Bill C-523
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C-523
First Session, Forty-first Parliament,
60-61-62 Elizabeth II, 2011-2012-2013
HOUSE OF COMMONS OF CANADA
BILL C-523
An Act to amend the Department of Health Act (disclosure of drug shortages)
first reading, June 4, 2013
Mrs. Sellah
411719
SUMMARY
This enactment amends the Department of Health Act to oblige drug suppliers to advise the Minister of any interruption or cessation of the production, distribution or importation of drugs and to oblige the Minister to prepare and implement an emergency response plan to address shortages of drugs.
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http://www.parl.gc.ca
http://www.parl.gc.ca
1st Session, 41st Parliament,
60-61-62 Elizabeth II, 2011-2012-2013
house of commons of canada
BILL C-523
An Act to amend the Department of Health Act (disclosure of drug shortages)
Her Majesty, by and with the advice and consent of the Senate and House of Commons of Canada, enacts as follows:
SHORT TITLE
Short title
1. This Act may be cited as the Mandatory Disclosure of Drug Shortages Act.
1996, c. 8
DEPARTMENT OF HEALTH ACT
2. The Department of Health Act is amended by adding the following after section 4.2:
Definition of “supplier”
4.3 (1) For the purpose of this section, “supplier” means a manufacturer, wholesaler, distributor or importer of drugs.
Notification of interruption of production, distribution or importation
(2) The supplier shall notify the Minister of any planned or foreseeable interruption of the production, distribution or importation of a drug at least six months in advance.
Notification of unexpected interruption
(3) In the case of an unexpected interruption of the production, distribution or importation of a drug, the supplier shall notify the Minister as soon as possible.
Notification of production, distribution or importation cessation
(4) A supplier who intends to cease produc-ing, distributing or importing a drug shall notify the Minister at least 12 months in advance.
Emergency response plan
4.4 The Minister shall, in cooperation with the provincial authorities, coordinate efforts to prevent and address shortages of drugs, inform, as necessary, patients and health care providers of possible shortages, and prepare and implement an emergency response plan to address any shortage of a drug that the Minister considers necessary for public health.
3. The Act is amended by adding the following after section 11:
Offence —s. 4.3(2) or (4)
11.01 (1) Any person who voluntarily contravenes subsection 4.3(2) or (4) is guilty of an offence and liable on summary conviction to a fine of not more than $1,800,000.
Offence —s. 4.3(3)
(2) Any person who voluntarily contravenes subsection 4.3(3) is guilty of an offence and liable on summary conviction to a fine of not more than $10,000 for each day on which the offence is committed or continued and not more than $1,800,000 in total.
TRANSITIONAL PROVISION
4. The emergency response plan referred to in section 4.4 of the Department of Health Act, as enacted by section 2, must be prepared within 18 months after the day on which this Act receives royal assent.
Published under authority of the Speaker of the House of Commons