Health Canada is moving to relax rules on importing drugs, such as pharmaceutical-grade heroin, knocking down yet another barrier to a last-resort addiction treatment amid a worsening overdose crisis.
Proposed changes to the federal Food and Drugs Regulations would allow for the bulk importation of drugs not currently marketed or available in Canada as needed in urgent public-health scenarios. While it would apply to public-health emergencies, such as a flu pandemic, federal Health Minister Jane Philpott introduced the legislation with the opioid crisis – and prescription heroin, specifically – in mind.
"I recognize the tremendous frustration and grief and loss of people who are most severely impacted by the overdose crisis," Dr. Philpott said in an interview on Friday. "This is one more step in our determination to save people's lives."
Health officials in British Columbia – where Vancouver's Providence Crosstown Clinic, the only Canadian facility that offers heroin-assisted treatment is located – have called for the expansion of the program, which targets drug users who do not benefit from more common opioid-addiction therapies such as methadone or buprenorphine-naloxone (Suboxone).
But regulatory hurdles meant they had to apply for access to the drug for each patient, import the drug from Switzerland and resubmit applications for each patient every six months. They expressed this frustration to Dr. Philpott, who had earlier overturned a previous ban on pharmaceutical heroin, also known as prescription heroin, and written to provincial health ministers to ask what else her office could do.
"It became clear to me that there were still significant barriers," Dr. Philpott said. "It was really highlighted to me when I visited Crosstown Clinic and met with the leadership there who explained to me just how onerous the current requirements were to be able to access diacetylmorphine [heroin] for their patients."
Proposed changes mean that a public-health official, such as a provincial health officer, can request the bulk importation of a drug authorized for sale in the U.S., the European Union or Switzerland but not currently available in Canada.
If authorized, the drug would be approved for bulk importation for one year, at which point the public-health official can notify the minister again that there continues to be a need for it.
Scott MacDonald, physician lead at Crosstown, said he was pleased to see a new way to access treatments in an emergency. "Health Canada has created a pathway to respond to a health crisis, whether the opioid crisis today or some other epidemic in the future."
A major hurdle that remains is funding – something Dr. Philpott said will largely fall to provinces.
"The important message to get out is that treating overdoses, and treating problematic substance use, is always better for the public cost than not treating," she said.
Providence Healthcare, which runs Crosstown Clinic, estimates that one person using illicit opioids costs society around $48,000 a year in health- and justice-related costs, compared with $25,000 a year on heroin-assisted treatment at Crosstown.
Dr. MacDonald said the program also builds relationships between medical staff and a vulnerable population that might not otherwise access health care. "The basic requirements are a room and a nurse," he said. "It's not complicated, but it does require funding commitment."
Patricia Daly, chief medical health officer for Vancouver Coastal Health, said there needs to be a "dramatic expansion" of the treatment.
"We need to ensure we have a good system of care to be able to offer treatment as soon as people are ready for it, to follow them through the treatment process," Dr. Daly told city council at an update on the overdose crisis last week.
"If they're not willing to take an oral therapy, perhaps they're willing to start with an injectable therapy. We need to consider all options going forward because this is getting people off the contaminated, illicit drugs and on to an alternative where we can stabilize them, where they are at much lower risk of serious consequences or death."
A total of 931 people died of illicit drug overdoses in B.C. last year, and another 347 in the first quarter of this year.