The proposed Bill C-17 to revise Canada's Food and Drugs Act is long overdue. It contains several positive elements to give Health Canada the power to recall drugs, but should be revised to substantially enhance patient safety, argue legal and health care professionals in an analysis in CMAJ (Canadian Medical Association Journal).
Health Canada, Canada's regulator of food and drugs, cannot currently recall drugs, even those recalled in other countries because of adverse reactions. Rather, Health Canada must negotiate drug recalls with pharmaceutical manufacturers. Bill C-17, An Act to Amend the Food and Drugs Act, is before the country's House of Commons and, if passed, will give more power to the Health Minister.
"If enacted, Bill C-17 would represent a substantial improvement over the status quo," writes Matthew Herder, a professor in the Faculties of Medicine and Law, Health Law Institute, Dalhousie University, Halifax, Nova Scotia, with coauthors. "Yet, Bill C-17 by no means offers a comprehensive solution to the many problems that have plagued the development, regulation and safe use of prescription drugs in the 50-plus years since thalidomide was withdrawn from the market."
There are several positive elements in the proposed bill that would help protect the safety of Canadians, including:
- power to recall drugs if "a therapeutic product presents a serious or imminent risk of injury to health"
- ability for the Health Minister to demand that manufacturers provide drug information
- power to enforce postmarket conditions and compel product label changes
- stronger penalties, such as fines of up to $5 million a day, for companies that do not comply with the Food and Drugs Act.
However, the authors urge that several elements be added to the proposed legislation to protect Canadians' health, including:
- ability of the Health Minister to suspend a manufacturer's licence to sell a prescription drug to avoid potential injury to human health
- legal exemption of the Health Minister from liability for lost sales to manufacturers in the event of a drug recall or suspension
- transparency of clinical trials
- provision for Health Canada to publish positive and negative regulatory decisions for greater transparency in decision-making.
"Bill C-17 is an important step toward the safe regulation of drugs because it enhances the ability of Health Canada to act in the face of threats to public health. It also introduces meaningful enforcement mechanisms, including substantial penalties, for noncompliance. However, it requires amendment to incorporate several additional key components of prescription drug safety. Bill C-17 has the potential to make an important and positive difference to public safety in Canada," conclude the authors. "We urge that Bill C-17 be revised and enhanced before it becomes law so that this potential can be realized."