RWE Committee Update and Launch Date

Jennifer Carroll

December 1st UPDATE:

PAAB is excited to announce that the Board has approved the changes to the Code that will allow for the application of the RWE guidance document as well as the use of those same formatting requirements for other data presentations such as subjective endpoints from open-label studies.

The Code change will come into effect on February 1st 2024. PAAB will not be accepting presentations with data under the Code changes until this date, to allow all companies adequate time to train their staff and assess their portfolios.

PAAB will be working over the next month, to create some additional training documents to assist in application of the new guidances and Code updates and removing “draft” watermark. The Code will be updated to reflect the new wording (found here) on February 1st.

We would like to thank the RWE Committee once again for all their work and feedback throughout the process, as well as the manufacturers, agencies, and associations who provided extensive feedback throughout the rounds of revisions. We feel the new framework will allow for the inclusion of RWE in advertising in a truthful, transparent and trustworthy manner that will work in the best interest of all Canadians who rely on informed healthcare professionals. With your collaboration, we believe this places Canada at the forefront of marketing best practices and we could not have done it without you.
We look forward to working with you throughout the implementation. Let us know what you think below.

October 13 UPDATE:

PAAB is pleased to announce that the draft PAAB Guidance on Real-World Evidence/Data has been forwarded on to Health Canada for consultation.

In addition to the RWE document, PAAB has also leveraged the work of the committee to inform additional proposed adjustments to review practices in order to further expand the information that can be shared with HCPs.

Both draft documents and proposed Code updates can be found here.

As a reminder, upon completion of consultation with Health Canada on the guidance, we will be providing a 3-month training period prior to implementation. This will allow sponsors and agencies to train on the applications of the proposed changes. A full launch timeline will be communicated pending approval of the proposed changes.

June 12 UPDATE:

Industry feedback has been integrated into the draft RWE guidance document. The depth of progress and the parallel consultation process with other guidance changes required us to give industry more time than initially expected for feedback. These are big changes so we extended timelines to make sure we got ample feedback. PAAB has now launched HCP consultation on the draft guidance. We optimistically anticipate completion of the HCP consultation by end of June/early July. At this time, feedback will be integrated and a final review of the draft will be completed by the expert RWE Committee. Once confirmed, the draft will be sent to Health Canada for review.

Please note that upon completion of the guidance, we will be providing a 3-month training period prior to implementation. This will allow sponsors and agencies to train on the applications of the proposed changes. A full launch timeline will be communicated pending approval of the proposed changes.

April 26 UPDATE:

The consultation period for the RWE draft document has closed. PAAB would like to thank all of the organizations and associations who provided feedback, totaling over 25 responses, for your valuable thoughts and suggestions.

We have started to consolidate the feedback and will be developing proposed revisions, clarifications, and elaborations based on the feedback.

Please stay tuned for updates and next steps which will be communicated through the PAAB Forum and our eBlasts.

March 13 UPDATE:

The RWE Committee has completed the draft guidance and it is now available upon request for external feedback. If your organization would like to provide feedback, please coordinate a point person to reach out to Pauline Dong (paulined@paab.ca) and myself (jenniferc@paab.ca) to acquire the draft document to collect feedback from your organization. We ask that all feedback be collated into a single response provided prior to the consultation deadline.

The consultation period will be from March 13th through to April 3rd. This consultation period was selected with the understanding that this guidance

In November of 2022, PAAB struck a committee to generate a framework for acceptance of Real-World Evidence (RWE) in healthcare professional advertising. While the framework will focus on evidentiary standards and disclosure criteria pertaining to RWE, it will set the stage for guidance pertaining to other forms of evidence which don’t meet evidentiary gold standards but have value to clinical practice. The committee is dedicated to ensuring the framework promotes the use of RWE in advertising in a manner that is truthful, transparent, trustworthy, and in the best interest of all Canadians who rely on informed healthcare professionals.

The committee consists of industry experts from manufacturers and agencies.

Amyn Sayani Ph.D. Director, Medical Evidence Scientific Affairs AstraZeneca Canada	Chrysanthy Christopoulous Medical Advisor and Strategist Lemieux Bedard
Jefferson Tea Vice-President, Medical & Scientific Affairs Takeda	Matt Slipek Sr Planner, Strategic Planning Havas
Manushvi Gupta Regulatory Manager Reckitt	Nina Hemery Medical Advisor Fisika
Virginie Giroux Director of HEOR Merck	PAAB: Patrick Massad - Commissioner Pauline Dong - Director of Policy Jennifer Carroll - Director of Communications

As the committee finalizes the draft document, we will head to industry consultation and consultation with healthcare professionals.

Please stay tuned for further development and updates along the development timeline. If you have any questions or comments, please post them in the chat below.

Jennifer Carroll

@Agency and @Manufacturer - Please see update above

vi-minh-tri.su 0

Hi PAAB. Thank you for the update. Do you have visibility on the timeline moving forward? How long is the Health Canada review supposed to take? And how long will it take PAAB to implement the revisions from Health Canada (if any)? Any information about the timeline would be much appreciated.

Jennifer Carroll

Hello @vi-minh-tri-su-0

We cannot control the timing or nature of the Health Canada response. We are hopeful that we can launch the document in January 2024. Information will continue to be shared as it is available.

vi-minh-tri.su 0

@jennifer-carroll Thank you for the information.