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Why so much secrecy when it comes to drug approval, Health Canada?

Health Canada’s silence on its reasons for delaying approval if the abortion-inducing drug RU-486, also known as mifepristone, has sparked concerns that decision may be political rather than scientific in nature.

Charlie Neibergall/Associated Press

Why has it taken Health Canada more than two years – and counting – to figure out whether or not to approve the abortion pill mifepristone?

Is it because the department has lingering questions about the safety of the drug, also known as RU-486, and needs more information to make an informed decision? Or is it possible that, even though the decision will be made by non-political bureaucrats, there are concerns elsewhere in Ottawa over the election-year consequences of green-lighting a pill that can make it safer and easier for women to terminate pregnancies?

Canadians are not allowed to know the answer because, unlike its U.S. counterpart, Health Canada treats nearly every aspect of the drug approval process as a state secret. And this, in turn, fuels rampant speculation and conspiracy theories when issues that some consider to be controversial, such as an abortion pill, arise.

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The drawn-out delay on the mifepristone decision might not seem such a big deal. But in reality, the secrecy highlights systemic problems with accountability and transparency at Health Canada that keep Canadians, their doctors and researchers in the dark when it comes to drug safety.

And it's hardly a new problem. In 2011, the interim Auditor-General slammed Health Canada for its lack of transparency on prescription drugs and said the department must make more information available to help Canadians understand the medications they may take. The department took some steps to increase transparency, but glaring problems remain and access to information about drug approvals, safety and post-market surveillance persist.

The situation at the U.S. Food and Drug Administration is drastically different. When a drug is approved, the FDA publishes reams of information on its website, including detailed reports on the clinical studies used to make the decision, the surveillance requirements a company must fulfill once a drug is on the market, even the correspondence between the company and members of the panel deciding on drug approval. In contentious cases where there may be significant debate or controversy over a particular medication, the FDA will typically hold public meetings at which outside researchers and other stakeholders can share evidence and expert opinion that will be used to make a final decision.

Here, when a drug is approved, Health Canada usually posts a "summary basis of decision" document online that gives a broad overview of what the product does, who should take it and why it was approved. Virtually no clinical data, exchanges of information with the company or names of the Health Canada employees deciding the drug's future are made available. Forget public meetings and consultations with outside experts.

Barbara Mintzes, a professor in the department of pharmacology and therapeutics at the University of British Columbia who regularly conducts drug-safety reviews as part of her research, said she and her colleagues typically have to use data from the United States because there is so little information made available by Health Canada. Health Canada often says that information on drug safety must be kept confidential because of the commercial interests of the companies involved. But if the United States can make it public, Mintzes argues, why can't we?

Health Canada accepts large sums of money from pharmaceutical companies (user fees to pay for the drug approval process), which risks creating the perception the regulator is more interested in serving the interests of drug companies than the interests of taxpaying Canadians.

So here's what we're left with: the knowledge that, despite the fact mifepristone has been approved in dozens of countries, is considered an essential medicine by the World Health Organization and a gold standard for medical abortion by doctors around the world, our medical regulator keeps delaying a decision.

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Its reasons for doing so could be completely reasonable and justified. But behaving in such an opaque manner erodes Health Canada's reputation as a neutral drug regulator interested in using facts and evidence to make clear and informed decisions that benefit the public.

If anything, the controversy bubbling up around mifepristone should convince the federal government to throw open the approvals process like our American neighbours. What better way to prove that it has our best interests at heart than to hold public hearings on drug safety, post the results of clinical studies and correspondence with pharmaceutical companies online and become truly open and transparent on the drug approvals process?

"Maybe they have a legitimate safety concern," Mintzes says. "In that case, shouldn't the public know about it?"

Just because other countries have approved a drug does not mean Canada is required to follow suit. But ultimately, the department is responsible for protecting Canadians and must be held accountable for its actions on drug safety. Under the current framework, that simply isn't possible.

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