Complaints and Monitoring (s.9 and 10) Malika Ladha PAAB Reviewer

One of the key activities of the PAAB include: “Training, adjudicating complaints, administering penalties, reporting of infractions, and other activities to encourage compliance with this code” - PAAB Code

Complaints PAAB Code section 9

Who can lodge a complaint? health professionals health care organizations pharmaceutical companies* federal regulatory bodies including Health Canada drug payer organizations including provincial ministries of health *Complaint must be signed by a senior official (a person fulfilling one or more of the following functions in an organization: Chief Executive Officer, Vice President, Head or Director of Marketing, Medical or Regulatory) Code section 9.1

Complaint process Stage 1: Intercompany dialogue (Code s9.4 and 9.5) Stage 2: Reassessment by PAAB (Code s9.6) Stage 3: Appeal to external panel (Code s9.7) Reporting – PAAB Quarterly Newsletter – PAAB Members – Rx&D Code of Ethical Practices (section 2) – Health Canada

Stage 1: Intercompany dialogue Complainant company will address the letter of complaint to the advertiser Advertiser will make a written response to the complainant – 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 PAAB Code. Complainant will then assess whether to – continue discussion with the advertiser – accept the advertiser’s response and therefore not pursue the complaint; or – conclude that further intercompany dialogue will not be productive and therefore proceed to Stage 2

Stage 2: Reassessment by PAAB Commissioner will conduct a reassessment of the complaint and may issue rulings Commissioner will examine the letter of complaint and the advertiser’s response Commissioner will attempt to clarify the issue and narrow down the areas of disagreement

Stage 2: Reassessment by PAAB 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 an agreement between complainant and advertiser is not thought to be feasible, 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

Stage 3: Appeal to external panel Either the complainant or advertiser has the right to appeal the Commissioner’s reassessment ruling to a Review Panel – Review Panel is comprised of three qualified individuals selected by the Commissioner from a larger pool of individuals named by national organizations in response to a request from the PAAB Decisions by review panels are binding and final Written submissions and oral presentation from the appellant and the other party Panel will make a decision

Sanctions Rapid cessation of advertising Recovery of material Corrective statements Published complaint outcomes Public reprimand through members Referral to Health Canada Referral to trade association—fines 10

Direct transfer to Health Canada Complaints including safety allegations Complaints about Direct-to-Consumer prescription drug advertising Complaints about advertising of unapproved products Noncompliance with PAAB rulings - applies to all companies

Monitoring PAAB Code section 10

PAAB Code section 10.1 i.The PAAB monitors all APS to determine whether they have received PAAB clearance. ii.Any company whose APS has been published without PAAB clearance is contacted immediately by the PAAB and requested to suspend further distribution of the APS until it has received PAAB clearance. The PAAB will send a copy of this letter to the publishers or their agents.  Penalties for violations will be dealt with under Sections 9.9 of the Code. iii.If a PAAB-accepted APS does not bear the PAAB logo the PAAB will contact the advertiser and request that the logo be inserted at the earliest opportunity.

Let’s look at some data…

Complaints Stage 2 Decisions - Past vs. Now 2010: total with logo, one of those upheld 2011: total with logo, two of those upheld 2012: total with logo, two of those upheld 2013: total with logo Total # of unique first submissions reviewed between 2010 and 2013 was ~27,000

Monitoring 2010: : : : 5

Questions?