CASE/0842/01/26
COMPLAINANT v BRITANNIA
Allegations relating to a webinar
CASE SUMMARY
This case was in relation to a Britannia presentation which was part of a webinar that was hosted on the website of a company specialising in diagnostics and medical devices. The complainant alleged that the presentation was disguised promotion for clozapine, was not certified, and did not include the required prescribing information and adverse event reporting statement.
The complainant further alleged that Britannia’s involvement was not made clear at the start of the presentation.
The outcome under the 2024 Code was:
Breach of Clause 5.1 | Failing to maintain high standards |
No Breach of Clause 2 | Requirement that activities or materials must not bring discredit upon, or reduce confidence in, the pharmaceutical industry |
No Breach of Clause 3.6 | Requirement that materials and activities must not be disguised promotion |
No Breach of Clause 5.6 | Requirement to clearly indicate a company’s role and involvement on material |
No Breach of Clause 6.1 | Requirement that information/ claims/ comparisons must be balanced |
No Breach of Clause 8.1 | Requirement to certify promotional material |
No Breach of Clause 12.1 | Requirement to include up-to-date prescribing information |
No Breach of Clause 12.6 | Requirement to include an adverse event reporting statement within promotional material |
No Breach of Clause 15.6 | Requirement that promotional material and activities must not be disguised |
No Breach of Clause 26.1 | Requirement not to advertise prescription only medicines to the public |
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 Britannia Pharmaceuticals Ltd was received from an anonymous, non- contactable complainant who described themselves as a member of the public.
COMPLAINT
The complaint wording is reproduced below with some typographical errors corrected:
“[url provided] Session 4 of this video discusses clozapine and is clearly promotional. Promoting without PI, AER, and no apparent certification of slides. Nor has the video been certified. This company seems to be a 3rd party acting on behalf of Britannia. No balance given clozapine is one of the most dangerous drugs. Disguised promotion. Involvement of Britannia not made clear from start of the video / slides Senior medical leader involved 5.1 and 2.”
When writing to Britannia, the PMCPA asked it to consider the requirements of Clauses 2, 5.1, 5.6, 6.1, 8.1, 12.1, 12.6 and 15.6 of the 2024 Code.
BRITANNIA’S RESPONSE
The response from Britannia is reproduced below:
“Thank you for your letter dated 8th January 2026, notifying Britannia Pharmaceuticals Ltd (Britannia) that the Authority has received a complaint from a member of the public.
We would also like to extend our gratitude to the Panel to allow us additional time to collate our response.
Although this case is historic and technically outside the pilot 2-year limitation period adopted by the PMCPA, we welcome this as this was the first time we heard of this matter. Britannia is committed to complying with the ABPI Code of Practice and takes these allegations seriously. In preparation for this response, we have conducted a full internal investigation into the matter, led by our Compliance Manager and Medical Director, which includes interviews with relevant parties
The findings of the internal investigation and interviews have been used to respond to the questions put to Britannia by the PMCPA and the Complainant.
Background and context
On 31st March 2022, [named Britannia employee and company role] participated as a guest speaker, one of four, in the [named diagnostics company] Connect Webinar Series titled ‘Enabling a Better Point-of-Care Diagnosis.’ The webinar aimed to discuss the [named medical device] near-patient testing analyser with an audience of biomedical scientists and laboratory-based personnel who were potential customers for the device. This audience are not Health Care Professionals (HCPs), nor do they meet the definition of Other Relevant Decision Makers (ORDMs).
There was no permission given by Britannia for the presentation to be recorded or placed on a third-party website, and Britannia were not aware that this had occurred until they received this complaint from the PMCPA on 8th January 2026. On receipt of this complaint, Britannia immediately emailed [named diagnostics company] and instructed them to remove the video from their website. The intended audience for the [named diagnostics company] website is biomedical scientists and laboratory-based personnel. The video was not on the homepage of the website and required 4 separate ‘clicks/links’ to find.
Response to Alleged Breaches under the 2024 ABPI Code:
Clause 5.6 - Declaration of Involvement & Clause 15.6 – Disguised Promotion:
Britannia believes that the information provided at the outset of the webinar adequately reflected Britannia’s role. It was clearly stated on the webinar webpage and at the outset of the presentation that the speaker was employed by Britannia.
There was no attempt to disguise the presenter’s affiliation or involvement.
Accordingly, Britannia respectfully denies any breach of Clause 5.6 and Clause 15.6.
Clause 6.1 - Information, Claims, Comparisons and Disparagement:
The clear and overriding focus of the presentation was on device use, not on medicines. Unfortunately, a Britannia medicine was briefly mentioned by generic name with indication to explain the context in which blood monitoring is required. The single contextual reference to a medicine was factual and no efficacy claims were made.
In this context, Britannia denies a breach of Clause 6.1, as the information was not misleading in any way.
Applicability of Clauses relating to promotional material (Clause 8.1, 12.1 & 12.6)
As the presentation was not a promotional presentation directed at HCPs or ORDMs, Clauses 8.1, 12.1 and 12.6 are not applicable in this case and are therefore denied.
Clause 5.1 – High standards
The employee involved is knowledgeable about the ABPI Code and had explicitly instructed the third-party in advance of the presentation that medicines must not be mentioned during their introduction. Unfortunately, due to human error or oversight, a single generic reference was included in the slides. The employee has successfully completed regular ABPI Code and company policy training, and has supported the business as a Compliance Champion and Appropriately Qualified Person (AQP) since 2024.
Had Britannia been aware that the content would be made publicly available, it would have ensured that the material was reviewed and approved in accordance with internal procedures, including removal of any reference to medicines.
Britannia accepts that, notwithstanding the circumstances, high standards were not fully met and therefore accepts a breach of Clause 5.1.
Clause 2
This was an unintended error relating to historic content over which Britannia had no control, and which did not raise any patient safety concerns.
Britannia took swift action on receipt of this complaint, emailing [named diagnostics company] on the same day to request they immediately took down the video. An internal investigation was carried out to establish what had happened and corrective action needed. The individual involved is fully aware that an error was made by including the single mention of generic name with indication.
Britannia were not aware that this video was available on [named diagnostics company] website as no permission was sought or given. The inclusion of the presentation recording had not been requested, endorsed, advocated or promoted by Britannia.
[Named diagnostics company] website is intended for biomedical scientists and laboratory-based personnel who do not meet the definition of HCPs or ORDMs. The video required a specific search and/or four separate clicks to access. Britannia therefore submits that a breach of Clause 2 is neither necessary nor proportionate.
Conclusion
Britannia has established a highly structured compliance framework integrating monitoring, governance, risk management, and training to ensure ongoing ABPI Code adherence. Integrity is embedded across the organisation, with proactive identification and mitigation of risks, transparent escalation procedures, and robust oversight mechanisms. Britannia remains committed to continual review, learning, and improvement of its processes, ensuring all materials, activities, and engagements maintain the highest ethical and Code-compliant standards.
Britannia takes its responsibilities under the Code seriously. This situation arose due to an unfortunate combination of human error and unauthorised third-party use of historic material. Appropriate learnings have been reinforced internally.”
REQUEST FOR A FURTHER RESPONSE FROM THE CASE PREPARATION MANAGER
Britannia’s response to additional clauses raised by the case preparation manager is reproduced below:
“Thank you for your letter dated 12th February 2026 to Britannia Pharmaceuticals Ltd (Britannia), in relation to Clause 3.6 and Clause 26.1.
Clause 3.6 – Disguised Promotion:
Clause 3.6 states that materials and activities must not be disguised promotion. As noted in your correspondence, this clause mirrors the wording of Clause 15.6 but applies in circumstances beyond communications directed at Healthcare Professionals (HCPs) or Other Relevant Decision Makers (ORDMs).
Britannia respectfully maintains that there was no disguised promotion in this instance. The webinar in question formed part of the [named diagnostics company] Connect Webinar Series and was organised and hosted by [named diagnostics company]. The clear and overriding focus was device-related and educational in nature. The webinar webpage clearly identified one of the speakers as a Britannia employee, and this was reiterated at the outset of the presentation. There was no attempt to conceal Britannia’s involvement or to present the material as independent or third-party content.
During the presentation, Britannia medicine was mentioned once by generic name with its indication solely to provide clinical context for why blood monitoring may be required in certain treatment pathways. No brand name was used. No claims were made regarding efficacy, safety, superiority, or comparative performance. There was no call to action, no encouragement to prescribe, request, recommend or purchase a medicine, and no product-focused messaging. The reference was factual and contextual for an audience of biomedical scientists and laboratory-based personnel.
In these circumstances, Britannia submits that the material cannot reasonably be characterised as promotional in intent, content or effect, and therefore does not constitute disguised promotion under Clause 3.6.
Clause 26.1 – Advertising Prescription Only Medicines to the Public:
Britannia respectfully submits that the circumstances of this case do not amount to advertising to the public within the meaning or spirit of the Code.
The recording was hosted on [named diagnostics company’s] website, aimed at biomedical scientists and laboratory-based personnel. The content, navigation and overall presentation of the site are directed at individuals working in laboratory and diagnostic settings. Although such individuals may not meet the Code’s definitions of HCPs or ORDMs, they are not representative of the lay public and require a level of technical and clinical understanding to perform their professional roles.
The recording was not placed on a homepage nor promoted as general public-facing content. It required multiple navigational steps to access and was not proactively disseminated, linked, endorsed or promoted by Britannia. The company did not grant permission for the recording to be uploaded and was unaware that it had been made available on the third-party website until receipt of the complaint on 8th January 2026.
The nature of the single, brief reference to the medicine was limited and factual. The medicine was referred to by generic name with indication solely to explain the clinical context in which monitoring might be required. There was no branding, no promotional claims and no encouragement to use the product. The presentation remained device- focused throughout.
Britannia notes that in previous Code cases (including Cases 0250/07/24, AUTH/2912/12/16 and AUTH/2680/11/13), the Panel has considered the overall context, nature of the website and intended audience when determining whether material constituted promotion to the public. In each case, the Panel recognised that accessibility to the public was not determinative; rather, the absence of overt promotional purpose and the presence of a clearly professional or specialist context were significant factors in its assessment. Britannia respectfully submits that similar contextual factors apply in this case.
Britannia does not hold a copy of the webinar recording, as this webinar was not a Britannia-organised activity. Following receipt of the complaint from the PMCPA, we contacted [named diagnostics company] to request a copy of the recording. [Named diagnostics company] has confirmed that it no longer holds a copy of the video because the individual who arranged the webinar and managed the recording has since sadly passed away, and no archived version of the recording can be located. Britannia understands the content of the webinar because the recording was accessible on the [named diagnostics company] website. On 8th January 2026, the recording was viewable online and could be reviewed directly. However, following the subsequent removal of the webpage from the [named diagnostics company] website, the recording is no longer accessible to Britannia. We regret to inform you that, due to technical issues with our IT systems, we have been unable to retrieve the PowerPoint slides that were shared with [named diagnostics company] in 2022, from the archived mailbox.
As soon as Britannia became aware that the recording was accessible via the [named diagnostics company] website, immediate action was taken to request removal of the webpage hosting the recording. The webpage was subsequently taken down.
We trust that the contextual background, the nature of the material, and the actions taken upon notification will assist the Panel in its assessment. Britannia remains committed to constructive engagement with the PMCPA and to ensuring continued alignment with both the letter and spirit of the Code.”
REQUEST FOR FURTHER INFORMATION FROM THE PANEL
Given Britannia’s response stated that it did not have a copy of the webinar in question, the Panel sent a copy of it to Britannia and gave it the opportunity to revise its response. Britannia’s response is reproduced below:
“Britannia can confirm that the recording recently provided by the PMCPA is the first downloaded copy of the webinar that we have received or held. As explained in our original response, we did not retain a copy of the recording [link to original response]. Prior to the webpage being removed, however, we were able to view the webinar directly on the [named diagnostics company] website, and it was on the basis of that viewing that our response of 6th March 2026 was prepared.
Having now reviewed the recording provided by the PMCPA, Britannia's position remains broadly unchanged, but we do wish to amend our response in light of the opportunity to review the webinar in more detail. We continue to maintain that this was a device-focused educational webinar targeted at biomedical scientists and laboratory- based personnel. There is no branding, no promotional claims, and no encouragement to prescribe, recommend or use the medicine. Britannia did not give permission for this webinar to be hosted on [named diagnostics company] website and was unaware it was there until receipt of the complaint. As soon as Britannia became aware that the recording was accessible via the [named diagnostics company] website, immediate action was taken to request removal of the webpage hosting the recording. The webpage was subsequently taken down.
Clause 3.6 – Disguised Promotion:
Clause 3.6 states that materials and activities must not be disguised promotion. As noted in your correspondence, this clause mirrors the wording of Clause 15.6 but applies in circumstances beyond communications directed at Healthcare Professionals (HCPs) or Other Relevant Decision Makers (ORDMs).
Britannia respectfully maintains that there was no disguised promotion in this instance.
The webinar in question formed part of the [named diagnostics company] Connect Webinar Series and was organised and hosted by [named diagnostics company]. The target audience was biomedical scientists and laboratory-based personnel. The clear and overriding focus was device-related and educational in nature. The webpage clearly identified one of the speakers as a Britannia employee, and this was reiterated at the outset of the presentation. There was no attempt to conceal Britannia’s involvement or to present the material as independent or third-party content.
During the presentation, Britannia’s medicine is not mentioned by name and only referred to by indication and potential side effects solely to provide clinical context for why blood monitoring may be required in certain treatment pathways. No claims were made regarding efficacy, superiority, or comparative performance. There was no call to action, no encouragement to prescribe, request, recommend or purchase a medicine, and no product-focused messaging. The reference was factual and contextual for an audience of biomedical scientists and laboratory-based personnel.
The generic name is mentioned on the webpage that hosted this video under the name of the webinar along with the presenter’s name and affiliation to Britannia. The company did not grant permission for the recording to be uploaded and was unaware that it had been made available on the third-party website until receipt of the complaint.
In these circumstances, Britannia submits that the material cannot reasonably be characterised as promotional in intent, content or effect, and therefore does not constitute disguised promotion under Clause 3.6.
Clause 26.1 – Advertising Prescription Only Medicines to the Public:
Britannia respectfully submits that the circumstances of this case do not amount to advertising to the public within the meaning or spirit of the Code.
The recording was hosted on a [named diagnostics company] website, aimed at biomedical scientists and laboratory-based personnel. The content, navigation and overall presentation of the site are directed at individuals working in laboratory and diagnostic settings. Although such individuals may not meet the Code’s definitions of HCPs or ORDMs, they are not representative of the lay public and require a level of technical and clinical understanding to perform their professional roles.
The recording was not placed on a homepage nor promoted as general public-facing content. It required multiple navigational steps to access and was not proactively disseminated, linked, endorsed or promoted by Britannia. The company did not grant permission for the recording to be uploaded and was unaware that it had been made available on the third-party website until receipt of the complaint on 8th January 2026.
Britannia notes that in previous Code cases (including Cases 0250/07/24, AUTH/2912/12/16 and AUTH/2680/11/13), the Panel has considered the overall context, nature of the website and intended audience when determining whether material constituted promotion to the public. In each case, the Panel recognised that accessibility to the public was not determinative; rather, the absence of overt promotional purpose and the presence of a clearly professional or specialist context were significant factors in its assessment. Britannia respectfully submits that similar contextual factors apply in this case.
As soon as Britannia became aware that the recording was accessible via the [named diagnostics company] website, immediate action was taken to request removal of the webpage hosting the recording. The webpage was subsequently taken down.
We trust that the contextual background, the nature of the material, and the actions taken upon notification will assist the Panel in its assessment. Britannia remains committed to constructive engagement with the PMCPA and to ensuring continued alignment with both the letter and spirit of the Code.”
PANEL RULING
This case was in relation to a webinar featuring a speaker from Britannia, that was hosted on the website of a company specialising in diagnostics and medical devices (referred to in this ruling as “the diagnostics company”).
The complainant stated that they were a member of the public and alleged that session four of the webinar discussed clozapine and was clearly promotional. The complainant also alleged that the video was not certified and did not include the required prescribing information and adverse event reporting statement. The complainant stated that the video was not balanced and that the involvement of Britannia was not made clear at the start of the video.
The webpage link provided by the complainant directed viewers to a webinars section of the diagnostics company’s website. The landing page listed the title of the webinar series and a description of each of the four individual sessions.
The webinar was held on 31 March 2022 and was titled “[Named diagnostics company] Webinar Series: Enabling a Better Point-of-Care Diagnosis”. Session four of the webinar was described as:
“Session 4: “Monitoring and Testing in the Community” with [named Britannia employee], Britannia Pharmaceuticals Ltd. [Named Britannia employee] discusses how the use of point-of-care instruments help manage Clozapine use in the Community and improve patient pathways.”
Further down the webpage the embedded webinar video was available to access.
The date of the webinar (31 March 2022) was more than two years before this complaint was received (January 2026). It was therefore potentially not proceedable under the PMCPA’s two- year limitation policy. However, on the basis that the link provided by the complainant was still active and accessible on the diagnostics company’s website at the time of the complaint, the case preparation manager concluded that it was less than two years since the material was last used or appeared and therefore the policy did not apply to this case.
Firstly, the Panel had to consider if Britannia was responsible for the contents of the webpage and the contents of the embedded recording.
The Webpage
Britannia submitted that it had not given permission for the presentation to be recorded or placed on the diagnostics company’s website.
It is a well-established principle that a company is responsible under the Code for the acts and omissions of third parties working on its behalf. A “third party” is defined in Clause 1.24 of the Code. However, in this case, the Panel accepted Britannia’s submission that the diagnostics company was not a third party working on its behalf; but rather Britannia had been invited to provide a guest speaker at one of the diagnostics company’s events.
The Panel was concerned that the diagnostics company had chosen to include the generic name of the medicine on its webpage hosting the video, under the title of session four, along with the presenter’s name and affiliation. However, given that the diagnostics company was not a third party of Britannia, and Britannia had not given permission for it to record or host the session on its website, the Panel concluded that Britannia had no role in the publication of the video on the website and was not responsible for the way in which the diagnostics company had described the contents of the webinar on its webpage.
The Panel therefore made its ruling solely on the contents of the recording of session four of the webinar, for which Britannia was responsible.
Session Four of the Webinar
Session four of the webinar was a presentation of approximately 23 minutes in duration and consisted of seven slides.
The guest speaker from Britannia was introduced to the audience by an employee of the diagnostics company at the beginning of the presentation. The title of the opening slide of the presentation was “[Named medical device] Practical Experience of Near Patient Testing” and the slide included the name and role of the speaker as “[named Britannia employee], Britannia Pharmaceuticals”. The guest speaker from Britannia presented slides and discussed, among other things, monitoring requirements, near patient, postal and local testing.
Slide three of the presentation was titled “Monitoring requirements” and contained the bullet “Antipsychotic medication for Treatment-Resistant Schizophrenics”. The slide contained four further bullets explaining the risk of agranulocytosis and the requirements for ongoing FBC monitoring.
Britannia submitted that:
the target audience of the webinar was biomedical scientists and laboratory-based personnel,
multiple navigational steps were needed to access the recording on the website,
the name of a Britannia medicine was not mentioned during the presentation; it was only referred to by indication and potential side effects, and this was solely to provide clinical context for why blood monitoring may be required in certain treatment pathways.
It is an established principle under the Code that a medicine can be promoted without its name being mentioned. The Panel assessed all the slides and the way in which they were presented. Slide three of the presentation included a single mention of an indication, the class of product (an anti-psychotic medication) and brief details of its licensed monitoring requirements. However, the overall focus throughout was on the benefits of the medical device and the benefits of monitoring using that device. Those benefits were presented in the context of near patient testing as against postal and local testing. It was clear however that the device was used by Britannia with a specific unnamed medicine and the speaker referred to the device as a unique selling point versus Britannia’s competitors and that it was part of a “package to try to make sure that many patients use our brand of medicine compared to our competitors.” Further, the identification of another “very rare” side effect and a reference to increased patient engagement were mentioned by the speaker in response to a question at the end of the presentation, albeit within the context of using the device. The Panel considered that the presentation did not make claims about the clinical benefits or treatment effectiveness of a specific Britannia medicine.
Although the definition of promotion in Clause 1.17 is broad, on balance, the Panel did not consider that the complainant had given specific or clear reasoning to establish which elements of the presentation were “clearly promotional” and why. It was not the Panel’s role to infer reasons on behalf of the complainant who had to establish their case on the balance of probabilities.
The Panel acknowledged that the presentation was targeted at biomedical scientists and laboratory-based personnel involved in the use, and purchase, of analysers in the context of ongoing monitoring requirements in a laboratory setting; it was not directed at health professionals or other relevant decision makers. The Panel had no information about the status of the individual biomedical scientists and laboratory personnel attending the original session such that it had not been established whether they were other relevant decision makers; the complainant bore the burden of proof in this regard. The Panel therefore concluded that the session was not promotional of clozapine, as alleged, and the Code requirements relating to certification, prescribing information and an adverse event reporting statement did not apply. The Panel ruled no breach of Clauses 8.1, 12.1 and 12.6.
Clause 26.1 stated that “Prescription only medicines must not be advertised to the public.” Although the complainant had described themselves as a member of the public, the Panel was satisfied, for the reasons given above, that Britannia was not responsible for the publication of the video on the webpage and further the presentation did not advertise a prescription only medicine to the public. The Panel therefore ruled no breach of Clause 26.1.
The complainant also alleged that the webinar was disguised promotion and that the involvement of Britannia was not made clear from the start of the video. Clauses 3.6 and 15.6 both prohibit materials and activities being disguised promotion. Given the Panel’s conclusion that the complainant had not established that the presentation was promotional, it could therefore not be disguised promotion. The Panel ruled no breach of Clauses 3.6 and 15.6.
The Panel accepted Britannia’s submission that its role was clearly stated at the beginning of the presentation and was sufficiently prominent to ensure that viewers were aware of Britannia’s involvement as a guest speaker at the outset. The Panel therefore ruled no breach of Clause 5.6.
Given that the complainant had not provided any reasoning as to why they considered the information provided during the presentation to not be balanced, the Panel ruled no breach of Clause 6.1.
The Panel was concerned that, at the time of the complaint, Britannia was unaware that a presentation delivered by one of its employees had been recorded and hosted on the diagnostics company’s website, with a specific reference to the Britannia employee discussing “how the use of point-of-care instruments help manage Clozapine use in the Community and improve patient pathways”.
The Panel accepted that the diagnostics company was not a “third party” under the Code and that Britannia did instruct it in advance that medicines must not be mentioned. Nevertheless, the Panel would have expected Britannia to have exercised greater care in the arrangement of the guest speaker and engaged in follow-up enquiries regarding how its speaker’s content was being used. The Panel also took account of the fact that Britannia accepted a breach of Clause 5.1. On balance, the Panel concluded that this case demonstrated a lack of governance and therefore ruled a breach of Clause 5.1.
Notwithstanding those governance failings, the Panel did not consider that the circumstances of this case met the threshold for a ruling that Britannia had brought discredit upon, or reduced confidence in, the pharmaceutical industry. Clause 2 was a sign of particular censure and was reserved for such use. The Panel ruled no breach of Clause 2.
Complaint received | 4 January 2026 |
Case completed | 11 August 2026 |
