A complaint was received in a private capacity from a health professional who stated that he/ she worked as a consultant to a pharmaceutical company. It had previously been decided, following consideration by the then Code of Practice Committee and the ABPI Board of Management, that private complaints from pharmaceutical company employees had to be accepted. To avoid this becoming a means of circumventing the normal procedures for intercompany complaints, the employing company would be named in the report. The complainant would be advised that this would happen and be given an opportunity to withdraw the complaint.
The principles set out above were applied to this complaint. Consultancy status should not be used to circumvent the normal rules for inter-company complaints.
The complainant was advised that if he/she wished to proceed with the complaint in a private capacity Novartis would be named in the case report; and the respondent company would be informed of his/ her professional status and the connection with pharmaceutical companies. The complainant so agreed.
As part of the complaint concerned an alleged breach of undertaking, that part of the complaint was taken up by the Director as the Authority was responsible for ensuring compliance with undertakings.
The complaint concerned an advertisement published in Pulse today.co.uk inviting readers to a Pfzer meeting to be held in January 2017. The invitation was headed ‘The ultimate stop smoking roadshow 2017 3 Events Across the UK’ and details of a relevant website were given. The complaint also concerned two invitations sent by email in December 2016 and January 2017 to attend road show events.
The complainant stated that although there was a statement that Pfzer had funded the programme (displayed on the website and the emails but too blurry to read on the advertisement), it was not clear where editorial control resided. The emails and the advertisement all stated that Pfzer products might be mentioned, but the complainant could fnd no link to the relevant prescribing information. There was no clear prominent statement as to where it could be found. As a consequence, there was no adverse event statement. The description of ‘ultimate stop smoking roadshow’ was inappropriate language and, given it was taking place in January, might not be the case by the end of the year – if any event could be described as ‘ultimate’ – it was not the most appropriate taste and failed to recognise the professional standing of the audience.
Given the lack of clarity on the emails, the advertisement and the website, the complainant was concerned regarding materials that were used on the day. Had these too failed to have prescribing information where appropriate? The complainant had no knowledge of these, but was concerned that the same issues might be present.
In a subsequent email, the complainant stated that he/she noted that Case AUTH/2818/1/16 mentioned disguised promotion and lack of clarity of declarations of sponsorship. The complainant requested that this matter also be reviewed to determine whether Pfzer had complied with its undertaking given in that case.
The detailed response from Pfzer is given below.
The Panel examined the invitations at issue. The advertisement published online in Pulse was headed ‘THE ULTIMATE STOP SMOKING ROADSHOW 2017’ followed by ‘3 EVENTS ACROSS THE UK’. The date of the meeting was given followed by 3 bullet points: Meeting the challenges; Clinical study news; and KOL-led presentations. The Panel was unsure why the declaration statement in the advertisement provided by the complainant was blurry but noted Pfzer’s submission that the online advertisement was clear and legible. The statement read ‘This program is initiated and funded by Pfzer and may include reference to Pfzer medicines relevant to the agenda topics’ followed by the Pfzer logo. The Panel also noted the references to Pfzer in the emails.
The Panel considered that Pfzer’s role in the initiation and funding of the program had been made clear. No breach was ruled in relation to each email and the online invitation published in Pulse.
The Panel noted that there was no direct or implied mention of any medicine in the invitation and emails. Recipients would be clear that Pfzer’s meeting would include treatment strategies and ‘may include reference to Pfzer’s medicines relevant to the agenda topics’. The Panel considered that whilst it might be prudent to provide prescribing information with the invitations as the invitation did not promote any specifc Pfzer medicines, it was not a breach of the Code not to do so. The adverse event reporting requirements were thus not triggered. The Panel ruled no breach.
The Panel noted that ‘ultimate’, as used in the material in question, was used to describe the event rather than a medicine. The Panel did not consider that the term ‘ultimate’ was a direct or indirect claim for a medicine on the materials at issue. The Panel thus ruled no breaches of the Code.
The Panel considered that, on balance, describing the series of meetings on the three items at issue as ‘the ultimate stop smoking roadshow’ did not recognise the special nature of medicines and the professional standing of the audience and a breach was ruled.
The Panel noted the complainant’s concern that materials used on the day failed to have prescribing information where appropriate. The Panel noted that the complainant had not seen the materials but posed a series of questions about them and a hypothetical scenario. The Panel noted Pfzer’s submission that the audience was made aware of the availability of prescribing information as necessary from the outset of the presentation and, in addition, material with prescribing information was available to attendees at the meeting. The Panel reviewed the slides and noted that although Pfzer medicines were included, no prescribing information was given nor did the slides state where such could be found.
[Post meeting note. On completion of this case Pfzer advised that of the presentations, all of which stated ‘This program is initiated and funded by Pfzer and may include reference to Pfzer medicines relevant to the agenda topics’, those presentations that referred to Champix (varenicline tartrate) included reference to the availability of its prescribing information at the meeting].
The Panel noted that it was an established principle that prescribing information for a presentation should either be part of it or be otherwise available to each delegate, a leavepiece provided to each delegate would suffce in this regard. If prescribing information formed part of the presentation in the absence of alternative formats, it should be displayed such that the audience had suffcient time to consider it. The Panel considered it prudent and good practice to include prescribing information on presentations at meetings even if the prescribing information was also made available on a leavepiece or similar. The Panel noted the nature of the allegation and Pfzer’s explanation above about the availability of prescribing information at the meeting and therefore ruled no breach of the Code.
The Panel noted its rulings above and overall did not consider that high standards had not been maintained and therefore ruled no breach in that regard.
The Panel noted the complainant’s further allegation that Pfzer might not have complied with its undertaking in Case AUTH/2818/1/16. In that case, the Panel considered that it was not suffciently obvious at the outset that an email invitation to a Sayana Press webinar, sent by a third party event organiser on Pfzer’s behalf, was promotional and from a pharmaceutical company. The Panel considered the promotional nature of that email was disguised and a breach was ruled. Turning to this case, Case AUTH/2931/1/17, the Panel noted its rulings above that the declaration of Pfzer’s role in the initiation and funding of the programme was clear. The Panel did thus not consider that Pfzer had failed to comply with its undertaking given in Case AUTH/2818/1/16. The Panel ruled no breach of the Code including Clause 2.