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Statement by the Honourable Rona Ambrose on the import ban of drug products from three plants in IndiaSeptember 30, 2014 - Ottawa - Health Canada Copy

Statement by the Honourable Rona Ambrose on the import ban of drug products from three plants in IndiaSeptember 30, 2014 - Ottawa - Health Canada
Protecting the health and safety of Canadians is our government's highest priority. Our expectation is that Health Canada uses the appropriate powers and tools at its disposal to help ensure that the drugs Canadians need meet the highest safety and quality standards.

To that end, Health Canada has taken decisive action today to stop the import into Canada of all drug products from three plants in India. They are:
Apotex Pharmachem India Pvt Ltd
Apotex Research Private Limited
IPCA Laboratories

The Department has ordered an import ban after it received new information yesterday from the United States Food and Drug Administration (US FDA). This latest information puts into question Health Canada's trust in the reliability of data that all three plants are required by law to provide to demonstrate the safety and quality of their products.

I would like to reassure Canadians that Health Canada actions are guided by science and evidence every step of the way.

The ban is a precautionary step. Health Canada has received no evidence that the products pose an immediate risk. Like the FDA, Health Canada does not feel that a recall of any products made at these plants is required at this time.

But when trust between a regulator and a company is broken, strong actions are required. The import ban will remain in place until such time as the Department is satisfied that the data integrity problems have been resolved.

Health Canada is in ongoing communication with provinces and territories to determine what impact a ban might have on the supply of medically necessary drugs. Should it be determined that there are no alternatives on the Canadian market to certain products from these plants they will be exempted from the import ban, but only after they have undergone testing by an independent quality assurance laboratory.

Our government will not tolerate a failure by drug companies to meet their obligations to abide by Canada's high safety and quality standards. New powers proposed in Vanessa's Law (Bill C-17) will provide the tools to better respond to drug safety issues including powers to order mandatory recalls of unsafe drugs so that Health Canada does not have to negotiate with companies when safety issues are identified, tough new fines for companies who put Canadians at risk, and the authorities required to publish even more data from drug reviews and clinical trials.

We will continue to take actions as needed to protect Canadians, and provide information in an open and transparent way.

- 30 -

The federal government is appealing a Federal Court decision that threatened to strike down its new policy on refugee health care as "cruel and unusual" treatment.

The federal government is appealing a Federal Court decision that threatened to strike down its new policy on refugee health care as "cruel and unusual" treatment.
Immigration Minister Chris Alexander also filed a motion to stay the judgment of Judge Anne Mactavish, whose ruling meant refugee applicants would once again have access to Canadian health care while they wait for a decision on their cases in Canada.
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The government claims 13 grounds for its appeal, including the argument that the judge made several errors of fact. It also says the judge "applied different standards of reliability to the evidence of the applicants and the respondents."

In an interview with CBC News, the lead lawyer who won the case said the government's months-long delay in filing the appeal, and the motion for a stay of judgment, means his team will have to scramble to prevent serious health problems among refugees from going untreated.
'Justice Mactavish in her decision made it clear denial of health coverage is putting people's lives at risk.'— Lorne Waldmann, Canadian Doctors for Refugee Care

"If the matter is stayed there will be a delay and so there will be thousands of persons who should be getting coverage as a result of that order who will be denied that coverage for a longer period of time," said Lorne Waldman, who represents the group Canadian Doctors for Refugee Care.

"Justice Mactavish in her decision made it clear denial of health coverage is putting people's lives at risk."

Waldman also vowed to try to speed up the appeal process.

"We're going to vigorously oppose the stay, and we're going to seek to have the appeal expedited so that we can have a final determination on all these issues," he said. "In our hope, if the judgment is upheld, refugees will be entitled to health-care coverage and get the coverage they need so they will not be exposed to a risk to their lives."

In a statement, three parties to the original case, Canadian Doctors for Refugee Care, the Canadian Association of Refugee Lawyers, and Justice for Children and Youth, denounced the government’s decision to appeal.
Lives at risk, judge ruled

In an email, Alexander's spokeswoman Codie Taylor said the minister is following up on his promise to appeal.

"As Minister Alexander said in July, the government will be appealing this flawed decision," she wrote. "The notice of appeal was recently filed and we will be aggressively defending the needs of genuine refugees and Canadian taxpayers."

Ottawa trimmed medical benefits for newcomers in 2012, leaving most immigrants with basic, essential health care but without supplementals such as vision and dental care.

However, rejected refugee claimants and refugee claimants from countries the government considers safe are eligible under the new law for care only when they pose a threat to public health.

In her ruling, Mactavish said the federal cabinet has the power to make the changes it did, and that the procedure was fair, but that the people affected by the changes are being subjected to "cruel and unusual" treatment.

"This is particularly, but not exclusively, so, as it affects children who have been brought to this country by their parents," Mactavish wrote in the 268-page decision.

"The 2012 modifications to the [Interim Federal Health Program] potentially jeopardize the health, the safety and indeed the very lives, of these innocent and vulnerable children in a manner that shocks the conscience and outrages Canadian standards of decency.

"I have found as a fact that lives are being put at risk."

Waldman noted the government quietly filed the appeal on Sept. 22 without any fanfare or notice to the opposing parties. And he added his office was only served notice yesterday, a week after the initial notice of appeal was filed.

He said it's an obvious stall tactic.

"The longer it takes for the judgment to be implemented the more people will be placed at risk, and that's simply unacceptable," he said.

Mactavish's ruling would have restored health care to refugee applicants this November, but if the stay is granted, that won't happen.