Bill C-398
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1st Session, 41st Parliament,
60-61 Elizabeth II, 2011-2012
house of commons of canada
BILL C-398
An Act to amend the Patent Act (drugs for international humanitarian purposes)
R.S., c. P-4
Her Majesty, by and with the advice and consent of the Senate and House of Commons, enacts as follows:
1. Section 21.01 of the Patent Act is replaced by the following:
Purpose
21.01 The purpose of sections 21.02 to 21.2 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 amended by replacing the definition “pharmaceutical product” with the following:
“pharmaceutical product” means any patented product listed in Schedule 1 in, if applicable, the dosage form, the strength and the route of administration specified in that Schedule in relation to the product and any other patented product, or product manufactured through a patented process, of the pharmaceutical sector needed to address public health problems, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics, and includes active ingredients necessary for its manufacture and diagnostic kits needed for its use.
3. Subsections 21.03(1) to (3) of the Act are replaced by the following:
Amending Schedule 1
21.03 (1) The Governor in Council may, by order, on the recommendation of the Minister and the Minister of Health, amend Schedule 1
(a) by adding the name of any patented product that may be used to address public health problems afflicting many developing and least-developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics and, if the Governor in Council considers it appropriate to do so, by adding one or more of the following in respect of the patented product, namely a dosage form, a strength and a route of administration; and
(b) by removing any entry listed in it.
Addition to Schedule 2
(2) 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 Schedule 2 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.
Removal from Schedule 2
(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 Schedule 2 to remove the name of a country if the country is not
(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.
4. (1) Subsection 21.04(1) of the Act is replaced by the following:
Authorization
21.04 (1) Subject to subsection (3), the Commissioner shall, on the application of any person and on the payment of the prescribed fee, authorize the person to make, construct and use a patented invention solely for purposes directly related to the manufacture of the pharmaceutical product named in the application and to sell it for export to one or more of the eligible importing countries listed in Schedule 2.
(2) Paragraph 21.04(2)(c) of the Act is repealed.
(3) Subsection 21.04(2) of the Act is amended by adding “and” at the end of paragraph (d) and by repealing paragraphs (e) and (f).
(4) Subparagraphs 21.04(3)(c)(i) and (ii) of the Act are replaced by the following:
(i) sought from the patentee or, if there is more than one, from each of the patentees, by certified or registered mail, a licence to manufacture and sell the pharmaceutical product for export to one or more of the eligible importing countries listed in Schedule 2 on reasonable terms and conditions and that such efforts have not been successful, and
(ii) provided the patentee, or each of the patentees, as the case may be, by certified or registered mail, in the written request for a licence, with the information that is in all material respects identical to the information referred to in subsection (2).
(5) Paragraph 21.04(3)(d) of the Act is repealed.
(6) Section 21.04 of the Act is amended by adding the following after subsection (3):
Solemn or statutory declaration not required
(4) Despite paragraph (3)(c), the solemn or statutory declaration referred to in that paragraph is not required in the case of an application to the Commissioner for an authorization to supply the product named in the application to one or more of the eligible importing countries listed in Schedule 2 for purposes of addressing a national emergency or other circumstances of extreme urgency in one or more of those countries or for purposes of public non-commercial use, but, in any such case, the authorization shall be limited to those purposes and the Commissioner shall notify the patentee or patentees of the issuance of the authorization as soon as reasonably practicable after it has been issued.
Conditions for export
(5) The holder of an authorization may export the product named in the authorization to the extent necessary to meet the needs of any country listed in Schedule 2 provided that
(a) in the case of a WTO Member, the Member has notified the TRIPS Council in accordance with the General Council Decision; or
(b) in the case of a country that is not a WTO Member, the country has provided written notice to the Government of Canada through diplomatic channels that the country has granted or intends to grant the necessary authorization under its domestic law to permit the legal importation, use and sale of that product within its territory by a person other than the patentee or patentees, as the case may be.
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. Section 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 or WTO Member to which it is to be exported, the quantities being exported to each country or WTO Member and the distinguishing features of the product, and of its label and packaging, as required by regulations made under the Food and Drugs Act, as well as information identifying every known party that will be handling the product while it is in transit from Canada to the country or WTO Member to which it is to be exported.
Information to be posted
(1.1) Before exporting a product manufactured under an authorization, the holder of the authorization must post on the website
(a) in the case of export to a WTO Member, a copy of the notification to the TRIPS Council by that Member in accordance with the General Council Decision; or
(b) in the case of export to a country that is not a WTO Member,
(i) a solemn or statutory declaration in the prescribed form by the holder of the authorization stating that the product is not patented in that country, or
(ii) a copy of the written notice referred to in paragraph 21.04(5)(b) that the country has provided to the Government of Canada through diplomatic channels.
7. Paragraph 21.07(b) of the Act is replaced by the following:
(b) the country or WTO Member to which the product is to be exported;
8. (1) Paragraph 21.13(a) of the Act is replaced by the following:
(a) the expiry of the period referred to in section 21.09 in respect of the authorization,
(2) Paragraph 21.13(c) of the Act is repealed.
(3) Subparagraph 21.13(d)(ii) of the Act is replaced by the following:
(ii) the name of the country or WTO Member to which the pharmaceutical product was, or is to be, exported is removed from Schedule 2, and
9. (1) Paragraph 21.14(g) of the Act is replaced by the following:
(g) the product was exported, other than in the normal course of transit, to a country or WTO Member not listed in Schedule 2; or
(2) Paragraph 21.14(h) of the Act is repealed.
10. 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
11. Section 21.19 of the Act is replaced by the following:
Website for notices to Canada
21.19 The Government of Canada shall maintain a public website on which it posts, immediately upon receipt, a copy of every written notice referred to in paragraph 21.04(5)(b) with which it has been provided.
12. Schedule 1 to the Act is amended by replacing the reference “(Definition “pharmaceutical product” in section 21.02 and paragraph 21.03(1)(a))” after the heading “SCHEDULE 1” with the reference “(Definition “pharmaceutical product” in section 21.02 and subsection 21.03(1))”.
13. Schedules 2 to 4 of the Act are replaced by the schedule set out in the schedule to this Act.