AUTH/3505/4/21 - Complainant v Britannia

Concerns about advisory boards and nursing service

  • Received
    19 April 2021
  • Case number
    AUTH/3505/4/21
  • Applicable Code year
    2019
  • Completed
    21 September 2021
  • No breach Clause(s)
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

An anonymous ex-employee complained about Britannia’s advisory boards for Lecigon (levodopa/carbidopa/entacapone), a new intestinal gel therapy for advanced Parkinson’s disease and nursing service.

The complainant stated that not all staff were aware of a previous complaint about Britannia advisory boards and it would make sense for employees to have an awareness so that mistakes were not repeated. He/she assumed the lack of transparency was so that profitable practices were continued, although not compliant.

The complainant alleged that when preparing the UK plans for the Lecigon launch, his/her colleagues in sales and marketing plannedadvisory boards, with minimal medical input, branded the advisory meetings as ‘EVOKE’ (a marketing term) and arranged multiple meetings when one would do. Further alleging that the company attempted to use the key account managers for advisory board facilitation and involvement in a multinational clinical trial to build advocacy.

The complainant stated that he/she had also raised concerns that Britannia’s nursing service was compromised by associating closely with the sales team. The sales team was planning on using data from the nursing service to enable sales/targeting for Lecigon (as part of the UK brand plan). This was already the case for APO-go.

The nursing platform was under the administration of the sales function rather than entirely within medical to prevent any possible compromise (perceived or otherwise) of patient data.

The complainant stated that he/she was concerned that his/her ex-employer did not take the Code or patient data seriously. He/she was also confused about the intent of not disclosing challenges and informing the broader organisation of any lessons learned. The complainant proposed that the PMCPA invite Britannia’s management to comment on the lack of compliance and adherence to the Code.

The detailed response from Britannia is given below.

The Panel noted the submission from Britannia as to the reasons for the advisory boards. The Panel then went on to consider the arrangements relevant to the allegations for each of the two advisory boards.

The Panel noted that Lecigon was a new product for Britannia. It was described as a new gel formulation therapy for people with Parkinson’s disease which was a therapeutic area where Britannia already had products.

Turning to the allegations made by the complainant, the Panel did not consider it was necessarily a breach of the Code if all staff were not aware of a previous relevant case as alleged. Clearly a company ruled in breach of the Code needed to provide the requisite undertaking and take all possible steps to avoid a similar breach of the Code in the future. Britannia submitted that it had provided details of the previous case to all relevant staff.

Britannia provided a copy of the launch plans which it stated were created by sales and marketing and explained that during its internal interviews there was reference made to an employee previously employed in medical being involved with the development, however, it was unable to confirm this involvement as the individual was no longer an employee.

With regard to the number of advisory boards, the Panel noted that the Medical Marketing Lecigon launch plan referred to a further two advisory boards but there was no evidence before the Panel with regard to whether these advisory boards had or were still to go ahead. The Panel noted Britannia’s submission that it had held two advisory boards in 2021 related to Lecigon which were justified as insights were required from both payors and key opinion leaders.

With regard to the complainant’s concern that colleagues in sales and marketing began planning advisory boards, with minimal medical input, the Panel noted Britannia’s acknowledgement that the presence of the proposed advisory boards within the Lecigon launch plans could be construed as being sales and marketing led and as such it had not maintained high standards in breach of the Code. The Panel noted, however, that it was not necessarily a breach of the Code to plan advisory boards with minimal medical input as alleged. The Panel noted Britannia’s submission that there was sales and marketing involvement in the early meetings regarding defining insights required, however, once these insights and objectives were defined, these individuals no longer attended any project meetings. The Panel noted Britannia’s submission that advisory board meetings initially proposed within the Lecigon internal launch plans were developed and led by medical with compliance oversight.

According to Britannia, the advisory board for payors was led by a Britanniacommercial employee as the objective was to gather insight and advice from NHS England payors with regards to the best funding and reimbursement pathway for Lecigon. The advisory board in May 2021 was instigated by a medical employee who had left the company when it was passed to a medical contractor. The Panel further noted Britannia’s submission regarding the attendance of various employees including marketing at various meetings including the payors advisory board.

The Panel did not consider that the complainant had established, on the balance of probabilities, that the arrangements for the two advisory boards were unacceptable with regard to the involvement of sales and marketing or the number of advisory boards and thus consultants contracted. No breach of the Code was ruled in relation to each advisory board based on the complainant’s specific allegations.

The Panel noted Britannia’s submission that it found no evidence of the two advisory boards held being part of the ‘EVOKE’ series as alleged and that no key account managers were present at either of the advisory boards nor were they involved in the facilitation or organisation of the meetings. The Panel considered that the complainant had not established, on the balance of probabilities, that the advisory board constituted disguised promotion in that regard as alleged and no breach was ruled.

The Panel noted its rulings above and consequently ruled no breaches of the Code including of Clause 2.

With regard to the nursing service, the Panel noted that, again, the complainant had not provided evidence that the nursing service data was compromised.

The Panel noted Britannia’s explanation that it used two software solutions, the first was the bespoke Nurse database and the second was the dashboard solution which was used by Britannia’s sales and customer service teams. The systems were not interlinked and were independent of each other; users did not have access to both systems.

The Panel was concerned that the service was under the administration of the sales function, with a commercial employee approving requests for users for the nurse database and being the internal budget holder. Britannia acknowledged that this was not ideal and planned to see if it could be reallocated to a member of the medical team to manage. It noted Britannia’s submission that the nurse service provided ongoing support to Parkinson’s disease patients once they had been selected for Apo-go therapy and that patient data was recorded by the nursing team. Britannia submitted that the nursing service operated independently from the sales team and commercial functions of the business. The Panel further noted Britannia’s submission that the sales team did not have access to nor were they able to view or utilise any data from the nurse database to aid targeting. No evidence had been provided to the contrary by the complainant.

The Panel did not consider that the complainant had provided evidence to show that the nurse service was inappropriately associated with the sales team or that the sales team planned on using data from the nursing service to enable sales/targeting for Lecigon (as part of the UK brand plan). The Panel therefore ruled no breaches of the Code including Clause 2.