AuthorT. Nessim Abu-Zahra/Simon Carvalho/David Edwards
As lawyers who have spent the majority of our careers at the Department
of Justice’s Health Canada Legal Services Unit, we are often reminded of
the importance of the regulation of pharmaceutical products for the health
and well-being of Canadians. We see evidence of this in the work of Health
Canada ocials, court decisions, parliamentary debates, legislative initia-
tives, trade agreements, and the media. We feel privileged to work in this
area and thought our experience could help us explain the law that governs
these products.
e COVID- pandemic further highlighted the importance of the
regulatory regime for drugs and medical devices, including the vaccines,
anti-viral drugs, masks, and ventilators that helped protect the health of
Canadians. For example, the pandemic led to rapid and substantial changes
to the law as the Government of Canada created new regulatory pathways
for products relating to COVID.
is book provides an outline of the laws relating to pharmaceutical
drugs and other classes of drugs, such as natural health products and bio-
logics. Part  describes the key rules for the manufacture and sale of these
products that are set out in the Food and Drugs Act and various regulations
made under that Act, including in a chapter on the regulatory response to
COVID-. Part  discusses the impact that the complex intellectual prop-
erty regime has on the drug approval process, and the balance that is sought
between the interests of brand-name and generic manufacturers. We hope
that this book will be helpful both for generalist readers and those who have
a more specialized interest in this area of law.

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