Thank you so much @jennifer-carroll for your detailed answer! I’ll probably send an email then with the eFile number and additional details soon.

Hi @dmauri

Hashtags can be considered in consumer spaces. It is important to note that if a sponsor creates or propagates a hashtag, they are responsible for all content linked to its use. This means that they take on all of the regulatory risk associated with the unrestricted use of the hashtag. In the context of a disease awareness campaign which is not linked in any way to a brand, there may be low regulatory risk. However, linking to the company increases the risk and should a post or link to the sponsor’s brand occur, it may prove difficult for the sponsor to remove this link. We would encourage a discussion with regulatory and legal to assess the appetite for regulatory risk.

Similarly, the same risks occur when you have the hashtag #CompanyATherapeuticAreaX as the sponsor has no control over the hashtags use.

Good afternoon @dmauri

Please see the PAAB Advisory on Disclosure of APS Placement Details. The answer will be dependent on the ad and where it is being placed. A general question you could ask yourself is, “Am I creating a link between the brand and articles which may be considered off-label by virtue of exclusive placement?”.

Note that the concern is the potential for placement to create a notable link between the brand and articles/content on the page(s) which could exceed the federal advertising regulations. This potential is amplified by exclusivity of ad placement.

Hey @mimic909, @palanski is correct that if there is proper gating, the ad may appear on the site.

Be careful not to apply this to the entire site, as we can see that there is advertising on the journal website referenced in your question prior to gating/before the paywall.

Hello @starship1

Please keep in mind that it is the sponsor’s (manufacturer’s) responsibility to ensure a robust validation mechanism for gating access to information that is intended for Canadian HCPs. An individual self-declaring that they are an HCP (without any additional verification) is not considered a valid gating mechanism. LinkedIn does not validate users’ information and therefore cannot be used as a mechanism for validation. It may be possible to target unbranded content to HCPs on LinkedIn, however it would require a dual review for a DTC audience and an HCP audience as the users would not be validated. In this case, any “linked” content which exceeds the consumer regulations would still require the user to be validated as an HCP. See the document Guidance on Gating Mechanisms for Healthcare Professional Targeted Digital Assets.

Good morning @starship1

A third-party website validation alone may not always be considered as a “robust gating mechanism”. Not all users of Medscape are validated HCPs. The sponsors should verify with the third-party platform, their validation mechanism and ensure ads are only placed in spaces which meet the outlines stated in the document Guidance on Gating Mechanisms for Healthcare Professional Targeted Digital Assets. Links from ads in a space that meets the requirements for HCP validation, are not required to revalidate the HCP.

Hi @supraja,

DTC SEO and SEM are subject to the Food and Drugs regulations, the Therapeutic comparative advertising: directive and guidance document and the Interim guidance – Fair balance in direct to consumer advertising of vaccines. Yes, they may include indication and patient population provided they do not contravene the federal regulations, particularly section 9(1) of the Food and Drugs Act. No, they may not contain competitor brand/generic/manufacturer names. Please see SEM Keywords PAAB Forum post and PF Q 456. The PAAB code applies to HCP advertising and patient information. DTC advertising is subject to the Health Canada regulations regardless of the preclearance agency who performs the review. When DTC advertising is used to drive HCPs or patients to a website, it is considered to be a dual audience and may be subject to the PAAB Code and Health Canada DTC regulations. If you are unclear if your tool falls in the dual category space, PAAB can provide an opinion.

@Jennifer-Carroll Thank you kindly for the response.

This helps provides our team with some starting points to consider. Should we need further response, we will be sure to submit an opinion, or arrange a consult meeting as suggested.

@jennifer-carroll thank you!

@jennifer-carroll Thank you!

Thank you! @jennifer-carroll

Hello @au3010

Yes, a non-indexed, non-guessable URL with controlled distribution (e.g., through HCPs), would not require a DIN gate. The manufacturer is responsible for ensuring the controlled distribution of the URL.

@jennifer-carroll Thank you for the quick response!

Hi @au3010,
It is possible to create an HCP directed website with multiple products. Each individual product section would be treated as a separate APS (both from an administrative and from a fee perspective). As this appears to be a specific project with multiple components where acceptability may be context driven and the submission process may be more complex, we suggest submitting for a written opinion to elaborate on the structure and high-level messaging so that we can provide more tailored feedback in consideration of the particular products that this tactic will pertain to.

Hey @taylor-murphy

Assuming “restricted access informational website” refers to a post-gate medical information site (non-advertising), a keyword-based search functionality is still considered best practice. As a reminder, the medical information letter (MIL) responses should only be provided in response to a specific request. Therefore, the keyword-based search functionality should be set out to require narrow searches that yield narrow search results. For example, the user would have to search “[drug name] AND order AND prepare AND dispose” (using the Boolean operator “AND”) for this MIL response to come up. Searching any one word, “order”, “prepare” or “dispose” should not bring up this article as the topics discussed within the MIL response go beyond the single term searched.

HI @au3010

Assuming that the HCP has already been validated, it is acceptable to grant them access to a patient website. When this is being done, the context of the information that they are going to be provided, should be clearly defined. This means that there should be clear copy informing the HCP that they are being granted access to content designed for patients.

Hello @nkh
It would not be acceptable to purchase other sponsors brand/generic name even if it was a product for use before or along with the sponsors product as this would create a link to the therapeutic use of the sponsors product for patients who are on the other brand but not the sponsors. This would be considered direct to consumer advertising which goes beyond name, price and quantity and which advertises the therapeutic use of the product.

Hello @jriordan

Yes, pharmaceutical product can have a webpage. Section C.01.44 of the Food and Drugs Act Regulations restricts the advertisement of a Schedule F drug (prescription drugs), to the general public to name, price, and quantity. If they are prescription and go beyond the limitations of the consumer regulations (name, price, quantity), the content should appear behind a gate to limit to the acceptable audiences (patient information or HCP advertising).

Google Ads or search engine optimization (SEO) generally occurs in the ungated public space and means that the totality of the content (search terms, descriptor, gate landing page and URL) cannot exceed the consumer regulations.

Good Morning @charlton

If the surface of the ad does not prompt the inclusion of indication and fair balance, then yes, it would be acceptable to not include the indication and fair balance on the static ad. If there are claims/therapeutic mention on the static ad or the combination of the static ad and the landing page, this would prompt the inclusion of the indication and fair balance on the first surface with a marketing benefit claim. As a reminder, a marketing benefit claim can be explicit (e.g. text) or implicit (e.g. images).

@jennifer-carroll Thank you!