Assessing the Constitutional Validity of Substantiation Laws for Medical Device Safety and Effectiveness Under the Medical Devices Regulations and the Food and Drugs Act

Abstract

This thesis examines federal scientific evidence requirements for medical device safety and effectiveness under the mainstream market entry licensing pathway under Part 1 of the Medical Devices Regulations, and under the new ‘agile’ market entry pathway, the Advanced Therapeutic Products Amendments, which amended the Food and Drugs Act. Apart from a narrow category of medical devices (near patient in vitro diagnostic devices), scientific evidence requirements are vague and do not enumerate explicit expectations for methodologically rigorous forms of scientific evidence. Medical device safety and effectiveness could be more predictable with explicit expectations for scientific rigour. The thesis analyzes if this absence of rigour, and the breadth of discretion to define scientific evidence requirements in the executive branch of government (Health Canada) conform to standards of valid criminal law under s. 91(27) of the Constitution Act, 1867. The thesis also evaluates the laws’ dependency on this power for their constitutional validity.