Guide to authorities under the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law): Power to require and disclose information

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• Power to require information: serious risk
• Power to disclose information: serious risk
• Power to disclose information: health and safety

Power to require information: serious risk

If the Minister of Health believes a therapeutic product may present a serious risk of injury to human health, the Minister may order a person to provide information that is in their control. To do so, the Minister must believe this information is necessary to determine whether the product presents such a risk. The authority to do so is outlined in subsection 21.1(1) of the Food and Drugs Act (Act).

Who can use this power?

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

To whom does it apply?

The Order applies to the person who controls the information that the Minister believes is necessary to determine whether a therapeutic product presents a serious risk of injury to human health. A "person" can be an individual, a research institution, a corporation or an authorization holder.

To what does it apply?

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

Threshold

There are 2 components to the threshold that must be met for the Minister to use this power. The Minister must believe that:

1. the therapeutic product may present a serious risk of injury to human health and
2. a person has within their control information that the Minister believes is necessary to determine whether the product presents such a risk

For the first component, information that a therapeutic product may present a serious risk of injury to human health may come from a number of sources, including:

• a pre-market scientific assessment of a clinical trial application
• a post-market scientific assessment based on sources like:
  • 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
• a recommendation based on post-market safety signal
• information from other international regulatory agencies
• reports published in the medical or scientific literature
• an inspection by Health Canada or another regulator

The Act does not contain a definition of "serious risk," to allow for flexibility in its application. For further discussion about "serious risk," refer to Annex A.

The second component of the threshold is largely a question of judgment. Officials or subject matter experts will recommend to the Minister to request further information to determine whether a therapeutic product presents a serious risk of injury to human health. The recommendation must be reasonable, factual and based on the information at hand.

Scope of the power

This power allows the Minister to order a person to provide the Minister with information that is in that person's control. The power may only be used to obtain existing information and not to order a person to create new information. In other words, it can't be used to require a person to conduct new analysis or studies.

The Order must also be made against the person in control of the information. It can't be used to seek out information from another person outside the scope of the power.

Before issuing an Order

Notification and opportunity to respond

Before issuing an Order under subsection 21.1(1), the Minister may notify the person about information in their control that the Minister believes is necessary to determine whether a therapeutic product presents a serious risk to human health. The notification would set out the facts upon which the Minister is basing this belief.

The notification would also provide the affected person with a reasonable opportunity to respond in the following ways that include:

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

An Order should specify the timeframe in which the person 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.

The issuance, or not, of a notification does not in any way limit or prevent the exercise of the power of the Minister 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 further discussion of 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 person in accordance with subsection 21.1(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 in question
4. a description of the information that's in the person's control that the Minister believes is necessary to determine whether the product presents a serious risk
5. the timeframe for providing or disclosing the information
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. 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.

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 evidence considered
  • any findings on important questions of fact and the accompanying analysis applying the facts of the law
  • any relevant criteria considered as part of the threshold determination
  • an explanation of how the evidence satisfies the threshold

Regulatory outcomes

Health Canada should evaluate the information obtained by the Minister under subsection 21.1(1). The evaluation should result in 1 of the following 3 outcomes:

1. information insufficient for the purposes of evaluation
2. no further action needed
3. additional regulatory action needed

Power to disclose information: serious risk

As outlined in subsection 21.1(2), the Minister may disclose confidential business information about a therapeutic product if the Minister believes the product may present a serious risk of injury to human health. The Minister does not need to notify the person to whose business or affairs the information relates or obtain their consent.

Who can use this power

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

What it applies to

As part of its normal regulatory functions, the regulator may obtain confidential business information (CBI) about a therapeutic product (for example, CBI that supports pre-market authorization or post-authorization). As long as the threshold is met, the Minister may disclose the CBI to any person.

This power is through the Act and applies to therapeutic products whether licensed or unlicensed (refer to the description in the Overview page).

Threshold

To use this power, the Minister must have reasonable grounds to believe that the therapeutic product may present a serious risk of injury to human health. There must be documented evidence that the therapeutic product could pose such a risk.

The Act does not contain a definition of serious risk of injury to human health. For further discussion about "serious risk," refer to Annex A.

Scope of the power

This power allows the Minister to disclose CBI about the therapeutic product. The Act sets out 3 conditions that must be met for information to be considered CBI:

"confidential business information," in respect of a person to whose business or affairs the information relates, means, subject to the regulations, business information

1. that is not publicly available
2. in respect of which the person has taken measures that are reasonable in the circumstances to ensure that it remains not publicly available and
3. that has actual or potential economic value to the person or their competitors because it is not publicly available and its disclosure would result in a material financial loss to the person or a material financial gain to their competitors

Under this provision, CBI should only be disclosed when it's necessary to mitigate the serious risk of injury to human health.

Note: Any disclosure of CBI on new chemical entities must comply with Canada's international treaty obligations, including those under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and Canada-United States-Mexico Agreement (CUSMA).

Power to disclose information: health and safety

Subsection 21.1(3) gives the Minister the power to disclose CBI about a therapeutic product without notifying the person to whose business or affairs the information relates. The Minister does not need to get their consent to disclose this information.

The CBI must concern the protection or promotion of human health or the safety of the public. Disclosure is only to certain individuals (refer to the following section on scope of power).

Who can use this power

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

What it applies to

This power applies to CBI collected about a therapeutic product. The regulator has obtained this information as part of its normal regulatory functions. For example, it was submitted to support pre-market authorization or post-authorization.

While subsection 21.1(2) allows CBI to be disclosed to anyone, subsection 21.1(3) only allows the CBI to be disclosed to certain individuals. The threshold for disclosure is lower.

Threshold

The Minister may use this power if the purpose for disclosing the CBI concerns the protection or promotion of human health or the safety of the public. The purpose speaks to the various regulatory activities that Health Canada conducts to help evaluate and monitor the safety, effectiveness, efficacy and quality of therapeutic products before and after they're marketed.

The "protection or promotion of human health" is intended to allow Health Canada to disclose CBI for 2 purposes:

1. protecting patients from safety risks or
2. promoting the safe use of therapeutic products

"Promotion" is interpreted narrowly, in keeping with Health Canada's role as a health regulator and its mandate to promote and protect the health of Canadians. In this context, the disclosure of CBI could be for the purpose of determining the appropriate prescribing of therapeutic products to optimize their use.

Scope of the power

The Minister can only disclose CBI for this purpose to the following entities or persons:

• a government
• a person from whom the Minister seeks advice
• a person who carries out functions relating to the protection or promotion of human health or the safety of the public

"Government" is defined in subsection 21.1(4) to include:

• a federal, provincial, territorial, municipal and foreign government
• an Aboriginal government as defined in the Access to Information Act
• a corporation named in Schedule III of the Financial Administration Act
• an international organization of states

This power establishes the Minister's authority to disclose CBI on a therapeutic product with the following:

• regulatory counterparts
• other federal departments and agencies
• provinces and territories
• scientific and medical experts
• members of departmental advisory bodies
• any other person who carries out functions related to protecting or promoting the health and safety of the public

Amendments concerning certain information on therapeutic products were made to the Food and Drug Regulations and Medical Devices Regulations on February 28, 2019. The amendments indicate that clinical information in drug submissions and medical device applications is no longer "confidential" once a final regulatory decision is made. Health Canada may then make this information public. Other information in therapeutic product submissions/applications may be eligible for disclosure under this authority.

Note: Any disclosure of CBI under this section concerning new chemical entities must comply with Canada's international treaty obligations under TRIPS and CUSMA.