A rational approach to regulation of gene therapy in Canada

Gene therapy offers prospects of dramatically improved treatments for and possibly true cures of previously intractable diseases, and has therefore attracted much public interest and hopeful expectation. At the same time, it involves new and exploratory techniques and potential risks to patients. The definition of a drug in the Canadian Food and Drugs Act clearly includes materials used to effect gene therapy and also the products of genetic manipulations. The regulatory framework in Canada is based on risk management. The potential hazards and benefits of gene therapy and similar interventions will be assessed for categorization according to risk and an appropriate level of control, with the additional principle of deriving positions that are harmonized with those of counterpart regulatory agencies.