Guide to authorities under the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law): Power to order a label change or package modification

Under section 21.2 of the Food and Drugs Act (Act), the Minister of Health may order the holder of a therapeutic product authorization to modify the product's label or replace or modify its packaging if it's believed that doing so is necessary to prevent injury to health.

Who can use this power

Only the Minister or designate can exercise this power. The regulator's decision to exercise the power relies upon Health Canada's scientific evaluation and recommendation.

Who it applies to

The Order applies to the holder of an authorization that authorizes the import or sale of the therapeutic product. This includes therapeutic products used in clinical trials or medical device investigational testing.

What it applies to

This power applies to therapeutic products (refer to description in the Overview page).

Threshold

The Minister may order the holder of a therapeutic product authorization to change a label or modify a package. The Minister must believe that doing so is necessary to prevent injury to health.

Health Canada assesses therapeutic products before they're available for sale in Canada.

However, new information about the risk/harms associated with the use of the product may become available following a clinical trial or once the product is on the market. The label may not adequately reflect this new information.

Confusion over similar brand names or product packaging also has the potential to cause harm.

New information about a product comes from a number of sources:

• before a product is marketed, for example:
  • during a clinical trial
• after a product is in the marketplace, for example:
  • additional studies submitted as part of terms and conditions placed on a market authorization
  • information received as part of a routine safety update
  • information received as part of an application for a new indication

This information may also come from:

• post-market safety signal detection by a manufacturer
• report from a patient or health care facility
• information shared by other international regulatory agencies
• reports published in medical and scientific literature
• an inspection or investigation performed by Health Canada or another regulator

These or other relevant sources are used to form the basis for a reasonable belief that a label change or package modification is needed to prevent injury to health.

Scope of the power

This power allows the Minister to order a therapeutic product authorization holder to change the label or modify a package. For example, the Minister may require that:

• a label be revised to include new safety information (for example, new warning)
• the brand-name or packaging be revised to prevent confusion and medication error

This power also permits the Minister to order label or package changes to therapeutic products used in clinical trials or medical device investigational testing.

Before issuing an Order

Notification and opportunity to respond

Before issuing an Order under section 21.2, the Minister may notify the therapeutic product authorization holder who sells or imports the product that they believe the product label or package requires modification to prevent injury to health. This notification sets out the facts and the relevant criteria upon which the Minister is basing this belief.

The notification also gives the authorization holder a reasonable opportunity to respond in a number of ways, such as:

• correct an error in fact
• dispute the proposed exercise of power
• comply voluntarily with the potential order

The notification should specify a reasonable timeframe in which the holder must respond. The severity and immediacy of risk presented by the product would inform the response time. For example, it can be 12 hours, 2 business days, 90 days and so on.

Issuing a notification does not limit or prevent the Minister from exercising the power to issue an Order. In general, a notice would be provided because the Orders may adversely impact the regulated persons. However, in urgent or exceptional circumstances, the notice may not be provided or may be dispensed with. For more information on sufficient notification, please refer to Annex B.

What an Order looks like

An Order is instructions, decisions or directions given by the Minister that are authorized by the legislation.

An Order issued by the Minister to the holder of a therapeutic product authorization in accordance with section 21.2 of the Act should include:

1. the therapeutic product holder(s) to which it applies
2. the legislative provision being relied upon
3. the therapeutic product in question
4. the risk of injury to be mitigated by changing the label or packaging (if known, the areas of the label to modify)
5. the timeframe for completing the ordered changes or modifications
6. the consequences for contravening the Order

In accordance with subsection 21.4(2), the Order is to be made public.

Orders issued by the Minister should be accompanied by reasoned decisions. The Order should clearly communicate the decision and the evidence used to make that decision so that the affected party understands how the result was reached. This allows for transparent decision-making.

Reasoned decisions accompanying the Order should be unbiased and include:

1. the legislative power being relied upon
2. the decision
3. an explanation of the basis for the decision and how it was reached, which may include:
   • a narrative and chronological review of the facts
   • the scientific evidence considered
   • any findings on important questions of fact and the accompanying analysis applying the facts to the law
   • any relevant criteria considered as part of the threshold determination
   • an explanation of how the evidence satisfies the threshold

Supporting regulations may be developed later with input from internal and external stakeholders.