Ontario's health minister says the company linked to diluted chemotherapy treatments given to about 1,200 people in Ontario and New Brunswick fell under Health Canada's jurisdiction at the time.
Marita Zaffiro, president of chemotherapy supplier Marchese Hospital Solutions, testified Monday at a provincial legislative committee that her company went to Health Canada and pharmacy college officials in Ontario and New Brunswick to inquire about regulatory approvals. Both levels of government declined.
On Tuesday, Ontario NDP health critic France Gélinas asked Health Minister Deb Matthews why the province refused to regulate Marchese after the company's request.
"I think it's very important to note that Marchese did approach the College of Pharmacists," Matthews responded.
"The College of Pharmacists reported back to Marchese that because … these were not drugs that were being mixed for individual patients, it did not fall under the definition of a pharmacy, therefore it did not fall under the jurisdiction of the College of Pharmacists. The College of Pharmacists referred Marchese to Health Canada. Health Canada is responsible for the manufacturing of drugs. Indeed it has a policy on its books that if a pharmacy does not fit under the definition of the pharmacy then it likely is manufacturing and falls under the jurisdiction of Health Canada."
When Zaffiro spoke publicly for the first time on Monday under oath to the provincial standing committee on social policy at Queen's Park, she said the company never attempted to operate without regulatory controls.
Marchese Hospital Solutions won the contract to supply pre-mixed chemotherapy drugs to hospitals in December 2011, Zaffiro said.
In an email to CBC News on Wednesday, Health Canada said it wanted to set the record straight about the discussions.
"Marchese came to us in November 2011 representing itself as a provincially accredited pharmacy with specific questions about proposed activities," said Leslie Meerburg, media relations officer for Health Canada.
"Health Canada provided advice to Marchese about those activities as they relate to the Food and Drugs Act, based on the information they provided. We outlined the activities that would require them to submit an application to Health Canada. To date, no such application has been received. At no time did Health Canada refuse to regulate Marchese."
Zaffiro said Marchese supplied products with a set amount of drug in each bag, rather than creating a mixture that contained a given concentration of the drug per per millilitre of saline.
Health Canada and the provinces and territories are working to improve oversight, including inspections of companies that aren't federally licensed as manufacturers or provincially accredited as pharmacies, while they look for a long-term solution.
A "communication issue" at the hospitals contributed to the overdilution issue, Zaffiro said. That's separate from the jurisdictional questions.
Barry Vickery has non-Hodgkin's lymphoma and is one of the more than 1,200 patients who received overdiluted chemotherapy. Vickery has joined a class-action lawsuit against Marchese and is disappointed with the finger-pointing.
"It makes you wonder where else there might be gaps," he said.