COVID-19 Interim Orders

AuthorT. Nessim Abu-Zahra/Simon Carvalho/David Edwards
COVID- Interim Orders
In March , the COVID- pandemic required governments to consider
how their drug and medical device regulatory frameworks could be adapted
to address the emerging public health crisis. In Canada, amendments to the
law were made quickly to create new regulatory pathways to enable access
to products related to COVID-. ese pathways were introduced by way
of temporary interim orders (IOs) made using an exceptional power in the
Food and Drugs Act (FDA). Health Canada also introduced a variety of
operational processes and policies that complemented the IOs.
Although this book does not cover the Medical Devices Regulations
(MDRs) or provisions in the FDA that relate to devices, this chapter will
describe the IOs for both drugs and devices, as the eorts to mitigate the risks
of COVID- involved not only vaccines but also the development, regula-
tion, sale, and use of devices such as ventilators, test kits, masks, and gloves.
As discussed in Chapter , devices are a category of products that are subject
to the FDA. ere are provisions in the Act that apply to devices, and, in the
MDRs, detailed rules regarding, among other things, the importation and
sale of devices. e MDRs classify medical devices into one of four Classes: I–
IV. Section  of those regulations provides that the classication rules are set
out in Schedule  of the MDRs, “where Class I represents the lowest risk and
RSC , c F-.
 SOR/-.
The Regulation of Drugs in Canada
Class IV represents the highest risk.” Class II, III, and IV medical devices
are subject to a product licence requirement, while Class I devices are not.
is chapter will focus on the rst IOs that were made to address
COVID-, and then speak briey about the subsequent IOs and regula-
tions that replaced them.
Regulations are normally made under the FDA by the Governor in Council,
which is in practice the federal Cabinet. e process to make laws in this
way is associated with various legal, administrative, consultation, and pro-
cess requirements. In light of the public health emergency associated with
COVID-, the Minister of Health exercised the power set out in section
.() of the FDA, which is the power to create new IOs governing, among
other things, COVID- drugs and devices:
30.1 () e Minister may make an interim order that contains any pro-
vision that may be contained in a regulation made under this Act if the
Minister believes that immediate action is required to deal with a signi-
cant risk, direct or indirect, to health, safety or the environment.
() An interim order has eect from the time that it is made but
ceases to have eect on the earliest of
(a)  days after it is made, unless it is approved by the Governor in
(b) the day on which it is repealed,
(c) the day on which a regulation made under this Act, that has the
same eect as the interim order, comes into force, and
(d) one year after the interim order is made or any shorter period that
may be specied in the interim order.
Similar IO powers exist in other statutes, including the Aeronautics Act,
the Canadian Environmental Protection Act, , the Department of Health
Act, the Quarantine Act, and the Canada Shipping Act, . IOs have been
RSC , c A-.
SC , c .
SC , c .
SC , c , s . e rst emergency orders made in response to the COVID-
pandemic were a Quarantine and Isolation Order and a Prohibition of Entry Order
made under s  of this Act.
SC , c .

To continue reading

Request your trial

VLEX uses login cookies to provide you with a better browsing experience. If you click on 'Accept' or continue browsing this site we consider that you accept our cookie policy. ACCEPT