Astellas UK has been suspended as a member of the Association of the British Pharmaceutical Industry (ABPI) with effect from June 24th, 2016.
23 Jun 2016 Posted in ABPI statement By Press Office
This is in connection with a number of serious breaches of the ABPI Code of Practice for the Pharmaceutical Industry.
The action is as a result of a complaint about an advisory board meeting held in Milan in February 2014 which was ruled to be in breach of the Code, including Clause 2 which deals with actions likely to bring discredit upon, or reduce confidence in, the pharmaceutical industry.
Following a second complaint and further action by the Prescription Medicines Code of Practice Authority (PMCPA), it also transpired that Astellas Europe had knowingly provided incorrect information to the PMCPA.
Subsequently, the PMCPA Appeal Board reported the companies to the ABPI Board. The PMCPA Appeal Board was extremely concerned about the multiple organisational and cultural failings, which included issues of deception and imposed additional sanctions.
The ABPI Board agreed with the PMCPA Appeal Board's assessment. The ABPI Board suspended Astellas UK from membership of the ABPI for twelve months. The companies are to be re-audited in September 2016. The ABPI Board will see this report and review the length of the suspension before the end of 2016. The re-audits must show demonstrable improvements in both companies – Astellas UK and Astellas Pharma Europe - particularly in relation to corporate culture.
Astellas has accepted the rulings and taken action to prevent their recurrence.
President of the ABPI, John Kearney, said:
"Breaches of the Code are viewed seriously and this is reflected by the suspension. Our industry works under strict regulations and any company that fails to meet these standards will be held accountable."
Timeline and process
The initial complaint (Case AUTH/2747/1/15) concerned the advisory board. Breaches of the Code were ruled to have taken place and Astellas Europe was reported to the Code of Practice Appeal Board. The company was required to issue a corrective statement to all the UK health professionals who attended.
In the subsequent case, Case AUTH/2780/7/15 , the Code of Practice Panel ruled breaches of the Code in relation to the truthfulness of Astellas Europe's earlier response and an allegation that a very senior employee of Astellas Europe had been dismissive of the findings. The appeal regarding the discussion of the case was unsuccessful and the Appeal Board upheld the Panel's rulings. The Panel also reported Astellas Europe and Astellas UK to the Appeal Board which decided that both companies should be audited and publicly reprimanded; it also required a second corrective statement be issued.
The audits of both companies by the PMCPA took place in December 2015 and, in its response to the report of the audits, Astellas Europe stated that new information had been discovered as a result of further internal investigation which was subsequently provided. This included a confidential report by external counsel.
Astellas Europe subsequently admitted that it had provided inaccurate information to the Panel and the Appeal Board. The Panel reconvened and, because of serious concerns, decided to report Astellas Europe and Astellas UK to the Appeal Board.
The PMCPA Appeal Board noted there was institutional failure with respect to compliance. The Appeal Board decided to require a further corrective statement and to publicly reprimand both companies. It also decided to report both companies to the ABPI Board. The ABPI Board took the decision to suspend Astellas UK from ABPI membership, effective from June 24th, 2016.
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The ABPI represents innovative research-based biopharmaceutical companies, large, medium and small, leading an exciting new era of biosciences in the UK.
Our industry, a major contributor to the economy of the UK, brings life-saving and life-enhancing medicines to patients. We represent companies supplying around 90 per cent of all medicines used by the NHS, and are researching and developing the majority of the current medicines pipeline, ensuring that the UK remains at the forefront of helping patients prevent and overcome diseases.
The ABPI is recognised by government as the industry body negotiating on behalf of the branded pharmaceutical industry, for statutory consultation requirements including the pricing scheme for medicines in the UK.