevail on GW Pharmaceuticals to reconsider its pricing strategy on Sativex which is presently under a ‘do not prescribe’ edict from NICE on the grounds that it is not cost-effective. The price of Sativex is extraordinarily high and products which, for all practical considerations of safety and efficacy, are identical are available over-the-counter for one-tenth of the price in US cannabis dispensaries. There is no justification for the price of Sativex except for the recovery of the cost of clinical trials which GW Pharma was required to engage in in order to obtain a marketing authorisation.  GW Pharmaceuticals should also be encouraged to make herbal cannabis products available as an alternative to Bedrocan, something it should be able to achieve within a few months with little difficulty.

13. Cannabis extracts and oils will be required for some patients, particularly children, and those that cannot or do not wish to use inhalation via a vaporiser.  Prescribing guidelines must recognise that the pharmacology of cannabis is totally different when ingested through the GI system or absorbed through the mucus membranes.  Absorption of oil through suppositories has also been found to a valuable method of ingestion.

14. While CLEAR fully supports decriminalisation of domestic cultivation of cannabis for personal use, homegrown cannabis should never be considered part of a therapeutic programme under the supervision of medical professionals.  The potential for contamination and poor quality is far too high.

Recommendation 6. In the short term, aside from low-THC exempt products known as CBD products, the only CDMPs readily available are from GW Pharmaceuticals, Bedrocan BV or Canadian producers, notably Tilray. Standardised herbal cannabis for vaporising or oils for other methods of ingestion should be available from these producers immediately.

15. Originally Nick Hurd MP, the Home Office minister, wrote in The Times, 29th June 2018, that cannabis would be rescheduled and could be prescribed by GPs whenever a benefit could be identified. Without any explanation that now appears to have morphed into ‘specialist’ or ‘senior’ clinicians and only in cases of ‘exceptional clinical need’.  As well as a broken promise which is causing widespread consternation, this is irrational, as are suggestions that cannabis should be regarded as a medicine of last resort.  The safety profile of cannabis is such that any rational, evidence-based policy would suggest cannabis as a medicine well before many analgesics, anxiolytics and anti-depressants which are widely, readily and regularly prescribed by doctors without any concern.

16. A workable definition of CDMPs together with well-informed prescribing guidelines that enable prescription by GPs for any condition where a benefit is identified is essential. Unless this is satisfactorily achieved, the one million people in the UK currently using cannabis as medicine will continue to do outside the law, outside any form of medicines regulation and without any medical supervision.  The likelihood is that this cohort of patients will continue to expand rapidly as knowledge of the therapeutic benefits of cannabis and its use in other countries becomes more widespread. The implications of failing to establish a proper regime are very significant for health, patient-doctor relationships, the criminal market in cannabis, the police and the criminal justice system. This is a nettle that must be grasped.

Recommendation 7. CDMPs should be available in accordance with the Home Office’s initial commitment, that is on prescription by GPs for any condition where a benefit can be identified

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Sainsbury’s Now Stocking Legal Cannabis Products As UK Policy Looks Increasingly Shambolic.

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In another demonstration of how fast attitudes are changing, Love Hemp water containing soluble CBD cannabis extract is now on sale in a number of Sainsbury’s stores.

This is a remarkable achievement by the team at Love Hemp who are remaining tight lipped about the terms of the deal.  A store manager told me that the product is on test in about 100 stores.

Cannabis prohibition is crumbling and the Home Office seems increasingly our of touch with reality with its futile attempts to enforce a policy which nobody is taking any notice of.  The real effect of the medical reforms should become clear within the next few weeks.  The expert panel process has been revealed as little more than a farce.  We still have an outstanding FOI Request on the issue but interim responses seem to confirm that not a single member of the panel, so-called ‘experts’ has any knowledge, experience or expertise in the use of cannabis as medicine.

We await the definition of a cannabis-based product which will determine which products will be re-scheduled and also a decision on who may prescribe.  Initial overtures from the MHRA to both CLEAR and the CTA to consult on these issues have come to nothing. It seems that little if anything has been achieved over the summer break.

Home Office licensing policy is also looking increasingly ridiculous.  It is refusing any licence application for low THC cultivation where any mention of CBD is made, while every other EU country is striding ahead and British CBD suppliers are having to import all their oil, which they do without any difficulty uner EU free movement rules.

A twist which reveals the absurdity of Home Office policy is that Love Hemp water, which is entirely THC free, is not the first cannabis product that Sainsbury’s has stocked.  For many years it has been stocking Good Hemp hempseed oil.  Recent lab tests have revealed that THC levels in Good Hemp oil exceed the 1mg limit in each bottle, meaning that it cannot be regarded as exempt under the Misuse of Drugs Regulations. In reality then Sainsbury’s is selling a product that is legally classified as a class B drug.

Written by Peter Reynolds

August 31, 2018 at 10:52 am

Cannabis Trades Association Receives Official Endorsement From the MHRA.

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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.

WARNING. CBD Flowers, Buds, Weed, Hash Are NOT Legal In The UK.

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This is an extremely serious warning which people need to take seriously.  Both CLEAR and the Cannabis Trades Association have independently dealt with several people who are being prosecuted for possession. The law treats these products exactly the same as any other cannabis. It makes no difference what the THC level is, it is a class B drug and the penalty for possession is up to five years in jail and an unlimited fine.

The confusion arises because of the misunderstood idea that the legal limit for THC is a maximum of 0.2%.  This is the limit for a low THC cultivation licence for what is defined as industrial hemp – but you still need a licence!  Without the licence the law regards industrial hemp exactly the same as the highest THC cannabis that the tabloids would describe as ‘super strength skunk’.

Products ‘derived from’ industrial hemp such as CBD oil or hemp teas can be ‘exempt products’ but there is yet more confusion here.  The THC limit in these products is not 0.2% because, self-evidently, when you extract oil from a low THC cannabis plant you concentrate the THC.  The limit in these products is 1mg of THC per container.  It doesn’t matter how large or small the container is, the limit is 1mg.  That limit also applies to the other ‘controlled drug’ found in such products, cannabinol (CBN).  ‘Exempt products’ must not contain more than 1mg of THC and/or 1mg of CBN in any single container.  The law that defines this is the Misuse of Drugs Regulations 2001. 2.(1)(c).

There are a number of websites offering these products for sale and, notoriously, one particular shop in Portobello Road.  Whilst these sellers may well misunderstand the law, ignorance is no defence. It is almost inevitable that sooner or later one or more of these sellers will be prosecuted and go to jail.

An email seeking confirmation of the position from the Home Office was replied to as follows:

“Thank you for your email.

I can confirm that the leaves and flowers of the genus Cannabis are controlled and defined as cannabis as outlined in Section 37(1) of the Misuse of Drugs Act 1971

“cannabis” (except in the expression “cannabis resin”) means any plant of the genus cannabis or any part of any such plant (by whatever name designated) except that it does not include cannabis resin or any of the following products after separation from the rest of the plant, namely—
(a)mature stalk of any such plant,
(b)fibre produced from mature stalk of any such plant, and
(c)seed of any such plant;”.

Once the separation of the stalk and seeds from the plant has occurred it will not be defined as cannabis. This also extends to the fibre produced from the stalk.

Regards

Jill Frankham
Senior Compliance Officer
Drugs & Firearms Licensing Unit”

 

 

Written by Peter Reynolds

July 8, 2018 at 4:35 pm

Posted in Consumerism

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Let’s Nail the Home Office’s Latest Smokescreen About Medical Cannabis

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As the evidence and support for legal access to cannabis for medical use grows, so the Home Office adjusts and reframes its arguments in denial.

This should come as no surprise. The ‘hostile environment’ revealed by the Windrush scandal runs through the Home Office like a stick of rock. The culture of this department is defined by Theresa May and it reflects her character and personality. It is secretive, demands total control and micro management of everything it touches and whenever it is challenged it finds another excuse to maintain its iron rule. It is institutionally dishonest.

A Home Office spokeswoman said:

“We recognise that people with chronic pain and debilitating illnesses are looking to alleviate their symptoms. However, it is important that medicines are thoroughly tested to ensure they meet rigorous standards before being placed on the market, so doctors and patients are assured of their efficacy and safety.”

The truth is rather different. In every jurisdiction throughout the world where medicinal cannabis has been legally regulated, it is through a special system outside pharmaceutical medicines regulation. You cannot regulate a 500 molecule plant-based medicine in the same way as a single molecule synthesised in a lab.

Regulation by the MHRA is the final excuse, the last obstacle to a revolution in healthcare in the UK. We need an ‘Office of Medicinal Cannabis’ as there is in the Netherlands, or ‘Access to Cannabis for Medical Purposes Regulations’ as administered by Health Canada. Colorado has its ‘Medical Marijuana Registry Program’ and other US states have similar arrangements. Israel’s Ministry of Health has its ‘Medical Cannabis Unit’. In Australia, its equivalent of the MHRA, the Therapeutic Goods Administration, has established its own set of medical cannabis regulations.

Every other government that has recognised the enormous benefit that medicinal cannabis offers has come to the same conclusion: cannabis is a special case. It is far more complex but much, much safer than pharmaceutical products.

So next time you hear this, the last, lame excuse from a government ideologically opposed to this long overdue reform, treat it and them with the contempt they deserve. They prefer that people should continue in pain, suffering and disability than that they should do what science and medicine says is right.

Written by Peter Reynolds

May 16, 2018 at 1:46 pm

Legalising Cannabis WOULD NOT Save £900 Million. A More Realistic Figure Is £6.7 Billion.

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The £900 million figure being touted around by the Taxpayers’ Alliance as the savings that could be achieved from legalising cannabis is a massive underestimate and isn’t based on the sort of model that is currently being implemented in US states.

CLEAR commissioned independent research in 2011 which shows that a model in the UK simlar to that in Colorado would produce a net gain to the UK economy of around £6.7 billion pa and perhaps as high as £9.5 billion pa.

Ben Ramanauskas, who authored the Taxpayers’ Alliance report, has referenced the research we commissioned in his study but has only considered the savings and not the massive opportunities for additional tax revenue which arise from bringing a £6 billion market out of the black economy.

Full study available here: https://s3.eu-west-2.amazonaws.com/assets.clear-uk.org/taxukcan.pdf

Written by Peter Reynolds

May 14, 2018 at 10:14 am

The UK Government’s Latest Excuse About Medicinal Cannabis Is Yet Another Deception.

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Nick Hurd MP, Home Office Minister

Nick Hurd MP, the Home Office minister, said again this week that as far as any consideration of cannabis for medical use is concerned, the government will “await the outcome” of the report on cannabis due from the WHO in 2019 “before considering the next steps”.

In fact, the results of an FOI request show that the UK government has refused to take part in the WHO committee which will “review cannabis and cannabis-related substances on their potential to cause dependence, abuse and harm to health, and potential therapeutic applications”. This despite the WHO issuing a questionnaire to the Department of Health and Social Care “designed to gather information on the legitimate use, harmful use, status of national control and potential impact of international control”.

Aside from the obvious concerns this raises, it is quite extraordinary considering that the UK is the world’s largest producer and exporter of legal cannabis.

Fundamentally the government’s postion on cannabis for medical use hasn’t changed since 1971. Those who follow the Home Office’s statements will have noticed gradual changes but they all seek to reinforce the fundamental premise that cannabis is a dangerous drug of abuse with no therapeutic benefit.

Recent ‘adjustments’, shall we call them, of the official position have dealt with the now overwhelming weight of evidence that cannabis does have very real and significant medical value.  The response has been to caution that all medicines must go through the etablished system of testing for safety and efficacy.

This is a deception as well.  As CLEAR revealed at the beginning of 2018, in every jurisdiction throughout the world where medicinal cannabis has been legally regulated, it is through a special system outside pharmaceutical medicines regulation.

Theresa May is ideologically opposed to the use of cannabis as medicine, it’s as simple as that.  She won’t permit it to be properly considered, discussed or investigated and every time something forces a response, such as a parliamentary question or an enquiry even from a fellow Conservative MP, another deceptive excuse is conjured up.

Victoria Atkins MP, Theresa May MP. Both Have Family Interests In Cannabis For Medical Use.

CLEAR can further reveal that the Home Office’s public position on prospects for licensed cannabis medicnes is also a deception. The statement that has been published is “As happened in the case of Sativex, the Home Office will consider issuing a licence to enable trials of any new medicine…”  We can’t name names just yet but we now have first hand knowledge that at least one publicly-quoted company with established cannabis production facilities in two other G7 countries has been refused permission by the Home Office even to apply for a licence.

The UK government’s stance on cannabis becomes murkier and murkier the deeper you look.  The stench of corruption becomes overpowering when you consider that Theresa May’s husband’s company is the largest single shareholder in GW Pharmaceuticals and the husband of Victoria Atkins MP, the drugs minister, holds a licence to produce 45 acres of cannabis for medical use.

Written by Peter Reynolds

May 12, 2018 at 6:24 pm