Case AUTH/3819/9/23
COMPLAINANT v GSK
Alleged failure to certify the mobile version of the GSK Tackle Meningitis website
CASE SUMMARY
This case related to differences between GSK’s Tackle Meningitis website when viewed on a desktop and a mobile. The complainant referred to two webpages of the website: the homepage and the ‘Know the symptoms’ webpage.
The outcome under the 2021 Code was:
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Breach of Clause 8.3 (x2)
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Failing to certify educational material for the public related to disease
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No Breach of Clause 5.1
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Requirement to maintain high standards
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No Breach of Clause 2
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Requirement that activities or materials must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
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This summary is not intended to be read in isolation.
For full details, please see the full case report below.
FULL CASE REPORT
A complaint was received from an anonymous, non-contactable complainant about GSK UK
Limited.
COMPLAINT
The complaint wording is reproduced in below:
“A GSK meningitis disease education website had not been certified separately for mobile phone viewing. The website is available at: [web link provided] NP-GB-GVU-WCNT-230002 Date of preparation: July 2023. On this home page towards the bottom, there were 5 separate tabs - Understand the risks, help protect your family, know the symptoms, expert perspectives and FAQs. On the desktop version all of these 5 tabs, there were no images next to them. On the mobile phone version all of these 5 tabs had an image next to them, for example a light bulb next to understand the risks, handshake image next to help protect the family, question mark image next to FAQs. On the know the symptoms webpage, there were major differences between desktop and mobile phone versions. The page is [web link provided]. On the desktop version of this page, there was a tab around get help immediately and further information about know the symptoms ask the expert, symptoms in babies and toddlers, a section on trust your instincts, how can I help tackle meningitis. All of these sections were not on the mobile phone version however. The mobile version of this particular page only had know the symptoms and trust your instincts as the 2 tabs. The layout and presentation of information was different on the understand the risks page. In conclusion, there were significant differences between the mobile phone and desktop versions of this website which should have required separate approval for each form. However, this clearly had not been the case meaning the content was clearly uncertified. Breaches of clauses 8.3 on several occasions, 5.1 and 2.”
When writing to GSK, the Authority asked it to consider the requirements of Clauses 2, 5.1 and 8.3 of the Code.
GSK’S RESPONSE
The response from GSK is reproduced below:
“GSK takes its obligations under the ABPI Code of Practice very seriously and is committed to following both the letter and spirit of the Code. While we are disappointed to see this complaint raised, GSK is confident that its materials are fully compliant with the Code and GSK strongly refutes breaches of Clauses 8.3, 5.1 and 2.
Meningitis disease awareness campaign
In alliance with [five named organisations including NHS England and the UK Health Security Agency] GSK has created a disease awareness campaign to educate young adults/students and their parents about meningococcal disease. The campaign comprises several social media assets designed to provide the key facts about the disease and to direct those interested to where they can find more information. Meningitis can have severe consequences, so it is important the public are aware of the key symptoms and how to respond if they suspect disease.
If interested members of the public wish to learn more about meningitis, as part of the campaign, GSK and the members of the coalition have designed a website called Tackle Meningitis
Tackle Meningitis
Tackle Meningitis is a website designed to raise awareness of meningitis, specifically bacterial meningococcal meningitis. In accordance with the MHRA Blue Guide, the website outlines the risks of the disease, common symptoms, what to do in an emergency and it includes some perspectives from experts within the infectious diseases field.
Homepage
In the copy of the email the complainant states that when viewing the website homepage on a desktop computer, he/she could see five tabs titled UNDERSTAND THE RISKS, HELP PROTECT YOUR FAMILY, KNOW THE SYMPTOMS, EXPERT PERSPECTIVES and FAQs. However, when viewing the same page on a mobile, the complainant noticed that adjacent to each of the headings were icons not seen when viewed on a desktop.
Know your symptoms
The complainant also mentioned that there were differences between the website when viewed on a desktop computer and a mobile when browsing the ‘KNOW THE SYMPTOMS’ page. When viewing the website on a desktop, clicking ‘GET HELP IMMEDIATELY’ automatically moves the page down to three icons explaining what to do if you think you or your child has meningitis. When the same page is viewed on a mobile, the ‘GET HELP IMMEDIATELY’ tab is not present but the same information explaining what to do if meningitis is suspected appears when the user clicks ‘TRUST YOUR INSTINCTS’.
The differences between the website viewed on a desktop and a mobile prompted the complainant to allege that a mobile version of the website had not been certified to the requirements of the Code.
Clause 8.3
In your letter you have asked GSK to bear in mind the requirements of Clause 8.3. The clause lists the various materials relating to non-promotional activities that also require certification in a similar manner stated in Clause 8.1, the clause designated for promotional materials. Included in Clause 8.3 is ‘educational material for the public or patients issued by companies which relates to diseases or medicines but is not intended as promotion for those medicines’. This sub-clause relates specifically to disease awareness campaigns.
Certification
Clause 8.3 requires that disease awareness campaign materials ‘must be certified in advance in a manner similar to that provided for by Clause 8.1’. Within the supplementary information of Clause 8, Clause 8.1 S.I. acknowledges that the final form of dynamic content is not static, so it is therefore not necessary to certify each possible combination. However, ‘care must be given to ensure dynamic content such as websites meets the requirements of the Code as a standalone item’.
In accordance with GSK’s standard operating procedure (SOP) for ‘Deployment and Approval of Promotional and Non-Promotional Web Content’, before all websites go live they must be reviewed in a test environment that resembles the live site as closely as possible – this is the final form; the staging site provides a robust way for a signatory to check that the dynamic content meets the requirements of Code. The signatory must check that the website behaves as intended on the platforms likely to be used by the intended audience, namely desktop and mobile devices.
Tackle Meningitis was certified by a medical signatory who is a UK registered physician, and the final form was reviewed and approved on a desktop and mobile in accordance with the Deployment and Approval SOP. The signatory then documented within Veeva Content Lab, the copy approval system used by GSK, that the final form approval (staging site) was completed on a laptop (Edge browser) and a company mobile (Safari browser). In addition, the mobile view of the website was added as an attachment within Content Lab – the pdf attachment reflects the description of the website, viewed on a mobile, given by the complainant.
It should be noted that if the website is accessed via a desktop browser using a smaller browser window, the website appears identical to the view on a mobile. In other words, the website is ‘responsive’, there is only one website, irrespective of the platform i.e., the website adjusts the content dynamically depending on the screen dimensions. Different dimensions alter the appearance of the website to accommodate those on different devices, the differences mentioned by the complainant are a technical matter of webpage functionality. To ensure there were no substantive changes to the content, and that the content remained appropriate in terms of legibility, readability, user experience and compliance with the requirements of the Code and GSK standard operating procedures, the website was reviewed and certified for desktop and mobile viewing. Reviewing the website in this manner also ensured each aspect of the website met the requirements of the Code as a standalone item.
In summary, GSK recognises the importance of robust certification processes to safeguard patients and the public, and it takes the requirements of certification seriously. The processes outlined in the web deployment and approval SOP ensure that dynamic content is tested and reviewed before going live. Screenshots of the Tackle Meningitis website viewed on different platforms were documented within Content Lab and a confirmation was provided by the signatory that these platforms had been reviewed in the test environment via the staging link. GSK is confident that the signatory had taken the necessary steps to ensure the website viewed on a mobile was still appropriate and met the requirements of the Code. Therefore, GSK strongly refutes any breach of Clause 8.3.
Clause 5.1
Clause 5.1 requires companies to maintain high standards at all times, GSK takes the requirements of this clause very seriously. To continue to maintain high standards GSK has in place processes to discuss and critique upcoming projects, to which this meningitis disease awareness campaign was subjected.
Before the 2023 campaign began, the project was taken to the Non-Promotional Governance Board on 6 April 2023 – non-promotional projects must be ratified before they can commence. The board, composed of experienced employees from Medical, Legal, Compliance, PV and Commercial, assessed any potential risks, the appropriateness of the project and compliance with the ABPI Code and GSK’s SOPs.
After going live, GSK has attended regular roundtable meetings with the coalition to ensure the campaign remains impactful for patients and the public, the meetings give GSK the opportunity to better understand patients’ needs through the charities and organisations in the coalition. In addition, regular meetings ensure any compliance issues can be discussed and addressed in a timely manner.
Lastly, the Tackle Meningitis website was certified according to the requirements of the Code, MHRA’s Blue Guide and GSK’s stringent approval SOPs. Therefore, GSK is confident that high standards have been maintained and refutes a breach of Clause 5.1.
Clause 2
Clause 2 relates to a failure to uphold confidence in the industry and a breach of this clause is a sign of particular censure. GSK is confident that its processes for ratifying non-promotional activities with the Non-Promotional Governance Board, and the robust processes followed in the website SOP, demonstrate a commitment to the principles of the Code and ultimately safeguard patients and the public. The website pages mentioned by the complainant have been certified according to the stringent requirements of Clause 8 and the medical signatory has taken the necessary steps to ensure the content viewed on different platforms remains compliant as standalone items. Tackle Meningitis has been designed in coalition with a number of charities, it is a useful resource for those interested in finding more about meningococcal disease; the website demonstrates GSK’s on-going commitment to patient safety and public health. GSK believes discredit has not been brought upon the industry and strongly refutes a breach of Clause 2.
Conclusion
To conclude, GSK is confident that the necessary steps have been taken to ensure the Tackle Meningitis website is fully compliant with the requirements for certification as stated within the Code. Therefore, GSK strongly refutes breaches of Clauses 8.3, 5.1 and 2.”
PANEL RULING
This case related to differences between GSK’s Tackle Meningitis website when viewed on a desktop and a mobile and the complainant’s overarching concern that this meant that the website had not been certified in accordance with the Code. The complainant referred to two webpages of the website: the homepage and the ‘Know the symptoms’ webpage.
The Panel noted GSK’s submission that “if the website is accessed via a desktop browser using a smaller browser window, the website appears identical to the view on a mobile” and that the website was “responsive” and adjusted the content dynamically depending on the screen dimensions. GSK further submitted that the final form had been certified on a desktop and mobile in accordance with its standard operating procedure (SOP); the signatory documented that the final form approval (staging site) was completed on a laptop (Edge browser) and a company mobile (Safari browser), with the mobile view added as an attachment to its approval system.
The Panel noted that GSK referred to the supplementary information to Clause 8.1, Certifying Dynamic Content, which stated:
‘When certifying dynamic content such as websites etc care must be taken to ensure the dynamic content meets the requirements of the Code as a standalone item. As the final form is not static, consideration needs to be given to the context in which it appears but each possible combination does not need to be certified.’
The Panel noted guidance issued by the PMCPA about whether material had to be certified for each platform it appeared on stated:
‘Does material have to be certified for each platform it appears on, e.g. computer, tablet and mobile?
Companies must ensure that the final form viewed is not distorted and the requirements of the Code are complied with, e.g. the legibility of the prescribing information.
If companies have the technology to ensure that that which is viewed irrespective of the platform will be appropriately formatted and are confident that the final form will be identical on each platform then these do not require separate certification.’
In the Panel’s view, the Code did not necessarily require a website to be certified multiple times for each different device it might be viewed upon, however, it considered that the appearance of the material on different devices should be taken into consideration prior to certification to ensure that the content met the requirements of the Code when viewed on each different commonly used type of electronic device, e.g. desktop, laptop, tablet, smartphone etc.
The Panel made its rulings on the homepage and ‘Know the symptoms’ webpage identified by the complainant. It did not know whether there were differences between other webpages that were not before it.
The Panel noted the homepage of the website included five tiles labelled ‘Understand the risks’, ‘Help protect your family’, ‘Know the symptoms’, ‘Expert perspectives’ and ‘FAQs’. The Panel noted the differences between the desktop and mobile versions highlighted by the complainant which included that there were 5 icons on the mobile version that formed part of each tile but these were not on the desktop version. The Panel also noted each tile on the desktop version had a one sentence description which was not present on the mobile version.
With regard to the ‘Know the symptoms’ webpage, the Panel noted the page included three tabs on the desktop version: ‘Know your symptoms’, ‘Trust your instincts’ and ‘Get help immediately’ but that the third tab was not present on the mobile version. The Panel noted GSK acknowledged the ‘Get help immediately’ tab was not present on the mobile version but submitted the same information explaining what to do appeared when the user clicked ‘Trust your instincts’.
GSK had not disputed that there were differences between the two versions of the website. The question for the Panel was whether the differences meant that there were two final forms of the website, a desktop and mobile version, and, if so whether each had been certified. The Panel did not consider that the content of either version of the webpages was dynamic as inferred by GSK.
Clause 8.3 required that educational material for the public or patients issued, amongst other things, must be certified in advance in a manner similar to that provided for by Clause 8.1.
The Panel considered that although both desktop and mobile versions of the website had formed part of the approval process and reviewed by a signatory, the website was not identical on each platform. The mobile version of the homepage included icons that were not present on the desktop version; there were also descriptors on the desktop homepage that were not present on the mobile version. On the ‘Know the symptoms’ webpage the ‘Get help Immediately’ tab present on the desktop was not present on the mobile version although the linked information was available through a different tab, ‘Trust Your Instincts’. The Panel considered that the final form of the two webpages before it differed substantively in content for the mobile versions compared to the desktop versions and each should have been certified separately which had not occurred. The Panel therefore ruled a breach of Clause 8.3 for each webpage.
The Panel took account of its breaches of Clause 8.3 but nonetheless considered that the content of both versions of the website appeared to form part of the approval process. The Panel did not consider it had been established that GSK had failed to maintain high standards in this regard and ruled no breach of Clause 5.1. The Panel did not consider that the circumstances warranted a breach of Clause 2, which was a sign of particular censure, and no breach of Clause 2 was ruled accordingly.
Complaint received 7 September 2023
Case completed 7 November 2024
