Note from the Commissioner

We have moved into 2016 with gusto, a year which marks 40 years of PAAB service in Canada. It is a busy time of year for submissions reviews and we have a number of projects ongoing, starting up or in the planning stages. We have a great staff and I expect the PAAB to continue its excellent performance within the preclearance review mechanism. Unfortunately, we are losing a very experienced manager in Glenn Golaz and we will miss him. To help people assess their knowledge of the PAAB Code and to assist them in identifying learning needs, we are into planning the gamification of the PAAB code with the support of Facilica. We hope to launch that in the next three months. That will be followed by a plan to implement a new e-training program that has been requested by clients through survey responses. We are into phase 3 of upgrades to the e-file system and we thank you for your helpful suggestions. We implemented a new dashboard for manufacturers to allow them to see their own files. In April, we are expecting the report from our early 2016 client survey and we may see more opportunities to improve our service. There is an ongoing PAAB Code review committee that has recommended a change in the format, structure and flow of the PAAB Code to modernize it and make it easier to use. It is too early to announce anything definitive arising from that project. The Health Canada bilat meeting is scheduled in April. Also, we hope to see you on June 27, 2016 at the PAAB 40 years celebration golf tournament at the beautiful Coppinwood golf course. Sign up now at www.paab/training/golf.ca. Sponsorship opportunities exist if you want to help make this event a great success. It is not a fundraiser for the PAAB and all funds will be put into the tournament to make it a lot of fun for all registrants. We hope the industry appreciates what the PAAB has done for it to promote the practice of ethical drug advertising over 40 years. We have not raised fees directly since 1998 when I became commissioner. Review compliance is high and complaints about advertising are low and I think there is a correlation there. PAAB has had a successful 40 years and you should come to the golf tournament to celebrate with us.

Glenn Golaz leaves the PAAB

Our manager of finance and administration has left the PAAB after many years of dedicated service. He has moved on to bigger and better things near to his residence. We will miss Glenn. A search for a replacement is under way.

Sincerely,



Ray Chepesiuk

PAAB Commissioner

PAAB Stats

January 1 through March 31, 2016

Number of submissions: 1848

Time to first response: average of 6.5 days. No files beyond day 10.

Time to revision response: average 2.4 days

Complaints
During the period January 1 to March 31 2016 there were no Stage 2 complaints.

Claims regarding RAMQ coverage PAAB has been asked by RAMQ to ensure that:

  1. All pieces including the copy "RAMQ" must acknowledge that this is the “Official Mark of the Régie de l’assurance maladie du Québec”. This may appear as a footnote on the same page.
  2. Coverage claims must be accompanied by reimbursement criteria (if applicable).  This information may appear in a footnote on the same page.
Additionally, the layout must not suggest that the authorized Federal indication is the reimbursement criteria (except where this is indeed the case). 

Please note that RAMQ prefers that the piece also includes a URL linked to the RAMQ webpage containing the PDF “Liste des médicaments” along with the date of access.  As a courtesy, this often appears in the reference list (i.e. not necessarily the same page as the claim).  
The Innovative Manufacturers eFiles Access System

The PAAB has developed an eFiles innovation to help manufacturers directly access their PAAB submissions files. We call it the Manufacturers eFiles Access System.  It is available at no cost to PAAB manufacturer clients.
 
Manufacturers will be able to access, in confidence, their own efiles sent through their agencies and also view data widgets and reports related to their own activity at the PAAB.  This includes, number of revisions, turnaround to first review and total time file is at PAAB and at the company. They will also be able to view PAAB letters that were sent to their agencies. There is an opportunity to see how their company compares to the industry average in several categories.
Each manufacturer will have to designate a senior official, director or above, to approve their registration at the PAAB through a secure access server.  Please pass on this information to your association members. They should contact Laurie Johns at 905-509-2275 x123 to register and get their access information.
Review Tips and Cases
Tips relating to inclusion of expert commentary in drug advertising
An individual's opinion may be acceptable when ...  Read more

References checklist
Clients can used this tool to help ensure the completeness of references within their submissions ...   Read more

APS checklist
Clients can use this tool to help ensure the completeness of their APS submissions ...   Read more

PAAB is here to help you with the submissions process, and we have heard your requests for case examples. In response, we have begun adding review tips and cases to the PAAB website. Every month, we'll add at least one new entry formulated specifically to address current submission trends or key issues. If you have any suggestions for future posts, please contact Deputy Commissioner Patrick Massad at  patrickm@paab.ca.

PAAB Views April 2016