Astellas UK has been suspended as a member of the Association of the British Pharmaceutical Industry (ABPI) following "serious breaches" of its Code of Practice.
The company stands accused breaking Clause 2 of the Code, which centres on actions likely to bring discredit upon, or reduce confidence in, the pharmaceutical industry, after its conduct in organising an advisory board meeting in 2014 and response to the complaint.
At the advisory board meeting, which was held in Milan, Astellas presented the benefits of its medicine enzalutamide in an unlicensed indication. The complainant - an anonymous, non-contactable health professional - alleged that the firm was not truthful as to why delegates had been invited to the meeting, and that the company promoted something it should not have done.
The ABPI's policing arm - the Prescription Medicines Code of Practice Authority - ruled that the company had indeed breached the Code, but it subsequently transpired after a second complaint that Astellas Europe had knowingly provided incorrect information for the initial case review.
The complainant stated that the account given to the PMCPA was "knowingly false and intentionally misleading". In its response to the questions regarding its advisory board meeting, Astellas claimed that all invitees were identified and grouped based on their 'clinical expertise' and experience.
However, the complainant provided a copy of the briefing given by Astellas to its affiliates which showed that all 30 opinion leaders chosen by each affiliate had to be; 'mid to top level opinion leaders with the potential to be local product champions' and 'data naïve', contradicting the firm's that attendees were chosen based on their clinical expertise.
The PMCPA Appeal Board reported the companies to the ABPI Board, noting that it was "extremely concerned about the multiple organisational and cultural failings, which included issues of deception and imposed additional sanctions".
The ABPI Board agreed, and suspended Astellas UK's membership for twelve months. It says the company has accepted the rulings and taken action to prevent their recurrence.
"Breaches of the Code are viewed seriously and this is reflected by the suspension," said ABPI president John Kearney. "Our industry works under strict regulations and any company that fails to meet these standards will be held accountable."
