Public reprimand for Sunovion

• Date posted
  17 December 2018
• Sanction
  Public reprimand,
• Case number/s
  AUTH/3027/3/18 - Voluntary admission by Sunovion

Sunovion Pharmaceuticals Europe Ltd has been publicly reprimanded by the Code of Practice Appeal Board for providing inaccurate and misleading information to the PMCPA (Case AUTH/3027/3/18).

In Case AUTH/3027/3/18, the Panel ruled breaches of the Code following a voluntary admission from Sunovion that it had failed to disclose and document its interactions with patient organisations to which it provided financial support and/or significant indirect/non-financial support. Sunovion accepted the Panel’s rulings and provided the requisite undertaking.

During its consideration of this case, the Panel was concerned to note that the information provided in response to the PMCPA’s audit report required in Case AUTH/2935/2/17 was incorrect and further, that only in response to the case preparation manager’s request for further comments did Sunovion discover that it had made errors in its initial voluntary admission in Case AUTH/3027/3/18. The Panel noted that self-regulation relied, inter alia, upon the provision of complete and accurate information and that Sunovion had already been criticised for not providing accurate information in the case that led to the company being audited, Case AUTH/2935/2/17.

On receipt of the case report for Case AUTH/3027/3/18, as set out in Paragraph 13.4 of the Constitution and Procedure, the Appeal Board considered that this case raised serious issues including about the provision of incomplete and/or inaccurate information and that the imposition of additional sanctions under Paragraph 11.1 should be contemplated.

At its subsequent consideration of the matter, the Appeal Board was concerned that due to poor judgement
and/or absence of the necessary process, the company had made a series of errors about its disclosure of payments in its responses to the PMCPA including during the re-audit required in Case AUTH/2935/2/17 in which it had already been criticised for not providing accurate information. Notwithstanding Sunovion’s submission that it now had a process in place to ensure such errors did not recur, the Appeal Board noted that self-regulation relied, inter alia, upon the provision of complete and accurate information from pharmaceutical companies.

The Appeal Board also decided to require an audit of Sunovion’s procedures in relation to the Code to take place at the same time as the re-audit in relation to Case AUTH/2935/2/17 and, on receipt of the report the Appeal Board, would consider whether further sanctions were necessary.