The health ministry is volunteering with a radical idea. Health Canada released a position paper yesterday suggesting that prescription meds should be tested for safety after becoming available. The ministry pronounces this idea a “fundamental shift” in the way drugs are regulated.

As elsewhere, pharmaceutical companies must prove safety and effectiveness in the True North before a drug can win approval from regulators. But there is no requirement to continue studying the impact of a drug - good or bad - after it goes on the market. In other words, meds may as well be hockey pucks.

“The new proposed model is that a drug should be evaluated throughout its life cycle for its benefit-risk profile,” the paper says. “Longer-term effects of a drug may not be apparent at the time of marketing. This makes the ongoing collection and analysis of information after the drug is marketed absolutely crucial.”

At first blush, this sounds like reason to cheer. But one wag calls the plan “extremely vague” and urges the crowds not get too excited just yet.

“It’s sort of disappointing. Behind it all, it sounds like they’re going to get drugs on the market faster,” says Jim Wright, a doc who heads Therapeutics Initiative, a University of British Columbia based unit that advises the province on pharmaceutical issues. “It sounds like they are still working far too closely with the pharmaceutical companies … It sounds like they are responding to pressure from the companies, not to pressure from the public who are interested in being protected from harm,” he tells The National Post.

In response, the main industry trade group, Pharmaceutical Companies, displayed a cautious face and says the paper is still being reviewed, but its members believe “guidelines must ensure that patient safety continues to be the number one priority,” says Jacques Lefebvre.

Of course. But the notion that ’something is better than nothing,’ doesn’t always follow. One hopes that whatever system Health Canada puts in place becomes a role model for the hobbled FDA. Given recent events, that shouldn’t be too difficult.

[tags]Canada, FDA, Health Canada, Safety[/tags]