Are prescription drugs newly approved by Health Canada safe? Not necessarily, claims Mary Wiktorowicz, a York University professor who recently conducted a study comparing drug approval and recall rates in Canada with those of the United States and several countries in the European Union.
“Drugs with potentially dangerous side effects are going out into the market and our medicine cabinets before they have been subject to as stringent testing as used in the US,” Wiktorowicz says. The study, published in the Journal of Health Politics, Policy and Law, reveals that in Canada, as much as 10 per cent of new drugs are discontinued due to safety problems not found in pre-market clinical tests. Wiktorowicz claims this is because the Canadian system for vetting new drugs has become more like those used in Britain and France, where recalls of new drugs (a good indicator of whether drugs with serious or long term side effects are entering the market) are four times higher than in the U.S.
Numerous factors are responsible for this shift, says Wiktorowicz. On the national front, a 40 per cent cut in spending to Health Canada’s Health Protection Branch (the branch in charge of federal approval of new drugs) between 1993/1994 and 1999/2000 has meant a reduction in expert staff and research. It has also meant that since 1998, private pharmaceutical companies have paid for 70 per cent of drug testing in order to get their products into the marketplace, a possible conflict of interest for researchers.
Internationally, Canada is feeling pressure created by other nations (such as Japan, the U.S. and the EU) to align (and for the most part lower) the nation’s drug testing standards.
However, while Wiktorowicz’s study shows that Canada’s drug recall rates are higher than in the U.S. (where the rate is three per cent), they are significantly lower than those of several European countries (where rates range from 10 to 12 per cent).
European countries have traditionally had a different approach to drug approvals. Unlike in the U.S., where the Food and Drug Administration makes drug approvals with no industry input, European government agencies tend to negotiate with and accommodate the pharmaceutical industry in order to speed approvals, attract research and development, and create high-tech jobs, says Wiktorowicz.
This is because extensive drug testing has a cost. The U.S. system, while the most effective at minimizing the risk of new drugs, is also the most expensive of the four countries studied. In addition, the U.S. national health plan does not regulate drug prices, which allows large pharmaceutical companies to recoup the cost of testing by upping the market price of drugs. In European countries, and to a lesser extent, in Canada, market drug prices are kept affordable for the public through government regulation. Faster drug approval rates provide an alternate means for the government of these countries to lessen this burden on industry.
“The importance all societies place on health and longevity makes the safety and effectiveness of medicines a high priority,” Wiktorowicz said. “In the current era of globalization, each nation must address the challenge of developing a regulatory framework that balances the competing goals of protecting the public interest while promoting industrial competitiveness.”
