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Astellas UK and Gedeon Richter (UK) named in advertisements following breaches of the ABPI Code

08/06/2017
Press Release

Astellas UK and Gedeon Richter (UK) Ltd have brought discredit upon, and reduced confidence in, the pharmaceutical industry. Both companies have been named in advertisements(1) following breaches of the ABPI Code of Practice for the Pharmaceutical Industry.  Astellas UK has been publicly reprimanded and Gedeon Richter required to issue a corrective statement.​

Astellas UK – Case AUTH/2883/10/16

Following a voluntary admission about its oversight of and materials produced for two patient support programmes related to Betmiga (mirabegron) and Vesicare (solifenacin succinate), Astellas was ruled in breach of the following clauses of the Code:

Clause   2       - Bringing discredit upon, and reducing confidence in, the pharmaceutical industry.                             

Clause   7.2    - Providing inaccurate and out-of-date material.

Clause   7.9    - Providing material that did not accurately reflect up-to-date information on possible side effects.

Clause   7.11 -  Describing a medicine as new for more than twelve months.

Clause   9.1   -  Failing to maintain high standards.

Clause 14.3   -  Failing to certify material.

Clause 14.5   -  Using material beyond two years without re-certification.

Clause 21      -  Failing to disclose transfers of value on the ABPI central platform.

Clause 24.1   -  Failing to disclose transfers of value on the ABPI central platform.

​The Code of Practice Panel reported Astellas UK to the Code of Practice Appeal Board. The public reprimand appears on the front cover of the PMCPA May Code of Practice Review which, with the interim case report, is available at www.pmcpa.org.uk.

Gedeon Richter – Case AUTH/2885/11/16

For distributing a patient support leaflet which failed to alert women not to use any form of hormonal contraception whilst taking Esmya (ulipristal acetate), Gedeon Richter was ruled in breach of the following clauses of the Code:

Clause 2       - Reducing confidence in the pharmaceutical industry.

Clause 7.2    - Giving inaccurate and misleading information.

Clause 9.1    - Failing to maintain high standards.

The Code of Practice Appeal Board required Gedeon Richter to issue a corrective statement to health professionals who had received the item at issue. The case report appears in the PMCPA May Code of Practice Review, and both are available at www.pmcpa.org.uk.

For more information contact: Elly Button: 02077478884/07956 437982 or email ebutton@pmcpa.org.uk.

Notes to Editors:   (1) The advertisements will appear in the British Medical Journal on 17 June 2017, the Nursing Standard on 21 June 2017 and the Pharmaceutical Journal on 24 June 2017.

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. The Code and other information including details about ongoing cases can be found on the PMCPA website www.pmcpa.org.uk.

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 complaints@pmcpa.org.uk.

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