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French Lawmakers Give Green Light to Two-year Medical Cannabis Trial

Oct 30, 2019

French Lawmakers Give Green Light to Two-year Medical Cannabis Trial

Lawmakers in the French National Assembly, the lower house of the French legislature, have approved a budget proposal that would fund a two-year-long trial program investigating the effectiveness of medical cannabis.

The trial program was previously approved by the French Senate in late-May, and by the French medical agency ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé) in July.

With funding secured, and with the approval of the ANSM and both houses of the French legislature on Friday 25 October, the trial is expected to begin in early 2020.

“I sincerely hope that the experiments can begin in the first quarter of 2020,” commented junior health minister Christelle Dubos after the vote.

 
The scope of the trial

French MP Olivier Véran, of President Emmanuel Macron’s centrist LREM (La République En Marche!) party, put forward the budget vote in the French National Assembly. He says that the trials could involve some 3000 people in France.

The medical cannabis treatments will be carried out at a number of hospitals, focusing on people with conditions such as epilepsy, chronic pain, cancer, or muscle spasms as a result of multiple sclerosis – all conditions that have previously been linked to positive outcomes when treated with cannabis, cannabinoids, or synthetic cannabinoids.

The trial will be open to patients deemed to be at a “treatment impasse,” who have not responded to other medical treatments, and who have exhausted alternative treatment options. Patients who are suffering from the side effects of chemotherapy, or who are in palliative care, will also be eligible to take part.

“It is not ethical to let patients who cannot be sedated or soothed by existing medicines to suffer,” said Catherine Simonin, spokesperson for the patient advocacy union France Asso Santé and the vice-president of anti-cancer group la Ligue Contre le Cancer, to FranceInfo, following the funding announcement. “We are in favor of this test, on the condition that it is monitored by a medical team.”

“There are definite benefits [of cannabis]… for people whose pain is not helped by existing medicines. But we must identify all of the side effects, including those that may be serious.“

In these new trials, patients will not be given cannabis flower to be smoked, but instead given cannabis derivatives in the form of oil capsules, infusions, or drops that can be taken orally.

Doctors will be able to join the trial on a voluntary basis, and those who become involved will receive additional training on the drug via an online education course. It’s hoped that the trial will allow French doctors and medical experts to better study the drug’s effects – including any potential side effects, and its effectiveness in treating various medical conditions.

Given the potential size of the trial, it’s thought that France will have to import pharmaceutical cannabis products to supply the trial participants – at least in the early months of the trial – until a domestic production and supply chain can be set up.

 

Medical cannabis in France and in Europe

French authorities are clear that whatever happens as a result of the trial, the French government will not consider legalizing cannabis for recreational use.

Speaking to FRANCE24 after the Senate vote, Professor Nicolas Authier, head of pharmacology at Clermont-Ferrand University Hospital Centre’s pain clinic, addressed the fears of the Les Républicains party who worried that approving this medical cannabis study could be the start of a ‘slippery slope’ towards recreational cannabis legalization.

“There is little risk that medical cannabis will be abused for recreational purposes. […] It has different users with different objectives,” commented Authier. “Those who take codeine for pain and those who smoke opium are taking the same substance but they don’t have the same purpose. Similarly, medical-grade cannabis will not satisfy those looking for psychoactive effects.”

In contrast to France, other European countries have already chosen to introduce major cannabis reform. In early 2019 Luxembourg announced its intention to become the first European country to legalize recreational cannabis use, and Germany’s 2017 decision to legalize medicinal cannabis now sees the country importing over 2,800 kilos of medical cannabis products to serve the needs of an estimated 60,000 medical cannabis patients. 

 

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