Health Canada is so secretive about its inspections of overseas drug-manufacturing plants that Canadians can’t be confident their medications are safe, says a drug policy researcher.
Alan Cassels of the University of Victoria said most prescription drugs are manufactured overseas but that Health Canada has released only limited information about its inspections of foreign manufacturing plants after he made numerous inquiries.
Cassels said Health Canada has told him only that it conducted 35 inspections between 2006 and 2011, but won’t provide data on which countries were involved or the findings.
“Health Canada can’t tell us what they inspected, what they found, what remedies they made and we have no idea whether the few inspections they did had any effect. So my question is, and I’ve had this question for many years, why is everything so secret?”
He said that while the federal regulator may be influenced by the pharmaceutical industry’s desire to protect its proprietary information, he’s merely after data related to people’s safety.
“Essentially, whose team is Health Canada on?”
But a spokesman for Health Canada said Monday that it has one of the safest and most rigorous drug-approval systems in the world.
Any foreign site that makes a drug product sold in Canada has to meet Canadian standards of good manufacturing practice, Sean Upton, a spokesman for Health Canada, said in a statement.
Upton said Health Canada will verify that these standards are being met in a number of ways, including inspection of foreign plants and taking in information provided by mutually recognized inspections conducted by other countries.
But Cassels said Health Canada issues warnings about certain overseas-manufactured drugs only when it gets information from the countries that produce them.
The agency has also not released data about drugs that are produced in Canada with chemicals imported from foreign countries, he said.
“It would shock most people to know that the manufacturing plants in Canada largely use raw ingredients from places like India, China and Puerto Rico and so on, which is not a bad thing, but how often are these plants inspected?”
Earlier this year, the Quebec-based plant of the generic pharmaceutical company Sandoz stopped making several commonly used painkillers, antibiotics and anesthetics while it upgraded its manufacturing standards after the U.S. Food and Drug Administration raised concerns.
The FDA inspected the site because the drugs manufactured there are used by Americans.
At the time, the head of Health Canada’s drug directorate said the government would expedite approval of offshore medications for use by Canadians as long as they meet regulatory standards for quality.
Cassels said that’s all the more reason Health Canada should provide information about its inspections of overseas drug-manufacturing plants.
However, he’s also concerned that recent government layoffs mean there will be fewer Health Canada staff to conduct such inspections in or outside the country.
“You’ve got a federal regulator that is already seriously undermanned and undergunned and clearly not doing the kinds of inspections overseas that we would expect them to be doing and at the same time laying off people, so even reducing their ability to make sure that the drug supply is safe.”
Upton said most of the drugs imported into Canada, or about 80 per cent, come from countries where there is a mutual-recognition agreement for inspections. The signing of these agreements includes an evaluation process to make sure that drug compliance programs from different regulator authorities are equal, he said.
Dr. Muhammad Mamdani, a pharmacist and director of the Applied Health Research Centre at the Li Ka Shing Knowledge Institute of Toronto’s St. Michael’s Hospital, agreed with Cassels and said the public needs assurance that their prescription drugs are safe.
He said safety standards for brand drugs, versus generics, may be more rigorous because pharmaceutical companies typically assume a huge liability if there are problems.
However, Health Canada should still reveal information about its inspection findings, Mamdani said.
And while generic drug makers, which benefit from the millions of dollars in clinical trials and research that have already been done, are required by Health Canada to have so-called good manufacturing practice certification, their safety practices must still be scrutinized, Mamdani said.
“A company can say it adheres to good manufacturing certification but then you have to do audits. The problem with the audits is how many audits are you going to do? How much money do you have to have? You’d have to fly out to all these countries and inspect all of them on a regular basis and for many reasons, it’s not practical or possible.”
However, Mamdani said Canada is part of the Pharmaceutical Inspection Cooperation Scheme of about 41 member countries, including the United States, Belgium, Australia, and Czechoslovakia, which share information on inspections so the process doesn’t have to be repeated.
“I’m not sure how much Canada leverages external groups’ evaluations,” he said. “I don’t know how many they do themselves.”
While it would be nearly impossible to conduct audits of every drug-manufacturing country’s plants, “Health Canada should at least disclose what they have done,” Mamdani said.
“They should be transparent. And if the drugs are safe, why shouldn’t the information be available?”
“At the very least, make available to the public a general sense of is the process working and is the drug safe?”