Patent Act (R.S.C., 1985, c. P-4)

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).

Marginal note:Proceedings

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

• Marginal note:Differences of opinion among members

  (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.

Marginal note:Orders

• 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.

• Marginal note:Interim orders, etc.

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

• Marginal note:Rescission and variation

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

• Marginal note:Certificates

  (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.

Marginal note:Enforcement of orders

• 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.

• Marginal note:Procedure

  (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.

• Marginal note:Effect of variation or rescission

  (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.

• Marginal note:Option to enforce

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

Marginal note:Report of Board

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

• Marginal note:Contents

  (2) The report shall contain

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

  • (b) the name of each rights holder and former rights holder in respect of whom an order was made under subsection 81(1) or 82(2) or section 83 during the year and a statement as to the status of the matter in respect of which the order was made.

• Marginal note:Report summary

  (3) The summary referred to in paragraph (2)(a) may be based on information and documents provided to the Board by any rights holder or former rights holder 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 rights holder or former rights holder.

• 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.

Regulations

Marginal note:Regulations

• 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, or invention protected by a certificate of supplementary protection, 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 the duties, in addition to those provided for in this Act, that 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, or invention protected by a certificate of supplementary protection, 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).

• Marginal note:Recommendation

  (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.

Meetings with Minister

Marginal note:Meetings with Minister

• 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.

• Marginal note:Agenda

  (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.

Agreements with Provinces

Marginal note:Agreements with provinces

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 rights holder or former rights holder 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.

Supplementary Protection for Inventions — Medicinal Ingredients

Interpretation

Marginal note:Definitions

104 The following definitions apply in this section and in sections 105 to 134.

authorization for sale

authorization for sale has the meaning assigned by regulations. (autorisation de mise en marché)

drug

drug means a substance or a mixture of substances manufactured, sold or represented for use in

• (a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals; or

• (b) restoring, correcting or modifying organic functions in human beings or animals. (drogue)

Minister

Minister means the Minister of Health. (ministre)