Patent Act (R.S.C., 1985, c. P-4)

Marginal note:Compliance

• 84 (1) A rights holder or former rights holder 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 a greater period after that date that the Board determines is practical and reasonable, having regard to the circumstances of the rights holder or former rights holder.

• Marginal note:Compliance

  (2) A rights holder or former rights holder 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 a greater period after that date that the Board determines is practical and reasonable, having regard to the circumstances of the rights holder or former rights holder.

• Marginal note:Debt due to Her Majesty

  (3) An amount payable by a rights holder or former rights holder 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.

Marginal note:Factors to be considered

• 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.

• Marginal note:Additional factors

  (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.

• Marginal note:Research costs

  (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 rights holder in Canada of that medicine to total world sales.

Marginal note:Hearings to be public

• 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.

• Marginal note:Notice of hearing to certain persons

  (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.

Marginal note:Information, etc., privileged

• 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.

• Marginal note:Disclosure, etc.

  (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.

Sales and Expense Information

Marginal note:Sales and expense information, etc., to be provided

• 88 (1) A rights holder for 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 the information and documents that the regulations or the order may specify respecting

  • (a) the identity of the licensees in Canada of the rights holder;

  • (b) the revenue of the rights holder, 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 rights holder in Canada on research and development relating to medicine.

• Marginal note:Additional information

  (2) If 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 rights holder or the expenditures made by a rights holder 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 of them.

• Marginal note:Compliance with order

  (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.

• Marginal note:Information, etc., privileged

  (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.

Marginal note:Report

• 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 rights holder in Canada in the preceding year on research and development relating to medicine is of the revenues of those rights holders 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 rights holders in Canada in the preceding year on research and development relating to medicine is of the total of the revenues of those rights holders from sales of medicine in Canada in that year.

• Marginal note:Basis of report

  (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).

• Marginal note:Exception

  (3) The Board shall, in the report, identify the rights holders 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.

• Marginal note:Tabling of report

  (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.

Inquiries

Marginal note:Inquiries

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.

Patented Medicine Prices Review Board

Marginal note:Establishment

• 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.

• Marginal note:Tenure

  (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.

• Marginal note:Reappointment

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

• Marginal note:Acting after expiration of appointment

  (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.

• Marginal note:Remuneration and expenses

  (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.

Marginal note:Advisory panel

• 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.

• Marginal note:Consultation

  (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.

Marginal note:Chairperson and Vice-chairperson

• 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.

• Marginal note:Duties of Chairperson

  (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.

• Marginal note:Duties of Vice-chairperson

  (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.

Marginal note:Staff

• 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.

• Marginal note:Idem

  (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.

• Marginal note:Technical assistance

  (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.

Marginal note:Principal office

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

• Marginal note:Meetings

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

Marginal note:General powers, etc.

• 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.

• Marginal note:Rules

  (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.

• Marginal note:By-laws

  (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.

• Marginal note:Guidelines

  (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 rights holder or former rights holder.

• Marginal note:Consultation

  (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.

• Marginal note:Non-application of Statutory Instruments Act

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