Bayer HealthCare named in advertisements for breaches of the ABPI Code of Practice
Bayer HealthCare has breached Clause 2 of the ABPI Code of Practice and is the subject of advertisements in the medical, pharmaceutical and nursing press.
Press Release 09 December 2012
Voluntary admission by Bayer – Case AUTH/2490/3/12
Bayer made a voluntary admission in relation to the distribution of unapproved documents associated with a proposed joint working project. Bayer was ruled in breach of the following clauses of the Code:
Clause 2 - Bringing discredit upon, and reducing confidence in, the
Clause 3.1 - Promoting a medicine for an indication for which it had no
Clause 4.1 - Failing to include prescribing information in promotional material.
Clause 4.10 - Failing to include a statement in relation to adverse event
reporting in promotional material.
Clause 4.11 - Failing to include an inverted black triangle on promotional
material to denote that special reporting requirements were
required in relation to adverse events.
Clause 7.2 - Making inaccurate and misleading claims.
Clause 7.3 - Making a misleading comparison with another medicine.
Clause 7.4 - Making unsubstantiated claims.
Clause 9.1 - Failing to maintain high standards.
Clause 12.1 - Disguising promotional materials.
Clause 14.1 - Failing to certify promotional material before issue.
Clause 15.2 - A representative failing to maintain high standards of ethical
The full case report has been published in the PMCPA August Code of Practice Review and is 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 15 September 2012 and The Nursing Standard on 19 September 2012.
Notes to Editors:
For more information please contact: Vicky Edgecombe, 020 7747 8884, mobile 07920 863650.
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.