AUTH/3261/10/19 - Complainant v Novo Nordisk

Alleged conduct of medical employees

  • Received
    12 October 2019
  • Case number
    AUTH/3261/10/19
  • Applicable Code year
    2019
  • Completed
    03 April 2020
  • No breach Clause(s)
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

A contactable individual complained about the conduct of regional medical advisors from Novo Nordisk. The complainant stated that the regional medical advisors were supposed to be reactive to clinicians but at Novo Nordisk they proactively asked representatives to take them into meetings even though they had not been invited. The complainant alleged that meetings conducted and booked by the representatives were normally held by the medical advisor and the representatives were also present. The medical advisor seemed to be doing more of the selling which the complainant stated was in absolute violation of any medical staff he/she had ever worked with. The complainant alleged that the medical advisors were given call rates by senior managers. They were under pressure to see a certain number of customers a day and had meeting targets. This made them pressure the representatives to get them to attend meetings with them. There was no clear line whether the meetings were reactive medical or promotional and proactive.

The complainant submitted that most people felt very uncomfortable with what the medical advisors were doing but senior management took no notice. The complainant stated that never in his/her career in the pharmaceutical industry had there been so much promotional activity by medical advisors and such pressure by them on the representatives to take them into every meeting whether the customer had requested their presence or not.

The detailed response from Novo Nordisk is given below.

The Panel noted that the complainant had the burden of proving his/her complaint on the balance of probabilities. All complaints were judged on the evidence provided by the parties. The complainant had made detailed allegations but provided little evidence in support.

The Panel noted that the Code defined promotion as any activity undertaken by a pharmaceutical company or with its authority which promoted the administration, consumption, prescription, purchase, recommendation, sale, supply or use of its medicines. A representative was defined as calling on members of the health professions and other relevant decision makers in relation to the promotion of medicines. This was a wide definition and could cover the activities of those employees that companies might not call representatives.

The Panel disagreed with Novo Nordisk’s submission that the regional medical advisor team was non-promotional and was not provided with any promotional materials to use with health professionals.

The Panel noted that given the regional medical advisor’s role and the broad definition of promotion in the Code there was a possibility that their interactions with health professionals etc, especially those initiated by the company, might be considered promotional. The Panel noted that the status of each such interaction should be considered on its individual merits.

The Panel noted that the briefing document for the regional medical advisors stated that RMAs have a predominantly non-promotional role. It stated that on-licence/label discussions could occur with both diabetes care specialists (sales representatives) (DCS)/diabetes outcome directors (DOD) and regional medical advisors present. The briefing further stated that a regional medical advisor could present proactive, on-licence data at a DCS arranged meeting and that this would be a promotional activity. The example of the pre-approved presentation used by the regional medical advisors provided was a presentation on the management of hyperglycaemia in type 2 diabetes . Slides included the indications for Victoza (liraglutide), Tresiba (insulin degludec), Levemir (insulin detemir) and Ozempic (semaglutide) as well as prescribing information.

In the Panel’s view part of Novo Nordisk regional medical advisor’s role was promotional. The Panel noted that whilst this was not necessarily unacceptable, provided it was done within the requirements of the Code, companies would need to be extremely careful to ensure that such promotional activity was very clearly separated from the non-promotional role of a medical and scientific liaison executive and the like and that the distinction must be clear to health professionals. The Code did not prohibit MSLs and the like from promoting medicines as such.

The Panel noted Novo Nordisk’s submission that there were times where a regional medical advisor might visit a health professional with a representative; such occasions were not routine and a legitimate need was required for the joint visit to take place.

The Panel further noted Novo Nordisk’s submission that meetings might be arranged by a representative where the regional medical advisor would present on licence data and use pre-certified slides but it was always made clear at these meetings that such presentations were being made by a regional medical advisor. The Panel did not consider such proactive presentations by Novo Nordisk staff could be anything other than promotional.

The Panel noted that the complainant bore the burden of proof and had not established that any of these meetings constituted disguised promotion. No breach of the Code was ruled.

The Panel noted that representatives must at all times maintain a high standard of ethical conduct in the discharge of their duties and must comply with all relevant requirements of the Code. The Panel noted that on the evidence before it the complainant had not established, on the balance of probabilities, that a regional medical advisor had pressurised representatives to book and take them to most meetings or had acted in a manner which was contrary to this requirement and based on the narrow allegation, the Panel ruled no breach of the Code.

The Panel noted Novo Nordisk’s initial submission that it was categorically untrue that regional medical advisors were given call rates by senior management or were under pressure to see a certain number of customers a day. The regional medical advisor team was not set call or contact rate targets.

The Panel noted Novo Nordisk’s submission that the regional medical advisors were expected to have regular non-promotional interactions with health professionals which might include responding to enquiries. Part of the role was also to act as an expert speaker, similar to an external key opinion leader, at meetings with groups of health professionals (details were provided of the number of meetings per month on average). According to Novo Nordisk this was a suggested activity level and was not a target on which performance was based and was not linked to remuneration or bonus.

The Panel further noted Novo Nordisk’s subsequent submission in response to a request for further information that there was a suggested minimum activity level of interactions with health professional per month (details provided). According to Novo Nordisk this was not a target on which performance was based and was not linked to remuneration or bonus and such an interaction was likely to occur following a request by a health professional to respond to a specific enquiry, to gauge interest in clinical trial participation or as a result of a presentation given.

The Panel accepted that there was a difference between a target for performance on which a bonus was paid and a suggested minimum activity. Employees would be motivated to meet their suggested activity levels.

The Panel noted that the complainant bore the burden of proof and had not established that the suggested minimum activity levels as described by Novo Nordisk were such that they were in breach of the requirements of the Code.

The Panel noted its comments and rulings above and on balance did not consider that there was evidence to show that based on the specific allegations Novo Nordisk had failed to maintain high standards. The Panel therefore ruled no breach of the Code including Clause 2.