Medical Grade Cannabis (MGC), CBMPs & GMP

MGC Pharmaceuticals

June 27 at 6:19 PM ·

We are happy to share with you, that we had very productive week in London.

Cannabis Europa, London, June 24th - 25th

CMC UK Medicinal Cannabis Policy Summit, Somerset House, London, June 27th
The Centre for Medicinal Cannabis (CMC) is the UK’s first and only industry membership body for businesses and investors operating in 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.
NOTE: MGC Pharmaceuticals was listed (see here) as a CMC member last week. Dr Uri Kramer is still listed (see here) as council.

This members only event has a wide ranging agenda with exclusive content, specialist input and extensive clinician and industry contributions, and we will be launching four new reports:

Prescribing Cannabis Based Medicinal Products in the NHS - a proposal for a UK pilot
A paper presented by two members of our Scientist & Clinicians Board, Dr Daniel Couch and Dr Charles Akle with Dr David Horn our Medical Director

CBD Policy Report
This report, which will form the basis of an academic paper from the University of Nottingham, will have three elements:
Market sizing - comprehensive analysis of CBD market in UK undertaken by a world class consultancy firm
Product testing - blind testing of the major CBD brands that are available in the UK (NOTE: 7 May 2019 - Arrival of first CannEpilTM shipment to United Kingdom)
UK market policy recommendations - related to approaches to quality assurance and regulation - This report will be authored by Blair Gibbs, CMC's Policy Director and Dr Andrew Yates, CMC's Pharmacy Lead

Condition report in connection to Pain
The first condition report produced by Dr Saoirse O'Sullivan, CMC's Science Lead, will examine the science behind CBMPs, future potentials for the use of CBMPs in pain within the UK, the legislative and regulatory context, and key policy recommendations

Using Novel research methodologies
Gaining a greater understanding of the use of real world data in CBMPs, this paper will be produced in conjunction with Emerald Clinics and authored by Dr Alister Vickery, the Professor of Primary Healthcare University of Western Australia

In addition to members and guest chairs including Sir Professor John Tooke the conference will be attended by senior officials from Department of Health and Social Care, NHS England, NHS Scotland, Health in Wales, Health and Social Care in Northern Ireland, National Institute of Health Research, MHRA, NICE and the Food Standards Agency

The Test

• The first major third-party testing exercise to be undertaken of CBD products in the United Kingdom was commissioned for this report. In total, 30 oil products available in the UK (both on and offline) were selected for the blind testing exercise using PhytoVista - a reputable UK-based laboratory.

• The exercise was designed to verify the range of quality of those CBD products being sold today, and to determine where the areas of concern might be. Those areas were defined as: health and safety; consumer rights; and criminal law.

• The results are highly revealing and provide a good overview of the true nature of the CBD products being sold in the UK. They reveal a wide range in terms of quality, and some concerning poor practice in a minority of cases. The best products are very high quality and are good options for today’s consumers, but a larger group of products present issues in one area or another.

• The biggest issues related to accuracy of labelling; the presence of controlled substances and some contaminants; and in one example from a high street pharmacy, the complete absence of any cannabinoids.

Highlights:

- Only 11/29 (38%) of the products were within 10% of the advertised CBD content and 11/29 products (38%) actually had less than 50% of the advertised CBD content. One product had 0% CBD.

- Almost half (45%) of the selected products had measurable levels of THC (mean content 0.04%) or CBN (mean content 0.01%) and are thus technically illegal within the UK.

- 1 sample had ZERO cannabinoid content - this was a High Street pharmacy product (30ml) retailing for £90.

- 1 product had 3.8% ethanol (3.4% qualifies as an alcoholic beverage)

- Dichoromethane was detectable in 7 products (3.8-13.1ppm) and cyclohexane was found in one product (27.9ppm). However, these percentages of solvents and heavy metals are still below the permitted daily dose levels in pharmaceutical products, although above food limit safety levels

• The industry as a whole must use these results to understand the areas of weakness in producing a quality product that consumers can trust, and use the findings to justify additional steps they should take for their own production, or for reassurance across their supply chain, that some of these negative results are not reflected in their own products.

• The exercise also exposed regulatory gaps - with no rules that set basic standards for important supply chain activities like testing of cannabinoid products, so those laboratories (in the UK or elsewhere) that conduct these examinations all use different processes and testing methodologies, and they may not be to a standard that is reliable, or would satisfy UK authorities.


BREAKING THE EMBARGO: A PROPOSAL TO BREAK UK PUBLIC HEALTH MEDICINAL CANNABIS IMPASSE