Bill C-56

If you have any questions or comments regarding the accessibility of this publication, please contact us at accessible@parl.gc.ca.

First Reading

PDF

	(a) if there is only one patentee, to the patentee, within the prescribed time, a royalty in an amount equal to two per cent of the value of the pharmaceutical products exported under the authorization; or
	(b) if there is more than one patentee, to each patentee within the prescribed time, a royalty in an amount equal to two per cent of the value of the pharmaceutical products exported under the authorization divided by the number of patentees.
Value	(2) For the purposes of paragraphs (1)(a) and (b), the value of the pharmaceutical products exported under the authorization is to be determined by reference to the terms of the agreement between the holder of the authorization and the government of the country or WTO Member, as the case may be, or the agent of that government, under which those products are to be manufactured and sold for export.
Duration	21.09 The use of a patented invention authorized by subsection 21.05(1) is authorized for a period of two years, or if another period is prescribed, for that other period, beginning on the date that the authorization is granted.
Use is non-exclusive	21.1 The use of a patented invention authorized by subsection 21.05(1) is non-exclusive.
Authorization is non-transfera ble	21.11 An authorization is non-transferable, except as permitted by paragraph 31(e) of the TRIPS Agreement.
Renewal	21.12 The Commissioner shall, on the application of the person to whom an authorization was granted and on the payment of the prescribed fee, renew the authorization if the person certifies under oath in the renewal application that the quantities of the pharmaceutical product authorized to be exported were not exported before the expiry of the authorization and that the person has complied with the terms of the authorization and the requirements of sections 21.07 and 21.08.
Termination	21.13 Subject to section 21.14, an authorization ceases to have effect on the earlier of
	(a) the expiry of the applicable period referred to in section 21.09 in respect of the authorization,
	(b) the day on which the Commissioner sends, by registered mail, to the holder of the authorization a copy of a notice sent by the Minister of Health notifying the Commissioner that the Minister of Health is of the opinion that the pharmaceutical product referred to in paragraph 21.05(3)(b) has ceased to meet the requirements of the Food and Drugs Act and its regulations,
	(c) the day on which the last of the pharmaceutical product authorized by the authorization to be exported is actually exported,
	(d) sixty days after the day on which
	(i) the name of the pharmaceutical product authorized to be exported by the authorization is removed from Schedule 1, or
	(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, 3 or 4, as the case may be, and not added to any other of those Schedules, and
	(e) on any other day that is prescribed.
Termination by Federal Court	21.14 On the application of a patentee, and on notice given by the patentee to the person to whom an authorization was granted, the Federal Court may make an order, on any terms that it considers appropriate, terminating the authorization if the patentee establishes that
	(a) the application for the authorization contained any material information that is inaccurate;
	(b) the holder of the authorization has failed to establish a website as required by section 21.07 or has failed to disclose on that website the information required to be disclosed by that section;
	(c) the holder of the authorization has failed to pay, within the required time, any royalty required to be paid as a result of the authorization; or
	(d) the product exported to the country or WTO Member, as the case may be, under the authorization has been, with the knowledge of the holder of the authorization, re-exported in a manner that is contrary to the General Council Decision and in quantities that are significant, considering the quantities originally exported.
Notice to patentee	21.15 The Commissioner shall, without delay, notify the patentee, or each of the patentees, as the case may be, in writing of any authorization granted in respect of the patentee's invention.
Advisory committee	21.16 The Governor in Council, on the recommendation of the Minister and of the Minister of Health, may establish an advisory committee to advise the Governor in Council on products to be listed in Schedule 1.
Review	21.17 (1) A review of sections 21.01 to 21.16 and their application must be completed by the Minister three years after this section comes into force.
Tabling of report	(2) The Minister must cause a report of the results of the review to be laid before each House of Parliament on any of the first fifteen days on which that House is sitting after the report has been completed.
R.S., c. F-27	FOOD AND DRUGS ACT
	2. Section 30 of the Food and Drugs Act is amended by adding the following after subsection (4):
Regulations to implement the General Council Decision	(5) Without limiting or restricting the authority conferred by any other provisions of this Act or any of its Parts for carrying into effect the purposes and provisions of this Act or any of its Parts, the Governor in Council may make any regulations that the Governor in Council considers necessary for the purpose of implementing the General Council Decision.
Definitions	(6) The definitions in this subsection apply in this subsection and in subsection (5).
``General Council '' « Conseil général »	``General Council'' means the General Council of the WTO established by paragraph 2 of Article IV of the Agreement Establishing the World Trade Organization, signed at Marrakesh on April 15, 1994.
``General Council Decision'' « décision du Conseil général »	``General Council Decision'' means the decision of the General Council of August 30, 2003 respecting Article 31 of the TRIPS Agreement, including the interpretation of that decision in the General Council Chairperson's statement of that date.
``TRIPS Agreement'' « Accord sur les ADPIC »	``TRIPS Agreement'' means the Agreement on Trade-Related Aspects of Intellectual Property Rights, being Annex 1C of the Agreement Establishing the World Trade Organization, signed at Marrakesh on April 15, 1994.
``WTO'' « OMC »	``WTO'' means the World Trade Organization established by Article I of the Agreement Establishing the World Trade Organization, signed at Marrakesh on April 15, 1994.
	3. Section 37 of the Act is amended by adding the following after subsection (1):
Exception - General Council Decision	(2) Despite subsection (1), this Act applies in respect of any drug or device to be manufactured for the purpose of being exported in accordance with the General Council Decision, as defined in subsection 30(6), and the requirements of the Act and the regulations apply to the drug or device as though it were a drug or device to be manufactured and sold for consumption in Canada, unless the regulations provide otherwise.
	COMING INTO FORCE
Coming into force	4. This Act comes into force on a day to be fixed by order of the Governor in Council.

Bill C-56

FOOD AND DRUGS ACT

COMING INTO FORCE