AUTH/2861/7/16 - Anonymous v Bristol-Myers Squibb

Promotion of Daklinza

  • Received
    29 July 2016
  • Case number
    AUTH/2861/7/16
  • Applicable Code year
    2016
  • Completed
    02 September 2016
  • No breach Clause(s)
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    November 2016 Review

Case Summary

​An anonymous, non-contactable complainant complained about the promotion of Daklinza (daclatasvir dihydrochloride) by Bristol-Myers Squibb Pharmaceuticals at a conference in June 2016. Daklinza was indicated in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults.

The complainant explained that the event covered all aspects of care including not only clinicians but also non-clinical and non-NHS delegates from many parts of the care community including the public providing volunteer care work.

The complainant attended a presentation in the keynote lecture theatre on day 1 that was open to all delegates including non-medical attendees and the public. A promotional piece for Daklinza, a prescription only medicine was put on every seat in the room. The complainant stated that such behaviour brought the industry into discredit as the meeting room was for education and not promotion. The complainant alleged that a prescription only medicine had been promoted to the public. This was a very serious breach.

The detailed response from Bristol-Myers Squibb is given below.

The Panel noted that the Code applied to the promotion of medicines to members of the United Kingdom health professions and to other relevant decision makers. 'Other relevant decision makers' was defined as particularly those with an NHS role who could influence in any way the administration, consumption, prescription, purchase, recommendation, sale, supply or use of any medicine but who were not health professionals.

The Panel noted that the conference was a specialist meeting not aimed at the public. It was described as an integrated care conference that enabled health and social care professionals to forge new partnerships and productive ways of working. It brought the NHS and local authorities together and represented the largest annual gathering of commissioners, providers and their suppliers. Delegates were described as senior managers or higher although this was not necessarily clear from examination of the delegate list. It was made up of four events and was described as a trade-only event targeting health professionals and more specifically NHS payors and commissioners. The Panel noted that the show also targeted those involved in home and residential care. The marketing to potential delegates was stated to be via professional trade publications and websites. Consumers and direct patients were refused entry.

The leavepiece at issue was put on the seats for the attendees of five non sponsored sessions.

The sessions were identified in advance and agreed verbally between Bristol-Myers Squibb and the organisers where it was considered that stakeholders would find the information regarding the National Institute for Health and Clinical Excellence (NICE) approval relevant.

The Panel noted that the complainant was concerned about the distribution of the leavepiece at a presentation on day 1 in the keynote lecture theatre. The presentation was not identified by the complainant. The Panel noted that the leavepiece was circulated at three presentations on that day, one in the keynote debate theatre 'Integrated care, what does it actually mean?' and the others in the Future of Clinical Commissioning Theatre and Medicines Optimisation Congress. The Panel noted the status of the audience on day 1 as set out in the delegate list. Although the Panel queried some of those listed, the majority were either health professionals or had a professional interest in healthcare such that, on the balance of probabilities, they appeared to meet the definition of other relevant decision makers. The nature of the identified sessions on day 1 would be clearly aimed at health professionals and/or other relevant decision makers. The Panel noted that the complainant had to establish that the attendees of the presentation that he/she referred to were other than health professionals and other relevant decision makers. The complainant had submitted no evidence in this regard. The Panel did not consider that providing the leavepiece to the attendees at the sessions on day 1 constituted advertising a prescription only medicine to the public as alleged. The Panel therefore ruled no breach of the Code.

The Panel was concerned that the relevant sessions for distribution of the material were agreed verbally; there were no written details about the arrangement or confirmation of any compliance assessment. Nonetheless, given its ruling of no breach, the Panel did not consider that Bristol-Myers Squibb had failed to maintain high standards nor had it brought discredit upon the pharmaceutical industry and ruled no breach of the Code including Clause 2.