British watchdogs suspend Astellas UK after investigations, audits, and a crackdown from Japanese HQ

Astellas UK

Astellas is in big trouble with British pharma cops. The Japanese drugmaker’s U.K. unit has been suspended from the Association of the British Pharmaceutical Industry after sending doctors on a junket to Milan to strategize about the prostate cancer drug Xtandi’s U.K. launch.

But the ABPI isn’t suspending Astellas for the junket itself. This is a classic case of the cover-up being worse than the crime. And the APBI isn’t alone in cracking down. A newly appointed president of Astellas Europe vowed to improve ethics and compliance in his business, partly by hiring new people for the unit's top ranks.

The suspension follows five complaints filed with the Prescription Medicines Code of Practice Authority about Astellas Europe and Astellas UK, at least one internal investigation at the company, and two audits of the company’s actions. “Senior managers failed to provide full and accurate details” to the PMCPA panel and appeal board charged with handling the audits, the memo stated, going on to conclude, “Very senior staff had lied and there was deception on a grand scale.”

Some details about the meeting “only came properly to light” after a follow-up investigation ordered by Astellas Japan--and after the PCMPA talked directly to Astellas Group’s CEO and president, the memo said. The company says it would have investigated even if the CEO had not been contacted, however.

“[S]uch multiple organisational and cultural failings meant that this was one of the worst cases [the PCMPA appeal board] had ever had to consider,” the memo said, going on to add, “The Appeal Board was appalled and astonished that senior managers from Astellas Europe had made a concerted attempt to deceive it and the PMCPA.”

After the ABPI decided to suspend the company, executives "sincerely apologized for the significant cultural and compliance failings created and caused by the actions and behaviours of some of its very senior managers,” the organization said in a memo about the case. The Astellas representatives said that, globally, “Astellas viewed the current position as a corporate crisis.”

The “main culprits” have already left the company, the Astellas reps told the industry organization, and other employees are undergoing corrective training.

The saga began in 2013, when the PMCPA received a complaint about the planned meeting in Milan. The PMCPA launched its first investigation then, and later determined that the Japanese drugmaker’s European leadership had provided incomplete and “misleading” information when questioned about the gathering. The audits and second complaint followed in 2014 and 2015.

Astellas UK was suspended from ABPI beginning June 24, for a period of 12 months. The company’s European and U.K. units will be re-audited in September, and the ABPI board will review the suspension then. "The reaudits must show demonstrable improvements at both companies particularly in relation to corporate culture,” the memo stated.

 

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