Bill C-83

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C-83

First Session, Thirty-eighth Parliament,

53-54 Elizabeth II, 2004-2005

HOUSE OF COMMONS OF CANADA

BILL C-83

An Act to amend the Food and Drugs Act (drug export restrictions)

first reading, November 25, 2005

THE MINISTER OF HEALTH

90361

SUMMARY

The purpose of this enactment is to protect an adequate supply of safe and affordable drugs for Canadians. The enactment amends the Food and Drugs Act to

(a) enable the Minister of Health to prohibit, by order, the export of a drug or class of drugs if the Minister is of the opinion that there is a shortage or likely shortage of a drug or class of drugs and an order is necessary to protect human health;

(b) enable the Minister to compel manufacturers, importers, exporters and sellers to provide information that the Minister may require for the purpose of exercising the Minister’s power to prohibit exports;

(d) increase the maximum penalties available under that Act.

Also available on the Parliament of Canada Web Site at the following address:
http://www.parl.gc.ca

1st Session, 38th Parliament,

53-54 Elizabeth II, 2004-2005

house of commons of canada

BILL C-83

An Act to amend the Food and Drugs Act (drug export restrictions)

R.S., c. F-27

Her Majesty, by and with the advice and consent of the Senate and House of Commons of Canada, enacts as follows:

1. Section 2 of the Food and Drugs Act is amended by adding the following in alphabetical order:

“record”
« registre »

“record” includes any material on which data are recorded, marked or stored and which is capable of being read or understood by a person or a computer system or other device.

2. The Act is amended by adding the following after section 21:

PART I.1

EXPORT RESTRICTION

Order

21.1 (1) If, in the opinion of the Minister, there is a shortage or there is likely to be a shortage of a drug or class of drugs, the Minister may, by order, prohibit any or all of the following if, in the opinion of the Minister, it is necessary in order to protect human health:

(a) the sale for export from Canada, on a retail basis, of the drug or class of drugs;

(b) the sale for export from Canada, on a wholesale basis, of the drug or class of drugs;

(d) the advertising for export from Canada, on a retail or wholesale basis, of the drug or class of drugs.

Drugs or class of drugs

(2) An order made under subsection (1) may only be made in respect of a drug or class of drugs that

(a) is manufactured, imported or sold for consumption in Canada; and

(b) is prescribed under paragraph 30(1)(d.1).

Additional measures

(3) If the Minister is of the opinion that an order or orders under subsection (1) may not be sufficient to protect human health in the event of a shortage or a likely shortage of a drug or class of drugs, the Minister may, by order, suspend the application of subsection 37(1) with respect to any drug or class of drugs and prohibit either or both of the following:

(a) the export from Canada, on any basis, of the drug or class of drugs; and

(b) the advertising for export from Canada of the drug or class of drugs.

Subsection 37(2)

(4) An order made under subsection (1) or (3) does not apply with respect to any supply of a drug manufactured for the purpose of being exported in accordance with subsection 37(2).

Renewal

(5) The Minister may, by order, renew an order for a further period or periods of no more than 90 days each if, in the opinion of the Minister, the shortage or the likelihood of a shortage of a drug or class of drugs continues to exist and the renewal of the order is necessary in order to protect human health.

Duration

(6) An order made under this section has effect from the time it is made but ceases to have effect on the earliest of

(a) 14 days after it is made, unless it is approved by the Governor in Council,

(b) the day on which it is repealed,

(c) in the case of an order made under subsection (1) or (3), 180 days after it is made or any shorter period that may be specified in it, and

(d) in the case of an order made under subsection (5), 90 days after it is made or any shorter period that may be specified in it.

Exemption from Statutory Instruments Act

21.2 (1) An order made under section 21.1

(a) is exempt from the application of sections 3, 5 and 11 of the Statutory Instruments Act; and

(b) shall be published in the Canada Gazette as soon as possible but in any case not later than 23 days after it is made.

Contravention of unpublished order

(2) No person shall be convicted of an offence consisting of a contravention of an order that, at the time of the alleged contravention, had not been published in the Canada Gazette unless it is proved that, at the time of the alleged contravention, the person had been notified of the order or reasonable steps had been taken to bring the purport of the order to the notice of those persons likely to be affected by it.

Tabling of order

(3) A copy of each order must be tabled in each House of Parliament within 15 days after it is made.

House not sitting

(4) In order to comply with subsection (3), the order may be sent to the Clerk of the House if the House is not sitting.

Request for reconsideration

21.3 (1) Any person may request that an order made under section 21.1 be reconsidered by submitting a request in writing to the Minister within 60 days after the day on which the order is published in the Canada Gazette.

Documentary evidence

(2) A request for reconsideration must include documentary evidence in support of the request and must comply with any prescribed requirements.

Minister’s response

(3) Unless the order in respect of which the request is made is repealed or expires within 30 days after the receipt of the request, the Minister shall, within that period, respond in writing to the person who made the request.

Information

21.4 A person who manufactures, sells, imports or exports a drug that has been prescribed under paragraph 30(1)(d.1) shall provide to the Minister, on the Minister’s request, any information that the Minister may require for the purposes of section 21.1 that is in the person’s possession or is reasonably available to them.

Prohibitions

21.5 (1) No person shall export or sell a drug for export from Canada, or advertise a drug for export from Canada, in contravention of an order made under subsection 21.1(1), (3) or (5).

Exception

(2) Subsection (1) does not apply in respect of the export of a drug by, or the sale of a drug to,

(a) a Canadian citizen or permanent resident within the meaning of subsection 2(1) of the Immigration and Refugee Protection Act if the drug is for their use or the use of a dependant and the quantity of drug sold or exported, as the case may be, does not exceed the quantity required for a 90-day period;

(b) an officer or a servant of Her Majesty in right of Canada or a member of the Canadian Forces if the drug is for their use or the use of an accompanying dependant and the officer, servant or member will be absent from Canada in the course of their duties; or

(c) any other individual in Canada if the drug is for the use of the individual or an accompanying dependant and the quantity of drug sold or exported, as the case may be, does not exceed the quantity required for a 90-day period.

Sentencing

(3) If a person is convicted, or discharged under section 730 of the Criminal Code, of contravening this section, the court sentencing or discharging the person shall, in addition to considering any other relevant factors, consider the amount of any profit that was made or would have been made as a result of the commission of the offence.

R.S., c. 31 (1st Supp.), s. 11(1)

3. (1) The portion of subsection 23(1) of the Act before paragraph (a.1) is replaced by the following:

Powers of inspectors

23. (1) Subject to subsection (1.1), an inspector may at any reasonable time enter any place where the inspector believes on reasonable grounds any article to which this Act or the regulations apply is manufactured, prepared, preserved, packaged, sold, imported, exported or stored, and may

(a) examine any such article and take samples of it, and examine anything that the inspector believes on reasonable grounds is used or capable of being used for that manufacture, preparation, preservation, packaging, selling, importing, exporting or storing;

(2) Paragraphs 23(1)(c) and (d) of the Act are replaced by the following:

(c) examine and make copies of, or extracts from, any record found in any place referred to in this subsection that the inspector believes on reasonable grounds contains any information relevant to the enforcement of this Act with respect to any article to which this Act or the regulations apply;

(d) seize and detain for any time that may be necessary any article or record by means of or in relation to which the inspector believes on reasonable grounds any provision of this Act or the regulations has been contravened;

(e) use or cause to be used any computer or data processing system at the place to examine any data contained in or available to the computer or data processing system;

(f) reproduce any record or cause it to be reproduced from the data in the form of a printout or other intelligible output;

(g) take a printout or other output for examination or copying; and

(h) use or cause to be used any copying equipment at the place to make copies of the record.

(3) Paragraph 23(2)(b) of the Act is replaced by the following:

(b) anything used for the manufacture, preparation, preservation, packaging, selling, importing, exporting or storing of a food, drug, cosmetic or device; and

(4) Section 23 of the Act is amended by adding the following after subsection (3):

Duties of persons required to maintain records

(4) A person who is required under the regulations to maintain records shall

(a) on the request of an inspector, provide or make those records available to the inspector or another inspector;

(b) give an inspector all reasonable assistance and furnish the inspector with any information the inspector may reasonably require;

(c) keep those records at the person’s place of business or residence in Canada or at any other place that may be designated by the Minister; and

(d) not falsify or unlawfully alter, destroy, erase or obliterate those records.

Inspector may require measures

(5) If an inspector has reasonable grounds to believe that a person has contravened or will contravene this Act or the regulations, the inspector may require the person to

(a) refrain from doing anything in contravention of this Act or the regulations, or do anything to comply with this Act or the regulations;

(b) cease the operation of any activity or any part of a work, undertaking or thing until the inspector is satisfied that the activity, work, undertaking or thing will be operated in accordance with this Act and the regulations; and

(c) take any other measures that the inspector considers necessary to prevent further contravention of this Act or the regulations.

Duration of requirement

(6) A requirement under subsection (5) may apply for a specified period or until the inspector is satisfied that no further contravention is likely to take place.

Notice

(7) A requirement under subsection (5) shall be communicated by delivering a written notice to the person referred to in that subsection and the notice must be accompanied by a statement of the reasons for the requirement.

Prosecutions

(8) A requirement under subsection (5) may be imposed whether or not the person has been charged with an offence relating to the contravention, but if the person is charged, the requirement may be confirmed, varied or rescinded by the court that tries the offence.

4. (1) Subsection 30(1) of the Act is amended by adding the following after paragraph (d):

(d.1) prescribing any drug or class of drug for the purpose of subsection 21.1(2);

(2) Paragraph 30(1)(f) of the Act is replaced by the following:

(f) requiring persons who sell food, drugs, cosmetics or devices to maintain the records that the Governor in Council considers necessary for the proper enforcement and administration of this Act and the regulations;

(f.1) requiring persons who sell drugs to provide to the Minister, on the Minister’s request, any record that they are required to maintain under this Act or the regulations;

(3) Section 30 of the Act is amended by adding the following after subsection (2):

Regulations re Part I.1

(2.1) Without limiting or restricting the authority conferred by any other provisions of this Act or any Part of it for carrying into effect the purposes and provisions of this Act or any Part, the Governor in Council may make any regulations that the Governor in Council considers necessary for the purpose of carrying the purposes and provisions of Part I.1 into effect.

5. Paragraphs 31(a) and (b) of the Act are replaced by the following:

(a) on summary conviction for a first offence to a fine not exceeding $100,000 or to imprisonment for a term not exceeding six months or to both and, for a subsequent offence, to a fine not exceeding $250,000 or to imprisonment for a term not exceeding 18 months or to both; and

(b) on conviction on indictment to a fine in the discretion of the court or to imprisonment for a term not exceeding three years or to both.

6. The Act is amended by adding the following after section 31.1:

Continuing offences

31.2 A person who commits or continues an offence on more than one day is liable to be convicted for a separate offence for each day on which the offence is committed or continued.

1993, c. 34, s. 73

7. Subsection 37(1) of the Act is replaced by the following:

Conditions under which exports exempt

37. (1) Subject to an order made under subsection 21.1(3), this Act does not apply to any packaged food, drug, cosmetic or device, not manufactured for consumption in Canada and not sold for consumption in Canada, if the package is marked in distinct overprinting with the word “Export” or “Exportation” and a certificate that the package and its contents do not contravene any known requirement of the law of the country to which it is or is about to be consigned has been issued in respect of the package and its contents in prescribed form and manner.

Coming into force

8. This Act comes 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

Available from:
Publishing and Depository Services
Public Works and Government Services Canada

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