Table 2.

A summary of key provisions in Bill C-17, An Act to Amend the Food and Drugs Act

FocusProposed section(s)
Power to recall drugs21.3(1) — If the Minister believes that a therapeutic product presents a serious or imminent risk of injury to health, he or she may order a person who sells the product to

  1. recall the product; or

  2. send the product, or cause it to be sent, to a place specified in the order.

Power to overcome information asymmetries21.1 — If the Minister believes that a therapeutic product may present a serious risk of injury to human health, 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.
21.6 — No person shall knowingly make a false or misleading statement to the Minister — or knowingly provide him or her with false or misleading information — in connection with any matter under this Act concerning a therapeutic product.
21.8 — A prescribed health care institution shall provide the Minister, within the prescribed time and prescribed manner, with prescribed information that is in its control about a serious adverse drug reaction that involves a therapeutic product or a medical device incident that involves a therapeutic product.
Power to enforce conditions on market authorizations, modify product labels and require assessments, tests, studies, etc.21.7 — The holder of a therapeutic product authorization shall comply with the terms and conditions of the authorization that are imposed under regulations.
21.2 — The Minister may, if he or she believes that doing so is necessary to prevent injury to health, order the holder of a therapeutic product authorization that authorizes the import or sale of a therapeutic product to modify the product’s label or to modify or replace its package.
21.31 — Subject to the regulations, the Minister may order the holder of a therapeutic product authorization to conduct an assessment of the therapeutic product to which the authorization relates and provide the Minister with the results of the assessment.
21.32 — Subject to the regulations, the Minister may, for the purpose of obtaining additional information about a therapeutic product’s effects on health or safety, order the holder of a therapeutic product authorization to

  1. compile information, conduct tests or studies or monitor experience in respect of the therapeutic products; and

  2. provide the Minister with the information or the results of the tests, studies or monitoring.

30(1.2)(b) — Without limiting the power conferred by any other subsection of this section, the Governor in Council may make regulations … authorizing the Minister to impose terms and conditions on authorizations … including existing authorizations, and to amend those terms and conditions.
Serious enforcement measures31.2 — Subject to section 31.4, every person who contravenes any provision of this Act or the regulations, as it relates to a therapeutic product, or an order made under any of sections 21.1 to 21.3 is guilty of an offence and liable

  1. on conviction by indictment, to a fine not exceeding $5 000 000 or to imprisonment for a term not exceeding two years or to both; and

  2. on summary conviction, for a first offence, to a fine not exceeding $250 000 or to imprisonment for a term not exceeding six months or to both and, for a subsequent offence, to a fine not exceeding $500 000 or to imprisonment for a term not exceeding 18 months or to both.

31.4 — A person who contravenes section 21.6, or who knowingly or recklessly causes a serious risk of injury to human health in contravening another provision of this Act or the regulations, as it relates to a therapeutic product, or an order made under any of sections 21.1 to 21.3 is guilty of an offence and liable

  1. on conviction on indictment, to a fine the amount of which is at the discretion of the court or to imprisonment for a term not exceeding five years or to both; and

  2. on summary conviction, for a first offence, to a fine not exceeding $500 000 or to imprisonment for a term not exceeding 18 months or to both and, for a subsequent offence, to a fine not exceeding $1 000 000 or to imprisonment for a term not exceeding two years or to both.

31.7 — If an offence under section 31.2 or 31.4 is committed or continued on more than one day, it constitutes a separate offence for each day on which it is committed or continued.