Canada’s Food and Drugs Act relies on drug companies to submit adverse reaction reports, which drug users submit if they suspect they are experiencing negative side effects. Drug users also can submit the reports directly to Health Canada, but it still leaves the government to rely on outside parties to report problems.
In 2009, Health Canada received 27,496 adverse reaction reports — a number that has increased steadily over time. Health Canada needs the power to require pharmaceutical companies to conduct more post-market monitoring and to share the results, Abbott said. The council also would like to see the federal government hold the power to impose penalties for companies that do not comply.
Health Canada is already modernizing its regulations to allow for stronger monitoring after the drug goes to market. The government also has established a Drug Safety and Effectiveness Network to study the safety of drugs in the market.
The Canadian pharmaceutical industry welcomes modernized regulation, said Mark Ferdinand, vice-president of police research and analysis for RX&D, the pharmaceutical industry association in Canada.
However, Ferdinand said consumers should recognize that there is already a formal, rigorous post-market reporting system in place.
“No one has any interest in seeing a drug used inappropriately in the real world. A lot of people have invested a lot of time, effort, certainly money … to ensure what they are producing and what they are providing to patients is safe and effective,” he said.
Ferdinand said drug safety often depends on the way medicine is prescribed. He said it has to be “the right medication, for the right person, at the right time.”