Health Canada to allow importation of drugs needed to treat opioid addiction

Prescription pills containing oxycodone and acetaminophen are shown in this June 20, 2012. (Graeme Roy / THE CANADIAN PRESS)

TORONTO -- Provinces and territories are now able to import urgently needed medications that are not available in Canada to treat the growing incidence of opioid dependence under new Health Canada regulations announced Tuesday.

"The new regulatory pathway will enable public health officials to access drugs that aren't approved in Canada that can be used in public health emergencies, like what we're seeing in the opioid crisis," Suzy McDonald, assistant deputy minister of the department's Opioid Response Team, told a media briefing from Ottawa.

"Our goal is to provide timely and greater access to drugs not available in Canada to help address health crisis situations," she said. "It enables public health professionals to access drugs that trusted regulators in the United States, the European Union or Switzerland have already reviewed and can be used as safe and effective treatments."

Health Canada has published an initial list of drugs for import, including injectable Vivitrol and orally dissolving Suboxone -- replacement medications for those trying to kick the opioid habit.

"The idea is that we would have more tools at the disposal of treating physicians for especially those very hard-to-treat patients or to have access to medications that are not used all that widely in Canada (because) ... a company hasn't decided to come and seek market access," said Dr. Supriya Sharma, chief medical adviser for Health Canada.

The imported medications will remain on the list for one year, after which time they will be removed unless Health Canada receives notification for continued access to the medication to address an urgent or continuing public health need.

Medications to treat opioid use disorder and tuberculosis have been identified by public health officials as those needing immediate access. Examples of other drugs that could be approved for importation through the process are those for treating pandemic viruses or other public and military health emergencies.

McDonald said specific medications are added to the list based on requests from provincial or territorial medical officers of health, who have determined there is an urgent need at the population level.

British Columbia, which has been experiencing a rash of opioid-related overdose deaths in recent years, has requested several medications aimed at treating residents with what's known as opioid use disorder.

Dr. Bonnie Henry, B.C.'s deputy provincial health officer, said many of the requested medications are sold in Canada, but not in optimal formulations.

"So it just basically increases the number of products that are available to support people when they're going through recovery from opioid use disorders," said Henry. "And the products that we've requested be available are ones that our addiction specialists have said they think would be helpful."

Last year, about 23,000 B.C. residents were receiving opioid-substitution therapy in the form of methadone or Suboxone. That figure include those who have not sought treatment for abuse of prescription opioids such as oxycodone or illicit fentanyl pills sold on the street.

The province recorded 935 opioid-related overdose deaths in B.C. in 2016. So far this year, there have already been 488 such deaths, said Henry, who conceded that "we don't seem to be turning the corner" on the crisis, despite a multi-pronged approach aimed at curbing the drug epidemic and reducing fatalities.

"These new medications aren't going to solve our problem," she said from Vancouver, "but they certainly make more options available for people."

It's not known how many Canadians are hooked on opioids, but the highly addictive drugs were responsible for an estimated 2,500 overdose deaths across the country in 2016 -- a number that is likely to be surpassed this year.

"It goes without saying that Canada is experiencing an unprecedented public-health crisis of opioid-related overdoses and deaths," said Dr. Theresa Tam, chief public health officer of Canada.

"If the current trend continues, deaths in Canada could be higher than 3,000 in 2017."

Tam said Health Canada is collecting data on the number of opioid-related overdose deaths from the provinces and territories and hopes to begin releasing those numbers on a quarterly basis starting in August.