Posts Tagged ‘prescription’
There’s No Such Thing as ‘Medical Cannabis’
I am increasingly concerned about the ‘medical cannabis industry’ and its resistance to wider reform. These people, some of them at least, have forgotten very quickly who got them the business opportunity in the first place!
Of course, there is no such thing as ‘medical cannabis’. The more accurate language is ‘medicinal cannabis’ but the preferred term has to be ‘prescription cannabis’. It’s exactly the same product as is sold on ‘the streets’, grown in people’s lofts, in illicit ‘factories’ or in hugely expensive licensed facilities. Often, still, the ‘legal’ variety is of inferior quality.
There’s also no truth in the argument that prescription cannabis is safer or lower in THC. The vast majority of what is prescribed in the UK is what the media would call ‘skunk’. Unless you’re underage or smoking it with tobacco, it is safe, much safer than many other things in your kitchen cupboards.
These divisions in the cannabis sector, stoked by newcomers from the protectionist pharmaceutical industry will achieve nothing for anyone. We need a unified message on the benefits of cannabis. Whether it’s prescribed for chronic pain, anxiety, multiple sclerosis or whether it’s smoked in a spliff with the lights down and some psychedelic music on, it’s all about making you feel better.
This is the universal truth about cannabis.
Review. Kanabo VapePod
I’ve been intrigued to try this vaporiser ever since I first heard of it. Its stand-out feature, though not a unique claim, is that it accurately dispenses cannabis vapour, clearly an important facility for medical use. Perhaps what’s even more important is that it’s part of a package from Kanabo, newly quoted on the London Stock Exchange, alongside cartridges of different cannabinoid content. It’s the first credible, all-in-one prescription product for vaporised medicinal cannabis.
It doesn’t disappoint. The packaging looks just right to be sitting on a pharmacy shelf. There’s no silly cannabis branding. You couldn’t mistake this for a children’s toy or a stoner’s gizmo. It hits the spot precisely: functional, medical, professional. It’s going to inspire confidence from anyone, including a naive cannabis consumer, when they collect this from their pharmacy. It elevates the sometimes jokey level of medicinal cannabis products to where they need to be. It is perfectly judged.
The device itself is a bit fatter and a bit shorter than the standard vape pens that we all know. It’s a black plastic, octagonal tube with a translucent coloured mouthpiece. I think I prefer its thickness compared to standard vape pens but that may be the size of my hands. A woman might still prefer the thinner design.
I was provided with two cartridges which come in smaller boxes. They’re described as “Pure Distillate Hemp Extract” and I have the “Reload. Feels like a moment of clarity and focus” and the “Relax. Quiet your mind & find tranquility”. The difference between them is the blend of terpenes which are added back into the distillate once it’s been refined. Inside the box is what looks much the same as the small vape cartridges that we’re already used to, with the mouthpiece already attached. It really couldn’t be easier. You just drop the cartridge into the end of the tube and it’s ready to go. Equally you can just pull one cartridge out, it’s held in by a magnet and replace it with another. The only thing I’ve found to criticise so far is that there is no distinguishing mark on the cartridges so it’s impossible to tell them apart.
Of course, I’ve only been provided with the CBD cartridges. Where this product is really going to come into its own is when prescribed with cartridges that contain THC.
So to the crucial issue. How does it accurately dispense vapour, metered dosing as it is called? It’s a patent pending device, designed in Israel, where the only other metered dosing vape, as far as I know, the Syqe, also originates. It seems to work simply by limiting the duration of an inhalation to about two seconds. In the interests of testing it out, I did see if I could cheat it and it’s definitely the case that if you pull harder you inhale more vapour. Each inhalation is supposd to dispense 1.2mg of CBD, so I think you can increase this fairly easily but only within a narrow band. It’s no criticism. I’m impressed with the way this works and I only wish I could try it with a THC cartridge. But this is a new world now, in a good way. I can’t see Kanabo sending me a THC cartridge to try if it’s not prescribed and that is the way it should be really.
As for the contents of the cartridges themselves, they’re clearly quality products and I fervently hope that prescribers will have the option of specifying from a wide range of cartridges with different cannabinoid and terpene content.
With the sole exception that each cartridge needs labelling so you know which one you’re using, I can’t fault this. It’s the right idea, well executed and this is the future of medicinal cannabis as a serious medicine.
A Quick, Easy Guide to The New UK Arrangements For Access To Cannabis As Medicine.
There’s already an awful lot of misunderstanding over the arrangements just introduced for medicinal cannabis and there’s no need for it because, to be fair, the government has been very clear.
There is an interim procedure which will be very, very difficult for most to achieve. You must have very strong support from your doctor and they, together with your local NHS Trust, must be prepared to put in a lot of work, form-filling and pay some substantial licensing fees. It’s all explained here. If you don’t understand it, don’t worry. Your doctor will and it’s only if he/she is prepared to pursue this path for you that you have any chance at all.
There also seems to be an idea that there’s a list of conditions for which cannabis will be available. There’s no truth in this at all. It’s up to your doctor and if they pursue this interim procedure, they will have to make the case why cannabis will work for you.
For most people, you are going have to wait until the autumn when cannabis will be re-scheduled and available on prescription from your GP. It will then be up to you to persuade your doctor. The biggest problem is likely to be that most doctors simply have no understanding of cannabis at all. Now would be a good time to start gathering together all the scientific evidence you can find about using cannabis to treat your condition(s).
Something is going to have to be done about introducing some training for doctors. Since December 2017, the Royal College of GPs has had a set of guidelines ready to issue to doctors but it’s been sitting on them. These were authored by CLEAR, clinical information by Professor Mike Barnes with methods of use and harm reduction information by Peter Reynolds. We are urging the Royal College to make these available to doctors immediately.
Initially the products available are likely to be the Bedrocan range but we expect some of the Canadian companies will quickly make products available. We also expect NICE to re-visit Sativex and reassess its cost-effectiveness. It must be time for some hard negotiation over the price. This is an opportunity for GW Pharma and Bayer to make a significant reduction which would be in their own long term interest.
UK Is The Only Country In the World To Criminalise Doctors Who Prescribe Cannabis
Bob Ainsworth MP. Like so many ex-ministers, now a supporter of cannabis law reform
It’s popularly believed that the obstacle to prescription of cannabis by doctors is that it is in schedule 1 of the Misuse of Drugs Regulations. In fact, in 2001, the then drugs minster, Labour’s Bob Ainsworth MP, enacted a little known provision of the Misuse of Drugs Act 1971 UK specifically to make prescribing of cannabis a criminal offence.
Extraordinarily, apart from mescaline, raw opium, coca leaf, DMT and some extremely rare substances that most people will never have heard of, cannabis is the only substance to which this ruling applies. The Statutory Instrument can be seen here. It designated cannabis as a drug to which section 7(4) of the Misuse of Drugs Act 1971 applies. I have reproduced the relevant sections at the end of this article.
Why? Well that is a very good question and one that will no doubt be subject to endless speculation. Could it be because only a couple of years previously the House of Lords Science and Technology Committee had recommended that it be available on prescription? No doubt the conspiracy theorists will connect it to that fact that only six months previously GW Pharmaceuticals PLC had floated on the Alternative Investment Market of the London Stock Exchange. It certainly demonstrates a determination by the then Labour government to restrict and prevent the medical use of cannabis as tightly as the law could possibly allow. It is unprecedented that such rigid controls should be placed, without any supporting evidence, on a substance which we know from recorded history has been used as a medicine for at least 5,000 years.
What is most important is what this means for law reform. Removing cannabis from schedule 1 would be insufficient to allow doctors to prescribe it. The Statutory Instrument would also need to be rescinded so that section 7(4) of the Act no longer applied to it.
Amber Rudd MP. A single stroke of her pen can save Alfie Dingley
However, what this highlights is that the scheduling of cannabis and its use as medicine is entirely within the discretion of the Home Secretary. The present incumbent, Amber Rudd MP, or any of her successors can, entirely on her own account, make any change to the scheduling of cannabis or doctors’ ability to prescribe it. She can also issue a licence on whatever terms she chooses to enable individual prescription, importation or possession.
In other words, the fate of Alfie Dingley and thousands more is entirely in Amber Rudd’s hands. The dishonest excuses advanced by junior Home Office minister Nick Hurd, that they “want to explore every option within the current regulatory framework” is obfuscation, doublespeak and deception at its most blatant.
The Misuse of Drugs Act 1971 section 7(3) and (4) Source: https://www.legislation.gov.uk/ukpga/1971/38/section/7
(3)Subject to subsection (4) below, the Secretary of State shall so exercise his power to make regulations under subsection (1) above as to secure—
(a)that it is not unlawful under section 4(1) of this Act for a doctor, dentist, veterinary practitioner or veterinary surgeon, acting in his capacity as such, to prescribe, administer, manufacture, compound or supply a controlled drug, or for a pharmacist or a person lawfully conducting a retail pharmacy business, acting in either case in his capacity as such, to manufacture, compound or supply a controlled drug; and
(b)that it is not unlawful under section 5(1) of this Act for a doctor, dentist, veterinary practitioner, veterinary surgeon, pharmacist or person lawfully conducting a retail pharmacy business to have a controlled drug in his possession for the purpose of acting in his capacity as such.
(4)If in the case of any controlled drug the Secretary of State is of the opinion that it is in the public interest—
(a)for production, supply and possession of that drug to be either wholly unlawful or unlawful except for purposes of research or other special purposes; or
(b)for it to be unlawful for practitioners, pharmacists and persons lawfully conducting retail pharmacy businesses to do in relation to that drug any of the things mentioned in subsection (3) above except under a licence or other authority issued by the Secretary of State,
he may by order designate that drug as a drug to which this subsection applies; and while there is in force an order under this subsection designating a controlled drug as one to which this subsection applies, subsection (3) above shall not apply as regards that drug.
Cruel And Irresponsible Response from UK Government To Parliamentary Report On Medicinal Cannabis.
Unsurprisingly perhaps, the response to the recent call from MPs and peers to legalise cannabis for medicinal use has come straight from the top. Theresa May’s longstanding reputation as a denier of science and evidence on drugs policy is reinforced by her peremptory dismissal of the expert report. It seems that, at least in the short term, the UK government is sticking by a policy that is discredited, ridiculous and deeply cruel.
It fell to Sarah Newton MP, minister of state at the Home Office, to respond to a parliamentary question from Roger Godsiff, Labour MP for Birmingham, Hall Green.
Roger Godsiff MP
“To ask the Secretary of State for the Home Department, if she will respond to the recommendations of the report by the All-Party Parliamentary Group for Drug Policy Reform Accessing Medicinal Cannabis: Meeting Patients’ Needs, published in September 2016.”
Sarah Newton MP
“The Prime Minister responded to the All-Party Parliamentary Group for Drug Policy Reform’s report ‘Accessing Medicinal Cannabis: Meeting Patients’ Needs’ on the 27 October.
Cannabis is controlled as a Class B drug under the Misuse of Drugs Act 1971 and, in its raw form, currently has no recognised medicinal benefits in the UK. It is therefore listed as a Schedule 1 drug under the Misuse of Drugs Regulations 2001.
It is important that all medicines containing controlled drugs are thoroughly trialled to ensure they meet rigorous standards so that doctors and patients are sure of their efficacy and safety. To do otherwise for cannabis would amount to a circumvention of the clearly established and necessary regime for approving medicines in the UK.”
In other words, this is nothing more than a re-statement of the same position that the UK government has held since 1971 when legal access to medicinal cannabis was halted. Quite clearly the government has given no consideration at all to the vast amount of scientific evidence and international experience that has accumulated over the last 45 years. The latest report which took nine months to produce, took evidence from over 600 witnesses and included a review of over 20,000 scientific studies is simply cast aside. To be honest, I doubt whether it has even been read by Ms May or anyone in the Home Office or Department of Health. This is the standard that now prevails in the UK – government of the people by an unaccountable, out-of-touch, unresponsive cabal of individuals elected by a deeply flawed system that gives democracy a bad name.
On the face of it, the claim that all medicines must be thoroughly trialled seems plausible – but it is not. It is a misleading half-truth clearly intended to squash the call for access to medicinal cannabis by painting a false picture.
Doctors are allowed to prescribe any medicine, licensed or unlicensed, as they see fit, based on their own judgement. But prescribing of cannabis is specifically prohibited by Statutory Instrument despite the scientific consensus that it is far less dangerous than many, probably most commonly prescribed medicines.
So it’s not a level playing field. It’s a policy that is based on prejudice and scaremongering about recreational use of cannabis. Ms Newton’s answer is at best disingenuous but then she probably doesn’t even realise that herself. For many years Home Office policy has been systematically to mislead and misinform on cannabis and evidently under Ms May’s successor, Amber Rudd MP, such dishonesty continues.
Theresa May MP
Something will eventually force the government’s hand to change its absurd position on cannabis. Sadly the very last consideration will be scientific evidence or the will of the people. Such factors hold no sway with UK governments. Only when enough of the political elite open their eyes and examine their conscience, or some key individuals or their family members, experience the need for medicinal cannabis will change become possible. Alternatively, political upheaval may present an opportunity. The Liberal Democrats were too cowardly, weak and concerned with building their personal careers when in coalition to advance the cause they now so bravely advocate. Perhaps the SNP, with 56 MPs, all in favour of medicinal cannabis may be our best hope.
Sarah Newton is merely a puppet of the Home Office bureaucracy. Theresa May’s mendacious position on all aspects of drugs policy is well established and she is as stubborn and bigoted as they come on such matters. Only when she, in person, is subject to sufficient pressure will this cruel, ignorant and hateful policy change.
CLEAR’s Submission To The Parliamentary Inquiry Into Medicinal Cannabis
This was the response that CLEAR submitted to the APPG in February 2016. In March 2016, Roland Gyallay-Pap, then managing director of CLEAR and Peter Reynolds, president, were called to give oral evidence to the Inquiry.
A PDF copy of this document may be downloaded here.
Introduction
In June 2015 the All-Party Parliamentary Group for Drug Policy Reform (APPG) published a short report arguing for a rescheduling of cannabis to make it more widely available for medical use. Following the publication of that report there are a number of key questions remaining that it would like to address by means of a Short Inquiry.
CLEAR Cannabis Law Reform has been asked to submit evidence to the Inquiry in answer to these specific questions:
- Whether switching the medical status of cannabis from schedule 1 to a less restrictive schedule would be beneficial?
- What do you understand to be the range and extent of unofficial use of cannabis for medical purposes?
- What has been the impact of the current schedule 1 status on research into the medicinal uses of cannabis?
- Is there useful evidence emerging from the regulation of cannabis in over 20 US states and elsewhere and what does it tell us about the case for cannabis to be included in the UK pharmacopeia?
- What would be the implications of licencing cannabis for medicinal use following a change in Schedule?
- What role could EU regulations play in developing the potential for the medicinal use of cannabis?
We have also added a further response with additional information.
- Access to prescribed Bedrocan medicinal cannabis is already possible based on careful use of loopholes and errors in existing English law.
Whether switching the medical status of cannabis from schedule 1 to a less restrictive schedule would be beneficial?
Yes, we consider that switching cannabis from schedule 1 to a less restrictive schedule would be beneficial, both so that it could be prescribed by doctors as medicine and so that it could more easily be used in research into its use and effects.
Cannabis has been in schedule 1 of the Misuse of Drugs Regulations1 (MoDR) since the Misuse of Drugs Act 19712 (MoDA) came into force. Drugs in schedule 1 are specified as having no medicinal value. However, an inquiry by the House of Lords Science and Technology Committee published in 19983 recommended that doctors should be permitted to prescribe cannabis and that it should be moved to schedule 2. Strangely the government’s response to this recommendation was further to tighten restrictions by the Misuse of Drugs (Designation) Order 20014, which designates cannabis under section 7(4) of MoDA so that it is unlawful “for a doctor, dentist, veterinary practitioner or veterinary surgeon, acting in his capacity as such, to prescribe, administer, manufacture, compound or supply” it.
In fact, cannabis has already been re-scheduled into schedule 4 under the international non-proprietary name of nabiximols (Sativex)5. Although this is specified as being an extract of THC and CBD, it is clear from statements by the manufacturing company, GW Pharmaceuticals, that nabiximols is whole plant cannabis. Dr Geoffrey Guy, founder and chairman of GW, is on the record:
“Most people in our industry said it was impossible to turn cannabis into a prescription medicine. We had to rewrite the rule book. We have the first approval of a plant extract drug in modern history. It has 420 molecules, whereas every other drug has just one.”6
GW pharmaceuticals has confirmed that this quotation is accurate.7
The MHRA has chosen to issue a marketing authorisation8 for nabiximols (Sativex) by regarding it as only a two molecule medicine. The marketing authorisation is therefore at best inaccurate, at worst dishonest.
What do you understand to be the range and extent of unofficial use of cannabis for medical purposes?
In 2011, CLEAR commissioned independent, expert research from the Independent Drug Monitoring Unit (IDMU). The report, ‘Taxing the UK Cannabis Market’9, reveals there are three million people using cannabis in the UK regularly (at least once per month). Since then CLEAR has regularly polled its members and followers and consistently one in three of respondents claim at least some part of their use is for medicinal reasons. It is reasonable to estimate therefore that there are up to one million people using cannabis for medicinal purposes in the UK. It is certain that there are hundreds of thousands of medicinal users and previous estimates in the region of 30,000 are far too low.
The most common indications for medicinal use declared by our respondents are chronic pain, fibromyalgia, Crohn’s disease, multiple sclerosis and cancer.
Our interpretation of the responses we have received is that generally cannabis is used as a palliative agent. Some people find it so effective that they consider it to be a ‘cure’ as long as they keep using it. Others find it extremely helpful in reducing the amount of toxic and/or dangerous pharmaceutical medicines they are prescribed. Often the side effects of pharmaceutical medicines are severe and debilitating and cannabis offers a way of minimising these.
CLEAR maintains a Medicinal Users Panel10 which members join in order to gain support in lobbying their MPs and/or attempting to obtain prescribed Bedrocan medicinal cannabis. The active membership of the panel varies between 20 to 80 people. Panel members have also been involved in delegations to meet government ministers and other parliamentarians
What has been the impact of the current schedule 1 status on research into the medicinal uses of cannabis?
In the UK there is very little research into the medicinal uses of cannabis, except that undertaken by GW Pharmaceuticals11. There has been some research carried out into single cannabinoids but the evidence is that the therapeutic effects of cannabis depend on the whole plant ‘entourage effect’.
The allopathic, reductionist approach to medicine, which is reflected in the way that the MHRA regulates medicines, is the fundamental, establishment doctrine that impedes research into cannabis.
Sadly, one of the biggest trials of MS patients, the CUPID study at the University of Plymouth12, intended to look at the many anecdotal reports of benefit, used synthetic THC and consequently the results were disappointing and irrelevant to the claims it sought to test.
It is far easier to obtain funding for research into the harms of cannabis which is undertaken with an almost absurd degree of repetition, most notably by the Institute of Psychiatry at King’s College London (IOPPN).13 It is also worth noting that IOPPN regularly and consistently overstates the results of its research, encouraging the media to report causal effects between cannabis use and mental illness which its research does not support.14
There is a huge stigma around cannabis, largely due to inaccurate, misleading and hysterical press coverage. For instance, neither of the pre-eminent MS patient groups, the MS Society and the MS Trust, will take a stand in support of patients, despite the fact that many use cannabis. Similarly, despite extraordinary human clinical trial results on Crohn’s disease, none of the Crohn’s patient groups will engage with the campaign. Mention cannabis and calls are not returned, people are scared by the stigma. The immediate reaction from all such patient groups is to overlook evidence of benefit and refer to risks to mental health which, in fact, are very low compared to pharmaceutical products. The press, unchallenged by politicians in its disproportionate attention to these risks, bears a heavy responsibility for this stigma and the lack of research.
Unlike many within the reform movement, CLEAR recognises and values the expertise and achievements of GW Pharmaceuticals. However, any doctor or scientist that expresses any interest in medicinal cannabis in the UK is immediately retained or contracted by GW. We receive hundreds of reports of doctors, GPs and consultants, who tacitly and sometimes explicitly support their patients’ use of cannabis but it is impossible to find any doctor who is prepared to speak out publicly. In the few instances where doctors have spoken out on behalf of patients, they have been contacted by Home Office officials and warned. One GP reported that he felt “intimidated”. By contrast, there are tens of thousands of doctors across Europe, Israel and North America who advocate for the use of medicinal cannabis and further research into its applications.
The security and record-keeping requirements for cannabis as a schedule 1 drug15 are wildly disproportionate to the real potential for harm, requiring a high security safe for storage and an audit trail fit for Fort Knox.
In addition the fee for a high THC licence is currently £4700.00 per annum and applications can take more than a year to process. These requirements, delays and corresponding costs severely impede research into medicinal cannabis.
Recently, in response to two government e-petitions, the Home Office issued the following statement:
“In 2013 the Home Office undertook a scoping exercise targeted at a cross-section of the scientific community, including the main research bodies, in response to concerns from a limited number of research professionals that Schedule 1 status was generally impeding research into new drugs.
Our analysis of the responses confirmed a high level of interest, both generally and at institution level, in Schedule 1 research. However, the responses did not support the view that Schedule 1 controlled drug status impedes research in this area. While the responses confirmed Home Office licensing costs and requirements form part of a number of issues which influence decisions to undertake research in this area, ethics approval was identified as the key consideration, while the next most important consideration was the availability of funding.”
We consider this response to be disingenuous and misleading. Cannabis is a special case. It is a combination of hundreds of molecules, unlike other schedule 1 drugs, most of which are single molecules. Also, as is well established in written and archaeological evidence, cannabis has been used effectively for at least 5,000 years as medicine without any evidence of harm.
Furthermore. ethical approval and funding are difficult largely due to the evidence-free scaremongering about cannabis and the consequential stigma, in which the Home Office plays a leading role. Ethical approval and funding do not seem to be a problem in researching potential harms of cannabis. Indeed, as noted above, there is a massive amount of such research even though much of it is repetitive and inconclusive.
Until it is recognised that for many years, under successive governments, the Home Office has been systematically misleading and scaremongering about cannabis, it is difficult to see how an evidence-based decision can be reached. The Home Office regularly makes assertions about cannabis that are completely without evidential support. There is an established prejudice and determination to misinform and this must be tackled at root as it amounts to misconduct and corruption.
Is there useful evidence emerging from the regulation of cannabis in over 20 US states and elsewhere and what does it tell us about the case for cannabis to be included in the UK pharmacopeia?
There is a vast amount of peer-reviewed, published evidence of the safety and efficacy of cannabis as medicine. Much of this arises from research carried out in the USA, the Netherlands and Israel, where medicinal cannabis regulation has been in place for many years.
It is a populist myth, promoted by the Home Office, the press, the BBC and the prohibitionist lobby, that there is no evidence supporting the use of cannabis as medicine.
In February 2015, a delegation of medicinal cannabis users from CLEAR met with George Freeman MP, the life sciences minister, at the Department of Health who is largely responsible for medicines regulation. At the conclusion of the meeting, Mr Freeman requested CLEAR to produce a summary of the available evidence.
The result is the paper ‘Medicinal Cannabis:The Evidence’16 (MCTE) which has received international acclaim, so much so that in association with Centro de Investigaciones del Cannabis (CIC), a Colombian non profit association, a Spanish language version has been published.
MCTE was submitted to George Freeman MP in April 2015. Since then he has repeatedly refused to meet CLEAR again or respond to us directly, even after multiple requests from individual MPs representing CLEAR members. His only responses, received through third parties, fail to address the evidence at all. He simply refers to the legal status of cannabis, the theoretical availability of Sativex and the MHRA process for issuing marketing authorisations in respect of medicines.
This refusal to engage, acknowledge or properly consider the very large amount of evidence that is available is indicative of an inexplicable prejudice within government. Although conspiracy theories abound, it is difficult to understand why ministers adopt this position.
Cannabis was one of the most used medicines in the British pharmacopeia until only about 100 years ago. It could be restored immediately by a stroke of the Home Secretary’s pen to remove it from schedule 1. This would immediately make it possible for doctors to prescribe medicinal cannabis from Bedrocan17, the Netherlands government’s exclusive contractor.
Bedrocan cannabis is carefully regulated by the Netherlands government’s Office of Medicinal Cannabis. It is available in five different THC:CBD ratios. It is already exported to many countries in Europe and the company has established itself in Canada as well. It is less than a tenth the cost of Sativex for equivalent cannabinoid content and can be consumed either by a medical vapouriser or as an infusion.
No minister in this or any previous government has ever presented a coherent reason for the refusal to allow cannabis to be used as a medicine. Their only response is to fall back on largely spurious or exaggerated claims about the harms of recreational use.
What would be the implications of licencing cannabis for medicinal use following a change in Schedule?
Cannabis would not need to be ‘licenced’ for medicinal use following a change in schedule. As soon as it removed from schedule 1, doctors would be able to prescribe it and businesses interested to grow, process and develop cannabis medicines would be able to obtain cultivation/possession licences from the Home Office.
Medicines are no longer ‘licenced’ in the UK. The MHRA grants marketing authorisations. The initial fee, simply for filling in the application form is £103,000.00, thus prohibiting any but the very largest, established businesses from even considering such a venture. The very term ‘marketing authorisation’ reveals the mindset of medicines regulators which is now more about commercial interests than the evaluation of the safety and efficacy of medicines.
The MHRA does have a regulatory scheme for ‘Traditional Herbal Registration’ (THR) but it only applies “if the medicine is used for minor health conditions where medical supervision is not required.”. An application for a THR for cannabis could not be made while it remains in schedule 1 but, if granted, would not permit its use for many conditions where there is excellent evidence of its efficacy.
The MHRA is locked in an inflexible, unscientific and restrictive process which can only evaluate medicines which are either one or two molecules. Its process is designed for synthetic, potentially very dangerous molecules and is entirely unsuitable for a plant based medicine such as cannabis. This is why, as explained above, Sativex has been improperly regulated as containing only two molecules: THC and CBD.
When the Sativex (nabiximols) patent expires, independent analysis of the medicine would certainly demonstrate that it is whole plant cannabis oil. Presumably alternative and/or generic versions could then be produced. However, by any standards, for all parties, the regulation and scheduling of Sativex is inaccurate, if not dishonest, and needs revision.
If cannabis is removed from schedule 1, most appropriately to schedule 4 alongside Sativex, in our judgement there will be a large number of businesses applying for cultivation/possession licences for research which will eventually result in applications for marketing authorisations. In the meantime, it can only be described as cruel and evidence-free not to permit doctors to prescribe Bedrocan, a safe, effective medicine already regulated by another European government.
It is likely that enabling the prescription of Bedrocan would result in substantial savings to the NHS medicines budget. However, any idea that this could be quantified based on existing evidence is fanciful. Certainly, compared to existing prescription medicines and Sativex, Bedrocan is very inexpensive, probably less than 10 euros per patient per day. However, the complexity of calculating which medicines it could replace by individual, partly or wholly and for how long makes the exercise so hypothetical as to be meaningless.
It must be true that once local, UK-based cultivation of medicinal cannabis was permitted, prices would reduce even further.
What role could EU regulations play in developing the potential for the medicinal use of cannabis?
Aside from France and Ireland (which is moving rapidly towards drugs policy reform), every other EU country has a more intelligent, compassionate and evidence-based policy towards medicinal cannabis. Based on existing policy and its record, the UK government would simply refuse to comply with any EU regulation of medicinal cannabis.
Under the Schengen Acquis (of which UK is a signatory, though not to the full Schengen Agreement), if a medicine is prescribed to a resident of a member state, that resident may travel to other member states with up to three month’s supply under the protection of a Schengen certificate. The effect of this is that a resident of the Netherlands, Belgium, Finland, Germany, Italy, etc. can bring prescribed cannabis, likely Bedrocan, into the UK and use it without restriction.
The crucial test here is residency, so it is not possible for a UK resident to travel to another country, obtain a prescription and then return to the UK legally with cannabis. Presently, a Schengen certificate for a UK resident has to be issued by the Home Office. Strangely and in contravention of this explicit provision, Norway (Non EU but a signatory to Schengen) does permit its residents to obtain prescriptions, usually in the Netherlands, and return home with cannabis.
It is also likely that given the hostility towards EU regulation, adding cannabis into that debate would be counterproductive. It would be used as another stick with which to beat the EU.
Access to prescribed Bedrocan medicinal cannabis is already possible based on careful use of loopholes and errors in existing English law.
As some members of the APPG are aware, CLEAR has been involved in trying to obtain legal access to prescribed Bedrocan since 2012. We now have approximately a dozen members who regularly receive private prescriptions from their doctors (both consultants and GPs) and travel to the Netherlands to have them dispensed.
In all instances, these individuals have either declared their medicine at customs and/or have made prior arrangements with the Border Force, producing supporting documentation.
This is possible because of errors and inconsistencies in the MoDA and the MoDR. All English drugs legislation, including the recent Psychoactive Substances Act 2016, is badly drafted, contradictory and scientifically illiterate.
The principle active ingredients of cannabis are delta-9-THC and cannabidiol (CBD). Bedrocan products are specified with different ratios of these substances. While cannabis is classified in schedule 1, so is delta-9-THC but it is also in schedule 2 described as dronabinol, which is the international non-proprietary name (INN) for delta-9-THC. CBD is not a controlled drug.
Therefore, if a doctor is prepared to write a prescription e.g. dronabinol (Bedrocan 22%) or dronabinol (Bediol 7.5%), three month’s supply of the medicine may be legitimately imported as a schedule 2 drug.
In the past four years only one CLEAR member has been frustrated in this. He had his medicine seized but he was not prosecuted. An appeal against the seizure failed.
Clearly, the vital factor in this scheme is a doctor who understands the law and the science and is prepared to write the prescription.
References
1. Misuse of Drugs Regulations 2001 http://www.legislation.gov.uk/uksi/2001/3998/contents/made
2. Misuse of Drugs Act 1971 http://www.legislation.gov.uk/ukpga/1971/38/contents
3. House of Lords Science and Technology Committee report 1998 http://www.parliament.the-stationery-office.co.uk/pa/ld199798/ldselect/ldsctech/151/15101.htm
4. Misuse of Drugs (Designation) Order 2001 http://www.legislation.gov.uk/uksi/2001/3997/made
5. Nabiximols (Sativex) https://en.wikipedia.org/wiki/Nabiximols
6. Cambridge News, 24th Jan 2012 http://www.cambridge-news.co.uk/Cannabis-company-enjoys-major-growth/story-22509041-detail/story.html
7. Email corres with Marc Rogerson, GW Pharma, 160312. Attached.
8. Sativex (nabiximols) marketing authorisation, MHRA , 2010 http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con084961.pdf
9. Taxing the UK Cannabis Market, IDMU, 2011 http://clear-uk.org/media/uploads/2011/09/TaxUKCan.pdf
10. CLEAR Medicinal Users Panel http://clear-uk.org/pages/medicinal-panel/
11. GW Pharmaceuticals website http://www.gwpharm.com/
12. CUPID study, University of Plymouth, 2015 http://www.ncbi.nlm.nih.gov/pubmed/25676540
13. Institute of Psychiatry at King’s College London website http://www.kcl.ac.uk/ioppn/index.aspx
14. King’s College Confirms Institute of Psychiatry Misled Media On Cannabis Brain Study. CLEAR, 2015 http://clear-uk.org/kings-college-confirms-institute-of-psychiatry-misled-media-on-cannabis-brain-study/
15. Controlled Drugs (Supervision of management and use) Regulations 2013, Dept of Health https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/214915/15-02-2013-controlled-drugs-regulation-information.pdf
16. Medicinal Cannabis: the Evidence, CLEAR, 2015 http://clear-uk.org/static/media/PDFs/medicinal_cannabis_the_evidence.pdf Attached
17. Bedrocan BV website http://www.bedrocan.nl/
Home Secretary Invites CLEAR To ‘Enter A Dialogue’ On Cannabis Law Reform.
Rt. Hon. Amber Rudd MP, Secretary of State for the Home Department
In a letter dated 15th August 2016, Amber Rudd, the new Home Secretary, has invited CLEAR to raise “any queries and concerns” about present UK policy on cannabis. This is the first time since 2006, with Charles Clarke, that the UK cannabis campaign has had any direct contact with a serving Home Secretary. It reflects the reality, now recognised in government, that changes in cannabis policy are imminent.
In recent months, there has been a manifest and significant change in attitudes within the Home Office. We have seen this through the process of obtaining a low THC cultivation licence for our partnership with GroGlo Research and Development. The response from the drugs licensing department has been enthusiastic. There has been no difficulty with our declared purpose of producing CBD oil for sale as a food supplement and we are now in detailed discussions on our application for a high THC licence, looking towards clinical trials for a medical product for chronic pain.
As soon as Theresa May announced that Amber Rudd would be heading up the Home Office, I contacted my MP, now Sir Oliver Letwin, thanks to Cameron’s resignation honours list. Although he will not openly support our campaign, in the past year or so he has been very helpful indeed, meeting with me on roughly a monthly basis and helping me navigate through the Conservative government. He has now put me in direct contact with Ms Rudd and I will be preparing a written submission as a preliminary to a face-to-face meeting.
In accordance with CLEAR policy, our first concern is how we can enable UK residents to gain access to medicinal cannabis on a doctor’s prescription. In practice that means Bedrocan products as there is presently no other source of prescribable, consistent, high-quality, herbal cannabis. I would expect that to change very soon though. Both Canada and Israel look like potential near-future sources. GW Pharmaceuticals is undoubtedly considering entering the market and our venture with GroGlo could shift gear depending on how quickly UK policy changes.
We will also be addressing the need for wider reform and a legally regulated market for adult consumers. Although medicinal access remains the top priority, there is no doubt that more overall harm is caused by prohibition of the recreational market. It is this that creates the £6 billon per annum criminal market which is the cause of all the social harms around cannabis. This will need to be handled much more carefully as, due to nearly a century of misinformation and media scaremongering, many people still retain great fear as to what legal cannabis will mean.
The one thing that has been very lacking in the cannabis campaign is pragmatism. Most campaigners for recreational use continue to be lost in a swirl of ‘free the weed’, teenage angst, outrage, revolution and delight in being a rebellious outlaw. That was until 2011 when CLEAR introduced a new approach which has led to more engagement with government than ever before. The emergence of the United Patients Alliance and now the End Our Pain campaign has helped this but these campaigns are focused only on medicinal use
The fact is that we need to work with Theresa May’s government and the anti-Tory tribalism that many still adopt is nothing but an obstacle to reform.
In addressing Ms Rudd, our overall strategy for wider reform will be:
1. A final separation from the ridiculous ‘free the weed’ movement and ‘stoner’ groups which are incapable of understanding how they are seen and despised by wider society.
2. Differentiation between medicinal use and the more controversial legalisation for adult, recreational use.
3. Shift public attention onto scientific and medical evidence rather than the very poor standard of media reporting.
4. End the fake policy that says ‘cannabis is dangerous therefore it must be regulated’. Educate that nearly all the harms around cannabis are caused by its prohibition, not by cannabis itself.
5. Emphasise the importance of harm reduction information, education about excessive use and essential investment in treatment for those who do suffer health harms.
6. Clarify that decriminalisation is no solution and is a dangerous option that would probably increase harm. The product needs to be sold within a properly regulated environment, careful that over-regulation would support a continuing criminal market.
How You Can Help The Campaign For Medicinal Cannabis.
Using The Volcano Vapouriser With Medicinal Cannabis
CLEAR is launching a new recruitment drive for its Medicinal Cannabis Users Panel. If you use cannabis as medicine, joining the panel is the most effective thing you can do both to advance the campaign and, in some instances, gain legitimate access to prescribed Bedrocan medicinal cannabis.
The panel has proved itself to be the most effective campaigning method ever used in the UK. As a direct result of the efforts of panel members, in the last two years there have been more meetings with government minsters, officials and senior MPs than the whole campaign has managed in the last 50 years.
You must be a member of CLEAR to join the panel, then you complete a detailed questionnaire providing information on your condition(s) and how cannabis helps. Each applicant is then interviewed by telephone to develop an individual plan. This will depend on a number of factors, such as your relationship with your doctor, your MP, how much time you have available and whether you are prepared to tell your story to the media.
If your doctor is prepared to help, there is now an established route to getting medicinal cannabis prescribed and legally imported into the UK. CLEAR has developed this process through experience working with doctors, MPs, the Home Office and the Border Force. We also have crucial support from the All Party Parliamentary Group (APPG) on Drug Policy Reform and a number of members of the House of Lords. This is on a private prescription basis only. The prescription has to be very carefully written, using exactly the correct wording and, to begin with, you will have to travel to Holland in person to have the prescription dispensed at a pharmacy. Thereafter it may be possible to have repeat prescriptions sent through the post.
Bedrocan Products
Bedrocan is the Dutch government’s official producer of medicinal cannabis. Five different varieties are available at a cost of approximately seven to eight euros per gram. See full details of the different products here.
All panel members are guided in how to approach their doctor and MP. Initial contact should be made by letter or email but then it is important to meet your doctor and MP face to face and provide them with high quality scientific evidence to support your case. CLEAR will offer guidance and help at every stage. If you wish then a member of our executive committee will accompany you to meetings to help you present your case. Whether or not your doctor is prepared to write a prescription for you, we aim to continue leading delegations of medicinal users to meet ministers. We have seen again and again what an impact this can have. When senior politicians who have no experience of medicinal cannabis meet genuine, decent, ordinary people with families and careers who tell their story with sincerity and conviction, it has an enormous impact.
If you live in the UK and are interested in joining the panel, please email a brief explanation of your interest to: meduserspanel@clear-uk.org
Please do not go into great detail at this stage. Applications should be no more than 200 words. We will respond to you with a questionnaire within seven to 10 days.
Peter Reynolds of CLEAR, Nick Rijke of MS Society. BBC Radio Kent, 8th April 2015
Julia George interviews Peter Reynolds of CLEAR, following publication of the report ‘Medicinal Cannabis:The Evidence’. Nick Rijke, of the MS Society, comments on using cannabis to treat multiple sclerosis and how Sativex, the only licensed cannabis medicine, is very difficult to obtain on prescription.
Medicinal Cannabis AdVan Campaign in London.
Artist’s Impression
Join The Campaign For Medicinal Cannabis On A Doctor’s Prescription.
Despite overwhelming evidence, the UK government insists that cannabis has “no medicinal value”. Present policy is deeply cruel and means that at least one million people in Britain are forced to become criminals in order to deal with their pain, suffering or disability.
We must change this dreadful and unjust policy. It’s time to help rather than persecute people who genuinely need cannabis to improve their health. DONATE HERE.
The AdVan Campaign.
CLEAR is the UK’s leading drugs policy reform group with more than 270,000 followers. We will run an AdVan for one week in central London during the busy pre-Christmas period. This will deliver the simple, direct message that you see above and it will be backed by a supporting PR campaign, lobbying of government ministers and MPs as well as further information on the CLEAR website.
Please donate whatever you can. Every pound makes a difference. We need to raise £3500 to run the AdVan for one week. If we raise more we will run it for longer. DONATE HERE.
Please Donate Now!
Our Simple And Reasonable Request To UK Government.
In 1998, GW Pharmaceuticals was granted a licence to grow cannabis and its cannabis oil medicine, Sativex, is now approved but doctors are prevented from prescribing it because it is so fantastically expensive.
The Dutch government approves a cannabis medicine called Bedrocan which provides exactly the same as Sativex at a tiny fraction of the price. Sativex costs between £375 – £560 per month. Bedrocan costs £35 – £95 per month.
All we ask is that if a doctor prescribes Bedrocan, the Home Office should issue an import licence. This is a narrow, tightly defined reform that will not encourage illicit use but will provide enormous help to some very poorly people. DONATE HERE.
Further Background.
Every year, thousands of medicinal cannabis users are prosecuted for possessing or growing cannabis. Often it is the only medicine that helps them with chronic pain, fibromyalgia, MS, Crohn’s disease, epilepsy, depression or many of the conditions related to aging. It is also used to mitigate the side effects of chemotherapy and HIV/Aids treatments.
In November 2014, the Liberal Democrat MP Norman Baker resigned as a government minister because of the Conservatives’ refusal even to consider drugs policy reform. In July 2014 he met with members of CLEAR and publicly called for cannabis to be legalised for medicinal use. Other ministers are more concerned with stopping people getting high (which they are going to do anyway) than in helping those with severe medical conditions. DONATE HERE.
Other Ways You Can Help
Join CLEAR at http://clearmembers-uk.org
Visit and ‘like’ our Facebook page http://www.facebook.com/ClearUK
Follow us on Twitter @CLEARUK
Peter Reynolds 