France takes major step towards medical cannabis generalisation

Via Business of Cannabis 

Following months of uncertainty and doubt, thousands of medical cannabis patients in France can now breathe a sigh of relief after the government finally confirmed that access to their treatment will continue.

On Monday, October 23, the government tabled an amendment to the Social Security Financing Bill (PLFSS) concerning medical cannabis, bringing it into France’s general medical framework for the first time.

Now, according to the new proposals, medical cannabis products will receive a ‘temporary authorisation’ for five years, with scope for these to be renewed by French authorities indefinitely.

Benjamin-Alexandre Jeanroy of Paris-based Augur Associates told us that while this represents a step towards fully-fledged generalisation, it ‘is a very important step because it brings medical cannabis into general law’.

“That is a huge victory in itself…While it’s still hard for patients, who still have to try every other treatment before being prescribed, it’s now part of the tool box for doctors to prescribe and patients to access.”

He added that once both chambers pass the PLFSS, there will be the capacity to start building a medical cannabis industry in France as pre-redacted ministerial decrees are expected to be published in the in the aftermath.

What Happened?

France launched its medical cannabis experiment in 2021, offering around 3,000 patients free cannabis products with an initial intended run-time of two years.

The trial was intended ‘to evaluate, in a real situation, the recommendations of the committee in terms of prescribing and dispensing conditions and the adherence of health professionals and patients to these conditions’, providing safety and efficacy data as a ‘secondary objective’.

Patients and industry stakeholders alike had expected that the experiment would be a near certain precursor to full regulation, yet with the experiment due to come to an end in March 2024, any mention of this was excluded from France’s PLFSS when it was published last month.

Following considerable pushback from the industry amid fears that not only would the thousands of patients lose access to their medicine, but also that the medical cannabis programme would be dead in the water, France’s Minister of Health confirmed in mid-October that the government would table an amendment to the bill which would address the issue.

The Amendment

This amendment was tabled last week, providing plans for a temporary status for medical cannabis products. Here are the key points:

• Medicinal products containing cannabis will now be subjected to a ‘temporary authorisation’ for five years, with the potential to be renewed by the ANSM in further five-year periods.
• Products will be authorised on a case-by-case basis.
• As mentioned earlier in October, generalisation will not take place before January 2025, pending a decision by European authorities.
• When the current experiment comes to an end in April 2024, there will be a maximum ‘transition period’ of nine months, by which time generalisation is expected.
• The government has set aside a budget of €10m for this transition period, which will enable patients to continue accessing their medicines and being reimbursed. This is five times the current budget for the experiment.
• After generalisation, access to cannabis for medical use will continue to be restricted to a last-resort treatment, and it can only be prescribed in hospitals.
• Prices for each product are yet to be determined, but will take into account prices across European countries of a comparable market size.
• The criteria for prescription of medical cannabis will be set subsequently by decree following an upcoming proposal from the ANSM.
• Flowers and other inhaled forms of cannabis products will be excluded.

While the move has been widely welcomed by the industry, which has rightly attributed the amendment to continued pressure from campaign groups, a number of key questions remain.

Primarily, campaigners have questioned why access remains so restrictive for patients, who need to have tried all other avenues of treatment before they can be considered for medical cannabis.

Furthermore, as no budget has yet been set for the generalisation, many have questioned whether reimbursement will continue as it has with the experiment.

French drug policy reform group L360 also raised concerns regarding data protection, as the current text says that companies supplying medical cannabis to patients must collect data on patient consumption and their reaction to treatment.

This article was originally published by Business of Cannabis and is reprinted here with permission.