The French Minister of Solidarity and Health has signed a lengthy decree specifying how a small-scale pilot program will be supplied with medical cannabis that ultimately will be given to patients free of charge.
That decree, signed Friday, was followed by the Agency for the Safety of Medicines and Health Products (ANSM) publishing the application process for suppliers on Monday.
As a result, most of the long-awaited regulatory legwork is done and the experimental program is ready to begin once the government selects the suppliers, who will be responsible for swallowing the program’s costs.
The program also will rely on imported medical cannabis.
In addition to supplying up to 3,000 patients with free product, participating companies will have to comply with pharmaceutical standards, including Good Manufacturing Practice.
Some details, such as how doctor education will work, also remain to be clarified. But the first prescription is expected by the end of March 2021 at the latest.
The experiment does not represent an immediate revenue opportunity for cannabis producers – at least not during the next two years. Prospects beyond that two-year period are uncertain.
Cannabis producers selected as suppliers of the French experiment will not only have to provide the products free of charge. They also will be responsible for assuring distribution – also at no cost – to French pharmacies as well as maintaining the pharmacovigilance of the products.
This means suppliers will have to partner with local pharmaceutical companies that will carry out import, distribution and drug-safety services.
Businesses will be responsible for footing all those costs, with no help from patients or public funds.
The new documents follow a previous decree authorizing the experiment.
The decree says companies selected to supply the experiment “may not claim or expect at the end of the experiment any guaranteed right or direct or indirect benefit linked to their participation, particularly in the event of (general legalization) of cannabis for medical use by the French authorities.”
Benjamin-Alexandre Jeanroy, CEO of Augur Associates, a Paris-based cannabis consultancy firm, told Marijuana Business Daily that France “decided to outsource all responsibility and costs of the experimentation to the private sector, without much reward for the risks taken nor any assurance of the opening of the market afterward.”
Jeanroy is worried about “what will happen with patients that have already been waiting for years if the French government does not find the suppliers.”
Nicolas Authier, a university professor and chair of the ANSM scientific committee on medical cannabis, is more upbeat.
Authier told MJBizDaily that selected suppliers “will still be the first on the market in case of legalization or generalization.”
“It would not be legal to give exclusivity to suppliers, but with hundreds of patients already treated (at the end of the experiment) and doctors used to prescribing their products, this is probably a marketing advantage,” he added.
Authier also mentioned that “the savings made by these suppliers on clinical research, where pharmaceutical products are also offered free of charge, should allow them to (supply) this small experiment. The cost will also be shared among several suppliers.”
Applications to be a supplier will be accepted – only in French – until Nov. 24.
The submissions require a significant amount of documentation, as well as samples that will have to be shipped to French authorities before the November deadline.
Shipping samples in such a short time could be a challenge for producers, considering that import and export permits, which take weeks to secure, are needed for international shipments of cannabis medicines.
The deadline to close a deal with a local pharmaceutical partner that will be responsible for distribution to pharmacies is Dec. 15.
Qualifying applications will be evaluated using a point system. Up to 50 points – out of 100 in total – will be granted based on products, 30 based on the manufacturing of the products and 20 based on the supply.
Two suppliers will be selected for each category of products: flower, oils and capsules.
One will be the main supplier and the second the substitute in case of supply disruptions.
Cannabis products will be used only as last resort and must meet pharmaceutical-quality standards, including Good Agricultural Practices, Good Manufacturing Practices and compliance with several parts of the European Pharmacopoeia and other European regulations.
The high entry barriers limit the number of potential suppliers to a handful.
Only patients with the following qualifying conditions will be able to participate in the trial:
- Refractory neuropathic pain.
- Certain forms of drug-resistant epilepsy.
- Certain intractable symptoms in oncology linked to cancer or anticancer treatment.
- Palliative situations.
- Painful spasticity from multiple sclerosis or other pathologies of the central nervous system.
Flower for inhalation by vaporization will be part of the experiment, as well as extracts – capsules or oils – with different THC and CBD ratios.
The products will have to be provided in their final form, packaged ready for the patients, with a shelf life of at least six months and with a leaflet including information about the product.
Applicants must specify in their offers the total quantity they estimate will be needed for the entire duration of the experiment as well as the monthly quantities.
They must also be able to ensure the continued supply of the products.
For flower, candidates must indicate whether they are able to provide vaporization devices throughout the duration of the experiment to each patient.
Vaporizing is the only acceptable route of administration for flower.
Applicants must indicate whether the vaporizers are registered as medical devices or provide the status of the evaluation procedure.
Questions about the application process can be emailed until Nov. 18 to [email protected].
Alfredo Pascual can be reached at [email protected]