Order Fixing the Day on which this Order is made as the Day on which Certain Provisions of the Act Come into Force: SI/2018-37

Canada Gazette, Part II, Volume 152, Number 9

Registration

May 2, 2018

PROTECTING CANADIANS FROM UNSAFE DRUGS ACT (VANESSA’S LAW)

Order Fixing the Day on which this Order is made as the Day on which Certain Provisions of the Act Come into Force

P.C. 2018-442 April 20, 2018

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 15(1) of the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law), chapter 24 of the Statutes of Canada, 2014, fixes the day on which this Order is made as the day on which section 4, subsection 6(2) and sections 10 and 11 of that Act come into force.

EXPLANATORY NOTE

(This note is not part of the Order.)

Proposal

This Order in Council brings into force section 4, subsection 6(2) and sections 10 and 11 of the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law). Section 4 amends the Food and Drugs Act giving the Minister of Health the ability to order a therapeutic product authorization holder to conduct an assessment of a therapeutic product, compile information, conduct tests and studies or monitor experience regarding a therapeutic product. Subsection 6(2) permits the Governor in Council to make regulations respecting these new order powers. Sections 10 and 11 make it an offence to contravene an order issued under these authorities and sets out the fines and penalties under different circumstances.

Objective

It is necessary to bring into force these sections of Vanessa’s Law at this time in order to make amendments to the Food and Drug Regulations respecting the issuance of orders by the Minister. The amendments to the Food and Drug Regulations will provide structure to the process the Minister will follow when issuing these new orders.

Background

The Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) was assented to on November 6, 2014. While many of the provisions came into force immediately, others were to come into force on a date fixed by the Governor in Council in order to allow the time for supporting regulations to be developed.

Implications

Prior to this the Minister did not have the authority to require an authorization holder to conduct an assessment of their product or compile information, conduct tests and studies or monitor experience in order to gain information for the purpose of assessing risk to human health and safety. It is expected that these new order powers would be used only in exceptional circumstances where an authorization holder has demonstrated an unwillingness to respond to requests made by the Department. Regulations will require that the Minister consider the feasibility of any tests and studies, compiling information or monitoring experience as well as the burden imposed on the authorization holder prior to issuing an order under section 21.32 of the Act.

Consultation

A detailed description of the consultations and comments from stakeholders is included in the Regulatory Impact Analysis Statement accompanying the Regulations Amending the Food and Drug Regulations and the Regulations Amending the Food and Drug Regulations (DIN Requirements for Drugs Listed in Schedule C to the Food and Drugs Act that are in Dosage Form). In general, stakeholders were supportive of the scope and processes that were proposed respecting these new order powers when the Regulations were prepublished in the Canada Gazette, Part I, on April 22, 2017.

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