Hello @llotter
No, the video is not considered exempt. If the review of the deck did not include the voiceover and/or there are any other additional features (e.g. animations, zoom, pop-ups, footnote presentation etc.), these could all impact the review. This video would require it’s own review.

Hello @username

It is possible to allow the doctor to choose aspects of the patient to build a patient case. However, variable elements which may be subject to quantification, would be required to have support within the piece. These are things like goal statements, comorbidities, concomitant therapy, consequences of the disease/condition, or observed outcomes. Also, undue emphasis (e.g. repetition, a common theme/trend, etc.) on any patient characteristic(s), would require product-specific support within the APS. This includes the “occupation” field if there appears to be a theme/trend related to this field.

Each permutation with quantifiable claims would require a separate submission.

Hi @jennifer-carroll!

Thanks for your reply. Makes total sense. The IMC ethics code for Market Research is quite brief so I appreciate you explaining the practical application. Agree with your conclusion, especially regarding breadth of audience, in this example.

Good Morning @georgian21

Rep emails are considered PAAB exempt when they are true one-to-one communications. If this is not truly a one-to-one communication (pre-prepared, sent to many etc.) it would not be considered exempt. (See Dissemination” in the document Clarification regarding digitization of APS: Helping healthcare product manufacturers plan for the evolving COVID-19 operational context)
To address the various scenarios:

This would be acceptable This would likely be acceptable upon confirmation from the Canadian medical body in the respective field (What constitutes current medical opinion) An assessment of the link and linked content would be made during the review process Link to specific sections would not be acceptable. Linking to the homepage of authoritative consensus guidelines may be considered

Yes @Donna, that would be fine.

@tmcd Please see response to PAAB Q&A 302.

Hi @NatBourre, the distinction is “company logo” versus “company name”. The code does not require a company logo. However, the company name is required on all pieces unless it contravenes other regulations, such as help-seeking messages. The distinction between “logo” and “name” was particularly relevant to the question as it featured concerns about displaying the corporate logo in the midst of a corporate branding change.

@SKW

If independent third party content on COVID-19 is being provided to a patient through a branded patient support program, an assessment of the linkage should be performed to ensure the acceptability of the content within the context of the brand. This remains true even if being sent without the brand logo (i.e. they are being sent the content because they are part of the branded patient support program). PAAB would do an assessment of the linkage to the content which could be done through an opinion file and would be subject to the four day turn around time.

Hello @SKW
In answer to your question, please note that the same email sent individually to several doctors would not be considered a 1:1 message. The message described above could be considered exempt if it meets the limitations of a corporate message with no product mention (e.g. identifying or alluding to a product name, class, category). See code section 1.5E. We strongly urge that the email copy goes through the manufacturer’s internal compliance channels. If there are any doubts that the message is truly corporate and does not allude to products, it can be submitted to PAAB for an opinion (4 day turnaround).

@Jennifer-Carroll said in There are a lot of clinical trials underway on Medical Cannabis. If some of these trials are successful and Medical Cannabis companies can start making claims will they be required to submit their APS's to PAAB?:

Medical cannabis is a healthcare product. Healthcare professional (HCP) advertising for medical cannabis therefore falls within the scope of the PAAB Code of Advertising Acceptance. Currently, medical cannabis advertising may not contain claims, even when directed to healthcare professionals. Advertising materials that do not contain claims are exempt from preclearance for any product category (excluding opioids).
However, specific medical cannabis products that are granted a form of Terms of Market Authorization (TMA) based on evidence relating to particular therapeutic uses will presumably be permitted to make claims in HCP advertising. Of course, those materials would exceed the exemption criteria outlined in the PAAB code and would not be exempt from preclearance.

Thanks Jennifer - this is very informative. We will share this with our customers.