Little Green Pharma (ASX: LGP) 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). 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.4
With the program nearing the end of the extension period, the
French Government has signed into law an amendment which supports the post-Pilot supply of medicinal cannabis from March 2024.
The Amendment confirms up to a 9-month 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.
The Supply Authorisation Period will see the establishment of a subsidised public access regime for medicinal cannabis in France, providing improved accessibility to French patients. An overview of the Transitional and Supply Authorisation Periods is provided below:
A €10 million (A$16.6 million) budget has been approved for the supply of medicinal cannabis to existing Pilot patients (estimated to be 2,000 at end of Pilot)
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.
Mr Long said the strategic pathway also positioned LGP favourably for potential market registration in the future, leveraging its extensive experience in supplying cannabis- based products in France.
“We undoubtably took a calculated risk back in 2021 to pursue this French Pilot opportunity, but with the implementation of a limited transitional period and a medicinal cannabis market that will provide a subsidy to patients, we are the best positioned company in the world to capitalise on what we believe could become one of largest medical cannabis prescribing countries in the world,” he said.
Mr Long noted that while LGP was excited to be at the forefront of the French market, it was worth noting the Company’s ambitions were greater than any single market.
“Our continuing strategy to break into a number of highly lucrative European markets really sets LGP apart from our Australian peers,” he said.
“From early in our infancy, we recognised that real growth potential lies in Europe where stringent standards and regulations offer companies like LGP a remarkable competitive advantage over our counterparts.”
