Internet, Audio, Visual, Audio/Visual (AV), Electronic, Social Media APS
These systems promote a company’s products and/or services to health care professionals, patients and/ or consumers.
A link should be provided to the complete Product Monograph when the activity is distributed as advertising or promotion. For patient information sites the sponsor may include both the Product Monograph and the “Information to the Consumer” section of the Product Monograph.
The nature and content of online activities depends on the audience that is being solicited. The three audiences that messages or information may be directed to include:
- Healthcare Professionals (HCP)
- Patients
- Consumers
The regulatory requirements for the content can vary by the nature of the content of the activity. The categories include:
- Advertising
- Medical and Disease Information
- Education and Learning Programs
- Corporate Information
For Federal regulatory requirements, see the Health Canada policy document:
The Distinction Between Advertising and Other Activities
These guidelines apply equally to web-sites and other electronic online activities within the sponsor’s control or influence where the intended audience is Canadians.
Media covered include, but are not limited to: banner ads, e-mail marketing campaigns, online patient drug therapy adherence programs, search engine marketing and optimization techniques, social media platforms, networks and bookmarks, widgets, gadgets, mobile platforms and applications, tablet software, blogs, wikis, Really Simple Syndication (RSS) feeds, CDs, DVDs, computer software, online detailing including but not limited to self-directed HCP or company representative directed, slide programs, video and television, coding systems (e.g. QR) and other online/Internet media/platforms.
When creating these APS, the sponsor should consider content, target audience and federal drug schedule within all of the requirements of the PAAB Code of Advertising Acceptance.
A) The name of the pharmaceutical company sponsor should be stated clearly on:
- Every page of the website controlled by the sponsor
- On every sponsored web-page of a site with no access control
- Except where regulatory requirements or third party owners prohibit use of the company name.
B) Preclearance reviews:
- Conceptual frameworks including topics and outlines relating to sponsored social media platforms, chat rooms, postings, bulletin boards and other forms of interactive on-line communication programs must be submitted for preclearance. Those elements or portions that are under the direct control of the manufacturer are required to be pre-cleared.
- New content added by the sponsor after the original preclearance acceptance should be sent for preclearance. It is the sponsor’s responsibility to ensure that ongoing user-generated content meets all of the Code and federal legal requirements. Corrective comments may be exempt preclearance if no new content is added.
C) Linking advertising to non-advertising can make the content of both delivery systems advertising.
- Linking factors include proximity, appearance, sequence, and context.
- Third-Party links to websites where entry is in proximity to content that contravenes the PAAB guidelines are prohibited. When a user clicks on a link to leave the sponsor’s
- website a message should appear informing the viewer.
- For consumer accessible sites, federal regulatory requirements restrict the advertiser from influencing the message environment such that the consumer can easily link content from distinct messages which taken together exceed the regulatory requirements for drug advertising.
- The sponsor may link to corporate global sites only by linking to the global site homepage. The sponsor should not link to the global site product pages or sections.
D) Banner or pop-up ads
Banner and pop-up ads that contain either direct or implied product claims must include risk/ benefit fair balance and be page-linked to the Product Monograph. These ads require the preclearance. Only banner ads that meet consumer advertising requirements can be used on consumer accessible sites.
E) Access Control:
Access is based on regulatory classification and content.
For physician, patient or consumer access to industry sponsored websites, platforms or networks, the sponsor should provide adequate and sufficient mechanisms to determine the regulatory category of the person requesting the information on-line.
For sites containing content related to prescription products and/or healthcare products promoting the treatment or cure of Schedule A diseases, the mechanism is required to pose a barrier restricting consumers from having access to the sponsored site.
For sites directed at patients: sponsors should provide control of distribution of the password allowing entry to the sponsored location.
The Drug Identification Number (DIN) is an acceptable password.
For sites directed at healthcare professionals: sponsors should provide a well-controlled entry system.
F) Privacy:
Sponsors are expected to ensure compliance with federal and provincial laws regarding collection and utilization
of personal information. Web-sites must conform to current industry standards for maintaining security, accuracy and privacy of the information on the site and the information it has collected.
G) Static Online Content:
Static online content includes information that is made available online but does not allow for a user to modify or comment on the content. This includes web pages that deliver content that is completely controlled by the sponsor.
For promotional content, all the current rules, regulations, policies and guidance that exist for drug advertising and other activities apply equally to online static content and content delivered via traditional media, such as journal ads. This includes but is not limited to, fair balance requirements in the Code and guidelines.
H) Dynamic Online Content:
There are two types of dynamic online content:
- Site-generated content (SGC): Content initiated by the sponsor but may be presented to the audience by third party
- User-generated content (UGC): Content/dialogue created by users in response to site generated content
The presence of UGC on a sponsored property can render a compliant page non-compliant by the comments that have been made.
For promotional content in areas that are within the sponsor’s control, all the current rules, regulations, policies and guidance that exist for drug advertising and other activities apply equally to online dynamic content and content delivered via traditional media (e.g. journal ads). This includes but is not limited to, fair balance requirements in the PAAB code and guidelines.
Terms and Conditions: The sponsor should provide in a clear and accessible manner the terms and conditions for users to engage
in UGC on a sponsored site, with clear statements regarding the types of comments that would be removed or modified.
Monitoring the Conversation: Sponsors must monitor the UGC to ensure that compliance is maintained.
I) Search Engine Optimization:
Sponsors should not provide the text of a meta data descriptor that contains direct or implied product claims to a search engine that would contravene any federal regulatory requirements for drug advertising. Any descriptor under the control of the sponsor, for patient and/or healthcare professional sites, that include direct or indirect claims, must be submitted
for preclearance. Keywords and other meta data tags that refer to competitor products are prohibited. The requirements involve the relationship between the meta-descriptor, the keyword, and the site/page. PAAB does not concern itself with the ultimate ranking of organic search results.
Meta-descriptors in organic search results for schedule D products may contain claims. They do not require fair balance.
J) Search Engine Marketing:
The meta data requirements are the same as Search Engine Optimization with the additional requirement that purchased keywords taken in context with the other material, not exceed the regulations.
The sponsor should not take steps to cause the composite of the user generated keyword, the meta-descriptor, the landing page, and the Uniform Resource Locator (URL) to exceed that which is permissible (for example, meta tags). Sponsored search ads containing claims must include fair balance.