C-393
Second Session, Fortieth 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
first reading, May 25, 2009
Ms. Wasylycia-Leis
402158
SUMMARY
This enactment amends the Patent Act and the Food and Drugs Act to make it easier to manufacture and export 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.
Also available on the Parliament of Canada Web Site at the following address:http://www.parl.gc.ca
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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
(c) sell the product or products for export to a country that is listed in the Schedule.
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.
SCHEDULE 
(Section 15)
SCHEDULE
(Section 21.03)
Afghanistan
Afghanistan
Albania
Albanie
Angola
Angola
Antigua and Barbuda
Antigua-et-Barbuda
Argentina
Argentine
Armenia
Arménie
Bahrain, Kingdom of
Bahreïn, Royaume de
Bangladesh
Bangladesh
Barbados
Barbade
Belize
Belize
Benin
Benin
Bhutan
Bhoutan
Bolivia
Bolivie
Botswana
Botswana
Brazil
Brésil
Brunei Darussalam
Brunéi Darussalam
Bulgaria
Bulgarie
Burkina Faso
Burkina Faso
Burundi
Burundi
Cambodia
Cambodge
Cameroon
Cameroun
Cape Verde
Cap-Vert
Central African Republic
République centrafricaine
Chad
Tchad
Chile
Chili
China
Chine
Chinese Taipei
Taipei chinois
Colombia
Colombie
Comoros
Comores
Congo
Congo
Costa Rica
Costa Rica
Côte d'Ivoire
Côte d'Ivoire
Croatia
Croatie
Cuba
Cuba
Cyprus
Chypre
Czech Republic
République tchèque
Democratic Republic of the Congo
République démocratique du Congo
Djibouti
Djibouti
Dominica
Dominique
Dominican Republic
République dominicaine
Ecuador
Équateur
Egypt
Égypte
El Salvador
El Salvador
Equatorial Guinea
Guinée équatoriale
Eritrea
Érythrée
Estonia
Estonie
Ethiopia
Éthiopie
Fiji
Fidji
Former Yugoslav Republic of Macedonia
Ex-République yougoslave de Macédoine
Gabon
Gabon
Gambia
Gambie
Georgia
Géorgie
Ghana
Ghana
Grenada
Grenade
Guatemala
Guatemala
Guinea
Guinée
Guinea-Bissau
Guinée-Bissau
Guyana
Guyana
Haiti
Haïti
Honduras
Honduras
Hong Kong, China
Hong Kong, Chine
Hungary
Hongrie
India
Inde
Indonesia
Indonésie
Israel
Israël
Jamaica
Jamaïque
Jordan
Jordanie
Kenya
Kenya
Kiribati
Kiribati
Korea
Corée
Kuwait
Koweït
Kyrgyz Republic
République kirghize
Lao People's Democratic Republic
République démocratique populaire lao
Latvia
Lettonie
Lesotho
Lesotho
Liberia
Libéria
Liechtenstein
Liechtenstein
Lithuania
Lituanie
Macao, China
Macao, Chine
Madagascar
Madagascar
Malawi
Malawi
Malaysia
Malaisie
Maldives
Maldives
Mali
Mali
Malta
Malte
Mauritania
Mauritanie
Mauritius
Maurice
Mexico
Mexique
Moldova
Moldova
Mongolia
Mongolie
Morocco
Maroc
Mozambique
Mozambique
Myanmar
Myanmar
Namibia
Namibie
Nepal
Népal
Nicaragua
Nicaragua
Niger
Niger
Nigeria
Nigéria
Oman
Oman
Pakistan
Pakistan
Panama
Panama
Papua New Guinea
Papouasie-Nouvelle-Guinée
Paraguay
Paraguay
Peru
Pérou
Philippines
Philippines
Poland
Pologne
Qatar
Qatar
Romania
Roumanie
Rwanda
Rwanda
Saint Kitts and Nevis
Saint-Kitts-et-Nevis
Saint Lucia
Sainte-Lucie
Saint Vincent and the Grenadines
Saint-Vincent-et-les-Grenadines
Samoa
Samoa
Sao Tome and Principe
Sao Tomé-et-Principe
Senegal
Sénégal
Sierra Leone
Sierra Leone
Singapore
Singapour
Slovak Republic
République slovaque
Slovenia
Slovénie
Solomon Islands
Îles Salomon
Somalia
Somalie
South Africa
Afrique du Sud
Sri Lanka
Sri Lanka
Sudan
Soudan
Suriname
Suriname
Swaziland
Swaziland
Thailand
Thaïlande
Timor-Leste
Timor-Leste
Togo
Togo
Trinidad and Tobago
Trinité-et-Tobago
Tunisia
Tunisie
Turkey
Turquie
Tuvalu
Tuvalu
Uganda
Ouganda
United Arab Emirates
Émirats arabes unis
United Republic of Tanzania
République-Unie de Tanzanie
Uruguay
Uruguay
Vanuatu
Vanuatu
Venezuela
Venezuela
Yemen
Yémen
Zambia
Zambie
Zimbabwe
Zimbabwe
Published under authority of the Speaker of the House of CommonsAvailable from:Publishing and Depository ServicesPublic Works and Government Services Canada