Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) (S.C. 2014, c. 24)
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Assented to 2014-11-06
R.S., c. F-27FOOD AND DRUGS ACT
4. Section 21.4 of the Act is replaced by the following:
Marginal note:Power to require assessment
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.
Marginal note:Power to require tests, studies, etc.
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
(a) compile information, conduct tests or studies or monitor experience in respect of the therapeutic product; and
(b) provide the Minister with the information or the results of the tests, studies or monitoring.
Marginal note:Statutory Instruments Act
21.4 (1) For greater certainty, orders made under any of sections 21.1 to 21.32 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 21.32 is publicly available.
5. The Act is amended by adding the following after section 21.71:
Marginal note:Health care institutions to provide information
21.8 A prescribed health care institution shall provide the Minister, within the prescribed time and in the 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.
6. (1) Section 30 of the Act is amended by adding the following after subsection (1.1):
Marginal note:Regulations — therapeutic products
(1.2) Without limiting the power conferred by any other subsection of this section, the Governor in Council may make regulations
(a) respecting the issuance of authorizations — including licences — that authorize, as the case may be, the import, sale, advertisement, manufacture, preparation, preservation, packaging, labelling, storage or testing of a therapeutic product, and the amendment, suspension and revocation of such authorizations;
(b) authorizing the Minister to impose terms and conditions on authorizations referred to in paragraph (a), including existing authorizations, and to amend those terms and conditions;
(b.1) requiring the Minister to ensure that decisions with regard to the issuance, amendment, suspension and revocation of authorizations referred to in paragraph (a), and to the imposition and amendment of terms and conditions referred to in paragraph (b), along with the reasons for those decisions, are publicly available;
(c) requiring holders of a therapeutic product authorization that authorizes the import or sale of a therapeutic product for a clinical trial or investigational test involving human subjects, or former holders of such an authorization, to provide the Minister, after the trial or test is completed or discontinued, or, if the authorization is suspended or revoked, after the suspension or revocation, with safety information that the holders or former holders receive or become aware of about the therapeutic product;
(c.1) defining “clinical trial” and “investigational test” for the purposes of this Act;
(d) requiring holders of a therapeutic product authorization to provide the Minister with information, in respect of any serious risk of injury to human health, that the holders receive or become aware of and that is relevant to the safety of the therapeutic product to which the authorization relates, regarding
(i) risks that have been communicated outside Canada, and the manner of the communication,
(ii) changes that have taken place to labelling outside Canada, and
(iii) recalls, reassessments and suspensions or revocations of authorizations, including licences, in respect of a therapeutic product, that have taken place outside Canada;
(d.1) specifying the business information obtained under this Act in relation to an authorization under paragraph (a) that is not confidential business information, or the circumstances in which business information obtained under this Act in relation to such an authorization ceases to be confidential business information;
(d.2) authorizing the Minister to disclose, without notifying the person to whose business or affairs the information relates or obtaining their consent, business information that, under regulations made under paragraph (d.1),
(i) is not confidential business information, or
(ii) has ceased to be confidential business information;
(e) respecting modifications of labels and modifications and replacements of packages referred to in section 21.2;
(f) respecting the recall of a therapeutic product or the sale of a therapeutic product that is the subject of a recall; and
(g) prescribing anything that is to be prescribed under section 21.71.
(2) Subsection 30(1.2) of the Act is amended by striking out “and” at the end of paragraph (f) and by adding the following after paragraph (f):
(f.1) respecting assessments referred to in section 21.31, and the provision of the results of the assessments to the Minister;
(f.2) requiring the Minister to ensure that decisions with regard to the making of orders under section 21.31, along with the reasons for those decisions, are publicly available;
(f.3) respecting the compilation of information, the conducting of tests and studies and the monitoring of experience that are referred to in paragraph 21.32(a), and the provision to the Minister of the information or results referred to in paragraph 21.32(b); and
(3) Subsection 30(1.2) of the Act is amended by striking out “and” at the end of paragraph (f) and by adding the following after paragraph (g):
(h) defining “serious adverse drug reaction” and “medical device incident” for the purposes of this Act;
(i) respecting the provision by health care institutions referred to in section 21.8 to the Minister of information referred to in that section; and
(j) prescribing anything that is to be prescribed under section 21.8.
(4) Section 30 of the Act is amended by adding the following after subsection (1.2):
Marginal note:Consideration of existing information management systems
(1.3) Before recommending to the Governor in Council that a regulation be made under paragraph (1.2)(i) or (j), the Minister shall take into account existing information management systems, with a view to not recommending the making of regulations that would impose unnecessary administrative burdens.
(5) The portion of subsection 30(2) of the Act before paragraph (a) is replaced by the following:
Marginal note:Regulations respecting drugs manufactured outside Canada
(2) Without limiting the power conferred by any other subsection of this section, the Governor in Council may make such regulations governing, regulating or prohibiting
Marginal note:1994, c. 47, s. 117
(6) Subsection 30(3) of the Act is replaced by the following:
Marginal note:Regulations — North American Free Trade Agreement and WTO Agreement
(3) Without limiting the power conferred by any other subsection of this section, the Governor in Council may make any regulations that the Governor in Council considers necessary for the purpose of implementing, in relation to drugs, Article 1711 of the North American Free Trade Agreement or paragraph 3 of Article 39 of the Agreement on Trade-related Aspects of Intellectual Property Rights set out in Annex 1C to the WTO Agreement.
Marginal note:2004, c. 23, s. 2
(7) Subsection 30(5) of the Act is replaced by the following:
Marginal note:Regulations to implement General Council Decision
(5) Without limiting the power conferred by any other subsection of this section, the Governor in Council may make any regulations that the Governor in Council considers necessary for the purpose of implementing the General Council Decision.
Marginal note:2012, c. 19, s. 416
7. Subsection 30.5(1) of the Act is replaced by the following:
Marginal note:Incorporation by reference
30.5 (1) A regulation made under this Act with respect to a food or therapeutic product and a marketing authorization may incorporate by reference any document, regardless of its source, either as it exists on a particular date or as it is amended from time to time.
Marginal note:1997, c. 6, s. 91
8. The portion of section 31 of the Act before paragraph (a) is replaced by the following:
Marginal note:Contravention of Act or regulations
31. Subject to sections 31.1, 31.2 and 31.4, every person who contravenes any of the provisions of this Act or of the regulations is guilty of an offence and liable
9. The Act is amended by adding the following after section 31.1:
Marginal note:Offences relating to therapeutic products
31.2 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
(a) 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
(b) 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.
Marginal note:Due diligence
31.3 Due diligence is a defence in a prosecution for an offence under this Act, other than an offence under section 31.4.
Marginal note:Offences — section 21.6 and serious risk
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
(a) 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
(b) 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.
Marginal note:Sentencing considerations
31.5 A court that imposes a sentence for an offence under section 31.2 or 31.4 shall take into account, in addition to any other principles that it is required to consider, the following factors:
(a) the harm or risk of harm caused by the commission of the offence; and
(b) the vulnerability of consumers of the therapeutic product.
Marginal note:Parties to offence
31.6 If a person other than an individual commits an offence under section 31.2, or commits an offence under section 31.4 by reason of contravening section 21.6, then any of the person’s directors, officers or agents or mandataries who directs, authorizes, assents to or acquiesces or participates in the commission of the offence is a party to the offence and is liable on conviction to the punishment provided for by this Act, even if the person is not prosecuted for the offence.
Marginal note:Continuing offence
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.
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