An anonymous ex-employee complained that, in 2009, Cephalon provided inappropriate hospitality to delegates it had sponsored to attend a European congress in Lisbon. The complainant referred to a congress feedback document which, inter alia, stated ‘we then went to a few bars and to a club until 3am – a few good photos to prove it!!!’. The complainant also submitted that the document implied that sublingual Effentora (fentanyl) had been promoted before the marketing authorization for such use had been granted. The complainant further noted that the document referred to the differentiation between Effentora and ProStrakan’s Abstral (fentanyl) and alleged that implied comparisons had been made that were incapable of substantiation and potentially misleading. The complainant considered that the document, which had not been approved as briefing material, gave a very poor impression; the representatives involved did not appear fully conversant with the Code and had failed to maintain high standards. Breaches of the Code were alleged, including a breach of Clause 2.
The Panel noted that the complaint had been prompted by an internal feedback document detailing the aspects of a congress in Lisbon to which Cephalon had sponsored thirteen health professionals. The document made much of the hospitality provided to customers with phrases such as ‘Dinner was fantastic’, ‘great night again’, ‘took them clubbing’ and ‘we then went to a few bars and to a club until 3am – a few good photos to prove it!!!’. The document concluded with ‘All the customers were really looked after and spoke positively about Effentora – lets make sure they start Rxing now!’. The Panel noted that the feedback document had been distributed within Cephalon including to sales teams. The Panel considered that recipients would read the document and assume that it represented accepted practice with regard to hospitality. The Panel considered that the feedback document was, in effect, briefing material which advocated a course of action which would be likely to lead to a breach of the Code. A breach of the Code was ruled.
The Panel considered that the impression given by the feedback document of a general party atmosphere, recorded on camera, was wholly unacceptable. In that regard the Panel considered that high standards had not been maintained. The Panel further considered that the references to the hospitality provided were such as to bring discredit upon the industry. Breaches of the Code were ruled including a breach of Clause 2.
Receipts from various restaurants and bars were provided. Restaurant costs ranged from £43 to £57/head. One bill was inflated as only 15 people attended but the 20 covers booked had to be paid for. Early morning bar bills included the purchase of spirits and cocktails. On one evening the group had watched fire-eaters and the feedback document implied that the evening finished at 3am.
Overall, the Panel considered that, on a cumulative basis, the hospitality provided went beyond subsistence. It appeared that the hospitality was not secondary to the main purpose of being in Lisbon ie to attend a congress. That one of the Cephalon employees photographed the group added to the overall impression of a social event and general party mood. The Panel noted that the Code stated that the impression created by the arrangements for any meeting must always be kept in mind. The Panel considered that the hospitality had been excessive and in that regard high standards had not been maintained. The Panel further considered that the arrangements were such as to bring discredit upon the industry. Breaches of the Code were ruled including a breach of Clause 2.
The Panel considered that Cephalon’s representatives had not maintained a high standard of ethical conduct and in that regard it ruled a breach of the Code.
The Panel noted its rulings above and considered that Cephalon had not complied with all applicable codes. A breach of the Code was ruled.
With regard to compliance, the Panel noted that Cephalon had submitted that it had provided significant training to all staff in the past 2 years. There was no evidence to show that staff had not been trained on the Code. No breach of the Code was ruled.
The Code required companies to be responsible for the actions of their representatives if these were within the scope of their employment even if they were acting contrary to the instructions which they had been given. In that regard Cephalon had clearly taken responsibility for its representatives. No breach of the Code was ruled.
The Panel noted that the feedback document stated that at the Cephalon-sponsored symposium it was announced that sublingual use of Effentora had been approved in Europe. Cephalon had submitted that there was no evidence of this and that the licence for sublingual administration was not granted until three months later. Sublingual placement was referred to in the symposium but the Panel did not consider that this was necessarily unacceptable; the legitimate exchange of medical and scientific information during the development of a medicine was not prohibited providing any such information or activity did not constitute promotion. Regardless of what was said in the symposium the Panel considered that the complaint was about the conduct of Cephalon’s representatives because at the outset the complainant stated that he was surprised at some of the things that other hospital specialists got away with and how the managers encouraged it. The Panel considered that there was no evidence to show that the representatives had promoted Effentora in a manner inconsistent with the particulars listed in its summary of product characteristics. No breach of the Code was ruled.
The Panel noted that the feedback document stated that one of the delegates asked for clear differentiation between Effentora and Abstral and that this was ‘a good opportunity to sell’. The complainant alleged that this implied that comparisons were made that were potentially misleading and which could not be substantiated. The Panel noted that there was no information as to what the representatives had said to the delegate in response to his request. On that basis the Panel ruled no breach of the Code.
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