Merz Pharma, Lilly and Daiichi-Sankyo named in advertisements for breaches of the ABPI Code of Practice
Merz Pharma, Lilly and Daiichi-Sankyo have each breached the ABPI Code of Practice for the Pharmaceutical Industry and brought discredit upon, and reduced confidence in, the pharmaceutical industry.
Press Release 30 November 2012
Merz – Case AUTH/2496/4/12
For making misleading and unsubstantiated claims and for failing to comply with an undertaking by implying that Bocouture/Xeomin was clinically equivalent to Vistabel/Botox, Merz 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 - Making an inaccurate claim.
Clause 7.3 - Making a misleading claim.
Clause 7.4 - Making an unsubstantiated claim.
Clause 9.1 - Failing to maintain high standards.
Clause 25 - Failing to comply with an undertaking.
Lilly and Daiichi-Sankyo – Cases AUTH/2506/5/12 and AUTH/2507/5/12
For promoting Efient in a manner that was misleading and inconsistent with its summary of product characteristics (SPC), Lilly and Daiichi-Sankyo were ruled in breach of the following clauses of the Code:
Clause 2 - Bringing discredit upon, and reducing confidence in, the
pharmaceutical industry.
Clause 3.2 - Promoting a medicine in a manner inconsistent with its summary
of product characteristics.
Clause 7.2 - Making inaccurate and misleading claims.
Clause 7.9 - Failing to reflect the balance of evidence about side effects.
Clause 9.1 - Failing to maintain high standards.
Merz – Case AUTH/2516/6/12
For failing to comply with an undertaking by implying that Bocouture was clinically equivalent to Botox, Merz 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 25 - Failing to comply with an undertaking.
The full case reports were published in the PMCPA November Code of Practice Review and are also available at www.pmcpa.org.uk.
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.
The advertisements will appear in the BMJ and The Pharmaceutical Journal on 1 December 2012 and The Nursing Standard on 5 December 2012.
Notes to Editors:
For more information please contact: Heather Simmonds, 020 7747 1438, mobile 07889 633907.
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 three of the following, the Director, Deputy Director, Secretary and Deputy Secretary of the Authority, acting with the assistance of independent expert advisers where appropriate. One member of the Authority acts as the case preparation manager for a particular case and does not participate when the Panel considers that case. 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.