Peter Reynolds

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Posts Tagged ‘Crispin Blunt

The Drugs Policy Debate. House Of Commons, 18th July 2017.

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This debate was held in Parliament following the publication on 14th July 2017 of the ‘2017 Drug Strategy’.

The debate may be watched in full here.  It starts at 13:17 and finishes at 19:00.

Highlights include:

Crispin Blunt MP at 14:09

 

 

 

 

 

Jeff Smith MP at 15:21

 

 

 

 

 

Norman Lamb MP at 16:10

 

 

 

 

 

 

Paul Flynn MP at 16:32

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Written by Peter Reynolds

July 26, 2017 at 4:07 pm

How To Campaign For Cannabis Law Reform Under A Theresa May Government.

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  • Lobbying Parliament

  • If the Government Won’t Regulate Cannabis Then We’ll Do It For Them

  • The CBD Market

  • Medical Cannabis

  • Educating And Influencing Researchers

For cannabis and drugs policy reform, out of 650 MPs, there could not have been a worse person to seize power than Theresa May.  There are a few who come close on both Tory and Labour benches but no one who has such a long record of bigotry, denial of evidence and refusal even to consider the subject.

Senior Tory MPs For Cannabis Law Reform

To be fair, I am a member of the Conservative Party, which to many people involved in the cannabis campaign is a mortal sin but my advocacy is based on science and evidence, not tribalism or wider politics.  In any case, though many find this fact hard to accept, there has always been more support from Tory MPs than Labour. Highly influential and senior Tory MPs such as Crispin Blunt, Peter Lilley and Dr Dan Poulter are powerful advocates for reform. I firmly believe that the only sustainable route to legalisation is commercialisation and the left wing, nanny state, anti-business types are already pushing the ‘Big Cannabis’ scare stories.

So what can we do and what are we doing to advance our cause in these dark days?  Theresa May always has been secretive, inaccessible, unresponsive and entirely disinterested in any opinion except her own.  How can we possibly make any progress with a PM who has already shown she is prepared to cover up or falsify evidence and defines herself by her belief in a supernatural power?

There is more support for cannabis law reform in Parliament than ever before.  It is now official policy of both the Liberal Democrats and the Scottish National Party. The support from Scotland is far more valuable than that from the discredited LibDems.  With the added factors of Brexit and Scottish Independence, the SNP is in a powerful position to advance its policies.  Also, in Ireland, both north and south, public support for medical cannabis reform is exploding.  Michelle O’Neill, SinnFein’s new leader, has pledged medical cannabis reform if she is re-elected (though she has no power to do so!).  Her negotiating position is immensely strong now that the problems at Stormont, the rise of Sinn Fein and the Brexit factor all combine to make a united Ireland a real possibility.

During the coalition government from 2010 to 2015, few doors were closed to us.  Over that period, CLEAR conducted more meetings with ministers and senior politicians than the entire UK campaign had achieved in 50 years.  Because we had support from the LibDems, and introductions from the Deputy Prime Minister, even Tory ministers were ready to see us, even if they were merely paying lip service.  That all stopped with the election of a majority Conservative government and after Cameron stepped down the doors were slammed in our faces, bolted and double-locked.  The campaign has been in the doldrums ever since. Or has it?

The last major achievement of the last few year’s campaigning was the release of the APPG report on medical cannabis in September 2016.  Alongside it, Professor Mike Barnes, CLEAR advisory board member, published his review ‘Cannabis: The Evidence for Medical Use‘.  To all impartial and reasonable observers, these documents should have initiated positive government action towards reform, even if it was only very limited in scope.  But no, Theresa May didn’t leave it to Amber Rudd, her successor as home secretary, she stepped straight in herself on the day of publication, before she could even have read it and dismissed the report out of hand.  This echoes the apocryphal story of James Callaghan, then PM, throwing the 1969 Wooton Report in the bin without even opening it.  Such is the inertia and prejudice that has not softened at all amongst the bigots despite 45 years of science and research proving that there are better, safer, more beneficial options available on cannabis.

Lobbying Parliament

For now, individual lobbying of MPs is our only route to power. Over the years we have refined our approach to this and we know what works.  Getting into ping pong correspondence with an MP is a waste of time.  An initial letter or email needs to be followed up with a face-to-face meeting and a determined focus on getting a tangible result. What sort of result you should look for depends on your circumstances but getting your MP to arrange a meeting with a government minister should be your goal.

If you’re a medical user then you’ll want to meet a health minister, preferably the Secretary of State, if not a junior minister or perhaps an advisor to the Department of Health.  Work with your MP to achieve the best result you can.  Your MP doesn’t necessarily have to agree with you about cannabis but they should facilitate your communication with government, that’s their job. If you’re more interested in the economic or social benefits to be gained from reform, you could ask for an introduction to the Chancellor, a treasury or business minister, or someone at the Cabinet Office who is involved in policy development.  CLEAR can usually provide someone to accompany you on meetings but this must be arranged in advance and agreed with your MP or whoever your appointment is with.  Alternatively, we can provide advice over the telephone on how to approach the meeting, what to ask for and what evidence or supporting material to take with you.

If the Government Won’t Regulate Cannabis Then We’ll Do It For Them

With an intransigent government that does it all it can to evade engagement on this issue, there is more that CLEAR is already doing.  If the government won’t take responsibility and regulate cannabis, then step by step we are going to do it for them.  Someone has to, there is far too much harm and suffering caused by present policy.

The CBD Market

Through 2016 the CBD market in the UK really began to take off.  These are products derived from industrial hemp, grown legally under licence that offer many of the therapeutic benefits of cannabis.  They should, in fact, be more accurately termed low-THC cannabis as apart from crystals and a few, rare examples of isolated CBD, they are whole plant extracts and contain all the cannabinoids, terpenes, flavonoids and other compounds found in the plants from which they are made.  Therefore they offer many of the ‘entourage effect’ benefits but with very low levels of THC.  It was obvious though that this market was heading for problems.  More and more dubious suppliers were starting up, many making brazen claims for the medical effects and benefits of their products and many without any product testing, quality assurance or honest customer service.  The law was then and always has been crystal clear, you cannot make medical claims for a product without it being properly licensed or regulated.  Inevitably, in June 2016 the MHRA stepped in and sent threatening letters to a number of CBD suppliers.

CLEAR took the initiative.  We wrote to the MHRA requesting a meeting.  We engaged with the leading CBD suppliers and our advisory board members Professor Mike Barnes and Crispin Blunt MP were quickly on the case.  The story has already been extensively reported but now, nearly a year on, our efforts are coming to fruition. We led the approach to the MHRA and in the process created what is now the Cannabis Trades Association UK (CTAUK).  It is now recognised by the MHRA, it has established a code of conduct and it is now the gold standard of quality, ethics and legality that can give anyone buying CBD products real peace of mind.  There are still cowboys out there, making false claims, selling products that offer no real benefit and even endangering their customers with products that are illegal under the Misuse of Drugs Act 1971 or the Psychoactive Substances Act 2016.  Now though, customers can go to the CTAUK website and choose a supplier that is operating legally, ethically and within the regulations that the industry itself has established.  We expect the MHRA very shortly formally to endorse CTAUK members as legitimate suppliers of CBD products as food supplements.

Medical Cannabis

Professor Nigel Mathers, Honorary Secretary, Royal College of GPs

Neither can we accept the government’s irresponsible and cruel policy towards people who need cannabis as medicine. So CLEAR has taken a further initiative. After Theresa May’s dismissal of the APPG report, we approached the Royal Colleges of medicine.  We pointed out that whatever the government might say, around one million people are using cannabis as medicine.  Doctors have a duty and an ethical responsibility to educate themselves on the subject and be able to provide properly informed care to their patients.  Our efforts have borne fruit.  Professor Mike Barnes and I have worked with Professor Nigel Mathers of the Royal College of GPs (RCGP).  We will be producing a draft set of guidelines on medicinal cannabis for GPs which will go the next meeting of the RCGP Council and is planned for publication in June 2017.  If the government won’t do it, we will and the medical profession agrees with us.  This will be the greatest practical advance ever made in medical cannabis in the UK.

Educating And Influencing Researchers

Dr Musa Sami, Peter Reynolds

The UK is the most prolific source of research into the harms of cannabis, particularly the tenuous links between cannabis and psychosis.  Despite dozens of studies, mainly from the Institute of Psychiatry at King’s College Hospital, this has never been shown to be any more than statistical correlation.  Most of these studies are confounded by tobacco use but the latest work from Professor Sir Robin Murray and his team shows an even stronger correlation between tobacco and psychosis than cannabis.

Across the world, UK scientists have become notorious for this scaremongering which seems little different from the ‘reefer madness’ hysteria.  To be fair, much of this is down to the UK media which has barely advanced since the 1930s in its reporting.  It provides the environment in which researchers are able to gain funding for research into cannabis harms but hardly ever for cannabis benefits.

CLEAR is now working with the Institute of Psychiatry to develop a new and more balanced way of surveying the effects of cannabis.  Dr Musa Sami has asked us to advise on the construction of a questionnaire on which the Institute will base its future work.

The Facts About CBD In The UK. December 2016.

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On 3rd October 2016 the Medicines and Healthcare products Regulatory Agency (MHRA)  issued notices to a number of CBD suppliers stating that cannabidiol (CBD) was being designated as a medicine and that sale of all CBD products must stop within 28 days, ostensibly by the 1st November.

A lot has happened since.  Most importantly, the Cannabis Trades Association UK (CTAUK) has been established to represent the industry and protect the interests of CBD consumers but there remains great confusion as to the legal status of CBD and whether these products will still be available.  This article sets out the facts and explains how the market is likely to develop. The most important point is that there is no need for panic.  There will be some changes but no one will lose access to CBD for the foreseeable future.

Background

Through the summer of 2016, rumours and half stories had been swirling around about the MHRA taking action on CBD. When the news broke it caused real panic, both for the thousands of people using CBD products and for those working in CBD businesses.  It looked like a real disaster for everyone. On the one hand the government, through the MHRA, was finally recognising the truth that CBD and cannabis are medicine.  On the other, it seemed that the whole industry was going to be shut down, businesses would close, people would lose their jobs and, most importantly, those who rely on CBD products for maintaining their health were going to suffer real harm.  If CBD was going to be regulated as a medicine it would require the investment of hundreds of thousands of pounds to obtain the necessary authorisation to put any products on the market.

It quickly became clear that the MHRA was unprepared for the reaction it received. Its switchboard was swamped by worried callers.  Social media exploded with the inevitable Big Pharma conspiracy theories and even the national press covered the story demonstrating that medicinal cannabis is now an issue of mainstream interest.

ctauk-logoCLEAR took action to rally our friends and colleagues in the legitimate cannabis business and this led to the creation of CTAUK.  The same day the news broke we wrote to the MHRA notifying it of the formation of the trade association and seeking a meeting.

On 13th October, the MHRA issued a statement on its website explaining its actions.

CLEAR’s advisory board members, Professor Mike Barnes issued a statement to the media and Crispin Blunt MP wrote to Dr Ian Hudson, the chief executive of the MHRA.  Even the British Medical Journal covered the story.

On 19th October the MHRA finally confirmed a meeting with the CTAUK to take place on 3rd November.  On 21st October, Dr Ian Hudson replied to Crispin Blunt’s letter.  CTAUK appointed solicitors who in turn obtained counsel’s opinion and on 28th October a solicitor’s letter was sent to the MHRA formally objecting to its action. On 1st November the MHRA updated its statement on its website softening its position by claiming that its notices to CBD suppliers were merely its “opinion” that it should be designated as a medicine.

The meeting took place at MHRA headquarters on 3rd November.  It was cordial and constructive and on 16th November CTAUK wrote to the MHRA formally proposing a system for the regulation of CBD.  Essentially this suggests that CBD products with daily adult dosage of up to 200mg should continue to be marketed as a food supplement.  Products with a daily adult dosage of up to 600mg would require a Traditional Herbal Registration and higher dosage products would require a full Marketing Authorisation.  We await the MHRA’s response.

The MHRA has since written to CBD suppliers requiring them within seven days to provide samples of their products along with various information about them.  However, CTAUK has been able to negotiate that our members have until the end of January to comply.  This is excellent news and demonstrates recognition of the association by the MHRA.

Is CBD Legal In The UK?

Yes, CBD is not a controlled drug under the Misuse of Drugs Act 1971, neither is it covered by the Psychoactive Substances Act 2016.  As long as it is marketed as a food supplement without any medicinal claims it is perfectly legal to sell and to buy.

Is The MHRA Going To Ban CBD?

No, the MHRA will have to assess each product on its own merits, particularly taking into account how it is marketed and whether any claims of medicinal benefit have been made.

What Will Happen In the Future?

We hope that the MHRA will accept our proposals for a system of regulation, meaning that only the highest dose products, such as GW Pharma’s soon-to-be- released ‘Epidiolex’ will require a full Marketing Authorisation.  However, even if the MHRA tries to take formal action about any other products, this is going to take many months and probably a much as a year before anything changes.  We remain confident that we will come to an agreement that will enable everyone to continue to access CBD products.

Crispin Blunt Asks Parliamentary Question On Medicinal Cannabis, 22nd November 2016.

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Crispin Blunt MP

Crispin Blunt MP

Q. To ask the Secretary of State for Health, whether (a) his Department and (b) the Medicine and Healthcare Products Regulatory Agency has reviewed the latest evidence, including evidence on different regulatory approaches in other jurisdictions, for the use of medical cannabis.

nicola-blackwood-in-hoc

Nicola Blackwood MP. Minister Of State For Health

A. The Medicines and Healthcare products Regulatory Agency (MHRA) reviews evidence submitted by a company seeking a marketing authorisation for a medicinal product in the United Kingdom. One product containing extracts of cannabis, Sativex, has been licensed as a medicinal product by the MHRA. However, no such application has been received in respect of herbal cannabis, and therefore the MHRA has undertaken no review of the evidence for its medicinal use. Outwith the MHRA licensing process, the Department has not conducted or commissioned a review of herbal cannabis or its regulation in other jurisdictions.

Source

 

Written by Peter Reynolds

November 23, 2016 at 1:34 pm

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-crop

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.