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Peter Reynolds

The life and times of Peter Reynolds

Posts Tagged ‘CLEAR

Guidelines On Cannabis For Medical Professionals.

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In a new initiative, CLEAR’s scientific and medical advisor, Professor Mike Barnes, has written to the presidents of several Royal Colleges proposing the development of guidelines around the use of cannabis as medicine.

Professor Mike Barnes

Professor Mike Barnes

This is a tricky situation for doctors.  Surveys and individual reports from CLEAR members indicate that many doctors tacitly endorse their patients’ use of cannabis but clearly cannot recommend the illegal use of cannabis, however safe and effective it may be.

Professor Barnes’ letter refers to the recent APPG report, his own paper ‘Cannabis: The Evidence for Medical Use’ and says:

“…cannabis now has a reasonable evidence base for the management of chronic pain, including neuropathic pain, and the management of spasticity as well as in the management of anxiety and a use in nausea and vomiting in the context of chemotherapy.”

In conjunction with CLEAR, Professor Barnes has written to:

Royal College of Anaesthetists
Royal College of General Practitioners
Royal College of Paediatrics and Child Health
Royal College of Physicians
Royal College of Psychiatrists

His letter goes on to explain that about one million people are using cannabis as medicine:

“I do feel that doctors need guidelines to assist them when patients request advice on the use of cannabis…doctors should be properly informed about harm reduction advice and should be aware of the clinical evidence that is now guiding medicinal use in several other countries around the world.”

Our proposal is for an initial meeting to discuss the idea.  If one or more of the Royal Colleges is prepared to back this initiative, CLEAR will set up and fund a working group of clinicians and medical education specialists to develop a set of guidelines.

 

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CLEAR Statement Concerning Cannabis Legalisation Measures In US Election.

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“This is marvellous news for liberty, health and human rights.  The USA, unlike Britain, has a functioning democracy where the will of the people prevails rather than the bigotry and self-interest of politicians.  It is wonderful to see that truth, justice and evidence is winning out over the lies and misinformation we have been fed about cannabis for almost 100 years.

In 1971, the British government abdicated all responsibility on cannabis and abandoned our communities and our children to criminal gangs.  Since then all the harms have multiplied exponentially.  The laws against cannabis fund organised crime, promote dangerous hidden farms which are fire risks, the destruction of rental property, selling to children, contaminated ‘moonshine’ cannabis, gang violence, lives ruined by criminal records and the cruel denial of safe, effective medicine that can relieve pain, suffering and disability.

Donald Trump has supported access to medicinal cannabis all along.  Many British politicians who consider him to be an unreasonable person should now look to themselves and ask whether they are being reasonable by supporting prohibition, even for medical use.

It is time for Theresa May, Amber Rudd and the UK government to take responsibility for the £6 billion pa cannabis market.  The tide of legalisation is now unstoppable and it would be deeply irresponsible for them to fail to act.  They must grasp this nettle now!”

Peter Reynolds, president of CLEAR Cannabis Law Reform

CLEAR Cannabis Law Reform Accounts 2015.

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Income

Compared to the previous year, CLEAR’s regular income in 2015 was up 79% to £17,074. The majority of income continues to come from memberships, with the remainder coming from donations, merchandise and Google advertising.

Regular income: £17,074

clear-income-2015

Expenditure

CLEAR spent a total of £12,023, a decrease of 11% on the previous year.

Total expenditure: £12,023

clear-expenditure-2015

Administration: membership administration, stationery, postage, telephone & internet, meeting expenses, etc. Administration costs have increased as an overall proportion of expenditure as there were no dedicated campaigns during the year.

Travel: expenses incurred meeting government ministers, MPs, agency representatives, media engagements, boards meetings, also re-imbursement of travel costs for Medicinal Use Panel members

Fundraising costs: PayPal fees and other fundraising costs

Promotion: Facebook advertising, printing of leaflets, design work, etc.

Written by Peter Reynolds

November 8, 2016 at 11:00 am

The British Medical Journal (BMJ) Features The CLEAR Medicinal Cannabis Campaign.

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By Nigel Hawkes

By Nigel Hawkes

“Muddled thinking” over cannabis leaves patients in limbo, warn campaigners

BMJ 2016; 355 doi: http://dx.doi.org/10.1136/bmj.i5556 (Published 14 October 2016) Cite this as: BMJ 2016;355:i5556

Download PDF here

Companies selling cannabis based products have been told to remove them from the market within 28 days, after a review by the Medicines and Healthcare Products Regulatory Agency (MHRA) determined that they were medicinal products.

Campaigners for cannabis law reform welcomed the recognition that cannabidiol (CBD) had medicinal properties but warned that the MHRA’s action would deprive thousands of users of a product they relied on. They said that it was impossible to obtain marketing authorisation in the timescale given and may never be possible given the high costs of clinical trials and lack of patent protection for a product that contained many components.

“In the long term, it’s a good thing,” said Peter Reynolds of the pressure group CLEAR Cannabis Law Reform. “But my immediate concern is for the tens of thousands of people who use CBD and have become reliant on it. We urgently need interim measures so that supplies can continue.”

The MHRA sent letters on 3 October to 18 companies that sold CBD, saying that it had concluded that CBD met the definition of a medicinal product as defined in the Human Medicines Regulations as “any substance or combination of substances which may be used or administered to human beings either with a view to restoring, correcting, or modifying physiological functions by exerting a pharmacological, immunological, or metabolic action or to making a medical diagnosis.”

This meant, the letter said, that CBD products required a marketing authorisation before they could be sold. Marketing authorisation for drugs requires lengthy clinical trials, only justifiable if the product has patent protection. An alternative route is under the traditional herbal medicines regulations, but that requires evidence that the product has 30 years of use and applies only to minor conditions, where medical supervision is not required. Reynolds said that he thought it unlikely that CBD could qualify by this route.

Mike Barnes, a neurologist and former NHS consultant and chief executive, is clinical adviser to CLEAR. He said, “The decision by the MRHA to treat CBD products as medicines has also been done without thought to the consequences for many thousands of people in the UK who currently benefit from the products. It will have very significant, and in many cases terminal, impact on the many legitimate businesses that provide high quality products.

“The government must now act to sort out their muddled thinking and try to help those people with long term and often painful conditions who benefit from the ready and hitherto legal availability of natural cannabis products. It is ironic that in acknowledging the therapeutic benefits of CBD, the MRHA is effectively suspending access to a product that has enhanced the lives of thousands for many years.”

Crispin Blunt, an MP and CLEAR supporter, has written to the MHRA saying that the decision to designate CBD as a medicine is directly contradicted by the Home Office’s position that cannabis has no medicinal value.

“It is vital that we do not let this anomaly in government policy cause harm to people’s health,” his letter said. He asked for details of how the decision was reached, the consultations undertaken, which specific regulatory regime MHRA proposed for these products, and whether the continued supply of these products, regulated as food supplements, could be ensured until such time that medicinal marketing authorisations could be obtained.

The MHRA has not yet posted details on its website about the decision. In a statement it said that people who used CBD should speak to their GP or other healthcare professional. “We can provide regulatory guidance to any company who may wish to apply for a licence,” the statement added.

The Man From The MHRA. Endangering Public Health With Precipitate Action On CBD.

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Dr Ian Hudson, Chief Executive, MHRA

Dr Ian Hudson, Chief Executive, MHRA

The Medicines and Healthcare Products Regulatory Agency (MHRA) apparent decision to designate cannabidiol (CBD) as a medicine is an unholy mess and has been handled about as badly as it is possible for a government agency to deal with a matter of public safety.

The desk of Dr Ian Hudson, the Chief Executive, will shortly be groaning under the weight of correspondence from MPs asking him to explain exactly what is going on.  We know that the MHRA call centre has been swamped with calls from people desperate for information and in fear that they will be cut off from supplies of the food supplement that is so important for their health.  Many are now being told that no final decision has been taken and everyone is in limbo waiting for some coherent response.  We say “apparent decision” because nothing is clear, no public statement has been issued and anything you have seen in the press is from responses to individuals.

Crispin Blunt, the Conservative MP and a member of the CLEAR advisory board has written to Dr Hudson urging him to meet with CLEAR, Professor Mike Barnes and the newly-formed UK Cannabis Trade Association to discuss what interim arrangements can be put in place.  Tens of thousands of people’s health has been placed in jeopardy and not for trivial matters.  People suffering from serious conditions such as epilepsy, chronic pain, anxiety and Crohn’s Disease have come to rely on CBD products to maintain their health. There are also hundreds of jobs in danger at suppliers providing CBD to the UK market.

We know that many CLEAR members have asked their MP to write to the MHRA seeking clarification.  In Crispin Blunt’s letter he goes further.

“The decision to designate CBD as a medicine is directly contradicted by the Home Office’s position that cannabis has no medicinal value.  It is vital that we do not let this anomaly in government policy cause harm to people’s health. I should be grateful, therefore, if you could explain how the MHRA reached its decision, the consultations it undertook, which specific regulatory regime it proposes for these products and whether the continued supply of these products, regulated as food supplements, can be ensured until such time medicinal marketing authorisations can be obtained.”

CLEAR has received a holding response from the MHRA indicating that a meeting will be arranged and that we will hear by the end of this week. Responsible action from a government agency that is supposed to protect, not endanger public health is urgently needed.

 

Professor Mike Barnes Speaks Out On the CBD Ban.

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Professor Mike Barnes, Scientific and Medical Advisor to CLEAR

Professor Mike Barnes, neurologist, scientific and medical advisor to CLEAR Cannabis Law Reform, has issued the following statement.

“It is encouraging that the MRHA is recognising that CBD has medicinal value but it is concerning that many people benefitting from CBD now will suffer in the short term as good quality manufacturers have to stop production pending MRHA approval” 

A redacted copy of the letter now being sent to all CBD suppliers can be seen here.

For some weeks, rumours and half stories have been swirling around about the MHRA taking action on CBD.

Initially a number of suppliers were warned about making medicinal claims, even testimonials from satisfied customers were ruled as unlawful.  Anything which suggested that CBD was a medicine or provided therapeutic effects was ruled out under UK medicines legislation.

Responsible CBD suppliers have known this for some time and were scrupulous in ensuring no such claims were made, even including disclaimers explicitly stating that their products were not for medical use. But as CLEAR has reported many times before, the CBD market is full of cowboys, get-rich-quick scam artists that tell bare faced lies about their products as well as making outlandish claims for the medicinal benefits.  The crackdown from the MHRA was inevitable when these fools put their short term gain ahead of developing a responsible and self-regulating market in which CBD could continue to be sold as a food supplement.

We have seen every sort of bad practice it is possible to imagine.  Some suppliers have attacked all of their competitors, stating that they are the only ‘ethical’ supplier and everyone else is telling lies.  MediPen put all its resources and efforts into marketing and PR without providing proper information to customers about what its product contained.  It achieved great coverage in tabloids like the Metro and the Mirror and even managed to spin a wholly misleading story that the NHS was “trialling” its product (In fact it was at last using an NHS accredited laboratory to test its product contents, that is all).  Another supplier called Sacred Kana was rebranding cheap and nasty Romanian hemp extract and selling a bottle for just over £50, claiming it contained 10,000 mg of CBD.  Testing showed that it actually contained less than 200 mg. Wrapped up in a warm, cuddly hippy-style marketing campaign, they were trying to pass themselves off as the Rick Simpson of CBD when all they are is conmen.

Responsible suppliers did include CBD information on their websites and often linked to scientific studies and research.  Clearly, even this has become too much for the MHRA and now the market is being closed down.  You can thank the greedy idiots, the conmen and the barrow boy salesmen trying to pretend they were scientists.

Of course the truth is that CBD is medicine, so the MHRA isn’t wrong.  Most CBD products are, in fact, low-THC, whole plant extracts, so they were, effectively, a legal form of cannabis.  The therapeutic benefits they offered were not just from CBD but from the ‘entourage effect’, recognised by science as the synergy between all the different components of cannabis.  Unfortunately, we even had some companies promoting the fact that their so-called ‘CBD oil’ actually contained significant proportions of THC and CBN, both ‘controlled drugs’ under the Misuse of Drugs Act 1971.

The crackdown was inevitable but it may leave tens of thousands of people with real health problems as they are no longer able to obtain what they were legitimately using as a food supplement.

Crispin Blunt MP, Political Advisor to CLEAR

Crispin Blunt MP, Political Advisor to CLEAR

Of course, designating CBD as a medicine is inconsistent with the UK government’s position that cannabis has “no medicinal value” but it’s been common knowledge that this is untrue for many years.  The only good news coming out of this debacle is that this could be the beginning of proper, honest regulation of cannabis as medicine. But if we’re looking at clinical trials before CBD can be marketed again, it could be many years away and that’s after someone or some company decides to invest the £250,000 or more that could cost.

CBD products will still be available offshore and you probably will be able to order online and have them delivered by post.  The price is bound to go up and you will be committing a criminal offence by importing an unlicensed medicine but no doubt may will choose to take this risk.

CLEAR is working with the UK Cannabis Trade Association and our Advisory Board members Professor Mike Barnes and Crispin Blunt MP, to try and persuade the MHRA to enter a consultation process and allow CBD to remain available as a food supplement in the short term.

In the longer term, as we know far too well, the only solution is for a proper system of regulation for cannabis. including its use as medicine.

CLEAR’s Submission To The Parliamentary Inquiry Into Medicinal Cannabis

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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.

A copy of the Powerpoint presentation delivered by CLEAR at the oral evidence hearing can 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/