Canada: User Fees Raise Safety Fears

In Canada, the year-old drug approval user fee scheme is said to haveled to harassment of federal regulators by companies and Health Canada management. Critics of the cost-recovery scheme, including former and current Health Canada regulators, claim that companies "constantly" call the regulators asking why their drug has not yet been approved.

Former regulator Michele Brill-Edwards says that within the industry "there is definitely a sentiment that the people who pay the piper have a right to affect the service." Moreover, a long-serving regulator is reported by the Ottawa Citizen to have filed an official complaint in May, alleging "persistent and repeat harassment by Health Canada management" to approve drugs of "questionable safety." The complaint alleges "mischaracterization and defamation" of the regulator's name by senior management and industry, and "intimidation and threat to undertake disciplinary action against me."

Joseph Losos, assistant deputy minister at Health Canada's Health Protection Branch, denies that there is any harassment or that safety concerns are taking a back seat. "There should be no question in my mind or your mind that the role of the Health Protection Branch is the safety of Canadians," he told an interview with the Montreal Gazette. "There's no wavering from that, there's no negotiating on it."