CASE AUTH/3909/5/24 NO BREACH OF THE CODE
COMPLAINANT v GSK
Alleged failure to certify the mobile version of a promotional website for Omjjara
CASE SUMMARY
This case was in relation to a webpage of a GSK promotional website aimed at UK health professionals about its product Omjjara (momelotinib). The complainant alleged that this webpage had not been certified for mobile phone use and that there were “major changes between the desktop and mobile version text rendering the mobile version uncertified”.
The outcome under the 2021 Code was:
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No Breach of Clause 5.1
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No Breach of Clause 8.1
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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 about GSK from an anonymous, contactable complainant who described themselves as a health professional.
The complainant has now become non-contactable.
COMPLAINT
The complaint wording is reproduced below:
“Whistleblowing on a promotional webpage for the product Omjjara that has not been certified for mobile phone use. The desktop version of the same page has a blue bar towards the top of the page and the text - get in touch. However, on the mobile phone version of the same page the text ''get in touch'' has been replaced by the words ''product menu''. As a result, there are major changes between the desktop and mobile version text rendering the mobile version uncertified. The uncertified uncompliant page is [URL provided] March 2024 | PM-GB-MML-WCNT-230012 (V1.0) [Information not relevant to the complaint]. Breaches of 8.1, 5.1, 2 in the ABPI 2021 code of practice booklet.”
When writing to GSK, the PMCPA asked it to consider the requirements of Clauses 8.1, 5.1 and 2 of the Code.
GSK’S RESPONSE
The response from GSK is reproduced below:
“GSK was extremely disappointed to have received a letter dated 23rd May 2024 from the PMCPA informing us of a complaint from an individual describing themselves as an anonymous healthcare professional regarding the above. The PMCPA has asked us to consider clauses 8.1, 5.1 and 2 of the 2021 ABPI code of practice (the code).
The complainant alleges that the promotional webpage PM-GB-MML-WCNT-230012 (V1.0), has breached clauses 8.1, 5.1 and 2 of the code, as the mobile version of the web page has not been certified separately.
GSK takes its responsibility of abiding by the letter and the spirit of the code and all other relevant UK rules and regulations very seriously. Following the complaint, we have reviewed the materials in question, as well as our internal ways of working. Following our review, GSK is comfortable that both our processes and the material in question are of suitable quality and of a high standard and are therefore in line with the code as they currently are. Consequently, we deny breaches of clauses 8.1, 5.1 and 2 of the 2021 ABPI Code of Practice.
GSK has laid out the specific responses to the individual clauses the PMCPA has asked us to consider in detail below.
Website background
The Omjjara (Momelotinib) webpage referred to in the complaint is part of a promotional website called GSKPro, which is aimed at UK Healthcare Professionals (HCPs). The website contains promotional information about all GSK products currently marketed in the UK. Within the website there is a section dedicated entirely to the product Omjjara. The complainant’s allegation relates to one of the pages from this section.
The Omjjara website can be accessed by the following methods:
- Direct access by HCPs via a search engine, such as Google, including confirmation that they are an HCP via a pop up, as opposed to a member of public for whom there is a link to a separate part of the website with relevant content.
- Via third party emails sent by [third-party medical publishers]. Both emails were sent to HCPs with an interest in Haematology and who had consented to receive promotional emails from pharmaceutical companies via these platforms.
- Via a click through link from the meeting page for an Omjjara promotional webinar held on 21.05.2024. This meeting page was only accessible to relevant, validated UK HCPs who were invited to the webinar.
GSK copy approval review and certification processes
GSK has robust and established processes and structures in place for the setup, review, and certification of all relevant materials, including promotional webpages and websites, which adhere to the code, GSK’s internal code and relevant UK regulations. Our processes are regularly updated in line with new learnings from a variety of sources including internal management monitoring as well as PMCPA case precedent. Every individual involved in any aspect of copy approval has to undergo mandatory training on the GSK copy approval Global SOP as well as the associated UK Work Instruction.
Throughout the copy approval process for webpages, both desktop and mobile platform views are meticulously checked, reviewed, and approved as part of the same job, ensuring that all content, functionality, dynamic content, and links work correctly on both views. We take this approach because when it comes to digital content such as webpages, there are multiple platforms on which content can be viewed. We therefore review and approve the two most common platform views: desktop and mobile views. It is unrealistic and exceptionally inefficient to separately certify every possible iteration of the same content to cover all the possible platforms/devices available, with their subtle individual variations of formatting etc. To our knowledge, this is a similar approach to that taken by most UK pharmaceutical companies as the issue affects us all in the same way.
To ensure that the review and approval process for webpages on our copy approval system is as robust as possible, GSK requires both the desktop and mobile renditions to be visible throughout as part of the job. Furthermore, it is a mandatory requirement of the GSK process for the staging links for the final form webpages to be examined on both a desktop and a mobile phone. This is to ensure that the content and layout is consistent across both platforms, that there are no substantive content changes between the two and that the mobile version displays all options equally despite the different format. The process allows for formatting and functionality variations between the two views, ensuring that both platforms meet the code's requirements for legibility, optimal visibility, mandatory information, and user-friendliness for the HCP target audience. Before any webpages are released to an external HCP audience therefore, GSK ensures that they are comprehensively reviewed, approved, and certified for use on both mobile and desktop platforms. We contend that the code requirements for certification across both views are therefore met by this approach and they do not require separate certification.
Clause 8.1
Clause 8.1 states that promotional material must not be issued unless its final form, to which no subsequent amendments will be made has been certified by one person on behalf of the company. The complainant claims that ‘a promotional webpage for the product Omjjara that has not been certified for mobile phone use’ and therefore clause 8.1 has been breached. GSK contends that this is incorrect because both the mobile and desktop versions of these materials have been reviewed, certified and the final form examined in line with the requirements of the code as described above. The webpages were certified by an experienced ABPI signatory UK Pharmacist.
The complainant stated that on the mobile phone version of the same page, the text ''get in touch'' had been replaced by the words ''product menu''. GSK would like to highlight however, that ''get in touch'' has not been replaced by ''product menu''. It appears as part of the “product menu” drop-down menu. The drop-down “product menu” is a technical necessity for the mobile version as, due to the size of the mobile screen, the section headers on the webpage would not otherwise be clearly legible to HCPs had they been presented in the same format as the desktop view. This difference in formatting of the functionality and navigation for the mobile view of the webpage is to ensure HCPs can clearly read the content and have a better user experience which GSK contends are in line with PMCPC guidance on certification: ‘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.’
Both the certified mobile and desktop versions of the webpages at issue had their layouts appropriately formatted for the two devices without altering any of the substantive content. It is important to note that the substantive content visible to HCPs on both platforms is identical in terms of text, images, and overall message. GSK contends that while the unique identifier job numbers are the same for both views, the job has been reviewed, certified and final form examined for use on both desktop and mobile as per the code requirements.
Furthermore, it is important to note that during GSK’s review and certification process, we ensure that the use of a drop-down menu on the mobile version does not obscure any critical information required for HCPs and as mandated by the code such as the Prescribing Information (PI), safety information, adverse event reporting information, etc.
GSK would also like to draw attention to the PMCPA case of Health professional v Roche (AUTH/3667/6/22) which bears some similarities to this complaint. In that case, ‘the Panel noted the navigation reference, ‘Resources > Congresses and Meetings > Future Positive Lite’ appeared on the desktop version and not on the mobile version of the webpage, the Panel did not consider this necessarily required separate certification’. In the Panel’s view, ‘this would be considered to be, on balance, a technical matter of webpage functionality and navigation as opposed to part of the substantive content of the webpage itself.’
GSK contends that our approach is currently the standard UK pharma industry approach to certifying digital materials or content which can be viewed on different devices. In the rapidly expanding digital environment, any alteration to this approach risks having a significant impact on the entire UK pharma industry with massive implications for resource, time, and effort for no discernible benefit in return in terms of patient care and safety, raising standards or code compliance.
For the reasons above, GSK contends that the final form certification and examination of materials PM-GB-MML-WCNT-230012 (V1.0) for both mobile and desktop meets the requirements of the Code. GSK therefore denies a breach of clause 8.1.
Clause 5.1
The material PM-GB-MML-WCNT-230012 (V1.0) have been created, reviewed, certified and final form examined for both mobile and desktop versions as already described in detail above. GSK contends that the entire process was carried out in accordance with the code and in line with GSK SOP/processes. The complainant has alleged that the different views (mobile and desktop) should have been certified as separate jobs. GSK strongly contends that this is a subjective interpretation of the code on their part and therefore unnecessary for the reasons we have laid out above.
GSK contends that our process encapsulates entirely the spirit of the code with regards to the rationale for certification of all promotional materials. We also contend that the robustness of the certification process and the quality of our materials are of the required standard with respect to the code. For these reasons, GSK maintains that high standards have been maintained and we deny a breach of clause 5.1.
Clause 2
The PMCPA has also asked GSK to consider clause 2. GSK contends that a breach of clause 2 is reserved for special sanction when significant failings have been identified, including a risk to patient safety.
As described in detail above, GSK contends that there is no evidence of failings in our systems and processes which we believe are robust and the webpage in question has been reviewed, certified and final form examined to a suitably high standard and in line with the code. Furthermore, patient safety has not been nor will be prejudiced by the materials in question.
For these reasons, and those covered in detail further above, we contend that GSK’s activities and materials do not risk bringing discredit upon or reducing confidence in the pharmaceutical industry. GSK therefore denies a breach of clause 2.
Additional information
The signatory who reviewed, approved, and certified the material at issue in Case AUTH/3909/5/24 is a [qualification] with more than [number of years] signatory experience.
[Information not relevant to the complaint]
Summary
GSK takes its responsibility of abiding by the letter and the spirit of the code extremely seriously. As laid out in our detailed response above, GSK denies breaches of clauses 8.1, 5.1 and 2 of the 2021 ABPI code of practice.”
PANEL RULING
The complaint related to a webpage of a GSK promotional website aimed at UK health professionals about its product Omjjara (momelotinib). The complainant alleged that this webpage had not been certified for mobile phone use and that there were “major changes between the desktop and mobile version text rendering the mobile version uncertified”.
The complainant provided the URL of the webpage in question and set out the differences between the desktop and mobile versions. The desktop version of the webpage had a blue bar towards the top of the page with the text “Get in touch”. According to the complainant, on the mobile phone version of the webpage, the text in the blue bar had been replaced with the words “Product menu”.
Clause 8.1 stated that promotional material must not be issued unless its final form, to which no subsequent amendments will be made, has been certified.
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 on. However, the Panel 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 different commonly used types of electronic device.
GSK, in its response, set out its certification process, which required both the desktop and mobile versions to be visible throughout as part of the job. There was also a mandatory requirement for the staging links for the final form webpages to be examined on both a desktop and a mobile phone to ensure that the content and layout was consistent across both platforms, and that there were no substantive content changes between the two.
The Panel noted GSK’s submission that both desktop and mobile versions of the webpage in question were certified as part of the same job and that on the mobile version “Get in touch” had not been replaced by “Product menu”, but that it appeared as part of the “Product menu” drop-down menu. GSK submitted that this drop-down menu was a technical necessity of the mobile phone version of the webpage as section headers would not be clearly legible if presented in the same format as a desktop view. GSK did not dispute that there were differences in appearance but submitted that the substantive content on both platforms was identical in terms of text, images and overall message.
The Panel observed that the blue banner with the wording “Get in touch” appeared on the desktop version and not on the mobile version of the webpage. On the mobile version the “Get in touch” tab appeared to have been shifted under a single “Product menu” with an arrow indicating a drop-down menu. The Panel did not consider this necessarily required separate certification. The Panel considered this to be, on balance, a technical matter of webpage functionality and navigation as opposed to part of the substantive content of the webpage itself.
In the Panel’s view, in the particular circumstances of this case, noting that the mobile version of the webpage had been certified alongside the desktop version, and that there were no substantive differences in the content between the desktop and mobile versions of the webpage, the Panel considered that the complainant had not established that changes between the desktop and mobile version of the webpage rendered the mobile version uncertified. The Panel therefore ruled no breach of Clause 8.1 and consequently no breach of Clause 5.1 and Clause 2.
Complaint received 22 May 2024
Case completed 9 May 2025
