Experimentation with therapeutic cannabis: specifications published

The specifications (CDC) for future drugs based on cannabis to be issued during the trial of medical cannabis in France was published yesterday.

The CDC sets out «the specifications for the quality of medical cannabis, the quantity of medical cannabis expected for the entire duration of the experiment» and «the conditions for making medical cannabis available, including the supply documentation system».

It also precedes the choice of suppliers, who should no longer have to wait for a call for tenders, as the experiment does not involve any monetary exchange. Potential suppliers will nevertheless have to pay close attention to the publication of the call for applications, which the Agence nationale de sécurité du médicament et des produits de santé (ANSM) will be responsible for issuing. They will then have 35 days to apply.

Who will finally be able to provide experimentation with medical cannabis?

The published decree provides details of the mechanism for delivering medical cannabis in France. Suppliers will have to work hand in hand with a pharmaceutical establishment which will ensure the exploitation of the medicinal products within the framework of the experiment, and which will therefore have to have the status of a pharmaceutical establishment and an importer status if the cannabis comes from a country outside the European Union.

As previously revealed, no French producer is authorized during the trial period if only with a view to the possible widespread use of medical cannabis in France.

Which products?

The decree also clarifies the choice of product that had been drawn up in the initial terms of the experiment. They will ultimately be divided between raw flower, capsules and sublingual oil. THC:CBD ratios are now listed for information only, to distinguish between THC-dominant, balanced and CBD-dominant products. 12 batches are listed, and will have to be allocated in duplicate with a «back-up» supplier in the event of failure of the first supplier:

• THC dominant ratio «indicative THC 20 : CBD 1».»
  • THC flower > 8 %, CBD < 1 %
  • Oil THC > 5 mg/ml, CBD < 1 mg/ml
  • oral form for ingestion THC > 5 mg/ml, CBD < 1 mg/ml
• Balanced ratio «indicative THC 1 : CBD 1».»
  • THC and CBD flower > 5 %
  • THC and CBD oil > 5 mg/ml
  • oral form for ingestion THC and CBD > 5 mg/ml
• Dominant CBD ratio «for information THC 1 : CBD 20».»
  • Flower THC 5 %
  • Oil THC 5 mg/ml
  • oral form for ingestion THC 5 mg/ml
  • Flower THC 5 %
  • Oil THC 5 mg/ml
  • oral form for ingestion THC 5 mg/ml

The order also specifies that: «Medical cannabis must be supplied as a finished product, in its final packaging, ready to be dispensed to the patient. At least two package sizes per form are desired. However, these sizes should not exceed the equivalent of one month's treatment. In addition, it is recommended that the supplier propose, in its offer, a packaging corresponding to 7 days of treatment.»

Where dried flowers are supplied, the decree also stipulates that a vaporizer «whose status is that of a medical device» and «adapted to the pharmaceutical form concerned» may be supplied with them.

To whom?

Last but not least, the framework for prescribing medical cannabis is no longer limited to the absence of a therapeutic alternative, but «in the event of insufficient relief or poor tolerance of accessible medicinal or non-medicinal therapies», which will open up the list of 3,000 people eligible for the experiment a little further, and make access to medical cannabis a little easier once it has been generalized.