CASE/0274/08/24 NO BREACH OF THE CODE
COMPLAINANT v ORGANON
Allegations about declaration of involvement
CASE SUMMARY
This case was in relation to the homepage of an expert advisory group website. It was alleged that financial support received from Organon was not disclosed at the outset of this webpage.
The outcome under the 2021 Code was:
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No Breach of Clause 2
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No Breach of Clause 5.1
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No Breach of Clause 10.9
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Requirements to include a sufficiently prominent declaration of sponsorship to ensure readers are aware of the pharmaceutical companies involvement at the outset.
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No Breach of Clause 25.3
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Requirement that companies must ensure that all sponsorship is clearly acknowledged from the outset
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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 about Organon was received from an anonymous, contactable complainant (who later became non-contactable) who described themselves as a health professional.
COMPLAINT
The complaint wording is reproduced below:
“The [named expert advisory group] are provided with financial support by Organon which includes funding of the advisory group meetings and activities. This financial support from Organon has not been disclosed from the beginning on the following webpage [link provided]. Organon were not acting in line with the compliance requirements, the medical review team should have been ensuring that compliance requirements were being adhered to but had not. PMCPA need to investigate the reasons for Organon’s non compliance. Clause 10.9, 5.1, 2 were in breach.”
When writing to Organon, the PMCPA asked it to consider the requirements of Clauses 25.3, 10.9, 5.1 and 2 of the 2021 Code.
ORGANON’S RESPONSE
The response from Organon is reproduced below:
“We are writing in response to the complaint received under Case AUTH/0274/08/24 regarding our sponsorship towards the [named expert advisory group]. We take all complaints very seriously and appreciate the opportunity to address these concerns thoroughly and transparently.
After a comprehensive internal review to fully understand the complaint, we aim to provide a clear and accurate response.
Commitment to Ethical Standards
At Organon, we are unwavering in our commitment to maintaining the highest standards of ethical conduct and regulatory compliance. We understand the importance of transparency and integrity, especially in our interactions with healthcare professionals and the public. We strive to ensure that all of our actions, including sponsorship of meetings, are conducted transparently and in full compliance with relevant guidelines and codes of practice.
Background
The [named expert advisory group] is an expert advisory group of leading clinicians and advocacy groups who have come together to discuss and make policy recommendations concerning the contraceptive needs of women of all ages and from all backgrounds.
Organon has supported the work of the [named expert advisory group] for a number of years and were approached by [named secretariat for expert advisory group] to provide sponsorship for secretariat services to support the running of the [named expert advisory group] for the 12 months between 1 March 2024 and 28 Feb 2025. Sponsorship of [amount] was requested as per the request.
Following the request a decision was made to sponsor the organisation and a sponsorship agreement signed by both parties.
Addressing the Complainant`s Concerns
We have reviewed the material at issue in this case and our involvement with the organisation and have found no evidence to support the allegations made by the complainant.
Declaration of sponsorship
The [named expert advisory group] website [link provided] includes a clear statement on the homepage referring to all their sponsors, as evidenced by the screenshot. The sponsorship statement is clear and transparent about the nature of the support received and the logos of the sponsoring companies are clearly displayed; we note that there are two other companies sponsoring the website as well as ourselves.
As such Organon consider that sponsorship of this organisation is clearly indicated, the wording of the declaration is unambiguous and accurately reflects the extent of our involvement as required by the Code, and deny any breach of Clauses 10.9, 5.1, 2 and 25.3.
Enclosures
Please find attached the following supporting documents:
• Request for Sponsorship
• Sponsorship agreement
• A screenshot of the [named expert advisory group] website
A copy of the summary of product characteristics has not been attached because no products are involved or referred to in this complaint. As the website in question was not approved by Organon, there is also no approval certificate to attach.
We appreciate the opportunity to clarify our position and thank you for bringing this matter to our attention.
Please do not hesitate to contact us, should you require any further information.”
PANEL RULING
This complaint related to the homepage of an expert advisory group website. It was alleged that financial support from Organon had not been disclosed at the outset of this webpage.
The Panel considered the information provided by the complainant and Organon, which included a screenshot of the expert advisory group’s homepage. At the top left of the homepage, the expert advisory group logo and name were present and adjacent to this, were links to other webpages:
• Our members
• Our work
• Useful resources
• Governance
Directly below the logo and webpage links was a sentence about what the expert advisory group did, which was followed by a banner image of various contraceptive methods. Below the image, was the heading “Our Mission” which was followed by the expert advisory group’s mission statement which spanned four paragraphs, the latter of which was a disclaimer in a much smaller text.
Immediately after the mission statement, was the heading, “Our Sponsors”; below the heading was the following text:
“Support for the [named expert advisory group] is provided by [named pharmaceutical company], Organon and [named pharmaceutical company], who fund [named expert advisory group] meetings, activities and the [named expert advisory group] secretariat, delivered by [named secretariat to expert advisory group]. Sponsor organisations have no influence or input in the selection or content of [named expert advisory group] projects or communications. Members of the [named expert advisory group] receive no payment from [named pharmaceutical company], Organon and [named pharmaceutical company] for their involvement in the group, except to cover appropriate travel costs for attending meetings.”
Logos for the three sponsors, all of the same size, appeared directly below the above statement, with Organon’s logo placed in the middle.
Considering the above, the Panel reflected on the allegation that Organon’s financial support was not disclosed at the outset of the homepage.
Clause 25.3 of the 2021 Code stated:
“Companies must ensure that all sponsorship is clearly acknowledged from the outset. The wording of the declaration of sponsorship must be unambiguous and accurately reflect the extent of the company’s involvement and influence over the material.”
Clause 10.9 of the 2021 Code stated:
“The declaration of sponsorship must be sufficiently prominent to ensure that readers are aware of it at the outset.”
The Panel considered the immediate and overall impression to the user and noted that the homepage was not a long, scrolling page with lots of content and there was a limited number of distinct links which would redirect a viewer to an additional page. The only substantive content on the homepage were the mission statement and the sponsorship declaration. The “Our Sponsors” heading was in a large and clear font (the same size as the “Our Mission” heading) and immediately followed the mission statement. The font size of the sponsorship declaration was also the same as that of the mission statement.
The Panel then considered the location of the declaration and whether it was sufficiently prominent, and at the outset of the webpage, as required by Clauses 10.9 and 25.3. Given the layout and content of the webpage, and the location and size of the sponsorship declaration, the Panel considered that the information about the sponsors had been given comparable prominence to the only other substantive content on the page; the mission statement. Organon’s involvement was included on the homepage, the first page a user would see when accessing the expert advisory group’s website and in the Panel’s view this was unlikely to be missed by a visitor to this homepage. The Panel considered that it would therefore be sufficiently clear to a user, at the outset, that Organon had provided financial support to the expert advisory group.
Given its conclusions that the sponsorship was acknowledged at the outset, and that it was sufficiently prominent, the Panel ruled no breaches of Clauses 10.9 and 25.3 in relation to the homepage of the website.
Having taken account of the above rulings of ‘no breach’, and in the absence of any other allegations from the complainant, the Panel concluded that there was no evidence of a failure to maintain high standards, nor that Organon had brought discredit upon, or reduced confidence in, the pharmaceutical industry. The Panel therefore ruled no breaches of Clauses 5.1 and 2.
Complaint received 18 August 2024
Case completed 5 August 2025
