Skip to main content

Canada’s third nationwide recall of birth control pills in six months is raising questions over the quality and safety of the foreign drug plants where the medications were produced.

Politics Insider delivers premium analysis and access to Canada's policymakers and politicians. Visit the Politics Insider homepage for insight available only to subscribers.

Health Canada has a credibility problem.

The safety of Canada's prescription drug supply is increasingly in doubt and the agency responsible for drug safety is doing little to reassure Canadians.

The most glaring cock-up comes in the area of oral contraceptives. In the past five months, there have been three recalls of birth control pills: Alysena-28, a product of Apotex, and Freya-28 and Esme-28, both from Myland Pharmaceuticals.

In each case, there were too many placebo pills in the pack. (Oral contraceptives generally come in packs of 28, including 21 pills containing hormones and seven sugar pills.) This raises the very real possibility that a woman taking The Pill could get pregnant.

That is a serious matter for the 430,000 women affected by these recalls, but Health Canada has not taken it seriously at all.

On the first and biggest recall, that of Alysena-28, department officials waited several days after being told of problems by the manufacturer to notify the public. They justified the delay by saying it was not a life-or-death matter.

Surely the risk of pregnancy in women taking contraceptives to prevent pregnancy should be a matter of some urgency? To think otherwise is to be seriously out of touch.

Former health minister Leona Aglukkaq promised a review of procedures, but who knows what will come of that? This government is not exactly known for its transparency.

Beyond the delays, just how good is the public notification process? Health Canada has issued press releases urging women to contact their physicians if they are using these products.

But letters haven't gone out to doctors or to individuals flagging the risk. (If we had decent electronic health records in this country that would be possible with a few keystrokes.)

There is no evidence either that the underlying issue in these recalls, poor quality control in drug manufacturing plants, is being addressed by Health Canada.

All three of these products are manufactured by generic drug companies, which may or may not be relevant. (After all, most drugs consumed in Canada are generics.) More important is where the drugs are manufactured. The Mylan products are made in India by Famy Care; the Apotex pills are made in Spain by Laboratorios Leon Farma.

There have been growing concerns over the quality and safety of drugs produced overseas and real doubts about Health Canada's ability to inspect foreign manufacturing plants and ensure proper quality control, issues exacerbated by significant cuts in the department.

Health Canada seems all too willing to turn a blind eye to some dubious practices and potentially unsafe drugs. For example, the U.S. Food and Drug Administration has halted all imports of drugs from the generic giant Ranbaxy because some of its plants failed quality inspections. In the past, Ranbaxy was also charged with fraud and the India-based company paid a $500-million fine to settle the case with U.S. regulators.

Canada, meanwhile, gives Ranbaxy the green light to sell 31 of its products, including seven deemed unsafe by the FDA. This despite the protests of groups like the Quebec Order of Pharmacists.

There are other domestic issues of concern, such as Health Canada's approval of nosodes, which are sometimes called homeopathic vaccines.

While the department has been careful to state that it has not approved these so-called alternative medicines as substitutes for vaccination – a position it reiterated this weekend on Twitter and in a press release – it's not clear why nosodes are approved at all. They are completely useless products, nothing short of quackery.

But Health Canada painted itself in a corner a few years back when it (and its political masters) made a decision to treat complementary "medicines" like mainstream ones, demanding a drug identification number and regulatory approval. This has given a number of dubious products credibility and blurred the lines between what is a medication and what is not.

Canadians spend $32-billion a year on drugs. The Health Canada seal of approval must mean something. It should be a promise to the public that a product is safe, effective and of high quality. It should an assurance that, when things do go wrong, they will be corrected swiftly, and the explanations will be clear.

Today, those are all questionable assertions.

André Picard is The Globe's health columnist.