2023 has been a milestone year for European cannabis. Europe’s first fully legal adult-use cannabis stores have opened in Switzerland. The first Cannabis Harm Reduction Associations have been licensed in Malta. The Netherlands finally has a legal supply of cannabis to its coffeeshops. France has all but managed to secure a full-scale medical cannabis system, while Germany’s coalition government has dragged the landmark CanG bill through numerous legislative battles, missing the deadline to have it enacted before the end of the year by a matter of weeks.
As Prohibition Partners’ state in their latest Global Report: 4th Edition, progress this year has been ‘incremental, rather than abrupt’.
These accomplishments may seem ‘incremental’ when reflecting on 2023 as a whole, but the long, arduous and complex battles, often fought by a handful of dedicated cannabis patient groups, advocates, and activists, cannot and should not be understated.
In a series of articles reflecting on what has been a difficult year on numerous fronts for the cannabis industry, we’ll look back on the of detail some of these hard-fought battles throughout Europe over the past 12 months.
France’s battle for medical cannabis
September 2022 – France’s medical cannabis pilot project was quickly approaching its deadline of March 2023. Following its launch in March 2021, 2,000+ patients had been receiving medical cannabis free of charge for nearly two years.
It was widely expected that, as stipulated by the government when the pilot was initially launched, medical cannabis would be ‘generalised’ and brought into France’s national health service in full following the pilot.
However, in September, an amendment was tabled by the government to extend the pilot for a further year, leaving patients and industry stakeholders questioning what this meant for generalisation, and whether the products would continue to be free for patients.
The government claimed that the experiment ‘has not yet been able to produce sufficient clinical results for us to be able to decide on (medical cannabis) generalisation’.
February 2023 – The first clinical data since the medical cannabis trial launched was published, painting an overwhelmingly positive response to treatment from the patient community.
According to the newly released data from the National Medicines Safety Agency (ANSM), as of October 18, 2022, 2,204 patients had been included in the experiment, 91% of whom said they were in support of medical cannabis legalisation in France.
However, the trial was only ever intended to provide safety and efficacy data as a ‘secondary objective’, instead focusing on the realities of rolling out a medical cannabis framework.
As such, to the dismay of many, these results had little impact on the future of the country’s increasingly uncertain generalisation plans.
With the pilot now extended for another year, its suppliers, which had until now been providing products at their own cost, were gearing up to partake in another tender process to supply the initiative.
April 2023 – A month later, and the tender process was not going to plan, seeing companies shun calls to continue their involvement due to significant cost burdens.
Initially, companies, including Aurora Cannabis, Tilray, Panaxia, and Little Green Pharma, responded positively to tender calls to provide their products for the French experiment free of charge.
Although, for the first time, some compensation was offered to those taking part, this came well below the minimum production costs for companies.
Reports suggested that more than half of the patients involved in the scheme had been left without access to treatment, due to the supply shortages.
With the French government yet to allocate a budget for the programme, or finalise any framework surrounding the regulation of medical cannabis, experts said there was a ‘very big need for a new push to come from the industry supporting patient voices’.
Questions were being raised over whether the few suppliers that remained in place would pull out.
July 2023 – Australian firm Little Green Pharma (LGP), which had already been supplying medical cannabis oil to the French pilot programme since its inception, announced that it had won a second call for tenders.
LGP said it would now supply up to US$1.6m (US$77 per bottle) of its CBD50 medical cannabis oil to the French pilot programme.
According to LGP, it remained the largest supplier of the experiment, seeing an estimated 85% of its 2,000+ participants in the trial use its products.
Reports suggest that LGP had initially refused to apply for the first call for tenders after the experiment was extended, seeing the French Ministry of Health offer to pay just €14 ($15.45) per bottle. It is thought that the government increased its offer during its second call for tenders.
September 2023 – The French government published its 2024 Social Security Financing Bill (PLFSS), set to determine the state’s budgetary allocations for the coming year.
To the dismay of patients and industry stakeholders, the bill made no mention of the medical cannabis project or any allocated budget, once again leaving the future of the industry in limbo.
Experts suggested that with the deadline for the pilot once again closing in, the bill’s opponents were ‘waking up’, and would ‘do everything to restrict access to these drugs as much as possible, even though they are intended for patients in therapeutic impasse and in severe suffering’.
With the draft of the PLFSS now set to be considered by parliamentarians before being enacted, the ‘only opportunity for its inclusion lies in the possibility of MPs proposing amendments’ to include medical cannabis.
One group, Access Aux Soins (Access to Care), launched a petition calling for patients to ‘put pressure on our representatives to add cannabinoid-based medicines to the 2024 PLFSS’, ahead of the beginning of debates on October 10.
October 2023 – France’s Minister for Health, Aurélien Rousseau, confirmed that the country’s medical cannabis experiment would continue, providing some solace for its thousands of patients.
Despite pressure from cross-party parliamentarians, elected officials, scientists and doctors, Mr Rousseau refused to commit to rolling medical cannabis out generally across France this year.
💊 accès aux médicaments à base de cannabinoïdes (“cannabis médical”) : écoutez les engagements du ministre de la santé @aur_rousseau suite à une question de la députée @CarolineJanvier devant la commission des affaires sociales de l’@AssembleeNat le 11/10/23 🏛️ #douleur #cancer pic.twitter.com/kAQyh05CpR
— Nicolas Authier (@NicolasAuthier_) October 12, 2023
The minister suggested that the lack of commitment to a fully fledged medical cannabis programme was due to a lack of ‘European marketing authorisation’, which he suggested could be ready by 2025.
Should European marketing authorisation not be granted by 2025, Mr Rousseau said the government planned to ‘switch to so-called compassionate access’, a special scheme used to enable patients to access certain drugs still in development.
Crucially, he confirmed that the government ‘will present an amendment so that obviously all the beneficiaries of this experimentation can continue to benefit from it’, thanks to an ‘adapted status that will then allow us to see over time’.
November 2023 – On Monday, October 23, the government tabled an amendment to the 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 would 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 Business of Cannabis 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 passed the PLFSS, there would be the capacity to start building a medical cannabis industry in France as pre-redacted ministerial decrees were expected to be published in the aftermath.
December 2023 – France’s National Assembly definitively approved the PLFSS for 2024, including the last-minute amendment on medical cannabis.
While this does not yet represent fully fledged generalisation of medical cannabis as many in the industry had hoped, the amendment stipulates that when the pilot 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 be reimbursed. This is five times the current budget for the experiment.
