79. (1) In this section and in sections 80 to 103,

“Board” means the Patented Medicine Prices Review Board continued by section 91;

“Consumer Price Index” means the Consumer Price Index published by Statistics Canada under the authority of the Statistics Act;

“Minister” means the Minister of Health or such other Member of the Queen’s Privy Council for Canada as is designated by the Governor in Council as the Minister for the purposes of this section and sections 80 to 103;

“patentee”, in respect of an invention pertaining to a medicine, means the person for the time being entitled to the benefit of the patent for that invention and includes, where any other person is entitled to exercise any rights in relation to that patent other than under a licence continued by subsection 11(1) of the Patent Act Amendment Act, 1992, that other person in respect of those rights;

“regulations” means regulations made under section 101.

(2) For the purposes of subsection (1) and sections 80 to 101, an invention pertains to a medicine if the invention is intended or capable of being used for medicine or for the preparation or production of medicine.

1993, c. 2, s. 7; 1996, c. 8, s. 32.

80. (1) A patentee of an invention pertaining to a medicine shall, as required by and in accordance with the regulations, provide the Board with such information and documents as the regulations may specify respecting

(a) the identity of the medicine;

(b) the price at which the medicine is being or has been sold in any market in Canada and elsewhere;

(c) the costs of making and marketing the medicine, where that information is available to the patentee in Canada or is within the knowledge or control of the patentee;

(d) the factors referred to in section 85; and

(e) any other related matters.

(2) Subject to subsection (3), a person who is a former patentee of an invention pertaining to a medicine shall, as required by and in accordance with the regulations, provide the Board with such information and documents as the regulations may specify respecting

(a) the identity of the medicine;

(b) the price at which the medicine was sold in any market in Canada and elsewhere during the period in which the person was a patentee of the invention;

(c) the costs of making and marketing the medicine produced during that period, whether incurred before or after the patent was issued, where that information is available to the person in Canada or is within the knowledge or control of the person;

(d) the factors referred to in section 85; and

(e) any other related matters.

(3) Subsection (2) does not apply to a person who has not been entitled to the benefit of the patent or to exercise any rights in relation to the patent for a period of three or more years.

1993, c. 2, s. 7.

81. (1) The Board may, by order, require a patentee or former patentee of an invention pertaining to a medicine to provide the Board with information and documents respecting

(a) in the case of a patentee, any of the matters referred to in paragraphs 80(1)(a) to (e);

(b) in the case of a former patentee, any of the matters referred to in paragraphs 80(2)(a) to (e); and

(c) such other related matters as the Board may require.

(2) A patentee or former patentee in respect of whom an order is made under subsection (1) shall comply with the order within such time as is specified in the order or as the Board may allow.

(3) No order may be made under subsection (1) in respect of a former patentee who, more than three years before the day on which the order is proposed to be made, ceased to be entitled to the benefit of the patent or to exercise any rights in relation to the patent.

1993, c. 2, s. 7.

82. (1) A patentee of an invention pertaining to a medicine who intends to sell the medicine in a market in Canada in which it has not previously been sold shall, as soon as practicable after determining the date on which the medicine will be first offered for sale in that market, notify the Board of its intention and of that date.

(2) Where the Board receives a notice under subsection (1) from a patentee or otherwise has reason to believe that a patentee of an invention pertaining to a medicine intends to sell the medicine in a market in Canada in which the medicine has not previously been sold, the Board may, by order, require the patentee to provide the Board with information and documents respecting the price at which the medicine is intended to be sold in that market.

(3) Subject to subsection (4), a patentee in respect of whom an order is made under subsection (2) shall comply with the order within such time as is specified in the order or as the Board may allow.

(4) No patentee shall be required to comply with an order made under subsection (2) prior to the sixtieth day preceding the date on which the patentee intends to first offer the medicine for sale in the relevant market.

1993, c. 2, s. 7.

83. (1) Where the Board finds that a patentee of an invention pertaining to a medicine is selling the medicine in any market in Canada at a price that, in the Board’s opinion, is excessive, the Board may, by order, direct the patentee to cause the maximum price at which the patentee sells the medicine in that market to be reduced to such level as the Board considers not to be excessive and as is specified in the order.

(2) Subject to subsection (4), where the Board finds that a patentee of an invention pertaining to a medicine has, while a patentee, sold the medicine in any market in Canada at a price that, in the Board’s opinion, was excessive, the Board may, by order, direct the patentee to do any one or more of the following things as will, in the Board’s opinion, offset the amount of the excess revenues estimated by it to have been derived by the patentee from the sale of the medicine at an excessive price:

(a) reduce the price at which the patentee sells the medicine in any market in Canada, to such extent and for such period as is specified in the order;

(b) reduce the price at which the patentee sells one other medicine to which a patented invention of the patentee pertains in any market in Canada, to such extent and for such period as is specified in the order; or

(c) pay to Her Majesty in right of Canada an amount specified in the order.

(3) Subject to subsection (4), where the Board finds that a former patentee of an invention pertaining to a medicine had, while a patentee, sold the medicine in any market in Canada at a price that, in the Board’s opinion, was excessive, the Board may, by order, direct the former patentee to do any one or more of the following things as will, in the Board’s opinion, offset the amount of the excess revenues estimated by it to have been derived by the former patentee from the sale of the medicine at an excessive price:

(a) reduce the price at which the former patentee sells a medicine to which a patented invention of the former patentee pertains in any market in Canada, to such extent and for such period as is specified in the order; or

(b) pay to Her Majesty in right of Canada an amount specified in the order.

(4) Where the Board, having regard to the extent and duration of the sales of the medicine at an excessive price, is of the opinion that the patentee or former patentee has engaged in a policy of selling the medicine at an excessive price, the Board may, by order, in lieu of any order it may make under subsection (2) or (3), as the case may be, direct the patentee or former patentee to do any one or more of the things referred to in that subsection as will, in the Board’s opinion, offset not more than twice the amount of the excess revenues estimated by it to have been derived by the patentee or former patentee from the sale of the medicine at an excessive price.

(5) In estimating the amount of excess revenues under subsection (2), (3) or (4), the Board shall not consider any revenues derived by a patentee or former patentee before December 20, 1991 or any revenues derived by a former patentee after the former patentee ceased to be entitled to the benefit of the patent or to exercise any rights in relation to the patent.

(6) Before the Board makes an order under this section, it shall provide the patentee or former patentee with a reasonable opportunity to be heard.

(7) No order may be made under this section in respect of a former patentee who, more than three years before the day on which the proceedings in the matter commenced, ceased to be entitled to the benefit of the patent or to exercise any rights in relation to the patent.

1993, c. 2, s. 7; 1994, c. 26, s. 54(F).

84. (1) A patentee or former patentee who is required by any order made under section 83 to reduce the price of a medicine shall commence compliance with the order within one month after the date of the order or within such greater period after that date as the Board determines is practical and reasonable, having regard to the circumstances of the patentee or former patentee.

(2) A patentee or former patentee who is directed by any order made under section 83 to pay an amount to Her Majesty shall pay that amount within one month after the date of the order or within such greater period after that date as the Board determines is practical and reasonable, having regard to the circumstances of the patentee or former patentee.

(3) An amount payable by a patentee or former patentee to Her Majesty under any order made under section 83 constitutes a debt due to Her Majesty and may be recovered in any court of competent jurisdiction.

1993, c. 2, s. 7.

85. (1) In determining under section 83 whether a medicine is being or has been sold at an excessive price in any market in Canada, the Board shall take into consideration the following factors, to the extent that information on the factors is available to the Board:

(a) the prices at which the medicine has been sold in the relevant market;

(b) the prices at which other medicines in the same therapeutic class have been sold in the relevant market;

(c) the prices at which the medicine and other medicines in the same therapeutic class have been sold in countries other than Canada;

(d) changes in the Consumer Price Index; and

(e) such other factors as may be specified in any regulations made for the purposes of this subsection.

(2) Where, after taking into consideration the factors referred to in subsection (1), the Board is unable to determine whether the medicine is being or has been sold in any market in Canada at an excessive price, the Board may take into consideration the following factors:

(a) the costs of making and marketing the medicine; and

(b) such other factors as may be specified in any regulations made for the purposes of this subsection or as are, in the opinion of the Board, relevant in the circumstances.

(3) In determining under section 83 whether a medicine is being or has been sold in any market in Canada at an excessive price, the Board shall not take into consideration research costs other than the Canadian portion of the world costs related to the research that led to the invention pertaining to that medicine or to the development and commercialization of that invention, calculated in proportion to the ratio of sales by the patentee in Canada of that medicine to total world sales.

1993, c. 2, s. 7.

86. (1) A hearing under section 83 shall be held in public unless the Board is satisfied on representations made by the person to whom the hearing relates that specific, direct and substantial harm would be caused to the person by the disclosure of information or documents at a public hearing, in which case the hearing or any part thereof may, at the discretion of the Board, be held in private.

(2) The Board shall give notice to the Minister of Industry or such other Minister as may be designated by the regulations and to provincial ministers of the Crown responsible for health of any hearing under section 83, and each of them is entitled to appear and make representations to the Board with respect to the matter being heard.

1993, c. 2, s. 7; 1995, c. 1, s. 62.

87. (1) Subject to subsection (2), any information or document provided to the Board under section 80, 81 or 82 or in any proceeding under section 83 is privileged, and no person who has obtained the information or document pursuant to this Act shall, without the authorization of the person who provided the information or document, knowingly disclose the information or document or allow it to be disclosed unless it has been disclosed at a public hearing under section 83.

(2) Any information or document referred to in subsection (1)

(a) may be disclosed by the Board to any person engaged in the administration of this Act under the direction of the Board, to the Minister of Industry or such other Minister as may be designated by the regulations and to the provincial ministers of the Crown responsible for health and their officials for use only for the purpose of making representations referred to in subsection 86(2); and

(b) may be used by the Board for the purpose of the report referred to in section 100.

1993, c. 2, s. 7; 1995, c. 1, s. 62.

88. (1) A patentee of an invention pertaining to a medicine shall, as required by and in accordance with the regulations, or as the Board may, by order, require, provide the Board with such information and documents as the regulations or the order may specify respecting

(a) the identity of the licensees in Canada of the patentee;

(b) the revenue of the patentee, and details of the source of the revenue, whether direct or indirect, from sales of medicine in Canada; and

(c) the expenditures made by the patentee in Canada on research and development relating to medicine.

(2) Where the Board believes on reasonable grounds that any person has information or documents pertaining to the value of sales of medicine in Canada by a patentee or the expenditures made by a patentee in Canada on research and development relating to medicine, the Board may, by order, require the person to provide the Board with any of the information or documents that are specified in the order, or with copies thereof.

(3) A person in respect of whom an order is made under subsection (1) or (2) shall comply with the order within such time as is specified in the order or as the Board may allow.

(4) Subject to section 89, any information or document provided to the Board under subsection (1) or (2) is privileged, and no person who has obtained the information or document pursuant to this Act shall, without the authorization of the person who provided the information or document, knowingly disclose the information or allow it to be disclosed, except for the purposes of the administration of this Act.

1993, c. 2, s. 7.

89. (1) The Board shall in each year submit to the Minister a report setting out

(a) the Board’s estimate of the proportion, as a percentage, that the expenditures of each patentee in Canada in the preceding year on research and development relating to medicine is of the revenues of those patentees from sales of medicine in Canada in that year; and

(b) the Board’s estimate of the proportion, as a percentage, that the total of the expenditures of patentees in Canada in the preceding year on research and development relating to medicine is of the total of the revenues of those patentees from sales of medicine in Canada in that year.

(2) The report shall be based on an analysis of information and documents provided to the Board under subsections 88(1) and (2) and of such other information and documents relating to the revenues and expenditures referred to in subsection 88(1) as the Board considers relevant but, subject to subsection (3), shall not be set out in a manner that would make it possible to identify a person who provided any information or document under subsection 88(1) or (2).

(3) The Board shall, in the report, identify the patentees in respect of whom an estimate referred to in subsection (1) is given in the report, and may, in the report, identify any person who has failed to comply with subsection 88(1) or (2) at any time in the year in respect of which the report is made.

(4) The Minister shall cause a copy of the report to be laid before each House of Parliament on any of the first thirty days on which that House is sitting after the report is submitted to the Minister.

1993, c. 2, s. 7.

90. The Board shall inquire into any matter that the Minister refers to the Board for inquiry and shall report to the Minister at the time and in accordance with the terms of reference established by the Minister.

1993, c. 2, s. 7.

91. (1) The Patented Medicine Prices Review Board is hereby continued, and shall consist of not more than five members to be appointed by the Governor in Council.

(2) Each member of the Board shall hold office during good behaviour for a period of five years, but may be removed at any time by the Governor in Council for cause.

(3) A member of the Board, on the expiration of a first term of office, is eligible to be reappointed for one further term.

(4) A person may continue to act as a member of the Board after the expiration of the person’s term of appointment in respect of any matter in which the person became engaged during the term of appointment.

(5) The members of the Board shall be paid such remuneration as may be fixed by the Governor in Council and are entitled to be paid reasonable travel and living expenses incurred by them in the course of their duties under this Act while absent from their ordinary place of residence.

1993, c. 2, s. 7.

92. (1) The Minister may establish an advisory panel to advise the Minister on the appointment of persons to the Board, which panel shall include representatives of the provincial ministers of the Crown responsible for health, representatives of consumer groups, representatives of the pharmaceutical industry and such other persons as the Minister considers appropriate to appoint.

(2) The Minister shall consult with an advisory panel established under subsection (1) for the purpose of making a recommendation to the Governor in Council with respect to the appointment of a person to the Board.

1993, c. 2, s. 7.

93. (1) The Governor in Council shall designate one of the members of the Board to be Chairperson of the Board and one of the members to be Vice-chairperson of the Board.

(2) The Chairperson is the chief executive officer of the Board and has supervision over and direction of the work of the Board, including

(a) the apportionment of the work among the members thereof and the assignment of members to deal with matters before the Board and to sit at hearings of the Board and to preside at hearings or other proceedings; and

(b) generally, the conduct of the work of the Board, the management of its internal affairs and the duties of its staff.

(3) If the Chairperson is absent or incapacitated or if the office of Chairperson is vacant, the Vice-chairperson has all the powers and functions of the Chairperson during the absence, incapacity or vacancy.

1993, c. 2, s. 7.

94. (1) Such officers and employees as are necessary for the proper conduct of the work of the Board shall be appointed in accordance with the Public Service Employment Act.

(2) Persons appointed under subsection (1) shall be deemed to be employed in the public service for the purposes of the Public Service Superannuation Act.

(3) The Board may engage on a temporary basis the services of persons having technical or specialized knowledge to advise and assist in the performance of its duties and, with the approval of the Treasury Board, the Board may fix and pay the remuneration and expenses of those persons.

1993, c. 2, s. 7; 2003, c. 22, s. 225(E).

95. (1) The principal office of the Board shall be in the National Capital Region described in the schedule to the National Capital Act.

(2) The Board may meet at such times and places in Canada as the Chairperson deems advisable.

1993, c. 2, s. 7.

96. (1) The Board has, with respect to the attendance, swearing and examination of witnesses, the production and inspection of documents, the enforcement of its orders and other matters necessary or proper for the due exercise of its jurisdiction, all such powers, rights and privileges as are vested in a superior court.

(2) The Board may, with the approval of the Governor in Council, make general rules

(a) specifying the number of members of the Board that constitutes a quorum in respect of any matter; and

(b) for regulating the practice and procedure of the Board.

(3) The Board may make by-laws for carrying out the work of the Board, the management of its internal affairs and the duties of its staff.

(4) Subject to subsection (5), the Board may issue guidelines with respect to any matter within its jurisdiction but such guidelines are not binding on the Board or any patentee.

(5) Before the Board issues any guidelines, it shall consult with the Minister, the provincial ministers of the Crown responsible for health and such representatives of consumer groups and representatives of the pharmaceutical industry as the Minister may designate for the purpose.

(6) The Statutory Instruments Act does not apply to guidelines issued under subsection (4).

1993, c. 2, s. 7.

97. (1) All proceedings before the Board shall be dealt with as informally and expeditiously as the circumstances and considerations of fairness permit.

(2) In any proceedings before the Board,

(a) in the event of a difference of opinion among the members determining any question, the opinion of the majority shall prevail; and

(b) in the event of an equally divided opinion among the members determining any question, the presiding member may determine the question.

1993, c. 2, s. 7.

98. (1) The Board may, in any order, direct

(a) that the order or any portion thereof shall come into force at a future time, on the happening of a contingency, event or condition specified in the order or on the performance to the satisfaction of the Board, or a person named by it, of any terms specified in the order; and

(b) that the whole or any portion of the order shall have effect for a limited time or until the happening of a specified event.

(2) The Board may make interim orders or reserve further directions for an adjourned hearing of a matter.

(3) The Board may vary or rescind any order made by it and may re-hear any matter.

(4) Where any person satisfies the Board that the Board would not have sufficient grounds to make an order under section 83 in respect of the person, the Board may, after the person pays any fees required to be paid by the regulations, issue to the person a certificate to that effect, but no certificate is binding on the Board.

1993, c. 2, s. 7.

99. (1) Any order of the Board may be made an order of the Federal Court or any superior court of a province and is enforceable in the same manner as an order of the court.

(2) To make an order of the Board an order of a court, the usual practice and procedure of the court in such matters may be followed or, in lieu thereof, the Board may file with the registrar of the court a certified copy of the Board’s order, and thereupon the order becomes an order of the court.

(3) Where an order of the Board that has been made an order of a court is varied or rescinded by a subsequent order of the Board, the subsequent order of the Board shall be made an order of the court in the manner described in subsection (1), and the order of the court shall be deemed to have been varied or rescinded accordingly.

(4) Nothing in this section prevents the Board from exercising any of its powers under this Act.

1993, c. 2, s. 7.

100. (1) The Board shall in each year submit to the Minister a report on its activities during the preceding year.

(2) The report shall contain

(a) a summary of pricing trends in the pharmaceutical industry; and

(b) the name of each patentee in respect of whom an order was made under subsection 80(2) during the year and a statement as to the status of the matter in respect of which the order was made.

(3) The summary referred to in paragraph (2)(a) may be based on information and documents provided to the Board by any patentee under section 80, 81 or 82 or in any proceeding under section 83, but shall not be set out in a manner that would make it possible to identify that patentee.

(4) The Minister shall cause a copy of the report to be laid before each House of Parliament on any of the first thirty days on which that House is sitting after the report is submitted to the Minister.

1993, c. 2, s. 7.

101. (1) Subject to subsection (2), the Governor in Council may make regulations

(a) specifying the information and documents that shall be provided to the Board under subsection 80(1) or (2) or 88(1);

(b) respecting the form and manner in which and times at which such information and documents shall be provided to the Board and imposing conditions respecting the provision of such information and documents;

(c) specifying a period for the purposes of subsection 80(2);

(d) specifying factors for the purposes of subsection 85(1) or (2), including factors relating to the introductory price of any medicine to which a patented invention pertains;

(e) designating a Minister for the purposes of subsection 86(2) or paragraph 87(2)(a);

(f) defining, for the purposes of sections 88 and 89, the expression "research and development";

(g) requiring fees to be paid before the issue of any certificate referred to in subsection 98(4) and specifying those fees or the manner of determining those fees;

(h) requiring or authorizing the Board to perform such duties, in addition to those provided for in this Act, as are specified in the regulations, including duties to be performed by the Board in relation to the introductory price of any medicine to which a patented invention pertains; and

(i) conferring on the Board such powers, in addition to those provided for in this Act, as will, in the opinion of the Governor in Council, enable the Board to perform any duties required or authorized to be performed by it by any regulations made under paragraph (h).

(2) No regulations may be made under paragraph (1)(d), (f), (h) or (i) except on the recommendation of the Minister, made after the Minister has consulted with the provincial ministers of the Crown responsible for health and with such representatives of consumer groups and representatives of the pharmaceutical industry as the Minister considers appropriate.

1993, c. 2, s. 7.

102. (1) The Minister may at any time convene a meeting of the following persons:

(a) the Chairperson and such members of the Board as the Chairperson may designate;

(b) the provincial ministers of the Crown responsible for health or such representatives as they may designate;

(c) such representatives of consumer groups and representatives of the pharmaceutical industry as the Minister may designate; and

(d) such other persons as the Minister considers appropriate.

(2) The participants at a meeting convened under subsection (1) shall consider such matters in relation to the administration or operation of sections 79 to 101 as the Minister may determine.

1993, c. 2, s. 7.

103. The Minister may enter into agreements with any province respecting the distribution of, and may pay to that province out of the Consolidated Revenue Fund, amounts received or collected by the Receiver General under section 83 or 84 or in respect of an undertaking given by a patentee or former patentee that is accepted by the Board in lieu of holding a hearing or making an order under section 83, less any costs incurred in relation to the collection and distribution of those amounts.

1993, c. 2, s. 7; 1994, c. 26, s. 55(F); 1999, c. 26, s. 50.

2004, c. 23, Sch. 1; SOR/2005-276.