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AUTH/2956/5/17 - Ex-employee v Napp

Case number:AUTH/2956/5/17
Case ref:Ex-employee v Napp
Description:Flutiform promotional practices
No breach:No Breach Clauses 2, 7.2, 7.4, 9.1, 15.9, 19.1 and 19.2
Appeal:No appeal
Status:No breach ruled, case report pending
Review:Published in the November 2017 Review
Received:08/05/2017
Completed:29/08/2017
Case Summary:

An ex representative, previously employed by Napp through a third party agency, complained about various promotional practices within Napp.

Napp’s detailed response to each allegation is given below.

The complainant stated that one of his key performance indicators (KPIs) was to get ten target GP practices to ‘switch’ a percentage of asthma patients on GlaxoSmithKline’s Seretide Evohaler (salmeterol plus fluticasone) to the equivalent doses of Napp’s Flutiform metered dose inhaler (MDI) within a specified timeframe. The complainant noted, however, that the prescribing particulars (age range and indications) of Seretide Evohaler and Flutiform were different and so the two were not wholly interchangeable. Further, the percentage switch conversion was unrealistic as there were no financial incentive schemes in named local clinical commissioning groups (CCGs) to switch. This, together with rebates from GlaxoSmithKline on Seretide Evohaler and from other manufacturers on other inhalers meant that some of the cost savings claimed by Napp for a switch to Flutiform were inaccurate. The complainant stated that he was under significant and sustained pressure to deliver on business outcomes. The complainant was further concerned that emailing surgery prescribing data could potentially breach data protection.

The complainant noted that Napp’s marketing material did not refer to asthma patients prescribed Seretide Evohaler who were also diagnosed with asthma-chronic obstructive pulmonary disease (COPD) overlap syndrome (ACOS); Flutiform was not licensed for COPD. Napp’s marketing message of a simple switch was misleading. Even in Napp’s own marketing material there were a number of differences between Seretide Evohaler and Flutiform, which meant that the medicines were not like-for-like formulations. A simple switch should not be taken as like-for-like dose changes, but the actual process of making changes which was rather more involved and required firm commitment from the practice.

The complainant stated that practices could do the switches themselves or via one of two services offered by Napp which were seen as independent non-promotional services but were set up to switch inhaler medicines to Flutiform. The complainant stated that he was briefed about this service via Napp’s intranet site but that specific in-house, face to-face training and validation were lacking. The complainant also stated that he did not know when these service were being provided within his target surgeries and that he could order non-promotional materials despite not having been trained. The complainant alleged that, in pursuit of sales, compliance towards switches and Napp’s briefing on switches from his manager (the area business manager (ABM)) was very lax. As Napp was driving switches, the non-promotional service should not have been used as the introduction was linked to Flutiform as a commitment from the customer to make changes through quality outcomes framework (QOF) and patient review in the first call and to then sign up to the service in the second call.

The Panel noted that the parties’ accounts differed; it was difficult in such circumstances to determine precisely what had happened. A judgement had to be made on the available evidence whilst noting that the complainant bore the burden of proof and had to establish his case on the balance of probabilities.

The Panel noted that the complainant’s concern was that the percentage switch conversion from Seretide Evohaler to Flutiform, as set out in his KPIs, was unrealistic. The Panel noted that it appeared that the KPIs had been agreed by the complainant and that he was required to achieve a stated switch success rate within ten target GP practices within 6-8 months. It was stated that a switch should be 50% or more of a surgery’s Seretide Evohaler marketshare to the equivalent dose of Flutiform. The Panel considered that the absence of incentive schemes in the CCGs did not necessarily mean that a switch would be unrealistic. Much would depend on whether health professionals considered that the benefits of a switch outweighed the work required to action it. The Panel did not consider that the complainant had proven that, on the balance of probabilities, the percentage switch was unrealistic for the reasons alleged. Nor that Napp in setting this KPI advocated, either directly or indirectly, any course of action which would be likely to lead to a breach of the Code. No breach of the Code was ruled.

The Panel further noted the complainant’s concern that there were rebates in place in the three named CCGs for Seretide Evohaler and another inhaler Sirdupla and therefore the cost saving figures in the leavepiece concerning medicines optimisation for one of the named CCGs were inaccurate and misleading. The Panel noted Napp’s submission that the leavepiece compared NHS list prices and national prescribing data to ensure licensed age ranges were taken into account when calculating the potential cost savings. The Panel noted Napp’s submission that the complainant had been briefed on the leavepiece and confirmed that he understood how to use it. The Panel considered that although discounts etc might make it possible to buy medicines at less than the NHS list price, it was not unreasonable for companies to base price comparisons on the NHS list price when this was made clear. The Panel did not consider that the complainant had proven that, on the balance of probabilities, the leavepiece was misleading in that regard. On the narrow grounds alleged the Panel ruled no breach of the Code.

The Panel reviewed two emails provided by the complainant in support of his allegation that he was under pressure to get practices to switch and the allegation that discussing surgery prescribing data and patient switches in emails could potentially breach data protection laws. The Panel noted Napp’s submission that the content of the first email displayed the manager’s concern that the likelihood of a switch in the named GP practice was low thus calling into question the complainant’s sales abilities. The second email predated the first and provided details of a business review held between the complainant and his ABM. The email highlighted the complainant’s progress against his mutually agreed KPIs.

The Panel did not consider that it was necessarily unacceptable for ABMs to require weekly progress updates provided that such did not contravene the requirements of the Code. The Panel did not consider that the complainant had proven that he had been under sustained pressure from the ABM to deliver on business outcomes that did not comply with the Code as alleged. No breach of the Code was ruled. Nor had the complainant proved that that the ABM requesting weekly updates would advocate directly or indirectly any course of action that would be likely to breach the Code. No breach of the Code was ruled.

The Panel noted Napp’s submission that the emails provided by the complainant did not contain any patient specific data and the information sought was anonymous in nature. The Panel further noted Napp’s submission that to the extent that the emails mentioned individual health professionals, this publicly available information was used for legitimate business purposes and was subject to appropriate safeguards. The Panel was concerned about activities in relation to the Code. It was not for the Panel to determine whether Napp’s activities were in line with data protection requirements per se.

Clause 1.11, however, stated that companies must comply with all applicable codes, laws and regulations to which they were subject. This clause had not been raised and the complainant had not provided evidence that the companies had been found in breach of data protection requirements. Given the circumstances the Panel therefore considered that there was no evidence that high standards had not been maintained and it ruled accordingly.

With regard to the use of the medicine for asthma overlap syndrome (AOS) and COPD as Flutiform was not licensed for COPD, the Panel noted Seretide Evohaler’s SPC and Napp’s submission that Seretide Evohaler was not licensed to treat ACOS or COPD and therefore there was no need for such a consideration within its materials which referred to switching including the leavepieces. Seretide Accuhaler was licensed to treat both asthma and COPD. The Panel did not consider that the material was misleading in that regard and no breach of the Code was ruled.

The Panel noted that the complainant provided the incomplete front page of a document which stated ‘A simple switch to Flutiform Real Difference’ and an extract from another leavepiece which included a table highlighting differences between Seretide Evohaler and Flutiform. The Panel noted the complainant’s allegation that describing the switch as ‘simple’ was misleading as making changes was more involved and required significant time investment from practices. The Panel noted that under the Code, a company could promote a simple switch from one product to another but could not assist in implementing that switch. The Panel noted that it would take time to review patients who potentially could be switched but considered that the reference to ‘a simple switch’ in the supplementary information to the Code referred to switching from one medicine to another in relevant patients. The Panel noted that the complete document provided by Napp was titled ‘A simple switch to Flutiform can make a real difference to your patients’. The leavepiece discussed some of the features of Flutiform followed by study results from patients switched from Seretide Evohaler to Flutiform.

The Panel further noted Napp’s submission that ‘simple’ was used to describe the switch from Seretide Evohaler to Flutiform as both products were similarly licensed for asthma maintenance and differences in licensed age ranges were clearly stated; both were MDI’s; and both contained the same inhaled corticosteroid, so no steroid dose conversion was necessary.

The Panel noted that the leavepiece referred to the licensed indication of Flutiform including the age range for the various strengths and that it was for patients 12 years and older (low and medium strengths) and adults (all dosage strengths). The leavepiece stated that patients previously controlled on Seretide Evohaler 250mcg could be switched to Flutiform 250mcg and maintain good asthma control. A bullet point below in less prominent font stated that this was based on a 12-week study in 225 adult asthma patients. The leavepiece did not include the licensed indication for Seretide including the age range or the differences in licensed age ranges between Flutiform and Seretide as stated by Napp. The Panel queried why the leavepiece did not state that patients aged 5 to 12 could not be switched from Seretide Evohaler to Flutiform. The second leavepiece referred to by the complainant, entitled ‘Do you have a medicines optimisation plan to switch asthma patients from Seretide Evohaler? Why choose Flutiform’, included the claim ‘A simple switch can make a real difference’ and asked the reader what was important to them when switching patients from Seretide Evohaler to Flutiform. The leavepiece compared various features of Flutiform, Seretide Evohaler and Fostair including change in steroid from Seretide Evohaler, patient-facing dose indicator and refrigeration required prior to dispensing. Page 3 compared Flutiform and Fostair in terms of dose delivery and steroid percentage at the lowest daily dose. Whilst the leavepiece stated the licensed indication of Flutiform including the age range for the various strengths, it did not refer to the licensed indications of Seretide or Fostair including the age range. There would be patients who could simply be changed from Seretide to Flutiform. Notwithstanding its comments about the two leavepieces above, the Panel did not consider that the complainant had proved that describing the switch in the leavepiece as simple was misleading due to the time investment required by surgeries. Based on this very narrow allegation the Panel ruled no breach of the Code.

The Panel noted the complainant’s concerns about the services offered by Napp to assist surgeries to switch from Seretide Evohaler to Flutiform. The Panel did not consider that there was any evidence before it to demonstrate that the service as implemented was included in individual sales targets or was only offered where a switch was guaranteed as alleged. No breaches of the Code were ruled.

The Panel considered the service in relation to the allegations about the promotional materials which focussed on switching patients to Flutiform. The Panel noted Napp’s submission that account managers, including the complainant, were only allowed to introduce the service briefly and in accordance with the approved briefing. In October 2016, the complainant received live, 1 hour, on-line training on the new pharmacist-led review service and a follow-up briefng document to further clarify the process which specified the dos and don’ts for account managers in terms of non-promotional vs promotional calls and to which was attached the service introduction document. Napp noted that the complainant acknowledged that he had read and understood the briefing document. The Q&A stated that once a therapeutic review was in progress in a practice, account managers were not allowed to discuss the asthma review service with any of the health professionals in that practice. The briefing included relevant requirements from the Code. The Panel noted Napp’s submission that the complainant was not informed about services within his target surgeries because there had been none whilst he was employed. The Panel further noted that the complainant had been instructed not to introduce the therapy review service.

The Panel noted that a briefing document, the training slides for account managers and the material provided by the complainant set out what discussions could take place in a promotional call and a non-promotional call. The promotional call flow diagram covered situations for customers who had agreed to switch either with no assistance or where assistance was requested. In both situations no therapeutic review would be offered. The flow diagram for the non-promotional call whereby the health professional had an interest in therapeutic review, the service introduction document was to be used and the practice referred to the ABM/ healthcare development manager (HDM). The Panel did not consider the training materials were sufficiently clear given that the main promotional message was for a switch to take place. In addition, leavepieces promoting the switch were to be left at the end of the call. There was no flow diagram or other instructions in the training material for the situation when the service was briefly introduced during a promotional call. It was not clear from the briefing documents for account managers that if a practice had agreed to switch, the service could not be offered in that practice even in a subsequent non-promotional call by the account manager or an ABM/HDM. However, this did not necessarily mean that the therapy review service offered by Napp was linked to the promotion of Flutiform as alleged. The Panel noted its comments and rulings above and although concerned about the relationship between the promotional messages about switching and the service which provided resource to change patients’ medication including to Napp’s product Flutiform, it did not consider that the complainant had shown on the balance of probabilities that the arrangements failed to meet the requirements of the Code. The Panel therefore ruled no breach of the Code. The Panel did not consider that the complainant had provided evidence that in pursuit of sales, Napp’s compliance and briefing on switches from the ABM were very lax as alleged. The Panel consequently ruled no breach of the Code including Clause 2.

The complainant noted that he was pressurised to increase sales and call and contact rate via emails from Napp and the contract agency but that these communications did not refer to the Code regarding solicited/unsolicited and the frequency of calling and remaining Code compliant.

The Panel noted that the email provided by the complainant was sent by the third party agency and it discussed the complainant’s progress in terms of improvement in his call rates and an increase in the number of 1:1 appointments confirmed. The Panel noted Napp’s submission that the complainant was urged to increase his activity; he had only seen around one target GP surgery every 5 weeks. The Panel considered that whilst it might be preferable to refer to the requirements of the Code whenever calls or contacts were discussed with representatives, given the complainant’s call rates there was no evidence to show that Napp, in encouraging him to increase his activity, had advocated either directly or indirectly any course of action which was likely to breach the Code. The Panel noted Napp’s submission that all of its account managers were trained on the Code including its requirements regarding call and contact rates. The Panel ruled no breach of the Code. There was no evidence that Napp had failed to maintain high standards in this regard nor that the company had brought discredit upon or reduced confidence in the pharmaceutical industry. The Panel ruled no breach of the Code including of Clause 2.

The complainant noted that Napp organised an external speaker through a series of meetings as a tactic to access health professionals at and after the meeting, however Napp did not provide any briefing about whether the speaker was only to be offered at nurse meetings and not GP meetings. The complainant provided an email which showed that his ABM was reluctant to sponsor a meeting for a particular group of GPs because previous experience showed that they were ‘not of particular value’. The complainant considered his AMB’s comments derogatory and unprofessional. The complainant further stated that the contract agency suggested in its communication with him that such a meeting was linked to a return on investment. The complainant was not sure if Napp was copied into this communication. The contract agency briefng to the complainant was simple and in breach with no written reference to the Code to protect itself as an organisation.

The Panel noted that Napp did not comment on the complainant’s allegation that Napp had used the promotional meetings as a tactic to gain access to health professionals at and after the meetings. The Panel considered that it was not necessarily unacceptable for meetings to be a means of interacting with health professionals. Noting the complete absence of evidence, the Panel considered that the complainant had failed to show that there had been a breach of the Code with regard to the use of the meetings and so it ruled no breach of the Code including Clause 2. In its response Napp had cited a clause of the Code which was not relevant to the matter; no breach of that clause was ruled.

The Panel did not consider that in referring to a group of GP’s as being ‘not of particular value’ the ABM had been derogatory as alleged; it was not necessarily unacceptable for a company to decide which health professionals to promote to based on a return of investment provided that requirements of the Code were met. The Panel did not consider that Napp had failed to maintain high standards; no breach of the Code was ruled.