Patented Medicine Prices Review Board Rules of Practice and Procedure

Patented Medicine Prices Review Board Rules of Practice and Procedure His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 96(2)a of the Patent Actb, approves the making of the annexed Patented Medicine Prices Review Board Rules of Practice and Procedure by the Patented Medicine Prices Review Board. S.C. 1993, c. 2, s. 7 R.S., c. P-4 The Patented Medicine Prices Review Board, pursuant to subsection 96(2)a of the Patent Actb, makes the annexed Patented Medicine Prices Review Board Rules of Practice and Procedure. Ottawa, October 30, 2012 The definitions in this section apply in these Rules. Act means the Patent Act. (Loi) Chairperson means the Chairperson of the Board designated under subsection 93(1) of the Act. (président) concerned minister means a federal Minister or a provincial minister referred to in subsection 86(2) of the Act, as the context requires. (ministre intéressé) counsel means a member of the bar of a province. (conseiller juridique) hearing includes a conference held under these Rules. (audience) party means a respondent; Board Staff; a concerned minister; or a person who has been granted leave to intervene under Rule 20. (partie) person includes an unincorporated organization or entity. (personne) respondent means a rights holder, or a former rights holder, against whom an order of the Board is proposed to be made under the Act. (intimé) Secretary means the Director of Board Secretariat or anyone acting on her or his behalf. (secrétaire) Composition of Board 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 These Rules apply in respect of any proceeding before the Board. Quorum In any proceeding, a quorum of the Board consists of two members. Defect in form or procedure 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 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 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. Board powers In relation to any proceeding, the Board may receive any evidence that it considers appropriate; take notice of facts that may be judicially noticed and of any generally recognized scientific or technical facts, information or opinions concerning patented or protected medicines; add parties at any stage of the proceeding; permit the amendment of any document filed with the Secretary; and decide any question of procedure. Directions — information, documents and facts The Board may, at any time, direct that a party provide any information or documents, in paper or electronic format, that the Board considers concerned to any proceeding; and that a particular fact be established by affidavit. Affidavits All affidavits must be filed with the Secretary. Witnesses appearing before Board 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. Admissibility of expert evidence 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 More than two expert witnesses may not be called by a party, per issue, without leave of the Board. Report, declaration and availability Every party who, in a proceeding before the Board, intends to introduce evidence given by an expert witness must 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 a statement of the issues addressed in the report, a description of the qualifications of the expert with respect to those issues, the expert’s curriculum vitae attached to the report as a schedule, the facts and assumptions on which the opinions in the report are based, a summary of the opinions expressed, 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, the reasons supporting each opinion expressed, any literature or other documents specifically relied on in support of the opinions expressed, a summary of the methodology on which the expert has relied; 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 ensure that the expert witness is available for examination and cross-examination at the hearing. Duration of examination in chief Examination in chief of any expert witness may not, without the Board’s consent, exceed 90 minutes. Computation of time 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 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. Manner of service Unless otherwise provided in these Rules, the giving of notice or the service of any document under these Rules must be effected by personal service in accordance with Rule 11; by courier, in which case service is deemed to have been made on the day of delivery of the document; 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 in any other manner that the Board may direct. Service of filed documents 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 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 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 of a document must be effected by leaving a copy of the document in the case of service on an individual, with that individual; in the case of service on a partnership, with one of the partners; in the case of service on a corporation, with an officer or director of the corporation; in the case of service on a concerned minister, with the concerned minister or the person apparently in charge of the office; or 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 The address for service for a party is if there is counsel of record for the party, the business address of counsel as shown on the last document filed by counsel; if a party is unrepresented, in the case of a concerned minister, the address of the concerned minister’s office, or in the case of any other person, the address of the person as shown on the notice of hearing; and if a notice of change of address for service has been filed with the Board, the new address. Notice of appearance Counsel must file a notice of appearance with the Secretary before representing a party before the Board. Beginning of representation 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 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 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 Any party that is not an individual must be represented by counsel in all proceedings. Manner of filing The filing of a document with the Board must be effected by personal service of the document on the Secretary; by delivery of the document by courier or by registered or certified mail to the Secretary; or by transmitting the document electronically to the Secretary. Electronic filing Any documents that are filed with the Board electronically must meet the following requirements: the electronic and paper versions of documents must have the same cover page, table of contents and page numbers; the filename of an electronic document must include the name of either the patented or protected medicine or the company if the hearing does not relate to a specific patented or protected 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 documents must be filed as PDF (Portable Document Format) documents or in any format authorized by the Secretary. Deemed filing date 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 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 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 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. Signed notice of hearing Proceedings are initiated by issuance of a notice of hearing signed by the Secretary. 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 A notice of hearing must be accompanied by in the case of an allegation of a patented or protected 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 in the case of an allegation of a failure to provide information and documents related to a patented or protected 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 A notice of hearing issued by the Board must specify the date and time of the teleconference referred to in Rule 22; contain a statement of the purpose of the hearing; 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; be accompanied by a schedule of events; and contain any other information that the Board considers appropriate. Public notice The Secretary must give public notice of each hearing in the Canada Gazette and in any other manner that the Chairperson may direct. Contents 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 the notice of hearing; any document filed with the Secretary by a party in relation to the proceeding; any direction, decision, notice or order of the Board in relation to the proceeding; the transcript of any pre-hearing conference; the transcript of the hearing in relation to the proceeding; and any other document or information that is directed by the Board to be placed on the record of the proceeding. Filing of response 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 A response must be set out in consecutively numbered paragraphs and must include an admission or denial of each ground or material fact set out in the statement of allegation or notice of application; the grounds on which the proposed order is opposed and the material facts on which the respondent is relying; the name and address of the person on whom service of any document in relation to the proceeding may be effected. No response filed 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. Filing of reply 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 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 If Board Staff does not file a reply, it is deemed to have denied each ground and each material fact alleged in the response. Motion for leave to intervene 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 A motion for leave to intervene must set out the name and address of the proposed intervener and of any counsel representing the intervener; a concise statement of the nature of the proposed intervener’s interest in the hearing and the reasons the intervention is necessary; a concise statement of the facts upon which the motion is based; and the issues that the proposed intervener intends to address. Filing of motion 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 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 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 whether the person has an interest in the proceeding that is sufficient to warrant the intervention; whether the intervention will prejudice any party to the proceeding; and whether the intervention will interfere with the fair and expeditious conduct of the proceeding. Filing of notice of appearance 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 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 concise statement of the representations that the concerned minister intends to make and the material facts on which the concerned minister is relying, and 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 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. Teleconference 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 fixing the hearing schedule; establishing the official language the parties wish to use during the proceeding; discussing the filing of evidence by the parties; considering the procedure to be followed and means of expediting the hearing, including determining whether written submissions will be submitted; determining the expected duration of the hearing; facilitating the exchange among the parties of information and documents to be submitted at the hearing; and identifying other issues to be resolved. Purpose 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 identifying or circumscribing the issues; 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 resolving any other issue that may facilitate the conduct of the hearing. Teleconference or written submissions 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 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 The Board may, if necessary, postpone, suspend or adjourn and may reconvene a pre-hearing conference on any conditions that the Board considers appropriate. Issuance of subpoena 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 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 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. Notice of motion Interlocutory matters must be commenced by notice of motion. Content of notice of motion A notice of motion must 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; 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; 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 be signed and dated by the moving party. Filing requirements 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 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 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 The Board, before or during the hearing of a motion on an interlocutory matter, may grant leave for a witness to give testimony orally in relation to any points at issues raised in the motion; and the cross-examination of any person making an affidavit. Pre-hearing conference 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 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. Location of hearings Hearings must be held at the principal office of the Board. The Board may, if necessary, postpone, suspend or adjourn and reconvene a hearing. Notice of postponement If the Board postpones a hearing, it must give notice of the postponement to the parties as soon as possible. Written submissions 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. New hearing 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 The Board may give directions, issue decisions and make orders in any form that it considers appropriate. Written reasons 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 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 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 The Board may vary or rescind any procedural direction, decision or order given, issued or made under these Rules; and correct a technical irregularity in any direction, decision or order given, issued or made by the Board. Registration These Rules come into force on the day on which they are registered. (Style of Cause) I, (name), resident in (city), in the (province/territory) of (name of province or territory) declare that I have been retained by (name of party/parties) to provide evidence in the matter (style of cause); it is my duty to provide evidence in relation to this proceeding as follows: to provide opinion evidence that is impartial, to provide opinion evidence that is related only to matters that are within my area of expertise, and to provide any additional assistance that the Board may reasonably require to determine a matter at issue. 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).