Astellas UK’s suspension from ABPI is extended for a year

A recent press release from the Association of the British Pharmaceutical Industry (ABPI) has announced that Astellas UK’s membership suspension has been extended for a further 12 months in connection with a number of breaches of the association's code.

Astellas UK was suspended from membership of the ABPI in June last year as a result of an advisory board meeting and deception, including providing false information to the Prescription Medicines Code of Practice Authority (PMCPA). Due to the severity of the case, the PMCPA Code of Practice Appeal Board imposed additional sanctions and reported Astellas UK and Astellas Pharma Europe to the ABPI Board. As a result of this, the ABPI decided to suspend Astellas UK’s membership for 12 months.

Re-audits were performed on both Astellas UK and Astellas Pharma Europe between September 2016 and April 2017, where three further cases (from voluntary admissions) were brought forward and reported to the ABPI Board by the PMCPA Appeal Board. These cases included a lack of oversight and training of agency nurses who delivered patient support programmes (including failing to update them with product changes) and failures to update and provide complete prescribing information for a number of medicines.

After considering an expulsion of Astellas UK from membership of the ABPI, the association’s board decided to extend the suspension for a further 12 months on the proviso of commitments from Astellas Pharma Europe, Astellas Global and the new Astellas UK general manager regarding the cases and actions to prevent their recurrence.

Further re-audits will be performed in October this year, during which significant improvements and progress at both companies are required otherwise expulsion from ABPI membership will be considered by the association’s board. Two-year suspension is the longest allowed under the ABPI Articles of Association.

Additionally, the ABPI has advised the Medicines and Healthcare products Regulatory Agency (MHRA) of its serious concerns about the conduct of Astellas UK and Astellas Pharma Europe, particularly in relation to the matters concerning patient safety.

“Breaches of the Code are viewed seriously and matters concerning patient safety are of the utmost concern,” stated Lisa Anson, president of the ABPI and chair of the ABPI Board. “The very seriousness of the matters are 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 responsible.”

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has been advised of the position.

Full details of the cases are published on the PMCPA’s site.