LGP to significantly benefit from new laws governing two-stage post-French Pilot medicinal cannabis supply in France
First stage is a 9-month transitional period covered by a €10m budget during which LGP and two other suppliers have an exclusive right to supply
Second stage is a bespoke, subsidised public access regime for medicinal cannabis products meeting certain product registration requirements
LGP and its distribution partners to capitalise on first mover advantage following their continuous supply to the Pilot since 2021 and long-established relationships with existing patient, hospital prescriber, and pharmacy networks
France represents one of the largest potential medicinal cannabis markets in Europe with a Total Addressable Market of €5.6 billion (A$9.3 billion)
Little Green Pharma Ltd (ASX: LGP, “LGP” or the “Company”) is poised to significantly capitalise on a major amendment to the French health security bill, paving the way for a substantial transformation in how medicinal cannabis is integrated into the French healthcare system.
In 2021, LGP and leading French pharmaceutical distributors, Intsel Chimos and Centre Lab, were appointed as primary supplier and distributor of LGP’s 1:20 THC:CBD and CBD50 medicinal cannabis oils for a two-year French pilot of medicinal cannabis products in the treatment of certain clinical conditions (“Pilot”).2 Both 1:20 THC:CBD and CBD50 medicinal cannabis oil products were produced at LGP’s Australian operations.
Following its initial success, the Pilot was extended for a third year until March 20243 with LGP and Intsel Chimos re-appointed as primary CBD oil supplier for both products.
With the program nearing the end of the extension period, the French Government has signed into law an amendment to theProjet de loi de financement de la Sécurité sociale (Social Security Financing Order) (“PLFSS”) which supports the post-Pilot supply of medicinal cannabis from March 2024.
The Amendment confirms up to a 9-month transitional period (“Transitional Period”) followed by a bespoke, subsidised public access regime for an indefinite period (“Supply Authorisation Period”).
During the Transitional Period, an exclusive supplier pool of only the existing suppliers engaged in the Pilot program – LGP, Aurora and Panaxia – will be entitled to supply patients with medicinal cannabis.
Little Green Pharma CEO Paul Long said the legislation was significant for LGP as it maintained the Company’s substantial first-mover advantage and was anticipated to substantially bolster the Company’s already strong revenue stream from European operations.
“Our active involvement as a continuous supplier to the French Pilot program positions the Company to be the major player after the Transitional Period,” Mr Long said. “This will involve us submitting a technical dossier that will adhere to upcoming specifications, expected to be released before the conclusion of the Pilot program.”
“Our previous experience in France enables us to streamline the evaluation process, given that our technical details are already known to the regulatory authorities, and that our products’ safety and efficacy have been conclusively demonstrated over the past few years.”
“Importantly, the amendment specifies exclusive access to supplying the French market will be granted solely to European registered companies who have a partnership with a French Pharmaceutical Establishment.”
“With our Danish entity fulfilling the necessary European Supply Authorisation requirements for France, LGP, along with our distribution partners Intsel Chimos and Centre Lab, is extremely well positioned to capitalise on long-established relationships with existing patient, hospital prescribers and pharmacy networks during the transitional phase and beyond,” he added.
About Little Green Pharma
Little Green Pharma is a global, vertically integrated and geographically diverse medicinal cannabis business with operations from cultivation and production through to manufacturing and distribution.
The Company has two global production sites for the manufacture of its own-branded and white-label ranges of GMP-grade medicinal cannabis products, being a Danish production facility with a potential nameplate capacity of over 30 tonnes of cannabis biomas per annum and a West Australia premium indoor GMP production facility specialising in premium hand-crafted cannabis strains.
Little Green Pharma products comply with all required Danish Medicines Agency and Therapeutic Goods Administration regulations and testing requirements. With a growing range of products containing differing ratios of active ingredients, Little Green Pharma supplies medical-grade cannabis products to Australian, European and overseas markets.
The Company has a strong focus on patient access in the emerging global medicinal cannabis market and is actively engaged in promoting education and outreach programs, as well as participating in clinical investigations and research projects to develop innovative new delivery systems.
For more information about Little Green Pharma go to: www.littlegreenpharma.com
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