A) Introduction

This section contains a guide for the resolution of complaints against pharmaceutical advertising that is subject to preclearance by PAAB. In following these administrative procedures, it should not be necessary for organizations to act through legal counsel. As with all self-regulation, organizations are encouraged to act in the spirit of the Code to seek resolution and abide by those terms, even in specific situations that are not directly anticipated within this section.

PAAB will rule on all complaints relating to materials sponsored by health product manufacturers that fall within the scope of the Code.

See Health Canada Guidance Document for more information.

B) Access to Complaint Procedure

Complaints against Advertising/Promotion Systems (APS) may be lodged by: health professionals, health care organizations, pharmaceutical companies, federal regulatory bodies including Health Canada and drug payer organizations including provincial ministries of health.

C) Complaint Letters

1. Format and Content of Complaint
   Complaints must be in written form. The complaint should set out in a clear manner such that the aspects of the APS that are the subject of complaint are defined clearly and refer to the sections of the Code that the APS is alleged to violate.

2. Attachments to the Complaint
   A copy of the APS under dispute should be attached. Articles or other information cited in the complaint also should be attached, unless these sources have been cited as references in an APS reviewed and accepted by PAAB.

3. Complaints against APS not reviewed by PAAB
   Complaints may also be lodged against promotional material that does not carry the PAAB logo and appears not to have been accepted by PAAB. In these cases, complaint letters should first assert that the piece should have been reviewed by PAAB, and then may complain against subject material of the Advertising / Promotion Systems (APS) alleged to violate the Code. As soon as the advertiser has been notified of the complaint against an APS that had not been issued a PAAB acceptance, any further use of that APS must cease until the complaint has been reviewed and a ruling issued.

D) Signing Authority

A senior official of the complainant organization must sign complaints. If the organization has directed a third party, such as an advertising agency, to prepare a complaint, the senior official must sign to indicate his or her concurrence.

 E) Process if Complainant is a Pharmaceutical Company

Complaint Resolution Stage 1:

1. Intercompany Dialogue
   PAAB wishes to encourage direct communications between the complainant and the advertiser. The complainant company should address the letter of complaint, described in Complaint Letters, directly to the advertiser, with a copy sent to the Commissioner.

2. Advertiser’s Response
   The advertiser shall make written response to the complainant no later than 10-business days after the complaint is received at the advertiser’s place of business. A copy of the response should be sent to the Commissioner. The response shall address each part of the complaint, and indicate whether the advertiser intends to revise the APS or, if not, why the APS does not violate the Code. Such a response might show, for example, how the contested claims are adequately supported by the references cited in the APS.

3. Procedure if Advertiser Not Notified
   If the complainant does not notify the advertiser but sends a letter of complaint to the Commissioner, the Commissioner will provide a copy to the advertiser. The 10-day period for response will begin on the date of receipt of this copy at the advertiser’s place of business.

4. Special Intercompany Dialogue Procedures
   Companies are encouraged to meet in an attempt to resolve the dispute. If a resolution is found, or an extension to the 10-day response period is needed, the complainant should notify the Commissioner.

5. Options Facing Complainant
   When the complainant receives a response from the advertiser, the complainant may wish to assess whether to:
   
   i) Continue discussion with the advertiser, possibly by writing another letter narrowing the points of dispute;
   
   ii) Accept the advertiser’s response and therefore not pursue the complaint; or
   
   iii) Conclude that further intercompany dialogue will not be productive and therefore seek review by the Commissioner in Stage 2. The complainant should send a letter of intent to proceed to Stage 2. The Commissioner should receive the letter within 10-business days of the date of receipt of the advertiser’s Stage 1 response by the complainant. The Stage 2 allegations should be clearly stated. Failure to comply with this section will result in the Commissioner voiding the complaint. If the complainant requests action after the 10-business day deadline, they may file a new Stage 1 complaint.

6. Registration of Complaints to Proceed to Stage 2 Resolution
   In order for a complaint to pass to Stage 2, the complaint must be registered by sending written confirmation to the Commissioner that the company wishes to pursue the complaint. A registration fee of $500 will be charged to the complainant company at this time; the fee is refundable if the complaint is found valid.

7. Procedure if Advertiser Does Not Respond
   If no response from the advertiser is received by PAAB or the complainant within 10-business days of the date of receipt of the complaint, the complainant company is entitled to move immediately to request registration of the complaint.

8. Registration of Complaint in Exceptional Circumstances
   The Commissioner is permitted to register a complaint (and proceed to the Stage 2 review), before the 10-day period for advertiser’s response has elapsed when regulatory or independent medical advice suggests that the claims may constitute an imminent and/or significant health hazard. No registration fee will be charged in these cases.

F) Process if Complainant is not a Pharmaceutical Company Complaints resolution Stage 1:
  

1. Initiation of Complaint
   The complainant may address the letter of complaint, described in Complaint Letters, to the Commissioner.

2. Notification of Advertiser
   The Commissioner will then send a copy of the complaint letter to a Senior Official of the advertiser, unless the complainant specifically requests anonymity; in that case the Commissioner will provide an excerpt of the complaint to the advertiser.

3. Advertiser’s Response
   The advertiser shall make written response to the Commissioner no later than 10-business days after receipt of the complaint. The Commissioner will ensure that the complainant receives a copy of the response. The response shall address each part of the complaint, and indicate whether the advertiser intends to revise the APS or, if not, why the APS does not violate the Code, showing, for example, how the contested claims are adequately supported by the references cited in the APS.

4. Registration of Complaint
   In order for a complaint to pass to Stage 2, the complaint must be registered. In Complaints Resolution Stage 1, complainants other than from pharmaceutical companies are not liable to pay registration fees. If the advertiser does not respond by 10-business days after receipt of the complaint, registration is deemed to occur on the subsequent business day. If the advertiser does respond within 10-business days, the complainant may request registration by notifying the Commissioner. The complainant should send a letter of intent to proceed to Stage 2. The letter should be received by the Commissioner within 10-business days of the date of receipt of the advertiser’s Stage 1 response by the complainant. The Stage 2 allegations should be clearly stated. Failure to comply with this section will result in the Commissioner voiding the complaint. If the complainant requests action after the 10-business day deadline, they may file a new Stage 1 complaint.

5. Registration of Complaint in Exceptional Circumstances
   The Commissioner is permitted to register a complaint (and proceed to Stage 2 review) before the 10-day period for advertiser’s response has elapsed, for example, when regulatory or independent medical advice suggests that the claims may constitute an imminent and/ or significant health hazard. 

G) Complaints Resolution Stage 2:

The Commissioner’s Reassessment

1. Commissioner’s Reassessment
   Once a complaint has been registered, the Commissioner will conduct a reassessment of the complaint and may issue rulings.

2. Scope of the Reassessment
   In the reassessment, the Commissioner shall examine the letter of complaint and the advertiser’s response. The review shall include evaluation of the data supporting promotional claims and if the APS had been previously reviewed, an examination of the way the Code was applied. The Commissioner may consult with PAAB Reviewers to request a revised opinion based on additional considerations, or may engage external advice.

3. Outcomes of the Reassessment
   The Commissioner will attempt to clarify the issue and narrow down the areas of disagreement. If an agreement between complainant and advertiser is thought to be feasible, the Commissioner may recommend further dialogue, a face-to-face meeting or other conciliation attempts. If none is possible, the Commissioner will issue a ruling, rejecting or accepting all or part of the complaint and as part of this ruling may withdraw clearance for the APS. Also the ruling may address the issue of whether a registration fee under Section 1.7.E.6: Registration of Complaints to Proceed to Stage 2 Resolution

4. Timelines
   The Commissioner’s reassessment will be completed within 15-business days, although this period may be extended by two weeks if written notice is given to both companies. 

H) Complaint Resolution Stage 3:

The Review Panel

1. Right of Appeal
   This right exists for the use of pharmaceutical industry sponsors of advertising. Either the complainant or advertiser has the right to appeal the Commissioner’s reassessment ruling to a Review Panel. Notice of appeal must be provided within 5-business days after the date of the ruling, in a letter to the Commissioner from a senior official of the organization.

2. Composition of Review Panel
   The appeal will be heard by a Review Panel, comprised of three qualified individuals. The Commissioner will select these three persons from a larger pool of individuals named by national organizations in response to a request from PAAB; the pool may contain physicians, pharmacists or senior pharmaceutical marketing officials. The Commissioner will request one Panelist to act as Chair. Subject to availability of Panelists, the hearing shall normally be held within 6 weeks of receipt of notice of appeal.

3. Panel Decisions
   Decisions by review panels are binding and final.

4. Objection to the Selection of Review Panel Members
   Each party will be notified in writing of the selected Panel Members.
   Either party may object to the inclusion of an individual Panelist if the objecting party has a reasonable apprehension of bias on the part of such Panelist. Such objection must be registered in writing to the Commissioner within 2-business days.

5. Conflict of interest
   Each person acting as a Review Panelist will be required to attest that he or she has no conflict of interest in participating in the appeal process.

6. Costs
   The party that is unsuccessful at appeal (whether that is the complainant or the advertiser), is liable to pay $5,000 plus actual costs for the review panel and preparation. In the event that the Review Panel decides partially in favour of both companies, the panel shall determine the appropriate sharing of costs between the two companies. 

7. Written Submissions
   The appellant must assemble its case in writing, along with supporting literature. If this material is extensive, the appellant is encouraged to provide an executive summary of no more than 5 pages in length. Per Complaints Resolution Stage 2 this material must be delivered within 15 business days of the said ruling to the Commissioner (meaning 10 business days after expiry of the right to appeal) who will ensure it is distributed to Panelists and to the other party. The appellant is permitted one extension of 5 business days for the delivery of the written case if notice of the extension is provided to the Commissioner and the other party. 
   
   After receipt of the written case, the other party will have 15-business days to prepare a written response and deliver it to the Commissioner, and is permitted one extension of 5-business days for the delivery of the written response if notice of the extension is provided to the Commissioner and the appellant.
   
   If either the written case or the response is longer than 20 pages, including appendices, 5 copies of the complete package should be delivered
   
   The Commissioner will ensure that the written case and the response are delivered to the panel members and to both parties to the appeal, at least 7-days in advance of the panel hearing.

8. Oral Presentation
   The appellant will be called upon to make a brief and concise oral presentation of its case. The other party will then have an opportunity to respond. A PAAB Reviewer will be permitted to describe the basis for the original ruling. Panel members may then direct questions to any party. The Chair may permit questions or comments from one party to the other, subject to both sides being given equal opportunity.
   
   The oral presentations are intended to summarize the written arguments. Neither company may employ any new evidence that was not cited in the written case. 

9. Panel Decision Process
   After the oral presentation, the panel will retire for a private discussion before making its decision. The decision will be made by majority vote. The conclusions made by the Panel will be sent to both parties via electronic means within 5-business days of the hearing. A signed hard copy of the decision will be delivered to both parties thereafter.

10. Implementation of Panel Decision
    If the Panel decision is not clear concerning the implementation of the decision on the clearance status of a particular APS, or concerning the schedule for replacing the withdrawn APS discussed in Withdrawal of Preclearance, the Commissioner will write an implementation letter to specify the effect of the panel decision.

11. Attendance at the Hearing
    The two parties are asked to limit their representation at the meeting to three persons.

12. Public Reporting
    Information such as the parties involved, a summary of the major points at issue, and whether the appeal was upheld in Review Panel decision may be reported to the public.

13. Failure to Co-operate with Procedure
    It is anticipated that Stage 3 Review Panel hearings will be rare, and all companies are expected to co-operate with these procedures. The Commissioner may deem a company to have failed to co-operate with the procedure if, for example, it refuses to prepare a written response or to appear at the hearing, or objects in an unreasonable manner to the selection of panelists. If the company fails to co-operate and, in the opinion of the Commissioner, is likely to gain a material commercial benefit from this failure to co-operate, the Commissioner is authorized to proceed with the Review Panel hearing and decision without that company’s co-operation. In such a case, the Commissioner is directed to ensure a high degree of fairness in the processes of the Review Panel, in the selection of Panelists, and presentation of written and oral material before the Panel. 

14. Modifications to Review Panel Procedure if Complainant is not a Pharmaceutical Company
    Certain procedures in Complaints and Appeals will be modified when the complainant is not a pharmaceutical company:
    
    i) These complainants are not liable to pay costs in Costs.
    
    ii) If the advertiser has taken the issue to appeal (because the advertiser lost the Stage 2 Commissioner’s reassessment), and the complainant does not wish to play an active role at the Review Panel stage, the Commissioner will take steps to ensure that the complainants’ case is brought forward for assessment by the Review Panel, including the preparation and submission of a written response based largely on the initial complaint, and presentation of an oral submission.
    
    iii) If the complainant has taken the issue to appeal, and in the opinion of the Commissioner the questions at issue are principally policy issues that should be brought to the attention of the Board of Directors, the Commissioner is authorized to send the issues to the Board of Directors for discussion rather than to invoke the Review Panel Complaints Resolution Stage 3. After this discussion, the Board of Directors would authorize a response to the complainant. The referral to the Board of Directors is appropriate when the questions at issue, in the opinion of the Commissioner, relate more to the complainants’ views as to how the PAAB Code should be written rather than matters of fact or interpretation of the existing Code.

I) Appeals of negative PAAB preclearance rulings for a proposed APS

1. Right of Appeal
   Apart from appeals relating to third-party complaints that are defined in Sections 1.7.B to 1.7.H, an advertiser who has submitted a proposed APS has the right to appeal a negative clearance ruling, on first submission or resubmission.

2. Discussion with Commissioner
   Advertisers are encouraged to discuss their differences first with the Commissioner. The advertiser may request that the Commissioner review the file, and the Commissioner may confirm or revise the negative preclearance ruling.

3. Appeal to Review Panel
   If not resolved in: Discussion with Commissioner, and if the company wishes to appeal an issue further, a written notice of appeal must be signed by a senior official of the appellant organization asking that the matter be heard by a Review Panel.

4. Procedure for Review Panel
   The Commissioner will ask the PAAB Chair to convene a panel of three PAAB Directors to hear the complaint and make a decision. A decision shall be sought within 30 days. If the appeal is unsuccessful, the appellant company is liable to pay $5,000 plus actual costs.

J) Penalties, Remedial Measures & Public Reporting of Complaints

1. Appropriate Penalties
   In rulings on complaints and in the implementation of Panel Decisions, the Commissioner may set out penalties against companies for Code violations. The appropriate penalty will be selected in accordance with the degree of the Code violation. Examples of penalties could range from immediate withdrawal of offending advertising, to notices in annual reports or newsletters, to public letters of apology. The Board of Directors may develop a Guideline on Penalties that outlines for the Commissioner’s use a hierarchy of appropriate penalties, including penalties other than those mentioned above, with sanctions of increasing severity for serious or repeated violations. The Commissioner may inform the appropriate trade association to assess the complaint ruling for further penalties if warranted.

2. Remedial Measures
   When material has been disseminated that is substantially misleading, or where the information may cause inappropriate product use or constitutes an imminent and/or significant health hazard, the Commissioner may require remedial measures contained in letters of correction or published notices. The Commissioner must approve content and form of these remedial measures. The remedial measures should be distributed to the original target audience using the same or similar media and must be implemented within 30-days of the Commissioner’s instruction.

3. Public Reporting
   The Commissioner is authorized to make public reports of notable Code violations in vehicles such as annual reports and newsletters. These reports shall include identification of the advertiser, the method of distribution, whether the information was submitted for PAAB review, the reason why the information was found to violate the Code, penalties required and any other relevant information. Particular attention is to be given to repeat offenses, and to advertisers that refuse to comply with a Commissioner’s ruling or Review Panel decision.

4. Reporting to Board Members
   The Commissioner also will make annual summary reports of complaints and their disposition to Board members, including ex-officio members representing regulators. 

5. Health Canada
   Where complaints have been brought to PAAB for resolution, and the advertiser has not complied with rulings by the Commissioner or a Review Panel, the Commissioner shall inform Health Canada to request an investigation within the requirements of the Food and Drugs Act. The Commissioner is also expected to bring to the attention of Health Canada advertising believed to present an imminent or significant health hazard. Detailed procedures are described in the current Health Canada document, setting out PAAB and Health Canada roles and consultation related to advertising review. View Health Canada’s Guidelines.