Case study 4

The Daily Telegraph of Friday, 24 July 2015 carried a number of articles critical of the activities of pharmaceutical companies in relation to payments to senior NHS staff. An article in The Daily Telegraph on 25 July named Stirling Anglian in relation to a meeting held in Germany. In accordance with Paragraph 6.1 of the Constitution and Procedure the matter was taken up as a complaint under the Code.

When notifed of the complaint Stirling Anglian was provided with a copy of two articles (‘The NHS offcials paid, wined and dined on spa trip’, and ‘Doctors may have to declare links to drug companies’) and an editorial (‘Health Worries’) which were all published in The Daily Telegraph 25 July 2015. These articles formed the basis of the complaint.

When informed by the PMCPA case preparation manager that the article ‘The NHS offcials paid, wined and dined on spa trip’ would be taken up under the Code, one of the authors confrmed that the reports spoke for themselves. The journalist was willing to be involved to the extent of considering any questions from the PMCPA.

The Daily Telegraph articles of 24 July stated that senior health offcials who helped decide which medicines were used by GPs and hospitals were ‘… being paid to work as consultants to pharmaceutical companies that want the NHS to “switch” to medicines they produce’. The articles headed ‘NHS bosses paid by drug frms’ and ‘Lavish trips laid on by drugs frms to “sway” NHS staff’ referred to an undercover reporter’s fndings. One article named two pharmacists one of whom was head of medicines management at a named clinical commissioning group (CCG) who attended a meeting in Germany at which a company took 12 ‘payors’ to ‘one of the top 10 hotels in the world’.

One of the articles reported that the named pharmacist who was head of medicines management claimed that each delegate was paid £500 a day to attend and all of those invited ‘switched’ to the company’s product after the trip. The named pharmacist was reported as stating the attendees were treated to dinner at a ‘flashy’ restaurant and up to ‘£1,000 worth of champagne’. The report stated that the named pharmacist did not consider the ABPI Code applied once ‘you’re outside the country’. The savings to the NHS and that there was a clinical beneft were also mentioned.

The Daily Telegraph of 25 July, which named Stirling Anglian in an article headed ‘The NHS offcials paid, wined and dined on spa trip’, included details about the arrangements; it stated that health offcials attended a luxury trip hosted by a pharmaceutical company lobbying to get its products used by the NHS. It referred to a dozen senior staff, some of whom were named, who were taken to Baden Baden, Germany. In the article a named pharmacist described the event as ‘superb’ and ‘all the delegates came back with a glow’. They were paid £500 per day to attend and ‘all the guests switched to the pharmaceutical company’s products following the trip’. Three of the attendees were quoted as stating that ‘no switches were made as a result of the meeting and decisions were made because drugs were cost effective or benefited the patient’. The article included photographs of the hotel which the named pharmacist described as ‘one of the top 10 hotels’. The article stated that the PMCPA would be examining whether ‘… the trip had breached the rules’ and that the Code stated that ‘lavish, extravagant or deluxe venues must not be used’.
The second article ‘Doctors may have to declare links to drug companies’ and the editorial ‘Health worries’ referred to the meeting but discussed broader issues of NHS culture and disclosure of payments.

The detailed response from Stirling Anglian is given below.

The Panel noted that it was a well established principle under the Code that a pharmaceutical company was responsible for the actions of third party agents acting on behalf of that company. Stirling Anglian was responsible under the Code for the activities of its agents these being the third party named in the article and the manufacturer in relation to all the arrangements for the meeting in question.

The Panel noted that it was acceptable for companies to pay health professionals and others for relevant advice. Nonetheless, the arrangements for such meetings had to comply with the Code, particularly Clause 23. To be considered a legitimate advisory board the choice and number of participants should stand up to independent scrutiny; each should be chosen according to their expertise such that they would be able to contribute meaningfully to the purpose and expected outcomes of the advisory board. The number of participants should be limited so as to allow active participation by all. The agenda should allow adequate time for discussion. The number of meetings and the number of participants should be driven by need and not the invitees’ willingness to attend. Invitations to participate should state the purpose of the advisory board meeting, the expected advisory role and the amount of work to be undertaken. If an honorarium was offered it should be made clear that it was a payment for such work and advice. Honoraria must be reasonable and reflect the fair market value of the time and effort involved.

As stated in the supplementary information to Clause 22, Meetings and Hospitality, there had to be valid and cogent reasons for holding meetings at venues outside the UK.

The Panel noted Stirling Anglian’s conflicting submissions regarding the selection criteria. Stirling Anglian submitted that selected delegates included those who, inter alia, had questions about its manufacturing facilities and supply chain and that the meeting gave attendees the opportunity to conduct due diligence on the supply chain and manufacturing partners. The Panel noted that those were not valid selection criteria for advisory boards which should address bona fide questions of the company, not of the attendees.

The Panel examined the agenda. The meeting appeared to have two distinct parts; the morning lasted 2 hours plus an hour for lunch. It started with an hour on ‘Operating and Company History’. This was followed by an hour on ‘Presentation SAP’ by Stirling Anglian. Half the group then toured the ‘Production and Laboratory’ with ‘Highlight Macrogol filling lines’ followed by lunch and the remainder of the group had lunch then the tour.

The afternoon meeting started at 13.30 with ‘Questions and discussions on what you have seen today’. This was followed by two group discussions each of 45 minutes on CosmoCol and theiCal-D3. ‘The Pipeline: Innovation, Tackling specials, new products and technology’ was discussed for 15 minutes. The last session was 30 minutes on ‘What have we learned today?’, ‘What action will you undertake on your return to the UK as a consequence of this event?’ and ‘If I were SAP I would …. Please complete the sentence’. All the discussions were group discussions other than the last session which was ‘delegates in turn’ and all discussion were ‘facilitated by [the third party]’. The meeting closed at 16:00.
The Panel noted that the dedicated time on the agenda for the attendees to provide advice was not clear and allowing time for group discussions did not appear to be sufficient. Even if it were, this amounted to less than 2 hours (13:45 – 15:30).

The Panel noted that the description of the accommodation and evening meal in The Daily Telegraph article was different to that submitted by Stirling Anglian. The Panel noted that a letter drafted by Stirling Anglian’s lawyers and signed by the named pharmacist retracted comments in relation to certain elements of hospitality referred to in the article. The letter stated that the comments made to the undercover reporter ‘were false or grossly exaggerated’ and he wished to correct the public record. The letter referred to the role of the third party in identifying various health professionals and experts in medicines management to provide advice to Stirling Anglian about how best to raise awareness of the company, its manufacturing/supply chain credentials and its medicinal products. It referred to Stirling Anglian paying economy airfare and £500 per day for attending. Hotel accommodation, dinner entertainment and ground transportation were paid by the manufacturer. The statement explained that delegates stayed in a straightforward business hotel near to Stirling Anglian’s manufacturer’s factory and a room at the hotel cost approximately £130 a night. He stated that he had grossly exaggerated when stating that the hotel was “probably the best in Baden Baden”, that in the rooms “the waste bins were gold plated” and that the rooms of any delegate had a jacuzzi. There was no factual basis to state that the hotel “was top 10 in the world”. The statement that a £1,000 was paid for champagne during the dinner entertainment on 2 July 2015 was inaccurate. The cost of the dinner (including any drinks) was approximately £70 per person. The statement concluded that the author had no reason to believe Stirling Anglian had breached the ABPI Code.

The Panel noted with concern Stirling Anglian’s submission that advisory boards were a ‘necessary and indeed entirely appropriate mechanism to engage with our customers and build awareness of our products’. Further that questions about the supply chain was a ‘bona fide reason for holding an advisory board in Germany’. The Panel noted that advisory boards were not an appropriate way to engage with customers and build awareness of products. The purpose must be for the company to obtain advice on bona fide questions.

The Panel examined the report on the meeting and was concerned that it, in parts, treated the entire meeting as an advisory board.

The meeting report noted that delegates all agreed that the trip was well executed, enjoyable and sociable. They did not feel, however, that the level of hospitality was in any way excessive. They appreciated the hospitality and enjoyed the presentations and factory tour. Some remarked that they were highly delighted to have been invited. There was unanimous agreement that every delegate would attend another advisory board of this type, if invited! The meeting report noted that the format of the advisory board was similar to the boards which were very successful. The manufacturer presented the history of the business, factory capacity and quality which produced a number of questions and comments. There was acknowledgement of good capacity for manufacturer and supply. There was a good degree of interest around twin dosing and resulting improved efficiency. One delegate mentioned use of calcium and vitamin D3 in caplet form, but stated the problem due to the total number of caplets per day. A third delegate stated at this point CosmoCol would be a particularly easy switch to make offering cost savings, improved flavour and improved range of flavours. Discussion around shelf life of CosmoCol was very positive.

The meeting report noted that a presentation was given by Stirling Anglian detailing pricing, product range and pipeline. Samples of theiCal-D3 were handed out. This prompted discussion round cost, savings and the advantage of once daily dosing. Discussion moved onto other pipeline products and returned to Macrogol pricing. It was acknowledged that Stirling Anglian had driven down Macrogol prices in the UK. Certain other specific questions were raised at this point including on price, supply guarantee and questions on communications around pipeline products.

The factory tour of the plant was thought to be interesting and useful by all delegates.

The advisory board commenced after a buffet lunch and delegates were invited to respond to various questions including:

‘What do you think about the meeting so far?’
‘How important do you feel it is to visit the factory in Germany? Could this be achieved by an advisory board in the UK?’
‘Prior to this meeting had you heard of Cosmocol?’ and ‘What are your thoughts on action on return?’

The Panel was concerned that the questions and responses received indicated that this was not a bona fide advisory board. Responses referred to generous hospitality, that the visit to the factory in Germany was essential and switching to CosmoCol. Two of the delegates were not aware of CosmoCol prior to the meeting.

The discussion then switched the theiCal-D3. Questions included: ‘What are your thoughts on theiCal-D3?’ and ‘What are your barriers to change?’
The Panel noted that responses included comments about the benefit of the once daily dosage regime and palatability. In general, delegates preferred this option to multiple doses of caplets. Comments around the favourable price point were received and widely acknowledged. Some delegates requested personal information around savings for their CCG, which Stirling Anglian agreed to provide.

The report then referred to a specific question from a delegate around future pipeline products from Stirling Anglian and their proposed costings. Stirling Anglian replied by giving approximate dates for proposed products which were desired by the delegates and their proposed costs were warmly anticipated.
The Panel noted that the question ‘What will your general actions be on return?’ was put to each delegate individually and according to the meeting report most of the answers included favourable comments about CosmoCol and switching and/or amending guidelines. There were also references to the theiCal-D3 switch programme. There was only one negative comment in relation to the prohibitive cost of a switch to CosmoCol.
The Panel noted the details of the presentations and discussions in the meeting report. The report appeared in parts to treat the whole meeting as an advisory board.

The Panel noted the company’s submission that the meeting arrangements combined a factory visit with an advisory board and that the payment was for the advice received. It appeared to the Panel that according to the report, more emphasis was placed on the visit to the manufacturers and building confidence in Stirling Anglian and its products and understanding what the attendees’ actions were on returning from the meeting rather than a genuine advisory board. Further, it was difficult to understand what advice was sought and would be obtained from the attendees, two of whom had attended another advisory board in another German city.

The Panel noted Stirling Anglian’s submission that this was the fifth such meeting held at the manufacturing site and five other advisory boards had been held. The Panel did not have the agendas or other information about these other meetings but considered that if there was any similarity in the agendas it was difficult to see how this number of meetings could be justified. In addition, the Panel queried whether there was a bona fide need for advice such as to justify the advisory board meeting in question.

The Panel noted that the meeting for UK health professionals was held outside the UK and, as noted above, there had to be valid and cogent reasons for holding such meetings outside the UK. The Panel was concerned that the primary justification for holding the meeting outside the UK was the need for NHS staff to conduct due diligence on Stirling Anglian’s manufacturing facilities and supply chain. The Panel noted the tour of the manufacturing facilities lasted an hour and queried whether in the particular circumstances of this case it was really necessary for the health professionals to travel to Germany to be reassured about the products and their supply. It would have been preferable for the manufacturers to come to the UK or to present using remote technology.
The Panel considered that overall the arrangements were not a valid advisory board: It was of concern that payment was received for 2 days at £500 per day rather than just for that part of the meeting (one afternoon) that Stirling Anglian described as the advisory board element. On the material before the Panel there did not appear to be a clear unequivocal issue upon which Stirling Anglian had sought advice which necessitated an advisory board; nor had the role of the participants in relation to the advisory board been made clear in the email invitation and elsewhere. The Panel noted its general comments above about the arrangements for the meeting. The Panel was especially concerned that at the end of the advisory board participants addressed what they would do differently as a result of the meeting which, in the Panel’s view, demonstrated that the primary focus of the day was in providing information to and influencing participants rather than the provision of advice to the company. The time spent obtaining advice appeared to be extremely limited and further no preparation was needed. Taking all the factors into account the Panel did not consider that the arrangements either for the whole day or just the afternoon were such that the UK health professionals had attended a genuine advisory board meeting. It therefore ruled a breach of the Code.

The Panel considered that, as it had ruled the arrangements did not meet the criteria for advisory boards, UK health professionals had been paid to attend a meeting where medicines were promoted including pipeline products. This was unacceptable. In addition, the payment was for two days and not limited to what Stirling Anglian described as the advisory body element. Further, it appeared that as a result of attending the meeting, health professionals’ general actions indicated that switches to Stirling Anglian’s products would be instigated. The Panel considered that the meeting was an inducement to recommend Stirling Anglian’s medicines. A breach of the Code was ruled.

The Panel noted that the third party was providing services on behalf of Stirling Anglian. The Panel noted that under Clause 21 contracts under which institutions, organisations, or associations provided any type of service were only allowed if such services or other funding were, inter alia, not an inducement to prescribe, supply, administer, recommend, buy or sell any medicine. The Panel noted its ruling above of a breach and thus considered that the service amounted to an inducement. The Panel noted that Stirling Anglian had not exercised due diligence over the service. A breach of the Code was ruled.
The Panel then considered the level of hospitality. It was concerned that irrespective of whether it was justifiable to visit the manufacturer, the arrangements were unacceptable. There was no need for the delegates to stay in Baden-Baden. Accommodation nearer to the manufacturer should have been used. The hotel used was not appropriate, it appeared to be a lavish and deluxe venue. The location and facilities were still more akin to leisure travel than business purposes. The Panel was also concerned about the cost of dinner. Stirling Anglian’s submission was inconsistent in this regard. The Panel noted the receipts for the pre-dinner drinks at the hotel which cost €447. Stirling Anglian submitted that this was not for the UK invitees but for staff from Stirling Anglian, the manufacturers and the third party. The Panel noted that the latter submission appeared to be inconsistent with an earlier submission which clearly stated on an agenda ‘18.30 meet at the Hotel… welcome drink 19.30 Dinner at the Restaurant…’. Overnight accommodation cost €199.
The Panel noted that the bill for the evening meal, twenty four people attended the dinner at a cost per head (excluding tax and gratuities) of £71.43.
The Panel did not consider that the hospitality was secondary to the main purpose of the event ie subsistence only. The level was not appropriate and was out of proportion to the occasion. Further, the costs exceeded the level that recipients would normally adopt when paying for themselves. A breach of the Code was ruled.

The Panel noted the supplementary information to the code Maximum Cost of a Meal which included the financial limit did not apply when a meeting was held outside UK in a European country where the national association was a member of EFPIA and thus covered by EFPIA Codes. In such circumstances the limits in the host country code would apply.

The Panel noted the limits in the German Code were relevant. The Panel noted the German limit of €60 and that around €100 or £71.43 was spent per head for dinner (excluding tax and gratuities). This was in excess of the local limit for a meal and therefore a breach of the Code was ruled.

The Panel considered that, overall, high standards had not been maintained and a breach of the Code was ruled.

The Panel noted that Clause 2 was reserved for use as a sign of particular censure. The health professionals that attended the meeting had received a payment for two days at £500 per day in connection with the promotion of medicines including pipeline products. The Panel noted that unacceptable payments was listed in the supplementary information to Clause 2 as an example of an activity likely to be in breach of that Clause. The Panel was extremely concerned that the role of the participants had not been made clear in the invitation or elsewhere. The Panel was also extremely concerned about the poor impression given by all of the arrangements. It noted its rulings above regarding the hospitality. Given Stirling Anglian’s ultimate responsibility for all of the arrangements including those parts organised by the third party and its manufacturing partner, the company did not appear to have exercised due diligence and ensured that third party activities met the requirements of the Code. The Panel considered that the arrangements brought discredit upon and reduced confidence in the pharmaceutical industry. A breach of Clause 2 was ruled.

The Panel noted its comments and rulings above and considered that its concerns about the arrangements and the company’s procedures warranted consideration by the Appeal Board. The Panel thus reported Stirling Anglian to the Appeal Board in accordance with Paragraph 8.2 of the Constitution and Procedure.

The Appeal Board was very concerned about the profound lack of Code expertise and oversight within Stirling Anglian that had allowed the meeting to go ahead. In the Appeal Board’s view the arrangements for the meeting had been shambolic.

The Appeal Board noted that the company had accepted the rulings of breaches of the Code including a breach of Clause 2 and that it had stopped organising advisory boards until it was confident that it had appropriate oversight. The Appeal Board further noted the company’s genuine contrition and that it had commissioned an external agency to audit its processes. Further the company had appointed a new general manager, was updating its procedures, training staff and considering employing compliance expertise.
Nonetheless, the Appeal Board was extremely concerned that UK health professionals had attended the meeting on the false understanding that it was an advisory board and had been paid to do so. This was unacceptable. Consequently, the Appeal Board decided, in accordance with Paragraph 11.3 of the Constitution and Procedure, to require Stirling Anglian to issue a corrective statement to all the UK attendees at the meeting. The corrective statement should refer to the case report. Under Paragraph 11.3 details of the proposed content and mode and timing of dissemination of the corrective statement must be provided to the Appeal Board for approval prior to use. [The corrective statement which was agreed by the Appeal Board prior to use appears at the end of this report].

The Appeal Board also decided, given its serious concerns about the conduct of Stirling Anglian as set out above, to require, in accordance with Paragraph 11.3 of the Constitution and Procedure, an audit of the company’s procedures in relation to the Code, to take place in January 2016. On receipt of the audit report, the Appeal Board would consider whether further sanctions were necessary.

On receipt of the report of the audit and the company’s comments in February 2016, the Appeal Board was encouraged by Stirling Anglian’s willingness to improve its procedures and processes to comply with the Code, but noted from the report that significant progress was needed.

The Appeal Board was extremely concerned that despite a report that highlighted deficiencies in the company’s knowledge and understanding of the Code and its failures with respect to compliance, Stirling Anglian had not provided any detail on when and how it would address those matters.
Stirling Anglian subsequently provided a further detailed response as requested. The Appeal Board was concerned that in an action plan some actions were marked as active with no indication of the expected date of completion. The Appeal Board decided that the company should be re-audited in June 2016 at which point it would be expected to demonstrate significant improvement.
Stirling Anglian was audited in June 2016 and although the Appeal Board was encouraged that the audit highlighted that Stirling Anglian had made meaningful improvements in compliance and that much work had been done, it also noted that there was still more to do. Stirling Anglian needed to ensure that its progress to date was maintained and built upon.

The Appeal Board decided that Stirling Anglian should be re-audited in April/May 2017 at which point the Appeal Board expected it to be able to demonstrate further and sustained improvement.

At its meeting in June the Appeal Board considered the report of the May 2017 re-audit and noted that the company’s standard operating procedures (SOPs) were due to be reviewed and updated by August and it decided that Stirling Anglian should provide the PMCPA with the outcome of its review, evidence of training and any new SOPs by early September.

On receipt of Stirling Anglian’s response the Appeal Board considered that the PMCPA should ask Stirling Anglian to further amend its SOPs in light of certain concerns. On the basis that this work was completed promptly, the progress shown to date was continued and a company-wide commitment to compliance was maintained, the Appeal Board decided that, on balance, no further action was required.

Read the full Case Study 4 here