AUTH/2234/5/09 - Lilly v Novo Nordisk

Promotion of Victoza prior to receipt of its marketing authorization

  • Received
    28 May 2009
  • Case number
    AUTH/2234/5/09
  • Applicable Code year
    2008
  • Completed
    08 September 2010
  • Breach Clause(s)
    2 (x4), 3.1 (x4, 7.2 (x4), 7.3 (x4), 7.9, 9.1 (x5) and 12.1 (x3).
  • Sanctions applied
    Undertaking received
  • Additional sanctions
    Advertisement
    Public reprimand
    Audit of company’s procedures
    Re-audit
  • Appeal
    No appeal by parties, report by Panel to Appeal Board
  • Review
    November 2010

Case Summary

Lilly alleged that, despite being recently ruled in breach of the Code for promoting Victoza (liraglutide) prior to the grant of a marketing authorization (Case AUTH/2202/1/09), Novo Nordisk continued to so promote Victoza. Lilly's product Byetta (exenatide) was licensed for the treatment of type 2 diabetes mellitus in combination with metformin and/or sulphonylureas in patients who had not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies.

Novo Nordisk advised that Victoza had been granted a marketing authorization on 30 June 2009.

The detailed response from Novo Nordisk is given below.

Lilly alleged that an online educational resource sponsored by Novo Nordisk involved the pre-licence discussion and promotion of liraglutide. Lilly noted that a screen which it accessed in April 2009 stated 'Thank you for registering with Liraglutide online!' and appeared when the 'New User Registration' hyperlink was activated.

In inter-company correspondence, Novo Nordisk stated that this was an 'oversight' and that 'measures will be implemented as soon as possible', instead of immediately, to address this. Lilly refuted the suggestion that this was an unintentional error; 'Thank you for registering with Liraglutide online!' clearly demonstrated Novo Nordisk's intent to use the training module for pre-licence promotion of liraglutide. The removal of this wording did not negate Lilly's allegation.

Lilly cited a number of examples throughout the online resource in support of its allegations that promoted liraglutide prior to the grant of its marketing authorization and misleadingly compared liraglutide with its product Byetta which, unlike liraglutide, was licensed. Lilly further alleged that some of the comparisons had disparaged Byetta. Lilly's detailed allegations are given below. Lilly further noted that it was only at the end of Section 4.2.1 titled 'Overview' that the statement 'Liraglutide is not yet licensed in the UK' appeared in very small font such that it was almost obscured. Lilly alleged that this did not however mitigate the substantive issue in question.

Lilly also noted that the availability of this website was highlighted in the 'Resources and Support' section of Prescriber, 5 March 2009. Lilly alleged that promoting the availability of the website to the medical press effectively also supported the pre-licence promotion of liraglutide.

Lilly alleged that this activity constituted the pre-licence promotion of liraglutide, it invited misleading claims and comparisons with licensed medicines and represented the disguised promotion of liraglutide. Lilly alleged breaches of the Code including a breach of Clause 2.

The Panel was extremely concerned to see that following registration a message 'Thank you for registering with Liraglutide online!' appeared. This was compounded by the name of the website 'Realising the promise of the GLP-1 receptor.' The Panel considered that the first impression was not of an educational online resource but promotion of liraglutide as alleged. The Panel noted that Novo Nordisk had removed the reference to liraglutide.

Overall the Panel was extremely concerned about the material in question. It included detailed information about liraglutide, a product that did not have a marketing authorization. The Panel considered that the material promoted liraglutide. In this regard the Panel noted the initial references to exenatide and the failure to be very clear about the differences in the regulatory status of the products. A breach of the Code was ruled. The material was misleading and included misleading comparisons. Breaches of the Code were ruled. The Panel ruled a breach of the Code in relation to a section on tolerability and safety. The Panel did not consider the material disparaged Byetta and no breach of the Code was ruled. The material was disguised promotion and a breach of the Code was ruled. High standards had not been maintained and a breach of the Code was ruled.

The Panel noted that promoting a medicine prior to the grant of the marketing authorization was an activity likely to be in breach of Clause 2. That clause was used as a sign of the particular censure. The Panel ruled a breach of Clause 2.

The front cover of the Sponsored supplement in The British Journal of Diabetes & Vascular Disease, November/December 2008, Volume 8 Supplement 2, 'The Modulating Effects of GLP-1 in Type 2 Diabetes: Proceedings from a symposium of the 43rd Annual Meeting of the European Association for the Study of Diabetes [EASD] Amsterdam, The Netherlands, 17 September 2007' stated 'This supplement has been supported by an educational grant from Novo Nordisk'. Lilly alleged that the supplement was being used promotionally by Novo Nordisk as evidenced by its distribution in the UK with The British Journal of Diabetes & Vascular Disease, January/February 2009, Volume 9 Issue 1.

Lilly alleged that the title and reference to theEASD Annual Meeting misleadingly implied that the supplement was independent. This was further compounded by the format and layout of the supplement which suggested it was a part of and integral to the accompanying medical journal. The statement 'This supplement has been supported by an educational grant from Novo Nordisk' on the cover disguised the promotional nature of the material, which was in fact a paid for insert, editorially controlled by Novo Nordisk, detailing the proceedings of the company's sponsored satellite symposium which involved the pre-licence promotion of liraglutide.

The author, and chair of the satellite symposium introduced the five articles and stated 'Agents such as the GLP-1 receptor agonist exenatide and the DPP-4 inhibitors sitagliptin and vildagliptin are now available (the latter not in the USA) for utilisation in regimens to treat type 2 diabetes, while the GLP analogue liraglutide may soon be available'. Lilly alleged that the unlicensed status of liraglutide was not clearly stated and that its availability was underplayed relative to the wording adopted for vildagliptin. Lilly noted that it was only here that the derivation of four of the five articles was explained, albeit briefly, and linked to '… a symposium held on 17 September 2007, during the European Association for the study of Diabetes Meeting in Amsterdam'; although Novo Nordisk's sponsorship was omitted.

Lilly cited a number of examples with regard to the alleged promotion of liraglutide prior to the grant of its marketing authorization.

Lilly also alleged that a common theme in this insert was to misleadingly associate the discussion of liraglutide alongside licensed treatments such as Byetta thus creating the misleading impression that liraglutide should be regarded in the same context as Byetta, a licensed treatment.

Lilly noted liraglutide's unlicensed status and alleged that a discussion about its long-term effects on progression of type 2 diabetes (remarkable for a medicine that was not yet licensed!), clearly invited the suggestion that liraglutide was clinically relevant in the treatment of type 2 diabetes and available. This impression was reinforced in a 'Key messages' box which reiterated the messages that 'Liraglutide is a once-daily GLP-1 analogue that has a promising clinical profile including substantial improvement in glycaemic control without a risk for hypoglycaemia, and weight loss as an added benefit'.

Lilly alleged that an article 'Mechanisms behind GLP-1 induced weight loss' invited a discussion of liraglutide data and its effect on weight loss, and by reference to licensed medicines such as exenatide and sitagliptin invited the reader to consider it as 'a desirable option for the treatment of type 2 diabetes, as [it] improves[s] glycaemic control, improve[s] pancreatic function and induce[s] clinically meaningful weight loss' and its'…potential to modify type 2 diabetes disease progression'.

Lilly noted that although this article was not from the Novo Nordisk satellite symposium it involved editorial input from a Novo Nordisk employee as evidenced by the 'Acknowledgements' which stated 'The author has received many helpful comments to the manuscript from [a named doctor] ...'; this being a senior specialist from Novo Nordisk.

In conclusion, Lilly alleged that presenting the output of a Novo Nordisk run meeting as an independent supplement to a journal demonstrated poor knowledge of the Code. Health professionals generally looked to medical journals as a source of independent information therefore Novo Nordisk should have made it clear that the authors wrote the articles on behalf of and as a result of its promotional activities. Lilly alleged that the misleading description and presentation of this insert and its pre-licence promotion of liraglutide represented a breach of the Code.

Lilly alleged that this activity constituted the pre-licence promotion of liraglutide, it invited misleading claims and comparisons with licensed medicines and represented the disguised promotion of liraglutide in breach of the Code including Clause 2.

The Panel noted that the supplement had been initiated by Novo Nordisk and its agency. The authors were mostly those who had taken part in the company sponsored symposium.

The Panel considered that Novo Nordisk was inextricably linked to the production of the supplement. There was no arm's length arrangement between the provision of the sponsorship and the generation of the supplement. Circulation was not limited to those who attended the Novo Nordisk sponsored meeting as it was circulated with The British Journal of Diabetes and Vascular Disease in the UK. The Panel noted that it was an established principle under the Code that UK companies were responsible for the activities of overseas affiliates that came within the scope of the Code. Thus Novo Nordisk UK was responsible under the Code for the distribution in the UK.

Given the company's involvement and the content of the supplement, the Panel considered that the supplement was, in effect, promotional material for liraglutide. The Panel considered that the material was a paid-for insert from Novo Nordisk, not a supplement from The British Journal of Diabetes and Vascular Disease for which the journal's editorial board would have been responsible. The insert was distributed with The British Journal of Diabetes and Vascular Disease when liraglutide did not have a UK marketing authorization. The Panel considered that the insert promoted liraglutide to UK health professionals prior to the grant of its marketing authorization. A breach of the Code was ruled.

The insert misleadingly implied that liraglutide was licensed which was not so. A breach of the Code was ruled. The insert also invited the reader to make misleading comparisons about the licensed status of GLP-1-based therapies as alleged. A breach of the Code was ruled. The insert implied that it was a report of an independent meeting. The Panel considered that the insert was disguised promotion and a breach of the Code was ruled. The Panel considered that the role of Novo Nordisk was not clear. It was misleading to merely state that the insert had been supported by an educational grant from Novo Nordisk when the meeting was a Novo Nordisk sponsored symposium. The Panel considered that high standards had not been maintained and a breach of the Code was ruled.

The Panel considered that presenting the output of a Novo Nordisk meeting as an independent supplement to a journal demonstrated apparent poor knowledge of the Code. Health professionals generally looked to medical journals as a source of independent information; where authors wrote on behalf of pharmaceutical companies this must be clear. In the Panel's view the majority of readers would have viewed the material at issue quite differently if they had known that it was the report of a company sponsored meeting. The Panel considered that the description and presentation of the insert was such as to reduce confidence in, and bring discredit upon the pharmaceutical industry. A breach of Clause 2 was ruled.

Lilly stated that a promotional Symposium on Diabetes Care, March 2009, sponsored by Novo Nordisk, concluded with a 'Key Note Lecture' which was chaired by a senior clinical nurse specialist and included a one hour lecture/presentation 'A New Molecule in Diabetes – From Conception to Reality' delivered by a senior specialist, Novo Nordisk.

Lilly alleged that from this presentation it appeared that Novo Nordisk had intentionally commercialised liraglutide by a keynote lecture to promote the product and misleadingly imply that it was a licensed and relevant treatment option for the management of diabetes. This was evidenced by the context in which this particular lecture was presented ie preceded by an extensive discussion of subjects such as 'Diabetes – A Weighty Issue, New Treatments, Guidelines for Diabetes Care'.

Lilly alleged that this activity again constituted the pre-licence promotion of liraglutide, it invited misleading claims and comparisons with licensed medicines and represented the disguised promotion of liraglutide in breach of the Code including Clause 2.

The Panel noted that Novo Nordisk was responsible for the meeting. The title of the final presentation 'A New Molecule in Diabetes – From Conception to Reality' implied that the new molecule (liraglutide) was available for use which was not so. No details had been provided about the delegates. The Panel noted that the contentreferred to GLP-1 and its clinical potential as well as GLP-1 analogues. It included detailed information about liraglutide. The presentation compared liraglutide with exenatide, vildagliptin, glimepiride, rosiglitazone and glargine. The last few slides compared liraglutide and exenatide in relation to HbA1c, HOMA, body weight and frequency of nausea. Each parameter favoured liraglutide and the HbA1c and HOMA data were statistically significant. The final slide showed advantages for exenatide compared with glargine in relation to a composite endpoint of HbA1c ≤ 7.4% and weight gain ≤ 1kg. There did not appear to be any mention of the licensed status of the product. The final slide concluded that GLP-1 based therapies were highly interesting for treatment for type 2 diabetes and that GLP analogues might be made once daily treatments.

The Panel considered that the presentation promoted liraglutide when it did not have a marketing authorization. Thus the Panel ruled a breach of the Code as alleged. The title of the presentation was misleading and a breach of the Code was ruled. The presentation included comparisons with licensed medicines and could be seen as taking unfair advantage of the reputation of licensed medicines; thus a breach of the Code was ruled. The Panel did not consider that the meeting constituted the disguised promotion of liraglutide. The presentation was clearly promotional and no breach of the Code was ruled.

The Panel considered that high standards had not been maintained and ruled a breach of the Code. The Panel noted that promoting a medicine prior to the grant of the marketing authorization was an activity likely to be in breach of Clause 2. That clause was used as a sign of particular censure. The Panel ruled a breach of Clause 2.

Lilly noted that Novo Nordisk, together with an endocrine and diabetes society, was developing a local research strategy involving collaboration between centres in that area. To support this, a senior member of Novo Nordisk's sales department helped convene/facilitate the meeting, February 2009 which included discussion of liraglutide data in diabetes and obesity, the latest Levemir (insulin detemir) data, ongoing development/research projects and opportunities for collaboration in areas of pharmacological research in the local area amongst other things. Novo Nordisk extended an open invitation for any health professionals interested in participating in collaborative research projects to attend.

Lilly alleged that this was clearly a promotional meeting sponsored by Novo Nordisk as evidenced by the tacit and direct involvement of sales and marketing staff; this was acknowledged by Novo Nordisk in inter-company correspondence. Lilly queried why a member of the sales department would be involved in a meeting purporting to be focused on the information needs of 'potential and existing investigators' and where the objective was'to update [delegates] on current and future research projects'.

Lilly alleged that the discussion of liraglutide data and other medicine development/research projects and data constituted pre-licence disguised promotion of liraglutide in breach of the Code including Clause 2.

The Panel noted that few details had been provided about this meeting. A presentation about 'On going development projects' had been given. The meeting appeared to have been held in response to an unsolicited request from the society for an update on ongoing and future research projects. From the agenda all of the speakers were from Novo Nordisk. The Panel was concerned that a senior member of the company's sales department had attended, albeit by invitation. The impression that that gave was important.

The Panel examined the slides used by Novo Nordisk for the presentation 'On going development projects'. The introduction referred to insulin research and development including future insulins and products Novo Nordisk was working on. It also referred to GLP-1 development. Information was presented about a study on islet transplantation which ran from April 2009.

The Panel was concerned that based on Novo Nordisk's activities already considered above, it was possible that liraglutide had been promoted to the audience. The Panel considered that this meeting appeared to be different to the one at issue above in that it was organised by Novo Nordisk in response to a request that the meeting be held. However the complainant had the burden of proving their complaint on the balance of probabilities. The Panel considered that given all the circumstances and the limited evidence before the Panel, the meeting could be regarded as the legitimate exchange of scientific information. Delegates were invited as potential or existing investigators, not as prescribers per se. No breach of the Code was ruled including Clause 2.

Lilly alleged that a promotional diabetes network meeting in March 2009 sponsored by Novo Nordisk invited presentations and discussions about the management of type 2 diabetes and presented information and various data about liraglutide, which, at the time, was unlicensed in the UK. A significant part of the meeting was devoted to a debate 'This house believes that GLP-1 agonists (such as exenatide and liraglutide) are the best second line therapy for type 2 diabetes'. Lilly alleged that the debate involved the presentation of liraglutide data to health professionals and engaged the audience in the pre-licence discussion of liraglutide and its place in the management of type 2 diabetes alongside licensed GLP-1-based therapies such as Byetta; this misleadingly implied that liraglutide was a licensed and relevant treatment option for the management of diabetes. The meeting was attended by Novo Nordisk salesrepresentatives, which further exemplified the promotional nature of this meeting.

Lilly alleged that reference to topics on new treatment options in diabetes, the incretin system, modulators or mimetics of GLP-1, GLP-1 receptor agonists and the dipeptidyl IV receptor antagonists, stimulated a discussion on the availability of new treatments such as liraglutide thereby promoting the medicine prior to the grant of the marketing authorization. Lilly queried Novo Nordisk's assertion that only its regional medical advisor remained during the debate; this was contrary to the observations of Lilly staff who also attended.

Lilly alleged that this activity constituted the pre-licence promotion of liraglutide, it invited misleading claims and comparisons with licensed medicines and constituted the disguised promotion of liraglutide. As such it was in breach of the Code including Clause 2.

The Panel was concerned about the arrangements for the meeting. Novo Nordisk knew about the agenda about a month before the meeting. The topic of the debate that agents such as exenatide and liraglutide were the best second line therapy for type 2 diabetes was of concern given that one product had a marketing authorization and the other did not but was about to be so authorized. The title of the debate implied that both products were licensed which was not so.

The Panel noted that Novo Nordisk had denied the allegation that its sales representatives were present during the debate; Novo Nordisk submitted that only its local regional medical advisor was present. The Panel was concerned, given the title of the debate, that the regional medical advisor had attended even though Novo Nordisk submitted it had a clear lack of involvement in the debate. The Panel had similar concerns to those mentioned above. Novo Nordisk stated that the speakers were ultimately chosen by the main organiser of the meeting. There was no evidence before the Panel about the extent to which, if at all, Novo Nordisk had been able to influence or comment upon speaker selection. However Novo Nordisk had no involvement in the slide selection or topics for discussion. The Panel did not consider that Novo Nordisk's payment for an exhibition stand at the meeting meant that Novo Nordisk had sponsored the meeting and was responsible for its content. The Panel noted its concerns about the title of the debate and Novo Nordisk's knowledge thereof. However, on the evidence before it, the Panel decided that Novo Nordisk was not responsible for content of this meeting and thus no breaches of the Code were ruled including Clause 2.

The annual conference of a diabetes managed clinical network conference, April 2009 discussed various diabetes related topics by way of formal presentations and workshops and included a workshop focussing on the incretin mimetics. Lilly alleged that although this meeting was facilitatedby Novo Nordisk its sponsorship was not declared on the conference agenda. Novo Nordisk also had a promotional stand at the meeting; three of its sales representatives together with the sales manager attended the presentations and workshops which discussed incretin mimetics.

Lilly noted that in inter-company correspondence Novo Nordisk acknowledged that it 'helped fund the travel expenses of a visiting professor' and it also did not declare sponsorship of the meeting materials. This was attributed to error and the medical department not being told about the meeting.

Whilst the latter explanation offered no mitigation, Lilly queried Novo Nordisk's assertion that the professor was invited by the diabetes managed clinical network independently of Novo Nordisk. Lilly had it on good authority that the professor's input was facilitated by Novo Nordisk and that this included payment of an honorarium. This could be disclosed should it be required.

 Lilly alleged that the professor's presentation 'Emerging New therapies in Diabetes Care' involved an unbalanced discussion of Byetta and liraglutide and invited a comparison of the two. In particular, reference was made to unpublished data from Novo Nordisk's Lead 6 study, a head-to-head comparison of Byetta and liraglutide. There was no clear indication of the licensed status of liraglutide and the impression created, by association to Byetta, was that liraglutide was available and a clinically relevant treatment option.

Lilly was also disappointed that both the speaker and Novo Nordisk disparaged Byetta throughout the presentation by referring to it as 'lizard spit'. Further, the discussion of Byetta was unbalanced and relatively abbreviated compared with that on liraglutide. To compound matters the speaker also stated that Byetta was only 50% homologous in comparison to human (physiological) GLP-1; although factually correct, the context in which this was discussed implied an inferior efficacy of Byetta. The speaker also inferred that liraglutide was developed later than Byetta because Novo Nordisk had deliberately taken longer researching this medicine in a more scientific way and hence liraglutide 97% homologous with human GLP-1; the implication being that Lilly had not conducted proper scientific research leading to the development of inferior products such as Byetta.

This presentation and the attendant workshop represented the pre-licence and disguised promotion of liraglutide which was further illustrated by the discussion of data comparing reduction of HbA1c and weight loss data for Byetta and liraglutide. This was misleading as it implied, by association to Byetta, a licensed product, that liraglutide was also available and clinically relevant.

This activity constituted the pre-licence promotion of liraglutide, it invited misleading claims andcomparisons with licensed medicines and constituted the disguised promotion of liraglutide. Lilly alleged breaches of the Code including Clause 2.

Lilly alleged that it was evident that Case AUTH/2202/1/09 did not represent an isolated instance of the pre-licence promotion of liraglutide by Novo Nordisk but was part of a concerted commercially driven objective. The above examples clearly demonstrated that Novo Nordisk had consistently, intentionally and widely promoted the availability of liraglutide in the UK prior to the grant of a marketing authorization. It was also evident that Novo Nordisk's medical and sales departments had not enforced the necessary standards with regard to compliance with the Code and also, on the company's own admittance, its internal policies and procedures.

In response to a request for further information Lilly stated that the undisclosed information it had regarding the honorarium paid to the professor was obtained from a managed care network which verbally confirmed that it had been paid £800 by Novo Nordisk to cover the professor's honorarium as a speaker. The managed care network then paid the professor.

 Further, Lilly alleged that a Novo Nordisk sales representative transported the professor from the airport to the meeting and then on to another meeting; this was at odds with Novo Nordisk's position that the diabetes managed clinical network selected and invited the speaker entirely independently of the company.

The Panel noted that the professor's presentation included background information about GLP-1. A slide of a Gila Monster lizard was included and another slide headed 'GLP-1 analogues-available/in development' stated that Byetta came from Gila saliva. The next product mentioned on this slide was liraglutide with details that it was once daily. There was no distinction as to which medicines had marketing authorizations and which did not. Similarly a slide headed 'Efficacy of incretin therapeutics' unfavourably compared HbA1c and body weight loss for Byetta with that for liraglutide and included FPG decreases and HbA1c reductions for Januvia (sitagliptin) and Galvus (vildagliptin). The only product that did not have a marketing authorization was liraglutide and again no mention of this difference was made in the slides. Two other slides showed statistically significant advantages for liraglutide over exenatide in reduction of HbA1c and improvement in beta-cell function over 26 weeks. The final slides referred to the pipeline for type 2 diabetes therapy.

The Panel was extremely concerned about the arrangements for Novo Nordisk's involvement in this meeting. It was not clear from Novo Nordisk's submission whether it had paid travel expenses only or paid an honorarium as alleged by Lilly. The role, if any of a Novo Nordisk representative inproviding/facilitating transport to and from the meeting was not clear. The agenda did not refer to Novo Nordisk's sponsorship of the professor. It was unacceptable for this not to be made clear on the documentation. In this regard the Panel considered that high standards had not been maintained and a breach of the Code was ruled.

The Panel noted Novo Nordisk's submission that the meeting was arranged by the diabetes managed clinical network which had selected and invited the speaker entirely independently of Novo Nordisk. However Novo Nordisk had contributed to the costs of the professor. Companies could not fund or otherwise facilitate a speaker as a means of avoiding the requirements of the Code. Given the title of the professor's presentation 'Emerging New Therapies in Diabetes Care' and the role of Novo Nordisk, it should have seen the materials prior to the presentation. The Panel was also concerned that Novo Nordisk was unsure as to where the professor had obtained Novo Nordisk unpublished material. Novo Nordisk should have checked the position with its head office.

Taking all the circumstances into account the Panel considered that, given Novo Nordisk's role, the sponsored presentation in effect promoted an unlicensed medicine. Thus a breach of the Code was ruled. This was disguised promotion and the material was misleading and included misleading comparisons. High standards had not been maintained. Breaches of the Code were ruled.

The Panel noted that Novo Nordisk had facilitated the professor's attendance and that he had somehow been given access to the company's unpublished data on file. The company's association with the speaker should have been made clear to the delegates. Novo Nordisk's omission in this regard reduced confidence in and brought discredit upon the industry. A breach of Clause 2 was ruled.

The Panel was extremely concerned that Novo Nordisk had promoted a medicine prior to the grant of its marketing authorization on a number of occasions. There appeared, in general, to be a poor understanding of the requirements of the Code. Novo Nordisk had acknowledged that its procedures were lacking; communication at all levels within the company was inadequate. The Panel considered that the circumstances warranted reporting Novo Nordisk to the Appeal Board for it to consider the matter in accordance with Paragraph 8.2 of the Constitution and Procedure.

The Appeal Board was extremely concerned about this case; the promotion of a medicine prior to the grant of its marketing authorization was a serious matter and displayed a poor understanding of the requirements of the Code. As well as being prohibited by the ABPI Code, it was also prohibited by the EFPIA Code on the Promotion of Prescription Only Medicines to, and Interactions with, Health Professionals. Headquarters staff in Denmarkshould know about the EFPIA Code. According to Novo Nordisk the website had been subjected to regulatory and legal review. The Appeal Board was not convinced that Novo Nordisk fully understood the seriousness of the matter and was especially concerned to note that the company had recently been found in breach of the Code for promoting liraglutide prior to the grant of its marketing authorization (Case AUTH/2202/1/09).

The Appeal Board noted that as a result of the rulings in this case Novo Nordisk had instigated a major review of its compliance systems, procedures and training. Code training of headquarters' staff was soon to be conducted by teleconference although the Appeal Board queried whether this was an effective training medium, given the seriousness of the case. The Appeal Board was very concerned about the apparent lack of influence that Novo Nordisk in the UK had over its headquarters in Denmark regarding compliance of material which came within the scope of the UK Code.

The Appeal Board decided in accordance with Paragraph 11.3 of the Constitution and Procedure to require an audit of Novo Nordisk's procedures in relation to the Code to be carried out by the Authority. The audit should be conducted as soon as possible. The Appeal Board suggested that relevant staff from Denmark should be interviewed. On receipt of the audit report the Appeal Board would consider whether further sanctions, including a report to the ABPI Board of Management, were necessary. In addition the Appeal Board decided that Novo Nordisk should be publicly reprimanded.

Upon receipt of the October 2009 audit report the Appeal Board was very concerned that as demonstrated in the audit reports of 2004/05 and the current audit report, Novo Nordisk clearly lacked processes to ensure compliance with the Code. This must be a priority for all including senior staff who must take more personal responsibility. The company must be able to show that this time it could change and develop attitudes and procedures which gave strong support to compliance.

The Appeal Board noted that Novo Nordisk was due to roll out a number of new standard operating procedures (SOPs) with training on them to commence early in 2010. This timeframe had been extended since the audit. The Appeal Board decided in accordance with Paragraph 11.3 of the Constitution and Procedure to require a further audit of Novo Nordisk's procedures in relation to the Code to be carried out by the Authority. The audit should be conducted in March 2010 when the Appeal Board expected Novo Nordisk's awareness of the Code and processes including the SOPs to be much improved and more embedded within the company. The re-audit in this case would take place at the same time as the audit required in Case AUTH/2269/9/09. On receipt of the audit report the Appeal Board would decide if furthersanctions were necessary.

Upon receipt of the March 2010 audit report the Appeal Board considered that Novo Nordisk's progress was not sufficiently rapid. It still had serious concerns about the company's approach and attitude to the Code. There were still significant problems with certification. Not all the standard operating procedures (SOPs) had been completed and trained out. This was now due to happen at the May sales conference (other than the SOP for medical and educational goods and services).

Overall, the Appeal Board considered that Novo Nordisk still did not appear to appreciate the seriousness of the situation. The Appeal Board considered requiring Novo Nordisk to submit material for pre-vetting as set out in Paragraph 11.3 of the Constitution and Procedure and/or report the company to the ABPI Board of Management. The Appeal Board decided to require another audit in June/July. On receipt of that audit report the Appeal Board would decide whether further sanctions, such as pre-vetting and/or a report to the ABPI Board were necessary.

Upon receipt of the July 2010 audit report the Appeal Board was concerned that it had taken some time but considered that significant progress had now been made. This must be maintained. The Appeal Board considered carefully all the options available noting that it had already decided that both cases (Cases AUTH/2234/5/09 and AUTH/2269/9/09) should be the subject of a public reprimand. It decided that no further action was necessary.