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Bill C-393

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First Reading

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2nd Session, 40th Parliament,

57-58 Elizabeth II, 2009

house of commons of canada

BILL C-393

An Act to amend the Patent Act (drugs for international humanitarian purposes) and to make a consequential amendment to another Act

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

R.S., c. P-4

PATENT ACT

1. Section 21.01 of the Patent Act is replaced by the following:

Purpose

21.01 The purpose of sections 21.02 to 21.16 is to facilitate access to pharmaceutical products to address public health problems afflicting many developing and least-developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics.

2. Section 21.02 of the Act is replaced by the following:

Definitions

210.02 The definitions in this section apply in sections 21.01 to 21.16.

“authorization”
« autorisation »

“authorization” means an authorization granted under subsection 21.04(1).

“pharmaceutical product”
« produit pharmaceutique »

“pharmaceutical product” means any drug, as defined in section 2 of the Food and Drugs Act, and includes monitoring products and products used in conjunction with a pharmaceutical product.

3. (1) Subsections 21.03(1) and (2) of the Act are replaced by the following:

Amending Schedule

21.03 (1) The Governor in Council may, by order, on the recommendation of the Minister of Foreign Affairs, the Minister for International Trade and the Minister for International Cooperation, amend the Schedule to add the name of a country if the country is

(a) recognized by the United Nations as being a least-developed country; or

(b) named on the Organization for Economic Co-operation and Development's list of countries that are eligible for official development assistance.

(2) Subsection 21.03(3) of the Act is replaced by the following:

Removal from Schedule

(3) The Governor in Council may, by order, on the recommendation of the Minister of Foreign Affairs, the Minister for International Trade and the Minister for International Cooperation, amend the Schedule to remove the name of a country if the country is neither

(a) recognized by the United Nations as being a least-developed country; nor

(b) named on the Organization for Economic Co-operation and Development's list of countries that are eligible for official development assistance.

4. (1) Subsection 21.04(1) of the Act is replaced by the following:

Authorization

21.04 (1) Subject to subsections (3) and (4), the Commissioner shall, on the application of any person and on the payment of the prescribed fee, authorize the person to

(a) manufacture the pharmaceutical product or products named in the application;

(b) make, construct and use any patented invention solely for the purpose of manufacturing the product or products; and

Authorization

(1.1) In addition to what is authorized under subsection (1), an authorization under that subsection authorizes the person to

(a) manufacture any active ingredient used in the manufacture of a finished product; and

(b) make, construct and use any patented invention solely for the purpose of manufacturing any active pharmaceutical ingredient used in the manufacture of a finished product.

Continuation if country removed from Schedule

(1.2) If a country is removed from the Schedule an authorization continues to apply with respect to that country for 30 days as though that country had not been removed from the Schedule.

(2) Subsection 21.04(2) of the Act is amended by adding “and” at the end of paragraph (a) and by repealing paragraphs (b) to (f).

(3) Subsection 21.04(3) of the Act is replaced by the following:

Conditions for granting of authorization

(3) The Commissioner shall grant an authorization only if the applicant has complied with the prescribed requirements.

5. Section 21.05 of the Act is replaced by the following:

Form and content of authorization

21.05 The authorization must be in the prescribed form and contain the prescribed information.

Labelling requirements

21.051 The holder of an authorization shall ensure that all products manufactured under the authorization are labelled in accordance with the prescribed requirements.

6. Subsection 21.06(1) of the Act is replaced by the following:

Disclosure of information on website

21.06 (1) Before exporting a product manufactured under an authorization, the holder of the authorization must establish a website on which is disclosed the prescribed information respecting the name of the product, the name of the country to which it is to be exported, and the distinguishing features of the product, and of its label and packaging.

7. Section 21.07 of the Act is repealed.

8. (1) Subsections 21.08(1) and (2) of the Act are replaced by the following:

Royalty

21.08 (1) Subject to subsection (3), on the occurrence of a prescribed event, the holder of an authorization is required to pay to the patentee or each patentee, as the case may be, a royalty determined in the prescribed manner.

Factors to consider when making regulations

(2) In making regulations for the purposes of subsection (1), the Governor in Council must consider the humanitarian purposes underlying the issuance of authorizations under subsection 21.04(1).

(2) Subsections 21.08(4) to (7) of the Act are repealed.

9. Section 21.09 of the Act is repealed.

10. Section 21.12 of the Act is repealed.

11. Section 21.13 of the Act is replaced by the following:

Relinquishment of authorization by holder

21.13 (1) A holder of an authorization may relinquish the authorization by giving written notice to the Commissioner.

Effect

(2) The authorization ceases to be valid when notice is given to the Commissioner under subsection (1).

Notice to patentee

(3) If an authorization in respect of a patentee's invention is relinquished, the Commissioner shall, without delay, notify the patentee in writing.

12. (1) Paragraph 21.14(a) of the Act is replaced by the following:

(a) the holder of the authorization has failed to comply with section 21.051;

(2) Paragraph 21.14(c) of the Act is repealed.

(3) Paragraphs 21.14(f) to (i) of the Act are replaced by the following:

(f) the product exported under the authorization has been, with the consent of the holder of the authorization, re-exported to a country that is not listed in the Schedule; or

(g) the product was exported, other than in the normal course of transit, to a country that is not listed in the Schedule.

(4) Section 21.14 of the Act is renumbered as subsection 21.14(1) and is amended by adding the following:

Relevant regional trade agreements

(2) Paragraph (1)(g) does not apply if a product is exported to a party to a relevant regional trade agreement that is not listed in the Schedule for re-export to parties to the agreement that are listed in the Schedule.

Relevant regional trade agreements

(3) An agreement is a relevant regional trade agreement for the purposes of subsection (2) if

(a) at least half the parties to the agreement are listed in the Schedule; and

(b) the agreement provides for trade in the product.

Suspension of application

(4) If an application is made under paragraphs (1)(a) to (e), the Federal Court may, on written request by the holder of the authorization, suspend its consideration of the application for a period of not more than thirty days to allow the holder to take whatever measures are necessary to remedy any deficiency identified in the application. If the holder remedies all of the deficiencies identified in the application within the time period prescribed by the Court, the Court shall dismiss the application.

13. The portion of subsection 21.16(1) of the Act before paragraph (b) is replaced by the following:

Obligation to provide copy of agreement

21.16 (1) Within fifteen days after entering into an agreement for the sale of a product to which the authorization relates, the holder of an authorization must provide by certified or registered mail, the Commissioner and the patentee, or each patentee, as the case may be, with

(a) a copy of the agreement; and

14. Sections 21.17 to 21.2 of the Act are repealed.

15. Schedules 1 to 4 of the Act are replaced by the schedule set out in the schedule to this Act.

R.S., c. F-27

FOOD AND DRUGS ACT

16. Subsection 37(2) of the Food and Drugs Act is replaced by the following:

Exception

(2) This section does not apply with respect to a product manufactured or sold under an authorization granted under subsection 21.04(1) of the Patent Act.

17. The Act is amended by adding the following after section 37:

Pharmaceutical products — international humanitarian purposes

38. (1) This section applies with respect to a product manufactured or sold under an authorization granted under subsection 21.04(1) of the Patent Act.

Part 1 not to apply

(2) Part 1 does not apply with respect to a product described in subsection (1).

Requirements for export

(3) No person shall export a product described in subsection (1) unless one of the following requirements is satisfied:

(a) the Minister has confirmed, in writing, that the product meets the requirements that would be applicable under this Act if Part 1 applied with respect to the product;

(b) the drug regulatory authority of the country to which the product is to be exported has given written approval of the product;

(c) a drug regulatory authority of another jurisdiction has given written approval of the product and the government of the country to which the product is to be exported has indicated, in writing, that such approval is satisfactory;

(d) a drug regulatory authority of another jurisdiction has given written approval of the product and the Minister has indicated, in writing, that in the Minister's view the requirements applied by that authority are at least as stringent as the requirements under this Act; or

(e) the product has been approved, in writing, under the Prequalification Programme of the World Health Organization.

Determination by Minister

(4) Upon request by a person who has filed or intends to file an application for an authorization under subsection 21.04(1) of the Patent Act with respect to a product, the Minister shall determine whether the product meets the requirements that would be applicable under this Act if Part 1 applied with respect to the product.