Public reprimand for Pharmamar

• Date posted
  01 February 2018
• Sanction
  Public reprimand,
• Case number/s
  AUTH/2979/9/17 - Anonymous, non-contactable complainant v PharmaMar

PharmaMar has been publicly reprimanded by the Code of Practice Appeal Board for failing to make any meaningful effort to undertake a thorough investigation
and to provide evidence to support its position in relation to being found in breach of the Code for the promotion of Yondelis (trabectedin) for an unlicensed indication. Such an approach raised grave concerns about the importance attached to compliance and self-regulation by the company (Case AUTH/2979/9/17).

In Case AUTH/2979/9/17 the Panel ruled breaches of the Code including Clause 2 as PharmaMar was responsible for a Meeting Highlights document from the 13th annual conference of the British Sarcoma Group (BSG) that promoted Yondelis (trabectedin) for an unlicensed indication. The Panel was extremely concerned about the conduct of senior employees and the lack of procedures for certification and it reported PharmaMar to the Appeal Board.

On consideration of that report the Appeal Board considered that this case raised serious concerns about PharmaMar’s processes and Code knowledge. The Appeal Board queried how such a fundamental failure of compliance on what should be well understood principles of the Code could occur. The Appeal Board considered that PharmaMar’s investigation into this issue was wholly inadequate. The Appeal Board considered that the level of Code expertise within the company appeared to be very poor given the fundamental errors and the company’s apparent lack of preparation for the report.

The Appeal Board also decided to require an audit of PharmaMar’s procedures in relation to the Code and to require PharmaMar to issue a corrective statement to all attendees to the BSG conference and its organisers.