Digital Material – 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 (an exception is the US)
- PLUS the need to separate promotional and non-promotional considerations
- PLUS the fact that everything you see on screen should be considered, including all attachments and links to other websites
- PLUS geographical considerations
- PLUS the need to consider alternative sites for patients or members of the public who may try to access sites intended for HCPs
- 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 and 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.
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 is the key words and phrases that describe the contents of the webpage. The purpose of 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.
Consider these Case Examples
Example 1
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 help 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).
Ruling
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.
Example 2
A complaint was made in the UK that an advertisement for Enbrel (etanercept), marketed by Wyeth, which appeared on www.yahoo.com, constituted direct to consumer advertising. The complainant stated that there was a small ‘get-out’ clause buried on one of the inside pages of the advertisement, which stated that the message was only for the attention of US residents and that other countries had different regulations related to the use of medicines. However, by the time anybody reached that section they would have already read the advertisement that advised anybody with severe arthritis, and not getting sufficient relief, to ask their prescriber about Enbrel.
The Panel noted that various pages of the advertisement stated ‘This site is intended for US audiences only’. Also the advertisement had been placed by the US company not Wyeth UK.
Which of the following do you agree with?
- As anyone could access this advert it constitutes promotion to the public the intended audience was clear and appeared on various pages
- The intended audience is clearly stated and so this is not promoting to a UK audience
- Wyeth UK cannot be held responsible as they did not place this advert on YouTube a UK company can be held responsible for material placed on the internet by one of its affiliates, if the content is directed to a UK audience.
Ruling
The Panel considered that although accessible to anyone, the website at issue was directed to a US audience; further, the advertisement itself did not address a UK audience. The material was thus not directed to a UK audience and so the Panel ruled no breach of the UK regulations.
Example 3
A website sponsored by Boehringer Ingelheim was the subject of a complaint in Australia.
The intent of the website (according to Boehringer Ingelheim) was to inform doctors and patients of the Australian Government’s decision, contrary to the advice of the PBAC, to delay the listing of a new stroke medication.
(The medicine in question was Pradaxa (dabigatran) although it was not specifically mentioned in the main body of the website).
The website did not include any information about who sponsored the website on any of its pages and access was not restricted.
The website contained the this statement:
Australia is facing an epidemic of stroke in people with atrial fibrillation and “this decision could be a matter of life or death for many thousands of elderly Australians with atrial fibrillation”.
Among the references for the various statements on the website was the Pradaxa Product Information and the PBAC public summary document for dabigatran. The website included an option to sign an online petition, and there was a ‘keep me updated’ option which required users to input their contact details.
Which of the following do you agree with?
- The subject matter of this website was ‘a matter of public interest’ the Committee acknowledged that the Government’s deferral of listing of a range of medicines was of concern for companies, healthcare professionals and members of the general public
- This is not promotion to the public as the product was not specifically named the Committee found that placement of the Pradaxa product information as a reference source identified that particular product and contributed to the promotion of it to the public
- The statement about stroke could create undue alarm by members of the public the Committee was concerned about the ‘highly emotive and inflammatory language’ used
- This activity is political ‘lobbying’ rather than promotion and therefore falls outside of the Australian Code although the Committee suggested that further guidance on this issue would be helpful
Ruling
The website was found to breach regulations for lack of transparency in terms of sponsorship, and promotion to the public and Boehringer Ingelheim were fined $125,000. Because the website was not compliant, the Committee banned Boehringer Ingelheim from using the contact details that it had obtained from the ‘keep me updated’ option to send any more information to users of the site.
