Astellas Pharmaceuticals Ltd named in advertisements for breach of ABPI Code of Practice
Press Release 17 December 2018
The company has brought discredit upon, and reduced confidence in, the pharmaceutical industry. In addition Astellas UK has been publicly reprimanded.
Health Professional v Astellas UK – Case AUTH/2984/10/17
For a payment to a hospital in 2010 as a medical educational good or service, which did not meet the requirements of the Code as it was inappropriately linked to the use of Advagraf (tacrolimus) and for failing to keep proper records, Astellas UK was ruled in breach of the following clauses of the 2008 Code:
Clause 2 - Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
Clause 9.1 - Failing to maintain high standards
Clause 18.5 - Failing to keep proper records of a payment that was inappropriately linked to the use of a medicine.
As a result of information obtained at a re-audit of Astellas UK in other cases in April 2018, the Code of Practice Panel(2) reported the company to the Code of Practice Appeal Board(2) for providing incomplete and misleading information and for failing to follow its own processes for investigating complaints. The Appeal Board considered that it was fundamental for effective self-regulation for companies to provide accurate information to the Panel and the Appeal Board and for failing to do so it publicly reprimanded Astellas UK. The Appeal Board also reported Astellas UK to the ABPI Board.
The ABPI Board concluded that although the company had made mistakes, taking all the circumstances into account including that the company was to be re-audited in 2019 it decided to take no further action. The full case report will be published in the PMCPA November Code of Practice Review. The public reprimand appears on the front cover of the Review. The case report is available at www.pmcpa.org.uk.
Notes to Editors:
(1) The advertisements will appear in the British Medical Journal, 5 January 2019, the Nursing Standard, 9 January 2019 and the Pharmaceutical Journal, 26 January 2019.
(2) The Code of Practice Appeal Board consists of an independent, legally qualified, chairman and includes independent members, as well as senior executives from pharmaceutical companies. For the consideration of any matter independent members, including the Chair, must be in a majority. Further details are available in the PMCPA Constitution and Procedure.
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The Prescription Medicines Code of Practice Authority (PMCPA) was established by The Association of the British Pharmaceutical Industry (ABPI) to operate the ABPI Code of Practice for the Pharmaceutical Industry independently of the ABPI. The PMCPA is a division of the ABPI. The Code covers the promotion of medicines for prescribing to health professionals and the provision of information to the public about prescription only medicines. If you have any concerns about the activities of pharmaceutical companies in this regard, please contact the PMCPA at 7th Floor, 105 Victoria St, London, SW1E 6QT or email: email@example.com. The Code and other information, including details about ongoing cases, can be found on the PMCPA website: www.pmcpa.org.uk.