AUTH/3027/3/18 - Voluntary admission by Sunovion

Working with Patient Organisations

  • Received
    16 March 2018
  • Case number
    AUTH/3027/3/18
  • Applicable Code year
    2016
  • Completed
    11 July 2019
  • Additional sanctions
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  • Appeal
    No appeal
  • Review
    Published in the May Review 2020 See also November 2018 Review

Case Summary

Sunovion Pharmaceuticals Europe voluntarily admitted a breach of the Code in relation to its failure to disclose support to patient organisations as required by the Code and the provision of inaccurate information to the PMCPA.

As Paragraph 5.6 of the Constitution and Procedure required the Director to treat a voluntary admission as a complaint, the matter was taken up with Sunovion.

Sunovion admitted that in its comments on the PMCPA audit report in relation to Case AUTH/2935/2/17 it had stated that it had not worked with any patient organisations. However, the company regretted that it had now found this not to be so. In 2016, Sunovion entered in to an agreement with a registered charity supporting patients with mental health problems. In September 2016 and June 2017 Sunovion paid the patient organisation to support administration and general running costs. In addition, Sunovion paid for the development of an early intervention guide for patients with schizophrenia and their families. Part of this was paid in October 2016 and the remaining amount in February 2017. The support provided was declared on the company's website from 15 March 2018.

The detailed response from Sunovion is given below.

The Panel noted that the Code required, inter alia, that each company must make publicly available, at a national or European level, a list of patient organisations to which it provided financial support and/or significant indirect/non-financial support, which must include a description of the nature of the support that was sufficiently complete to enable the average reader to form an understanding of the significance of the support. The list of organisations being given support must be updated at least once a year. The relevant supplementary information stated that companies were encouraged to be prepared to make available up-to-date information about such activities at any time in response to enquiries.

The Panel acknowledged that it was not entirely clear whether as a minimum companies could update their lists on a certain date once a year covering the previous twelve months of payments in which case no payment would ever be disclosed more than twelve months after it was made or whether the annual update could be by no later than the 31 March each year in relation to payments made in the previous calendar year. This latter approach would be consistent with the relevant supplementary information in the 2012 edition of the Code and similar to the permitted approach when disclosing transfers of value under the Code. The Panel noted that as a minimum the published list of patient organisations had to be updated annually.

The Panel considered that the approach adopted by a company should be made clear on its website. Sunovion made no submission in this regard. The Panel considered it prudent and good practice for a company to update its list as soon as reasonably possible and noted that the relevant Clause referred to updating the list at least once a year.

The Panel noted that Sunovion had paid a patient organisation in October 2016 to support administration and general running costs. A copy of the certified agreement covering the payment in 2016 was provided. The agreement also covered payments in 2017 and 2018, but neither of these payments had been made contrary to the company's disclosure on 15 March 2018. That disclosure was updated on 27 March.

The Panel noted that in addition Sunovion had paid for the development of an early intervention guide for patients; part of this was paid in October 2016 and the remaining amount was paid in February 2017. The Panel noted Sunovion's submission that there was no written agreement to cover this payment and that the amount of support was less than that originally thought and disclosed on 15 March 2018 and was therefore updated on 27 March 2018.

The Panel noted the ambiguity of the Clause which covered disclosure of payments to patient organisations as described above but considered that regardless of the approach taken the two 2016 payments had not been disclosed as required by the Code and a breach of the Code was ruled in relation to both 2016 payments.

The Panel noted that the incorrect February 2017 payment was disclosed by 15 March 2018 and updated on 27 March 2018 to accurately reflect the amount actually paid. The Panel noted the ambiguity of the relevant Clause and considered on balance that disclosure prior to 31 March the following calendar year was not unacceptable and ruled no breach of the Code in relation to the 2017 payment.

The Panel noted the sensitivities surrounding the pharmaceutical industry working with patient organisations; robust agreements setting out the arrangements, and certification of those agreements were important steps in ensuring that such interactions complied with the Code and in that regard they underpinned the self-regulatory compliance system. That projects and sponsorship were able to go ahead without a certified agreement in place was unacceptable. Further, public disclosure of support was an important means of building and maintaining confidence in the industry. The Panel noted that Sunovion had sponsored the development of an early intervention guide without first having a certified agreement in place and the company's support for the patient organisation in 2016, was not properly disclosed until March 2018. Whilst a certified agreement was in place for the separate payment to the patient organisation in 2016 overall the Panel considered that high standards had not been maintained. A breach of the Code was ruled.

The Panel was further concerned that the information provided in response to the PMCPA's audit report was incorrect and further that only in response to the case preparation manager's request for further comments, did Sunovion discover that the amount of financial support paid was less than stated in its initial voluntary admission. This, coupled with the fact that there was no certified agreement for one payment, in the Panel's view, indicated that there was poor governance and control of materials. 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 let to the company being audited, Case AUTH/2935/2/17. The Panel considered that Sunovion had brought discredit upon or reduced confidence in the industry and therefore the Panel ruled a breach of Clause 2.

Sunovion provided the requisite undertaking and assurance and the Appeal Board received the case report as set out in Paragraph 13.4 of the Constitution and Procedure.

The Appeal Board noted the Panel's rulings of breaches of the Code regarding the voluntary admission from Sunovion about disclosure of payments made to patient organisations. The Panel had considered it was a serious matter.

The Panel's concerns included that the information provided in response to the PMCPA's audit report in another case concerning Sunovion, Case AUTH/2935/5/17 was incorrect. Further only in response to the case preparation manager's request for further comments in Case AUTH/3027/3/18 did Sunovion discover that the amount of financial support paid was less than stated in its initial voluntary admission. This coupled with the fact that there was no certified agreement for the payment of £2,750 in the Panel's view indicated that there was poor governance and control of materials. 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 Case AUTH/2935/2/17.

The Appeal Board considered that Case AUTH/3027/3/18 raised serious issues including about the provision of incomplete and/or inaccurate information. The Appeal Board was of the view that consideration should be given to imposing further sanctions under Paragraph 11.1 of the Constitution and Procedure.

The company was advised that the Appeal Board was considering imposing additional sanctions and asked to respond in writing, as well as be given the opportunity to appear before the Appeal Board when the matter was considered. Sunovion was provided with a copy of the papers.

The detailed comments from Sunovion about the possible imposition of further sanctions is given below.

The Appeal Board noted that the company had apologised and admitted that it had made errors.

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 decided that in accordance with Paragraph 11.3 of the Constitution and Procedure, Sunovion should be publicly reprimanded for providing inaccurate information to the PMCPA.

Following consideration of the re-audit report and Sunovion's comments on it the Appeal Board's decision to require a further re-audit in Case AUTH/2935/2/17, the Appeal Board decided that the issues that had arisen in Case AUTH/3027/3/18 should the subject of an audit which would take place April 2019 at the same time as the re-audit in Case AUTH/2935/2/17. On receipt of the report of the audit the Appeal Board would consider whether further sanctions were necessary.

Sunovion was audited in April 2019 and on receipt of the report of the audit in July 2019 the Appeal Board noted that there had been significant progress at Sunovion since the re-audit in June 2018 in Case AUTH/2935/5/17. The Appeal Board noted that Sunovion had a compliance action plan to address recommendations from the re-audit. The Appeal Board noted some actions were already completed and that others were due to be completed very shortly. On the basis that this work was completed, the progress shown to date was continued and a company-wide commitment to compliance was maintained, the Appeal Board decided that no further action was required.