After two years of study and discussion, the federal government has finalized new rules for medical marijuana and granted a reprieve to pharmacists who opposed the rules in their draft form.
Health Minister Leona Aglukkaq rolled out the regulations Monday for formal publication in the Canada Gazette.
Under the new regime, the government will no longer produce or distribute medical cannabis, and medical-marijuana users will no longer be allowed to grow the product at home. Health Canada said that since the medical-marijuana program was introduced in 2001, it has expanded to 30,000 people from the original 500 authorized to use the product.
“This rapid increase has had unintended consequences for public health, safety and security as a result of allowing individuals to produce marijuana in their homes,” the department said in a news release.
“Under the new regulations, production will no longer take place in homes and municipal zoning laws will need to be respected, which will further enhance public safety.”
Under the new regulations, the government will allow patients to buy prescribed amounts only from licensed growers who will be required to meet strict conditions.
In previous versions of the regulations, pharmacies were to distribute the product just like other medications, provoking unease from pharmacists, who expressed concerns about dispensing a product without sufficient research. They also cited security concerns.
The final version removes the pharmacists from the loop, leaving patients to rely on mail order for their medical marijuana.
“While the courts have said that there must be reasonable access to a legal source of marijuana for medical purposes, we believe that this must be done in a controlled fashion in order to protect public safety,” Aglukkaq said in a statement.
“These changes will strengthen the safety of Canadian communities while making sure patients can access what they need to treat serious illnesses.”
She used similar reasoning last week when she introduced new hurdles for the creation of supervised drug-injection sites in response to a court ruling.
Physicians and pharmacists alike questioned the regulatory changes, saying there is little evidence that medical marijuana is either effective or safe. The umbrella group representing the country’s colleges of physicians and surgeons said the changes won’t protect people. “We believe that the new federal medical-marijuana regulations put patients and the general public at risk,” said Dr. Rocco Gerace, president of the Federation of Medical Regulatory Authorities of Canada. “Physicians should not be asked to prescribe or dispense substances or treatments for which there is little or no evidence of clinical efficacy or safety.”
In December, the president of the Canadian Medical Association, Dr. Anna Reid, described the proposed marijuana rules as “akin to asking doctors to write prescriptions while blindfolded.”
“Not only does prescribing drugs that haven’t been clinically tested fly in the face of medical training and ethics, but marijuana’s potential benefits and adverse effects have not been rigorously tested.”
The Canadian Pharmacists Association responded in February to a set of draft rules.
“There is little information available on safety, effectiveness, dosage, drug interactions or long-term health risks,” the association said in its letter to Health Canada.
“Pharmacists, physicians and nurse practitioners need evidence-based information to support safe and effective prescribing and dispensing of [medical marijuana].”
The association said it didn’t know how many pharmacies would be willing to participate in a revamped system.
“While the distribution process would be regulated, there remains the concern with pharmacists dispensing a product that does not have adequate safety and effectiveness evidence. In addition, the potential security risks to pharmacies due to robberies would need to be considered.”