Preface

• Author: T. Nessim Abu-Zahra/Simon Carvalho/David Edwards
• Pages: 19-20

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Preface

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.