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PROSPECTUS
ADVANCING ACCESS TO MEDICINAL CANNABIS IN THE UK OCTOBER 2019
The Centre for Medicinal Cannabis (CMC) is the UK’s first and only membership body for stakeholders in the medicinal cannabis sector operating in the cannabis-based
medicinal products (CBMPs) and cannabidiol (CBD) wellness markets.
We have a unique capability to engage intelligently and strategically with all influential political and public policy stakeholders as well as relevant regulatory bodies.
We exist to promote the sectors, both in the interest of our members and also to advance access to high-quality products for patients and all those who benefit from their use.
2
About CMC
The CMC was launched as a not-for-profit industry body in December 2018. We exist to increase access to medicinal cannabis and regulated CBD products in the United Kingdom for all who will benefit. We will deliver this remit through a programme of policy formulation, political engagement, key stakeholder management, education, public events and advocacy.
We follow a strategic, innovative and evidence-based approach to ensure we impact on relevant public policy deliberations by broadening the range of institutions and influencers involved, presenting new data and global perspectives, and ensuring that progressing legal patient access to medicinal cannabis remains high profile.
CMC financial supporters are comprised of global industry leaders, investors and philanthropists. Our business members are of impeccable repute. Our programme of work is agreed quarterly at board meetings. Delivery is through a multidisciplinary team and we are advised by an eminent Council of Clinicians.
Introduction Mission Statement
A Vision for the UKThe United Kingdom - drawing on the inherent strengths of its publicly funded National Health System, top-tier research universities, and world class life sciences sector - should be the home to the safest, most innovative, and best regulated medicinal cannabis market anywhere in the world - one that not only improves patient health and reduces suffering, but contributes substantially to scientific progress and the evidence base globally for this new frontier in medicine.
CENTRE FOR MEDICINAL CANNABIS
Prospectus
About CMC
Introduction
Mission Statement
CMC Team
Clinician and Scientist Board
Advisory Board
Support and Funding
CBD
CBD Charter Overview
CMC in the CBD space
CBD Market Study
Novel Foods
CMC Work
Engaging Policy Stakeholders
Reports
Events
Advisory Statements
Consultation
CMC Network
Policy Stakeholders
Experts
Clinical Researchers
Clinicians (Prescribers & Medical Practitioners)
Patients
Members
CMC Membership Benefits
Join Us
3
About CMC
The CMC is managed by a multidisciplinary team of experienced professionals from a broad range of industries.
We are all dedicated to ensuring that UK patients who could benefit from medicinal cannabis can access CBMPs and that CBD wellness products are sensibly regulated.
CMC Team
Founder
Paul was an internet entrepreneur, he is now an investor in FinTech businesses. He’s passionate about people who can benefit from medicinal cannabis having affordable, informed access through the medical profession, both in the UK and globally. Philanthropically he’s funded CMC and Volteface. He’s not, and will never be, an investor in the cannabis sector.
Paul Birch
Regulatory & Compliance Lead
Parveen Bhatarah, PhD, FRSC, completed her PhD in organic chemistry, The synthetic approach to Nagilactone, at Imperial College London and is a Fellow of the Royal Society of Chemistry. She has held various directorship roles in the generic and herbal pharmaceutical industry; she has over 20 years of expertise in bulk drug substance and product development, including clinical trials, commercial launches, technology transfers and manufacture for ANDA & MA submissions. She has developed several innovative technologies in pharmaceutical fields as is clear from her patents. She has worked closely with various international health authorities on numerous commercial generic pharmaceutical and herbal pharmaceutical product launches and submissions. Most recently, in the cannabis space she was instrumental in the THC project for seed-to-capsule development, passing pre-approval inspection by US-FDA.
Dr Parveen Bhatarah
CENTRE FOR MEDICINAL CANNABIS
Prospectus
About CMC
Introduction
Mission Statement
CMC Team
Clinician and Scientist Board
Advisory Board
Support and Funding
CBD
CBD Charter Overview
CMC in the CBD space
CBD Market Study
Novel Foods
CMC Work
Engaging Policy Stakeholders
Reports
Events
Advisory Statements
Consultation
CMC Network
Policy Stakeholders
Experts
Clinical Researchers
Clinicians (Prescribers & Medical Practitioners)
Patients
Members
CMC Membership Benefits
Join Us
4
About CMC
Pharmacy Lead
Andy has over 15 years’ pharma experience working in the medical, commercial, business development and strategy functions. He has extensive experience in all aspects of medicine development programmes and was responsible for multiple collaborative agreements with academia, biotechnology and peer pharma. Andy is a UK pharmacist who received his PhD in cannabinoid medicinal chemistry from the University of Nottingham. He runs an independent pharmaceutical consultancy and holds an Honorary Lectureship at Keele University.Ad eost, volut ommoditate eate eles
Dr Andy Yates
Strategic Counsel
Steve is the Founder and Director of Volteface with 25 years’ experience of working in social change and political campaigns. He directed the campaign with Charlotte Caldwell to reform policy relating to access to medicinal cannabis. Steve was formerly Chief Executive of David Cameron’s Big Society Network and has curated change programmes for Channel 4 Television, the Royal Society of Arts and PWC.
Steve Moore
Science Lead
Saoirse has been researching the role and effects of endocannabinoids and phytocannabinoids through basic and clinical research for 17 years - see her research on Research Gate and Google Scholar. Saoirse works with patient groups and healthcare professionals to educate them on the benefits of cannabis-based medicines. Saoirse runs the independent consulting business CanPharmaConsulting and is scientific advisor to several pharmaceutical companies.
Dr Saoirse O’Sullivan
CENTRE FOR MEDICINAL CANNABIS
Prospectus
About CMC
Introduction
Mission Statement
CMC Team
Clinician and Scientist Board
Advisory Board
Support and Funding
CBD
CBD Charter Overview
CMC in the CBD space
CBD Market Study
Novel Foods
CMC Work
Engaging Policy Stakeholders
Reports
Events
Advisory Statements
Consultation
CMC Network
Policy Stakeholders
Experts
Clinical Researchers
Clinicians (Prescribers & Medical Practitioners)
Patients
Members
CMC Membership Benefits
Join Us
5
CMC NetworkAbout CMC
Development Director
Shomi is an entrepreneur who has worked across multiple sectors in Europe and Asia. He moved into the cannabinoid space two years ago after having experienced first-hand how beneficial these readily available products could be and has since focused his efforts in bringing quality standards to the industry. He was instrumental in setting up the Cannabinoid Trust - a not-for-profit organisation assisting many companies with product testing.
Shomi Malik
Development & Quality Lead
Marc has spent the past 10 years studying holistic medicines, cannabinoids and manufacturing. More recently Marc has consulted for some of the largest CBD manufacturing companies in the UK. His far-ranging experience covers plant genetics, cultivation, extraction, product development and mass manufacturing as well as the legislative and compliance aspects of the industry.
Marc Burbidge
Operations Director
Victoria started in Corporate Social Responsibility for large private companies but soon felt disillusioned by the lack of actual impacts and differences being made in communities that needed support. This subsequently led her to work in the third sector, collaborating with think tanks and charities.
Victoria became interested in alternative therapies and medicines through her experiences teaching yoga, which then led her to explore and become an advocate for medicinal cannabis, striving for a drastic change in UK legislation.
Victoria Logan
CENTRE FOR MEDICINAL CANNABIS
Prospectus
About CMC
Introduction
Mission Statement
CMC Team
Clinician and Scientist Board
Advisory Board
Support and Funding
CBD
CBD Charter Overview
CMC in the CBD space
CBD Market Study
Novel Foods
CMC Work
Engaging Policy Stakeholders
Reports
Events
Advisory Statements
Consultation
CMC Network
Policy Stakeholders
Experts
Clinical Researchers
Clinicians (Prescribers & Medical Practitioners)
Patients
Members
CMC Membership Benefits
Join Us
6
About CMC
We exist to increase access to medicinal cannabis and regulated CBD products in the United Kingdom for all who will benefit...
‘‘‘‘
Research Lead
Former Political Director of United Patients Alliance who provide advocacy, support and education for medicinal cannabis patients whilst campaigning and lobbying for legal access in the UK. He is interested in the relationship between medicinal cannabis and mental health. Jon joined the campaign for legal access to cannabis as a medicine in 2014.
Jon Liebling
CENTRE FOR MEDICINAL CANNABIS
Prospectus
About CMC
Introduction
Mission Statement
CMC Team
Clinician and Scientist Board
Advisory Board
Support and Funding
CBD
CBD Charter Overview
CMC in the CBD space
CBD Market Study
Novel Foods
CMC Work
Engaging Policy Stakeholders
Reports
Events
Advisory Statements
Consultation
CMC Network
Policy Stakeholders
Experts
Clinical Researchers
Clinicians (Prescribers & Medical Practitioners)
Patients
Members
CMC Membership Benefits
Join Us
7
About CMC
The CMC’s Council of Clinicians and Scientists provides a source of expertise and insight into the potential of medicinal cannabis treatments relating to a broad array of conditions. We advise public healthcare institutions in the UK as they get to grips with prescription and patient guidelines introduced by the NHS on 1 November 2018.
The Council injects impetus into the drive to create more private-public partnerships to progress clinical and other studies to help generate the data that will inform future clinical decision making.
Clinician and Scientist BoardAn authoritative panel of senior specialist cannabis clinicians and scientists.
Charles Akle is a Fellow of the Royal College of Surgeons and was awarded the prestigious Hallett Prize, in addition to a number of awards and prizes in his undergraduate career. He trained in Medicine at Guy’s Hospital in London and researched into transplantation and immunology early in his career, obtaining his Master of Surgery degree. This set the scene for his return to active medical research after retirement.
He was a prominent London-based surgeon and a pioneer in the development of laparoscopic surgery, helping to train many of today’s excellent surgeons in Europe. He was also active in establishing and promoting a better relationship between the private and public health sectors in the UK, building on the fact that many new developments in medicine, such as In vitro Fertilisation and laparoscopic surgery, began in the private sector.
Dr Charles Akle
As Chief Medical Officer, Dr Keith Aqua brings more than 25 years of industry experience as a certified clinical investigator to Mile High Labs. He is responsible for the development of Mile High Labs’ clinical trial program to advance the world’s research on CBD applications and their medical effects on humans.
Alongside his clinical research, Dr Aqua is a board certified obstetrician/gynecologist with a thriving private practice. He received a BA from the University of Pennsylvania and an MD from the Ohio State University. After completing his residency at the University of Arizona Health Sciences Centre, he co-founded the Institute for Women’s Health and Body, a large single-specialty group located in Palm Beach County, Florida. In 2001, he founded Visions Clinical Research and in 2015 the Atlantic Clinical Research Collaborative.
Dr Keith Aqua
CENTRE FOR MEDICINAL CANNABIS
Prospectus
About CMC
Introduction
Mission Statement
CMC Team
Clinician and Scientist Board
Advisory Board
Support and Funding
CBD
CBD Charter Overview
CMC in the CBD space
CBD Market Study
Novel Foods
CMC Work
Engaging Policy Stakeholders
Reports
Events
Advisory Statements
Consultation
CMC Network
Policy Stakeholders
Experts
Clinical Researchers
Clinicians (Prescribers & Medical Practitioners)
Patients
Members
CMC Membership Benefits
Join Us
8
About CMC
Dr Atkinson has comprehensive academic and industry experience in technology development, project management, new product application, and systems optimisations in medical, drug development, genomics and biological applications. He is a member of the founding team developing Grow Biotech from a start-up to an international cannabis biotechnology company.
Dr Atkinson is also the co-founder / COO of Cannabis research company Lunaverse Inc., co-founder / CTO of medical device company Innovative Trauma Care Inc. and CSO of Biobasix Solutions Inc., a management consulting firm that developed novel therapeutics for rare diseases.
He has a combined PhD in Plant Molecular Biology and Biochemistry from the University of Alberta and a post-doctoral fellowship at University of California Berkeley.
Dr Ian Atkinson
Dr Matthew Brown MD (Res) MRCS FRCA FFPMRCA is a consultant in pain medicine. Matt trained at King’s College London, winning the War Memorial and Wolfson Foundation Scholarships and graduating with distinction. His clinical training in pain medicine was conducted at The Royal National Orthopaedic Hospital and the National Hospital for Neurology and Neurosurgery in London. Matt fulfilled his long-term interest in clinical research by gaining a National Institute for Health Research Academic Clinical Fellowship. This enabled him to conduct novel, award-winning research into pain at both Imperial College and King’s College, London. Subsequently Matt completed a Doctorate in Medicine at the Institute of Cancer Research (becoming the first anaesthetist in the Institute’s history to do so and winning the Chairman’s Prize at graduation). Matt has published and lectured widely on the subject of pain in cancer.
His research interests include pain in cancer survivors and unmet need in this population, persistent post-surgical pain, chemotherapy induced peripheral neuropathy (CIPN) and the use of medical cannabis.
Dr Matthew Brown
Daniel Couch, MB ChB MRCS MBA PhD, completed his medical degree in 2007, graduating from the University of Leicester, and has worked internationally in General Surgery after achieving membership of the Royal College of Surgeons in 2011.
Daniel completed his PhD in 2018 from the University of Nottingham on cannabinoid pharmacology, focusing on the use of CBD in humans, and has 12 internationally published scientific papers.
Daniel also recently completed his MBA from the University of Nottingham, graduating as the highest ranked student of the year. He has ongoing interests in entrepreneurship, having started two successful companies.
Dr Daniel Couch
CENTRE FOR MEDICINAL CANNABIS
Prospectus
About CMC
Introduction
Mission Statement
CMC Team
Clinician and Scientist Board
Advisory Board
Support and Funding
CBD
CBD Charter Overview
CMC in the CBD space
CBD Market Study
Novel Foods
CMC Work
Engaging Policy Stakeholders
Reports
Events
Advisory Statements
Consultation
CMC Network
Policy Stakeholders
Experts
Clinical Researchers
Clinicians (Prescribers & Medical Practitioners)
Patients
Members
CMC Membership Benefits
Join Us
9
About CMC
David Casarett, MD, MA, is a palliative care physician and health services researcher whose major research interest is understanding and improving the way that health systems care for patients near the end of life. He is a Professor of Medicine at Duke University and the Chief of Palliative Care for Duke Health where he directs the Duke Center for Palliative Care.
Dr Casarett is the principal of Cannabis Outcomes, a full-service research and consulting group focused on bringing methodological expertise to medical cannabis research and care delivery.
Dr David Casarett
Professor Uri Kramer is a former Director of Paediatric Epilepsy Service at Tel Aviv Sourasky Medical Centre in Tel Aviv, Israel.
Professor Kramer led research into medical cannabis treatments for severe cases of epilepsy, in which he is an acknowledged global expert. He has a wealth of experience in various fields (Neurology, Paediatric Neurology and Child Development). He advises and helps direct the key strategy for the commencement of clinical trials using medicinal cannabis for severe epilepsy and nausea in Australia and Europe.
Professor Kramer was the President of the Israeli League Against Epilepsy, giving him unique insight into the daily struggles of the patients his research benefits. Currently he is a Professor of Paediatrics in Tell Aviv University. He has been a Member of the Strategic Advisory Board at MGC Pharmaceuticals Limited since July 2016.
Prof Uri Kramer
Rosemary Mazanet, MD, PhD, is the Chief Science Officer at Columbia Care, and has been the Chair of their Scientific Advisory Board since 2014.
Trained as an internist and oncologist in the Harvard Hospitals, she moved to early Amgen, Inc. where she led clinical development teams that filed successful INDs and Marketing applications in the 1990s. She subsequently moved to apply her expertise to the public equity markets in NY, where she was well known in the Biotechnology and Specialty Pharma sectors.
She has held roles as a Director or a consultant to many companies and firms, and has been a Trustee of the University of Pennsylvania Health System (her alma mater) for more than a decade.
Dr Rosemary Mazanet
CENTRE FOR MEDICINAL CANNABIS
Prospectus
About CMC
Introduction
Mission Statement
CMC Team
Clinician and Scientist Board
Advisory Board
Support and Funding
CBD
CBD Charter Overview
CMC in the CBD space
CBD Market Study
Novel Foods
CMC Work
Engaging Policy Stakeholders
Reports
Events
Advisory Statements
Consultation
CMC Network
Policy Stakeholders
Experts
Clinical Researchers
Clinicians (Prescribers & Medical Practitioners)
Patients
Members
CMC Membership Benefits
Join Us
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About CMC
Jonathan Page, PhD, is Aurora’s Chief Science Officer, responsible for overseeing all science-related initiatives. The Aurora science team undertakes cutting edge research on plant breeding and genetics, biomedical applications of cannabinoids, cultivation technology and product development. Dr Page is a globally renowned cannabis scientist, with 37 peer-reviewed publications, and was the co-lead of the Canadian team of scientists who first sequenced the cannabis genome.
His work also helped discover the biochemical pathway leading to the major cannabinoids. Prior to his appointment, Dr Page served as CEO of Anandia, the world-leading cannabis science company he co-founded.
Dr Jonathan Page
Chief Medical Officer, Althea
Dr Robert Pawinski is an experienced Pharmaceutical Physician in both academia and industry. Robert has led a clinical, epidemiology and health economics research team where he was principal investigator in multiple trials, as well as working as a clinician in the private and public sectors in the UK and abroad. Robert has extensive senior experience in two of the Big Five Global Pharma, and small and mid-sized pharmaceutical companies in a leadership role as QPPV, EU Medical Director.
Robert also has experience working at a senior government level with bodies like the WHO, NICE, the MHRA and EMA. He also also has deep knowledge of the EU and emerging markets from access and clinical trial perspectives, with over 27 peer-reviewed publications on pain and infectious diseases, including in The Lancet and JAIDS.
Dr Robert Pawinski
Zeid Mohamedali, MD, PhD, FRCSC, serves as a Consulting Urologist at several hospitals in British Columbia.
Dr Mohamedali has over 20 years of experience in medical research and clinical practice, with expertise in oncology and urology. He has been a member of the Medical Advisory Board of Urodynamix Technologies Ltd. since February 2007, and has served as its Director since November 2006.
He has received numerous awards and honours for his research from the American Urological Association, the Canadian Cancer Society, the Natural Sciences and Engineering Research Council of Canada and the Medical Research Council of Canada. He is a Fellow of the Royal College of Physicians and Surgeons, and is Board Certified in Urology by the Medical Council of Canada. Dr Mohamedali received his MD and PhD degrees from the Faculty of Medicine at the University of British Columbia.
Dr Zeid Mohamedali
CENTRE FOR MEDICINAL CANNABIS
Prospectus
About CMC
Introduction
Mission Statement
CMC Team
Clinician and Scientist Board
Advisory Board
Support and Funding
CBD
CBD Charter Overview
CMC in the CBD space
CBD Market Study
Novel Foods
CMC Work
Engaging Policy Stakeholders
Reports
Events
Advisory Statements
Consultation
CMC Network
Policy Stakeholders
Experts
Clinical Researchers
Clinicians (Prescribers & Medical Practitioners)
Patients
Members
CMC Membership Benefits
Join Us
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About CMC
Our approach is strategic, innovative and evidence-based to ensure we impact on relevant public policy deliberations...
‘‘‘‘
Alistair Vickery is Executive Medical Director of Emerald Clinics, an Australian network of bespoke independent medical clinics using real world data for evidence-based management of cannabinoid therapy. He is a specialist general practitioner with more than 30 years’ experience in clinical practice, education and research. He is the Adjunct Associate Professor of Primary Health Care at the University of Western Australia and Chair of Black Swan Health: one of the largest not-for-profit primary health care service providers in Western Australia.
Alistair has extensive research experience employing big data to provide high-level analysis and statistical modelling to determine effective placement of clinical services, equity in health service delivery, and better health outcomes. Alistair has designed and delivered medical education across the continuum of medical training from undergraduate to continuing professional development.
Prof Alistair Vickery
World-renowned pain specialist and medical cannabis researcher Dr Mark Ware, director of clinical research at the Alan Edwards Pain Management Unit of the McGill University Health Centre (MUHC), was nominated vice-chair of an important federal task force that provided guidance to the Canadian government as it prepared to introduce legislation to legalise cannabis in spring 2017.
Dr Ware, who is also an associate professor of Family Medicine and Anaesthesia at McGill University and a scientist in the Brain Repair and Integrative Neuroscience (BRaIN) Programme of the Research Institute of the MUHC (RI-MUHC), has been studying the use, safety and effectiveness of medical cannabis for the past 16 years. He is also involved in population-based studies on the impact of pain and the evaluation of complementary therapies in pain and symptom management.
Dr Mark Ware
CENTRE FOR MEDICINAL CANNABIS
Prospectus
About CMC
Introduction
Mission Statement
CMC Team
Clinician and Scientist Board
Advisory Board
Support and Funding
CBD
CBD Charter Overview
CMC in the CBD space
CBD Market Study
Novel Foods
CMC Work
Engaging Policy Stakeholders
Reports
Events
Advisory Statements
Consultation
CMC Network
Policy Stakeholders
Experts
Clinical Researchers
Clinicians (Prescribers & Medical Practitioners)
Patients
Members
CMC Membership Benefits
Join Us
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About CMC
Mr Anand is a recognised thought leader in the Canadian cannabis space and brings 15 years of leadership experience in the health, charitable/non-profit, and private sectors in Canada.
Within the global cannabis sector, Mr Anand has worked with senior government officials, politicians, policy-makers, health professional organisations, clinical practitioners, educators, investors, patients and producers. He has also served on the boards of various pharmaceutical associations across Canada, the United States and Europe. He holds a Master’s in Business Administration and Management from Vancouver Island University.
Advisory BoardWe’re grateful to our domain experts for their help.
Deepak Anand
Nick is the Chief Executive of Memery Crystal and a senior partner in the firm’s corporate team. Memery Crystal are the leading UK law firm advising the emerging cannabis sector on business set-up, capital markets, mergers and acquisitions, private fundraising, licensing and commercial contracts. Nick has a personal interest in medicinal cannabis as a Trustee of the charity ‘Olivia’s Vision’, the UK’s leading Uveitis charity, raising awareness of the condition from which his daughter, Olivia, suffers. Uveitis, like many autoimmune diseases, is being targeted for medical cannabis research. Nick has been widely quoted on both TV and print media in respect of the emergence of cannabis as an asset class.
Nick Davis | Legal Advisor
David was formerly a UK surgeon; he has now for 15 years been a senior Business Management Consultant operating within the medical sector. He is exceptionally qualified and has wide experience within both clinical and management settings across the UK NHS, including NHS Acute Trusts and NHS Commissioners (CCG). His expertise spans medical business start-ups, business case development, Transformational Change, Clinical Process Redesign, and performance management within the NHS.
Dr David Horn | Medical Advisor
CENTRE FOR MEDICINAL CANNABIS
Prospectus
About CMC
Introduction
Mission Statement
CMC Team
Clinician and Scientist Board
Advisory Board
Support and Funding
CBD
CBD Charter Overview
CMC in the CBD space
CBD Market Study
Novel Foods
CMC Work
Engaging Policy Stakeholders
Reports
Events
Advisory Statements
Consultation
CMC Network
Policy Stakeholders
Experts
Clinical Researchers
Clinicians (Prescribers & Medical Practitioners)
Patients
Members
CMC Membership Benefits
Join Us
13
About CMC
Co-founder of MessageSpace, a digital advertising agency based in Westminster which works with political parties, charities, trade unions and campaigns. He founded the popular Guido Fawkes political news website in Britain. Paul is also a director of GGN (an investment holding company in Hong Kong) and of Campaign Action in Ireland, where he lives.
Paul Staines
Sarah is a Lecturer in Clinical Pharmacy and Therapeutics at the University of Birmingham. Her research interests focus on patient safety, specifically relating to medication errors, medicines optimisation and the use of electronic patient records.
Sarah is also the Editorial Lead for the SCRIPT eLearning programme, a national web-based programme available to prescribers across the NHS. She oversees the development and maintenance of new and existing modules across all variants of the programme. She supervises research to investigate users’ reaction to eLearning, whether intended learning outcomes are being achieved, and whether learning changes practice.
Dr Sarah K Pontefract | Education Lead
A passionate advocate and practitioner of both critical thinking and tactical cross-pollination of disciplines, Sepe holds a Doctorate in Bioengineering from the University of Oxford.
Sepe’s innovative approach to problem solving fuelled through the application of diverse scientific fields, analytics, neuroscience, behavioural science and evidence-based principles has led him to contribute to various high-profile initiatives ranging from President Obama’s Transition Health Policy to the UK Prime Minister’s Sustainable Development Plan and the late Dr Richard Rockefeller’s innovative healthcare models.
Dr Sepe Sehati | Innovation Lead
CENTRE FOR MEDICINAL CANNABIS
Prospectus
About CMC
Introduction
Mission Statement
CMC Team
Clinician and Scientist Board
Advisory Board
Support and Funding
CBD
CBD Charter Overview
CMC in the CBD space
CBD Market Study
Novel Foods
CMC Work
Engaging Policy Stakeholders
Reports
Events
Advisory Statements
Consultation
CMC Network
Policy Stakeholders
Experts
Clinical Researchers
Clinicians (Prescribers & Medical Practitioners)
Patients
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CMC Membership Benefits
Join Us
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About CMC
CMC financial support comes from global industry leaders, investors and philanthropists. We only accept funding from legal licensed companies operating in the medicinal cannabis sector and serving patients in Europe and other global markets.
Support and FundingLaurène Tran is the executive director of ACTIVE (Association for Cannabinoids, Terpenes, and Innovative Ventures in Europe) a pan-European association uniting entrepreneurs, investors, and experts with an interest in cannabinoids for wellness and medicinal purposes. In collaboration with Allen & Overy, she led legal and policy reports on CBD in France and in Europe with the contributions of several elected officials.
Laurène is also an Adjunct Lecturer and Researcher in Tech and Policy at Sciences Po Paris. Before committing herself to building a safe and strong European CBD ecosystem, she worked at The Family, an investment firm supporting ambitious tech entrepreneurs in Europe. Laurène holds Master’s degrees in Economics and Sociology from Sorbonne Paris Cité. She is a graduate of ESSEC Business School.
Laurène Tran | European Affairs Advisor
CENTRE FOR MEDICINAL CANNABIS
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Introduction
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CMC Team
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Support and Funding
CBD
CBD Charter Overview
CMC in the CBD space
CBD Market Study
Novel Foods
CMC Work
Engaging Policy Stakeholders
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CBD
In August 2019, the CMC announced the release of a Cannabinoid Industry Quality Charter to help foster a legally compliant, socially responsible and innovative CBD industry in the UK.
Signatories of the charter will be committing to a framework of legal compliance and quality controls. The legal compliance pathway is primarily based on Novel Foods authorisation which will be delivered via a new partnership between the CMC and Global Regulatory Services (GRS).
The new industry charter is being launched for consultation in the wake of CMC’s CBD in the UK report which was published in June this year.
The charter is comprised of seven pillars.
Legal frameworks
It is essential that all cannabinoid producers and sellers have an understanding of the laws and regulations in their respective sectors, (food supplements, cosmetics and inhalables), enabling full compliance. Without exception signatories to the charter must pursue the necessary authorisations to be granted permission to legally distribute cannabinoid products. Initial work will primarily entail pursuing Novel Foods authorisation, working closely with the FSA.
Testing
Quality and safety is established through robust testing. Working with accredited laboratories, the CMC will facilitate a programme whereby each
submission of raw material or a finished product will be tested at accredited laboratories, pertinent methodology being evaluated by all stakeholders. This ensures the methods used can be scrutinised, improved upon and trusted by relevant stakeholders; crucial in an industry where there are no standardised methodologies.
Labelling
Fair, honest and safe sale of cannabinoid products is dependent on a number of labelling regulations to ensure that the consumer understands what they are buying and is not misled. Compliant signatories must adhere to a set of labelling guidelines described within the charter.
Manufacturing
Using the ISO 9001 framework and cGMP, the charter includes a set of principles based on best practice of accreditation organisations from around the world. The CMC expects members to adhere to these guidelines.
Controlled drugs
Without exception, the CMC’s UK members will adhere to the UK’s laws on scheduled substances, specifically zero detectable amounts of CBN and THC. The CMC will work with the relevant authorities to establish a definition of the term ‘detectable’.
Marketing ethics
All signatories to the charter will commit to providing clear, honest and ethical marketing messages. All advertising, whether online, offline or in-store, should not make reference to medical claims (as defined by MHRA), sexuality, violence, illegal behaviour, political affiliation or religion through its imagery or language.
CBD Charter Overview
CENTRE FOR MEDICINAL CANNABIS
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About CMC
Introduction
Mission Statement
CMC Team
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CBD
CBD Charter Overview
CMC in the CBD space
CBD Market Study
Novel Foods
CMC Work
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CBD
Sustainability & social impact
While the cannabinoid industry is in its infancy there is an opportunity to shape business activity to ensure its commitment to social and environmental good. The charter outlines principles to help tackle the world’s most pressing problems concerning land and natural resource use, responsible waste management, fair employment and plastic pollution.
Once the charter has sufficient signatories the most pressing action for the CMC will be to work with the Foods Standards Agency (FSA) and the European Food Safety Agency (EFSA) to ensure that CMC members work towards full compliance through timely submissions of Novel Foods (or other applicable) applications for their products. This will ensure that they are on the road to full compliance within an acceptable and agreed time frame. Clarification will be pursued on a grace period for those submitting a novel food application will be pursued.
Background - CMC CBD UK Market Study
In June 2019 the CMC launched their groundbreaking study of the UK CBD market. Valued at £300 million, the UK CBD market was much larger than previous estimates.
Blind testing of 30 popular UK CBD brands demonstrated that many CBD products on the market did not contain what was indicated on the label. Only 38% of the products were within 10% of the advertised CBD content and 38% had less than 50% of the advertised CBD content. One product had 0% CBD. Almost half of the selected products had measurable levels of THC or CBN, making them technically illegal in the UK.
One of the key recommendations in the study was the introduction of a cannabis-related kitemark to give consumers trust in the products containing cannabinoids and other substances derived from cannabis available on the market.
As it stands all CBD products that are classed as food supplements are technically illegal due to the fact that no-one has been granted a Novel Foods licence from the European Food Safety Authority (EFSA).
CENTRE FOR MEDICINAL CANNABIS
Prospectus
About CMC
Introduction
Mission Statement
CMC Team
Clinician and Scientist Board
Advisory Board
Support and Funding
CBD
CBD Charter Overview
CMC in the CBD space
CBD Market Study
Novel Foods
CMC Work
Engaging Policy Stakeholders
Reports
Events
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CBD
In order to support our members who are active in the CBD wellness sector, CMC undertook the most thorough market study of the UK CBD market to date. We found that the market was much larger than had previously been suggested, larger than those for vitamin C and D combined, and had great potential for growth. However, through testing, we discovered that the quality of products varied wildly. Not only that, inaccurate information is being circulated in this sector leading to confusion over what is actually legal.
In essence, the CBD market sector had become too large to ignore and was in desperate need of better regulation to protect consumers. To that end, CMC launched a CBD-focused business charter and brought together a highly skilled team with decades of experience working within the pharmaceutical and food regulatory environment to help foster a professional and compliant sector. We also made a partnership with the leading life-sciences regulatory services consultancy, Global Regulatory Services (GRS).
In June 2019, the CMC released the report CBD in the UK: Towards a Responsible, Innovative and High-quality Cannabidiol Industry, after conducting the most comprehensive review ever undertaken of the sector in the UK.
Market research commissioned by the CMC estimates that the CBD market is currently one of the fastest-growing wellbeing product categories in the UK. At the current rate it will be worth almost £1 billion per annum by 2025.
The report is comprised of four elements:
• Market sizing - comprehensive economic analysis of CBD market in UK
• Product testing - blind testing of 30 major CBD brands available on UK market
• Consumer survey of 2000 members of the public by YouGov
• CMC Policy recommendations - presented to senior officials at the UK Home Office, MHRA, FSA and DHSC.
CBD in the UK
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CBD
Following a series of high level meetings with senior officials in UK government departments and regulatory agencies, it was clear there is a need for ‘novel foods’ compliance in order for products containing cannabidiol (CBD) to be fully legal in the UK marketplace.
CMC forged a partnership with the leading life-sciences regulatory services consultancy, Global Regulatory Services (GRS).
GRS are well versed in the Novel Foods application process, having worked in this space since the launch of the company 12 years ago. During this time they have also worked with companies developing cannabis-derived products in other areas of the life sciences. This has led to an in-depth understanding of the science behind CBD as well as compliance with mandatory requirements such as Good Manufacturing Practice (GMP).
Novel Foods
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CMC Focus
Engaging Policy Stakeholders
CMC is currently working with medical, academic and regulatory stakeholders with a view to commissioning national clinical trials for CBMPs to be jointly financed between industry and government. This is in an effort to expedite medical access in the UK, which might otherwise take many years if left to develop organically.
We are engaged with four governmental departments/agencies concerning the medicinal cannabis agenda in the UK: the Department of Health and Social Care (DHSC), the National Institute for Health and Care Excellence (NICE), the Medicines and Healthcare Products Regulatory Agency (MHRA) and the Home Office. The aim of this work is potentially to expedite public access to CBMPs beyond their current trajectory by employing randomised controlled trials, based upon the availability of real-world data.
Please see CMC Network - Policy Stakeholders (page 26) for more detailed information on each of these agencies.
We are also working closely with the UK’s Foods Standards Agency (FSA) and the European Food Safety Authority (EFSA) towards full compliance for products containing CBD and other cannabinoids.
Medicinal Cannabis
Government
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CMC Focus
CBD UK Policy Report
Outline and Terms of Reference
In Q2 2019, the CMC is undertaking a new research project on cannabidiol (CBD) in the UK to be published in June. This project, led by our Policy Lead Blair Gibbs, will generate a detailed policy report examining the state of the CBD market in the UK and the political and regulatory contexts, and make recommendations.
This report will not attempt to estimate consumer spending patterns or quantify the size and value of segments in this rapidly expanding market. Instead, the CMC’s report will focus on the more vital issues relating to policy, the status of the law and the interests of consumers. It will set out how CBD products are regulated in the UK and the gaps and areas of potential weakness in those rules.
In reviewing the status of the law and the regulatory landscape around CBD in the UK, the report will compare approaches taken in other jurisdictions. It will address definitions and the recent outcomes of EU and WHO reviews, as well as summarising the research around the health impacts of CBD and the wider evidence base.
Continued >
ReportsThe CMC undertakes rigorous research to produce exclusive reports for our members. We also produce reports for public dissemination. Below you will find examples of these offerings.
CMC Members Exclusive Report Example
CENTRE FOR MEDICINAL CANNABIS
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CMC Focus
The report will conclude with recommendations that are evidence-based and politically deliverable, with the overarching goal of helping the industry, regulators and policy-makers to reach agreement on the best way forward. In order to support the growth of a responsible, innovative and consumer-friendly CBD market in the years ahead, the report will make proposals around best practice and quality standards so that the UK can improve its regulation of CBD products.
Our objective for this project is to inform policy-makers, the media and the public about the present context for CBD, and to outline how the UK can ensure that those who seek the health benefits of cannabidiol are better protected. In so doing, we aim to set out an approach that, if adopted here, would likely influence other regimes globally.
For further information or inquiries regarding research into our CBD report, contact: [email protected]
The report will summarise the sources of CBD, the supply chain for products, and the rules governing hemp cultivation and CBD extraction, processing and importation. The report will profile a selection of the product range in the market and explore how consumers currently use CBD, including new survey data and analysis.
The theme of the report will be protecting consumers, and consistent with the CMC’s core mission to support patients, the CBD review will look at how to ensure high standards and how best to support consumers to access quality products, and make educated decisions with the fullest information.
To this end, the review will include consideration of practices around labelling, traceability, testing regimens, and distribution and retail. The CMC has commissioned original laboratory testing to inform the recommendations based on a sampling of retail products currently being sold in the UK and the implications of these findings, in line with the approach taken by other research institutes in Europe.
CENTRE FOR MEDICINAL CANNABIS
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CBD
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CMC Focus
In particular the report focuses upon risk of addiction, risk of psychosis, the potential for drug interaction, and the similarities, disadvantages, and advantages relative to the alternatives: opiates and their analogues.
This work is supported by both patient and clinician testimonies.
Finally and in summary, the report will consider why in the UK, unlike in other jurisdictions, use in pain is not permitted; what would have to change; and how the CMC might support researchers, research funding authorities, producers, and regulators to permit use of CBMPs for pain within the UK.
Our objective for this project is to inform policy stakeholders, producers, media, the public, patients and their carers about the present context for use of CBMPs in pain, how the UK differs in this respect from other jurisdictions, and to outline how those who seek NHS safe access for pain might be satisfied in the future.
For further information or to contribute to the research for the pain report, contact: [email protected]
Use of Cannabis-Based Medicinal Products (CBMP) in Pain
In Q1 2019 the CMC undertook a research project on the use of CBMPs in pain in the UK. This project, led by our Science Lead Dr Saoirse O’Sullivan, generated a detailed report examining the science behind CBMPs, future potential for use of CBMPs in pain within the UK and the legislative and regulatory contexts. It also made recommendations.
Current usage of CBMPs for pain relief is extra-judicial in the UK. There is no NICE guidance that permits such use even for CBMPs with current marketing authority from the MRHA. The report therefore does not attempt to estimate consumer spending patterns or quantify the size and value of segments in this rapidly expanding market. Instead, the report focuses on surveys of patient use, the science behind current use, effective dose regimens, routes and modes of administration, variability in dose response and the issues that arise, side effects, and the potential for future regulated use for different disorders.
CMC Members Exclusive Report Example
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CBD
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CMC Focus
Medicinal Cannabis in the UK: A Blueprint for Reform
While this report addresses some of the shortcomings of the current UK approach, it is designed to be forward-looking and constructive, in order to help those who are tasked with setting policy and implementing guidelines and regulations, as well as those who must work on behalf of patients - the physicians, pharmacists, and providers - to navigate this new and unfamiliar system.
For this reason our report is mostly focused on providing constructive suggestions for improving the current medicinal cannabis system, based on better practice elsewhere. It draws on policy insights,scientific data, industry experience, stakeholder perspectives, and patient attitudes.
The report makes 30 recommendations and outlines the steps that should be taken if the policy objectives we describe are to be achieved. It concludes by describing a vision for the future and makes the case for the government to now develop a strategy to deliver that vision.
Download Medicinal Cannabis in the UK: A Blueprint for Reform
CMC Public Report Example
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CMC Focus
Our Annual Policy Summit takes place in June. This event is exclusively for our members, clinicians, policy-makers and regulators and is the foremost event of its kind in the UK. By invitation only.
We have inaugurated an annual lecture delivered by a distinguished clinician or scientist on a chosen theme related to medicinal cannabis. In April 2019 the lecture was given by Professor Iain McGregor: the Academic Director of the Lambert Initiative and an NHMRC Principal Research Fellow. He is responsible for academic and organisational leadership, strategic direction, governance and reporting, and the development and achievement of preclinical and clinical research strategies. By invitation only.
The CMC can draw on our network to enable custom events on request. As an example, we recently arranged a trip for British MPs to visit medicinal cannabis operations in Canada. These services are available on consultation and are not included in the membership fee.
Our member-exclusive reports are the results of rigorous research by leading experts. Member-exclusive webinars to share findings will be hosted by the experts that produce our reports.
UK Medicinal Cannabis Policy Summit
CMC Annual Lecture Bespoke Events
Member Exclusive Webinars
EventsThe CMC hosts several public events, member-exclusive events, seminars, lectures and webinars.
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CMC Focus
The CMC can draw on the knowledge of our team of experts to produce credible and actionable advisory statements. We use these statements to engage with the person or department that needs the information, to guide them to take the necessary action. As an example of such a campaign, we recently engaged with the Chair of the UK Foods Standards Agency on the topic of improved regulations concerning cannabidiol (CBD), offering collaboration which would involve access to CMC experts, council and members.
CMC experts provide consultancy services on a number of levels. We actively engage, seek collaboration and offer expert consultations with Policy Stakeholders as they navigate the complexities of cannabis science and policy. We also provide boutique consultancy benefits to our members on matters such as government relations, public affairs, events management and media engagement. Please be aware that custom member services are available on consultation and are not included in the membership fee.
We regret that we cannot offer consultancy services that may undermine impartiality towards any of our membership.
Advisory Statements Consultation
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CMC Network
The DHSC has a role in both the development and regulation of medicinal cannabis, now that CMBPs have Schedule 2 status. Therefore, it has instructed the National Institute for Health and Care Excellence (NICE) to produce a clinical guideline on the prescribing of cannabis-based products for medicinal use in humans. This guidance is expected by October 2019 at the latest. Secondly, it works with the National Institute for Health Research (NIHR) to ensure their themed call “cannabis-based products for medicinal use” attracts research proposals that will address NHS priorities and emerging clinical practice.
NICE provides evidence-based recommendations developed by independent committees, including professionals and lay members, and consulted on by stakeholders. They are due to publish prescribing guidelines for cannabis based medicinal products in October 2019. The CMC, along with CannPASS, Families4Access and United Patients Alliance, represent the voice of patient and parent stakeholders, providing insight and attending workshops throughout this process.
Department of Health & Social Care (DHSC)
National Institute for Health & Care Excellence (NICE)
Policy StakeholdersThe medicinal cannabis agenda in the UK involves a wide network of public and private stakeholders, each of whom have an important role to play in creating a viable regime for patient access. We are engaged with four governmental departments/agencies.
MHRA is responsible for ensuring that medicines and medical devices work, are safe and are of an appropriate quality. MHRA’s primary aim is to safeguard public health through a system of regulation. Pharmaceutical manufacturers and distributors operating in the UK marketplace are subject to a system of licensing and inspection, which ensures that licensed medicinal products conform to internationally agreed standards, and that those medicines are manufactured/imported, stored and distributed in compliance with the required regulatory standards.
Companies and individuals in England, Wales or Scotland need to apply for Home Office licences if they wish to produce, supply, possess, import or export ‘controlled drugs’. For the purposes of the UN Convention on the Control of Narcotics, the Home Office additionally acts as, and discharges the functions of, the National Cannabis Agency.
Medicines & Healthcare Products Regulatory Agency (MHRA)
The Home Office
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CMC Network
The CMC draws upon the collective knowledge of our esteemed Clinician and Scientist Board: an authoritative panel of senior specialist cannabis clinicians and scientists. These experts cover a broad range of disciplines and are each distinguished within their respective fields.
CMC can also take counsel relating to policy, innovation, education, legal and other fields from our knowledgeable and experienced Advisory Board.
CMC also has a partnership with the leading life-sciences and award winning regulatory services consultancy, Global Regulatory Services. They have a vast level of expertise with the Novel Foods application process and work directly with the relevant regulatory agencies to ensure all necessary documentation is to the highest standard before submission.
To learn more about CMC Clinician and Scientist and Advisory Boards please see the About CMC section of this prospectus (page 2).
The CMC runs a dedicated platform that facilitates the exchange of ideas and research findings between cannabinoid researchers to stimulate research activity and enable support from the CMC and our members. Researchers may produce a document - based on our template - covering their proposed or existing research and including their contact details. These documents are made available to our members via our exclusive members’ portal.
For more information on the members’ portal please see CMC Membership Benefits - Exclusive Members Portal on page 29.
Experts Clinical Researchers
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CMC Network
At the request of Health Education England (HEE), a public body of the Department of Health, the CMC assisted the University of Birmingham to produce online training materials for trainee doctors concerning CBMPs. The HEE’s function is to provide national leadership and coordination for education and training within the health and public health workforce. The resulting training materials are also available to all UK medical professionals.
As our US members will be fully aware, the NHS operates in a very different manner to the US system. Cannabis based medicines are unlicensed medicines in the UK. Under the UK Medicines Act it is an offence to promote an unlicensed medicine to the public or medical practitioners. Within the UK public health system a prescriber has little influence on which brand of medicine a patient will receive via the NHS. With these points in mind, for the time being, direct access to medical practitioners is not likely to be a significant entry point into the UK market. Patient access is liable to be via entry into clinical trials; therefore, supporting these trials will likely be a more effective route to market.
The CMC hosts a dedicated web page for UK clinicians (prescribers and medical practitioners) where they can see the latest CMC activities that may interest them. A dedicated email channel ([email protected]) is available for any questions they may have surrounding CBMPs. These queries will be addressed by our medical support department.
At the end of the day, all the work the CMC does will have the greatest impact on the thousands of UK patients who will benefit from safe access to CBMPs. To ensure that we fully understand the needs of UK medicinal cannabis patients and carers we work closely with patient cannabis advocacy groups such as the UK’s Cannabis Patient Advocacy and Support Services (CannPASS), the United Patients Alliance (UPA) and Families 4 Access. All these non-profit organisations work to support patients, parents and carers whilst promoting safe, effective, affordable and equitable access to medicinal cannabis for all who could benefit.
CMC members are committed to meeting patient needs by producing the highest quality cannabis-based medicine. They share our determination that patient access should no longer be reliant on the criminal market.
The majority of CMC funding is provided by our members (see About CMC - Support and Funding on page 14 for more details). In the next section we outline the exclusive benefits our members gain from supporting CMC.
Clinicians (Prescribers & Medical Practitioners) Patients
Members
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CMC Membership Benefits
Becoming a CMC member grants you high-level access to a wide network of medicinal cannabis public and private stakeholders with important roles to play in creating a viable regime for patient access. However, it does not end there. We offer an array of member benefits to ensure your company is at the forefront of UK medicinal cannabis and CBD research, regulation and policy reform.
The CMC undertakes rigorous research to produce exclusive UK focused reports for our members. For an example of a recent report please see CMC Work - Members Exclusive Report on page 22.
The CMC members’ portal gives members access to an exclusive overview of existing and proposed cannabinoid clinical trials in the UK. This provides an entry point into the UK medicinal cannabis market. The clinicians and researchers performing the actual cannabinoid clinical trials make available dossiers including the contact details of the responsible clinician or researcher, by which members may contact them directly.
This service gives a transparent, real-time view to all members of the current state of cannabinoid research in the UK. This grants our members a valuable resource: a level playing field for participation in UK cannabinoid research and clinical trials.
We have an engaging programme of public events, member exclusive events, seminars, lectures and webinars which enables our members to network with our broad community of experts, influencers and stakeholders.
Exclusive Content
Exclusive Members’ Portal
Exclusive Events
With the support of our members, the CMC undertakes incomparable policy analysis and rigorous research such as our Blueprint and reports. These reports and commentary will dictate the development of UK medicinal cannabis and CBD policy. CMC membership ensures that you are able to review and help shape these outputs empowering you to be a part of the UK cannabis debate and consultation process in policy reform.
Bespoke services, including government relations, public affairs, events management and media engagement, are only available to members. These services are available upon consultation and are not included in the membership fee. We regret that we cannot offer consultancy services that may undermine impartiality towards any of our membership.
Collective Output
Boutique Services
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Join Us
To join the CMC please contact: [email protected]
He will be delighted to answer any more questions you may
have and will guide you through the membership process.
6 month membership
£25,000
Prices are subject to VAT
3 month membership
£12,500
12 month membership
£40,000
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