Dear reader, welcome to your monthly cannabis brief.
We discuss the Netherlands getting ready to launch the supply chain experiment in December, German legalisation delays and draft changes, Japan and Canada approving pharmaceutical cannabis products, and US rescheduling debates.
Australian, UK and Brazilian medical markets remain highly dynamic with new entries, Germany, Portugal, Israel and Australia publish import/export data, while market consolidation perseveres in Canada.
Clinical research on applications of CBD to treat glaucoma, heart disease, autism or melanoma shows that we are only scratching the surface of cannabinoid medicine.
We hope you enjoy this month’s cannabis brief!
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1. Regulatory updates:
In the Netherlands, the political landscape is changing with the victory of far-right PVV in parliamentary elections, which was one of few parties to oppose the supply chain experiment.
- However this does not mean that the experiment is in danger, as a wider coalition will be required to form a government and repealling the supply chain experiment legislation would be a long process.
- Coffee shop owners are concerned by the inclusion of East Amsterdam in the experiment decided last month, arguing to the different rules that will apply to these clubs versus the rest of the city.
- The government has published the leaflet that cannabis flowers and hash will need to include in the packaging of products for the supply chain experiment.
- Fyta, a licensed supplier for the coffee shop experiment, has been rejected a license to produce and export medical cannabis as well as API registration.
- National Drug Monitor shows 1.1 million Dutch people used cannabis in 2022.
In Germany, the entry into force of the cannabis law is being delayed to April 1, 2024. Regulations for cultivation associations are postponed to July 1st, 2024.
- Some of the stringest regulations are being relaxed, such as the ban zone for the smoking of cannabis around schools and youth facilities, or the possession amounts that entail a criminal liability.
- A poll on public attitudes towards legalisation shows a stalemate in public support.
- A survey among cannabis associations carried out by CSC-Maps shows that clubs plan to offer lower prices than the black market, while finding areas for cultivation/distribution, and the financial support to carry out investments are their main concerns.
- Additionally, the tender process for medical cannabis cultivation is being scrapped, with an open licensing system being introduced, and removing limits on products that domestic growers can supply.
- Industrial hemp clauses allowing the prosecution of farmers for hot crops are not being scrapped in the new legislation for the time being.
Japan has legalised pharmaceutical cannabis production and use with the intended goal to allow patient access to Epidyolex, currently under clinical trials in the country.
- The Japanese government is considering the banning of HHCH and similar semi-synthetic cannabinoids, following intoxication of 5 individuals from unregulated gummies at a festival.
Canada has approved Jazz’s CBD pharmaceutical Epidiolex for child epilepsy.
- A petition to increase THC limits in edibles to 100mg gains traction in Canada, as current 10mg limit too low. This follows Health Canada stopping the sales of ingestible extracts (capsules) with higher THC content by package back in June.
In Argentina, the presidential victory of Javier Milei opens up uncertainty as to the future of cannabis regulations in the country. While in favour of drug liberalisation, the current model based on public-owned companies will suffer from budget cuts.
- Hemp grain has been included in the food code, opening up new opportunities for the use of hemp seed in the production of various food products.
- The Faculty of Agronomy of the Buenos Aires University (UBA) will carry out a hydroponic cultivation trial in its facilities.
In Israel the new medical cannabis dosing categories are rolling out soon, with the inclusion of more categories such as T22 and a reduction in content deviation vs label to only 10%.
- Changes on the law allow funding of medical cannabis from National Insurance for victimes of hostilities in the same grounds as disabled veterans.
Hemp vs Marijuana war in the US takes form of lawsuits regarding the status of minor cannabinoids and licensing rules in legal markets, as potential rescheduling of cannabis looms:
- A Gallup poll shows highest-ever support for legalisation sitting at 70%.
- The state of Ohio has voted to legalize recreational marijuana.
- Marijuana lab-testing analysis finds routine THC inflation and data manipulation.
- Low-THC beverages allowed in general stores in Minnessota cause regulatory controversy.
New therapeutic vape regulations in Australia could impact medical cannabis manufacturers through new import procedures and quality standards.
- Rise of pharmacy compounding in Australia raises concerns of regulators.
- A proposal to legalise recreational cannabis by the Green party causes controversy.
In the UK a conservative MP is pushing for the creation of a ‘special fund’ to guarantee children can access medicinal cannabis.
CBD oils, drinks and capsules get recalled in France due to excess cannabinoid concentration. Neighbours are against the construction of a medical cannabis farm in Dordogne.
In Spain the new left-wing cabinet has taken office with a pro-legalisation medical doctor as Health minister.
Medical cannabis law stopped in the Ukrainian parliament due to high number of ammends by opposition to the bill.
Thai government drafts rules to tighten up cannabis market with uncertain effects.
Rio de Janeiro in Brazil introduces a program to distribute CBD medicines free of charge.
In Morocco, the first legal shipment of cannabis took place in the Northern region of Chauen.
Infographic of the month: Australian market
2. Market and Company Updates:
A survey conducted by Medigrowth reveals 6% of Australians have used medical cannabis under prescription and 22% have considered obtaining it.
- Cannatrek, Australian medical cannabis market leader, doubles revenues in fiscal year 2023 up to A$89.6M with A$14.6 net profit.
- Medcan launches its owned branded flowers grown in Australia. A survey by Cann I Help clinic reveals that non-GMP product remains in the market.
- New Zealand LP Medical Kiwi launches first NZ-branded medical cannabis flowers through Alliance Healthcare Australia.
- BOD Australia develops technology to make water soluble compounds, but it is suspended from the ASX.
- Promethean BioPharma joins the race to register a CBD tablet for pain patients as an OTC.
- Danish cannabis company Stenocare launches new extracts to the Australian market.
- British CBD brand Dragonfly rejected to list on the ASX exchange.
The UK market remains in a state of flux with updates in both the medical cannabis and CBD sectors of the country:
- Curaleaf launches German subsidiary Four20 products in the UK through its manufacturer Rokshaw.
- Khiron launches first Jersey-grown flower products to the UK market – 24/1 unirradiated.
- Grow Pharma reaches new supply agreements with Portuguese LPs Cannprisma and Herdade das Barrocas. Its subsidiary IPS Pharma will launch vapes under new brand Vida Vapes.
- Domestic supplier Celadon inks £9 million yearly supply contract from H2 2024.
- Lyphe group announces that operations will be unaffected by the company entering administration.
- Kanabo will supply British Cannabis CBD products through its platform.
- Drugstore chain Holland & Barrett will begin trial of OTC medicines in 20 of its stores.
- Scottish brand Voyager Life stocks products on Pets at Home Website.
- Publicly-traded Cellular Goods lists CBD products on Chill.com.
- RASB Media cancels CBD show in London refusing refunds.
EMCDDA publishes analysis on the European illicit cannabis market: worth €11 billion, over 20 million Europeans have consumed cannabis in the last year. Trend towards a higher THC concentration perseverates in the unregulated market.
Germany saw a new records in imports of medical cannabis in Q3 2023, with almost 25 tonnes of flower or flower-equivalent extracts imported in the first three quarters of the year.
- Canada increases its lead as top supplier. Portugal, Colombia and Lesotho gain share of the import market. Denmark, Australia and Macedonian imports stagnate.
- Cantourage reports €17.2M revenues in the first 3 quarters of the year and reduces its negative EBITDA. Theh distributor has reached a new supply agreement with Canadian Oceanic Releaf.
- Cannamedical brings new Macedonian strains to market from EU-GMP grower Sinceritas.
- Leading mail-order pharmacy Grünhorn launches its own dispensary brand in the country through sales partner Canymed.
- A survey carried out in 2020-2021 shows that the use and health perception of cannabidiol-containing products have been increasing among the population.
Rescaling of Canadian licensed cultivation peseveres, with estimates that 1/3 of Canadian greenhouse and indoor cultivation have been taken offline.
- Beverages giant Constellation Brands will not expand its financial support to Canopy Growth, as it completes sale of subsidiary BioSteel and continues cost and debt-reduction efforts.
- British American Tobacco (BAT) doubles down investment on Organigram.
- Aurora boasts positive cashflow thanks to positive trend of medical sales in Europe and Australia.
- In Canada, Decibel announces C$30M revenue in Q3 with 43% gross margin as it plans to expand internationally in the US and abroad.
- Cronos LP will sell and leaseback its Peace Naturals Campus in Ontario.
- Australian cannabis producer Cannim, that produces also in Jamaica, has obtained facility to grow in Ontario.
- Acqualitas, a Nova Scotian organic producer, obtains EU-GMP from German inspectors.
In Brazil, pharmaceutical giant Eurofarma enters CBD market by achieving registration of 4 extracts in the booming market, growing exponentially according to a recent report:
- 430,000 patients are assumed to use CBD through the three access schemes allowed in the country (approved products, special imports and patient associations) generating annual revenues of $143M.
- Uruguayan producer GreenMed gets ANVISA GMP to enter Brazilian Market.
Historical basque seed bank Dinafem is finally making itself heard after enduring a police raid of over 400kg of seeds in 2020 and forced to stop operations in Spain.
- Andalusian grower Medical Plants claims to obtain commercial growing authorisation after receiving its GMP early in the year, making it the second Spanish LP after Linneo Health.
- MM Flowers, owned by berry producers in Huelva, obtains permit to validate medical cannabis production processes.
In California, the largest cannabis distributor Grassdoor has collapsed, easing operations and laying off all employees. This follows the collapse of Herbl that closed doors in June.
- US multistate operators continue to exit markets to focus on more profitable states.
- Barcelona-based Dutch seed bank Royal Queen Seeds opens seed store in New York.
Israeli government published statistics on international cannabis trade revealing a sharp decrease in importations from 24 tonnes in 2022 to just over 15 tonnes in 2023.
- Canada remains the largest supplier by far, while Portugal and Uruguay decrease their share as suppliers to the Israeli market.
In Portugal, INFARMED unveils that 5.4 tonnes were exported in the first half of the year.
- While exports to Israel dropped to a halt, the Polish and Australian market are opening up to Portuguese production.
- Lisbon-based extractor Somaì inks supply deal with Cannaforest to manufacture APIs.
In France, the first domestic LP Delled-LaFleur has produced cannabis extracts for the first time.
Indian ayurveda medicine producer HempStreet bags $1M funding to expand product range, carry out clinical trials and explore international markets.
Jujuy public enterprise Cannava has registered the first Argentinian-grown CBD medicine for sale throughout the country.
Cannasouth launches flower grown in New Zealand to local patients.
The first private medicinal cannabis clinic Medicann has opened in Ireland.
Emilia-Romagna region seeks to develop hemp supply chain with €500k loan.
3. Science updates
CBD clinical studies to treat a variety of minor ailments are progressing:
- Skye Bioscience launches phase 2 study of CBD Emulsion to treat glaucoma.
- CardiolRx™ studies use of CBD for heart disease.
- Israeli SciSparc is developing a patented CBD solution for Autism Spectrum Disorder.
- MGC Pharma study shows antiproliferative effects of cannabis extract against melanoma cells.
- Sapient Therapeutics announces positive results of solid-dose CBD pharmacokinetics trial against Epidiolex.
DEMECAN and the University of Düsseldorf begin a study on spasticity in multiple sclerosis.
Study on Cannabichromene (CBC), a minor cannabinoid, shows anti-inflammatory potential.
Genetic factors are related to cannabis use disorder, a multi-ancestry genome study finds.
- French Aelis Pharma advances phase 2b study of its CB1 inhibitor to be used against cannabis use disorder.
A study on the impact of fertilisation and pruning shows nitrogen does not increase cannabinoid concentration, sunlight distribution is key for yields and potency.
Australian project seeks to identify the best-performing hemp varietiesin the country.
17th century Italians were using cannabis, a forensic analysis in Milan reveals.