Guide to authorities under the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law): Overview

Organization: Health Canada

Date published: August 2023

On this page

• Objective
• Background
• About this guide
• Role of the regulator
• Scope and application
• Principles
• Applying the law

Objective

Authorities came into force for drugs (other than natural health products) and medical devices upon Royal Assent of Bill C-17 (41-2), the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law), on November 6, 2014.

The authorities conferred by the Protecting Canadians from Unsafe Drugs Act were extended to natural health products upon Royal Assent of Bill C-47 (44-1) on June 22, 2023.

This guide will:

• help Health Canada apply the authorities fairly, consistently and effectively
• support the development of operational tools for the authorities (for example, standing operating procedures, guidance documents, process maps and templates)
• guide the development of potential future regulations related to the authorities

Background

Bill C-17 (41-2) and subsequently Bill C-47 (44-1) amended the Food and Drugs Act (Act) regarding therapeutic products with a goal to improve safety. These authorities:

• strengthen the safety oversight of therapeutic products throughout their lifecycle
• mandate certain health care institutions to report serious adverse drug reactions (ADRs) and medical device incidents (MDIs)
• promote greater confidence in the oversight of therapeutic products by increasing transparency, for example
  • allowing for regulations to require therapeutic product authorization holders to register clinical trials
  • requiring the Minister to make orders publicly available
  • allowing for regulations to require decisions under certain authorities, along with the reasons for those decisions, be made public
• set out increased penalties and fines for non-compliance

These authorities allow the Minister of Health to act when a safety issue is identified. Actions include the ability to order a company to carry out a mandatory product recall or perform additional tests or studies on a therapeutic product.

With the enactment of Bill C-17 (41-2) and Bill C-47 (44-1), certain authorities came into force immediately. These included the ability of the Minister to:

• require a person to provide information
• disclose confidential business information in certain circumstances
• order a change to a label or a modification to a package
• order a recall

Other authorities were subject to regulations and came into force when those regulations were included under the Food and Drugs Regulations and the Medical Devices Regulations. For natural health products, those other authorities would require supporting regulations to be made under the Natural Health Products Regulations before they are brought into force.

About this guide

This guide sets out principles, policies and standards that should typically be followed when Health Canada identifies situations where it may be appropriate for the Minister to exercise the power to:

• require a person to provide information
• disclose confidential business information in certain circumstances
• order a change to a label or a modification to a package
• order a recall
• require an assessment
• require tests or studies

Specifically, it:

• sets out guiding principles, policies and standards that should govern decisions made by Health Canada as a regulatory decision-maker
• covers "what" triggers the Minister's ability to make use of these powers and explains to "whom" the powers apply
• strives to ensure that Health Canada applies the authorities consistently

The overall goal is to improve both compliance and the quality of regulatory decision-making.

This guide is intended to help Health Canada staff implement their mandates and objectives fairly, consistently and effectively. It is an administrative instrument, not a legal instrument.

This document should be read along with the relevant parts of other applicable guidance documents.

Role of the regulator

Health Canada's role as a health regulator stems from the federal government's constitutional law-making power over criminal law. Criminal law is the basis for the Act. This legislation aims to protect the health and safety of the public through the control of possible hazards from food, drugs, natural health products, cosmetics and medical devices.

The Act and its regulations give the Minister and Health Canada the authority to regulate food, drugs (including natural health products), medical devices and cosmetics. As a therapeutic product regulator, Health Canada's role is to verify that regulatory requirements for the safety, quality and efficacy of therapeutic products are met through the following activities:

• scientific assessments
• product market authorization
• site and establishment licensing
• monitoring and surveillance
• compliance and enforcement

Scope and application

These authorities apply to therapeutic products. They give the Minister an improved ability to identify, assess and take action when a therapeutic product presents a risk of injury to the public.

In addition to prescription and non-prescription drugs, therapeutic products include:

• vaccines
• medical devices
• tissues and organs
• cell and gene therapies
• natural health products
• blood and blood products

Principles

Although the Act sets out the powers available to the Minister, the administration of legislation in Canada is subject to generally applicable legal principles. These principles require that administrative powers be exercised fairly, reasonably and in accordance with the powers that have been conferred on the body exercising them.

The following principles should guide the application of the powers in the Act by the Minister and Health Canada. These administrative law principles ensure that the process by which the laws are administered and enforced is accessible, fair and efficient.

• Principle 1: The regulator should exercise a statutory power of decision reasonably and in a procedurally fair manner that's free from bias or the appearance of bias.
• Principle 2: The regulator should exercise statutory powers of decision based on evidence, taking account only those considerations that are relevant to the exercise of the power. Decisions should be documented.
• Principle 3: Statutory powers of decision should be exercised in a transparent manner. Decisions and reasons for them should be expressed in a logical and understandable narrative.

Applying the law

Elements of the law

When deciding whether to exercise a power, the Minister (or an official acting on the Minister's behalf) first determines whether the elements of the law have been met.

There are 5 elements in a power:

1. who can use the power
2. to whom the power applies
3. to what the power applies
4. the threshold or considerations that need to be met to exercise the power
5. the scope of the power

The following example for the authority that confers a power on the Minister to require information (subsection 21.1(1) of the Act) shows how these elements can be broken down:

• If the Minister (1) believes that a therapeutic product (3) may present a serious risk of injury to human health (4), the Minister may order a person (2) to provide the Minister with information that is in the person's control (5) and that the Minister believes is necessary to determine whether the product presents such a risk (4).

Interpreting the elements

When determining whether the elements of the law have been met, the Minister relies on the recommendations of Health Canada. Experts analyze the scientific information, taking into account any limitations in methodology as well as perceived risk.

Openness and transparency

In addition to transparency measures that are required by regulation, administrative law principles hold that the Minister should disclose and explain the scientific evidence and reasoning used to support decisions. Increased transparency around regulatory decision-making helps regulated parties and the public better understand how decisions are made. This also enhances the integrity of the regulator.

Designation of authority

The powers give the Minister of Health the authority to use them. As a general rule, the Interpretation Act makes it clear that the term "Minister" includes officials in the department who act in a capacity appropriate to the exercise of the power.

Health Canada may designate officials to carry out the various regulatory functions. These designated officials and their superiors up to and including the Deputy Minister and Minister become capable of issuing Orders. Throughout this guide, "Minister" includes the "Minister" or "Minister's designate."

Consequence of contravening an Order

A person who contravenes an order made under the Act in relation to therapeutic products is guilty of a criminal offence. They may be liable for fines and penalties set out in section 31.2 or 31.4 of the Act.

To deal proactively with cases of potential or continued non-compliance with the Act, the Minister may apply to a court for an injunction (refer to section 21.5 of the Act). An injunction allows the courts to direct a person to refrain from an action that contravenes the Act or to do something to prevent a contravention of the Act.

The person named in the application is given 48 hours' notice before an injunction is issued. The person is not notified in advance if the situation is urgent and notice would not be in the public interest.