ABPI Extends Suspension of Astellas UK

28.06.2017 -

The Association of the British Pharmaceutical Industry (ABPI) has suspended Astellas UK’s membership for a further 12 months from Jun. 24 because of several serious breaches of its Code of Practice.

The association said recent cases at both Astellas UK and Astellas Pharma Europe have shown “wholly inadequate oversight and control and a lamentable lack of concern for patient safety.”

The ABPI very nearly expelled the company but the association’s board said it decided to extend the suspension instead, noting the commitments made from Astellas Pharma Europe, Astellas Global and the new Astellas UK general manager.

“Breaches of the Code are viewed seriously and matters concerning patient safety are of the utmost concern. The very seriousness of the matters is reflected by the extension to the suspension and the clear warning that significant improvement is required. Our industry works under strict regulations and any company that fails to meet these standards will be held accountable,” said Lisa Anson, president of the ABPI and chair of the ABPI board.

Astellas UK was originally suspended from the ABPI in June 2016 because of breaches related to an advisory board meeting and deception, including providing false information to the ABPI’s policing arm, the Prescription Medicines Code of Practice Authority (PMCPA), by Astellas Pharma Europe.

Both companies were re-audited in September 2016 and April 2017, between which three further cases arising from voluntary admissions were considered by the PMCPA.

The case in October 2016 related to a lack of oversight and training of agency nurses who delivered patient support programs, including failing to update them with product changes. The PMCPA Appeal Board said this case raised very serious concerns about patient safety and public confidence in the pharmaceutical industry.

The second case in February 2017 once again focused on failures to update and provide complete prescribing information for a number of medicines. The PMCPA Appeal Board described the case as “shocking” and said Astellas UK’s failure to understand the scale of the problem was “concerning.”

Re-audits will take place at Astellas UK and Astellas Pharma Europe in October of this year the ABPI has warned the companies that if the re-audits do not show significant improvement and progress, the board will consider expelling Astellas UK from the association.

The two-year suspension is the longest allowed under ABPI rules. The ABPI has also advised the Medicines and Healthcare products Regulatory Agency (MHRA) of its concerns about the companies’ conduct, as well as the European Federation of Pharmaceutical Industries and Associations (EFPIA).