Federal government faces lawsuit from Canadian drug maker

by Leo Almazora05 Oct 2016
According to a report in the Globe and Mail, the Crown, the Attorney General of Canada, former Health Minister Rona Ambrose, and several Health Canada officials have been named as defendants in a suit filed by major drug manufacturer Apotex.

In the suit, Apotex claims that when the government imposed an import ban on it in 2014 – a ban that was later quashed by the Federal Court - it was defamed in press releases and information published on the websites of Health Canada and the former minister.

Apotex President and CEO Jeremy Desai said the legal action was necessary to protect the firm and its reputation.

“The previous government, under then-minister of health, Rona Ambrose, acted improperly and without justification to ban our imports from India and caused Apotex very serious financial and reputational damage,” Dr. Desai said in a statement.

Not taking things lying down, the federal government has expressed its intention to fight the claims. A statement from Health Canada spokesman Eric Morrissette said the matter is being evaluated thoroughly to determine next steps. The government must file its statement of defense within a 30-day window after charges are filed.

“Health Canada’s priority – first and foremost – is to protect the health and safety of Canadians. We will continue to oversee and enforce laws and regulations in place to do just that,” Mr. Morrissette said. “There are currently no import restrictions on products or ingredients made at the” two Apotex Indian manufacturing facilities. “Both sites have a compliant rating,” he added.

The import ban, which was announced on Sept. 30, 2014, prevented Apotex from bringing in products from two of its manufacturing facilities in India. Health Canada at the time expressed “significant concerns” with the manner of research data collection and reporting at those facilities, though it noted “no specific safety issues” with products on the market from those plants.

Following Apotex’s challenge of the Health Canada decision, a Federal Court judge ruled in October 2015 that the ban was unfair and driven by “improper purpose” – to ease pressure faced by the then-health minister that resulted from a string of media stories about Apotex. He further ordered that the ban be lifted and statements from the minister and Health Canada published online be retracted.

Though Mr. Morrisette noted that Health Canada had accordingly updated its website, Apotex claims that defamatory content remains; the company’s lawsuit asks for the removal of additional online postings. The company also wants to have the data-integrity requirement lifted from its abbreviated new drug applications.

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