Canada - World Health Organization Regional Office for Europe

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Health systems in transition Canada
The constitution confers exclusive jurisdiction over the patenting of new
inventions, including novel prescription drugs, to the federal government. The
Patent Office is part of the Canadian Intellectual Property Office, a special
operating agency associated with the Federal Department of Industry Canada.
In the late 1980s and early 1990s, the federal government shifted policy direction
by increasing patent protection to the OECD norm of 20 years and by abolishing
compulsory licensing in an effort to increase the level of investment, research
and development by the international pharmaceutical industry in Canada (Anis,
2000). At the same time, the federal government established the PMPRB to
regulate the factory gate prices of patented drugs (see section 2.3.2). Provincial
and territorial governments use a number of regulatory tools to contain the
cost of their respective drug plans although these vary considerably across
jurisdictions. These regulatory tools include reference pricing (reimbursing on
the basis of the lowest cost pharmaceutical in a given therapeutic category),
licensing, bulk purchasing, tendering and discounting (Paris & Docteur, 2006;
Grootendorst & Hollis, 2011).
2.8.5 Regulation of medical devices and aids
The federal government regulates medical devices through the Medical Devices
Program in the Therapeutic Products Division of Health Canada. Diagnostic
and therapeutic medical devices fall under one of the four enumerated classes
in the Medical Devices Regulations of the federal Food and Drugs Act (see
Table 2.4). The Medical Devices Program assesses the safety, effectiveness and
quality of medical devices by a combination of pre-market review, post-approval
surveillance and quality systems in the manufacturing process (Health Canada,
2007).
Canada is also an active participant in the International Medical Device
Regulators’ Forum, which is working towards harmonizing the regulation
for medical devices in all participating countries. Health Canada is also
engaged in two bilateral harmonization initiatives, one with the Food and
Drug Administration in the United States to develop, manage and oversee a
new process that will allow a single regulatory audit to satisfy the needs of
multiple regulatory jurisdictions, and the second with the Therapeutic Goods
Administration in Australia to mutually recognize Quality Management
Systems certification for medical device manufacturers (Health Canada, 2007).