AUTH/3375/8/20 - Voluntary admission by Daiichi-Sankyo

Breach of undertaking

  • Received
    28 August 2020
  • Case number
    AUTH/3375/8/20
  • Applicable Code year
    2019
  • Completed
    12 February 2021
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
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  • Appeal
    No appeal

Case Summary

Daiichi-Sankyo UK Ltd voluntarily admitted that it had breached its undertaking in Case AUTH/3285/12/19 in that further transfers of value had not been included in the company’s submissions to Disclosure UK. The transfers of value related to a therapy review service provided via a third-party to general practices. The relevant data had been collated but not submitted. The matter had come to light as Daiichi-Sankyo prepared for the audit required by the Appeal Board in Case AUTH/3285/12/19.

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 Daiichi-Sankyo.

The detailed response from Daiichi-Sankyo is given below.

The Panel noted that in Case AUTH/3285/12/19 Daiichi-Sankyo had been ruled in breach of the Code for under-reporting transfers of value in relation to support given to health professionals to attend conferences in 2016, 2017 and 2018 and for failing to have adequate processes in place to correctly disclose such transfers of value; the Panel in that case had been extremely concerned as to the scale of under-reporting and Daiichi-Sankyo’s inadequate processes in that regard and further breaches of the Code were ruled.

Turning to the current case, the Panel noted Daiichi-Sankyo’s submission that transfers of value of around £800 000 to healthcare organisations in 2017, 2018 and 2019 in relation to therapy reviews were missing from its Disclosure UK submissions in 2018, 2019 and 2020, respectively.

The Panel considered that the information published on Disclosure UK when the voluntary admission was submitted in August 2020 was not comprehensive in relation to 2017 and 2018 transfers of value provided to healthcare organisations for therapy reviews; Daiichi-Sankyo had not met the requirement to disclose by 30 June of the relevant year. The Panel ruled breaches of the Code for each of those years.

The Panel noted that during the Covid-19 pandemic in 2020, the ABPI and the PMCPA agreed that it would not be appropriate to write to NHS workers, hospitals or other NHS organisations while they were otherwise focussed on responding to the pandemic. To prevent the annual communications from being distributed, on 30 June 2020 companies’ 2019 non-R&D data was temporarily published on Disclosure UK in aggregate, instead of being broken down by individuals and organisations. The Panel noted that companies were, however, encouraged to publish the detailed 2019 data on their own websites where possible. The 2019 disclosure data was re-published on 27 November 2020 disaggregated, as normal on Disclosure UK.

The Panel noted that the temporary change to disclosure as a result of the pandemic should not have affected Daiichi-Sankyo’s disclosure of its 2019 transfers of value to healthcare organisations in relation to therapy reviews in aggregate by 30 June 2020. The Panel noted, however, that Daiichi-Sankyo had not submitted the relevant data to Disclosure UK. The Panel therefore considered that the information published on Disclosure UK when the voluntary admission was submitted in August 2020 was not comprehensive in relation to 2019 transfers of value provided to healthcare organisations for therapy reviews. Consequently, as the data had not been disclosed, Daiichi-Sankyo had not met the requirement to disclose the data, albeit in aggregate in the temporary circumstances described above, by 30 June 2020. Breaches of the Code were ruled.

The Panel was concerned to note Daiichi-Sankyo’s submission that whilst it had reconciled and collated the healthcare organisation-level details for the therapy review invoices in its system for £822,000 (96%) of the total amount, which included £65,000 in 2017, £259,000 in 2018 and £498,000 in 2019, there was still £35,000 (4%) that could not be fully identified as a service provider no longer had records for 2017. The Panel thus queried whether the company’s original submission that it had collated the data to begin with was thus completely accurate.

The Panel considered that the magnitude of under-reporting was of serious concern and queried why the issue had not come to light sooner particularly given that the company’s undertaking in Case AUTH/3285/12/19 was provided on 13 February 2020. The error had only been identified as a result of an audit that Daiichi-Sankyo had commissioned to assess the robustness of its Code-related governance framework. Daiichi-Sankyo had submitted that the root cause explanation for the reporting oversight was that its processes failed to identify that the therapy reviews were within the scope of disclosure.

The Panel noted that the disclosure of transfers of value was an important part of self-regulation and it was of serious concern that Daiichi-Sankyo had significantly under-reported transfers of value to healthcare organisations in relation to therapy reviews for so many years. High standards had not been maintained and therefore the Panel ruled a breach of the Code as acknowledged by Daiichi-Sankyo.

The Panel noted that a ruling of a breach of Clause 2 was used as a sign of particular censure. It considered that the failure to disclose the required information on Disclosure UK was extremely concerning as was the scale of the under-reporting. Daiichi-Sankyo’s processes were wholly inadequate in that regard. The Panel ruled a breach of Clause 2.

The Panel noted that a form of undertaking and assurance was an important document which underpinned self-regulation. Companies had to give an undertaking that all possible steps would be taken to avoid similar breaches of the Code in future. It was very important for the reputation of the industry that companies complied with undertakings.

The Panel noted that Daiichi-Sankyo had provided its undertaking in relation to Case AUTH/3285/12/19 on 13 February 2020. In the Panel’s view, whilst the failure to disclose the 2017 and 2018 transfers of value to healthcare organisations in relation to therapy reviews by 30 June 2018 and 30 June 2019, respectively, were not covered by that undertaking, the Panel noted that, when this voluntary admission was submitted in August 2020, the relevant data for 2017 and 2018 had still not been disclosed. Furthermore, the Panel noted that 2019 transfer of values to healthcare organisations in relation to therapy reviews had not been disclosed, albeit in aggregate in the temporary circumstances due to the Covid-19 pandemic, by 30 June 2020. It appeared that the company’s processes in relation to disclosing transfers of value as required by the Code remained inadequate. In the Panel’s view, Daiichi-Sankyo had breached its undertaking given in Case AUTH/3285/12/19 and a breach of the Code was ruled.

The Panel considered that Daiichi-Sankyo’s failure to comply with its undertaking given in Case AUTH/3285/12/19 meant that it had not maintained high standards and had brought discredit upon, and reduced confidence in, the industry. Breaches of the Code, including of Clause 2, were ruled.

The Panel considered that, on balance, and bearing in mind the need for proportionate regulation it would not report Daiichi-Sankyo to the Appeal Board as closely similar matters had been at issue in Case AUTH/3285/12/19 which had led to the ongoing audit process and a forthcoming re-audit would refer to this case.