Astellas UK’s suspension as a member of the Association of the British Pharmaceutical Industry (ABPI) is to be extended for a further 12 months with effect from June 24 in connection with a number of serious breaches of the ABPI Code.
Recent cases have shown wholly inadequate oversight and control at both Astellas UK and Astellas Pharma Europe and a “lamentable lack of concern for patient safety.”
Astellas' original suspension in June 2016 related to an advisory board meeting (Case AUTH/2747/1/15) and deception, including providing false information to the PMCPA by Astellas Pharma Europe (Case AUTH/2780/7/15). The Prescription Medicines Code of Practice Authority (PMCPA) Code of Practice Appeal Board imposed additional sanctions due to the seriousness of the case and reported the companies to the ABPI Board. Astellas UK was subsequently suspended from membership of the ABPI for 12 months from 24 June 2016.
Both companies were re-audited in September 2016 and April 2017. Between these re-audits three further cases arising from voluntary admissions made by Astellas UK and Astellas Pharma Europe, were considered by the PMCPA. These cases were reported to the ABPI Board by the PMCPA Appeal Board.
Case AUTH/2883/10/16 (Astellas UK, October 2016) highlighted a lack of oversight and training of agency nurses who delivered patient support programmes, including failing to update them with product changes. It is crucial that patients can rely completely upon the industry for up-to-date and accurate information. The PMCPA Appeal Board considered this case raised serious concerns with regard to patient safety and public confidence in the pharmaceutical industry.
Cases AUTH/2939/2/17 and AUTH/2940/2/17 (Astellas UK and Astellas Pharma Europe, February 2017) focused on failures to update and provide complete prescribing information for a number of medicines—again raising very serious concerns around patient safety and revealing multiple failings. The companies' lack of processes with regard to updating prescribing information was described by the PMCPA Appeal Board as "shocking" and Astellas UK's failure to understand the scale of the problem was concerning.
Astellas has accepted the rulings in these three cases and taken action to prevent their recurrence.
Having considered expelling Astellas UK from membership of the ABPI, the ABPI Board decided in June 2017 to extend the suspension by 12 months, noting commitments from Astellas Pharma Europe, Astellas Global and the new Astellas UK General Manager. The companies had made voluntary admissions and it is imperative that the October 2017 re-audits show significant progress. If the report of the re-audits do not show significant improvement and progress at both companies, then the ABPI Board will consider expelling Astellas UK from membership of the ABPI.
The companies should consider undergoing an external assessment of progress, particularly in relation to risk management of compliance in the broadest sense, including matters beyond the scope of the Code, with the outcome to be available at the time of the October 2017 re-audits. The two year suspension is the longest allowed under the ABPI Articles of Association.
The ABPI Board also took the decision to advise 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.
President of the ABPI and Chair of the ABPI Board, Lisa Anson said, "Breaches of the Code are viewed seriously and matters concerning patient safety are of the utmost concern. 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 accountable."
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has also been advised of the position.