CLEAR Advises Department of Health and MHRA on Definition of Cannabis-Derived Medicinal Products.
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
Nick Hurd MP, The Home Office And Their Massive Broken Promise On Medicinal Cannabis.
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’
Chuka Umunna Wants To Make Britain’s Failed Democracy Even More Dysfunctional.
Those 650 people in the House of Commons who earn fat salaries and enjoy very generous expense accounts have failed us beyond redemption. The huge opportunity that was Brexit, that we chose by referendum in the most fundamental exercise of democracy, has been destroyed by bickering, self-interest and incompetence.
I first walked into the Palace of Westminster in 1983 and since then, particularly in the last seven years, I have met and worked with many MPs from cabinet ministers to renegade backbenchers. Sadly, my conclusion is that with barely a handful of exceptions they are useless, mostly a waste of our time and money and more of an impediment to our peace and prosperity than anything else.
Our two party system, our archaic parliamentary procedures, our hopeless first-past-the-post voting mean that British democracy is not fit for purpose. It doesn’t benefit us, the people, it only serves those who work in the Westminster bubble. Yes, I include the parasite commentators, journalists, lobbyists and civil servants as well, where again I would make precious few exceptions.
Now Chuka Umunna, a politician who I have always disliked for his creepy, pious, virtue signalling personality, is whining about the exercise of true democracy in the Labour Party where unpopular MPs are being deselected by the party membership. He would prefer that the Blairite-dominated Parliamentary Labour Party of a few hundred members should override the half a million party members. He wants to see power placed firmly back in the hands of Labour’s MPs and let’s be clear, Blairite MPs are particularly heinous examples of the corrupt, self-serving waste of our time and money that I complain of.
He even calls party members “dogs” in a display of the most outrageous hypocrisy from a man who has been at the forefront of criticising other people’s language in the fake antisemitism row, the bickering over Brexit and the wildly exaggerated attacks on men and heterosexual culture. He is a pimp who whores out his own media profile for personal gain, irrespective of truth, justice, decency and least of all the electorate which pays his wages.
It is MPs who should more accurately be described as dogs, perhaps wolves, who prey on the electorate solely for their own purposes. The sooner these arrogant, out-of-touch animals from all parties are brought to heel the better. It’s trite to say that Guy Fawkes had the right idea but while I wouldn’t blow them all up (we should preserve the building at least!), I would sack them all tomorrow. I’d make them all stand for re-election under a proportional representation system and I’d ensure that any of them could be forced to stand again at any time at the behest of a significant number of their constituents. No system of democracy could be worse than what we have now. In fact, the British parliamentary system barely deserves the name.
Chuka Umunna, Theresa May, Margaret Hodge, Chris Grayling – yes, these are examples of MPs who I believe have no place at all in our system of government and there at least 600 others who come a very close second. Our Members of Parliament are a disgrace. They have let us all down again and again and the Brexit fiasco should be the final straw.
Review. Hydrology 9 Vaporiser.
The Hydrology 9 has reawakened my enthusiasm for vaporisers. It has its faults but overall this is a great machine and a real advance in vaporiser technology. It also has one nifty little feature that is very simple but makes a huge difference. It’s genius in fact and more of this later.
I’ve assessed it over about four weeks and all that remains is to see how well it lasts. This is an expensive machine at around £200.00 and if it packs up after a few months that isn’t going to be any good. I have high hopes though. Like all vaporisers it does need looking after and regular cleaning. The problem with some is that the dismantling and cleaning is what causes them to deteriorate.
The first and golden rule about vaporisers is that they all take practice before you learn to use them properly. Each one is different and until you get the ‘knack’ they can all seem very frustrating. The Hydrology 9 is no exception and it took me a week before it finally started working for me. As usual, I was at the point of giving up and then suddenly everything clicked. Another three weeks on and it’s become a very special friend, I am loving it!
Click to enlarge
The most dramatic effect of starting to use it regularly is that my consumption of cannabis has plummeted. What I would put in one neat joint fills the Hydrology 9 about six times over, far more than I want to consume in a whole evening. The quality of the high is much better as well, smoother, cleaner, fresher and, well, higher! If you’ve never really appreciated vaping before the breakthrough comes when you realise that half of the effect from smoking a joint is the carbon monoxide fugging up your brain. I’ll never stop smoking joints because I enjoy them and sometimes nothing else will do but vaporising has to be first choice.
It’s very well made. The water chamber isn’t entirely leak free but not so that it’s a problem as long as you keep it tightly closed at both ends. You load it at the bottom by unscrewing the bottom lid to reveal a small chamber. When you screw the lid back on there’s an outer revolving ring that operates a stirrer inside the chamber. This is the genius feature that I was referring to. It enables you to stir the weed while you’re actually vaping it, ensuring the hot air reaches all the way through and it’s thoroughly consumed. A simple but incredibly effective idea that I’m sure we will soon see on other vaporisers.
My only reservation is that I don’t think the battery is powerful enough. I have settled on using it at its fourth highest out of five heat settings. If it’s freshly charged then it will just about last for three or four fully-loaded chambers – but only just. You have to be careful to give it a rest before each inhalation. Go back on it too quickly and the heat will drop right off. Of course, you do get used to it and learn to adapt the way you operate it but I would definitely prefer a more powerful battery. This raises one other concern about its longevity. How long will the battery last and what will it cost to replace it? My favourite to date handheld vaporiser has been the Puri5 Magnum 2. My best investment with this has been to purchase three spare batteries and a mains charger. It’s very easy to swop an exhausted battery for a new one and I always have one fully charged on standby. This, perhaps with a more powerful battery is the only significant improvement I would like to see in the Hydrology 9.
Overall I rate the Hydrology 9 extremely highly and although I haven’t yet come to a final conclusion, it may well yet take the accolade of being my favourite ever vaporiser.
Sainsbury’s Now Stocking Legal Cannabis Products As UK Policy Looks Increasingly Shambolic.
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.
I Have Joined The Labour Party. #AndImATory
For some months now I have called myself a ‘Corbynista’. I am proud to back a man who demonstrates more integrity, courage, decency amd honour than almost every other Member of Parliament put together. Today, in the face of the ever-escalating smear campaign, the completely ludicrous and false allegations of antisemitism, the vile abuse of the BBC and the despicable right wing press, I have signed up to become a member of the Labour Party.
I remain a Tory because I believe in fundamental principles of individual liberty, individual responsibility, small goverment and free markets. I am not and never will be a socialist. I do not believe it is is right that the state should own the means of production and supply because this inevitably leads to complacency and inefficiency. Competition is a healthy motivation and inline with human nature. Socialism, in my view, is a delusion. It has never worked, anywhere in the world and it never will. However, I do consider that there are certain industries that are best owned by the state, those that are natural monopolies such as energy, water, the railways, the road system, the basic health service and basic communications and internet infrastructure. So I would support re-nationalisation of these industries.
I am unlikely to remain a member of the Labour Party forever. My reason for joining in the short term is to support Corbyn as the only decent leader in our country and because the overriding priority now is to bring down this corrupt, self-serving Conservative government. The Conservative Party is unfit for government. It has trashed the huge opportunity that Brexit offered by appalling, irresponsible infighting. It would be best if it simply disintegrated. It has brought shame on our nation and many, perhaps most, of its MPs simply disgust me with their venal and selfish behaviour. Mind you, I feel the same way about the treacherous, Blairite Labour MPs who have repeatedly stabbed Corbyn in the back. Chuka Ummuna, Chris Bryant, Margaret Hodge, Luciana Berger, Yvette Cooper, Harriet Harman and others – I put them in the same category as most Tory MPs – worthless.
It’s true, in the past five years I have belonged to the Liberal Democrat, Conservative and now Labour parties. I very much hope for the establishment of a new, centre-right, liberal and progressive party and I would join it in a flash. Some may find this difficult to understand but I am not a tribalist. I think tribalism is probably the most destructive force in politics. What drives me is principles first and policies second. Once we have got rid of the Conservatives, I shall become concerned with policies again and those will be in line with my fundamental Tory principles. I remain a true Tory, not the corrupt, self-serving, authoritarian example set by the diabolical Mrs May.
For now I am a member of the Labour Party and I will do all I can to see Jeremy Corbyn become our next prime minister.
The Victoria Derbyshire Show’s Next Interviewees Arrive At New Broadcasting House.
Future BBC policy will be to enable all interviewees to cover their face if they wish. Politicians and civil servants have expressed their gratitude.
In particular, several cabinet minsters have called for an immediate increase in the licence fee and for all BBC presenters to be elevated to the House of Lords. Victoria Derbyshire has been awarded a damehood for her courage in pioneering this new policy. ITV and Sky are expected to introduce similar provisions within the next few days.
Channel 4 is introducing an immediate ban on any interviewee who refuses to cover ther face.
