AUTH/2631/8/13 - Anonymous v Bayer

Case Summary

AUTH/2631/8/13 ANONYMOUS v BAYER - see (1) below

Sponsorship of a meeting

[See also: CASES AUTH/2617/7/13, AUTH/2628/8/13, AUTH/2629/8/13 LUNDBECK, CHIESI, MENARINI]

An anonymous, non-contactable complainant was concerned about pharmaceutical company sponsorship of the annual scientific meeting of the Bihar Jharkhand Medical Association (BJMA), UK, held in Bolton in July 2013.  The complainant only named Lundbeck and so the complaint was taken up with that company.  On receipt of Lundbeck’s response, a copy of the scientific agenda provided to Lundbeck by the BJMA listed other companies which had also sponsored the meeting and so the matter was additionally taken up with them.

The complainant alleged that the meeting in question was not a fully educational meeting and was more of a weekend family gathering event, with scientific sessions, children’s activities and entertainment etc combined; the meeting programme detailed children’s football and variety performances, including BJMA’s Got Talent.  The BJMA Facebook page stated ‘We have arranged a high quality scientific meeting running in two parallel sessions, variety of entertainment programme, finest cuisine from a renowned caterer and various sporting events for the children.  Despite the escalating costs involved in organising such a big event, we have managed to keep the delegate fee to a very reasonable level.  We hope that you would encourage your family and friends to attend in large numbers and make the programme a big success’.

The complainant was concerned that pharmaceutical companies should not have sponsored such an event and should not have stands promoting their products in front of members of the public.

The detailed responses from Lundbeck, Chiesi, Menarini and Bayer are given below.

It appeared to the Panel that the main purpose of the meeting was the social/cultural aspects, a view reinforced by the documentation for the meeting.  The Panel did not consider that the meeting met the requirements of the Code.  The two day meeting had a maximum scientific content of just over three hours.  The meeting was mainly a social event; the limited scientific programme did not appear to be the main purpose of the event.  The Panel had little information about the costs of putting on the exhibition on the Saturday.  The organising secretary had stated that the money paid by pharmaceutical companies ‘hardly met the cost of the scientific meeting’.  This seemed at odds with the activities arranged and that each delegate was to pay £60 to cover everything other than accommodation.  The fact that companies had sponsored speakers was also of concern.  Lundbeck had paid for two speakers and for an exhibition stand.  The company briefed the speakers.

Chiesi had paid for a speaker and for an exhibition stand which it later decided not to use because of lack of clarity regarding the positioning of the stand in relation to the room where the scientific sessions were being held.  Chiesi briefed the speaker.

Menarini had paid for two speakers and for an exhibition stand.  Menarini had chosen the subject areas and the speakers and the meeting organisers had agreed that they were suitable.  Menarini had briefed the speakers.

Bayer had paid for one speaker and for an exhibition stand.  The company had briefed the speaker and had provided slides for the speaker to use.

All the companies’ involvement with their speakers was at odds with the declaration on the programme that pharmaceutical companies had not influenced the content of the slides.

It appeared that companies had limited information about the meeting before agreeing to support it.  They should have ensured that comprehensive copies of documentation had been supplied by the organisers.

In relation to alleged promotion to the public, the Panel noted the companies’ submissions including that only registered delegates accessed the exhibition area.  Chiesi had not had an exhibition stand and thus there could be no breach in relation to promoting to the public.  The complainant had not provided any details regarding this allegation.  The complainant had the burden of proving his/her complaint on the balance of probabilities.  The Panel considered that this had not been discharged in relation to the alleged promotion to the public and the role of Lundbeck, Menarini and Bayer and no breaches of the Code were ruled.

Taking all the circumstances into account the Panel considered that the arrangements for the meeting did not meet the requirements of the Code such that it was not a meeting for a primarily educational purpose as set out in that clause.  Pharmaceutical company involvement in the agenda ie sponsoring speakers and paying for exhibition space and the impression given by pharmaceutical company involvement, particularly in the documents provided by the complainant was unacceptable.  The Panel ruled a breach of the Code with regard to Lundbeck’s, Chiesi’s, Menarini’s and Bayer’s involvement.  Chiesi appealed this ruling.  The Panel considered that high standards had not been maintained and each company was ruled in breach of the Code.  These rulings were not appealed. 

The Panel noted that Clause 2 was used as a sign of particular censure and reserved for such use.  The supplementary information referred to excessive hospitality.  The Panel decided the circumstances were such as to bring discredit upon and reduce confidence in the pharmaceutical industry and each company was ruled in breach of Clause 2.  Chiesi appealed this ruling. 

Upon appeal by Chiesi of the ruling in Case AUTH/2628/8/13 that the meeting did not comply with the Code and the ruling of a breach of Clause 2, the Appeal Board noted that hospitality as defined in the supplementary information to the Code was limited to meals, drinks, accommodation, genuine registration fees and the payment of reasonable travel costs which a company might provide to sponsor a delegate to attend a meeting.  It was an established principle of the Code that any meeting held or sponsored by a pharmaceutical company must have a clear educational content.  The Appeal Board had some reservations about the educational content at the meeting.  The Appeal Board noted that although Chiesi had paid £1,000 which it had subsequently requested be returned, there was no evidence that it had provided any hospitality for the meeting.  There was an impression from the agenda that Chiesi had contributed to the catering costs.  The email from the organiser stated that whilst other pharmaceutical companies’ payments would be used to pay for catering for delegates, Chiesi’s would not.  On this very narrow ground the Appeal Board ruled no breach of the Code in relation to the hospitality allegation. The appeal on this point was successful.

The Appeal Board noted its comments above and considered that a significant factor in this case was the apparent deliberate lack of key information from the organisers.  The Appeal Board noted the Panel’s ruling that high standards had not been maintained and considered that Chiesi could have undertaken greater diligence to ensure that its involvement with the meeting complied with the Code but did not consider that in the circumstances it had brought discredit upon, or reduced confidence in the pharmaceutical industry.  The Appeal Board ruled no breach of Clause 2.  The appeal on this point was successful.

An anonymous, non-contactable complainant was concerned that several pharmaceutical companies had sponsored the 34th Annual Scientific Meeting of the Bihar Jharkhand Medical Association (BJMA), UK, held in 2013.  The meeting was held in a Bolton hotel.  The complainant only named Lundbeck Ltd and so the complaint was taken up with that company.  On receipt of Lundbeck’s response, a copy of the scientific agenda provided to Lundbeck by BJMA listed other companies which had also sponsored the meeting and so the matter was additionally taken up with those companies.

The Panel noted that a number of companies had participated by sponsoring at least one speaker and paying for exhibition space.  There were differences between the responses including the meeting agendas.  The Panel considered each case on the facts of that specific case.  The only document considered in all the cases that had been provided by some of the companies but not all, was the list of health professional attendees provided by the BJMA to some of the companies.

COMPLAINT

The complainant was concerned that the meeting in question was not a fully educational meeting and was more of a weekend family gathering event, with scientific sessions, children’s activities and entertainment etc combined.  The complainant noted that the meeting programme stated that there would be children’s football and variety performances, including BJMA’s Got Talent.  The BJMA Facebook page stated ‘We have arranged a high quality scientific meeting running in two parallel sessions, variety of entertainment programme, finest cuisine from a renowned caterer and various sporting events for the children.  Despite the escalating costs involved in organising such a big event, we have managed to keep the delegate fee to a very reasonable level.  We hope that you would encourage your family and friends to attend in large numbers and make the programme a big success’.

The complainant was concerned that pharmaceutical companies should not have sponsored such an event and should not have stands promoting their products in front of members of the general public.  The complainant stated that several pharmaceutical companies sponsored the event but the only company name he/she could recall was Lundbeck.

When writing to the relevant companies, the

Authority asked each to respond in relation to Clauses 2, 9.1, 19.1, 22.1 and 22.2 of the Code.

CASE AUTH/2617/7/13 – LUNDBECK

RESPONSE

Lundbeck submitted that it had agreed to provide funding to support the meeting in question.  The organisers expected between 200-500 UK health professionals to attend based on previous years’ meetings.

Lundbeck paid £2,000 for a promotional stand in the exhibition area associated with the scientific meeting and was told that the funding would be used to support the catering in association with the scientific meeting only.  This would comprise tea/ coffee outside the scientific meeting rooms on arrival and at breaks and a buffet curry lunch for delegates only.  This was considered an appropriate level of hospitality and secondary to the main purpose of the meeting.

Lundbeck considered that this was a reasonable level of financial support for a national scientific meeting with this number of delegates.  The scientific agenda provided to Lundbeck on 11 June stated:

‘Declaration: The pharmaceutical companies have only paid towards the speaker fees and catering costs for the scientific meeting.  They haven’t influenced the content of the slides.’

The invoice sent to Lundbeck from the BJMA in June clearly also stated the payment was for ‘exhibition space at the conference’.

Lundbeck also agreed with the organisers to support the attendance of two speakers at the scientific meeting: a nurse consultant to speak on ‘Reducing alcohol related harm – what steps can we all take to help our patients?’ and a consultant psychiatrist, to speak on ‘Understanding and managing depression and anxiety: a practical guide’.  Both speakers were briefed by Lundbeck regarding their obligations under Lundbeck’s Speaker Agreement.  These agreements were then signed in accordance with the relevant standard operating procedure (SOP).  Each speaker received an honorarium of £500 (plus reasonable travel expenses if required).

Lundbeck knew that a gala dinner would be held in association with the event but this was on the evening of 6 July in a different part of the hotel from the scientific meeting and would have no association with the company’s support of the meeting.  Lundbeck was not aware of any other activities planned in association with the event.

On the first day of the meeting (6 July 2013) two field-based regional account directors arrived at the hotel around 8.30am to set up the stand and meet the speakers.  The scientific meeting and medical exhibition area were on the level 1 mezzanine floor of the hotel which was dedicated to the scientific event.  Access to the meeting and exhibition area was via a registration desk for enrolment and badge issue.  Registered delegates followed signs to the scientific meeting on the mezzanine floor and accessed the exhibition and scientific meeting rooms through double doors.  Only badge wearing, registered delegates accessed the exhibition area and scientific sessions which were not held in a publicly accessible area of the hotel.

Lundbeck submitted that tea and coffee were available in the exhibition area outside the scientific meeting rooms and lunch was provided in a separate room for conference delegates only and not accessible to the general public.  There were no ‘non-scientific’ activities witnessed in proximity to the scientific meeting.

The two Lundbeck attendees packed up the stand and left the meeting around 2.30pm on the afternoon of Saturday, 6 July 2013 whilst the afternoon sessions were in progress; neither went to the gala dinner and no payments were made for the gala dinner.  No-one from Lundbeck attended the meeting on 7 July.

The scientific meeting and exhibition took place at a hotel in close proximity to a football stadium.  Lundbeck staff checked with the meeting organisers in advance to ensure the meeting was outside the football season; the organisers confirmed that the venue was to be used strictly for its conference facilities only.

With regard to attending delegates, post-meeting the organisers provided Lundbeck with a list of 268 delegates who registered for the event.  However, the Lundbeck attendees did not get the impression that all these delegates were present on the morning of Saturday, 6 July.

In addition to Lundbeck, the scientific meeting agenda provided by the meeting organisers documented companies that sponsored the scientific sessions including Chiesi Ltd, Menarini, and Bayer.

Lundbeck stated that the arrangements for this meeting were approved locally by the regional account directors in accordance with the company’s SOP for meetings.  The approval form for the meeting itself was not archived along with the other meeting documentation and the speaker approval forms and agreements.  This would be acted on and further training on this aspect of meetings approval would be undertaken with those responsible for organising and approving such meetings.

Lundbeck stated that it was clear that it had only supported the scientific meeting in association with the annual meeting.  The meeting had a strong scientific content and support comprised funding, speaker provision and catering for the scientific meeting delegates only.  The scientific content and medical exhibition areas were separate from the general public areas of the hotel and accessible to registered badge wearing delegates only.  Similar provision also applied to the hospitality which was provided in association with the meeting.  Promotional information for prescription only medicines was not therefore available to the public as alleged.

Lundbeck provided a statement from the organisers which read:

‘The £2000 Lundbeck paid for a stand went only towards the costs of room hire for the scientific meeting, AV support staff and equipment, signage, delegate packs and modest hospitality for meeting delegates only.

The medical exhibitions and scientific sessions were in a dedicated area of the hotel away from the general public areas and accessed by registered delegates only.’

With respect to the arrangements for supporting this meeting, Lundbeck therefore considered that high standards had been maintained.  Hospitality was provided to health professionals only in association with the scientific meeting which was modest and secondary to the main purpose of the meeting.  There was no advertising of prescription only medicines to the public.  No information was made available about prescription only medicines to the public, directly or indirectly and under no circumstances could Lundbeck’s activities be considered to have brought discredit upon, or reduced confidence in, the pharmaceutical industry.  Lundbeck denied breaches of Clauses 2, 9.1, 19.1, 22.1 and 22.2.

FURTHER INFORMATION FROM THE MEETING ORGANISER (relevant to all cases)

The Panel asked the meeting organiser to briefly outline the objectives of BJMA, provide a copy of the final agenda and to confirm which pharmaceutical companies were involved in the meeting be that sponsoring a speaker, paying for exhibition space or advertising in the souvenir.  The meeting organiser was asked for a copy of the souvenir and to confirm that the registered delegates would include health professionals and their family members, including children.  It was pointed out that the registration form asked for the age of those registered.  The meeting organiser was asked what the £60 delegate fee was to cover and whether the refreshments for the meetings were available to all the registered delegates ie the health professionals and those that accompanied them.  The meeting organiser was also asked whether any extra fees were charged for the activities such as for the children’s football, the talent competition and the dinner on the Saturday evening or did the charge of £60 per registered delegate cover all these costs?

The meeting organiser explained that the BJMA was a 34 year old organisation.  It recently celebrated its annual conference in Bolton, next year, as usual, it would be meeting in Birmingham.  So far, it had not experienced any concern about the functioning of BJMA.  The conference had always been organised very professionally.  There were two types of sponsors for the conference.  First one was being sponsored by pharmaceutical companies which were exclusively to meet the cost for the scientific meeting attended by doctors only.  The meeting was entirely as per ABPI guidelines.  It was very well structured and speakers were of a very high quality.  Money raised by pharmaceutical companies was not more than 5% – 10% of the total budget, which hardly met the cost of the scientific meeting.  The social component of the conference was sponsored by non-pharmaceutical companies and delegate fees.  The annual souvenir contained many advertisements but none from pharmaceutical companies.

A copy of the organiser’s response was provided to Lundbeck and other companies.

Lundbeck had no additional comment to make.

GENERAL COMMENTS FROM THE PANEL (applicable to all cases)

The Panel noted that the complainant was anonymous and non-contactable.  As with any complaint, the complainant had the burden of proving his/her complaint on the balance of probabilities; the matter would be judged on the evidence provided by the parties.  Before considering each individual case, the Panel reviewed relevant requirements of the Code in relation to meetings, hospitality and sponsorship. 

Clause 19.1 stated that meetings must be held in appropriate venues conducive to the main purpose of the event.  Hospitality must be strictly limited to the main purpose of the event and must be secondary to the purpose of the meeting ie subsistence only.  The level of subsistence offered must be appropriate and not out of proportion to the occasion.  The costs involved must not exceed that level which the recipients would normally adopt when paying for themselves.  The supplementary information to Clause 19.1 made it clear that the provision of hospitality was limited to subsistence, accommodation, genuine registration fees and the payment of reasonable travel costs which a company might provide to sponsor a delegate to attend a meeting.  The venue must not be lavish, extravagant or deluxe and companies must not sponsor or organise entertainment such as sporting or leisure events.  In determining whether a meeting was acceptable or not, consideration needed to be given to the educational programme, overall cost, facilities offered by the venue, nature of the audience, subsistence provided and the like.  It should be the programme that attracted delegates and not the associated hospitality or venue.  The supplementary information also stated that a useful criterion in determining whether the arrangements for any meeting were acceptable was to apply the question ‘would you and your company be willing to have these arrangements generally known?’  The impression that was created by the arrangements for any meeting must always be kept in mind.

The Panel noted that there were a number of ways that pharmaceutical companies could be involved in meetings organised by third parties.  This included general sponsorship of such a meeting, sponsoring a specific part of it, sponsoring delegates to attend or paying to exhibit.

With regard to the implications of a pharmaceutical company paying to exhibit at a third party meeting, the Panel considered that if a company only paid for an exhibition stand then this might not necessarily be in breach of the Code even if certain aspects of the meeting did not meet the requirements of the Code.  Companies, however, should undertake due diligence at the outset in relation to compliance and the overall meeting arrangements when deciding whether to pay for an exhibition stand.  In the Panel’s view certain conditions were relevant.  Firstly, the exhibition must be a formal part of a genuine scientific or medical meeting independently organised, for example by a learned society.  The meeting overall must not be of a wholly or mainly social or sporting nature.  Secondly, the amount paid for the exhibition space must cover the genuine costs of putting on the exhibition and not be used to pay for or subsidise activities that did not meet the requirement of the Code.  Thirdly, preferably a number of other companies must also be exhibiting. Fourthly, it should be made clear to all attendees that the pharmaceutical company had only paid for a trade stand.  Fifthly, the venue must be appropriate and broadly in line with the requirements of the Code. Finally, apart from paying for an exhibition stand the company must have no other involvement in the meeting or in the arrangements for it.  This would include sponsoring delegates to attend or sponsoring other aspects of the meeting.  Each case would be considered on its own merits bearing in mind all the relevant circumstances.  The overall impression of the arrangements was an important consideration.

The Panel examined the material provided by the complainant.  This included a letter from BJMA dated 26 January 2013.  The first paragraph referred to the ‘34th Annual Scientific’ meeting and the second paragraph stated that ‘the reunion is expected to be attended by nearly 500 delegates from across the country’.  The letter listed the costs of an exhibition stall, banners and the rates for ‘advert in the Souvenir’.  Membership details of the ‘Reception’, ‘Finance’, ‘Cultural’, ‘Food’, ‘Decoration’, Scientific’, Youth’ and ‘Children’ committees were given.

Another document dated 24 February but which also bore the date 26 January announced the ‘Scientific meeting’ and that the ‘entire team was working hard to make the weekend a memorable event.  We have arranged a high quality scientific meeting running in two parallel sessions, variety of entertainment programme, finest cuisine from a renowned caterer and various sporting events for the children’.  The letter also stated that the delegate fee had been kept ‘to a very reasonable level’ and the organisers hoped ‘you would encourage your family and friends to attend in large numbers and make the programme a big success’.  Delegates were responsible for their own hotel bookings.  A document describing the event was provided which referred to the scientific presentations from 10am to 12 noon in the listing of the events for each day and ‘Presentations’ (1.303.45pm) in the afternoon of 6 July.  The programme for 6 July stated ‘Variety Performances’ which included BJMA’s Got Talent, a children’s football event and, after the presentations referred to above, a gala dinner and dance.  7 July included a cultural programme.  The special highlights section referred to a live performance by a dance troupe, world class catering by a named organisation, exhibition stalls including clothing, jewellery, hair salon and spa and various activities for children, including a football camp, disco, bouncy castle, face painting, sumo wrestling, etc and the first ever BJMA’s Got Talent.  Two further pages were provided by the complainant, the first promoting the children’s football camp.  The second promoted BJMA’s Got Talent beneath a heading ‘34th Annual Scientific meeting …’.  BJMA’s Got Talent ran from 2-4pm on 6 July in the Lion of Vienna Suite.

The Panel examined the agenda provided to Lundbeck by the meeting organisers.  This version of the agenda named six pharmaceutical companies in addition to Lundbeck.  The complaint had been taken up with each of these by the case preparation manager.  The version of the agenda provided to Lundbeck by the meeting organisers differed to the agenda provided by the complainant.

PANEL RULING IN CASE AUTH/2617/7/13

According to the agenda provided by Lundbeck, the meeting commenced on Saturday, 6 July with registration at 9am.  Four talks of 30 minutes each were held in Hall A.  Lundbeck was described as sponsor for the first talk ‘Reducing Alcohol related harm – what steps can well (sic) all take to help our patients’.  The second talk ‘New concepts in asthma management’ listed Chiesi as the sponsor.  The third talk ‘Management of chronic stable angina: an update’ listed Menarini as sponsor and the final talk ‘Gout: same old, same old?’ listed another named company as sponsor.  In parallel, four talks each of 30 minutes were listed for Hall B.  These being ‘Management of chronic dermatitis’, Understanding and managing depression and anxiety: a practical guide, ‘Type 2 Diabetes – New therapies’ and ‘New concepts in the management of heart failure’.  The listed sponsors were Lundbeck and two other named companies; there was no named sponsor for the one talk.  The post lunch session ran in Hall A and none of the five non-clinical talks were sponsored by pharmaceutical companies.  At 4-5pm the agenda stated ‘ARM/ AGM BJMA’.  On Sunday, 7 July the first talk at

10.30am was ‘GMC Update’.  This was followed by ‘Management of Actinic keratosis’ and ‘The changing face of Anticoagulation in Primary Care: new solutions to old problems’ sponsored by a named company and Bayer respectively.  This was followed by the declaration ‘The pharmaceutical companies have only paid towards the speaker fees and catering cost for the scientific meeting.  They haven’t influenced the content of the slides’.  The final page of the agenda included two photographs, one of a flag and the other of a man playing a drum and what appeared to be women dancing.

The Panel noted that the case preparation manager had written to the secretary of the local organising committee to ask for the details of the pharmaceutical companies sponsoring the event.  The response reiterated that the event was the 34th reunion of the BJMA Scientific Conference.  The secretary confirmed that there was a mixture of ‘… reputable sponsors, including various banks, reputable solicitors, specific accountant, GMC and pharmaceutical companies.  The secretary confirmed that the money raised from pharmaceutical companies, which took part in the exhibition, was only to fund the scientific section of the conference.  The organisers stated that they took care to make sure that the scientific sections and exhibition halls were in an area of the hotel which was away and separate from any public areas which were accessed only by the registered delegates attending the scientific meeting.

The Panel noted that the meeting in question was organised by the BJMA.  The BJMA was of course free to organise whatever meetings it wanted to for its own members.  If there had been no involvement from pharmaceutical companies then the meeting would not have been covered by the Code.  The involvement of the pharmaceutical companies meant the matter was covered by the Code.  According to the agenda provided by Lundbeck seven pharmaceutical companies had provided sponsorship in the form of paying speakers.  The agenda referred to ‘Exhibits Open’.  It was not clear from the agenda provided by Lundbeck which companies had exhibition space.  This agenda included the declaration ‘The pharmaceutical companies have only paid towards the speaker fees and catering costs for the scientific meeting.  They have not influenced the content of the slides’.  This declaration also appeared in the agenda provided by the complainant although no pharmaceutical companies were listed.  In addition, the documents provided by the complainant did not mention pharmaceutical company sponsorship on the documents sent to announce the meeting nor on the more detailed documents which described all the activities.

The Panel was also mindful of the established principle that a pharmaceutical company could not support a third party activity if that activity was itself in breach of the Code.

The list of health professional attendees had been provided by BJMA to Lundbeck after the meeting.  The majority of attendees were general practitioners and hospital doctors.  The vast majority were listed as from the UK, a few of those listed were from India, some were listed as retired.  Attendees had a very wide range of specialities including consultant anaesthetists, urologists, gynaecologists, paediatricians, cardiologists, orthopaedics, sexual health and geriatricians.  The Panel noted that the professional link among the disparate groups listed and the basis of BJMA membership was that they were graduates from certain Indian medical colleges.

The Panel noted that a wide range of groups existed within the medical and scientific communities.  Membership of certain groups might be based on medical speciality or professional status or on different criteria such as cultural or, as with the BJMA, academic heritage.  In the Panel’s view, when membership was based on matters other than medical speciality and professional status, companies should be especially vigilant to ensure the relevant requirements of the Code were satisfied.  In addition, given the wide range of clinical roles held by attendees, it was difficult to see how the limited educational agenda could be of sufficient professional relevance to all attendees.

The Panel queried whether the scientific content was reasonable in relation to the requirements of the Code.  According to the agenda provided by Lundbeck, scientific sessions ran from 10am -12 noon on the Saturday and from 10.50am - 12 noon on the Sunday.  This gave a maximum scientific content of just over three hours bearing in mind the parallel nature of the Saturday sessions.  In addition, on Saturday afternoon there were talks from 1.30pm until 3.45pm, only one of which, ‘Dealing with partnership disputes in general practice’, might possibly be considered as relevant given the requirements of Clause 19.  The four other talks related to financial matters including investment in Indian real estate.  The BJMA ARM/AGM ran for an hour.  The 20 minute GMC update on Sunday (10.30 – 10.50am) might possibly be considered as relevant to Clause 19.  The refreshments listed were lunch on both days and refreshments after the Saturday afternoon session.  The Panel noted that a number of companies paid for exhibition space and queried whether the amount charged was reasonable.

It appeared to the Panel that the main purpose of the meeting was the social/cultural aspects and in its view this was reinforced by the documentation for the meeting.  The Panel did not consider that the meeting met the requirements of the Code.  The two day meeting had a maximum scientific content of just over three hours.  The meeting was mainly a social event and it appeared to the Panel that the limited scientific programme was not the main purpose of the event.  The Panel had little information about the costs of putting on the exhibition on the Saturday.  The organising secretary had stated that the money paid by pharmaceutical companies ‘hardly met the cost of the scientific meeting’.  This seemed at odds with the activities arranged and that each delegate was to pay £60 to cover everything other than accommodation.  The fact that companies had sponsored speakers was also of concern.  Lundbeck had paid for two speakers and for an exhibition stand.  The company briefed the speakers which appeared to be at odds with the declaration on the programme that pharmaceutical companies had not influenced the content of the slides.  It appeared that companies had limited information about the meeting before agreeing to support it.  Lundbeck should have ensured that comprehensive copies of documentation had been supplied by the organisers.

The Panel noted that Lundbeck representatives had left the meeting early on the Saturday afternoon.

In relation to alleged promotion to the public, the Panel noted Lundbeck’s submission that only registered delegates accessed the exhibition area.  The complainant had not provided any details regarding this aspect of his/her allegation.  The complainant had the burden of proving his/her complaint on the balance of probabilities.  The Panel considered that this had not been discharged in relation to the alleged promotion to the public and no breaches of Clauses 22.1 and 22.2 were ruled.

Taking all the circumstances into account the Panel considered that the arrangements for the meeting did not meet the requirements of Clause 19 such that it was not a meeting for a primarily educational purpose as set out in that clause.  Pharmaceutical company involvement in the agenda ie sponsoring speakers and paying for exhibition space and the impression given by pharmaceutical company involvement, particularly in the documents provided by the complainant was unacceptable.  The Panel ruled a breach of Clause 19.1 with regard to Lundbeck’s involvement.  The Panel considered that high standards had not been maintained and a breach of Clause 9.1 was ruled.

The Panel noted that Clause 2 was used as a sign of particular censure and reserved for such use.  The supplementary information referred to excessive hospitality.  The Panel decided the circumstances were such as to bring discredit upon and reduce confidence in the pharmaceutical industry and a breach of Clause 2 was ruled.

*     *     *     *     *

CASE AUTH/2628/8/13 – CHIESI

RESPONSE

Chiesi explained that it purchased a space in which to place a promotional stand and provided a speaker for the meeting.  Chiesi paid £1,000 which was invoiced in April 2013 by the meeting organisers.  Based on information from the meeting organisers prior to receiving the invoice, this payment was for ‘stand space’ over a planned two day event in July where an educational meeting was going to take place.

The payment was transferred to BJMA in June to support, in good faith, the funding of a bona fide, scientific meeting.  Nevertheless, Chiesi performed additional due diligence in seeking and receiving written reassurance from the meeting organisers in July that the funding was for appropriate purposes namely, ‘… hiring the Lion of Vienna Suite on Sunday, PA system, projection system, catering for delegates attending scientific session on Sunday’.  From the BJMA response Chiesi was satisfied that the funding was not being used for anything other than the above and was entirely acceptable.

A few days prior to the meeting and on receipt of the final agenda, Chiesi decided not to place the stand at the two day meeting.  Firstly because of a lack of clarity regarding the locality of the pharmaceutical company stands in relation to the room where the scientific sessions were being held, and secondly, because the  declarations that were inserted on the final meeting programme at Chiesi’s request, did not refer to the provision of a stand specifically.  The organisers were given notice of Chiesi’s wish not to erect a stand and steps were taken to recoup monies associated with the stand space purchase in that the organising Chiesi representative spoke directly to the meeting organiser regarding potential repayment of the fees.

The meeting was attended by just one Chiesi sales representative on Sunday, 7 July 2013 purely to accompany the Chiesi sponsored speaker.  The Chiesi sales representative met the speaker on Sunday morning prior to the session and immediately after the presentation; both the speaker and the sales representative left the meeting and venue, prior to lunch.

No Chiesi staff attended the meeting on Saturday and there was no attendance made, or paid for, regarding the dinner on Saturday evening.

Chiesi submitted that the speaker was a renowned international opinion leader and was assessed by Chiesi as being an appropriate speaker at this large scale educational meeting.  In addition, the speaker was ideally located for attendance.

Chiesi submitted that it took proactive steps to ensure that the programme was explicit regarding the fact that Chiesi had provided and reimbursed a speaker.  As a result, on Day 2 of the finalised programme, agreed with the meeting organisers, adjacent to the speaker’s name the following statement was inserted, ‘This speaker has been provided and paid

for by CHIESI Limited’.  Additionally, in a yellow highlighted box the following underlined statement in bold font appeared, ‘Chiesi Limited have also provided and paid for a speaker on the agenda’.  This additional declaration was made at the request of Chiesi to ensure transparency.  Chiesi confirmed that this amended agenda was used during the meeting as verified by the representative accompanying the Chiesi provided speaker.  This agenda was not the version that was provided in the original complaint.  Chiesi submitted that the version used during the meeting was that provided by Chiesi.

Chiesi stated that it briefed the speaker during faceto-face and telephone discussions taking place in the six months prior to the meeting.  As the speaker had previously spoken on numerous occasions in similar circumstances under a Chiesi agreement, he was already familiar with the high standards and expectations set out in the speaker meeting agreement form having signed the form on each occasion.  The signed speaker agreement form was provided.  This form outlined the legal obligations that both parties must uphold but also reminded the speaker that he/she must comply with specific guidance in relation to the content and delivery of the presentation to ensure that the high standards expected under the Code were upheld.  The speaker signed an agreement and presented a slide deck approved specifically for this meeting, which was reviewed and approved through Chiesi’s formal process.

The meeting organiser first discussed the potential of an educational meeting with Chiesi representatives as early as April 2012.  More discussions between the meeting organisers and Chiesi sales representatives regarding the potential for Chiesi to support the two day meeting took place from mid-January 2013 leading to a formal written request from the meeting organisers on 21 March 2013.  At this point no agenda was available but confirmation was provided that approximately 350 doctors were expected at the event.  Throughout the interaction with the meeting organisers the meeting was considered a bona fide, educational meeting where Chiesi was purchasing floor space to position a stand, and arrange for a speaker to present at the scientific session.  The meeting organisers were not able to send Chiesi a draft outline of the programme until mid June 2013 and the impression from this programme remained that this was an educational meeting of high scientific content.  The draft needed subsequent amendments to correct basic inaccuracies regarding both the speaker session that Chiesi was sponsoring and also the correct date of the session.  A corrected programme was provided almost immediately.

The draft programme was reviewed at head office, when made available, as part of due diligence and as a result, Chiesi took proactive steps to ensure that the programme was explicit about Chiesi’s sponsorship and speaker provision.  Subsequently, as agreed with the meeting organisers, adjacent to the speaker’s name the statements set out above were inserted.

As already stated, prior to the meeting, Chiesi made a decision not to have a stand at the meeting.  It

was therefore attended by just one Chiesi sales representative on the Sunday to accompany the Chiesi sponsored speaker.

The Chiesi sales representative who attended the meeting venue on Sunday morning clearly recalled the amended programme containing the Chiesi declarations on the large meeting programme board outside the plenary sessions.  He also confirmed that approximately 100 to 120 delegates were in the plenary session when the speaker delivered his presentation to the scientific audience.  At no point was it evident that either lay members of the public or inappropriate delegates were present either in the plenary session or directly outside the meeting room.  A delegate list provided by the meeting organisers confirming that the two day event was attended by health professionals and academics was provided.

Additionally, Chiesi confirmed that the layout of the meeting facilities were such that anybody approaching the meeting area was immediately greeted by persons managing a registration desk.  The risk of lay persons knowingly or unknowingly entering the scientific areas/sessions restricted to health professionals was therefore controlled.

Chiesi submitted that the document submitted by the complainant and the statements made on the BJMA Facebook page were never received by, or viewed by, anyone from the company.  The publicly available website of the BJMA was reviewed in order for approval to attend and support the meeting and no evidence at the time of viewing, led Chiesi to believe that this meeting was not a genuine scientific interaction.  Certainly at no time was it made aware of additional non-scientific activities.

With regard to the statement that ‘The Pharmaceutical companies have only paid towards the speaker fees and catering costs for the scientific meeting.  They haven’t influenced the content of the slides’.  Chiesi submitted that it ensured that the programme explicitly stated adjacent to the speaker’s name the following ‘This speaker has been provided and paid for by CHIESI Limited’.  Additionally, in the yellow highlighted box the following underlined statement in bold font appeared, ‘Chiesi Limited have also provided and paid for a speaker on the agenda’.

Chiesi paid the speaker directly for preparation and delivery of his presentation.  No monies were provided directly in reference to catering costs and a sum of £1,000 was paid to the BJMA to allow the placement of a promotional stand.

A formal written request from the meeting organisers, on 21 March stated that approximately 350 doctors were expected.  Approximately 100 to 120 delegates were in the plenary session for the presentation according to the Chiesi sales representative that attended.

The sales representative observed only tea, coffee and biscuits being made available to delegates.

Chiesi did not provide funding dedicated to catering and thus it did not obtain a breakdown of catering costs per head however, Chiesi obtained written reassurance from the meeting organisers on 3 July 2013 that the stand related charge was to be used for appropriate purposes.

Chiesi apologised that its response might appear repetitive, however it was vital that the full extent of the control that Chiesi demonstrated throughout this meeting development was clarified and to demonstrate that all decisions were made with the best intent and in no way lowered standards expected by the Code.

Having conducted a thorough investigation and interviewed all parties involved, Chiesi submitted that all staff involved in the discussion and support of this meeting followed all appropriate standard operating procedures (SOPs) and were compliant with the Code in all their activities.  Every step was taken to ensure that there was absolute transparency of Chiesi’s appropriate involvement.  As such, Chiesi refuted any assertion that its involvement represented a breach of Clauses 9.1, 19.1 or 2.

Since Chiesi did not place a stand at the meeting, nor undertook any promotional activity, and could confirm that the delegates only were present during the scientific session similarly it was not in breach of Clauses 22.1 or 22.2.

FURTHER COMMENT FROM CHIESI

The further information from the meeting organiser was provided to Chiesi which pointed out that the meeting organiser clearly stated that the conference had two types of sponsors, and that pharmaceutical companies had provided support exclusively to meet the costs of the scientific meeting only.  This reaffirmed its perspective and in fact it gained reassurances from the organiser that this was the case.  Chiesi submitted that as it had gone beyond just purchasing stand space, in providing a speaker, it took additional steps to ensure that the final declaration on the agenda clearly stated that Chiesi had provided a speaker in order for attendees to have clear transparency of the company’s involvement.  Chiesi submitted that both actions were compliant with its SOPs.

Chiesi submitted that the meeting organiser provided additional reassuring clarity by confirming that the scientific element of the conference was attended by ‘doctors only’ and not by members of the public.  Chiesi was not involved in any social aspects of the conference.  Pharmaceutical companies did not advertise in the annual souvenir and Chiesi confirmed that it did not, nor was it ever asked, to sponsor or advertise in the annual souvenir.

Finally, Chiesi stated that the response from the meeting organiser provided the PMCPA with evidence that its involvement was with the scientific meeting only.  Also the company hoped this demonstrated that its involvement was in accordance with the Code and as such did not represent a breach of Clauses 9.1, 19.1, 2 and similarly Clauses 22.1 or 22.2.

PANEL RULING IN CASE AUTH/2628/8/13

The general comments by the Panel above apply here.

The Panel examined the agenda provided to the pharmaceutical company named in the complaint by the meeting organisers.  This version of the agenda named a total of seven pharmaceutical companies.  The complaint had been taken up with each of the additional six companies, (one of which was Chiesi) by the case preparation manager.  The version of the agenda provided to the pharmaceutical company named in the complaint by the meeting organisers differed to the agenda provided by the complainant.  The agenda provided by Chiesi was, again, different.  It was unclear which version of the agenda had been provided to delegates.  Nonetheless, Chiesi was adamant that its representative had seen the final Chiesi version of the agenda on a large meeting programme board on 7 July.

The Panel noted that Chiesi had proactively sought to have changes made to the agenda provided to it by the meeting organisers regarding declarations of sponsorship.  In this regard the Panel noted an email from Chiesi to the meeting organiser dated 3 July.  The response from the meeting organiser to this email stated that an agenda had been sent to Chiesi on 13 June.  This was a revised version of the agenda sent to Chiesi on 11 June following comments it had received from Chiesi about the date and time of one of the presentations.

According to the final agenda provided by Chiesi, the meeting commenced on Saturday, 6 July with registration at 9am.  Four talks of 30 minutes each were held in Hall A.  Lundbeck was described as sponsor for the first talk ‘Reducing Alcohol related harm – what steps can we all take to help our patients’.  The second talk ‘Understanding Neuropathic Pain’ had no named sponsor.  The third talk ‘Management of chronic stable angina: an update’ listed Menarini as sponsor and the final talk ‘Gout: Current concepts and management’ also listed

Menarini as sponsor.  In parallel, three talks each of

25 or 30 minutes were listed for Hall B.  These being ‘Management of chronic dermatitis’, Understanding and managing depression and anxiety: a practical guide, ‘New concepts in the management of heart failure’.  The listed sponsors Lundbeck and a named company with no named sponsor for the third talk.  The agenda showed a break between 10.50 and 11.20am.  The post lunch session ran in Hall A and none of the three non-clinical talks were sponsored by pharmaceutical companies.  At 4–5pm the agenda stated ‘ARM/AGM BJMA’.  On Sunday, 7 July the first talk at 10.00 was ‘GMC Update’.  This was followed by ‘New concepts in asthma management’, sponsored by Chiesi, ‘Management of Actinic keratosis’ and ‘The changing face of Anticoagulation in Primary Care: new solutions to old problems’ sponsored by a named company and Bayer respectively.  This was followed by the declaration ‘The pharmaceutical companies have only paid towards the speaker fees and catering cost for the scientific meeting.  They haven’t influenced the content of the slides.  Chiesi Limited have also provided and paid for a speaker on the agenda’.  The previous versions of the agenda provided to Chiesi on 11 and 13 June included the final page of the agenda which included two photographs, one of a flag and the other of a man playing a drum and what appeared to be women dancing.  This appeared to have been removed from the final agenda provided by Chiesi.  The talks on property investment opportunities in London and investment in Indian real estate were only on the previous version of the agenda provided to Chiesi by the organisers on 11 June.

The Panel noted that the case preparation manager had written to the secretary of the local organising committee to ask for the details of the pharmaceutical companies sponsoring the event.  The response reiterated that the event was the 34th reunion of the BJMA Scientific Conference.  The secretary confirmed that there was a mixture of ‘… reputable sponsors, including various banks, reputable solicitors, specific accountant, GMC and pharmaceutical companies.  The secretary confirmed that the money raised from pharmaceutical companies, which took part in the exhibition, was only to fund the scientific section of the conference.  The organisers stated that they took care to make sure that the scientific sections and exhibition halls were in an area of the hotel which was away and separate from any public areas which were accessed only by the registered delegates attending the scientific meeting.

The Panel noted that the meeting in question was organised by the BJMA.  The BJMA was of course free to organise whatever meetings it wanted to for its own members.  If there had been no involvement from pharmaceutical companies then the meeting would not have been covered by the Code.  The involvement of the pharmaceutical companies meant the matter was covered by the Code.  According to the agenda provided by the company named in the complaint (Lundbeck) seven pharmaceutical companies had provided sponsorship in the form of paying speakers.  The final agenda provided by Chiesi named five pharmaceutical companies in total.  The agenda referred to ‘Exhibits Open’.  It was not clear from this which companies had exhibition space.  This agenda included the declaration ‘The pharmaceutical companies have only paid towards the speaker fees and catering costs for the scientific meeting.  They have not influenced the content of the slides’.  In addition, it stated that ‘Chiesi Limited have also provided and paid for a speaker on the agenda’.  The statement ‘This speaker has been provided and paid for by CHIESI Limited’ appeared next to the details of the speaker.  The documents provided by the complainant did not mention pharmaceutical company sponsorship on the documents sent to announce the meeting nor on the more detailed documents which described all the activities.  The conference agenda stated ‘The Pharmaceutical companies have only paid towards the speaker fees and catering costs for the scientific content they haven’t influenced the content of the slides’ although no pharmaceutical companies were listed.

The Panel was also mindful of the established principle that a pharmaceutical company could not support a third party activity if that activity was itself in breach of the Code.

The list of health professional attendees had been provided by BJMA to Chiesi after the meeting.  The majority of attendees were general practitioners and hospital doctors.  The vast majority were listed as from the UK a few of those listed were from India, some were listed as retired.  Attendees had a very wide range of specialities including consultant anaesthetists, urologists, gynaecologists, paediatricians, cardiologists, orthopaedics, sexual health and geriatricians.  The Panel noted that the professional link among the disparate groups listed and the basis of BJMA membership was that they were graduates from certain Indian medical colleges.

The Panel noted that a wide range of groups existed within the medical and scientific communities.  Membership of certain groups might be based on medical speciality or professional status or on different criteria such as cultural or, as with the BJMA, academic heritage.  In the Panel’s view, when membership was based on matters other than medical speciality and professional status, companies should be especially vigilant to ensure the relevant requirements of the Code were satisfied.  In addition, given the wide range of clinical roles held by attendees, it was difficult to see how the limited educational agenda could be of sufficient professional relevance to all attendees.

The Panel queried whether the scientific content was reasonable in relation to the requirements of the Code.  According to the final agenda provided by Chiesi, scientific sessions ran from 10am -12 noon on the Saturday and from 10.20am–12 noon  on the Sunday.  This gave a maximum scientific content of just over three and a half hours bearing in mind the parallel nature of the Saturday sessions.  In addition, on Saturday afternoon there were talks from 1.30 until 3.30, only one of which ‘Dealing with partnership disputes in general practice’ might possibly be considered as relevant given the requirements of Clause 19.  The two other talks related to financial matters including ‘managing your pensions’.  The BJMA ARM/AGM ran for an hour.  The 20 minute GMC update on Sunday which started at 10.00 – 10.20am might possibly be considered as relevant to Clause 19.  The refreshments listed were lunch on both days and refreshments after the Saturday afternoon session.  A previous version of the agenda submitted to Chiesi included talks on ‘Property Investment Opportunities in London’ and ‘Investment in Indian Real Estate’.  The Panel noted that a number of companies paid for exhibition space and queried whether the amount charged was reasonable.

It appeared to the Panel that the main purpose of the meeting was the social/cultural aspects and in its view this was reinforced by the documentation for the meeting.  The Panel did not consider that the meeting met the requirements of the Code.  The two day meeting had a maximum scientific content of just over three and a half hours.  The meeting was mainly a social event and it appeared to the Panel that the limited scientific programme was not the main purpose of the event.  The Panel had little information about the costs of putting on the exhibition on the Saturday.  The organising secretary had stated that the money paid by pharmaceutical companies ‘hardly met the cost of the scientific meeting’.  This seemed at odds with the activities arranged and that each delegate was to pay £60 to cover everything other than accommodation.  The fact that companies had sponsored speakers was also of concern.  The Panel noted that Chiesi had paid for a speaker and for an exhibition stand which it later decided not to use because of lack of clarity regarding the positioning of the stand in relation to the room where the scientific sessions were being held.  Chiesi had taken steps to try to recoup the money.  The Chiesi representative had only attended on the Sunday.  Chiesi had briefed the speaker which appeared to be at odds with the declaration on the programme that pharmaceutical companies had not influenced the content of the slides albeit that Chiesi had asked for the additional statement that it had provided and paid for a speaker on the agenda.  It appeared that companies had limited information about the meeting before agreeing to support it.  Chiesi should have ensured that comprehensive copies of documentation had been supplied by the organisers.

In relation to alleged promotion to the public, the Panel noted Chiesi’s submission and considered that as the company had not had an exhibition stand there could be no breach of Clauses 22.1 and 22.2 and ruled accordingly.

Taking all the circumstances into account the Panel considered that the arrangements for the meeting did not meet the requirements of Clause 19 such that it was not a meeting for a primarily educational purpose as set out in that clause.  Pharmaceutical company involvement in the agenda ie sponsoring speakers and paying for exhibition space and the impression given by pharmaceutical company involvement was unacceptable.  The Panel ruled a breach of Clause 19.1 with regard to Chiesi’s involvement.  The Panel considered that high standards had not been maintained and a breach of Clause 9.1 was ruled.

The Panel noted that Clause 2 was used as a sign of particular censure and reserved for such use.  The supplementary information referred to excessive hospitality.  Chiesi had made some efforts to amend the agenda and had decided not to have an exhibition stand.  Nonetheless, its efforts were not sufficient.  On balance the Panel decided the circumstances were such as to bring discredit upon and reduce confidence in the pharmaceutical industry and a breach of Clause 2 was ruled.

APPEAL FROM CHIESI

Chiesi noted the Panel’s view that it appeared that the main purpose of the meeting was the social aspects and that these had been sponsored by pharmaceutical companies.  Chiesi submitted that it only knew about the educational aspects and tried to ensure that Code requirements were met in sponsoring the educational meeting.  Chiesi denied a breach of Clause 19.1 and submitted that its actions did not bring the industry into disrepute.

Chiesi further noted the Panel’s comment that Chiesi should have ensured that comprehensive copies of documentation had been supplied by the organisers. 

Chiesi submitted that it was badly let down by the meeting organisers.  Chiesi conducted due diligence in ensuring the meeting was appropriate, the agenda had a clear declaration of involvement, the stand was compliant and the slides were approved.

Chiesi stated that it was asked by the third party to sponsor the meeting and accordingly wanted to ensure the meeting was appropriate to sponsor.  Chiesi noted the general inconsistency within the Code and amongst the industry as to what ‘sponsorship’ was.  The term was used for very different activities:

• sponsoring delegates to attend third party meetings implied support
• sponsorship of promotional meetings implied organisation
• declarations of sponsorships implied arm’s length arrangements.

Chiesi understood that this sponsorship request would mean that it was responsible for ensuring that the aspects of the meeting which it sponsored complied with the Code, and this included the catering costs and speaker arrangements and slides, and importantly, in terms of the overall educational content of the meeting.  Chiesi did not consider that it was responsible for aspects such as the selection of delegates, choice of venue etc.

Chiesi noted that in Case AUTH/2471/1/12, the Appeal Board suggested there should always be written documentation with respect to assessing sponsorship of third party meetings.  Chiesi fully appreciated that the agenda was essential to check whether the quantity and quality of education was sufficient to be the main attraction to the meeting, the subsistence was in proportion to the education and the topics were relevant to the audience.

Chiesi submitted that the agenda provided by the meeting organiser indicated this was an educational meeting.  In particular:

• t he          meeting              lasted   all          day        Saturday              and       Sunday morning with no indication of a gala dinner or social agenda
• S aturday afternoon          sessions              were     related to              topics    that would help delegates in their professional lives and were deemed to be educational and of value
• s ufficient              education,         delivered            by              respected           experts on varied topics, was considered of value to the varied background of delegates.

Chiesi submitted that it also checked that the meeting met the following criteria:

• organised by an independent learned society
• educational in nature and not mainly social, with clear benefits to the NHS
• national delegates from a variety of disciplines attracted to a varied agenda
• catering costs in line with subsistence limits and in proportion to education
• stand material fully approved beforehand
• other companies exhibiting
• speaker highly respected and well-regarded as an expert on asthma
• speaker engagement in compliance with Clause 20 and slides fully approved beforehand.

Therefore, Chiesi submitted that the educational meeting it sponsored complied with the Code.

Chiesi stated that it had asked those who had attended the meeting what their impression of the meeting was, specifically in relation to company sponsorship.

A consultant thought the meeting was both social and educational.  ‘For the Doctors there was a separate educational meeting and there was a social section where there [sic] other family members could integrate with each other’.  He went on to state that, ‘The letter I received showed the social side but the separate invitation I had to the Doctor meeting was educational’.  In his opinion, the role of the pharmaceutical companies was to ‘support the educational side only’ and company sponsorship was ‘completely for educational support only’.  He thought the educational sessions were very good.

A GP also thought the meeting was both social and educational, stating that there were ‘two different meetings at once’.  He gleaned this from the agenda.  In his view, the role of the pharmaceutical companies was ‘to support the educational stands only at the meeting’.  He was not sure if company sponsorship had paid towards the social aspects of the meeting and also thought the educational sessions were very good.

A Chiesi sponsored speaker and professor who was present on the Sunday stated ‘The components that I attended were primarily educational.  All medical meetings clearly have an element of networking, and sometime during breaks for socialising: that was, as expected, also the case for this meeting’.  He also went on to state that ‘The meeting agenda had strong educational facets that led to thought provoking conversations about improving patient care’.  In his opinion when asked about whether he thought pharmaceutical companies had paid for any social aspects he stated ‘No, not from what aspects I saw’ and further stated about the sessions ‘Excellent varied topics, covering areas that actually provide medical education in areas that the company does not have products’.  Again, he thought sessions were very good.

A GP thought there were two separate meetings, a social event and an educational scientific meeting.  ‘For the Doctors there was a separate educational scientific meeting’.  He went on to state that, ‘I thought the Pharma companies had only supported the scientific sessions and had also paid for a stand at the meeting’.  In his opinion the role of the pharmaceutical companies was to support and sponsor the educational scientific elements only.  ‘There was a clear distinction between the social side and the scientific meeting.  The meeting I attended was purely scientific’.  He also thought the educational sessions were very good.

Chiesi noted that delegates mentioned separate meetings and agreed that the educational sessions were very good.  In Case AUTH/2471/1/12, the Appeal Board noted the educational content and ruled no breach of Clause 2.

Chiesi submitted that the Panel made contradictory statements in its ruling: ‘Chiesi should have ensured that comprehensive copies of documentation had been supplied by the organisers’ and ‘The version of the agenda provided to the pharmaceutical company named in the complaint by the meeting organisers differed to the agenda provided by the complainant.  The agenda provided by Chiesi was, again, different.  It was unclear which version of the agenda had been provided to delegates’.  In Chiesi’s view, the meeting organiser was accountable for ensuring that when requested, accurate copies of documentation were supplied to all the sponsoring pharmaceutical companies.  This should have been the single final copy in use, on the website and distributed to delegates (including the complainant).

Chiesi noted that in fairness to all third parties, it considered each request for sponsorship under its own merits according to strict criteria.  Chiesi conducted due diligence in ensuring compliance relating to the following areas:

• the meeting was appropriate in terms of the organizing body, attendees, education, venue and subsistence
• the agenda was checked for a clear declaration of involvement
• the stand was questioned in terms of compliance
• the slides were approved together with a speaker agreement.

Chiesi was disappointed that even after questioning the meeting organiser it was not informed about the social agenda that the Panel considered formed the attraction to this meeting.  As a demonstration of how seriously it took its commitment to compliance with the Code, Chiesi noted that at the last minute it decided not to have a stand at the meeting because it did not know where the stand was to be placed and the omission of a stand in the declaration of involvement.

Given the level of due diligence applied and the strong belief in meeting compliance requirements, Chiesi submitted that it would not have sponsored any social meeting (had it known that this meeting was a social event).  Chiesi reiterated its view that the sponsored educational meeting complied with the Code.

Chiesi summarised its efforts in requesting documentation, clarity and compliance from the meeting organiser:

January Representative asked relationship manager for speaker for Sunday 7 July and contribution towards stand costs.

March  Relationship manager asked representative for further information on the meeting including the programme.

2 April                Representative advised that there was currently no formal programme.

11 April               Relationship manager requested information on the audience and representative advised that 200 doctors across the UK attending.

13 June               Representative provided agenda.

30 June               Speaker sent his slides to relationship manager for approval.

1 July                                 Relationship manager noted inaccuracy in agenda – speaker presenting on asthma and not GMC and requested speaker’s slides be approved in Zinc.

3 July                   Email from another representative that he had requested the final agenda from the organisers.  Meeting organiser emailed that no room for declaration other than next to speaker’s name.  Meeting agenda forwarded for Zinc approval.  After discussion with medical and compliance, relationship manager asked meeting organiser to clarify nature of dinner on Saturday night.  Relationship manager emailed meeting organiser to explain the importance of including the required declarations and to gain further information about what Chiesi’s sponsorship was being used for and what was happening on the Saturday evening.  Meeting organiser confirmed that the main declaration could be changed and the agenda reformatted and explained what Chiesi sponsorship was being used for, PDF of new programme.  Medical and compliance happier with agenda.

4 July                   Meeting organiser confirmed stand positions.  Medical alerted that stands might be in the main plenary room.  Medical confirmed that as no mention in the disclaimer about the stand, Chiesi could not erect a stand.

5 July                   Speaker alerted as to meeting logistics, speaker agreement and final approved slides.

Chiesi submitted that in terms of the declaration of involvement on the agenda, the ruling in Cases AUTH/2546/11/12, AUTH/2547/11/12, AUTH/2548/11/12, AUTH/2552/11/12, AUTH/2554/11/12, AUTH/2556/11/12, AUTH/2559/11/12, AUTH/2560/11/12, AUTH/2561/11/12 and AUTH/2563/11/12 was borne in mind.  Chiesi was therefore mindful of third party meeting agendas and insisted that its involvement was explicitly declared on such materials.

The final agenda provided therefore stated:

• ‘The pharmaceutical companies have only paid towards the speaker fees and catering costs for the scientific meeting. They have not influenced the content of the slides’
• ‘Chiesi Limited have also provided and paid for a speaker on the agenda’
• ‘This speaker has been provided and paid for by CHIESI Limited’.

Chiesi submitted that one of the reasons the stand was not erected was because the declaration of involvement did not mention it.

Chiesi submitted that it was clear from this chronology that it went to a great deal of effort to apply due diligence and take corrective action.  It was not clear from the ruling what more Chiesi could have done with respect to this matter, as it submitted that it was badly let down by the meeting organiser.

Chiesi submitted that it would be helpful if the Panel and Appeal Board could address the lack of clarity in the ruling:

• should companies exert complete control over third party meetings they sponsor?
• should companies question and be suspicious of third party documentation provided and communications?
• as compliance could never be guaranteed at third party meetings, should pharmaceutical companies be encouraged not to sponsor them at all?

Chiesi submitted that if a breach of Clause 2 was upheld, it would effectively prevent pharmaceutical companies sponsoring any third party meetings in the future.

Chiesi submitted that the rulings from Cases AUTH/2546/11/12, AUTH/2547/11/12, AUTH/2548/11/12, AUTH/2552/11/12, AUTH/2554/11/12, AUTH/2556/11/12, AUTH/2559/11/12, AUTH/2560/11/12, AUTH/2561/11/12 and AUTH/2563/11/12 stated if a company had a stand only at a third party meeting then it would not be held responsible for the rest of the meeting (if other criteria were met).

Chiesi submitted that since companies commonly provided a stand and sponsored other aspects of a third party meeting, it was not entirely clear in this case, whether the Panel considered Chiesi was fully responsible for the entire meeting.  If this was the case, Chiesi was concerned that this represented an untenable situation for pharmaceutical companies sponsoring third party meetings.  Chiesi submitted that third parties would not welcome the independence of their meetings being jeopardised by pharmaceutical companies exerting control.  Yet this seemed the only way for companies to avoid similar breaches.

Chiesi submitted that upholding a breach of Clause 2 would not be consistent with recent rulings.  A recent successful appeal (Case AUTH/2611/6/13) demonstrated that the Appeal Board considered it fair for a pharmaceutical company to make assumptions about the actions of a third party.  A breach of the Code was not upheld. 

In addition, the ruling in Cases AUTH/2546/11/12, AUTH/2547/11/12, AUTH/2548/11/12, AUTH/2552/11/12, AUTH/2554/11/12, AUTH/2556/11/12, AUTH/2559/11/12, AUTH/2560/11/12, AUTH/2561/11/12 and AUTH/2563/11/12 suggested that there was an impression that pharmaceutical companies were linked to the sponsorship of social events.  No company was found in breach of Clause 2 even though the educational agenda listed golf and gala dinner.

In summary, Chiesi submitted that the meeting in question was educational and it had applied due diligence to ensure the educational meeting it sponsored complied with the Code.  In Chiesi’s opinion, the meeting organiser was accountable for ensuring that when requested, accurate copies of documentation were supplied to all the sponsoring pharmaceutical companies.

Chiesi stated that it would welcome support in sending this as a clear message to third party meeting organisers.  Chiesi hoped that it was evident that, given the level of due diligence applied and strong belief in meeting compliance requirements, it would not have sponsored any social meeting.

Chiesi accepted that internal procedures were not followed in the initial communication between the field and head office and it therefore it had already accepted that high standards were not maintained in breach of Clause 9.1.

Chiesi submitted that delegates were attracted to the meeting by its educational content.  Further, delegates thought the education was very good.  Chiesi denied a breach of Clause 19.1.

Chiesi submitted its specific actions did not bring the industry into disrepute and therefore it was not in breach of Clause 2.

APPEAL BOARD RULING

The Appeal Board noted that the Panel’s ruling of a breach of Clause 9.1 related to its view that the meeting was not primarily for an educational purpose.  In addition, pharmaceutical company involvement in the agenda ie sponsoring speakers and paying for exhibition space, and the impression given by pharmaceutical company involvement was unacceptable.  The Panel had considered that high standards had not been met.  The Appeal Board noted that Chiesi had accepted this ruling on a different basis this being that Chiesi’s internal procedures were not followed in the initial communication between the field and head office.

The Appeal Board noted that, based on the material provided to Chiesi by the meeting organiser, Chiesi had agreed to have a promotional stand at the meeting and to sponsor a speaker to talk on asthma at a cost of £1,000 which was half the normal fee for a stand and a speaker.  In reply to an email from Chiesi, the organiser stated that the Chiesi sponsorship would be used for organising the scientific session only.  The organiser referred to a dinner on the Saturday evening and a cultural event for the delegates but provided no further details of any social aspects.  It appeared that Chiesi had not asked for further information and while noting that there was a limit to what investigation a company should have to undertake to establish the nature of any third party meeting it wished to sponsor, the Appeal Board queried whether Chiesi could have done more.  Companies needed to be certain that meeting arrangements complied with the Code.  If meeting organisers were not prepared to provide full details of events then pharmaceutical companies should very carefully consider whether they should be involved.  The Appeal Board, however, noted the difficulty that Chiesi had experienced in obtaining  comprehensive and accurate information from the organiser and in that regard noted the organiser had not informed the company about the social arrangements which ran alongside the scientific meeting.  In the Appeal Board’s view, Chiesi had been badly let down by the organiser.

The Appeal Board noted that Chiesi had agreed to have a stand at the meeting and sponsor a speaker.  It was concerned that the sponsorship declaration on the final programme, ‘Declaration The Pharmaceutical companies have only paid towards the speaker fees and catering costs for the scientific meetings.  They have not influenced the content of the slides.  Chiesi Limited have also provided and paid for a speaker on the agenda’ did not accurately reflect Chiesi’s involvement.  Chiesi had done more than ‘provided and paid for a speaker’, it had briefed the speaker and formally reviewed and approved the presentation.  When Chiesi reviewed the final agenda a few days before the meeting it decided not to have a stand at the meeting because of associated compliance issues (although it was unable to recoup the cost of its sponsorship in this regard) and so its involvement was limited to a representative attending the Sunday morning session to accompany the Chiesi sponsored speaker.  The Appeal Board noted the educational content of the meeting and that the delegates included GPs and hospital doctors from a range of medical and surgical specialties.  In that regard the Appeal Board noted the difficulty in making one agenda relevant to all attendees.  The Appeal Board noted an email from the organiser to Chiesi dated 3 July which stated that ‘…the Chiesi sponsorship is being used for the scientific session only (of course other pharmaceuticals like Bayer, Eli Lilly and GMC are also contributing to the Sunday morning session – the cost of hiring the Lion of Vienna Suite on Sunday, PA system Projection system, catering for delegates attending the scientific session on Sunday)’.  This email also stated that on the Saturday there was a dinner and cultural event for delegates attending the conference.  The sponsorship from pharmaceutical companies would not be used to fund these – non pharmaceuticals were sponsoring this event.  The Appeal Board noted that Chiesi had not agreed to pay for any social aspect of the meeting and had been told that its sponsorship would be used for organising the scientific session only.  The invoice from the BJMA included a handwritten noted signed by the organiser that the £1,000 invoice was for stand space.   This invoice was authorized by Chiesi on 20 June 2013.  The Appeal Board noted that hospitality as defined in the supplementary information of Clause 19.1 was limited to refreshments/ subsistence (meals and drinks), accommodation, genuine registration fees and the payment of reasonable travel costs which a company might provide to sponsor a delegate to attend a meeting.  It was an established principle of the Code that any meeting held or sponsored by a pharmaceutical company must have a clear educational content (Clause 19.1 supplementary information).  The Appeal Board had some reservations about the educational content at the meeting.  The Appeal Board noted that although Chiesi had paid £1,000 which it had subsequently requested be returned, there was no evidence that Chiesi had provided any hospitality for the meeting.  There was an impression from the agenda that Chiesi had contributed to the catering costs.  The email from the organiser stated that whilst other pharmaceutical companies’ payments would be used to pay for catering for delegates, Chiesi’s would not.  On this very narrow ground the Appeal Board ruled no breach of Clause 19.1.  The appeal on this point was successful.

The Appeal Board noted its comments above and considered that a significant factor in this case was the apparent deliberate lack of key information from the organisers.  The Appeal Board noted the Panel’s ruling of a breach of Clause 9.1 and considered that Chiesi could have undertaken greater diligence to ensure that its involvement with the meeting complied with the Code but did not consider that in the circumstances it had brought discredit upon, or reduced confidence in the pharmaceutical industry.  The Appeal Board ruled no breach of Clause 2.  The appeal on this point was successful.

*     *     *     *     *

CASE AUTH/2629/8/13 – MENARINI

RESPONSE

Menarini submitted that it did not directly provide hospitality for this event; it agreed to a payment of £1,500 for an exhibition stand plus two sessions within the scientific meeting.  The company understood that this money was used by the organisers to contribute to the cost of room hire and catering for the scientific meeting.  The venue, a hotel at a football stadium was appropriate and conducive to the main purpose of the event ie medical education. The hospitality provided to health professionals within the scientific meeting was secondary to the purpose of the meeting ie subsistence only, and did not exceed the level which the recipients would normally adopt when paying for themselves.  The hospitality provided within the scientific meeting also did not extend beyond the members of the health professions and appropriate administrative staff.

Prior to the meeting Menarini was unaware of any activities or hospitality arranged for the partners and families of health professionals alongside the scientific meeting.  It now understood that such activities took place separately to the scientific meeting but submitted that this was entirely segregated and that it did not provide hospitality or support for it in any way.

Menarini submitted therefore that it did not breach Clause 19.1.

Menarini submitted that it did not promote or advertise medicines to the public in any way at this event.  The scientific meeting sponsored by Menarini was accessible only to health professionals and supportive administrative staff.  A system of registration and name badges was in place at the event and members of the organising committee were at the doors of the scientific meeting ensuring that non-health professionals did not enter.

Menarini therefore submitted that it did not breach Clauses 22.1 or 22.2.

Accordingly, Menarini was confident not to have breached Clauses 19.1, 22.1 or 22.2 in this matter and had acted at all times to maintain the high standards of the pharmaceutical industry and committed no breach of Clauses 9.1 or 2.

Menarini provided a floor plan of the layout of the Premier Suite where registration and the buffet lunch for the scientific meeting both took place.  It understood that the medical exhibition and scientific presentations took place in the Lion of Vienna Suite, below the Premier Suite, but had not been able to obtain a floor plan for this.  Name badges were worn by delegates for the scientific programme and members of the organising committee were present on the entrances to the Lion of Vienna and Premier Suites to prevent non-health professionals from entering.

Menarini now understood that activities were taking place for the partners and families of the health professionals elsewhere.  However, it was not aware of this before the meeting and at the event, it appeared to Menarini staff to be appropriately segregated from the scientific meeting and thus did not arouse their concern.

Menarini had committed to a payment of £1,500 for an exhibition stand plus two sessions on the scientific programme ‘Management of chronic stable angina: an update’ 11am to 11.30am and ‘Gout: Same old, same old?’ 11.30am to 12 noon.

It did not specifically ask for or receive a detailed breakdown of what the organisers used the money for, but understood it to contribute to the costs of providing the scientific meeting ie room hire and catering.

The only other payments committed in relation to this meeting were to be made directly to the two speakers in relation to the above sessions.

The Menarini attendees at the meeting were a key account specialist and three account managers.  All arrived between 8am and 8.30am and estimated that they left between 1.30pm and 2pm ie after the medical exhibition and presentations had finished and once they had taken down the exhibition stand and materials.  None of them knew of, attended or were invited to the gala dinner.  No payment was asked for or made for the gala dinner.

Having agreed to sponsor two sessions on the scientific programme, Menarini agreed the subject areas with the meeting organisers and the speakers it suggested were recognised opinion leaders who had previously delivered high quality medical education for GP audiences on the subjects of stable angina and gout.  The conference organisers agreed that these subjects and speakers were suitable.  Menarini then ascertained that they were available to speak on the day and to the subject in question, discussed with them the name and purpose of the meeting with an expected attendance of between 200-300 health professionals, most of whom would be GPs.  A suitable speaker fee was agreed in line with Menarini’s standard operating procedure (SOP) and a standard consultancy agreement form was signed by each.

One of the meeting organisers emailed a draft copy of the scientific meeting programme to one of the account managers who, on the same day, asked the organisers to correct this draft which showed another pharmaceutical company as sponsors of the gout session rather than Menarini.  Menarini had since discovered that there were a number of different versions of the agenda circulated by the BJMA.

At no time had anyone at Menarini seen a programme for any element of the meeting other than the scientific meeting, nor had it any knowledge prior to the event of any element to the meeting other than the scientific meeting.  Furthermore Menarini was not aware of any registration form with different age groups, nor was it aware of the BJMA website prior to the meeting.

The £1,500 committed for an exhibition stand and two sessions on the scientific programme provided a suitable level of subsistence-type hospitality within the scientific programme only.  Tea and coffee was available in the Lion of Vienna Suite, and a buffet lunch of chicken curry (or vegetarian option) with two choices of starters was served on plastic plates in the Premier Suite and was available for delegates at the scientific meeting only ie not family members of health professionals or the general public.

No payment was agreed or made specific to catering costs other than the £1,500 detailed above which was for the exhibition stand plus two sessions on the scientific programme.

Menarini staff estimated that 200 delegates attended the scientific session (the exhibition space and the presentations made in Hall A and Hall B) (estimated by the individuals varied from 150-250).  The number of delegates who were in Hall A during the presentations by the Menarini sponsored speakers was 44.

Non-health professionals did not have access to the lunch and refreshment breaks of the scientific meeting.  A system of registration and name badges was in place at the event and members of the organising committee were at the doors of the scientific meeting ensuring that non-health professionals did not enter.

Menarini did not know the catering costs paid by the conference organisers.  The £1,500 fee paid was for an exhibition stand plus two sessions on the scientific programme, which it understood the conference organisers used to pay, or part-pay, for the room hire and catering.  If the £1,500 was the full catering amount across 200 delegates, the catering cost per head would be £7.50.  A theoretical calculation was made of the estimated catering cost per head were Menarini’s full payment of £1,500 used to cater for the anticipated audience of 69 delegates attending the stable angina and gout speaker sessions – this gave an anticipated theoretical cost per head of £21.74 and dividing the £1,500 by the actual number attending the stable angina and gout speaker sessions gives an actual cost per head of £34.09.

However, Menarini stressed that its support of the meeting was a £1,500 payment for an exhibition stand and two sessions on the scientific programme, not specifically sponsorship of the catering thus making this calculation a theoretical one only.

A copy of the meeting organiser’s comments was provided to Menarini which had no further comments.

PANEL RULING IN CASE AUTH/2629/8/13

The Panel’s general comments above apply here.

The Panel examined the agenda provided to the pharmaceutical company named in the complaint by the meeting organisers.  This version of the agenda named a total of seven pharmaceutical companies.  The complaint had been taken up with each of the additional six companies (one of which was Menarini) by the case preparation manager.  The version of the agenda provided to the company named in the complaint by the meeting organisers differed to the agenda provided by the complainant.  The agenda provided by Menarini was again different.

According to the agenda provided by Menarini, the meeting commenced on Saturday, 6 July with registration at 9am.  Four talks of 30 minutes each were held in Hall A.  Lundbeck was described as sponsor for the first talk ‘Reducing Alcohol related harm – what steps can well (sic) all take to help our patients’.  The second talk ‘GMC update’ listed Chiesi as the sponsor.  The third talk ‘Management of chronic stable angina: an update’ listed Menarini as sponsor and the final talk ‘Gout: same old, same old?’ also listed Menarini as sponsor.  In parallel, four talks each of 30 minutes were listed for Hall B.  These being ‘Management of chronic dermatitis’, Understanding and managing depression and anxiety: a practical guide, ‘Type 2 Diabetes – New therapies’ and ‘New concepts in the management of heart failure’.  The listed sponsors were Lundbeck and two named pharmaceutical companies.  There was no named sponsor for one of the talks.  The post lunch session ran in Hall A and none of the five non-clinical talks were sponsored by pharmaceutical companies.  At 4–5pm the agenda stated ‘ARM/ AGM BJMA’.  On Sunday, 7 July the first talk at 10.30am was ‘New concepts in asthma management’ which did not list a sponsor.  This was followed by ‘Management of Actinic keratosis’ and ‘The changing face of Anticoagulation in Primary Care: new solutions to old problems’ sponsored by a named company and Bayer respectively.  This was followed by the declaration ‘The Pharmaceutical companies have only paid towards the speaker fees and catering cost for the scientific meeting.  They haven’t influenced the content of the slides’.  The final two pages of the agenda included two photographs, one of a flag and the other of a man playing a drum and what appeared to be women dancing.

The Panel noted that the case preparation manager had written to the secretary of the local organising committee to ask for the details of the pharmaceutical companies sponsoring the event.  The response reiterated that the event was the 34th reunion of the BJMA Scientific Conference.  The secretary confirmed that there was a mixture of ‘… reputable sponsors, including various banks, reputable solicitors, specific accountant, GMC and pharmaceutical companies.  The secretary confirmed that the money raised from pharmaceutical companies, which took part in the exhibition, was only to fund the scientific section of the conference.  The organisers stated that they took care to make sure that the scientific sections and exhibition halls were in an area of the hotel which was away and separate from any public areas which were accessed only by the registered delegates attending the scientific meeting.

The Panel noted that the meeting in question was organised by the BJMA.  The BJMA was of course free to organise whatever meetings it wanted to for its own members.  If there had been no involvement from pharmaceutical companies then the meeting would not have been covered by the Code.  The involvement of the pharmaceutical companies meant the matter was covered by the Code.  According to the agenda provided by Menarini six pharmaceutical companies had provided sponsorship in the form of paying speakers.  The agenda referred to ‘Exhibits Open’.  It was not clear from the agenda provided by Menarini which companies had exhibition space.  This agenda included the declaration ‘The pharmaceutical companies have only paid towards the speaker fees and catering costs for the scientific meeting.  They have not influenced the content of the slides’.  This declaration also appeared in the agenda provided by the complainant although no pharmaceutical companies were listed.  In addition, the documents provided by the complainant did not mention pharmaceutical company sponsorship on the documents sent to announce the meeting nor on the more detailed documents which described all the activities.

The Panel was also mindful of the established principle that a pharmaceutical company could not support a third party activity if that activity was itself in breach of the Code.

Menarini provided their own attendance list which stated twenty-two GPs, fourteen other GPs, one primary care trust manager, six consultants and one specialist registrar were in attendance.  The company did not appear to have a full list of attendees to the meeting.  A post meeting list had been provided by BJMA to some of the companies.  The majority of attendees were general practitioners and hospital doctors.  The vast majority were listed as from the UK a few of those listed were from India, some were listed as retired.  Attendees had a very wide range of specialities including consultant anaesthetists, urologists, gynaecologists, paediatricians, cardiologists, orthopaedics, sexual health and geriatricians.  The Panel noted that the professional link among the disparate groups listed and the basis of BJMA membership was that they were graduates from certain Indian medical colleges.

The Panel noted that a wide range of groups existed within the medical and scientific communities.  Membership of certain groups might be based on medical speciality or professional status or on different criteria such as cultural or, as with the BJMA, academic heritage.  In the Panel’s view, when membership was based on matters other than medical speciality and professional status, companies should be especially vigilant to ensure the relevant requirements of the Code were satisfied.  In addition, given the wide range of clinical roles held by attendees, it was difficult to see how the limited educational agenda could be of sufficient professional relevance to all attendees.

The Panel queried whether the scientific content was reasonable in relation to the requirements of the Code.  According to the agenda provided by Menarini, scientific sessions ran from 10am to 12 noon on the Saturday (including a 30 minute GMC update) and from 10.30 – 12 on the Sunday.  This gave a maximum scientific content of around three hours bearing in mind the parallel nature of the Saturday sessions.  In addition, on Saturday afternoon there were talks from 1.30 until 3.45pm, only one of which ‘Dealing with partnership disputes in general practice’ might possibly be considered as relevant given the requirements of Clause 19.  The four other talks related to financial matters including investment in Indian real estate.  The BJMA ARM/AGM ran for an hour.  The 30 minute GMC update on Saturday might possibly be considered as relevant to Clause 19.  The refreshments listed were lunch on both days and refreshments after the Saturday afternoon session.  The Panel noted that a number of companies paid for exhibition space and queried whether the amount charged was reasonable.

It appeared to the Panel that the main purpose of the meeting was the social/cultural aspects and in its view this was reinforced by the documentation for the meeting.  The Panel did not consider that the meeting met the requirements of the Code.  The two day meeting had a maximum scientific content of around three hours.  The meeting was mainly a social event and it appeared to the Panel that the limited scientific programme was not the main purpose of the event.  The Panel had little information about the costs of putting on the exhibition on the Saturday.  The organising secretary had stated that the money paid by pharmaceutical companies ‘hardly met the cost of the scientific meeting’.  This seemed at odds with the activities arranged and that each delegate was to pay £60 to cover everything other than accommodation.  Menarini had paid for two speakers and for an exhibition stand.  Menarini had chosen the subject areas and speakers and the meeting organisers had agreed that they were suitable.  The fact that companies had sponsored speakers was also of concern.  Menarini had briefed the speakers which appeared to be at odds with the declaration on the programme that pharmaceutical companies had not influenced the content of the slides.  It appeared that companies had limited information about the meeting before agreeing to support it.  Menarini should have ensured that comprehensive copies of documentation had been supplied by the organisers.

The Panel noted that Menarini representatives had left the meeting early on the Saturday afternoon.

In relation to alleged promotion to the public, the Panel noted Menarini’s submission that only health professionals and supportive (sic) administrative staff accessed the exhibition area.  The complainant had not provided any details regarding this aspect of his/her allegation.  The complainant had the burden of proving his/her complaint on the balance of probabilities.  The Panel considered that this had not been discharged in relation to the alleged promotion to the public and no breaches of Clauses 22.1 and 22.2 were ruled.

Taking all the circumstances into account the Panel considered that the arrangements for the meeting did not meet the requirements of Clause 19 such that it was not a meeting for a primarily educational purpose as set out in that clause.  Pharmaceutical company involvement in the agenda ie sponsoring speakers and paying for exhibition space and the impression given by pharmaceutical company involvement was unacceptable.  The Panel ruled a breach of Clause 19.1 with regard to Menarini’s involvement.  The Panel considered that high standards had not been maintained and a breach of Clause 9.1 was ruled.

The Panel noted that Clause 2 was used as a sign of particular censure and reserved for such use.  The supplementary information referred to excessive hospitality.  The Panel decided the circumstances were such as to bring discredit upon and reduce confidence in the pharmaceutical industry and a breach of Clause 2 was ruled.

*     *     *     *     *

CASE AUTH/2631/8/13 – BAYER (1)

RESPONSE

Bayer stated that it sponsored what it believed to be a scientific meeting organised by an independent third party.  All approval procedures were followed according to Bayer’s standard operating procedure (SOP).

The meeting sponsorship was agreed by the Bayer key account manager (KAM) and approved by the regional business manager (RBM).  The speaker was arranged by the professional relations team (PRT) and the speaker agreement approved by the general medicine business unit in head office.

Bayer made only one payment to the BJMA and this was £1,000 for an exhibition stand.  The Bayer KAM and RBM had an initial meeting in November 2012 with a BJMA representative to discuss sponsorship of the 34th annual scientific meeting.  During this meeting many questions were raised with regard to the arrangements with the need to comply with the Code in mind.  Copies of the email correspondence dated 30 January 2013 in which further questions, raised by head office, were posed and an email, letter and invoice from BJMA were provided.  The letter of 26 January 2013 clearly referred to a scientific meeting on both days with over 500 delegates.  Bayer was not aware of any arrangement other than the scientific programme until the lunch time on the first day of the meeting 6 of July 2013 and consequently the Bayer representatives, having been faced with a fait accompli, expressed their concerns.  Despite the lunch arrangements it must be emphasised that at no time was the scientific programme or exhibition accessible to the general public.  A GP with special interest in cardiology was contacted by the head office professional relations manager and agreed to speak at the meeting.  He was briefed about the meeting arrangements.

The Bayer KAM’s provided a detailed account of the meeting arrangements.

Copies of the floor plans for Saturday 6 July and Sunday 7 July document were provided.

Bayer paid £1,000 for the exhibition stand which was to be used to hire the meeting rooms for the BJMA scientific meeting and for catering for health professionals on Saturday lunchtime and coffee/tea.

On Saturday: two Bayer staff attended (8am-4.30pm) and (8am-3.30pm) and on Sunday: three (10am1.30pm as meeting over-ran by approximately one hour) from Bayer attended.  No Bayer staff were invited to attend or attended the Gala dinner; the Gala dinner had no connection to the scientific programme and was not part of its sponsorship agreement.

Bayer was asked to provide a speaker to talk on ‘Anticoagulation in Primary Care’ in April 2013.  The Bayer KAM asked the PRT team to suggest a suitable speaker for this event, providing them with the BJMA 2013 letter dated 26 January 2013, draft conference agenda, and any other information during telephone conversations.  After contacting a number of potential candidates a speaker was agreed.  Speaker honorarium discussion was between the PRT team and the speaker, neither the KAM nor the BJMA had any involvement in the sum agreed.  Bayer briefed the speaker for the meeting, adapting an existing speaker briefing document which was approved before discussion with the speaker.  The speaker briefing was undertaken by a Bayer representative, prior to the meeting.  The speaker used an approved slide set which was provided by Bayer on the day of the meeting by the representative.

Bayer’s understanding of the meeting programme was that this was a purely scientific conference for health professionals, who were members of the BJMA medical association, from across the UK.  The Bayer KAM and RBM met the local organising secretary in November 2012 (an account of the meeting discussion was provided).  The meeting organiser outlined the meeting and invited Bayer to support it.  At no time was there any reference to the meeting being anything other than a scientific meeting.  The emails and conversations with the meeting organiser were all with regard to BJMA’s scientific meeting and this was what Bayer agreed to be involved with.  Approximately 45 to 50 delegates attended the Bayer scientific session.

Bayer submitted that the food was of ordinary Indian restaurant cooking standard, it was served from two tables to people who queued.  The food was prepared by an off-site caterer, who set up two large white vans in the car park with a large awning, preparing and cooked the food on site.  Bayer was not involved in the catering arrangements and did not know the costs.

The catering arrangements for the Saturday were as follows: On the mezzanine floor, designated for the scientific meeting, a coffee station was available throughout most of the day.  These refreshments were for health professionals moving between the two meeting rooms and also for exhibition stand staff.  The route to the meeting area clearly stated the way for health professionals.  Health professionals were served lunch in a communal dining hall on a different floor and no pharmaceutical company activity was present in this area.  Whilst the two separate events were served lunch in the same area, Bayer was assured that the two activities were funded via separate sources.  On the Sunday coffee/tea was available in the meeting room.  This was the only refreshment on offer and was only available to the health professionals in the meeting room.  Bayer did not know catering costs per head. 

In conclusion, Bayer sponsored a scientific meeting in good faith on the information provided by BJMA, it was not aware of any other arrangements or activities associated with the 34th Annual Scientific Meeting of the Bihar Jharkhand Medical Association.  All approvals were in accordance with Bayer SOPs and consequently Bayer submitted that it had not breached Clauses 2, 9.1, 19.1, 22.1 or 22.2.

Bayer was provided with a copy of the further comments from the meeting organiser and had no further submission to make.

PANEL RULING IN CASE AUTH/2631/8/13

The Panel’s general comments above apply here.

The Panel examined the agenda provided to the pharmaceutical company named in the complaint by the meeting organisers.  This version of the agenda named a total of seven pharmaceutical companies.  The complaint had been taken up with each of the additional six companies (one of which was Bayer) by the case preparation manager.  The version of the agenda provided to the company named in the complaint by the meeting organisers differed to the agenda provided by the complainant.  The Panel referred to the agenda provided by the pharmaceutical company named by the complainant.  Bayer did not provide a copy of the agenda but stated that it was displayed at the meeting.

According to the agenda provided by the pharmaceutical company named by the complainant the meeting commenced on Saturday, 6 July with registration at 9am.  Four talks of 30 minutes each were held in Hall A.  Lundbeck was described as sponsor for the first talk ‘Reducing Alcohol related harm – what steps can well (sic) all take to help our patients’.  The second talk ‘New concepts in asthma management’ listed Chiesi as the sponsor.  The third talk ‘Management of chronic stable angina: an update’ listed Menarini as sponsor and the final talk ‘Gout: same old, same old?’ listed another named company as sponsor.  In parallel, four talks each of 30 minutes were listed for Hall B.  These being ‘Management of chronic dermatitis’, Understanding and managing depression and anxiety: a practical guide, ‘Type 2 Diabetes – New therapies’ and ‘New concepts in the management of heart failure’.  The listed sponsors were Lundbeck, two named companies and there was no named sponsor for one third talk.  The post lunch session ran in Hall A and none of the five nonclinical talks were sponsored by pharmaceutical companies.  At 4–5pm the agenda stated ‘ARM/ AGM BJMA’.  On Sunday, 7 July the first talk at 10.30am was ‘GMC Update’.  This was followed by ‘Management of Actinic keratosis’ and ‘The changing face of Anticoagulation in Primary Care: new solutions to old problems’ sponsored by a named company and Bayer.  This was followed by the declaration ‘The pharmaceutical companies have only paid towards the speaker fees and catering cost for the scientific meeting.  They haven’t influenced the content of the slides’.  The final page of the agenda included two photographs, one of a flag and the other of a man playing a drum and what appeared to be women dancing.

The Panel noted that the case preparation manager had written to the secretary of the local organising committee to ask for the details of the pharmaceutical companies sponsoring the event.  The response reiterated that the event was the 34th reunion of the BJMA Scientific Conference.  The secretary confirmed that there was a mixture of ‘… reputable sponsors, including various banks, reputable solicitors, specific accountant, GMC and pharmaceutical companies.  The secretary confirmed that the money raised from pharmaceutical companies, which took part in the exhibition, was only to fund the scientific section of the conference.  The organisers stated that they took care to make sure that the scientific sections and exhibition halls were in an area of the hotel which was away and separate from any public areas which were accessed only by the registered delegates attending the scientific meeting.

The Panel noted that the meeting in question was organised by the BJMA.  The BJMA was of course free to organise whatever meetings it wanted to for its own members.  If there had been no involvement from pharmaceutical companies then the meeting would not have been covered by the Code.  The involvement of the pharmaceutical companies meant the matter was covered by the Code.  According to the agenda provided by Lundbeck seven pharmaceutical companies had provided sponsorship in the form of paying speakers.  The agenda referred to ‘Exhibits Open’.  It was not clear from the agenda provided by Lundbeck which companies had exhibition space.  This agenda included the declaration ‘The pharmaceutical companies have only paid towards the speaker fees and catering costs for the scientific meeting.  They have not influenced the content of the slides’.  This declaration also appeared in the agenda provided by the complainant although no pharmaceutical companies were listed.  In addition, the documents provided by the complainant did not mention pharmaceutical company sponsorship on the documents sent to announce the meeting nor on the more detailed documents which described all the activities.

The Panel was also mindful of the established principle that a pharmaceutical company could not support a third party activity if that activity was itself in breach of the Code.

Bayer had not provided a list of health professional attendees.  Bayer provided a copy of the meeting request form which listed, as meeting contacts, six GPs and eight hospital doctors by name.  In addition, another 253 unnamed attendees were listed as present.  Bayer stated that around 45 – 50 delegates attended the Bayer scientific session.  Bayer did not appear to have a full list of attendees to the meeting.  A post meeting list had been provided by BJMA to some of the companies.  The majority of attendees were general practitioners and hospital doctors.  The vast majority were listed as from the UK a few of those listed were from India, some were listed as retired.  Attendees had a very wide range of specialities including consultant anaesthetists, urologists, gynaecologists, paediatricians, cardiologists, orthopaedics, sexual health and geriatricians.  The Panel noted that the professional link among the disparate groups listed and the basis of BJMA membership was that they were graduates from certain Indian medical colleges. 

The Panel noted that a wide range of groups existed within the medical and scientific communities.  Membership of certain groups might be based on medical speciality or professional status or on different criteria such as cultural or, as with the BJMA, academic heritage.  In the Panel’s view, when membership was based on matters other than medical speciality and professional status, companies should be especially vigilant to ensure the relevant requirements of the Code were satisfied.  In addition, given the wide range of clinical roles held by attendees, it was difficult to see how the limited educational agenda could be of sufficient professional relevance to all attendees.

The Panel queried whether the scientific content was reasonable in relation to the requirements of the Code.  According to the agenda provided by Lundbeck, scientific sessions ran from 10am to 12 noon on the Saturday and from 10.50 – 12 noon on the Sunday.  This gave a maximum scientific content of just over three hours bearing in mind the parallel nature of the Saturday sessions.  In addition, on Saturday afternoon there were talks from 1.30pm until 3.45, only one of which ‘Dealing with partnership disputes in general practice’ might possibly be considered as relevant given the requirements of Clause 19.  The four other talks related to financial matters including investment in Indian real estate.  The BJMA ARM/AGM ran for an hour.  The 20 minute GMC update on Sunday (10.30–10.50am) might possibly be considered as relevant to Clause 19.  The refreshments listed were lunch on both days and refreshments after the Saturday afternoon session.  The Panel noted that a number of companies paid for exhibition space and queried whether the amount charged was reasonable.  The Panel noted that Bayer stated that lunch was served to all attendees not just those health professionals attending the meeting. It appeared to the Panel that the main purpose of the meeting was the social/cultural aspects and in its view this was reinforced by the documentation for the meeting.  The Panel did not consider that the meeting met the requirements of the Code.  The two day meeting had a maximum scientific content of just over three hours.  The meeting was mainly a social event and it appeared to the Panel that the limited scientific programme was not the main purpose of the event.  The Panel had little information about the costs of putting on the exhibition on the Saturday.  The organising secretary had stated that the money paid by pharmaceutical companies ‘hardly met the cost of the scientific meeting’.  This seemed at odds with the activities arranged and that each delegate was to pay £60 to cover everything other than accommodation.  The fact that companies had sponsored speakers was also of concern.  Bayer had paid for one speaker and for an exhibition stand.  The company briefed the speaker and had provided slides for the speaker to use which was at odds with the declaration on the programme that pharmaceutical companies had not influenced the content of the slides.  It appeared that companies had limited information about the meeting before agreeing to support it.  Bayer should have ensured that comprehensive copies of documentation had been supplied by the organisers.  It appeared that Bayer had not seen a copy of the agenda prior to the meeting.

In relation to alleged promotion to the public, the Panel noted Bayer’s submission that only registered delegates accessed the exhibition area.  The complainant had not provided any details regarding this aspect of his/her allegation.  The complainant had the burden of proving his/her complaint on the balance of probabilities.  The Panel considered that this had not been discharged in relation to the alleged promotion to the public and no breaches of Clauses 22.1 and 22.2 were ruled.

Taking all the circumstances into account the Panel considered that the arrangements for the meeting did not meet the requirements of Clause 19 such that it was not a meeting for a primarily educational purpose as set out in that clause.  Pharmaceutical company involvement in the agenda ie sponsoring speakers and paying for exhibition space and the impression given by pharmaceutical company involvement was unacceptable.  The Panel ruled a breach of Clause 19.1 with regard to Bayer’s involvement.  The Panel considered that high standards had not been maintained and a breach of Clause 9.1 was ruled.

The Panel noted that Clause 2 was used as a sign of particular censure and reserved for such use.  The supplementary information referred to excessive hospitality.  The Panel decided the circumstances were such as to bring discredit upon and reduce confidence in the pharmaceutical industry and a breach of Clause 2 was ruled.

Case AUTH/2631/8/13:   Complaint received 7 August 2013      Case completed    25 October 2013

Case AUTH/2617/7/13: Complaint received 22 July 2013     Case completed  25 October 2013

Case AUTH/2628/8/13: Complaint received 7 August 2013 Case completed  27 November 2013

Case AUTH/2629/8/13: Complaint received 7 August 2013 Case completed  25 October 2013