Takeda Europe and Lilly named in advertisements for breaches of the ABPI Code of Practice
28 November 2008
Takeda Europe and Eli Lilly are the subjects of advertisements in the medical, pharmaceutical and nursing press which highlight breaches of The Association of the British Pharmaceutical Industry (ABPI) Code of Practice for the Pharmaceutical Industry.
Under provisions in its Constitution and Procedure, the Prescription Medicines Code of Practice Authority (PMCPA) advertises brief details of all cases where companies are ruled in breach of Clause 2 of the Code, are required to issue a corrective statement or are the subject of a public reprimand.
Takeda Europe breached the Code by using a misleading claim in an advertisement which did not reflect the possible side effects, did not encourage the rational use of a medicine and could have had implications for patient safety. As a result, the company was ruled in breach of the following clauses of the Code:
• Clause 2 - Bringing discredit upon, or reducing confidence in, the pharmaceutical industry.
• Clause 3.2 - Promoting a medicine in a way that was inconsistent with its summary of product characteristics.
• Clause 7.2 - Failing to ensure that all claims were accurate, balanced, fair, unambiguous and based on up-to-date evidence.
• Clause 7.9 - Failing to reflect available evidence about side-effects.
• Clause 7.10 - Failing to encourage the rational use of a medicine.
Lilly breached the Code by encouraging patients to ask their health professional for a specific prescription only medicine through use of a chart and action plan on a website and a leaflet. As a result, the company was ruled in breach of the following clauses of the Code:
• Clause 2 - Bringing discredit upon and reducing confidence in the pharmaceutical industry.
• Clause 9.1- Failing to maintain high standards.
• Clause 22.2 - Encouraging members of the public to ask their health professional to prescribe a specific prescription only medicine.
The advertisements will appear in the BMJ and The Pharmaceutical Journal in the week ending 28 November 2008. The advertisement concerning Lilly will also appear in The Nursing Standard on 10 December 2008. The case reports:
• Takeda Europe – Case AUTH/2125/5/08
• Lilly – Cases AUTH/2151/7/08 and AUTH/2163/8/08 were published in the November Code of Practice Review and are available in the ‘completed cases’ section of the PMCPA website at www.pmcpa.org.uk.
Notes for editors
Niamh MacMahon 020 7747 8884
Out of hours 079 2086 3650
The Prescription Medicines Code of Practice Authority (PMCPA; www.pmcpa.org.uk) was established by The Association of the British Pharmaceutical Industry (ABPI) on 1 January 1993 to operate the ABPI Code of Practice for the Pharmaceutical Industry at arm's length from the ABPI itself. The Code and other information, including details about ongoing cases and completed cases, is available at www.pmcpa.org.uk.
Complaints submitted under the Code are considered in the first instance by the Code of Practice Panel which consists of the Director, Secretary and Deputy Secretary of the Authority, acting with the assistance of independent expert advisers where appropriate. Both the complainant and the respondent company may appeal to the Code of Practice Appeal Board against rulings made by the Panel.
The Appeal Board is chaired by an independent legally qualified chairman and includes independent members from outside the industry. Details of its composition can be found in the Constitution and Procedure.