French pilot project may cast new light on access to medical cannabis

A landmark experimentation recently authorised in France can foster patient access to medicinal cannabis in the country and become a role model for Europe.

Last month, the French government signed a decree that will kick off a two-year medical cannabis pilot project which will target 3,000 patients suffering from serious conditions, such as chronic pain and epilepsy.

Although originally scheduled in 2020, the launch of the programme has been postponed until early 2021 due to delays caused by the handling by the French health ministry of the COVID-19 pandemic.

The experimentation is limited to only certain therapies dealing with refractory neuropathic pain, some severe and drug-resistant forms of epilepsy, palliative situations and painful spasticity of multiple sclerosis or other central nervous system pathologies.

Accessible therapies also include supportive care in oncology for the treatment of cancer or cancer pain. Patients included in the programme will have access to these products in form of dried cannabis flowers and oils and completely free of charge.

This is the second pilot scheme for medical marijuana in Europe set in place after a 4-year one started in Denmark in 2018 and is still running

Under the Denmark experimentation rules, doctors were allowed to prescribe cannabis-based drugs ensuring a safe entry-point for companies that wanted to enter the European medical cannabis market.

More than two-thirds of prescriptions for medical cannabis in Denmark concerned pain-related conditions, while 18% of prescriptions were prescribed to patients for treating epilepsy.

Overall, 4,300 patients have been prescribed with medical cannabis since the beginning of the programme.

EU market for medical cannabis still far from full bloom

A temporary shortage of Dutch hemp flowers intended for export to Germany has put the spotlight on a lack of diversified supply sources and uniform quality standards in the growing European market for medical cannabis.

A role model

The French pilot scheme will be monitored at every stage to allow further studies and analysis and an electronic national monitoring register informed by doctors and pharmacists participating in the experiment will be set up.

This will inevitably set the stage for verifying the feasibility of legalising patient access to medicinal cannabis prescriptions at a later stage.

While full legalisation of cannabis for medical purposes still seems a long way off in France, the programme could also enhance the reputation of medical marijuana, still perceived as only recreational.

Patients will need a prescription from doctors or other health professionals, while all products require the approval by the National Medical Safety Agency (ANSM) and have to comply with pharmaceutical standards and Good Manufacturing Practice (GMP).

The implementation of the project has also been preceded by a Parliamentary fact-finding mission on the uses of cannabis for medicinal, well-being and recreational purposes.

In an interim report on legalising the therapeutic use of cannabis, the Parliamentary mission estimated that 700,000 patients in France could become eligible for this treatment.

The French medicine agency set up a specialised temporary scientific Committee (CSST) on medicinal cannabis to design the experiment.

Medical cannabis weeded out from short-term EU policy agenda

There is no European plan to address in the short-term the regulatory barriers for the use of cannabis for medicinal purposes, the Council presidency of the EU and the European Commission have confirmed to EURACTIV.

Problems persist

The implementation decree came after several delays, provoked the anger of patient associations and stakeholders.

In an op-ed published in the French daily Le Parisien in September, 51 of the main proponents of the experiment urged the government to take strong and immediate action and speed up the decree.

The members of the ANSM’s scientific advisory committee also threatened to resign, fearing a further delay in the implementation of the measure.

Although the decree was issued on 7 October, concerns remain and some outstanding issues are still to be sorted out.

As it is currently illegal to cultivate the flower of the hemp plant and thus medicinal cannabis in France, the project will have to rely on imported goods.

Suppliers that would manage to get in the scheme might enjoy the first-mover advantage in the emerging and potentially huge market of medical cannabis in Franche if national authorities will decide to legalise the use.

The deadline for interested parties is next week (24 November) and selected suppliers will be assessed by a points system.

However, this overreliance on exports could undermine the development of an authentic French sector, some stakeholders have complained.

Another pitfall might come from the lack of a proper budget for the programme, which would require €15-20 million according to Professor Nicolas Authier, who chairs the ANSM’s scientific advisory committee on medical cannabis.

Medical cannabis stakeholders are pushing for an ad-hoc budget to be decided on during the current discussion and vote of the French annual budget law.

[Edited by Zoran Radosavljevic]

Read more with Euractiv

EU expands vaccine options with CureVac contract