Second Session, Forty-first Parliament,
62-63 Elizabeth II, 2013-2014
STATUTES OF CANADA 2014CHAPTER 24
An Act to amend the Food and Drugs Act
ASSENTED TO
6th NOVEMBER, 2014
BILL C-17
SUMMARY
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.
Available on the Parliament of Canada Web Site at the following address:http://www.parl.gc.ca
62-63 ELIZABETH II
——————
CHAPTER 24
An Act to amend the Food and Drugs Act
[Assented to 6th November, 2014]
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:
ALTERNATIVE TITLE
Alternative title
1. This Act may be cited as the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law).
R.S., c. F-27
FOOD AND DRUGS ACT
1993, c. 34, s. 71(3)
2. (1) The definition “device” in section 2 of the Food and Drugs Act is replaced by the following:
“device”« 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 »“label”
« 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;
“therapeutic product”« 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:
Therapeutic Products
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.
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.
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.
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.
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.
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.
Prohibition — selling
(3) Subject to subsection (5), no person shall sell a therapeutic product that the Minister orders them, or another person, to recall.
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.
Exception
(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.
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.
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.
Availability of orders
(2) The Minister shall ensure that any order made under any of sections 21.1 to 21.3 is publicly available.
Injunction
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.
Notice
(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.
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.
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).
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.
4. Section 21.4 of the Act is replaced by the following:
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.
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.
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.
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:
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):
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):
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:
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
1994, c. 47, s. 117
(6) Subsection 30(3) of the Act is replaced by the following:
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.
2004, c. 23, s. 2
(7) Subsection 30(5) of the Act is replaced by the following:
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.
2012, c. 19, s. 416
7. Subsection 30.5(1) of the Act is replaced by the following:
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.
1997, c. 6, s. 91
8. The portion of section 31 of the Act before paragraph (a) is replaced by the following:
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:
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.
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.
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.
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.
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.
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.
10. The portion of section 31.2 of the Act before paragraph (a) is replaced by the following:
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 21.32 is guilty of an offence and liable
11. The portion of section 31.4 of the Act before paragraph (a) is replaced by the following:
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 21.32 is guilty of an offence and liable
1996, c. 19, s. 78
12. Subsection 35(1) of the Act is replaced by the following:
Certificate of analyst
35. (1) Subject to this section, in any prosecution for an offence under any of sections 31 to 31.2 and 31.4, a certificate purporting to be signed by an analyst and stating that an article, sample or substance has been submitted to, and analysed or examined by, the analyst and stating the results of the analysis or examination is admissible in evidence and, in the absence of evidence to the contrary, is proof of the statements contained in the certificate without proof of the signature or official character of the person appearing to have signed it.
TRANSITIONAL PROVISION
Therapeutic product authorizations
13. The definition “therapeutic product authorization”, as enacted by subsection 2(3), applies to authorizations — including licences and suspended authorizations or licences — that were issued before the day on which this section comes into force and that authorize, as the case may be, the import, sale, advertisement, manufacture, preparation, preservation, packaging, labelling, storage or testing of a therapeutic product.
COORDINATING AMENDMENTS
Subsections 6(2) and (3)
14. (1) If subsection 6(2) comes into force before subsection 6(3), then the English version of subsection 6(3) is amended by replacing “paragraph (f)” with “paragraph (f.3)”.
(2) If subsection 6(3) comes into force before subsection 6(2), then the English version of subsection 6(2) is amended by
(a) striking out “striking out “and” at the end of paragraph (f) and by”; and
(b) striking out “and” at the end of the paragraph (f.3) of the Food and Drugs Act that it enacts.
(3) If subsections 6(2) and (3) come into force on the same day, then subsection 6(2) is deemed to have come into force before subsection 6(3) and subsection (1) applies as a consequence.
COMING INTO FORCE
Order in council
15. (1) Section 4, subsection 6(2) and sections 10 and 11 come into force on a day to be fixed by order of the Governor in Council.
Order in council
(2) Section 5 and subsections 6(3) and (4) come into force on a day to be fixed by order of the Governor in Council.
Published under authority of the Speaker of the House of Commons