COVID-19 Interim Orders

• Author: T. Nessim Abu-Zahra/Simon Carvalho/David Edwards
• Pages: 145-161



ELEVEN

COVID- Interim Orders

A. INTRODUCTION

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.

B. INTERIM ORDER POWER

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

Council,

(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 .