Posts Tagged ‘MHRA’
If the Government Won’t Regulate Cannabis Then We’ll Do It For Them
The CBD Market
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.
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.
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.
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
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.
Essentially, UK government policy on cannabis hasn’t altered since 1971. Despite the vast amount of new evidence published since then and revolutionary change, particularly on medicinal use, all across the world, successive governments have stubbornly and obstinately refused to consider any sort of reform.
It doesn’t matter which party has been in power, Conservative, Labour or the coalition, it’s a subject that ministers and MPs simply refuse to engage with. It’s easier that way for them and be in no doubt: laziness, fear of a media backlash and deeply ingrained prejudice are the key factors in this impasse.
We had the downgrade to class C in 2003 and then back up to B in 2009 but this was a turgid and useless effort. No notice was taken of any evidence arising from this experiment. It was enacted to enable police to concentrate more on class A drugs and reversed based on Gordon Brown’s ‘Presbyterian conscience’ and a grubby, corrupt deal with Paul Dacre to win the Daily Mail’s political support. In fact, use went down while cannabis was class C and back up again when it was upgraded but governments have no interest in facts or evidence on this subject, only in political expediency and spinning advantage with the media.
The clamour for medicinal access has increased enormously, just as the evidence for its safety and efficacy has become overwhelming. The UK is now virtually isolated amongst first world countries with a cruel, inhumane and anti-evidence policy which makes us a laughing stock with all who are properly informed. It’s not a laughing matter for the victims though. For those persecuted by this nasty policy it is tears, pain, suffering, disability – all of which could be alleviated to at least some extent just by a stroke of the Home Secretary’s pen. It is sickening that all those who have held that office over the last 45 years escape without any shame or opprobrium on their character.
CLEAR receives hundreds of letters and emails every year from people who have written to their MP about medicinal cannabis and it is astonishing that unlike almost every other policy, exactly the same words are used by all MPs. They slavishly repeat the Home Office line which is ruthlessly enforced across party lines.
There have been some subtle changes. The marketing authorisation issued for Sativex in 2010 has led to a minor change in the tired and inaccurate line ‘there is no medicinal value in cannabis’. It’s now become ‘there is no medicinal value in raw cannabis’. This is scientifically and factually incorrect. Pharmacologically, Sativex and the ‘raw’ plants from which it is made are identical. It is whole plant cannabis oil and its authorisation by the MHRA as an extract of THC and CBD is fundamentally dishonest. GW Pharmaceuticals reveals it contains more than 400 molecules, the MHRA says it only contains two and “unspecified impurities”.
More recently, and in the face of an explosion of supportive evidence, another line has been added. This states that ‘the UK has a well established process for the approval of medicines through the MHRA and that any company wishing to bring a medicinal cannabis product to market should follow this procedure. In fact, inside sources suggest that the government is very keen to see new cannabis-based medicines approved by the MHRA. It would take the wind out of the sails of the medical cannabis campaign
This is the very last excuse for denying access to medicinal cannabis. It is nothing but an excuse and one that is misleading and based on deception. If we can expose how weak, inappropriate and fake it is, the government will have nowhere else to hide.
Firstly, as demonstrated with Sativex, the MHRA process is incapable of dealing with a medicine that contains hundreds of molecules. It is designed by the pharmaceutical industry for regulating single molecule medicines, usually synthesised in a lab, which have the potential to be highly toxic. CLEAR rejects the tired, boring theory that ‘Big Pharma’ is engaged in a massive conspiracy to deny access to cannabis and to ‘keep people ill’ so it can continue to sell its products to the NHS. The MHRA isn’t engaged in such malevolent conduct, it’s simply incapable of properly evaluating a whole plant extract through its existing methods.
The bright, shining truth of this, that totally demolishes the government’s position, is that in every jusrisdiction throughout the world where medicinal cannabis has been legally regulated, it is through a special system outside pharmaceutical medicines regulation. Every other government that has recognised the enormous benefit that medicinal cannabis offers has come to the same conclusion: cannabis is a special case. It is far more complex but much, much safer than pharmaceutical products.
Of course, there is also the ludicrous status of cannabis as a schedule 1 drug, which prevents doctors from prescribing it. If it was moved to schedule 2, alongside heroin and cocaine, or to schedule 4 alongside Sativex (the logical choice), doctors could be prescribing it tomorrow and high-quality, GMP and EU regulated medicinal cannabis from Bedrocan would be immediately available.
So the MHRA is the final excuse, the last obstacle to a revolution in healthcare in the UK. We need an ‘Office of Medicinal Cannabis’ as there is in the Netherlands, or ‘Access to Cannabis for Medical Purposes Regulations’ as administered by Health Canada. Colorado has its ‘Medical Marijuana Registry Program’ and other US states have similar arrangements. Israel’s Ministry of Health has its ‘Medical Cannabis Unit’. In Australia, its equivalent of the MHRA, the Therapeutic Goods Administration, has established its own set of medical cannabis regulations.
This is now the most important factor in achieving medical cannabis law reform. Next time you contact your MP or in any advocacy or campaign work you do, this is where to focus your energy. Cannabis is a special case, it is not like other medicines. Once we can open the eyes to this truth the path ahead will be clear.
Any CBD products marketed in the UK as derived from ‘indica’ cannabis are illegal and you could be prosecuted for possession, importation or supply as with any other form of prohibited cannabis.
The situation which started last October with the MHRA trying to shut down marketing of CBD products arose because of irresponsible, cowboy companies making medicinal claims about their products. It was well understood by all professional CBD companies that this would cause problems and indeed it has. Only the intervention of CLEAR and the formation of the Cannabis Trades Association UK has saved the market from collapse.
We are deeply concerned to see that at least one company is now advertising some CBD products as derived from indica cannabis grown in the Netherlands. This is unlawful. The only cannabis strains that may be grown as industrial hemp and therefore used to produce exempt products are on the EU approved list. There are no indica strains.
You have been warned. Please do not endanger yourself.
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.
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.
This statement was published on the MHRA website at lunchtime today.
“Update 1 November 2016
An MHRA spokesperson said:
While MHRA has given its opinion that products containing cannabidiol (CBD) used for medical purposes are medicines, we have also carefully considered the needs of individuals using CBD products to treat or manage the symptoms of medical conditions.
Our primary concern is patient safety. In order to ensure that products remain available until individuals have the opportunity to discuss their treatment with their doctor, companies now have until 31 December 2016 to voluntarily operate within the law, by withdrawing their existing products from the market, or working with MHRA to satisfy the legal requirements of the Human Medicines Regulations 2012.
We have today written to the manufacturers of CBD to make them aware of the timeline for engagement.
It is vital that medicines meet safety, quality and efficacy standards to protect public health.”
Originally the MHRA wrote to CBD suppliers in threatening terms:
“You must cease to sell, supply, promote, advertise or process orders for the above products until appropriate authorisation has been granted for them. You must confirm this in writing within 28 days from the date of this letter that you have taken the above steps.”
So quite a change in tone. The MHRA seems to have recognised that contrary to its declared mission ‘to improve health’, its original statement actually endangered the health of tens of thousands of people.
Additionally, solicitors representing the UKCTA have now written to the MHRA seeking clarification of its intentions and making three crucial points:
- The letters to CBD suppliers and the MHRA’s original press statement have caused serious financial damage to the CBD industry.
- The MHRA has conducted no effective consultation with stakeholders.
- The MHRA’s own guidelines require it to consider each product on a case by case basis and a blanket ban on products containing CBD would be unlawful.
Professor Mike Barnes, scientific and medical advisor to CLEAR, commented:
“The MHRA’s new stance is an improvement from their previous position. However, I cannot see any value in delaying only a few months. Some patients might be able to find an alternative medicine from their doctor but many people will have already tried alternative medications and found that CBD is the only satisfactory treatment for their condition. This is the case, for example, for children with epilepsy who will have almost certainly have been under the care of a specialist and tried available anticonvulsants and found that CBD is the only treatment that works for them. The MHRA does not seem to realise the impact of this arbitrary and rushed decision which will clearly be detrimental and potentially have very serious (and in some cases life threatening) implications for some people. The MHRA need to work with the manufacturers and the medical profession to determine the best way forward that both recognises that cannabis based products have medicinal value, and as such need proper trials of efficacy and safety, yet on the other hand does not place existing users at risk of harm”.