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Trade Dispute Procedure for Therapeutic Comparative Claims Previously Approved by ASC

Please note that this Trade Dispute Procedure for Therapeutic Comparative Claims Previously Approved by ASC applies solely to complaints challenging the scientific validity of therapeutic comparative claims previously approved by ASC. Any other competitor complaint involving comparative advertising would be accommodated under ASC’s regular Advertising Dispute Procedure. To ensure that you are using the applicable procedure, please contact ASC before filing a complaint.

1. Complainant to Provide Required Documentation to Initiate Complaint under Therapeutic Comparative Trade Dispute Procedure

  • Complainant Advertiser submits the following to ASC:
    1. Letter of complaint signed or authorized by a senior executive officer in Canada.
    2. Sufficient evidence that reasonable grounds exist for ASC to accept a Complaint under this Procedure.
      Evidence Required: Either one of two options:
      • Option 1: Results of two head-to-head clinical trials conducted to not less than the same standards delineated in Health Canada’s Directive and Guidance Document. (Three copies.) OR
      • Option 2: Results of one head-to-head clinical trial (conducted to not less than the same standards delineated in Health Canada’s Directive and Guidance Document), plus a comprehensive review of the available body of evidence in the literature. (Three copies.)
    3. Name(s) of clinical reviewer(s) on ASC’s Roster who, in Complainant’s opinion, possibly has/have a conflict/bias. (Note: Defendant Advertiser has previously identified possible conflicts/bias with Reviewers on Roster during the claim approval process1.)
    4. Required Filing Fee – Please contact ASC’s Drug section regarding fee.

2. Notification to Defendant Advertiser about the Complaint

  • Copy of Complaint (letter only) provided by ASC to Defendant Advertiser.
  • ASC also requests Defendant’s written confirmation that Defendant will participate in the trade dispute process until the conclusion of the Mandatory Resolution Meeting(s), in the event that ASC accepts the Complaint. Note: If Complaints are received from more than one Complainant Advertiser about the same therapeutic comparative claim, ASC shall have the right to consolidate the Complaints.

3. ASC’s Review for Completeness

  • ASC satisfies itself that the Complaint file is complete.
    • If not, the file is suspended and both Parties are informed of the suspension. The Complainant Advertiser is then given 30 consecutive days to submit requisite materials to ASC. If ASC does not receive these materials within the 30-day period, the Complaint file is closed and all materials are returned to the Complainant. The Complaint can only be reactivated if the Complainant Advertiser initiates a new Complaint, accompanied by a new Filing Fee.

4. Notice to the Parties (if ASC accepts Complaint for further review)

  • ASC notifies both parties that the Complaint will proceed.
  • ASC secures Confidentiality Agreement from both parties that the process will not be disclosed to anyone other than the two involved Parties.
    • However, if a Mandatory Resolution Meeting does not result in an agreement between the Parties, and either Party elects to litigate the matter, then nothing more with reference to this Complaint may be volunteered or admitted in the legal proceedings by either or both Parties other than the fact that this dispute resolution process was undertaken without producing a mutually acceptable resolution.

5. Review/Assessment of Complainant’s Scientific Evidence

  • The Complainant’s evidence is forwarded to one of the non-conflicted clinical reviewers of ASC’s Roster for an initial assessment of the Complainant’s evidence. (Note: The selected clinical reviewer will not have a conflict in fact; nor will he/she have participated in the original approval of the contested claim.)
  • During the review, the clinical reviewer may request additional information/clarification from the advertiser. Such requests are facilitated by ASC.
  • The non-conflicted clinical reviewer advises ASC whether or not reasonable grounds now exist to proceed with a Complaint based on the evidence.
  • This determination, once made, is not appealable or reversible.
    • If the clinical reviewer determines that reasonable grounds exist to proceed with the Complaint, ASC gives written notice to both parties that a Mandatory Resolution Meeting will take place within 10 working days of ASC’s written notice to that effect.
    • If the clinical reviewer determines that reasonable grounds do not exist to proceed with the Complaint, the Complaint file will be closed and may not be reactivated by the Complainant Advertiser except by initiating a new Complaint with new evidence, accompanied by a new Filing Fee.

6. Mandatory Resolution Meeting(s) Convened by ASC

  • ASC convenes and chairs one or more meetings between the Defendant Advertiser and the Complainant Advertiser to provide the parties with an opportunity to reach a mutually acceptable resolution of the Complaint. The first of such meetings must commence within the 10-day interval noted above.
    • Parties may share their evidence at this stage but are not obligated to do so. If, through one or more Mandatory Resolution Meetings, the Parties are unable or unwilling to reach a mutually acceptable Resolution, each Party will receive ASC’s Summary Statement (marked “Unresolved Dispute”) reporting the outcome of the deliberations that ended at the conclusion of the Resolution Meeting(s).
    • If no mutually acceptable resolution of the complaint is achieved through one or more Mandatory Resolution Meetings, either Party may pursue its conventional legal options and remedies, including litigation.
1. If ASC is unable to identify a non-conflicted candidate from its clinical Roster, ASC reserves the right to expand the Clinical Roster, subject to vetting by involved parties for potential conflict/bias.