Posts Tagged ‘medicine’
The UK Government’s Very Last Excuse For Denying Access To Medicinal Cannabis.
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.
Grubby, Corrupt Deal Between Brown And Dacre
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.
Home Secretaries Have A Lot To Answer For
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.
The Facts About CBD In The UK. December 2016.
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.
CLEAR 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.
Cruel And Irresponsible Response from UK Government To Parliamentary Report On Medicinal Cannabis.
Unsurprisingly perhaps, the response to the recent call from MPs and peers to legalise cannabis for medicinal use has come straight from the top. Theresa May’s longstanding reputation as a denier of science and evidence on drugs policy is reinforced by her peremptory dismissal of the expert report. It seems that, at least in the short term, the UK government is sticking by a policy that is discredited, ridiculous and deeply cruel.
It fell to Sarah Newton MP, minister of state at the Home Office, to respond to a parliamentary question from Roger Godsiff, Labour MP for Birmingham, Hall Green.
Roger Godsiff MP
“To ask the Secretary of State for the Home Department, if she will respond to the recommendations of the report by the All-Party Parliamentary Group for Drug Policy Reform Accessing Medicinal Cannabis: Meeting Patients’ Needs, published in September 2016.”
Sarah Newton MP
“The Prime Minister responded to the All-Party Parliamentary Group for Drug Policy Reform’s report ‘Accessing Medicinal Cannabis: Meeting Patients’ Needs’ on the 27 October.
Cannabis is controlled as a Class B drug under the Misuse of Drugs Act 1971 and, in its raw form, currently has no recognised medicinal benefits in the UK. It is therefore listed as a Schedule 1 drug under the Misuse of Drugs Regulations 2001.
It is important that all medicines containing controlled drugs are thoroughly trialled to ensure they meet rigorous standards so that doctors and patients are sure of their efficacy and safety. To do otherwise for cannabis would amount to a circumvention of the clearly established and necessary regime for approving medicines in the UK.”
In other words, this is nothing more than a re-statement of the same position that the UK government has held since 1971 when legal access to medicinal cannabis was halted. Quite clearly the government has given no consideration at all to the vast amount of scientific evidence and international experience that has accumulated over the last 45 years. The latest report which took nine months to produce, took evidence from over 600 witnesses and included a review of over 20,000 scientific studies is simply cast aside. To be honest, I doubt whether it has even been read by Ms May or anyone in the Home Office or Department of Health. This is the standard that now prevails in the UK – government of the people by an unaccountable, out-of-touch, unresponsive cabal of individuals elected by a deeply flawed system that gives democracy a bad name.
On the face of it, the claim that all medicines must be thoroughly trialled seems plausible – but it is not. It is a misleading half-truth clearly intended to squash the call for access to medicinal cannabis by painting a false picture.
Doctors are allowed to prescribe any medicine, licensed or unlicensed, as they see fit, based on their own judgement. But prescribing of cannabis is specifically prohibited by Statutory Instrument despite the scientific consensus that it is far less dangerous than many, probably most commonly prescribed medicines.
So it’s not a level playing field. It’s a policy that is based on prejudice and scaremongering about recreational use of cannabis. Ms Newton’s answer is at best disingenuous but then she probably doesn’t even realise that herself. For many years Home Office policy has been systematically to mislead and misinform on cannabis and evidently under Ms May’s successor, Amber Rudd MP, such dishonesty continues.
Theresa May MP
Something will eventually force the government’s hand to change its absurd position on cannabis. Sadly the very last consideration will be scientific evidence or the will of the people. Such factors hold no sway with UK governments. Only when enough of the political elite open their eyes and examine their conscience, or some key individuals or their family members, experience the need for medicinal cannabis will change become possible. Alternatively, political upheaval may present an opportunity. The Liberal Democrats were too cowardly, weak and concerned with building their personal careers when in coalition to advance the cause they now so bravely advocate. Perhaps the SNP, with 56 MPs, all in favour of medicinal cannabis may be our best hope.
Sarah Newton is merely a puppet of the Home Office bureaucracy. Theresa May’s mendacious position on all aspects of drugs policy is well established and she is as stubborn and bigoted as they come on such matters. Only when she, in person, is subject to sufficient pressure will this cruel, ignorant and hateful policy change.
Guidelines On Cannabis For Medical Professionals.
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
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.
CLEAR Statement Concerning Cannabis Legalisation Measures In US Election.
“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
Report Of Meeting With MHRA On Regulation of Cannabidiol (CBD).
Tom Whettem, Canabidol; Anthony Cohen, Elixinol UK; Tom Rowland, CBD Oils UK; Karl Spratt, Hempire; Peter Reynolds, CLEAR Cannabis Law Reform; Mike Harlington, GroGlo Research & Development
Yesterday, 3rd November 2016, six delegates from the UK Cannabis Trade Association (UKCTA) met with Medicines and Health Products Regulatory Agency (MHRA) representatives at the agency’s headquarters in Victoria.
We were courteously received. The meeting was cordial, productive and enabled both sides to clarify their positions and better understand each other’s perspective.
In summary, in my opinion, there is no immediate threat to to CBD consumers or businesses. The MHRA has now extended until 31 December 2016 the date by which businesses should voluntarily comply with its opinion, either by withdrawing existing products from the market, or by complying with necessary regulation. Thereafter, the next step would be to begin the process of statutory enforcement. This would take a matter of some months and I believe, even were this to be started, we are looking at more than a year before any impact would be felt. More importantly, based on the meeting, I think the outcome is likely to be that we can negotiate a form of regulation that will work for everyone.
The MHRA team was led by Gerald Heddell, Director of Inspection, Enforcement and Standards. Also present were regulatory advisors David Olszowska and Chris Groutides; Dr Chris Jones, Manager of the Medicines Borderline Section; Greg Markey, Senior Medical Assessor and Malcolm Evans, Head of Patient, Public and Stakeholder Engagement. Mr Heddell opened the meeting by thanking us for bringing to the agency’s attention just how many people are using CBD, some for quite serious medical conditions.
The MHRA set out its reasons for its opinion that products containing CBD used for medical purposes are medicines. Greg Markey explained the mechanisms of action and pharmacology that had been considered and Dr Jones explained that the Borderline Section existed to deal specifically with products where it was difficult to determine whether they should be regarded as medicines or food supplements. The example was offered of vitamin C where if it was being used to treat scurvy then it was clearly a medicine, whereas if it was used to supplement a normal diet it could be regarded as a food supplement. We were able to explain that all so-called CBD products on the market, with the exception of crystals, are actually whole plant extracts from low-THC cannabis, usually industrial hemp. We pointed out that the growth in the CBD market had been driven by people seeking the therapeutic benefits of medicinal cannabis which until now had been denied by the British government.
The nub of the issue is really the nature of the condition for which CBD is used. The MHRA has already issued orphan designations for CBD for Dravet Syndrome, graft versus host disease and perinatal asphyxia. Orphan designations are granted where the benefit of a medicine can be recognised even though necessary regulatory processes have not yet been completed. It is important to understand that this is what has guided the MHRA’s opinion, viewing CBD as a medicine for very serious conditions.
We discussed a range of options whereby, at the lowest level, CBD products could continue to be marketed as a food supplement. For minor conditions, not requiring medical supervision, it may be possible to obtain a Traditional Herbal Registration (THR) at a cost of a few hundred pounds. A third option is a ‘Specials’ exemption where a doctor or prescriber has specified and taken responsibility for an unlicensed medicine for a particular patient. Finally, the highest level is a Marketing Authorisation (MA) where the costs including fees and clinical trials are probably a minimum of £250,000.
It is our view that CBD products should be regulated at all these different levels dependent on the purpose for which they are used and the concentration at which CBD is present. We have agreed that we will write formally setting out these proposals and the MHRA will respond accordingly.
The UKCTA and a number of individual companies have now obtained legal advice including counsel’s opinion. We have shared this with the MHRA and formal solicitors letters have already been served. In essence, the advice is that the MHRA has failed to comply with its own guidelines and requirements in issuing its opinion to CBD suppliers and that any requirement to comply with regulations would have to be addressed on an individual, product by product basis.
So, all in all, we believe the meeting was a success. We demonstrated that the new trade association is to be taken seriously and that we will work constructively with the agency. There was visible surprise at the level of professionalism we presented, particularly with the legal advice we had obtained. I believe we convinced the MHRA that we could establish a set of rules, guidelines and standards that would enable the industry to comply with its requirements.
The CBD market in the UK is presently worth several million pounds a year. If it is to continue to grow, provide safe, effective products for consumers and patients and job security for its workers, then we need to establish UKCTA so that it effectively represents the whole industry. We need to show that we are responsible, we care, we are professionals and we are ready to put our collective head above the parapet as a legal, ethical and regulated industry.
MHRA Backtracking Super Fast On CBD Ban.
In advance of the meeting between the UK Cannabis Trade Association (UKCTA) and the MHRA on Thursday, there has been a flurry of activity which amounts to a climb down by the regulator.
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
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”.
