Astellas suspended from UK pharma trade body
Astellas has been suspended from the UK’s pharma trade association, for misleading an investigation into a breach of the country’s medicines code of practice.
This is the first time since 2008 that a company has been suspended from the Association of the British Pharmaceutical Industry (ABPI), and only around half a dozen firms have been suspended in the history of the code, which has been in place since 1958.
The ABPI said Astellas had first seriously breached the UK’s code of practice by inviting health professionals to a meeting in Milan in February 2014, ostensibly to obtain advice about prostate cancer.
But a health professional attending the meeting complained to the Prescription Medicines Code of Practice Authority (PMCPA) that Astellas gave a presentation about the benefits of its Xtandi (enzalutamide) prostate cancer drug in an unlicensed indication.
The health professional alleged Astellas had not been truthful about the reasons for the meeting, and the PMCPA ruled that Clause 2 of the code had been breached, meaning the company’s actions were likely to bring discredit upon, or reduce confidence in, the industry.
But following a second complaint by a whistleblower from Astellas, it also transpired that Astellas Europe “knowingly provided incorrect information” to the PMCPA’s investigation.
Astellas had told the PMCPA that those invited to the meeting were asked on the basis of their clinical expertise in prostate cancer.
But the whistleblower provided a copy of a briefing showing Astellas invited people who were ‘mid- to top-level opinion leaders with the potential to be local product champions’.
They were further requested to be ‘data-naïve’, which, the whistleblower said, contradicted the claim that attendees had been chosen based on their clinical expertise.
The PMCPA’s appeal board reported this and ‘multiple organisational failings’ to the ABPI board, which decided to suspend Astellas UK for 12 months.
The ABPI said it would re-audit Astellas UK and Astellas Europe in September and review the suspension before the end of 2016.
Re-audits must show demonstrable improvements in both companies – Astellas UK and Astellas Pharma Europe – particularly in relation to corporate culture.
ABPI president, John Kearney, said: “Breaches of the code are viewed seriously and this is reflected by the suspension. Our industry works under strict regulations and any company that fails to meet these standards will be held accountable.”
In an emailed statement, Astellas said it ‘accepted fully’ the ABPI management board’s decision and was ‘committed to achieving the standards of compliance necessary…to have its membership to the ABPI reinstated’.
The statement went on, ‘Astellas believes that a strong compliance governance and framework is essential and a comprehensive plan has been in place over recent months to create and maintain a culture where compliance, ethics and integrity are embedded and reinforced at all levels within the organisation.’
The last company to be suspended from the APBI was Roche, in 2008, for inappropriate supply of its medicine to an operator of a clinic, and payment to that person towards the purchase of another clinic. Roche is not a member of the organisation currently.
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