Health Minister Rona Ambrose acted for an “improper purpose” when, during a political and media firestorm, she banned drug products from Canadian pharmaceutical giant Apotex’s two Indian facilities, a federal court judge has ruled.
The decision, handed down by Justice Michael Manson this week, said Ambrose ignored the company’s right to respond to the government’s concerns before the sweeping regulatory action was taken a year ago. The judge also quashed the ban and told the minister to take back her public statements related to the ban.
“The import ban was motivated by the minister’s desire to ease pressure triggered from the media and in the House of Commons,” the ruling said, adding that it was “an action taken without legal authority.”
Apotex says it feels vindicated by the decision.
“Apotex always has been and remains a most trusted partner in the global healthcare community. Apotex is fully dedicated to producing highest quality, safe, and efficacious medicines for all of our global consumers,” said Apotex CEO and president Dr. Jeremy Desai in a company press release.
Ambrose issued a short statement, but did not address the judge’s comments. “As Minister of Health, I remain committed to protecting the health and safety of Canadians.” A Health Canada spokesman said the department is reviewing the decision.
After the Apotex suit was filed in court last year, Ambrose told the Star that she stood by her decision to ban Apotex products. “Canadians expect Health Canada to take the action needed to help protect them from drug safety risks,” she said at the time. “We stand by our decision to take precautionary action to protect the health and safety of Canadians.”
During cross-examination of Health Canada witnesses during the case, officials stated there was no evidence that products “produced a risk or threat to the health of consumers,” the judge noted in his ruling.
In the court challenge, Apotex alleged Ambrose acted with “malice” toward the company and buckled under political pressure after a Star investigation that detailed U.S. regulatory findings of widespread problems in the company’s Bangalore facilities.
Agents from the U.S. Food and Drug Administration, in reports obtained by the Star, stated they found staff at the Indian plants discarding unfavourable lab results and retesting suspect samples until they yielded the desirable outcome. (The federal court ruling does not make any findings regarding the conditions of the Indian plants.)
Pressure on Parliament Hill on the minister mounted after the articles last year, while critics lambasted Ambrose’s department as “feeble, inadequate and incompetent.”
Apotex, which has decried the costly ban as illegal, has always said its Indian-made products are safe and effective.
The federal court ruling by Manson quashed the import ban, though Health Canada had already lifted it about a month ago, allowing the pharmaceutical giant to import its products under strict conditions. The regulator said in September that recent inspections of the two Indian facilities found “satisfactory progress” had been made to address its concerns about the company’s data integrity. The ban had lasted 11 months. The court ruling does not say if the strict conditions are still in place.
The judge ordered the government to pay at least part of Apotex’s court costs, though the decision does not provide specifics.
The decision also says that the order for Ambrose and Health Canada officials to retract their public statements related to the import ban shall be done “on terms to be agreed to by the parties.”
In announcing the ban last year, Ambrose declared the trust between Apotex and the regulator was “broken.”
However, the judge ruled the minister’s statements, intended to show the public she was taking strong action, were improperly fuelled by political expediency.
“If the import ban was motivated by the purpose of protecting health and safety, it is curious that the minister and Health Canada would publicly assure that the banned drug products were safe and at no point issued any recall,” Manson said in his decision.
The judge found there was no evidence that there were serious health risks requiring the government to invoke an immediate ban without consulting the company.
The regulator had known about the problems at the plants for months and had been communicating with Apotex behind the scenes about what the company was doing to get its facilities up to acceptable standards, the decision said.
Meanwhile, just days before the ban, a Health Canada official told Apotex that the regulator’s own inspection had given one of the two facilities a passing grade.