Guide to the environmental risk management authorities under the Food and Drugs Act: Authority to require and disclose information
- Overview
- Authority to require and disclose information
- Authority to order a label change or package modification
- Authority to recall the product
- Authority to compile information or require tests, studies or monitoring
- Determining risk to the environment
- Key considerations for managing risks to the environment
On this page
- Section 21.301
- Authority to require information when there could be a serious risk to the environment
- Process for making an order to require information
- Authority to disclose information when there could be a serious risk to the environment
- Authority to disclose information for the protection of the environment
Section 21.301
The following subsections of the Food and Drugs Act (FDA) set out the authority to require and disclose information.
Subsection 21.301(1), the authority to require information when there could be a serious risk to the environment:
“If the Minister believes a therapeutic product may present a serious risk to the environment, the Minister may order a person to provide the Minister with information that is in the person’s control and that the Minister believes is necessary to determine whether the product presents such a risk.”
Subsection 21.301(2), the authority to disclose information when a therapeutic product may present a serious risk to the environment:
“The Minister may disclose confidential business information about a therapeutic product without notifying the person to whose business or affairs the information relates or obtaining their consent, if the Minister believes that the product may present a serious risk to the environment.”
Subsection 21.301(3), the authority to disclose information for the protection of the environment:
“The Minister may disclose confidential business information about a therapeutic product without notifying the person to whose business or affairs the information relates or obtaining their consent, if the purpose of the disclosure is related to the protection of the environment and the disclosure is to:
- (a) a government;
- (b) a person from whom the Minister seeks advice; or
- (c) a person who carries out functions relating to the protection of the environment, including the assessment and management of risks to the environment.”
Authority to require information where there could be a serious risk to the environment
Scope
Subsection 21.301(1) of the FDA applies to therapeutic products only.
Any person who controls information that the Minister believes is necessary to determine whether a therapeutic product presents a serious risk to the environment can be subject to this authority.
This authority allows the Minister to make an order requiring a person to provide them with information that is in their control if the Minister believes it is necessary to determine whether a therapeutic product presents a serious risk to the environment. The authority may only be used to obtain existing information and not to order a person to create new information. In other words, it cannot be used to require a person to conduct new analyses or studies.
About the threshold that needs to be met before using this authority
The Minister can only use this authority if they believe that:
- (a) a therapeutic product may present a serious risk to the environment and
- (b) a person has, within their control, information that the Minister believes is necessary to determine whether a therapeutic product presents such a risk to the environment
We will establish the first component of the threshold through a scientific evaluation. For further discussion on determining whether an authorized therapeutic product presents a risk to the environment, refer to “Determining risk to the environment.”
The second component of the threshold is largely a question of judgment. Designated officials or subject matter experts will recommend to the Minister to request further information to determine whether a therapeutic product presents a serious risk to the environment. The recommendation must be reasonable, factual and based on the available information.
For further discussion on additional elements to consider before exercising this authority, refer to “Key considerations for managing risks to the environment.”
Process for making an order to require information
Before making an order under subsection 21.301(1) of the FDA, the Minister, with support from officials, must ensure the threshold has been met and that the order meets the policy objectives. They will conduct scientific, policy and regulatory analyses to ensure these criteria are met.
Notification and opportunity to respond
When we are considering an order under this authority, we will consult, when applicable, with the relevant parties. In addition, in general, before making an order, we would provide prior notification to the person subject to the order. However, in urgent or exceptional circumstances, we may not provide a notification.
The notification would:
- inform the person that the Minister believes that information regarding the therapeutic product that is in the person’s control is necessary to determine whether it presents a serious risk to the environment
- set out the facts and the relevant criteria used to form the basis of this belief and
- give the person the opportunity to voluntarily provide the required information
Unless circumstances warrant otherwise, the notification would also provide the affected person with a reasonable opportunity to:
- correct an error in fact
- dispute the proposed exercise of the authority or
- voluntarily comply with the measures outlined in the notification
The notification may also specify the timeframe in which the person must respond. The severity and immediacy of the risk presented by the therapeutic product would determine the timeframe.
The Minister can issue an order whether they have previously notified the person or not. For further discussion, refer to “Sufficient notice.”
Development of the order
An order made under subsection 21.301(1) of the FDA is not a statutory instrument as defined in the Statutory Instruments Act. Therefore, the Minister may delegate the making, amending or revoking of an order to officials, as appropriate.
If we determine that an order under these authorities is the best option to address the issue, officials will conduct the necessary analysis to support its development.
We will consult with relevant stakeholders during the development of the order. These consultations may take different forms depending on such things as the number of stakeholders who are affected or the urgency of the situation.
An order made under subsection 21.301(1) of the FDA to a person would include the following:
- the name of the person or persons it applies to
- the legislative authority being relied on
- the name of the therapeutic product and/or relevant authorization that is subject to the order including, for example, any relevant details such as the:
- lot number
- manufacturing site
- a description of the information that is in the person’s control that the Minister believes is necessary to determine whether the therapeutic product presents such a risk
- the timeframe for providing or disclosing the information and
- the consequences of contravening the order
We may develop supporting regulations at a later date.
Publication
In accordance with subsection 21.4(2) of the FDA, the order has to be made public. Where necessary, we may redact certain information before publishing an order, for example, to protect a person’s privacy or confidential business information (CBI).
We will also make supporting information public. This will include the reason for making the order as well as an explanation of the basis for the decision and how it was reached. Supporting information may include:
- a narrative and chronological review of the facts
- the scientific evidence 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 and
- an explanation of how the evidence satisfies the threshold
Steps the Minister can take after examining the information provided under the order
We will evaluate the information obtained under subsection 21.301(1) of the FDA to determine whether the therapeutic product presents a serious risk to the environment. Following the evaluation of the information, we may choose to make the results of the examination public.
Authority to disclose information when there could be a serious risk to the environment
Scope
Subsection 21.301(2) of the FDA applies to CBI about a therapeutic product. This information could have been obtained in support of the pre-market evaluation or obtained post-authorization.
This authority allows the Minister to disclose CBI about a therapeutic product if they believe it may present a serious risk to the environment and disclosing it is necessary to mitigate the risk. The Minister does not need to notify the person to whose business or affairs the information relates or obtain their consent. As long as the threshold is met, the Minister may disclose the CBI publicly, as well as to any person.
Note that any disclosure of CBI, under this authority, must comply with Canada’s international treaty obligations, including those under the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) and the Canada United States Mexico Agreement (CUSMA).
Only the Minister can disclose CBI under subsection 21.301(2) of the FDA. The regulator’s decision to exercise the authority relies on officials’ scientific evaluation and recommendation.
About the threshold that need to be met before using this authority
The Minister can only use this authority if they believe that a therapeutic product may present a serious risk to the environment and there is documented evidence that a therapeutic product can pose such a risk.
Subsection 21.301(2) of the FDA allows CBI to be disclosed to anyone. For further discussion on the determining whether an authorized therapeutic product presents a risk to the environment, refer to “Determining risk to the environment.”
For further discussion on additional elements to consider before exercising this authority, refer to “Key considerations for managing risks to the environment.”
Authority to disclose information for the protection of the environment
Scope
Subsection 21.301(3) of the FDA applies to CBI about a therapeutic product. This information may have been obtained in support of the pre-market evaluation or obtained post-authorization.
This authority allows the Minister to disclose CBI about a therapeutic product without notifying the person to whose business or affairs the information relates. The CBI must concern the protection of the environment. Disclosure can only be to the following entities or individuals:
- (a) a government
- (b) a person from whom the Minister seeks advice or
- (c) a person who carries out functions relating to the protection of the environment, including the assessment and management of the risks to the environment
These can include:
- regulatory counterparts
- provinces and territories
- scientific and medical experts
- other federal departments and agencies
- members of departmental advisory bodies or
- any other person who carries out functions relating to the protection of the environment
Note that any disclosure of CBI under this authority must comply with Canada’s international treaty obligations, including those under TRIPS and CUSMA.
Only the Minister can disclose CBI under subsection 21.301(3) of the FDA. The regulator’s decision to exercise the authority relies on officials’ scientific evaluation and recommendation.
About the threshold that needs to be met before using this authority
The Minister can only use this authority for the protection of the environment. Disclosing CBI would help Health Canada to conduct various regulatory activities that evaluate and monitor the environmental risk of therapeutic products after they are authorized for use.
Subsection 21.301(2) of the FDA allows CBI to be disclosed to anyone. The threshold for disclosure under subsection 21.301(3) of the FDA is lower as it only allows CBI to be disclosed to certain entities or individuals.