Canada seeks to shift safety burden back to drug makers

The government said that the proposal, Bill C51, is designed to modernize the country's Food and Drug Act, and "crack down on negligent manufacturers, importers and retailers who knowingly endanger their customers​." The amendment would enable Canadian health officials to demand that firms selling potentially dangerous pharmaceutical products provide additional evidence of safety to both consumers and regulators. Drug companies will also be required to monitor where their products are sold and notify the authorities of any adverse events that are reported. Firms that fail to comply with the new regulations may face fines of C$1m, or C$5m if any subsequent criminal conviction is upheld. The new laws would also allow Canadian authorities to prohibit the importation of products that are deemed dangerous to human health and to force the withdrawal of drugs that do not comply with safety regulations. Early last month, the Canadian Government officially opened the Food and Drugs Act Liaison Office in an attempt to further improve its accountability and monitoring mechanisms. The office is intended to provide consumers and public stakeholders with an independent and confidential information resource. Food and Consumer Safety Action Plan ​​Canada's Primer Minister Stephen Harper said the new act, which forms part of the government's "Food and Consumer Safety Action Plan," will provide more protection for consumers and punish those companies that "care more about the almighty dollar than the safety of their consumers​." He told a meeting of the Canadian Consumer Specialty Products Association that, at present, the government is unable to order a mandatory recall of drug products and added that the new proposal had been designed to address this deficiency. These thoughts were echoed by Health Minister Tony Clement, who said that the amendment will "[reverse] the onus onto manufacturers or sellers of products to illustrate they abide by the rules​." CCSPA president Shannon Coombs welcomed the announcement and said that moves to "[modernize] the Hazardous Products Act and the Food and Drugs Act and enhance the current regulatory framework​," represent a real step forward. Coombs added that the Consumer Ingredient Communication Initiative, recently launched by the CCSPA, would fit well with the new laws. CGPA backs legislative changes ​ The Canadian Generic Pharmaceutical Association also expressed its support for the proposals. CGPA president Jim Keon said that the country's regulators "need tools to ensure patient safety after prescription drugs are approved and come to market."​ Keon said because new branded drugs can be approved having been tested in limited number of patients, certain safety issues only emerge when such products are marketed to the wider population. He added that, in contrast, "when generic prescription medicines are approved in Canada, the brand-name version has already been on the market for an average of 10-14 years and the safety issues are generally well known​."