Vol. 151, No. 14 — July 12, 2017

Registration

SI/2017-32 July 12, 2017

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. 2017-776 June 20, 2017

His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 15(2) 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 5 and subsections 6(3) and (4) 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 5, and subsections 6(3) and 6(4) of the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law). These sections amend the Food and Drugs Act to require the reporting by health care institutions of serious adverse drug reactions and permit the Governor in Council to make regulations that specify what this reporting will be and how it will be done.

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 that will require health care institutions that provide acute care services to report serious adverse drug reactions associated with foreign drugs sold for use in respect of an urgent public health need. The amendments to the Food and Drug Regulations will allow for the importation and sale of foreign drugs that have not been authorized for sale in Canada, but for which there is an urgent public health need.

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. Section 5 requires prescribed health care institutions to provide to the Minister of Health prescribed information about serious adverse drug reactions, in a prescribed time and manner. Subsection 6(3) provides the Governor in Council with the necessary regulation making authorities to support section 5. Subsection 6(4) requires that the Minister take into account existing information management systems, with a view to not recommending the making of regulations that would impose unnecessary administrative burden on those health care institutions.

Implications

This will be the first time that health care facilities will be required to report serious adverse drug reactions under the Food and Drugs Act. Currently, the manufacturer or importer of a drug authorized for sale in Canada is required to report. However, as an authorization will not be issued for foreign drugs imported for use in respect of an urgent public health need, responsibility for reporting has necessarily been shifted to those health care institutions that would be best placed to identify serious adverse drug reactions that may be associated with the use of these foreign drugs in Canada.

Consultation

Consultations respecting the reporting of serious adverse drug reactions by health care institutions with provinces/territories, hospitals and associations representing health care institutions have been ongoing since 2015. Consideration has also been given to avoiding unnecessary regulatory burdens on those required to report under the amendments to the Food and Drug Regulations. 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 (Importation of Drugs for an Urgent Public Health Need).

Departmental contact

Bruno Rodrigue
Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Department of Health
Holland Cross, Suite 14
11 Holland Avenue
Ottawa, Ontario
K1A 0K9
Address Locator: 3000A
Telephone: 613-957-0374
Fax: 613-941-7104
Email: LRM_MLR_consultations@hc-sc.gc.ca