France’s National Assembly has approved a two-year initiative that will offer an alternative treatment to 3,000 patients for whom no other options remain.
The testing will involve a six-month phase-in period, six months for patient enrollment, six months for patient treatment and monitoring, and six months for data analysis, according JD Supra, a legal website.
The study aims to help people suffering from conditions such as neuropathic pain, severe epilepsy, painful spasticity in multiple sclerosis sufferers and certain nervous system pathologies. It will also treat people in palliative care.
“It is not ethical to let patients who cannot be sedated or soothed by existing medicines to suffer,” Catherine Simonin, a spokesperson for patient advocacy union France Asso Santé, and the vice-president of anti-cancer group la ligue contre le cancer, told FranceInfo.
“People for whom pain leaves them no quality of life. 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,” Simonin said.
“There is also the risk of addiction, and we must be sure that there is no lessening of its impact, and that there are no risks for certain organs.”
The French National Agency for Safety of Medicinal Products has opted for a wide range of product formats, and will administer the drug in the form of oils, dried flowers, capsules or infused beverages. Doctors have been invited to participate in the trial on a volunteer basis and will be given special training to help them do so.
The trial is expected to commence once a funding arrangement, one of the few remaining sticking points, has been sorted out by France’s government. The country also needs to secure sourcing for the cannabis to be used in the trial, a tender that will provide early access to what is expected to be an accommodating market for the drug.