An anonymous representative who promoted Toviaz (fesoterodine) for Pierre Fabre, complained on behalf of a group of representatives about call rates and the certification of meetings. Toviaz was indicated for the treatment of symptoms of overactive bladder syndrome.
The complainant was particularly critical about the conduct of senior staff within the company with regard to the Code and stated that representatives had been instructed to see clinicians more than the average 3 times per year. At a recent sales meeting it was suggested that representatives should not take holidays as they would thus not be selling. The complainant alleged that none of the training used at the meeting had been certified. Similarly, promotional speaker meetings had not been approved or certified but representatives were told to go ahead anyway because the meetings were business critical and the risk was low.
The complainant queried whether an overseas corporate consultant understood UK regulations and whether he/she had sat the ABPI Examination.
The detailed response from Pierre Fabre is given below.
The Panel noted that the sales meeting presentation at issue discussed sales activity and marketing strategy and in this regard it considered that the presentation was briefing material which needed to be certified. Pierre Fabre acknowledged that the presentation had not been certified and in that regard the Panel ruled breaches of the Code.
With regard to overcalling, the Panel noted that during their initial training course the Toviaz representatives had been instructed about the requirements of the Code regarding the number of calls they could make on health professionals. There had been some confusion on this matter at the sales meeting in June 2017 and the representatives had been orally rebriefed at that event and had received approved written instructions but not until August. A presentation at the sales meeting included individual data on sales and bonuses. The data was not set within the context of the number of calls allowed under the Code. In the Panel’s view, such data might put pressure on representatives to increase their activity and potentially breach the Code. Despite these concerns and the sales force recording system logged calls such that face-toface calls could not be differentiated from group calls, the Panel noted that the complainant bore the burden of proof. The Panel considered that it had not been shown on the balance of probabilities that representatives had been instructed to see clinicians more than three times a year on average. There was no evidence of overcalling. No breaches of the Code were ruled. The rulings were upheld on appeal. The Panel noted that the corporate consultant did not fulfil the definition of a representative; he/she did not call upon health professionals in relation to the promotion of medicines. There was thus no requirement for him/her to take the ABPI Examination and in that regard the Panel ruled no breach of the Code. This ruling was upheld on appeal.
The Panel noted the complainant’s concerns that representatives’ meetings had not been approved or certified. The Panel noted that the Code required companies to check all meetings to ensure compliance with the Code and to certify those which involved travel outside the UK. The Panel did not consider that the representatives meetings needed to be certified; the arrangements had been documented and approved. No breach of the Code was ruled. This ruling was upheld on appeal.
The Panel noted its comments and rulings above and also ruled no breach of Clause 2 of the Code. The complainant’s appeal of this ruling was successful; the Appeal Board ruled a breach of Clause 2.
Apart from his/her appeal of the Panel’s ruling of no breach of Clause 2, the complainant’s appeal was largely unsuccessful as detailed above. However, in submitting his/her reasons for appeal, the complainant noted that in its response, Pierre Fabre had not submitted the whole of the presentation used at the sales meeting. The Appeal Board considered that the additional slides fell within the scope of the complaint and could be considered. The Appeal Board considered that the Panel’s rulings with regard to the presentation not being certified applied to the newly submitted slides as acknowledged by Pierre Fabre.
The Appeal Board noted that Pierre Fabre had initially provided an incomplete set of slides from the sales meeting. This omission was a serious matter; it was essential that pharmaceutical companies provided complete and accurate information to the Panel and so the Appeal Board decided that, in accordance with Paragraph 11.3 of the Constitution and Procedure, Pierre Fabre should be publicly reprimanded. The Appeal Board noted that this case had raised serious concerns about Pierre Fabre’s compliance structure. However, comprehensive and timely action had been taken including wholesale changes to address the issues highlighted. On balance, the Appeal Board thus decided not to require an audit of the company’s procedures.