INTERIM CASE REPORT
An interim case report has been published in this case as the final report was delayed because the Code of Practice Appeal Board reported the company to the ABPI Board which required an audit of Novo Nordisk’s procedures in relation to the Code (Paragraph 12.2 of the Constitution and Procedure refers) following which the ABPI Board decided to suspend Novo Nordisk from membership of the ABPI for a period of 2 years and required further audits.
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A complainant who described him/herself as a concerned UK health professional provided a screenshot of a LinkedIn post by a provider of clinical training to health professionals, which contained an image of what appeared to be an overweight female on her mobile phone holding a drink, sat on a bench in a park, and stated:
‘With #obesity affecting around 1 in 4 #adults in the #UK, is your #pharmacy offering a #weight management service? We have funding to get you started if not! Join us Sunday morning for a FREE #webinar to start your journey. Our #nurse will guide you all the way so you are not alone in your setting up. We will #walkthewalk with you [link]?’
The complainant stated that the post linked to the training provider’s webpage which was headed Free Weight Management Course (WEBINAR + PGD [patient group direction]).
The complainant alleged that it was a Novo Nordisk sponsored free weight management course, which meant that the meeting took place on behalf of Novo Nordisk. The website stated that Novo Nordisk had reviewed all the materials for accuracy.
The complainant drew attention to one of the facets of the training which would cover GLP1-RA in the treatment of obesity, which was the only treatment option mentioned and that Novo Nordisk was at the time the only company that had a GLP-RA available for the treatment of obesity.
The complainant alleged that the LinkedIn post did not make clear Novo Nordisk’s involvement, nor stated whether it was a promotional or non-promotional meeting; given that the course was for a therapy area, Novo Nordisk was involved in, and ended up giving, a PGD to ensure that even non-prescribers could indirectly prescribe its product, this appeared to be promotional.
The complainant stated that the PGD given was part of what Novo Nordisk was offering individual health professionals. This had a value and it was being given to individuals for their own personal benefit to run private clinics which was bribing health professionals with an inducement to prescribe.
The complainant noted that on the website the course had been run several times, so there was a large number of health professionals who had been offered this by Novo Nordisk.
The complainant alleged that the LinkedIn post did not appear to have been approved by Novo Nordisk, nor did the website where the material was held. There were no overt links to prescribing information in either place, although the website did mention the class of treatments that was being promoted.
The detailed response from Novo Nordisk is given below.
The Panel noted Novo Nordisk’s submission that the training provider had been providing training courses on obesity and weight management services since February 2019 and had offered more extensive training on obesity and weight management (including Saxenda) from June 2019; the training provider sought sponsorship from Novo Nordisk to support the training provision at the beginning of 2020. The Panel noted Novo Nordisk’s submission that it had agreed to provide sponsorship to ensure that health professionals would receive training from a reputable provider. The sponsorship provided was, according to Novo Nordisk, for the period from February 2020 to December 2021 to support the cost per attendee for a training course for health professionals about obesity and providing a ‘how to provide a weight management service’, as a webinar or an e-learning module, and the cost of provision of a Patient Group Direction (PGD) to prescribe Saxenda to those health professionals who had completed the course and who wished to offer Saxenda as part of their weight management service.
The Panel noted Novo Nordisk’s submission that it had supported both activities (training course and PGD) at arm’s length and had no influence on the content of the training other than to check the accuracy of the information in the appropriate part of the training slides. The content of the training course had been created by and was owned by the training provider. The PGD for Saxenda had been prepared by another third party, a company that provided clinical services to pharmacists but was offered by the training provider.
The Panel noted that the Medical Weight Management + PGD webinar slides provided by Novo Nordisk, in a slide titled ‘medical weight management’, discussed three pharmacological treatments, namely: orlistat (brand names: Alli, Xenical, Beacita) which the speaker notes stated could be bought over-the-counter and had very common gastrointestinal side-effects which caused problems with adherence; naltrexone/bupropion (Mysimba) which, according to the speaker notes, was contraindicated for patients with hypertension and due to severity of potential side-effects, was stated as being ‘a riskier drug’. It was noted that it was rarely prescribed in the NHS, but it was possible to get a PGD to provide this in a private weight management clinic or pharmacy; and liraglutide (brand name Saxenda); no side-effects were included in the speaker notes for Saxenda on this slide and it was stated that Saxenda could be provided by an appropriate health professional with a valid PGD.
The Panel noted that the following slide was titled ‘cross-trial comparison’. Whilst the slide stated that ‘variance in study methods and design mean that cross-trial comparisons should not be relied upon for accuracy’, the Panel noted that the speaker notes stated that the results suggested that liraglutide might have the best efficacy of the three and that whilst naltrexone/bupropion had similar efficacy and might be effective in a certain subset of people, it was rarely prescribed due to its potential psychoactive effects.
The Panel further noted that module 3 of the webinar, which consisted of 21 slides, focussed on the role of human endogenous GLP-1 and how GLP-1 analogues worked to suppress appetite focussing on Saxenda, the evidence for the use of liraglutide (Saxenda) 3mg to treat obesity and maintain weight loss (The SCALE study), the indications, licensing, summary of product characteristics (SPC) information and PGD directives; and the administration, titration, dosing, safety reporting and storage of Saxenda. None of the other two treatment options were covered in similar detail.
The fourth module of the webinar titled ‘Providing a Weight Management Service’ included in the speaker notes that this final module would cover, inter alia, how to talk to patients about obesity, and assess eligibility for Saxenda. The speaker notes for this section included: advice on how to speak to patients about their weight and if suitable for Saxenda to explain how it works and evidence for its use, expected results, that there were side-effects in 40% of people which usually settled within a month, cost of treatment and any extra benefits and the possibility of non-response. The speaker notes further stated that whilst the health professional could recommend Saxenda, the patient needed to make the decision.
The Panel noted that, similarly, the e-learning course material, whilst including reference to Orlistat, Saxenda and Mysimba and their indications and mode of actions, focussed on GLP1-RA (Saxenda) treatment of obesity in more detail.
The Panel noted that it was possible for a company to sponsor materials and activities in which its own products were mentioned and not be liable under the Code for its contents, but only if there had been a strictly arm’s length arrangement with no input by the company and no use by the company. It had previously been decided, in relation to material/activities aimed at health professionals, that the content would be subject to the Code if it was promotional in nature or if the company had used the material for a promotional purpose. Even if neither of these applied, the company would be liable if it had been able to influence the content of the material in a manner favourable to its own interests.
The Panel noted that the sponsorship agreement for the weight management course between the training provider and Novo Nordisk stated, ‘Novo Nordisk will be in attendance at training meetings and will be given delegates to follow up’; the third slide of the Medical Weight Management + PGD webinar titled ‘Declarations & GDPR’ stated ‘Novo Nordisk would like to contact you following this course to send further resources and demo equipment, and to support and facilitate setting up a weight management service. Please indicate if you consent to your data being shared with Novo Nordisk. Your contact details will not be shared with any other party or used for any other purpose’.
According to the contract, signed February 2020, Novo Nordisk would be recognised as the ‘official sponsor’ of the weight management course in question and it appeared to the Panel that Novo Nordisk was the only sponsor. Furthermore, the Panel noted that the contract had stipulated the sponsorship declaration wording which stated, inter alia, that Novo Nordisk had reviewed the training materials used on the course for medical and factual accuracy. In the Panel’s view, the company would have had a clear idea of what would be covered before deciding whether or not to fund the project. The Panel thus considered that Novo Nordisk would have been aware that Saxenda would be covered positively within the course, including being the primary medicinal treatment discussed, particularly considering that it had also agreed to fund the cost of provision of a Patient Group Direction (PGD) to prescribe Saxenda to those health professionals who had completed the course and who wished to offer Saxenda as part of their weight management service. Noting its comments above, the Panel considered that the course (webinar and e-learning) was, in effect, promotional material for Saxenda for which Novo Nordisk was responsible.
The Panel noted that the LinkedIn post at issue appeared to have been posted by the training provider. The Panel noted the complainant’s concern that the LinkedIn post did not appear to have been approved by Novo Nordisk, nor did the linked website where the material was held.
The Panel noted that whilst the body of the LinkedIn post did not refer to Saxenda, the linked webpage, which formed part of the post, referred to GLP1-RA in the treatment of obesity. The Panel noted the complainant’s assertion that contemporaneous to the complaint, Novo Nordisk was the only company that had a GLP1-RA available for the treatment of obesity. The Panel noted that it was an accepted principle under the Code that it was possible, given the broad definition of promotion, for material to be promotional without mentioning a product by name.
On the evidence before it, the Panel considered that the LinkedIn post, which included the linked webpage, promoted Saxenda and had not been certified as required by the Code. High standards had not been maintained in that regard and a breach of the Code was ruled. Novo Nordisk’s appeal on this point was unsuccessful.
The Panel considered that the content of the LinkedIn post, which included the linked webpage, constituted the promotion of Saxenda to health professionals without the required prescribing information and thus the Panel ruled a breach of the Code. Novo Nordisk’s appeal on this point was unsuccessful.
The Panel noted that there was no declaration stating Novo Nordisk’s involvement in the weight management course in the body of the LinkedIn post; readers would have to click on the linked webpage to see any reference to Novo Nordisk. The Panel queried whether the wording of the sponsorship declaration on the linked webpage was sufficient; there was no reference to the PGD being for Saxenda or that Novo Nordisk might be in attendance at meetings and given delegates details to follow up as referred to in the signed contract. Regardless of what was stated in the declaration of sponsorship on the linked webpage, the Panel considered that the requirement for readers of sponsored material and meetings to be aware at the outset had not been met and breaches of the Code were ruled.
The Panel noted its comments above that the webinar, in effect, promoted Saxenda which Novo Nordisk was responsible for, and considered that Novo Nordisk’s involvement in relation to such promotion, including that its medicine would be discussed in detail, was not made sufficiently clear at the outset. Therefore, a breach of the Code was ruled. Novo Nordisk’s appeal on this point was unsuccessful.
The Panel noted Novo Nordisk’s submission that a PGD was a written instruction for the sale, supply and/or administration of medicines to groups of patients who might not be individually identified before presentation for treatment. The Panel noted Novo Nordisk’s submission that it paid for the cost per attendee for a training course for health professionals about obesity and providing a ‘how to provide a weight management service’ which, in the Panel’s view, promoted Saxenda. In addition, Novo Nordisk paid for a Patient Group Direction (PGD) to prescribe Saxenda to those health professionals who had completed the course and who wished to offer Saxenda as part of their weight management service.
The Panel noted that the written agreement stated that 13,000 health professionals were intended to be trained over 2 years on how to set up a weight loss service, with each delegate provided with a 1 year PGD, and that the financial support to be provided by Novo Nordisk had a maximum contract value of £357,500. was over £350,000. The Panel noted Novo Nordisk’s submission that as of 1 July 2021, 4,399 health professionals had completed the training and 599 PGDs had been activated (13.6% of attendees on the training).
In the Panel’s view, the provision of funding by Novo Nordisk for the PGD was clearly linked to the promotion of Saxenda; the Panel did not consider there could be any intention other than to directly increase the use of Saxenda. Furthermore, the Panel noted that the cost of the provision of the PGD to prescribe Saxenda was given to individual health professionals. Such funding to individual health professionals did not meet the requirements of the Code and was an inducement to prescribe, supply, administer and/or recommend Saxenda and the Panel therefore ruled a breach of the Code. Novo Nordisk’s appeal on this point was unsuccessful.
The Panel noted its comments and rulings above and considered that Novo Nordisk had failed to maintain high standards and a breach of the Code was ruled. Novo Nordisk’s appeal on this point was unsuccessful.
The Panel considered that the arrangements between Novo Nordisk and the training provider, particularly in relation to the PGD, brought discredit upon, and reduced confidence in, the pharmaceutical industry. A breach of Clause 2 was ruled. Novo Nordisk’s appeal on this point was unsuccessful.
Following its consideration of Novo Nordisk’s appeal, given the gravity of the breaches ruled, the Appeal Board considered whether further sanctions were warranted.
The Appeal Board was very concerned that Novo Nordisk did not recognise that this was a large-scale Saxenda promotional campaign which Novo Nordisk knowingly paid for and which was disguised. In the Appeal Board’s view the gravity of the breaches was compounded by Novo Nordisk’s failures to recognise that its own behaviour was not compliant with the Code. Novo Nordisk had apparently failed to recognise that the content of the training it sponsored which focused on its medicine Saxenda was clearly promotional; failed to recognise that the arrangements including attendance of Novo Nordisk representatives at the webinars and their subsequent follow up with delegates meant that it could not be considered an arm’s length sponsorship; and failed to recognise that covering the cost of a PGD was a benefit being offered to individual health professionals and amounted to an inducement. The Appeal Board was concerned about the potential impact on patient safety of providing unbalanced information to a wide audience, particularly given that the arena of weight loss was a highly emotional arena, and particularly given the lack of balance of Saxenda’s safety profile and side effects when comparing it with its competitors.
The arrangements relating to the breaches showed a wide-ranging lack of understanding of the requirements of the Code and an obfuscation of responsibilities.
The Appeal Board decided that in accordance with Paragraph 11.3 of the Constitution and Procedure, that Novo Nordisk should be publicly reprimanded for its failings and the potential impact on patient safety outlined above.
The Appeal Board considered the remaining sanctions available to it including that it could require an audit of Novo Nordisk.
The Appeal Board’s view was that the circumstances were so egregious that a report to the ABPI Board was the only appropriate course of action. Taking all the circumstances into account, the Appeal Board decided that in accordance with Paragraph 12.1 of the Constitution and Procedure, Novo Nordisk should be reported to the ABPI Board.
The Appeal Board noted that under Paragraph 12.2 of the Constitution and Procedure, the ABPI Board could require an audit to assist it in deciding whether further sanctions in the form of suspension or expulsion of a company were required.
The ABPI Board was seriously concerned over the scale of and the nature of the activities which had been ruled in breach of the Code. The ABPI Board was also concerned about what appeared to be inappropriate commercial focus given the content of the training which Novo Nordisk described as independent and at arm’s length in its responses to the Panel and Appeal Board. Further the ABPI Board was concerned about the company’s compliance culture, Novo Nordisk’s internal governance systems and processes, and a perceived naivety and lack of accountability from Novo Nordisk.
The ABPI Board was unanimous that taking no further action would not be appropriate. Nor did the ABPI Board consider that expulsion from membership of the ABPI was warranted at this stage, but this option could be exercised later.
The process by which a member pharmaceutical company might be suspended from the ABPI was covered in the ABPI’s Articles of Association, which made it clear that a majority of at least 75% was required for the ABPI Board to decide to suspend a member company.
A majority (but less than 75%) of the ABPI Board members present were minded to immediately suspend the company from membership of the ABPI, but ultimately the ABPI Board decided to request that the PMCPA undertake an audit of Novo Nordisk as set out in Paragraph 12.2 of the PMCPA Constitution and Procedure as soon as possible to assist the ABPI Board in understanding the company culture and whether this case was a one-off issue or an indicator of a wider compliance failure.
On consideration of the report of the audit and Novo Nordisk’s comments upon it, the ABPI Board would then decide whether any further action was required.
On consideration of the December 2022 audit report and Novo Nordisk’s comments on it and the company’s presentation the ABPI Board remained seriously concerned over the case and Novo Nordisk’s response to it. The audit report had not eased those concerns.
Board members were worried about Novo Nordisk’s ability to fix the very serious issues shown up by the case and the audit. Among other concerns, it appeared that only now, after the audit, was the company beginning to put all the necessary compliance structures and processes in place. Board members questioned the seriousness and urgency with which the company was acting, especially considering the essential mission the industry had to protect patients.
ABPI Board members believed that always ensuring patient safety – whilst also protecting the industry’s privileged position of being permitted to self-regulate – was of paramount importance. Board members discussed the three options open to them and were unanimous that taking no further action would not be appropriate.
Board members noted the requirements for suspension (Article 9.2 of the
ABPI’s Articles of Association) and expulsion from membership of the ABPI (Article 9.1.6 of the ABPI’s Articles of Association).
The Board wished to understand which sanction would best: protect patient safety; send a strong message about the severity of the breaches in question and the proportionate and appropriately serious response of the ABPI Board according to the responsibilities companies have under self-regulation; and encourage rapid cultural and process change within Novo Nordisk and requested additional clarifying information about the self regulatory and statutory regulatory positions in this regard.
The meeting was adjourned pending the requested information. On receipt of that information, the Board reconvened.
Companies should be capable of complying with self-regulation and that the system should be capable of getting companies back to where they needed to be in terms of compliance
Taking all relevant factors into account, those Board members present and voting unanimously agreed on a final decision: Novo Nordisk would be suspended from the ABPI for two years and that suspension would also be subject to various compulsory conditions imposed by the ABPI Board. The Board required that the company be re-audited in late 2023 and late 2024. The re-audits would be expected to show clear significant improvements and that Novo Nordisk was sustaining that improvement. If demonstratable progress was evidenced and maintained by the end of the two year suspension, the ABPI Board would be minded to allow Novo Nordisk to resume full engagement with the ABPI. However, if progress was lacking, the ABPI Board reserved the right to take further decisions following the review of either re-audit report. The ABPI Board also required regular updates on the company’s progress against its compliance improvement plan and pre-vetting of the company’s materials.
The ABPI Board would make a further decision about these arrangement upon consideration of the report of the re-audit in late 2023.