Astellas has been handed a one-year suspension from the UK’s pharma industry association after senior managers at its European business attempted to cover-up compliance failings.
It’s the first time a company has been suspended from the Association of the British Pharmaceutical Industry (ABPI) since 2008, when Roche was handed a six-month suspension for Code breaches related to sales of its obesity drug Xenical (orlistat) to private clinics.
The Astellas case began with a 2014 advisory board meeting in Milan, a complaint about which was ruled a clause 2 breach of the Code as one likely to bring discredit on the UK industry.
Attendees at the Milan meeting received a payment for attending what they believed to be a legitimate advisory board, which the ABPI’s Code of Practice watchdog the PMCPA said it was not.
The PMCPA also decided attendees had been paid to attend a promotional meeting for an unapproved indication for a drug, also contravening the Code.
However, Astellas’ response to this first case was then itself the subject of a second complaint by an anonymous employee, who revealed senior managers had “knowingly provided incorrect information” to the PMCPA (Prescription Medicines Code of Practice Authority).
The PMCPA Appeal Board said it was “extremely concerned about the multiple organisational and cultural failings, which included issues of deception”.
The “multiple organisational and cultural failings”, the PMCPA said, made it “one of the worst cases it had ever had to consider”.
“There was an institutional failure with respect to compliance. Very senior staff had lied and there was deception on a grand scale. The [PMCPA] Appeal Board was appalled and astonished that senior managers from Astellas Europe had made a concerted attempt to deceive it and the PMCPA.”
The deception was uncovered, in part, because the PMCPA decided to interview Astellas’ global CEO and president during an audit of company procedures.
As a result of the investigation Astellas will make a series of changes to its procedures, including putting dedicated compliance professionals in place at all its European affiliates.
A new head of ethics and compliance will be appointed and report to the global company, and senior medical affairs leadership roles will no longer managed by Europe but instead report to the global company.
Astellas is also putting in place new procedures, including whistle blowing arrangements.
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.”