The Alberta government has yet to receive approval from Health Canada for its plan to import millions of bottles of children’s pain medication from a Turkey-based pharmaceutical manufacturer, and it’s not clear when the drugs would land on store shelves if that happens.
Health Minister Jason Copping said Wednesday the process to secure regulatory approval is “almost complete” and could happen within days, but didn’t provide further details. Mr. Copping and Premier Danielle Smith said on Dec. 6 that the province reached an agreement with Atabay Pharmaceuticals and Fine Chemicals to supply five million bottles of acetaminophen and ibuprofen. They said they were hopeful the first shipment would arrive by Christmas.
Mr. Copping said the first shipments could arrive within days of federal approval. It would then take another three to four days for distribution.
“We’ve cleared a number of hurdles and there’s a few left,” he said at an unrelated event in Calgary. “First step: we need to finalize Health Canada and we’re working very hard on it and hopefully, in the next few days, we’ll be able to finalize that process.”
The minister said product labelling is still being assessed by Health Canada, in addition to final sign-off “in terms of the factory in Turkey and reviewing the documents there.” The minister also said the government is “looking at other options” to expedite the process, such as importing the first shipment in advance of a green light from Ottawa.
Health Canada spokesperson Anne Génier said in a statement that there was no new information to share on Ottawa’s approval process.
Federal officials previously said they had met with the Alberta government and alerted it to requirements necessary for the importation of foreign products, including that the Canadian importer have a drug establishment licence and the manufacturer meets Canada’s safety and efficacy standards. There must also be bilingual labelling for cautions, dosing directions and ingredients.
The announcement earlier this month came as a wave of respiratory infections strained the province’s children’s hospitals and cleared store shelves of acetaminophen and ibuprofen approved for young patients.
Ottawa has also been working to increase supply. The federal government said in early December that two million additional bottles of those medications had been acquired through domestic supply and foreign importation, the majority of which are already in circulation, while another 800,000 units were expected to be distributed this month to Canadian pharmacies and retailers.
Waste water testing data compiled by researchers at the University of Calgary show that infections of COVID-19 and influenza may have peaked in Alberta, while levels of RSV, another respiratory virus that can pose a particular risk to young children, continue to be high. Even if the medication supply stabilizes and infections decline before Alberta receives the shipments from Turkey, Mr. Copping said it will be worthwhile.
“I’d rather have it and not need it, than need it and not have it,” he said. “The fact of the matter is we have other provinces asking us for this as well. We’re working with Health Canada. So, it is necessary, it is important to get it as quick as possible.”
Due to global competition, the government said it was required to purchase the minimum set by the supplier, which is why the amount of bottles greatly exceeds the province’s need. The government said it intends to share the supply with other provinces and territories. The province has yet to provide a public figure on the cost but is paying a “small premium.”
Mr. Copping said Wednesday the government is still assessing the total cost but will ensure the medication is affordable for Albertans.