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Peter Reynolds

The life and times of Peter Reynolds

Posts Tagged ‘MHRA

Cannabis and CBD. UK and EU Bureaucrats -v- The People and Parliament.

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For decades, public opinion and knowledge on cannabis has been way ahead of those in Parliament and civil servants in the Home Office and the Department of Health.

In other countries, governments have been more ready to update themselves on scientific knowledge and they are more speedily held to account through more effective democracies. At last, the UK Parliament has acted on access to cannabis for medical use as it should have 20 years ago.  Both Canada and the Netherlands introduced legal access in 2001 and California even five years before that.

But the will of Parliament is being stifled and subverted by bureaucracts in the NHS and the Department of Health.  As MPs are never shy to remind us, under our constitution, Parliament is supreme.  That makes the conduct of these civil servants unlawful.  They are being obstructive about the prescribing of cannabis.  They need to be compliant with the law or they become guilty of maladminstration.  We should have no more patience with this wilful misconduct.  Their responsibility is to facilitate implementation of the law, not find ways to delay it because of their personal opinions.

The same goes for the Home Office which has done absolutely nothing to revise its cannabis licensing policy in accordance with the new regulations.  Well-qualified, experienced, international corporations, willing to make multimillion pound investments in Britain to produce the cannabis-based products (CBPMs) which we need are being refused licences for no good reason. If the products are not available, how will they ever reach the patients who Parliament has decreed are entitled to access them?

For 50 years, the Home Office has run a systematic campaign of disinformation because it is institutionally opposed to cannabis. Until Sajid Javid, civil servants have thwarted the efforts of all minsters that have tried to introduce any drugs policy reform.  Now he has to stand up against the subversive forces within his own department or someone has to fund judical review of the Home Office’s maladminstration of cannabis licensing. Just as in the Windrush Scandal, the Home Office maintains a ‘hostile environment’ based on senior civil servants’ personal prejudices rather than the best interests of Britain and now, the law.

CBD. Big Pharma Protectionism, Bureaucrat Box-Ticking or Both?

Many people are not yet aware of the meddling that is going on with CBD products.  There is a real threat that they could be removed from sale within the next few months.  This depsite their soaring popularity with the public and that hundreds, if not thousands of people are now employed in our burgeoning CBD industry.

CBD products are, in fact, whole plant extracts from low-THC cannabis which meet the criteria under drugs law to be exempt.  They have become very popular because people were seeking a legal way of accessing the medicinal benefits of cannabis which have become widely understood, mainly as the internet has provided knowledge previously suppressed by government and media scaremongering.

Two years ago, the meddling began as civil servants from the MHRA, the medicines regulator, stepped in with heavy-handed threats to close the market down because of unlawful medicinal claims.  To be fair, there was good justification for this.  Medicines regulation is an essential function of government, otherwise we will have snake oil confidence tricksters selling coloured water as a cancer cure.  So CLEAR acted and organised a response to the MHRA from the leading CBD companies.  Now, the responsible and ethical companies have regulated themselves, stopped making medicinal claims and market their products as food supplements, just like vitamins and minerals than can help to maintain health and boost wellness.

So CBD companies have successfully negotiated their way through both drugs and medicines law but now the food police have stepped in with yet more problems.  This time the civil servants objections are entirely unnecessary and unjustifiable but they are the most serious threat that CBD companies and consumers have faced.

The Food Standards Agency (FSA) from the UK and its opposite numbers in other EU countries have placed cannabis extracts in the EU Novel Foods Catalogue, which is for products that have not been consumed to a significant degree in the EU before 1997. This means that without going through a lengthy and very expensive authorisation process, all CBD products could become unlawful to sell.

Why?  When I met with the FSA and its novel foods team just over a week ago, it acknowledged that the purpose of the novel foods regulations was to ensure that food products and supplements are safe.  It also confirmed that it had no evidence that cannabis extracts or CBD products are unsafe. So, on the face of it, this seems to be simply a matter of bureaucrats who want their boxes ticked, for no other reason than that is what bureaucrats do.

But the widely-held opinion from those in the know, is that what is really behind this are the vested interests of painkiller companies who are seeing a big impact on sales of their products. Even the World Health Organization has recently given CBD an unequivocal endorsement as safe and effective, whereas the toxicity of paracetamol, ibuprofen, other NSAIDs and opioids is now well understood.

You see, however CBD products are sold, it is an indisputable fact that they are purchased for their medicinal benefit – and that they work.  This is a big threat to pharmaceutical company profits and so they are wielding their big stick.  They tried through the MHRA to close down CBD and now they are trying through the FSA.

Exactly the same thing is happening in the USA.  The recent passage of the Farm Bill has removed CBD from the Controlled Substances Act but now the FDA (which combines the functions of our MHRA and FSA) has stepped in and said it is illegal to sell as a food supplement because it is the active ingredient in a licensed medicine.

We Will Overcome

So a battle royal is starting.  What the outcome will be is uncertain.  It is complex and multi-threaded.  Different strategies are being developed and varying ideas are being put forward as to how to deal with this threat.  Many people now rely on CBD for their health and the imminent threat of it not being available is a danger to individuals and so to our entire society.

Whatever happens, I am certain that commonsense and the people will prevail.  For a century, the use of cannabis as medicine has continued despite every effort from governments and vested interests to stamp it out.  The same will happen with CBD.  Even it it disappears from the high street, it will continue to be available online and if it can’t be sold as a food supplement, it will move into a new category.

Once again, it will take politicians far too long to wake up and out-of-control civil servants will try to pursue their own agenda which, I am quite sure, is under the corrupt and improper influence of big business.  It will be challenging and very difficult but the people have dealt with these dark forces before and we will continue to do so.

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Written by Peter Reynolds

February 10, 2019 at 2:19 pm

Daily Mail Profits From Illegal Advertising For Cannabis

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On the same day that the Mail publishes yet another inaccurate and misleading article on cannabis and CBD in particular, it is carrying a full page advertisement for CBD which breaches medicines, food and advertising law.

The ad, from Woods Supplements at https://www.woodshealth.com/, claims medicinal benefits for its product for joint pain, migraine, psoriasis, acne, depression, pain and inflammation.

While there is probably a substantial amount of truth in these claims, it is unlawful to make them without the product having a licence or marketing authorisation (MA) from the MHRA.

Why does this matter? I advocate for the medicinal use of cannabis in all its forms, so why would I object to any company making these claims?

Medicines regulation is essential, otherwise we will have people selling bottles of coloured water as a cancer cure.  Most CBD companies are responsible and understand it is unlawful to make medicinal claims, so irresponsible companies like Woods Supplements need to be stopped.  They are stealing business from responsible companies. So Woods Supplements is NOT a reputable company as it claims in its ad.

But despite the MHRA regularly flexing its muscles and talking tough, it does nothing.  There is simply no enforcement going on. Remember in 2016, it threatened to shut the entire CBD industry down over medicinal claims?  Most companies work extremely hard at considerable cost to stay compliant but the MHRA does nothing to support them.

As for the Daily Mail, scourge of truth about cannabis, profiting by illegal advertising, what should be done?  Well as these offences can result in a two year jail term and the publisher and editor of the Daily Mail are clearly complicit in them, when we can expect to see them marched from their desks in handcuffs?

Presumably the directors of Woods Supplements will be waiting at HMP Brixton to welcome them.

Written by Peter Reynolds

January 30, 2019 at 4:53 pm

Another Attack by Bureaucrats on CBD and its Consumers

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Today’s article in the Daily Mail on CBD follows that publication’s usual pattern – there is a kernel of truth but on top of that is piled inaccuracy upon misleading comment upon nonsense.

So let’s deal with the truth and send the nonsense back to the Daily Mail where it belongs.

Within the last few days it has emerged that the UK Food Standards Agency (FSA), has been working surreptitiously with its opposite numbers in four other EU countries to add all products derived from cannabis except hempseeds to the EU Novel Food Catalogue. This step has been taken without any communication or consultation with the CBD industry or the millions of consumers benefiting from the products. It is important to understand that inclusion in this catalogue does not create law.  Suppliers of CBD are entitled to continue marketing their products if they consider they are not ‘novel’.

What does ‘novel’ mean?  The EU novel foods legislation states that any food or ingredient used in foods that was not in widespread use prior to 1997 will be subject to an authorisation process that must demonstrate either evidence of widespread use prior to 1997 and/or that it is safe.

To be clear, the Daily Mail’s claim that this means “experts probe whether it has any real health benefits” is nonsense. It has nothing to do with that at all.

Love Hemp, CBD market leaders

Anyone who has any knowledge at all about cannabis will understand how ludicrous it is to suggest that it is ‘novel’ in any form.  It is even described as the oldest cultivated plant in the Guinness Book of Records. It is widely recognised to have been cultivated for at least 12,000 years.

So this move by the FSA and its equivalents in France, Germany, Italy and the Netherlands is, demonstrably, bureaucracy for bureaucracy’s sake. Cannabis is the oldest crop cultivated and used by mankind. Asking for evidence of its widespread use before 1997 is no different and as absurd as asking for the same evidence for wheat or barley.

The CBD industry and consumers faced a similar atack from the Medicines and Healthcare products Regulatory Agency (MHRA) in 2016.  Then, as now, it was CLEAR that stepped in and organised the response.  The MHRA quickly backed off, accepted that it had no power to carry out a wholesale shutdown of the industry and the leading CBD companies began a process of self-regulation which has led to the development of a very successful marketplace.  Millions of consumers now gain great benefit from CBD products which help to maintain health and improve wellbeing.

Whichever side of the Brexit debate you are on, it is precisely this sort of overbearing, oppressive bureaucracy at an EU level that led many people to vote leave. There can be no sensible suggestion that CBD is harmful.  In 2017, the World Health Organisation (WHO) published an unequivocal conclusion that CBD “does not cause harm”. It is, therefore, safe and is demonstrated to be so by thousands of years of use.  So why is the EU and the FSA, its agent in the UK, engaged in this spurious and wholly unnecessary attack?  Can it be for any other reason than simply to sustain the bureaucracy and create work for the bureaucrats keeping them in their comfortable jobs?

It remains to be seen whether the FSA will try to explain its actions.  CLEAR’s trade association for CBD businesses, Cannabis Professionals (CannaPro), has been dealing with the FSA for some time and trying, unsuccessfully, to obtain straight answers. We participated in a conference which included the Head of Novel Foods in December 2018 and only yesterday we wrote to him complaining that, if anything, the situation was becoming more confused.  Now, unconfirmed statements from the FSA suggest that it is requesting Trading Standards to work with it on ‘enforcement’ and to remove CBD products from shelves. In our view the FSA and Trading Standards would be exceeding their lawful authority if they took this action as inclusion in the EU Novel Food Catalogue does not represent law.

It’s also important to understand the context in which the FSA bureaucrats are flexing their muscles and trying to talk tough.  For some time, CBD isolate has been in the EU Novel Food Catalogue and it has been genrally accepted by the industry that it is genuinely novel.  All responsible businesses have stopped selling isolate but there are a host of disreputable companies still selling isolate and neither the FSA nor Trading Standards have taken any enforcement action whatsoever.

Similarly, when the MHRA tried to get tough in 2016, it had a legitimate complaint that unlawful claims of medicinal benefit were being made.  All responsible businesses have ceased to make such claims but the marketplace is still full of confidence tricksters and the MHRA has taken no enforcement action whatsoever.  There are full page advertisements appearing in newpapers (including the Daily Mail) making the most outrageous medicinal claims but the MHRA does nothing. And this lack of enforcement severely damages responsible businesses that are working hard to remain compliant.

So, the truth is that even when justified and necessary, no enforcement is taking place.  In austerity Britain, even if you report a burglary or a car theft, the police will do nothing about enforcement.  The FSA’s action may well cause some of the major retailers to step back from the market.  It will certainly cause unnecessary confusion and damage to this burgeoning market but there is zero chance that it will stop people buying and selling CBD products.  Thousands of jobs now depend on the British CBD industry and millions of people find the products helpful and beneficial.

Key Points of Advice and Guidance

Don’t panic.  If you’re using CBD it will continue to be available. You might find it easier to buy it online in future.

Don’t panic.  If you’re a CBD business, the future remains bright, you should be used to a few obstacles in your path!

Don’t panic.  If you are visted by Trading Standards, stay calm and explain that your products contain nothing ‘novel’ and have been in widespread use for hundreds of years.

Don’t panic.  All CannaPro Certified businesses will have support in compiling evidence that your products are not ‘novel’. You are entitled to be given time to submit this.

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A final point that needs to be made on this subject.  When CLEAR organised the successful response to the MHRA’s intervention in 2016, it led directly to the establishment of the Cannabis Trades Assocation UK (CTA).  For reasons concened mainly with the ethical conduct and antecedents of Mike Harlington, who we appointed to run the CTA, we, along with many CBD businesses have disassociated themselves. This is turn led to the formation of Cannabis Professionals.

One of the main concerns about Harlington were his false claims of a ‘special relationship’ with the MHRA and FSA. These events should put the final nail in the coffin of those lies.  He and the CTA have had more than two years to establish a successful working relationship with these authorities but this has clearly been an absolute failure.  More than ever, the UK’s legal cannabis, CBD and hemp businesses need proper and effective representation.  Clearly, the CTA is unable to provide that.

Cannabis Professionals. The Trade Association for the UK’s Cannabis, CBD and Hemp Businesses

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Cannabis Professionals (CannaPro) is the trade association for the UK’s cannabis, CBD and hemp businesses.

CannaPro will represent this fast-growing sector to the authorities, standing up to the Home Office, MHRA, FSA and Trading Standards, advocating for members’ interests, not acting as a government enforcer but as our members’ champion and to promote the development of the legal cannabis sector.

CannaPro will offer guidance and support to all businesses, helping them to navigate through law and regulations on drugs, medicines, food and cosmetics.

CannaPro will also launch a social media campaign, aiming to inform and educate the public about the benefits of CBD and the pitfalls.  The market is full of scammers, fake claims and snake oil salesmen.  Because of the historic stigma and fear around cannabis, government authorities are doing nothing, many people are misinformed and misunderstand.  CannaPro will explain the facts clearly and direct consumers to certified businesses which they can rely on.

Membership of CannaPro is without charge. All guidance will be published openly for everyone to benefit from. Free-of-charge support and answers to individual questions will be available online.

Businesses wishing to be certified by CannaPro will be reviewed for their products, trading standards, marketing and conduct. Certified companies will be entitled to display the CannaPro badge as a mark of quality, ethics and reliability.

Backed by CLEAR, the UK’s longest-established cannabis group with a network exceeding all other UK drugs policy groups combined, CannaPro members will benefit from CLEAR’s wide reach and influence with UK consumers.

Website: https://cannapro-uk.org

Facebook Group: https://www.facebook.com/groups/cannapro/

Written by Peter Reynolds

November 20, 2018 at 4:52 pm

The MHRA On CBD/Hemp Products And Its Relationship With Trade Associations

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This is an email from the MHRA to a CBD/Hemp supplier which name is redacted.  It clearly sets out the MHRA’s position regarding the Cannabis Trades Association, its ‘Cannabis Products Directive’ proposal and how anyone is able to obtain advice from the MHRA without having to join any trade association.  It also explains how medical claims may only be made about a CBD product if it has the required licence known as a marketing authorisation.

This is authoritative guidance from the medicines regulator which is an agency of the Department of Health and Social Care.  If you have received alternative guidance or suggestions that you must join a trade association to sell CBD products, this is incorrect.

 

From: xxxx.xxxx@mhra.gov.uk
Date: October 2018
Subject: CTA and CBD
To: Redacted

Dear xxxx,

Thank you for your email of 22ndSeptember 2018 to the Agency. Please note that we can only comment with regards to our position and advise you to contact appropriate Government Departments with regards to obtaining their views.

The CTA represent a number of companies in the UK who market CBD and they have proposed a framework, which they have termed the ‘Cannabis Products Directive’, that effectively sets out quality requirements for their members.

The Medicines Borderline Section of the MHRA has been clear from the outset that we will work with companies and trade bodies to ensure compliance in respect of CBD products. This is in line with our approach across the borderline and we do not require a company has membership of a trade body to enter into dialogue with us. There are a number of trade bodies, covering a range of product types who are well versed in borderline matters and they are able to advise companies but, if a company does not want to become a member, we can provide them with advice regarding their products. On occasions we may work with trade bodies; as they are able to communicate information on our behalf to their members and we may assist them if they want to come up with guidance on a specific aspect etc. However, ultimately MHRA is responsible the licensing of medicines and for the classification of borderline medicinal products and this cannot be passed to third parties.

We list a large number of trade bodies etc who have an interest in borderline matters in a ‘Useful addresses’ Appendix in our Guidance Note 8 (GN8).

Our current position with regards to CBD is as follows:

MHRA has offered an opinion on the regulatory status of CBD and advised that we are currently evaluating the evidence of pharmacological effect. At present we are providing the following general guidance to enquirers until we determine the status of CBD.

MHRA is of the opinion that products containing CBD, when used for a medical purpose, should be regulated as medicinal products. The MHRA’s opinion has been issued at this stage with the intention of seeking voluntary compliance by companies supplying CBD for medical purposes. This does not preclude MHRA from seeking to use Part 9 of the Human Medicines Regulations to classify any particular product.

A “medicinal product” is defined in Article 1 of Council Directive 2001/83/EEC and included as Regulation 2 of the Human Medicines Regulations. The definition is as follows:

(1) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or

(2) Any substance or combination of substances which may be used by 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”

In respect of the first limb of the definition, were you to market any product that makes a medicinal claim, this would mean that the product falls within the definition of a medical product. For the avoidance of doubt, you should also be aware that this includes any testimonies, studies, links to articles, historical uses etc that you may wish to include on your website or any other promotional material. Further guidance in relation to medicinal claims can be found in our Guidance Note 8

Insofar as the second limb of the definition of a medical product applies to your products, it is a matter of fact that there have been a number of clinical trials which demonstrate that CBD has a therapeutic effect, particularly in the treatment of severe epilepsy. MHRA’s clinical assessors have reviewed relevant scientific and clinical evidence to support the mode of action of CBD in the treatment of a range of medical conditions. It should also be noted that the European Medicines Agency has given CBD products an orphan designation on four occasions, for three different clinical conditions; graft versus host disease, perinatal asphyxia and Dravet syndrome.

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/orphans/2014/11/human_orphan_001425.jsp&mid=WC0b01ac058001d12b

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/orphans/2016/10/human_orphan_001832.jsp&mid=WC0b01ac058001d12b

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/orphans/2015/08/human_orphan_001612.jsp&mid=WC0b01ac058001d12b

The MHRA is now working with trade bodies in relation to making sure products containing CBD, used for a medical purpose, which can be classified as medicines, satisfy the legal requirements of the Human Medicines Directive as transposed into UK law by the Human Medicines Regulations 2012. This work is ongoing. Given the ongoing evaluation, MHRA can give no assurance that any particular product, including products under development, will not subsequently be classified as a medicinal product.

‘The advice contained within this email relates to the MHRA’s opinion regarding the status of CBD. The Home Office can advise on psychoactive substances and the Misuse of Drugs Act and any products which are subject to these regulations. Your products must comply with the relevant regulations at all times. It is possible that your products may contain residual levels of THC, and/or other controlled substances. We therefore advise that you contact the Home Office first who can advise in respect of psychoactive substances and the Misuse of Drugs Act. The Home Office can also advise with regards to what licences will be required to grow/import/export such products/substances from/into the UK. Please note that we are only providing general information above and this is in no-way, shape or form an approval of any product. We have not seen any information relating to the products in question and therefore, we cannot comment on its acceptability. If you wish to license your products as medicines in the UK then the attached links provide more information about how to obtain a marketing authorisation (MA) in the UK which we hope you will find helpful. Home Office has also published a Factsheet in respect of CBD and you are advised to review this first: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/674713/Factsheet-_Cannabis__CBD_and_Cannabinoids-_January_2018.pdf

The Agency reserves the right to change its view in the event of any information or evidence which has a bearing on the status of the products, including the way in which they are presented and promoted. This also includes any information, which we have not assessed. You should seek independent advice or consult a suitable trade association or the appropriate regulatory authority about the acceptability of any product you are considering selling, supplying or advertising.

The licensing process is by no means easy, especially with little regulatory knowledge.  We have included links below which will direct you to the relevant pages on the MHRA website.  As an indication of the Legal Basis, you should focus on an 8(3) Full Application, submitted under the complex fee.  A National procedure is for authorisation in the UK only.

In order to market the product in the UK, a Marketing Authorisation is required.  As there are no step by step guidelines, please see the below links for the submission of new marketing authorisation applications (MAA).

https://www.gov.uk/apply-for-a-licence-to-market-a-medicine-in-the-uk

(Guidance regarding how to apply for a market authorisation in the UK)

http://ec.europa.eu/health/documents/eudralex/vol-3/index_en.htm

(EU scientific guidelines for medicinal products)

https://www.gov.uk/apply-for-a-licence-to-market-a-medicine-in-the-uk#application-process-all-procedures

(Licence application forms)

https://www.gov.uk/apply-for-a-licence-to-market-a-medicine-in-the-uk#fees

(Fees)

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/313624/MHRA_fees_definitions.pdf

(MHRA fees definitions)

Furthermore,  to obtain marketing authorisations in the UK you must have a registered office or representative either in the UK or another EU member state. GMP (Good Manufacturing Practice) inspections will take place after marketing authorisation applications have been submitted if the site has not been inspected by an EU authority in the last 3 years and does not hold a valid GMP certificate.

Please see the below link with regards to the requirements for having Manufacturers and Wholesale Dealers licences: Importers Licence queries.

https://www.gov.uk/apply-for-manufacturer-or-wholesaler-of-medicines-licences

 

Written by Peter Reynolds

October 18, 2018 at 12:41 pm

Statement Concerning The Cannabis Trades Association UK

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With regret, I have withdrawn my endorsement of and support for the Hemp Trade Association Ltd (HTA) trading as Cannabis Trades Association UK (CTA).

I created and founded CTA in September 2016. Since November 2016, HTA has traded under the CTA name with my permission and I was appointed to its advisory board.  That permission has been withdrawn from 18th October 2018 and I have resigned from the advisory board with immediate effect.

The reasons behind this are complex and great effort has been made to resolve differences and agree a way forward but this has proved impossible to achieve.  The reasons include but are not limited to:

Systematic Dishonesty

Over the two years of HTA’s existence many false claims have been made, in particular about HTA’s relationship with the MHRA and FSA, alleged exclusive stakeholder arrangements and HTA’s ‘authority’ to regulate the CBD market.  Further claims have been made by the chairman about his links with the security services, other Home Office staff, ‘inside information’ and unlawful use of government computer systems to run DBS and criminal record checks on prospective members. HTA’s reputation and that of its members was severely damaged by the chairman’s recent conduct in relation to the States of Guernsey, which resulted in official government repudiation of his claims, and his personal feud with a major CBD supplier which is not a member.

Misuse of Members’ Funds

Members pay membership fees primarily in order to have their interests effectively represented to government and the authorities. In practice, very little if any of this takes place and instead membership fees are used to finance the chairman’s ambitions to establish the Cannabis Products Directive (CPD) across Europe. While some members are supportive of the CPD initiative, it is not HTA’s purpose, nor is extending HTA’s operations outside UK.

Failure to Represent Members’ Interests

Instead of representing members’ concerns and interests to the authorities, HTA acts as an enforcer for the authorities. The chairman has confirmed in writing that HTA will “never go against” and will always “work with the authorities”. Members who have complained about lack of action against non-compliant CBD suppliers have been told to “stop bitching”.  Non-compliant CBD suppliers is the issue of principal concern to members but HTA has failed to take this up effectively. As a result, it is a positive disadvantage to be a member of HTA as members are subject to stricter enforcement and additional costs than non-members.

Maladminstration of HTA, a Company Limited By Guarantee

HTA was fomed as company limited by guarantee deliberately to place control in the hands of its members rather than its directors. Members have not been properly included in decisions.  They have been subjected to autocratic rule, prevented from obtaining proxy votes and resolutions at general meetings have been railroaded through without time for proper discussion. Protests by members at such treatment have resulted in them being ejected from discussion groups.

Bullying, Threats and Intimidation

A large number of reports have been received from former and current members detailing instances of such behaviour as coercion to join HTA or to comply with HTA policies.

Chairman’s Antecedents

Evidence has come to light which reveals that the chairman has a string of 28 dissolved companies behind him and a large number of oustanding county court judgements relating to those companies. He is also indebted to the company of another director of HTA in a substantial five figure sum for a period in excess of two years with no effort made to commence repayment. As a result that director has now resigned.

Unlawful Restrictions on Members

Legal advice has been received which confirms that HTA has been exercising unlawful restrictions on members preventing them from trading freely.  This supports allegations that have been published accusing HTA of running a ‘protection racket’.

 

 

 

Written by Peter Reynolds

October 16, 2018 at 2:48 pm

CLEAR Advises Department of Health and MHRA on Definition of Cannabis-Derived Medicinal Products.

with 5 comments

Last week, CLEAR was invited to participate in a teleconference with representatives of the Department of Health and Social Care (DHSC) and the Medicines and Healthcare products Regulatory Agency (MHRA).  This followed our written submissions made over the last few weeks.

The teleconference included two representatives from each party. The DHSC was represented by the Medicines Pharmacy and Industry section. The MHRA was represented by the Licensing Division.

CLEAR has now submitted a summary of all the advice offered which is reproduced below.

1. The definition of cannabis-derived medicinal products (CDMP) is for products that will be re-scheduled in the Misuse of Drugs Regulations out of schedule 1 and ostensibly into schedule 2.  These products will be available for prescription by doctors.

2. With the exception of Sativex, a whole plant cannabis extract with a THC:CBD ratio of 1:1, there are no cannabis-derived medicinal products available in the UK which have been licensed by the granting of a marketing authorisation (MA) or a Traditional Herbal Registration (THR). THR licensing is for minor ailments only that do not require the supervision of a doctor. MA licensing would be required for any CDMP aiming to treat most of the conditions for which cannabis is currently being used illicitly unless such CDMPs are prescribed as an unlicensed medicine.

3. In every other jurisdiction in the world where CDMPs are legally available, governments have recognised that licensing regimes designed to regulate single molecule pharmaceutical medicines synthesised in a lab are not suitable for regulating CDMPs. All such governments have either established entirely new cannabis regulators or created a specialist division within the existing medicines regulator.  If there is a genuine intent to enable legal access to CDMPs by the estimated one million people currently using illicit cannabis as medicine, this is the only practical route forwards. The cost and length of time involved in obtaining an MA makes them prohibitive for a plant-based medicine. Given the experience of using cannabis as medicine over many millennia, its non-toxic nature and very low risk profile, the rigorous approach of an MA is unnecessary.

Recommendation 1. A CDMP regulator should be established encompassing genuine expertise in the use of cannabis as medicine. The Cannabis Trades Association UK (CTA) is already in the process of developing the Cannabis Products Directive (CPD) in co-operation with the MHRA and FSA.

4. There is no justification or evidence that can support cannabis being in such a restrictive schedule as schedule 2 alongside opioids and cocaine.  The potential for causing social harm, which is the criterion used to determine the correct schedule, is several orders of magnitude greater with all existing schedule 2 drugs. They are all demonstrated to produce far higher levels of problematic dependence and long-term health harms than cannabis.

Recommendation 2. CDMPs should be re-scheduled into schedule 4 alongside Sativex.

5. The primary objective of the definition should be to ensure that the products are safe. Cannabis is non-toxic with no practical lethal dose and any harmful health or social effects are only likely with sustained and abusive use. In normal, moderate and especially medical use the potential for any harm is extremely low, certainly no higher than with common over-the-counter medicines. The main safety considerations are therefore the risk of contamination during cultivation and in subsequent processes such as extraction and refinement of oils, arising from the use of pesticides, herbicides, nutrients and solvents.

6. The definition should be wide enough to encompass all cannabis products that are produced to specified quality standards. It should not be so narrow as to prohibit high THC and/or low CBD products that may well be appropriate in individual circumstances. Prescribing guidelines should be issued to enable doctors to make appropriate clinical judgements on appropriate THC:CBD ratios for different conditions. These guidelines must be compiled by experts in the use of cannabis as medicine, not by the ‘non-experts’ who have been appointed to the expert panel on cannabis-derived medicine.  FOI Requests have revealed that none of the members of the panel have any knowledge, experience or expertise in the use of cannabis as medicine.

7. The definition should be wide enough to provide for a future in which doctors can vary THC:CBD ratios and terpene content in accordance with evidence for therapeutic effect. For example, in paediatric epilepsy, CBD has been shown to be the most important compound but some children require a small percentage of THC for it to become effective.  Doctors should be free to vary dosage in the same way as they do with many licensed medicines in accordance with the way the patient responds.

8. Regulators/authorities will properly require some independent assessment of the safety of products as defined above. The only such assessments currently available are Good Manufacturing Practice (GMP) and certification by the Cannabis Trades Association UK (CTA). By definition, these certifications are only available for products that are legally available and CTA only operates within the UK where only exempt, low-THC products (known as CBD products) are legally available. GMP certification is available on some cannabis products legally available outside the UK.

9. Cannabis consists of around 500 molecules including approx. 110 cannabinoids, 120 terpenes and 20 flavonoids which provide the important therapeutic effects, most effectively, when working together in what is known as ‘the entourage effect’. The most significant cannabinoids are believed to be THC and CBD. THC has long been demonised as the principal psychoactive component but it has very important therapeutic effects, notably as an analgesic, an anti-spasmodic and an appetite stimulant. CBD works as an analgesic, anti-inflammatory, anxiolytic and anti-psychotic.  It is beyond doubt that they work best together as they enhance each other’s positive effects and ameliorate any side effects. It is vital that cannabis for medical use contains a balance of both.  In some conditions, THC is more important than CBD and in others the reverse will be the case. We recommend that for medical use the ratio of THC:CBD should ideally not be less than 10:1.  This will protect against any negative effects of THC which a very small proportion of patients may be vulnerable to. In most instances, for medical use, the ideal THC:CBD ratio will be 1:1. Doctors should however be free to prescribe outside these parameters including high THC and high CBD products, subject to prescribing guidelines.

Recommendation 3. The definition of CDMPs should be primarily concerned with safety in the production process. CDMPs should have either a. GMP certification b. CTA certification c. an existing MA d. an existing THR. The composition and cannabinoid ratios of CDMPs should be a matter for determination by doctors in accordance with prescribing guidelines.

Recommendation 4. Prescribing guidelines for CDMPs should be developed by experts in the use of cannabis as medicine, not by the ‘non-experts’ who have been appointed to the expert panel on cannabis-derived medicine. 

10. Cannabis has traditionally been smoked and millions of people have gained great benefit from it over many centuries. The principal benefits of smoking, which are extremely important, without any of the negative effects, can now be achieved through vaporising. The benefits are rapid onset of therapeutic effect and accurate self-titration of dose.  When ingested, either through the GI system or absorbed through the mucus membranes, onset is much slower, the effect is prolonged and accurate titration is very difficult to achieve. Vaporisers are already in widespread use and a variety of different types are available.  The Storz and Bickel ‘Volcano’ has a CE mark and is a licensed medical device in Canada and Israel. The Teva Pharma ‘Syqe’  has completed three clinical trials with positive outcomes for safety and efficacy.

11. Vaporised, pharmaceutical-quality, standardised herbal cannabis with consistent cannabinoid and terpene levels is the gold standard in the use of cannabis as medicine.  Presently the only way to achieve this in Europe is with GMP-certified cannabis produced by Bedrocan BV, the Netherlands government officially contracted producer.  Some Canadian producers are also GMP certified.

Recommendation 5. Vaporisers should be made available on loan, for subsidised purchase or free-of-charge in accordance with existing provision for those in receipt of benefits.

12. The DHSC should prevail on GW Pharmaceuticals to reconsider its pricing strategy on Sativex which is presently under a ‘do not prescribe’ edict from NICE on the grounds that it is not cost-effective. The price of Sativex is extraordinarily high and products which, for all practical considerations of safety and efficacy, are identical are available over-the-counter for one-tenth of the price in US cannabis dispensaries. There is no justification for the price of Sativex except for the recovery of the cost of clinical trials which GW Pharma was required to engage in in order to obtain a marketing authorisation.  GW Pharmaceuticals should also be encouraged to make herbal cannabis products available as an alternative to Bedrocan, something it should be able to achieve within a few months with little difficulty.

13. Cannabis extracts and oils will be required for some patients, particularly children, and those that cannot or do not wish to use inhalation via a vaporiser.  Prescribing guidelines must recognise that the pharmacology of cannabis is totally different when ingested through the GI system or absorbed through the mucus membranes.  Absorption of oil through suppositories has also been found to a valuable method of ingestion.

14. While CLEAR fully supports decriminalisation of domestic cultivation of cannabis for personal use, homegrown cannabis should never be considered part of a therapeutic programme under the supervision of medical professionals.  The potential for contamination and poor quality is far too high.

Recommendation 6. In the short term, aside from low-THC exempt products known as CBD products, the only CDMPs readily available are from GW Pharmaceuticals, Bedrocan BV or Canadian producers, notably Tilray. Standardised herbal cannabis for vaporising or oils for other methods of ingestion should be available from these producers immediately.

15. Originally Nick Hurd MP, the Home Office minister, wrote in The Times, 29th June 2018, that cannabis would be rescheduled and could be prescribed by GPs whenever a benefit could be identified. Without any explanation that now appears to have morphed into ‘specialist’ or ‘senior’ clinicians and only in cases of ‘exceptional clinical need’.  As well as a broken promise which is causing widespread consternation, this is irrational, as are suggestions that cannabis should be regarded as a medicine of last resort.  The safety profile of cannabis is such that any rational, evidence-based policy would suggest cannabis as a medicine well before many analgesics, anxiolytics and anti-depressants which are widely, readily and regularly prescribed by doctors without any concern.

16. A workable definition of CDMPs together with well-informed prescribing guidelines that enable prescription by GPs for any condition where a benefit is identified is essential. Unless this is satisfactorily achieved, the one million people in the UK currently using cannabis as medicine will continue to do outside the law, outside any form of medicines regulation and without any medical supervision.  The likelihood is that this cohort of patients will continue to expand rapidly as knowledge of the therapeutic benefits of cannabis and its use in other countries becomes more widespread. The implications of failing to establish a proper regime are very significant for health, patient-doctor relationships, the criminal market in cannabis, the police and the criminal justice system. This is a nettle that must be grasped.

Recommendation 7. CDMPs should be available in accordance with the Home Office’s initial commitment, that is on prescription by GPs for any condition where a benefit can be identified