Posts Tagged ‘Bedrocan’
The Definition Of A Cannabis-Derived Medicinal Product Must Include Standardised Herbal Cannabis Or Sajid Javid’s Reform Will Fail.
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.
Dame Sally’s Caution On “Grown Cannabis” Does Not Bode Well For Access To Herbal Cannabis As Medicine.
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.
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/
CLEAR Member Lara Smith To Be ‘Star Patient’ In Parliamentary Report On Medicinal Cannabis.
Vicky Hodgson, Norman Baker, Lara Smith, Peter Reynolds, Nick Ellis. CLEAR meeting at Home Office, July 2014.
The launch of the APPG report on its inquiry into medicinal cannabis is a public event which anyone can attend. It takes place at the House of Lords committee room 2 on 13th September 2016 at 11.00am.
Baroness Molly Meacher and Caroline Lucas MP, are co-chairs of the APPG. The guest speakers will be:
Frank Field MP
Ron Hogg, Police and Crime Commissioner for County Durham
Professor Mike Barnes, Neurologist, CLEAR Scientific and Medical Advisor
Lara Smith, Medicinal Cannabis Patient, Life Fellow of CLEAR
Lara Smith
Lara was awarded a Life Fellowship of CLEAR in August 2014 in recognition of her enormous contribution to our campaign. She suffers from a terrible chronic pain condition which is only relieved by cannabis. Her consultant is one of those few courageous doctors in the UK who have supported their patient by prescribing access to Bedrocan medicinal cannabis products. Using the protocol which CLEAR pioneered, which exploits loopholes in the Misuse of Drugs Act 1971, Lara now gains legal access to Bedrocan products on a regular basis. She has to travel to the Netherlands in person to collect her medicine every three months and it has to be paid for on a private basis. The important thing is she gets the medicine she needs and she is within the law.
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.
Another Pack Of Lies On Cannabis From The UK Government.
Yet another cannabis petition amongst hundreds of similar pleas was filed earlier this autumn. This one though is more tightly focused on removing cannabis from schedule 1, which defines it as having no medicinal value. The petition is also commendably concise but characterises itself as a ‘demand‘ that cannabis be rescheduled, an unfortunate choice of words.
Nevertheless, congratulations are due in that it has exceeded the threshold of 10,000 signatures which means the government must respond. That response is now in and it is predictably dishonest, dismissive and authoritarian in its tone. The Home Office has responsibility for drugs policy so it has drafted the response but it surely must have consulted with the Department of Health.
In fact, I was told only this week by a senior minister that “… the search into the medicinal use of cannabis is something that falls within the jurisdiction of the Department of Health.” That may be a subtle shift in policy from which we can draw some hope. But I fear that the response to this petition offers no hope at all. It is stubborn, obstinate, inaccurate and in denial of evidence and experience.
To be clear, the Home Office has been systematically lying and misleading the British people about cannabis for at least 50 years. The Department of Health is timid on the issue, leaves the public statements to the Home Office heavies and seems more interested in generating fee income for the Medicines and Healthcare products Regulatory Agency (MHRA), than in actually treating patients effectively.
I analyse the response paragraph by paragraph.
“Herbal cannabis is listed in Schedule 1 as a drug with no recognised medicinal uses outside research. A substantial body of scientific evidence shows it is harmful and can damage human health.”
By far the majority of scientists and doctors now recognise that cannabis has real and significant medicinal uses. Of course it is possible that cannabis can cause harm, as can any substance. However, there is no scientific evidence that shows cannabis as being any more harmful than over-the-counter medicines or many common foods. Professor Les Iversen, chair of the Advisory Council on the Misuse of Drugs, is on the record saying: “cannabis is a safer drug than aspirin and can be used long term without serious side effects”.
“The Government will not encourage the use of a Schedule 1 controlled drug based on anecdotal evidence. It is important that a medicine is very thoroughly trialled to ensure it meets rigorous standards before being licensed and placed on the market so that doctors and patients are sure of its efficacy and safety. “
It is not the government’s role to encourage the use of any drug as medicine, that is the role of a doctor. Only by removing cannabis from schedule 1 can that decision be placed in doctors’ hands. There is a vast quantity of peer-reviewed, published scientific evidence on the medicinal use of cannabis including human clinical trials. It is false to suggest that only anecdotal evidence is available. See ‘Medicinal Cannabis: The Evidence’. Thousands of doctors and millions of patients are sure of the efficacy and safety of cannabis based on existing research, trials and experience. Many commonly prescribed medicines have nowhere near as much evidence behind them as cannabis.
“Cannabis in its raw form (herbal cannabis) is not recognised as having any medicinal purposes in the UK. There is already a clear regime in place to enable medicines (including those containing controlled drugs) to be developed and subsequently prescribed and supplied to patients via healthcare professionals. This regime is administered by the Medicines and Healthcare products Regulatory Agency (MHRA), which issues Marketing Authorisations for drugs that have been tried and tested for their safety and efficacy as medicines in the UK.”
The lack of recognition for the medicinal purposes of cannabis is a grave error with no evidence that supports it. Cannabis is a traditional medicine which recorded history shows has been used safely and effectively for at least 5,000 years. The only thing that stands in the way of cannabis being prescribed by doctors is its schedule 1 status. The MHRA is a diversion and is irrelevant. It exists to trial and regulate new medicines and requires a £100,000 application fee before very costly clinical trials take place. This is an unnecessary obstacle to a traditional medicine which contains more than 400 compounds. The MHRA process is designed for potentially dangerous, single molecule drugs and is not applicable to cannabis.
“It is up to organisations to apply for Marketing Authorisation for products that they believe have potential medicinal purposes so that these can be subject to the same stringent regime and requirements that all medicines in the UK are subjected to.”
Many substances and drugs which have medicinal purposes are regulated either as Traditional Herbal Products or food supplements. It is the schedule 1 status of cannabis which prevents it being regulated and controlled in this way which is far more appropriate given its very low potential for harm and the very wide range of conditions for which it can be useful.
“Since 2010 UK patients can use the cannabis-based medicine ‘Sativex’ for the treatment of spasticity due to multiple sclerosis. ‘Sativex’ can also be prescribed for other conditions at the prescribing doctor’s risk. ‘Sativex’ was rigorously tested for its safety and efficacy before receiving approval, and is distinguished from cannabis in its raw form. It is a spray which is standardised in composition, formulation and dose and developed to provide medicinal benefits without a psychoactive effect. Due to its low psychoactive profile ‘Sativex’ was rescheduled from Schedule 1 and placed in Schedule 4 Part 1 to enable its availability for use in healthcare in the UK.”
Sativex is a massively expensive form of cannabis oil which is not prescribed because of its cost. It is at least 10 times the price of Bedrocan medicinal cannabis as regulated by the Netherlands government which could be immediately made available in the UK. It is a deliberate falsehood to claim that Sativex does not have a psychoactive effect. The statutory document ‘Summary of Product Characteristics’ describes “euphoric mood” as a “common” side effect. The scheduling of Sativex in schedule 4 is a deception requiring 75 words falsely to distinguish it from other forms of cannabis whereas every other drug in every other schedule requires just one word.
“The MHRA is open to considering marketing approval applications for other medicinal cannabis products should a product be developed. As happened in the case of ‘Sativex’, the Home Office will also consider issuing a licence to enable trials of new medicines to take place under the appropriate ethical approvals. “
Cannabis, which contains 400 + compounds is not suitable for MHRA regulation which is designed for single molecule drugs which are potentially dangerous. There is no significant danger from the use of cannabis when prescribed by a doctor. This is already well established in scientific evidence and the referral to the MHRA is a diversion and an excuse for failing simply to put the decision in doctors’ hands.
“In view of the potential harms associated with the use of cannabis in its raw form and the availability of avenues for medicinal development, the Government does not consider it appropriate to make changes to the control status of raw or herbal cannabis. “
The government has offered no evidence of the potential harms to which it gives such weight. No “development” of cannabis is required. It is a traditional medicine consisting of the dried flowers of the cannabis plant.
“The Government’s view is that the Misuse of Drugs Act 1971 and regulations made under the Act continue to facilitate the development of medicines which are made from Schedule 1 controlled drugs. The legislation is aimed at protecting the public from the potential harms of drugs and is not an impediment to research into these drugs or development of medicines.”
The government’s view is intransigent and as demonstrated by this response is ignorant of the available evidence. This response reinforces the government’s clear intention not to consider the evidence and simply to deny it. The evidence shows that the potential harms of cannabis as medicine are trivial and inconsequential. If its schedule 1 status was not an impediment to research, there would already be a great deal more research into cannabis as medicine.
“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.”
The Home Office is entirely untrustworthy and dishonest on anything to do with cannabis. Researchers, scientists, doctors and those already using cannabis as medicine simply do not trust anything it says on the subject based on long experience of its calculated dishonesty and misinformation.
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.
