Transcript Fair Balance (FB) - PAAB Training 2016

Complaints and Monitoring
(s.9 and 10)
Malika Ladha
[email protected]
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?
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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
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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
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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
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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.
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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
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2010: total 8 2011: total 8 2012: total 5 2013: total 2 -
2 with logo, one of those upheld
4 with logo, two of those upheld
3 with logo, two of those upheld
0 with logo
Total # of unique first submissions reviewed between
2010 and 2013 was ~27,000
Monitoring
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2010: 16
2011: 8
2012: 3
2013: 5
Questions?