Vol. 146, No. 25 — December 5, 2012

Registration

SOR/2012-247 November 23, 2012

PATENT ACT

Patented Medicine Prices Review Board Rules of Practice and Procedure

P.C. 2012-1547 November 22, 2012

His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 96(2) (see footnote a) of the Patent Act (see footnote b), approves the making of the annexed Patented Medicine Prices Review Board Rules of Practice and Procedure by the Patented Medicine Prices Review Board.

The Patented Medicine Prices Review Board, pursuant to subsection 96(2) (see footnote c) of the Patent Act (see footnote d), makes the annexed Patented Medicine Prices Review Board Rules of Practice and Procedure.

Ottawa, October 30, 2012

MARY CATHERINE LINDBERG
Chairperson of the Patented Medicine
Prices Review Board

PATENTED MEDICINE PRICES REVIEW BOARD RULES OF PRACTICE AND PROCEDURE

INTERPRETATION

1. The definitions in this section apply in these Rules.

“Act”
« Loi »

“Act” means the Patent Act.

“Chairperson”
« président »

“Chairperson” means the Chairperson of the Board designated under subsection 93(1) of the Act.

“concerned minister”
« ministre intéressé »

“concerned minister” means a federal Minister or a provincial minister referred to in subsection 86(2) of the Act, as the context requires.

“counsel”
« conseiller juridique »

“counsel” means a member of the bar of a province.

“hearing”
« audience »

“hearing” includes a conference held under these Rules.

“party”
« partie »

“party” means

(a) a respondent;
(b) Board Staff;
(c) a concerned minister; or
(d) a person who has been granted leave to intervene under Rule 20.

“person”
« personne »

“person” includes an unincorporated organization or entity.

“respondent”
« intimé »

“respondent” means a patentee, or a former patentee, against whom an order of the Board is proposed to be made under the Act.

“Secretary”
« secrétaire »

“Secretary” means the Director of Board Secretariat or anyone acting on her or his behalf.

BOARD

Composition of Board

2. For the purposes of these Rules, the members assigned by the Chairperson under subsection 93(2) of the Act to deal with a matter constitute the Board.

APPLICATION

Application

3. These Rules apply in respect of any proceeding before the Board.

QUORUM

Quorum

4. In any proceeding, a quorum of the Board consists of two members.

GENERAL

Defect in form or procedure

5. (1) A proceeding or any part of a proceeding may not be defeated by reason only of a defect in form or procedure.

Unanticipated procedural matters

(2) Any procedural matter or question that is not provided for in the Act, in these Rules or in any regulations made pursuant to the Act that arises in the course of any proceeding may be dealt with in any manner that the Board directs in order to ensure the fair and expeditious conduct of any proceeding.

Board discretion

(3) For the purpose of ensuring the fair and expeditious conduct of any proceeding, the Board may vary, supplement or dispense with any requirement set out in these Rules.

PROCEDURE AND EVIDENCE

Board powers

6. (1) In relation to any proceeding, the Board may

(a) receive any evidence that it considers appropriate;
(b) take notice of facts that may be judicially noticed and of any generally recognized scientific or technical facts, information or opinions concerning patented medicines;
(c) add parties at any stage of the proceeding;
(d) permit the amendment of any document filed with the Secretary; and
(e) decide any question of procedure.

Directions — information, documents and facts

(2) The Board may, at any time, direct

(a) that a party provide any information or documents, in paper or electronic format, that the Board considers concerned to any proceeding; and
(b) that a particular fact be established by affidavit.

Affidavits

(3) All affidavits must be filed with the Secretary.

Witnesses appearing before Board

7. Witnesses appearing before the Board must testify under oath or solemn affirmation and may be examined by the party calling the witness and cross-examined by parties adverse in interest.

EXPERT WITNESSES

Admissibility of expert evidence

8. (1) Expert witness evidence is not admissible in a proceeding before the Board in respect of any issue unless the issue has been raised in the pleadings or in a pre-hearing conference order or the expert witness evidence is called for the purpose of rebutting the evidence of an expert witness introduced by another party.

Maximum number

(2) More than two expert witnesses may not be called by a party, per issue, without leave of the Board.

Report, declaration and availability

(3) Every party who, in a proceeding before the Board, intends to introduce evidence given by an expert witness must

(a) file with the Secretary and serve on each of the parties in accordance with the Board’s schedule of events, an expert witness report that is supported by an affidavit and that must include
- (i) a statement of the issues addressed in the report,
- (ii) a description of the qualifications of the expert with respect to those issues,
- (iii) the expert’s curriculum vitae attached to the report as a schedule,
- (iv) the facts and assumptions on which the opinions in the report are based,
- (v) a summary of the opinions expressed,
- (vi) in the case of a report provided in response to another expert’s report, an indication of the points of agreement and of disagreement with the other expert’s opinions,
- (vii) the reasons supporting each opinion expressed,
- (viii) any literature or other documents specifically relied on in support of the opinions expressed,
- (ix) a summary of the methodology on which the expert has relied;
(b) file with the Secretary and serve on each of the parties a signed Expert Witness Declaration in Form 1 set out in the schedule; and
(c) ensure that the expert witness is available for examination and cross-examination at the hearing.

Duration of examination in chief

(4) Examination in chief of any expert witness may not, without the Board’s consent, exceed 90 minutes.

TIME LIMITS

Computation of time

9. (1) If a time limit set out in these Rules expires on a Saturday, Sunday or a holiday, the period is extended to the next business day.

Deemed service

(2) Any document that is served after 5:00 p.m. at the local time for the recipient is deemed to be served at 9:00 a.m. on the next business day.

NOTICE AND SERVICE

Manner of service

10. (1) Unless otherwise provided in these Rules, the giving of notice or the service of any document under these Rules must be effected

(a) by personal service in accordance with Rule 11;
(b) by courier, in which case service is deemed to have been made on the day of delivery of the document;
(c) by electronic transmission of a copy of the document to the address for service, in which case service is deemed to have been made on the day of transmission; or
(d) in any other manner that the Board may direct.

Service of filed documents

(2) If a document is required to be filed with the Board pursuant to these Rules or a direction of the Board, except in connection with ex parte motions, the person who files the document must, concurrently with the filing, serve a copy of the document on every person who is, at the time of service, a party to the proceeding.

Proof of service to be filed

(3) Proof of service of any document that is required to be served must, at the request of the Board, be filed with the Secretary.

Service on respondent residing outside Canada

(4) If these Rules require or permit giving notice to or the service of any document on a respondent who does not reside or carry on business at a specified address in Canada, the giving of notice or the service may be effected by giving notice to or serving the representative of the respondent who is appointed pursuant to section 29 of the Act.

PERSONAL SERVICE

Personal service

11. Personal service of a document must be effected by leaving a copy of the document

(a) in the case of service on an individual, with that individual;
(b) in the case of service on a partnership, with one of the partners;
(c) in the case of service on a corporation, with an officer or director of the corporation;
(d) in the case of service on a concerned minister, with the concerned minister or the person apparently in charge of the office; or
(e) if counsel has filed a notice of appearance on behalf of a person referred to in any of paragraphs (a) to (d), with counsel.

ADDRESS FOR SERVICE

Address for service

12. The address for service for a party is

(a) if there is counsel of record for the party, the business address of counsel as shown on the last document filed by counsel;
(b) if a party is unrepresented,
- (i) in the case of a concerned minister, the address of the concerned minister’s office, or
- (ii) in the case of any other person, the address of the person as shown on the notice of hearing; and
(c) if a notice of change of address for service has been filed with the Board, the new address.

COUNSEL

Notice of appearance

13. (1) Counsel must file a notice of appearance with the Secretary before representing a party before the Board.

Beginning of representation

(2) A party is represented by counsel before the Board beginning on the date of filing of the notice of appearance.

Notice of change of counsel

(3) A person may change counsel by filing a notice of change of counsel with the Board, together with proof of service of that notice on counsel and on all other parties.

Notice of withdrawal of counsel

(4) Counsel may withdraw from a proceeding by filing with the Board a notice of withdrawal, together with proof of service of that notice on all parties.

Any party that is not an individual

(5) Any party that is not an individual must be represented by counsel in all proceedings.

FILING

Manner of filing

14. (1) The filing of a document with the Board must be effected

(a) by personal service of the document on the Secretary;
(b) by delivery of the document by courier or by registered or certified mail to the Secretary; or
(c) by transmitting the document electronically to the Secretary.

Electronic filing

(2) Any documents that are filed with the Board electronically must meet the following requirements:

(a) the electronic and paper versions of documents must have the same cover page, table of contents and page numbers;
(b) the filename of an electronic document must include the name of either the patented medicine or the company if the hearing does not relate to a specific patented medicine, the name of the party filing the document, the title of the document and the date which appears on the document or must meet alternative requirements, if any, set out by the Secretary; and
(c) documents must be filed as PDF (Portable Document Format) documents or in any format authorized by the Secretary.

Deemed filing date

(3) The date of receipt marked by the Secretary on a document is deemed to be the date on which the document was filed with the Secretary.

Copies

(4) Three paper copies of any document that is served by a party must be filed with the Secretary. If the document is filed electronically, the three copies must be filed with the Secretary within 48 hours of electronic filing.

Confirmation of filing

(5) On the request of a party or any interested person filing a document with the Secretary, the Secretary must provide the party or interested person with confirmation of that filing.

Confidential documents

(6) If a party files a document with the Board that contains confidential information, it must ensure that “CONFIDENTIAL/CONFIDENTIEL” appears prominently on the cover and pages of the document which contain confidential information.

NOTICE OF HEARING

Signed notice of hearing

15. (1) Proceedings are initiated by issuance of a notice of hearing signed by the Secretary.

Personal service

(2) A notice of hearing must be served personally on the respondent, all concerned ministers and on any other person that the Board may direct, in accordance with Rule 11.

Statement of allegation or notice of application

(3) A notice of hearing must be accompanied by

(a) in the case of an allegation of a patented medicine sold at an excessive price, a statement of allegation set out in consecutively numbered paragraphs containing the material facts, the allegations and the order sought by Board Staff in the proceeding; or
(b) in the case of an allegation of a failure to provide information and documents related to a patented medicine, a notice of application set out in consecutively numbered paragraphs containing a statement of the relief sought by Board Staff, the grounds for the relief and the material facts on which Board Staff intends to rely.

Content of notice of hearing

16. (1) A notice of hearing issued by the Board must

(a) specify the date and time of the teleconference referred to in Rule 22;
(b) contain a statement of the purpose of the hearing;
(c) state that the hearing will be held in public unless, on representations made by a respondent, the Board is satisfied that specific, direct and substantial harm would be caused to the respondent by the disclosure of information or documents relating to the hearing;
(d) be accompanied by a schedule of events; and
(e) contain any other information that the Board considers appropriate.

Public notice

(2) The Secretary must give public notice of each hearing in the Canada Gazette and in any other manner that the Chairperson may direct.

RECORD OF PROCEEDING

Contents

17. Subject to section 87 and subsection 88(4) of the Act, if the Board issues a notice of hearing, the Secretary must establish a record of the proceeding that includes

(a) the notice of hearing;
(b) any document filed with the Secretary by a party in relation to the proceeding;
(c) any direction, decision, notice or order of the Board in relation to the proceeding;
(d) the transcript of any pre-hearing conference;
(e) the transcript of the hearing in relation to the proceeding; and
(f) any other document or information that is directed by the Board to be placed on the record of the proceeding.

RESPONSE

Filing of response

18. (1) A respondent who wishes to oppose the making of an order sought by Board Staff that is set out in a statement of allegation or in a notice of application must, within 20 days after being served with the notice of hearing, file with the Secretary and serve on all other parties a response that is dated and signed by the respondent.

Content of response

(2) A response must be set out in consecutively numbered paragraphs and must include

(a) an admission or denial of each ground or material fact set out in the statement of allegation or notice of application;
(b) the grounds on which the proposed order is opposed and the material facts on which the respondent is relying;
(c) the name and address of the person on whom service of any document in relation to the proceeding may be effected.

No response filed

(3) If a respondent has not filed a response within the period set out in subsection (1), the Board may, where the Board is satisfied that a copy of the notice of hearing was served on the respondent and where the Board has received any evidence that it required the respondent to provide, make any finding and issue any order that the Board considers appropriate under section 83 of the Act.

REPLY

Filing of reply

19. (1) If Board Staff wishes to reply to the response it must, within 20 days after being served with the response, file with the Board and serve on all other parties a reply that is dated and signed by Board Staff.

Content of reply

(2) A reply must be set out in consecutively numbered paragraphs and must set out an admission or denial of each ground or material fact that was set out in the response.

No reply filed

(3) If Board Staff does not file a reply, it is deemed to have denied each ground and each material fact alleged in the response.

INTERVENTION

Motion for leave to intervene

20. (1) Any person who claims an interest in the subject-matter of a proceeding may, within any period and under any conditions that the Board may specify, bring a motion to the Board for leave to intervene in the proceeding.

Content of motion for leave to intervene

(2) A motion for leave to intervene must set out

(a) the name and address of the proposed intervener and of any counsel representing the intervener;
(b) a concise statement of the nature of the proposed intervener’s interest in the hearing and the reasons the intervention is necessary;
(c) a concise statement of the facts upon which the motion is based; and
(d) the issues that the proposed intervener intends to address.

Filing of motion

(3) A motion for leave to intervene must be filed with the Board and served on the parties in accordance with Rule 10.

Filing of representations

(4) The parties who are served with a motion for leave to intervene may make submissions with respect to the motion by filing their submissions with the Board and serving a copy of the submissions on the person seeking leave to intervene.

Factors considered by the Board

(5) Subject to section 87 of the Act, if a person has moved to intervene in a proceeding, the Board may grant or deny the intervention and impose any conditions or restrictions on the intervention that it determines to be appropriate after considering relevant factors, including

(a) whether the person has an interest in the proceeding that is sufficient to warrant the intervention;
(b) whether the intervention will prejudice any party to the proceeding; and
(c) whether the intervention will interfere with the fair and expeditious conduct of the proceeding.

APPEARANCE BY MINISTER

Filing of notice of appearance

21. (1) A concerned minister who intends to appear and make representations with respect to a matter that is before the Board must, within 20 days after being served with the notice of hearing, file with the Board and serve on all parties a notice of appearance that is dated and signed by the concerned minister.

Content of notice of appearance

(2) A notice of appearance must set out the name and address of the individual on whom service of any document intended for the concerned minister may be effected and must be accompanied by

(a) a concise statement of the representations that the concerned minister intends to make and the material facts on which the concerned minister is relying, and
(b) a list of the documents that may be used in evidence to support the material facts on which the concerned minister is relying.

No notice of appearance filed

(3) A concerned minister who has not filed a notice of appearance within the period set out in subsection (1) need no longer be served by the parties.

CASE MANAGEMENT CONFERENCE

Teleconference

22. The Secretary must convene a teleconference with counsel to be held no later than 45 days following the issuance of the notice of hearing for the purpose of

(a) fixing the hearing schedule;
(b) establishing the official language the parties wish to use during the proceeding;
(c) discussing the filing of evidence by the parties;
(d) considering the procedure to be followed and means of expediting the hearing, including determining whether written submissions will be submitted;
(e) determining the expected duration of the hearing;
(f) facilitating the exchange among the parties of information and documents to be submitted at the hearing; and
(g) identifying other issues to be resolved.

PRE-HEARING CONFERENCE

Purpose

23. (1) The parties must appear before the Board at the date, time and place fixed by the Board for a pre-hearing conference for the purpose of

(a) identifying or circumscribing the issues;
(b) allowing the Board to receive and consider representations referred to in subsection 86(1) of the Act and determine whether the hearing will be held in private; and
(c) resolving any other issue that may facilitate the conduct of the hearing.

Teleconference or written submissions

(2) The Board may direct that issues referred to in subsection (1) be addressed during a teleconference with the parties or in written submissions to be filed with the Secretary in any manner that the Board may determine.

Filing and content of written submissions

(3) The Board may require any party who participates in the pre-hearing conference to file and serve, at any time before or during the pre-hearing conference and in any manner that the Board may determine, a written submission setting out any information that the Board considers necessary to expedite the proceeding, including a concise statement of any procedural issues or questions on the merits that the party intends to raise at the hearing.

Postponement, suspension or adjournment

(4) The Board may, if necessary, postpone, suspend or adjourn and may reconvene a pre-hearing conference on any conditions that the Board considers appropriate.

SUBPOENAS

Issuance of subpoena

24. (1) In any proceeding, the Board may, on its own motion or on motion by a party, issue a subpoena for the attendance of witnesses and for the production or inspection of documents.

Reasons for subpoena

(2) If a party applies to the Board for a subpoena, the party must provide reasons in support of the issuance of the subpoena and must identify the person and documents or information to be named in the subpoena and their relevance to the proceeding.

Subpoena signed and issued

(3) A subpoena that is issued by the Board must be signed by the Secretary and served by the Board or the party who applied for the subpoena, as the case may be, by personal service in accordance with Rule 11 on the person summoned to appear before the Board, at least five days before the day fixed for that person’s appearance.

MOTION FOR INTERLOCUTORY RELIEF

Notice of motion

25. (1) Interlocutory matters must be commenced by notice of motion.

Content of notice of motion

(2) A notice of motion must

(a) set out the relief sought, the grounds for the motion and the official language or languages that the moving party wishes to use at the hearing of the motion;
(b) be accompanied by an affidavit that sets out the facts on which the motion is based that do not appear on the record of the proceeding;
(c) be accompanied by written submissions that set out a summary of the points at issue, a concise statement of submissions, a concise statement of the order sought and a list of authorities to be referred to; and
(d) be signed and dated by the moving party.

Filing requirements

(3) The moving party must file the notice of motion and accompanying memorandum and affidavit with the Board and must serve a copy of each of them on each party in accordance with Rule 10.

Hearing date

(4) The date fixed for the hearing of a motion must not be earlier than two days after the date of service of the documents referred to in subsection (3).

Testimony by affidavit

26. (1) Subject to subsection (2), the testimony before the Board on a motion in an interlocutory matter must be by affidavit.

Oral testimony and cross-examination

(2) The Board, before or during the hearing of a motion on an interlocutory matter, may grant leave for

(a) a witness to give testimony orally in relation to any points at issues raised in the motion; and
(b) the cross-examination of any person making an affidavit.

Pre-hearing conference

27. (1) If a pre-hearing conference is held under Rule 23, any motion for interlocutory relief must be made at that pre-hearing conference.

Motion to be heard by Board

(2) If no pre-hearing conference is held, or the pre-hearing conference has ended before the filing of a notice of motion, any motion on an interlocutory matter must be heard by the Board at a date, time and place that is fixed by the Board.

HEARINGS

Location of hearings

28. Hearings must be held at the principal office of the Board.

Postponement, suspension or adjournment

29. (1) The Board may, if necessary, postpone, suspend or adjourn and reconvene a hearing.

Notice of postponement

(2) If the Board postpones a hearing, it must give notice of the postponement to the parties as soon as possible.

SUBMISSIONS

Written submissions

30. The Board may direct that written submissions be presented by the parties in addition to or instead of oral representations and may give any directions with respect to time limits relating to those submissions that it considers appropriate.

DIRECTIONS, DECISIONS AND ORDERS

New hearing

31. The Board may reconvene a hearing in order to receive further evidence relating to the subject-matter of the original hearing or may rehear any matter in whole or in part before giving any direction or making any decision or order relating to the hearing.

Form of directions, decisions and orders

32. The Board may give directions, issue decisions and make orders in any form that it considers appropriate.

Written reasons

33. (1) If the Board makes an order under the Act, it must issue written reasons for the order, if possible within 180 days after the completion of the hearing on the merits.

Publication

(2) Every order of the Board under the Act must be published in the Canada Gazette and may also be published in any other publication that the Chairperson designates.

Effective date

34. The effective date of any direction, decision or order of the Board is the date on which it is given, issued or made, unless the Board specifies a later date.

Technical irregularities and procedural directions, decisions and orders

35. The Board may

(a) vary or rescind any procedural direction, decision or order given, issued or made under these Rules; and
(b) correct a technical irregularity in any direction, decision or order given, issued or made by the Board.

COMING INTO FORCE

Registration

36. These Rules come into force on the day on which they are registered.

SCHEDULE

FORM 1
(Rule 8)

PATENTED MEDICINE PRICES REVIEW BOARD

EXPERT WITNESS DECLARATION

(Style of Cause)

I, ...................................................... (name), resident in ................................. (city), in the ................................ (province/territory) of ..................................... (name of province or territory) declare that

(a) I have been retained by ............................................................................. (name of party/parties) to provide evidence in the matter ............................ (style of cause);
(b) it is my duty to provide evidence in relation to this proceeding as follows:
- (i) to provide opinion evidence that is impartial,
- (ii) to provide opinion evidence that is related only to matters that are within my area of expertise, and
- (iii) to provide any additional assistance that the Board may reasonably require to determine a matter at issue.
(c) I acknowledge that the duties referred to above take precedence over any obligation which I may owe to any party by whom or on whose behalf I am engaged.

Dated at ................................................... (place and province or territory) this ....................... (date) day of ............................. (month), ............ (year).

_____________________
(Signature)

REGULATORY IMPACT
ANALYSIS STATEMENT

(This statement is not part of the Rules.)

Issue

The Patented Medicine Prices Review Board (the Board) is mandated with the responsibility of ensuring that the prices at which patentees sell their patented medicines in Canada are not excessive and to report to Parliament on the price trends of medicines and research and development expenditures by patentees. As the Board is an independent, quasi-judicial body established by Parliament in 1987 under the Patent Act (the Act), its ability to carry out its statutory mandate is dependent on relevant and effective excessive price guidelines (the Guidelines) and on its ability to conduct hearings, when required.

Section 96 of the Act gives the Board certain powers, rights and privileges of a superior court. The Board assesses the price at which patentees sell patented medicines, and may, following a public hearing, issue a remedial order with respect to excessive pricing. The Board may also issue an order to require a patentee to file prescribed information or to address a failure to comply with a previous Board order.

The Act provides that the Board may, with the approval of the Governor in Council, make general rules for regulating the practice and procedure of Board hearings. To date, notices of hearing have been issued in 25 cases, and at those hearings the Board has applied draft Rules which were last revised and examined by the Regulations Section of the Department of Justice in April 2002. To ensure it can continue to effectively deliver on this core component of its mandate, the Board submitted the Patented Medicine Prices Review Board Rules of Practice and Procedure (the Rules) to the Governor in Council for formal approval. These Rules will constitute a published standard set of procedures for all participants to follow in proceedings before the Board.

The Board plays an important role in contributing to the health care system and protecting consumer interests. The Board’s Annual Report 2011 noted that since 1993, the Board has approved a total of 87 Voluntary Compliance Undertakings (VCUs) and initiated 25 public hearings. These measures resulted in price reductions of patented drug products and the offset of excess revenues by way of payments to the Crown and/or additional price reductions.

Ensuring the hearing process is transparent and more efficient was identified as an operational priority for the Board in recent years because hearings had increased significantly in number and complexity. The Board relies on voluntary compliance whenever possible since it is less time-consuming and less costly to all parties. The ability to hold public hearings when needed, however, is a core component of the Board’s mandate and authority. These Rules are more detailed and reflect the Board’s experience with hearings and some of the evolution that has occurred in judicial and quasi-judicial proceedings over the last decade.

Objectives

As an independent, quasi-judicial body, the Board must give parties a fair and timely hearing, when needed. These rules will regulate the practice and procedure of Board hearings. They will enhance

the transparency of the Board’s activities;
consistency in the exercise of its formal powers;
fairness to all parties appearing before the Board; and
the timely completion of hearings.

Description

The efficient administration of cases, facilitated by the use of rules, helps contribute to the overall objectives of the Act including the objective, as per subsection 97(1) of the Act, that all proceedings before the Board shall be dealt with as informally and expeditiously as the circumstances and considerations of fairness permit. These Rules will allow the Board to codify practices already adopted in recent proceedings, incorporate relevant practices introduced in other judicial and quasi-judicial proceedings, and facilitate case management.

The Rules will allow for terminology or practices already informally adopted by the Board to be codified, including

identification of the Board “Secretary” as the Director of Board Secretariat;
listing the documents to be submitted with the notice of hearing;
expressly conferring a formal right of reply to Board Staff;
technological developments (e.g. filing of electronic in addition to any paper copies of documents); and
handling of confidential materials.

The Rules draw from provincial and federal court rules to introduce improvements in areas such as expert witnesses and case management, including

the requirement for expert witnesses appearing before the Board to sign an Expert Witness Declaration form acknowledging their duty to provide opinion evidence that is objective and impartial;
the rules that apply to expert witness affidavits and reports;
the restrictions on the scope of expert evidence and a new limit on the number of expert witnesses that may be called per party per issue without leave of the Board;
identification and service of documents; and
hearing coordination and case management through the Board Secretary’s use of teleconference early in the hearing process.

The Rules also introduce or amend certain timelines for various steps in a proceeding. These timelines are consistent with the objective of completing these proceedings as efficiently and expeditiously as possible. At the same time, the Rules will give the Board the flexibility to vary these requirements. These changes include the following:

timelines for the filing of pleadings;
case management conference to be held within 45 days of issuance of a notice of hearing; and
a new requirement that the Board must endeavour to issue written reasons within 180 days of completion of a hearing on the merits.

Regulatory and non-regulatory options considered

The Act requires the holding of a public hearing and a reasonable opportunity for affected parties to be heard, before the Board makes a finding and issues a remedial order. While the Board could establish procedures for each hearing on a case-by-case basis, the making of general rules of practice and procedure is considered preferable as it will enhance the transparency of the Board’s activities and consistency in the exercise of its formal powers. The Rules were prepublished in the Canada Gazette, Part Ⅰ, in 2001 and have since been used to guide the practice and procedure of Board hearings. With more hearing experience, the Board now has Rules which reflect current practices and facilitate case management.

Benefits and costs

These Rules will benefit both persons appearing before the Board and the public interest and ensure that the Board continues to conduct its formal proceedings consistently with the requirements of administrative law and the Act. No additional cost will be incurred by industry, the public or Government as a result of the making of these Rules. In many instances the Rules simply codify current practice before the Board and introduce amendments intended to assist with streamlining or expediting the hearing process while preserving fairness and the rights of affected parties to be heard.

Rationale

The making of the Rules will benefit the Canadian public by enhancing the overall efficiency and effectiveness of the Board’s hearings. The Rules will provide clearer and more transparent direction on the practices and procedures of the Board to parties and their counsel appearing before the Board, and Board members who render decisions on cases. This direction will further ensure that parties appear and present their cases in a consistent manner, facilitating the efficient administrative processing of cases.

The effectiveness of the Board’s compliance process has continued. While patentees continue to avail themselves of Voluntary Compliance Undertakings to resolve issues, the ability to hold public hearings when needed remains a core component of the Board’s mandate and authority and a right of the patentee to be heard. At the time of publication of the Board’s Annual Report 2011, there were 1 282 existing patented drug products. Of those, 68 were under investigation, and 3 were the subject of quasi-judicial proceedings before the Board. Three Board decisions were also subject to judicial review before the Federal Court.

Consultation

The Rules were prepublished in the Canada Gazette, Part Ⅰ, on May 9, 1998, for public comment. Four submissions, mostly of a technical nature, were received and carefully reviewed by the Board. As a result, the Board made minor changes to the general provisions and to certain provisions governing intervenors and personal service of documents. The Rules were then pre-published in the Canada Gazette, Part Ⅰ, for a second time on June 2, 2001. Only one submission was received in response to the 2001 prepublication.

Largely due to the success of the Board’s Compliance Policy, only five notices of hearing had been issued by the Board in four cases by 2001. As a result, although some further minor amendments were made to the version of the Rules revised and examined by the Regulations Section of the Department of Justice in April 2002, which the Board has been relying on, the Board concluded that it should wait until it had more experience with hearings before making these Rules.

After gaining valuable experience in conducting hearings, which had increased in number and complexity, the Board undertook informal consultations on the rules in recent years. Comments were provided in December 2010 and January 2011, by six counsel who regularly appeared in proceedings before the Board. Notification of the proposed Rules was then published in the Board’s April 2011 NEWSletter, and a Notice and Comment was issued by the Board on May 16, 2011. Both these documents are available on the Board’s Web site. Only a single submission was received from an association of pharmaceutical companies in response to the invitation to submit any written comments on the Rules by June 30, 2011. The single submission was supportive of resolving matters before the Board as informally and expeditiously as possible and of the objectives of the Rules to find the appropriate balance of streamlining and expediting the hearing process while preserving fairness and the rights of a patentee to be heard.

Over the course of the informal consultations, stakeholders affected by these procedural changes who have commented have been universally supportive of the proposed Rules. The Board has carefully considered and, where appropriate, acted on any comments received through consultations. The Board maintains that timelines in the Rules are sufficient, fair and consistent with the objective of moving these proceedings along as expeditiously as possible. Furthermore, it will remain open to parties appearing before the Board requesting longer timelines, or other variations from strict application of the Rules in individual cases if necessary, as the Board will continue to have the flexibility to vary the requirements of the Rules for the purpose of ensuring the fair and expeditious conduct of any proceeding.

The Rules were prepublished in the Canada Gazette, Part Ⅰ, on June 16, 2012; no comments were received during the 30-day comment period.

Upon prepublication in the Canada Gazette, Part Ⅰ, and as part of the Board’s normal communications and consultation procedures, the Board also

wrote directly to administrative law practitioners who appear regularly before the Board to inform them of the consultation and invite them to participate in the process, and posted the Rules on its Web site and informed its electronic subscribers of the consultation schedule. Electronic subscribers include patentees, industry associations, statutory parties, representatives of consumer associations and major patient health advocacy groups, and
published an article in the Board’s quarterly NEWSletter, inviting interested parties to participate in the consultative process.

Implementation, enforcement and service standards

Implementation of the Rules will begin following their coming into force on the date they are registered and be applied in future hearings. Implementation will include communication of the Rules to stakeholders by way of the Board’s Web site, the quarterly NEWSletter, and the Annual Report.

The Board has the powers, rights and privileges of a superior court 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.

In addition, pursuant to section 99 of the Act, any order of the Board can be made an order of the Federal Court or a superior court of a province and is enforceable in the same manner as an order of that court.

No additional costs to industry, the public or Government will arise from the implementation and enforcement of the Rules.

Contact

Sylvie Dupont
Director
Board Secretariat and Communications
Patented Medicine Prices Review Board
Standard Life Centre
333 Laurier Avenue W, Suite 1400
Ottawa, Ontario
K1P 1C1
Telephone: 613-954-8299
Fax: 613-952-7626
Email: sylvie.dupont@pmprb-cepmb.gc.ca

Footnote a
S.C. 1993, c. 2, s. 7

Footnote b
R.S., c. P-4

Footnote c
S.C. 1993, c. 2, s. 7

Footnote d
R.S., c. P-4