Key topic 1: Websites
Websites have the advantage of being able to convey a significant amount of information in a single medium.
Considerations for signatories therefore include:
- all the usual rules for promotional materials
- PLUS the need to protect the public from seeing promotional content
- PLUS the need to separate promotional and non-promotional content
- PLUS the fact that everything you see on screen should be considered, including all attachments and links to other websites
- PLUS the need to consider alternative sites for patients or members of the public who may try to access sites intended for HCPs
- PLUS geographical considerations
- PLUS the legal requirements relating to web-sites such as cookies, data privacy etc
- PLUS how search engines will relate to the site and meta data
- PLUS how different devices and internet browsers will display the data
- PLUS elements of the site that allow two way data sharing
Click on the following aspects of website review for more information:
Links
Links should only be made to appropriate sites. Providing links to sites that contain information on unlicensed uses or products may be judged to constitute off-label promotion. Signatories should make a judgment on the basis of multiple aspects. Both the intent and the likely consequences of providing a link should be considered.
Consider the following example:
In the UK GSK placed a number of advertisements in medical journals to raise awareness of restless leg syndrome. At the time their product ropinirole was in development for this indication.
The advertisements contained the website link to the ESG website - Ekbom Support Group, a support group for patients with restless leg syndrome.
The news section of the website referred to an article which reported that ropinirole was ‘safe and effective for the treatment of RLS’.
Which of the following do you agree with?
- This could be viewed as promoting ropinirole for an unlicensed indication the advertisement by GSK effectively directed readers to off label information about their product
- As the ESG site content could change at any time, GSK could not be held responsible for linking to it because of the dynamic nature of websites it can be risky to link to them unless you can make regular checks to ensure that they remain compliant
- Companies should not link to websites that they have no control over this is allowable, but safer if the site content does not contain any product information (an exception would be linking to a site such as the electronic medicines compendium, which contains UK SmPCs for products for example).
This was in fact deemed to be promoting ropinirole for an unlicensed indication. The Panel considered that GlaxoSmithKline was, in effect, directing patients to a site that contained misleading messages about the safety of ropinirole in an unlicensed indication and that this might indirectly encourage patients to ask their doctors to prescribe it. The ruling was upheld on appeal.
Metadata
All metadata related to content for websites must be reviewed – remember that metadata may be viewable by a member of the public or a health professional. In some circumstances, the metadata content could potentially constitute a product claim, e.g. if the metadata includes "best treatment for COPD", this would be a claim and an unacceptable one. Signatories should check the metadata and this should be part of the data submitted by the originator for approval.
Metadata
Metadata is the key words and phrases that describe the contents of the page.
The purpose for metadata is to assist search engines in the organization of web pages and it should provide the proper/relevant information that will make a specific page searchable and bring it to the attention of the intended audience.
Downloads
Brochures, slides, etc. which are included for downloading from digital media communications should be approved in their own right and should comply with regulations and codes that will apply to them as a standalone item (e.g., promotional material should include prescribing information or a link to it if required by applicable regulations and codes.)
Signatories should consider copyright aspects of downloadable items. Appropriate copyright protection notices should be declared.
Where the downloaded item is software or other material that AstraZeneca wants to protect – the download should be accompanied by license terms that the user should agree to before they are able to use the item.
