The French Minister of Solidarity and Health signed a long decree specifying how a small-scale pilot program will be supplied with medical cannabis which will eventually be given free to patients.
This decree, signed on Friday, was followed by the Medicines and Health Products Safety Agency (ANSM), which published the supplier application process on Monday.
As a result, most of the long overdue regulatory efforts have been completed and the experimental program is ready to go once the government has selected the suppliers, who will be responsible for paying the costs of the program.
The program will also rely on imported medical cannabis.
In addition to providing up to 3,000 patients with free products, participating companies will need to adhere to pharmaceutical standards, including good manufacturing practices.
Certain details, such as how the training of doctors works, also remains 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 income opportunity for cannabis producers – at least not over the next two years. The outlook beyond this two-year period is uncertain.
Cannabis producers selected as suppliers of the French experience will not only have to provide the products for free. They will also be responsible for ensuring the distribution – also free – to French pharmacies as well as maintaining the pharmacovigilance of products.
This means that suppliers will need to partner with local pharmaceutical companies who will provide import, distribution and drug safety services.
Businesses will be responsible for covering all of these costs without the help of patients or public funds.
The new documents follow a previous decree authorizing the experiment.
Is it worth it?
The decree specifies that the companies selected to provide the experience “cannot claim or expect at the end of the experience any guaranteed right or direct or indirect benefit linked to their participation, in particular in the event of (general legalization) of the cannabis for medical use by the French authorities. ”
Benjamin-Alexandre Jeanroy, CEO of Augur Associates, a Paris-based cannabis consultancy, said Marijuana Business Daily that France “has decided to subcontract all the responsibility and the costs of the experiment to the private sector, without much reward for the risks taken or any assurance of the opening of the market thereafter”.
Jeanroy is worried about “what will happen with patients who have already been waiting for years if the French government cannot find the suppliers”.
Nicolas Authier, university professor and president of the ANSM scientific committee on medical cannabis, is more optimistic.
Authier said MJBizDaily that the selected suppliers “will always be the first on the market in the event of legalization or generalization”.
“It would not be legal to give exclusivity to the suppliers, but with hundreds of patients already treated (at the end of the experiment) and doctors used to prescribing their products, it is probably a marketing advantage”, he added.
Authier also mentioned that “the savings made by these providers on clinical research, where pharmaceuticals are also offered for free, should allow them to (provide) this little experience. The cost will also be shared between several suppliers. ”
Applications to become a supplier will be accepted – in French only – until November 24.
Submissions require a significant amount of documentation, as well as samples which will need to be sent to the French authorities before the November deadline.
Sending samples in such a short time frame could be a challenge for producers, as import and export permits, which take weeks to obtain, are required for international shipments of herbal medicines. cannabis.
The deadline to enter into an agreement with a local pharmaceutical partner who will be responsible for distribution to pharmacies is December 15.
Eligible applications will be assessed using a points system. Up to 50 points – out of a total of 100 – will be awarded based on products, 30 based on product manufacturing and 20 based on offer.
Two suppliers will be selected for each product category: flowers, oils and capsules.
One will be the main supplier and the second the substitute in the event of a supply disruption.
Cannabis products will only be used as a last resort and must meet pharmaceutical quality standards, including good agricultural practice, good manufacturing practice and compliance with several parts of the European Pharmacopoeia and others. European regulations.
High barriers to entry limit the number of potential suppliers to a handful.
Only patients who meet 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 related to cancer or cancer treatment.
- Situations palliatives.
- Painful spasticity due to multiple sclerosis or other pathologies of the central nervous system.
Flowers for inhalation by vaporization will be part of the experiment, as well as extracts – capsules or oils – with different THC and CBD ratios.
Products should be supplied in their final form, packaged ready for patients, with a shelf life of at least six months, and with a package leaflet containing product information.
Candidates must specify in their offers the total quantity they consider necessary for the entire duration of the experience as well as the monthly quantities.
They must also be able to ensure the continuous supply of products.
For flowers, applicants should indicate whether they are able to provide vaporization devices for the duration of the experiment to each patient.
Spray is the only acceptable route of administration for flowers.
Applicants should indicate whether vaporizers are registered as medical devices or provide the status of the assessment procedure.
Questions about the application process can be sent by email until November 18 to [email protected].
Alfredo Pascual can be reached at [email protected]