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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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Nick Hurd MP, The Home Office And Their Massive Broken Promise On Medicinal Cannabis.

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Nick Hurd MP, Home Office Minister

On 29th June 2018 in The Times newspaper, Nick Hurd MP, minister of state at the Home Office, published the following promise:

“If medicinal and therapeutic benefits are identified, the intention would be to reschedule cannabis-related medicine as a treatment available through GPs. Whilst recent cases in the media have involved epilepsy this would be open to patients suffering from all illnesses where such treatment is identified to benefit them.”

Source: ‘Out-of-date rules must not come before compassion for those who need medicinal cannabis’

Recently, including in response to a written parliamentary question on 7th September 2018, this promise has been dramatically broken and Mr Hurd’s message is now wholly different:

“The Home Secretary has confirmed that cannabis-derived medicinal products will be rescheduled. This means that senior clinicians will be able to prescribe the medicines to patients with an exceptional clinical need.”

Source: ‘Cannabis: Medical Treatments:Written question – 167359’

So ‘GPs’ has now become ‘senior clinicians’ and ‘open to patients suffering from all illnesses where such treatment is identified to benefit them.’ has become ‘exceptional clinical need’.  These are dramatic and far reaching changes which wholly change the nature of the promise made by Nick Hurd and will result in a highly restricted and limited regime making it very difficult for anyone to access cannabis as medicine.

This is a betrayal of the estimated one million people in the UK currently using cannabis to treat medical conditions.  It demonstrates how when this issue was in the headlines it provoked what was a sensible, measured and appropriate response. Now that the media storm has passed, in typical Home Office style, a totally different, hardline and repressive policy is being pushed through as quietly as possible.  No attempt has been made to explain why there has been such a dramatic change and it is quite clear that the Home Office hopes this will go through without attracting media attention.

CLEAR has submitted an FOI Request seeking a full explanation which can be seen here: ‘Provide full details concerning minister’s broken promise on the use of cannabis as medicine’

Written by Peter Reynolds

September 10, 2018 at 10:22 am

Posted in Health, Politics

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

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

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

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

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

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

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

Written by Peter Reynolds

July 26, 2018 at 5:57 pm

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.

An ‘Expert Panel’ On Medicinal Cannabis Without A Single Expert On It?

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Dr Michael McBride, Chair of the Cannabis-based Medicines Expert Panel

To be fair, the members of the expert panel are hardly a surprise.  It’s the medical establishment writ large.  The chairman, Dr John McBride, was, according to Charlotte Caldwell, “instrumental” in stopping Billy’s medicine being prescribed, despite the original prescription coming from a consultant neurologist specialising in paediatric epilepsy.

A government which has denied any medicinal value in cannabis for nearly 50 years needs ‘cover’ for its long overdue U-turn.  Surely though, there needs to be at least one member of the panel who has some expertise in the subject? It’s doubtful that any of the members have ever seen a vaporiser or could tell the difference between weed, hash and a concentrate. They’d probably just call them all ‘skunk’.

Professor Dame Sally Davies, Chief Medical Officer

The intention is probably to turn ‘medicinal cannabis’ into a pill or a bottle of medicine, a nice square peg that these bureaucrats can slot into their square hole. Such servants of the status quo are incapable of considering that modern medicine might have anything to learn from traditional, plant-based medicine that has been used successfully for millennia, instead of barely a century of the simplistic, reductionist theory that they represent.  Of course it shouldn’t be a matter of either/or, we should use the best of both theories because both have much to offer to the health of the nation.

It’s instructive that Professor Dame Sally Davies managed to find “overwhelming” evidence of the medicinal value of cannabis in about 24 hours flat. The evidence has been wilfuly ignored by every government and the self-serving individuals who have held the role of Home Secretary since 1971.

It’s astonishing though that in her review, delivered at lightning speed, she’s come up with this pejorative term “grown cannabis” yet seems enthusiastic about synthetic cannabinoids on which there is precious little clinical research and strong evidence of severe, even life-threatening side effects, totally different from the natural product.

Dame Sally writes: “Cannabis has many active chemicals and only cannabis or derivatives produced for medical use can be assumed to have the correct concentrations and ratios. Using other forms, such as grown or street cannabis, as medicine for therapeutic benefit is potentially dangerous.”

Where else does cannabis come from if it isn’t ‘grown’?  It has to be synthesised in a lab. Why on earth would Dame Sally want to go down that route when no other jurisdiction enabling legal access to medicinal cannabis has done so? Bedrocan products are grown specifically for medical use and standardisation of “correct concentrations and ratios” is exactly what the company is focused on.

This is a clash between two different approaches to medicine which, as I say should be regarded as complementary, not contradictory but we cannot possibly move forward if the only ‘experts’ have no expertise!

To be fair, this is all unfolding at breakneck speed.  Imagine Theresa May hovering in the wings, the hard line prohibitionist eager for any opportunity to kick this back into touch. As it stands, the expert panel will fail, it’s bound to.  We have to give Dame Sally a chance to adjust to the new reality.  With the assistance of Professor Mike Barnes, CLEAR will be keeping a close watch on progress and we will keep Dame Sally apprised.  We have already written to her twice this week setting out our concerns and we will do so on a regular basis.

 

 

 

 

Written by Peter Reynolds

July 5, 2018 at 7:06 pm

Dame Sally’s Caution On “Grown Cannabis” Does Not Bode Well For Access To Herbal Cannabis As Medicine.

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Professor Dame Sally Davies

Great news all round!  Professor Dame Sally Davies has, within a matter of days concluded that cannabis does have medicinal value and needs to be removed from schedule 1. No surprise really as the evidence is, as Dame Sally says, “overwhelming”. The simple fact is that our government has been deliberately ignoring it for years.

However, reading Dame Sally’s report yesterday I was immediately struck by her use of the term “grown cannabis” in a disparaging sense. I’m tempted to ask ‘where else does it come from?’ unless its synthetic and that is my second point of concern. I’m surprised by her apparent enthusiasm for synthetic cannabinoids on which there is precious little clinical research and strong evidence of severe, even life-threatening side effects, totally different from the natural product.

Professor Mike Barnes, CLEAR’s medical advisor, and I discussed the report this morning and while we both welcome it, we’re very concerned that access to raw herbal cannabis, specifically the Bedrocan product range, may continue to be refused.

In everything that I have learned over more than 30 years and great deal of practical experience working with patients, vaporised herbal cannabis is the gold standard for safety and efficacy.  Bedrocan products are available in almost every other country in Europe. They can be prescribed and dispensed in the UK tomorrow and if this route is denied to patients there will be uproar.  This is what patients want and need.

I defer to Mike Barnes in his expertise on the evidence but he agrees with me that vaporised herbal cannabis must be fundamental to the new arrangements.  Oils are obviously more suitable for children and some conditions in adults but children will not be the majority of patients needing access and the pharmacology and titration of cannabis when taken orally is very different and nowhere near as effective.

It would suit the medical establishment and the continuing, moralistic, prohibitionst lobby if cannabis for medicine was all about products which are “derived from” or “based on”, not the dried flowers from the plant which is what we must have if this reform is to succeed. If so, this will mean that many, perhaps most, people will prefer to continue in the illegal market and that, in my view, would be a failure of this process that we are now engaged in.

Written by Peter Reynolds

July 4, 2018 at 11:58 am

Nick Hurd MP, The Times. ‘Out-of-date rules must not come before compassion for those who need medicinal cannabis’

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Nick Hurd MP

This article by Nick Hurd MP, the Home Office Minister, is re-published from the Times of Friday, 29th June 2018.

It is the most significant recent government statement on cannabis.

 

 

 

 

Out-of-date rules must not come before compassion for those who need medicinal cannabis

There are times when life presents a situation for which the status quo is no longer viable; when the case for compassion stands in direct challenge to the rules of the day. This is perhaps no better illustrated than in the case of two young boys and their need for a medicine current legislation does not allow within the UK.

The laws restricting access to cannabis-related medicine in this country have stood for decades. The highly emotive cases of Alfie Dingley and Billy Caldwell have brought home the urgent need to reconsider those rules.

It is impossible not to feel huge empathy for parents expressing their desperation at the difficulty of accessing a treatment they consider essential to the health and wellbeing of their children. I am very aware that behind those high-profile cases stand other families and individuals experiencing the same frustration at the current restrictions.

The home secretary and I are in the process of reviewing the case for rescheduling cannabis-related medicine. This review will be evidence led and should be completed in the autumn.

If medicinal and therapeutic benefits are identified, the intention would be to reschedule cannabis-related medicine as a treatment available through GPs. Whilst recent cases in the media have involved epilepsy this would be open to patients suffering from all illnesses where such treatment is identified to benefit them.

While we await this review, we are confined to working within the existing rules which require a licence. I am delighted that we were able to issue one on behalf of Alfie Dingley — the first ever licence for the long-term treatment of an individual using cannabis-related medicine in the UK.

However, this process took too long and I want to thank Alfie’s family and the clinical team for their patience in working with us to reach this landmark.

We have also issued an emergency licence to treat Billy Caldwell at the request of his clinical team at Chelsea and Westminster Hospital. I have assured Ms Caldwell that Billy will continue to have access to the medicine should his medical team request it and have made clear that we will do what we can to facilitate a long-term licence application for Billy.

We have worked intensively to put in place a much better route for clinicians to secure licences on behalf of their patients until a decision is taken on rescheduling. An expert panel of clinicians will advise Ministers on individual applications. I want to reassure those involved that we are determined to strip this process of any unnecessary bureaucracy. As such, any application can expect to receive a final decision within two to four weeks.

We also want to remove anxiety on fees and are committed to urgently reviewing the fees paid for licences that are awarded as a result of the advice of the expert panel.

The bottom line is that we do not want people to suffer needlessly because of rules and processes that no longer feel fit for purpose.”

Written by Peter Reynolds

July 1, 2018 at 9:17 am