The PAAB has drafted a general framework which we believe has the potential to develop into global best-in-class guidance documents on RWE. It is predicated on a fresh approach which substantially broadens the sorts of data that could potentially be included in APS by managing how that data is presented AND how the potential validity and reliability issues are disclosed. This could benefit Canadians by promoting informed healthcare professional decision-making. Consequently, it also has the potential to promote the perceived value of HCP advertising.

This concept leverages the safety net provided by Canada’s broad adoption of advertising preclearance.  As Canadians we all want our unique system to be viewed globally as a tool that enriches the data available to HCPs by providing appropriate context and necessary disclosures for informative data presentations while still filtering out the lowest quality data and any data that is overtly inconsistent with the Terms of Market Authorization.  Our most ambitious aim is to turn our Canadian system into the envy of the rest of the world.  But we’ll need your help to do so!

If you are an expert in appraisal of RWE and the above two paragraphs energize/motivate you, we are looking forward to building on our proposed standards with you. Together, we’ll shape this guidance document for HCP consultation and Health Canada consultation. The expert committee will begin meeting in mid-November.  We forecast that we’ll need approximately 3-hours per month of your time until February. Please reach out to patrickm@paab.ca if you are interested.  In your email, please outline your experience relating to RWE for our consideration.  We’d also love to hear from writers who would be willing to write and/or proofread the external facing versions of the guidance documents. 

October 6, 2022