Guide to authorities under the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law): Power to recall or require assessments, tests and studies

On this page

• Power to recall (section 21.3)
• Power to require an assessment (section 21.31)
• Power to require tests, or other activities (section 21.32)

Power to recall (section 21.3)

Minister's powers: risk of injury to health (subsection 1)

If it's believed that a therapeutic product presents a serious or imminent risk of injury to health, the Minister may order a person who sells the product to:

• recall the product or
• send the product, or cause it to be sent, to a place specified in the Order

Recall Order: corrective action (subsection 2)

If it's believed that corrective action can deal effectively with the risk, instead of requesting the product's return, the Order may allow corrective action to be taken in respect of the product.

Prohibition: selling (subsection 3)

Subject to subsection (5), no person shall sell a therapeutic product that the Minister orders them, or another person, to recall.

Power to authorize sale (subsection 4)

The Minister may authorize a person to sell a therapeutic product, with or without conditions, even if the Minister has ordered them, or another person, to recall it.

Exception (subsection 5)

A person does not contravene subsection (3) if they sell a therapeutic product that they've been authorized to sell under subsection (4). However, they must sell it in accordance with any conditions that the Minister establishes.

Contravention of unpublished Order (subsection 6)

No person shall be convicted of an offence for contravening subsection (3), unless it's proved that at the time of the alleged contravention:

• the person had been notified of the recall order or
• reasonable steps had been taken to bring the purpose of the recall order to the notice of those persons likely to be affected by it

Who can use the 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 person who sells the therapeutic product. Under the Act, seller includes:

• anyone offering a therapeutic product for sale, such as a pharmacy
• a person distributing a therapeutic product, such as a drug sample in a doctor's office
• a person distributing blood from a blood establishment

What it applies to

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

Provisions relating to voluntary recall in the regulations continue to operate.

Threshold

If it's believed that the therapeutic product presents a serious or imminent risk to health, the Minister may order a person selling the product to recall it or have it sent to a place that the Minister specifies.

The Food and Drugs Act (Act) does not define "serious risk". This allows for flexibility in its interpretation. For more information about "serious risk", please refer to Annex A.

For the purposes of this section, "imminent" can be interpreted as "ready to take place" or "close at hand".

Scope of the power

The Minister uses this power to order the recall of a therapeutic product that's believed to present a serious or imminent risk of injury to health.

Subsection 21.3(1) allows the Minister to order a seller to remove a therapeutic product from the marketplace. This would typically involve the return of a therapeutic product to the seller. It may also include an Order to send the product to a particular place (for example, a warehouse for examination or quarantine).

Under subsection 21.3(2), the Minister may also order the seller to take corrective action. Generally, this is for cases involving large medical devices (for example, MRIs) where correcting the product is an effective means of dealing with the risk.

When a recall has been ordered, subsection 21.3(4) lets the Minister authorize a person to sell a therapeutic product that's subject to a recall to be sold with or without conditions. In this case, recalling the product would pose a greater risk to health than the reason for the recall. An example is a permitted sale of a life-saving drug not compliant with good manufacturing practices, to a group of patients for whom no alternative is available due to a drug shortage.

Before issuing an Order

Notification and opportunity to respond

Before issuing an Order under subsection 21.3(1), the Minister may notify the seller that the therapeutic product may pose a serious or imminent risk of injury to health and that the product will be subject to a recall Order. The notification would set out the facts and the relevant criteria used to form the basis of this decision.

Unless circumstances warrant otherwise, the notification would also provide the seller with a reasonable opportunity to:

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

The notification should specify the timeframe in which the seller must respond. The severity and immediacy of risk that the product presents would inform the timeframe. 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. For more information on sufficient notification, please refer to Annex B.

The Minister considers the nature of the risk posed by the product before deciding to issue an Order without prior notice.

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 seller in accordance with subsection 21.3(1) of the Act should include:

1. the person(s) to whom it applies
2. the legislative provision being relied upon
3. the therapeutic product subject to the Order (including lot number, manufacturing site and so on)
4. the requirement for the person to provide a recall plan satisfactory to the Minister
5. other instructions for conducting the recall (such as taking corrective action, performing effectiveness checks), including if necessary, the site to which the recalled product will need to be sent
6. the timeframe for conducting the above activities
7. 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. They should clearly communicate the decision taken 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.

Power to require an assessment (section 21.31)

Subject to the regulations, the Minister may order the holder of a therapeutic product authorization to conduct an assessment of the product in question. The holder must then provide the Minister with the results of the assessment.

This power is to be read in conjunction with its supporting regulations under section C.01.052 of the Food and Drug Regulations and section 62.1 of the Medical Devices Regulations.

Supporting regulations under the Natural Health Products Regulations may be developed at a later date with input from stakeholders.

Who can use the power

Only the Minister or designate can exercise the power. The regulator's decision to exercise the power is based on Health Canada's scientific evaluation and recommendation.

Who it applies to

The Order applies to the holder of one or more of the following therapeutic product authorizations:

• a drug identification number (DIN) that's been assigned under subsection C.01.014.2(1) of the Food and Drug Regulations
• a drug establishment licence (DEL) that's been issued under subsection C.01A.008(1) of the Food and Drug Regulations
• a notice of compliance (NOC) that's been issued under section C.08.004 or C.08.004.1 of the Food and Drug Regulations
• a medical device licence that's been issued under section 36 of the Medical Devices Regulations

What it applies to

This power applies to therapeutic products only (refer to the description in the Overview page). However, it will not apply to natural health products until section 21.31 is brought into force by an Order in Council.

Threshold

The Minister may order an authorization holder to conduct an assessment of the relevant therapeutic product and provide the results of the assessment, if the Minister has reasonable grounds to believe as follows:

1. The benefits or risk of injury to health associated with the therapeutic product are "significantly different" than they were when the authorization or licence was issued
2. Establishment licence (EL) holder (for drugs) who is an importer: the manner in which the drug is imported or the manner in which the drug is fabricated, packaged/labelled or tested outside of Canada may pose a risk of injury to health
3. EL holder (for drugs) other than an importer: the manner in which the holder conducts an authorized activity may pose a risk of injury to health

Scope of the power

The Minister may issue an assessment Order if new information indicates the benefits of or risks associated with a therapeutic product have changed since the previous authorization was issued. The Minister can only order the authorization holder to assess information that is currently available.

The power to order a test and study under section 21.32 gives the Minister the ability to obtain additional information about the product's effects on health or safety.

Before issuing an Order

Notification and opportunity to respond

Before issuing an Order under section 21.31, the Minister may notify the authorization holder that the threshold for issuing an assessment order has been reached. The Minister may not order the holder to conduct an assessment solely on information that had been previously provided to support an application for market authorization or to license an establishment.

The notification sets out the facts and the relevant criteria upon which the Minister is basing this Minister's belief.

The notification also provides the holder with a reasonable opportunity to:

• correct an error in fact
• dispute the proposed exercise of the power
• discuss compliance with the potential order

An Order should specify the timeframe in which the holder must respond. The severity and immediacy of risk that the product presents would inform the timeframe. 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 authorization holder in accordance with section 21.31 of the Act should include:

1. the person(s) to whom it applies
2. the legislative provision being relied upon
3. the therapeutic product and relevant authorization subject to the Order (including lot number, manufacturing site)
4. the rationale as to why the Minister now believes that the benefits or risks associated with the therapeutic product are different than when the authorization was issued or amended
5. the timeframe for responding to the Order and providing the Minister with the results of the assessment
6. the consequences for contravening the Order

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

Orders issued by the Minister should be accompanied by reasoned decisions. They should clearly communicate both 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:

• the legislative power being relied upon
• the decision
• 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 or other new 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

The results of an assessment and steps taken

After examining the results of an assessment, the Minister will:

• provide the authorization holder with the results of the examination
• publish a summary of the results of the examination
• publish a description of any steps the Minister has taken or may take as a consequence of the examination

If the benefits or risks associated with the therapeutic product are not significantly different from when the authorization was issued or amended, the Minister may take no further action.

If, however, there is sufficient information to determine that the benefits or risks associated with the therapeutic product are significantly different from when the authorization was issued or amended, the Minister may take regulatory action. This may include cancelling a DIN or suspending an NOC, a DEL or a medical device licence.

Under subsections C.01.014.6(3) and C.08.006(3) of the Food and Drug Regulations, the Minister may cancel the assignment of a DIN or suspend an NOC if:

• the authorization holder has failed to comply with the Order
• the Minister determines the results of the assessment are not sufficient to establish that the benefits associated with the drug outweigh the risks of injury to health

Under section C.01A.017.1 of the Food and Drug Regulations, the Minister may suspend a DEL if:

• the licensee has not complied with the Order
• the Minister determines the results of the assessment are not sufficient to establish that the licensing requirements in paragraph C.01A.005(l), subparagraph C.01A.005(m)(ii) or (iii) or paragraph 01A.005(o) continue to be met

Under section 41.1 of the Medical Devices Regulations, the Minister may suspend a medical device licence if:

• the licensee has not complied with the Order
• the Minister determines the results of the assessment are not sufficient to establish that the benefits associated with the device outweigh the risks to health or safety

Before taking this type of action, the Minister considers whether there are other more appropriate means to reduce the risks. The Minister may give the authorization holder an opportunity to demonstrate how these means will be implemented.

Power to require tests, or other activities (section 21.32)

To obtain more information about a therapeutic product's effects on health or safety, the Minister may order the holder of a therapeutic product authorization to:

• compile information, conduct tests or studies, or monitor users' experiences with the product
• provide the Minister with the information or results of tests, studies or monitoring

This power must be read in conjunction with its supporting regulations under section C.01.053 of the Food and Drug Regulations and section 62.2 of the Medical Devices Regulations.

Supporting regulations under the Natural Health Products Regulations may be developed later with input from stakeholders.

Who can use the 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 is made against the holder of one or more of the following therapeutic product authorizations:

• a DIN that's been assigned under subsection C.01.014.2(1) of the Food and Drug Regulations
• a DEL that's been issued under subsection C.01A.008(1) of the Food and Drug Regulations
• a NOC that's been issued under section C.08.004 or C.08.004.1 of the Food and Drug Regulations
• a medical device licence that's been issued under section 36 of the Medical Devices Regulations

What it applies to

The Order applies to therapeutic products only (refer to the description in the Overview page). However, it will not apply to natural health products until section 21.32 is brought into force by an Order in Council.

Threshold

The Minister may issue an Order under section 21.32 of the Act if there are reasonable grounds to believe as follows:

• for drug DIN or NOC holder: there are significant uncertainties relating to the benefits or harms associated with the drug
• for drug EL holder: the manner in which the holder conducts an activity has introduced significant uncertainties relating to the benefits or harms associated with the drug
• for medical device licence holder: there are significant uncertainties relating to the benefits or adverse effects associated with the device
• authorization holder: is unable to provide the Minister with information sufficient to manage those uncertainties
• the applicable requirements in the regulations, along with any terms and conditions that have been imposed on the authorization, do not allow for sufficient information to be obtained to manage those uncertainties

The Minister must consider whether:

• the activities the holder will be ordered are feasible
• there are less burdensome ways of obtaining additional information about the therapeutic product's effects on health or safety

The Minister should be satisfied about 2 things:

• the holder will be able to conduct the activities in a timely manner without undue burden
• information produced as a result of the activities will likely resolve the uncertainties

Scope of the power

This power allows the Minister to order a test or study, compile information or monitor user experience that the Minister considers necessary to assess uncertainties associated with the therapeutic product.

The Minister reserves this power for cases where a lack of knowledge could negatively impact human health and safety. For example, there may be cases where information supporting the safety of a therapeutic product is determined to be invalid. Deficiencies in the test methods used to obtain the information failed to detect harms associated with the product.

Before issuing an Order

Notification and opportunity to respond

Before issuing an Order under section 21.32, the Minister may notify the authorization holder that based on new information, the Minister believes the threshold for issuing such an Order has been reached. The notification sets out the facts and relevant criteria upon which the Minister is basing this belief.

The notification also provides information demonstrating that the Minister considered whether:

• the activities the holder will be ordered to undertake are feasible
• there are less burdensome ways of obtaining additional information about the therapeutic product's effects on health or safety

The notification also provides the authorization holder with a reasonable opportunity to:

• correct an error in fact
• dispute the proposed exercise of the power
• discuss compliance with the potential Order

The Order should specify the timeframe in which the holder must respond. The severity and immediacy of risk the product presents would inform the timeframe. 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. For further information on sufficient notification, 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 authorization holder in accordance with section 21.32 of the Act should include:

1. the person(s) it applies to
2. the legislative provision being relied upon
3. the therapeutic product and relevant authorization subject to the Order (including any applicable details such as lot number, manufacturing site)
4. a description of the uncertainties and the activities ordered by the Minister intended to resolve them
5. an explanation of how the Minister assessed the feasibility of the activity and whether other less burdensome means of obtaining the information were considered
6. the timeframe for responding to the Order and providing the Minister with the results of the activity
7. the consequences for contravening the Order

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

Orders issued by the Minister should be accompanied by reasoned decisions. They should clearly communicate both the decision and the evidence used to make that decision so 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:

• the legislative power being relied upon
• the decision
• 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 or other new 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

The results of an examination and steps taken

The Minister may decide to take further action if they are not satisfied that the uncertainties have been resolved or adequately managed.