An anonymous, non-contactable complainant who described him/herself as a registered nurse complained about arrangements for an educational meeting about aesthetics organised by Galderma (UK) in association with a nurse support group. The complainant provided the agenda which listed four presentations, two of which were particularly relevant to medicines marketed by Galderma; one was about botulinum toxins (Galderma marketed Azzalure) and the second was about the company’s product Pliaglis (tetracaine/lidocaine), a topical anaesthetic for use in dermatological procedures. The covering letter sent with the agenda stated that there was no meeting charge for members of the nurse support group but ‘due to the high calibre of the speakers provided by Galderma you are required to have purchased a minimum of Two Emervel Classics from [named pharmacy] between now and the 16th November 2013’.
The complainant was disgusted that he/she was forced to buy at least two boxes of Galderma’s dermal fillers to be able to attend. The complainant submitted that firstly it was just wrong and, secondly, he/she did not like or use the particular filler, and thirdly was not even trained on it.
The complainant submitted that these actions did not do the industry any favours and just lowered standards, which was exactly the opposite of what he/she hoped to achieve.
The detailed response from Galderma is given below.
The Panel disagreed with Galderma’s submission that as the complaint specifically concerned the ‘purchase of a medical device’ in relation to attendance at an event which focused on medical devices it did not fall within the scope of the Code. The Panel noted that the Code applied, inter alia, to the promotion of medicines to health professionals. The Panel noted that the agenda included a presentation on botulinum toxins in aesthetics which compared the available products including Azzalure and a presentation on Pliaglis by a Galderma employee. A Pliaglis leavepiece was also available. In addition, the Panel noted that the agenda stated that the meeting provided ‘an opportunity to present evidence in your prescribing portfolio relating to Toxin’. The Panel considered that the meeting clearly promoted Galderma’s prescription only medicines and in this regard noted that the complainant had attended because he/she was particularly interested in the presentation on botulinum toxins.
The Panel noted that Galderma had, inter alia, contacted and verbally finalised arrangements and paid the speakers, two of whom were suggestedby the nurse support group including a consultant oculoplastic surgeon and a senior aesthetic product developer with Galderma. Galderma provided an additional internal speaker, sourced and funded the venue, drafted and provided the flyer and agenda to the nurse support group for distribution and provided general support. The covering email to the agenda, drafted by the nurse support group described the event as a ‘Galderma educational day’. Seven Galderma staff attended including five sales staff. The Panel considered that given Galderma’s role and the content of the meeting, the matter of complaint came within the scope of the Code.
Whilst noting that elements of the meeting referred to medical devices, the Panel considered that the content in relation to prescription only medicines and the overall meeting arrangements had to comply with the Code. This would include the requirement for delegates to purchase a product before attending. If the meeting content was only about medical devices then it was likely that the Code would not apply.
The Panel noted that the email sent with the agenda stated that there was no charge for the meeting but certain purchases were required. The covering letter further stated that ‘[named pharmacy] have kindly confirmed a special offer price for us all of £74.34 per box. You will also receive a free Restylane Skin Booster and complimentaries on the day. For a cost of £150 we get a fabulous deal, equivalent to £240 worth of products plus the meeting’. Delegates had to bring their invoices to the conference as proof of purchase to gain entry. Attendees who were not members of the nurse support group were charged £40 to attend and were also required to purchase 2 packs from the named pharmacy. The Panel noted Galderma’s submission that it was not uncommon within the aesthetics industry for there to be a requirement to purchase a product before attending educational or training sessions. The Panel noted its finding above that the overall arrangements had to comply with the Code. It could also be argued that attendees were paid £90 to listen to talks promoting medicines. The Panel considered that the discount offered on the obligatory purchase of Emervel together with the items received on the day meant that attendees were given a pecuniary advantage of a minimum of £90 in connection with the promotion of Azzalure and Pliaglis and a breach of the Code was ruled.
The Panel considered that patient safety was extremely important and was concerned about patient safety given that a health professional was required to purchase a product that he/she knew nothing about and upon which he/she was not trained. No training was provided at the meeting. In addition paying health professionals to attendpromotional meetings was unacceptable. The Panel considered that overall high standards had not been maintained and a breach was ruled. In addition the Panel considered that the circumstances were such that Galderma had brought discredit upon and reduced confidence in the pharmaceutical industry. A breach of Clause 2 was ruled. This ruling was appealed.
Given Galderma’s conduct in this case, the Panel reported the company to the Appeal Board under Paragraph 8.2 of the Constitution and Procedure for it to consider whether further sanctions were warranted.
Upon appeal the Appeal Board noted that in Galderma’s view as long as a health professional knew the general technique for injecting dermal fillers, not being trained to administer a specific filler did not have adverse implications for patient safety and thus the Panel’s ruling was based on a misunderstanding. The Appeal Board noted, however, that the ruling of a breach of Clause 2 referred to all the circumstances of the case, it was not limited to matters of patient safety.
The Appeal Board was concerned to note Galderma’s submission that the meeting had been organised by a sole key account manager (KAM) at short notice acting on his/her own without Galderma’s knowledge; this information had not been submitted to the Panel and, that very little detail had been provided in Galderma’s appeal. The Appeal Board was not convinced that the KAM was the only person who knew about the meeting; it noted Galderma’s submission that six other Galderma staff were at the meeting; the employee who had presented on Pliaglis and five other sales staff. The Appeal Board queried how a single KAM was able to cooperate with a nurse support group, agree a product discount, book national and international speakers, generate meeting materials, source and fund the venue etc without a more senior member of staff having to formally agree and approve the arrangements.
The Appeal Board was extremely concerned about the overall arrangements for the meeting and the lack of control. It noted that the presentations had not been certified and there were no speaker agreements or contracts. The Appeal Board was extremely concerned that the presentation on botulinum toxins by a Galderma employee, discussed the use of botulinum toxin in a number of unlicensed indications. This was totally unacceptable and contrary to the Code.
The Appeal Board considered that the overall arrangements were such that Galderma had brought discredit upon and reduced confidence in the pharmaceutical industry. The Panel’s ruling of a breach of Clause 2 was upheld. The appeal was thus unsuccessful.
In relation to the report from the Panel, the Appeal Board noted the rulings of breaches of the Code. The Appeal Board was appalled and extremely concerned about the materials and arrangements forthe meeting; there had been astonishing failures at all levels.
The Appeal Board queried why the submission that a lone KAM, acting contrary to company policy, was responsible for the issues in this case, had only appeared as a brief statement in the appeal and not in the various responses to the Panel, especially considering the number of times the Panel had had to ask Galderma for information. Notwithstanding the KAM’s apparent disregard for company policies, Galderma was still responsible for his/her actions under the Code. The Appeal Board questioned Galderma’s care and attention taken in its responses to the Panel and its appeal in this case. External confidence in self regulation relied upon a full and frank disclosure at the outset. This and the circumstances of the meeting implied a fundamental lack of understanding of the requirements of the Code and a lack of control exhibited by Galderma. The Appeal Board queried how seriously Galderma took its corporate responsibilities under the Code.
The Appeal Board was extremely concerned about Galderma’s conduct, and having considered all the sanctions available under Paragraph 11.3 of the Constitution and Procedure decided that the company should be publicly reprimanded.
The Appeal Board also decided to require an audit of Galderma’s procedures in relation to the Code to be carried out as soon as possible and at the same time as that in Case AUTH/2684/12/13. On receipt of the audit report the Appeal Board would consider whether further sanctions were necessary. Following notification of the Appeal Board’s consideration, Galderma agreed a date for the audit but after receiving the detailed reasons it then declined to be audited or sign the undertaking and assurance related to the Appeal Board ruling and informed the Authority that it no longer accepted the jurisdiction of the PMCPA. This prompted a second report to the Appeal Board.
The Appeal Board noted that by failing to provide the requisite undertaking and assurance and declining the audit Galderma had failed to comply with the procedures set out in Paragraph 10 of the Constitution and Procedure and thus the Appeal Board decided, in accordance with Paragraph 11.4, to remove Galderma from the list of non member companies which had agreed to comply with the Code. Thus responsibility for Galderma under the Code could no longer be accepted. The Medicines and Healthcare Products Regulatory Agency (MHRA) and the ABPI Board of Management were subsequently advised of the Appeal Board’s decision.