Assented to 2014-11-06
An Act to amend the Food and Drugs Act
This enactment amends the Food and Drugs Act regarding therapeutic products in order to improve safety by introducing measures to, among other things,
(a) strengthen safety oversight of therapeutic products throughout their life cycle;
(b) improve reporting by certain health care institutions of serious adverse drug reactions and medical device incidents that involve therapeutic products; and
(c) promote greater confidence in the oversight of therapeutic products by increasing transparency.
Whereas the safety of drugs and medical devices is a key concern for Canadians;
And whereas new measures are required to further protect Canadians from the risks related to drugs and medical devices, other than natural health products;
Now, therefore, Her Majesty, by and with the advice and consent of the Senate and House of Commons of Canada, enacts as follows:
Marginal note:Alternative title
1. This Act may be cited as the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law).
R.S., c. F-27FOOD AND DRUGS ACT
Marginal note:1993, c. 34, s. 71(3)
« instrument »
“device” means an instrument, apparatus, contrivance or other similar article, or an in vitro reagent, including a component, part or accessory of any of them, that is manufactured, sold or represented for use in
(a) diagnosing, treating, mitigating or preventing a disease, disorder or abnormal physical state, or any of their symptoms, in human beings or animals,
(b) restoring, modifying or correcting the body structure of human beings or animals or the functioning of any part of the bodies of human beings or animals,
(c) diagnosing pregnancy in human beings or animals,
(d) caring for human beings or animals during pregnancy or at or after the birth of the offspring, including caring for the offspring, or
(e) preventing conception in human beings or animals;
however, it does not include such an instrument, apparatus, contrivance or article, or a component, part or accessory of any of them, that does any of the actions referred to in paragraphs (a) to (e) solely by pharmacological, immunological or metabolic means or solely by chemical means in or on the body of a human being or animal;
(2) The definition étiquette in section 2 of the French version of the Act is replaced by the following:
« étiquette »
étiquette Sont assimilés aux étiquettes les inscriptions, mots ou marques accompagnant les aliments, drogues, cosmétiques, instruments ou emballages ou s’y rapportant.
(3) Section 2 of the Act is amended by adding the following in alphabetical order:
“confidential business information”
« renseignements commerciaux confidentiels »
“confidential business information”, in respect of a person to whose business or affairs the information relates, means — subject to the regulations — business information
(a) that is not publicly available,
(b) in respect of which the person has taken measures that are reasonable in the circumstances to ensure that it remains not publicly available, and
(c) 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;
« produit thérapeutique »
“therapeutic product” means a drug or device or any combination of drugs and devices, but does not include a natural health product within the meaning of the Natural Health Products Regulations;
“therapeutic product authorization”
« autorisation relative à un produit thérapeutique »
“therapeutic product authorization” means an authorization — including a licence and a suspended authorization or licence — that is issued under the regulations and that authorizes, as the case may be, the import, sale, advertisement, manufacture, preparation, preservation, packaging, labelling, storage or testing of a therapeutic product;
3. The Act is amended by adding the following after section 21:
Marginal note:Power to require information — serious risk
21.1 (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.
Marginal note:Disclosure — serious risk
(2) 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 of injury to human health.
Marginal note:Disclosure — health or safety
(3) 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 or promotion of human health or the safety of the public 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 or promotion of human health or the safety of the public.
Definition of “government”
(4) In this section, “government” means any of the following or their institutions:
(a) the federal government;
(b) a corporation named in Schedule III to the Financial Administration Act;
(c) a provincial government or a public body established under an Act of the legislature of a province;
(d) an aboriginal government as defined in subsection 13(3) of the Access to Information Act;
(e) a government of a foreign state or of a subdivision of a foreign state; or
(f) an international organization of states.
Marginal note:Modification or replacement — labelling or packaging
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.
Marginal note:Minister’s powers — risk of injury to health
21.3 (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
(a) recall the product; or
(b) send the product, or cause it to be sent, to a place specified in the order.
Marginal note:Recall order — corrective action
(2) For greater certainty, if the Minister makes an order under paragraph (1)(a) and believes that corrective action is an effective means of dealing with the risk, the order may require the person who sells the product to, instead of requesting the product’s return, request the product’s owner or user to allow corrective action to be taken in respect of the product and then take that corrective action, or cause it to be taken, if the request is accepted.
Marginal note:Prohibition — selling
(3) Subject to subsection (5), no person shall sell a therapeutic product that the Minister orders them, or another person, to recall.
Marginal note:Power to authorize sale
(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.
(5) A person does not contravene subsection (3) if they sell a therapeutic product that they have been authorized under subsection (4) to sell, provided that they sell it in accordance with any conditions that the Minister establishes.
Marginal note:Contravention of unpublished order
(6) No person shall be convicted of an offence for the contravention of subsection (3) unless it is 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 purport of the recall order to the notice of those persons likely to be affected by it.
Marginal note:Statutory Instruments Act
21.4 (1) For greater certainty, orders made under any of sections 21.1 to 21.3 are not statutory instruments within the meaning of the Statutory Instruments Act.
Marginal note:Availability of orders
(2) The Minister shall ensure that any order made under any of sections 21.1 to 21.3 is publicly available.
21.5 (1) If, on the application of the Minister, it appears to a court of competent jurisdiction that a person has done, is about to do or is likely to do anything that constitutes or is directed toward the commission of an offence under this Act in respect of a therapeutic product, the court may issue an injunction ordering the person, who is to be named in the application, to
(a) refrain from doing anything that it appears to the court may constitute or be directed toward the commission of the offence; or
(b) do anything that it appears to the court may prevent the commission of the offence.
(2) No injunction is to be issued under subsection (1) unless 48 hours’ notice is served on the party or parties who are named in the application or unless the urgency of the situation is such that service of notice would not be in the public interest.
Marginal note:False or misleading information — therapeutic products
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.
Marginal note:Terms and conditions of authorizations
21.7 The holder of a therapeutic product authorization shall comply with the terms and conditions of the authorization that are imposed under regulations made under paragraph 30(1.2)(b).
Marginal note:Clinical trials and investigational tests
21.71 The holder of a therapeutic product authorization referred to in paragraph 30(1.2)(c) shall ensure that prescribed information concerning the clinical trial or investigational test is made public within the prescribed time and in the prescribed manner.
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