Harmonization of drug standards may put private profit before public health

January 19, 2011

OTTAWA—As Health Canada begins its final consultations on proposals to “modernize” standards on prescription drugs, a study released today by the Canadian Centre for Policy Alternatives (CCPA) finds Health Canada’s harmonizing initiatives to date, part of the modernization initiative, have been putting private profit ahead of public health.

According to the study, by Dr. Joel Lexchin, harmonizing standards on drug regulation among countries could bring important benefits to Canada—but only if harmonization is to the highest standards. 

“The evidence to date suggests that we have been harmonizing down,” says Lexchin. “Regulatory harmonization needs to be undertaken in the interests of public health, not private profit. To date that has not been happening.”

The study outlines how Health Canada has been deliberately ignoring harmonization efforts that would raise standards while working with the drug industry to lower drug safety standards and speed new drugs to market.

Proponents of harmonization argue that international regulatory cooperation can improve Canadians’ access to new drugs by speeding up the drug approval process. The study notes that breakthrough drugs represent less than 1% of all new drugs and there is highly suggestive research linking faster regulatory approval to increases in safety problems.

“While faster approvals get drugs to market more quickly, they may also compromise safety—an important consideration as an increasing number of people are exposed to new drugs that ultimately are pulled from the market because of safety concerns,” Lexchin says.


Who’s Calling the Tune: Harmonization of Drug Regulations in Canada is available on the CCPA website at http://policyalternatives.ca

For more information contact Kerri-Anne Finn, CCPA Senior Communications Officer, at 613-563-1341 x306.