Underlining the cautious approach Europe is taking to the liberalisation of medical cannabis are the pilot trial access schemes for medical cannabis currently in operation across several European countries including; Denmark, France, Ireland and Luxembourg.
The purpose of these trials is explicitly to investigate the controlled distribution of medical cannabis products in each country and to assess the harms and benefits of such systems in their domestic settings. The trials are initially time-limited with a view to appraisal at the end of the trial period and the chance for further, more permanent developments. In reality, the purpose of these trials is also to soothe the worries of conservative regulators and politicians in Europe who would not agree to full initial legalisation but can accept this gradual implementation. Each of these trial access schemes made significant progress throughout the course of 2021 and they are showing early promising signs.
France
France approved a two-year pilot programme in 2019 which officially began on the 26 March 2021, after considerable delays due to the global pandemic, among other issues. The pilot access scheme in France is intended to treat 3,000 patients over the period, for conditions including neuropathic (chronic) pain, painful spasticity in multiple sclerosis, epilepsy and general oncology.
In the words of a spokesperson for the Ministry of Solidarity and Health, the results of the trial will allow regulators, ‘to determine the framework that could be put in place for the creation of a system for the prescription and dispensing of such drugs in France’ in case, ‘it is desirable to introduce these drugs for use in common law’. The trial has several novel aspects which make it interesting, for example, medicines must be provided free of charge to patients from the six suppliers providing nine specific products overall to be distributed by six French pharmaceutical distributors. As of February 2022, 1,218 patients have received their initial treatment, with over 200 hospitals and 1,100 doctors signed up to participate in the experiment.
Ireland
Ireland approved their five-year pilot programme in June 2019, and launched it in July 2021 with the first patient receiving medical cannabis in September of that year. The scheme will run for five years and has a similar purpose to the French trial, but it is more limited in scope, allowing only senior doctors to prescribe to patients for only the following conditions: spasticity associated with multiple sclerosis, intractable nausea and vomiting associated with chemotherapy and treatment-resistant epilepsy.
The scheme supplements the access via ministerial approval which saw just 67 patients treated up to the launch of the pilot scheme. Just six products from three producers are available on the scheme as of February 2022. All costs can be covered for patients on a case-by-case basis. The limited set of doctors prescribing medical cannabis and the five-year horizon for reappraisal means this scheme does not show promise that a permanent solution to cannabis access will be set up in Ireland in the short term
Denmark
Denmark is home to the most well established medical cannabis pilot programme in Europe. Begun in January 2018, the programme currently serves around 500 unique patients per quarter in Denmark.
The scheme was initially conceived as a four-year project but in May 2021, a majority of parliament voted to extend the lifespan of the project for another four years, and it is now set to last, at least, until 2025. The trials allow any doctor to prescribe medical cannabis from a list of five flower and full-spectrum oil products for the following conditions: painful spasms due to multiple sclerosis or spinal cord injury, nausea after chemotherapy, and crucially, neuropathic pain, though some leeway is given for other conditions. Patients within the trial scheme have 100% of their costs covered by the government if their condition is terminal, and 50% in other cases. The pilot scheme has struggled since the CannTrust scandal and the instability of the supply of oil products which meant that many patients left this access pathway. In addition, it competes with a system of magistral distribution where medical cannabis isolates can be prescribed and bought at pharmacies.
Luxembourg
Luxembourg authorised a two-year pilot trial in 2018, which began in February 2019. The scheme was due for appraisal early in 2021 but, at that point, a six-month review of the success of the treatment with patients had begun.
The scheme allows for any doctor to provide medical cannabis oil and flower from a restricted set of medicines and specifically for cancer-related conditions, palliative or chronic pain conditions and those related to multiple sclerosis. As of February 2022, a new appraisal of the scheme is in process and it is expected to be published soon. The scheme allows for full coverage of costs by the Ministry of Health. The latest data indicates 600 patients were prescribed medical cannabis in 2020, meaning Luxembourg has almost as many legal prescriptions per population as the leader in Europe; Germany.
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