Clifford Chance

The Association of the British Pharmaceutical Industry (ABPI) is a major trade association for the British pharmaceuticals industry. The ABPI represents companies involved in the research, development and use of new medicines in the UK. The ABPI's Code of Practice for the Pharmaceuticals Industry (Code) sets out the requirements that the pharmaceuticals industry must comply with, and it supports companies' commitment to self-regulation and to operate in a professional, ethical and transparent manner.

The Code defines the UK industry standards for the promotion of prescription medicines to health care professionals (HCPs) and all ABPI members are required to comply with the Code. The Prescription Medicines Code of Practice Authority (PMCPA) is the self-regulatory body which administers the Code, albeit independently of the ABPI. The PMCPA is responsible for the provision of advice, guidance and training on the Code as well as the operation of the complaints procedure under which the materials and activities of pharmaceutical companies are considered in relation to the Code's requirements.

In March 2023, following an extensive investigation and appeals process conducted by the PMCPA, the ABPI Board decided to suspend Novo Nordisk as a member of the ABPI for two years due to serious breaches of the Code – only the eighth occasion of such a significant sanction being handed out in the past 40 years. In particular, Nordisk had failed to comply with the Code in its sponsoring of a third-party course for the provision of weight management services and related Patient Group Direction (PGD).

Background

Sometime in 2021, a third party (the "Provider") posted a LinkedIn update stating:

‘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].’

Through registration via the link in the LinkedIn post, the Provider offered (1) a webinar/e-learning training course on "how to provide a weight management service"; and (2) a one-year PGD to prescribe Saxenda.

Nordisk-sponsored the cost per attendee (worth £13.70 per attendee on Nordisk's estimations) between February 2020 and December 2021. The cost to a health care practitioner of independently sourcing an equivalent PGD was estimated at £79 per HCP. The LinkedIn post did not refer to Nordisk or Saxenda, although on clicking through, the Provider's website did state that the advertised course was sponsored by Nordisk.

The training course materials contained 21 slides of content relating to the GLP1-RA class of drugs for the treatment of obesity – of which Nordisk's Saxenda was the only product available in the UK at the time. Slides described other classes of drugs, but emphasised their side-effects compared to Saxenda. Further slides described how to assess eligibility for Saxenda. The Sponsorship Agreement between Nordisk and the Provider also provided that Nordisk personnel had a right of attendance at training meetings and would be given delegates' details for follow-ups.

The Complaint

The PMCPA requested Nordisk to consider its compliance with the following clauses of the 2019 version of the Code (the 2021 version of the Code not having been in effect at the time of the incident):

• Clause 2: Activities or materials associated with promotion must never bring discredit upon, or reduce confidence in, the pharmaceutical industry.
• Clause 4.1: Promotional material must contain the Code-mandated prescribing information.
• Clauses 9.10; 12.1, 22.4: Material and activities sponsored by a pharmaceutical company must clearly indicate they have been sponsored and not be disguised.
• Clause 18.1: No gift, pecuniary advantage or benefit may be supplied, offered or promised to HCPs in connection with the promotion of medicines or as an inducement.

Nordisk's Response

Nordisk denied any breach of the Code. In particular, Nordisk's position was that the sponsorship of both the training and PGD were carried out on an arm's length basis and as such were not promotional activity for which Nordisk was responsible under the Code.

The Provider had been offering training on weight management services independently since at least 6 months prior to the date of the sponsorship agreement with Nordisk, and Nordisk did not have any direct input into the contents of the training other than to check for accuracy. Equally, Nordisk had no input nor could it determine who requested or received the PGD. Nordisk also stated that it had no control over or awareness of the allegedly offending LinkedIn post, and in any event the external (linked-to) website contained a clear declaration of Nordisk's involvement.

The PMCPA Panel's conclusions

The Panel dismissed Nordisk's submissions that it had supported both activities (i.e. the training course and the PGD) at arm's length. The Panel found that Nordisk's ability to verify the contents of the slides (even if only for accuracy), attend training events and follow-up with delegates showed the sponsorship was not at arm's length. Nordisk appealed the Panel's conclusions.

The PMCPA Appeal Board's Findings

Course sponsorship

The Appeal Board noted that for sponsored training to escape the governance of the Code, "the arrangements must be such that there can be no possibility that the pharmaceutical company has been able to exert any influence or control over the final content of the material."

Factors which might mean there had not been a strictly arm’s length arrangement would include, but not be restricted to:

• Initiation of the material, or the concept for it, by the pharmaceutical company.
• Influence from the pharmaceutical company on the content/balance/scope of the material.
• Choice/or direct payment of the authors by the pharmaceutical company.
• Influence from the pharmaceutical company on the list of persons to whom the material is sent.

The fact that the course had been established before Nordisk entered into a sponsorship agreement with the Provider and that the materials were prepared by the Provider did not exclude application of the Code. Clauses 9.10 and 22.4 of the Code were therefore found to have been breached due to insufficient indication that materials were sponsored, as was Clause 12.1 (no disguised promotions). Further, Clause 9.1 (high standards / lack of certification) and Clause 4.1 (lack of prescribing information) of the Code had been breached too.

PGD sponsorship

The Appeal Board found that Nordisk's covering the cost of the PGD was "clearly linked to the promotion of Saxenda" and amounted to a benefit to the HCPs receiving it. As such, it was found to be an inducement to prescribe, supply, administer, and/or recommend Saxenda – and the Panel therefore ruled a breach of the Code 18.1.

Further, the Appeal Board found that the LinkedIn post promoting the training course (i.e. the webinar and e-learning) constituted, in effect, promotional material for Saxenda for which Nordisk was responsible. Although the post itself did not mention Nordisk nor Saxenda, it was possible for material to be promotional without mentioning a product by name.

Under Clause 14 of the Code, promotional materials covered by the Code must not be issued unless their final form has been certified on behalf of the company. As the post had not been certified, the Panel had identified a breach (although as the case manager had not raised Clause 14, the Panel found a breach of Clause 9.1 relating to high standards). Additionally, Clause 4.1 of the Code was breached given that the LinkedIn post did not contain the required prescribing information.

Finally, Clauses 9.10 and 22.4 of the Code were found to have been breached, as the post and external (linked-to) website did not sufficiently or at all in the case of the LinkedIn post, declare that they were sponsored material.

Overall impact

Most seriously, the Appeal Board found that the emphasis on Saxenda in the training materials, the failure to consider other pharmacological options in those materials, and the existence of the PGD inducement, showed that the training was "in reality focussed on how to set up and profit from a Saxenda weight management service." "The lack of fair balance or discussion of established treatment options represented provision of unbalanced and misleading content as to the management of weight." This was sufficient to bring discredit on and reduce confidence in the pharmaceutical industry – and so amounted to a breach of Clause 2 of the Code.

Sanctions

The Appeal Board determined that Nordisk should be publicly reprimanded and referred Nordisk to the ABPI Board, which considered the case and required a further detailed audit. Following the audit of Nordisk's compliance processes in relation to the Code, the ABPI Board suspended Nordisk's membership for two years (which means that Nordisk continues to be subject to the Code and the PMCPA's jurisdiction, but it will not be able to access the wider benefits of ABPI membership).

In order to resume full membership, Nordisk will need to show sustained improvement and demonstrate a return to industry compliance standards, including through the submission of quarterly updates to the ABPI Board on the progress made against an overall improvement plan.

Key Takeaways

Suspensions from the ABPI are rare, and the application of such a heavy sanction reflects the seriousness with which the ABPI Board views failures to comply with the Code.

The decision reflects both the fact that the Appeal Board considered the training given was not in the best interest of patients, being too focused on Saxenda prescriptions, and that Nordisk did not at any stage during the investigations and appeals process accept any fault. Equally, however, there are certain findings that may place pharmaceutical companies in a difficult position with respect to the balance of an educational versus promotional program: for example, Nordisk was found to be at fault because it had the right to review content of slides (i.e. for having any control over their content), but equally was at fault for not certifying a LinkedIn post.

Further, it would appear that had Nordisk admitted fault at an earlier stage in the process, and identified remedial steps, the sanction may have been less severe although again this presents a balancing act where a pharmaceutical company is reasonably entitled to defend its actions as opposed to accepting a liability.

The decision is an important reminder on the importance of ensuring robust arm's length provisions when entering into sponsorship arrangements with third parties, and the desirability of appropriate contractual provisions to ensure that third party agents are also mindful of the Code when working on behalf of pharmaceutical companies.