Grunenthal Ltd and Vifor Pharma UK Limited named in advertisements for breaches of the ABPI Code of Practice
Grünenthal Ltd and Vifor Pharma UK Limited have each breached Clause 2 of the ABPI Code of Practice and are the subject of advertisements in the medical, pharmaceutical and nursing press. In addition, Grünenthal has been publicly reprimanded.
Press Release 06 July 2012
Grünenthal – Case AUTH/2327/6/10
For the manner in which its health economic liaison managers raised interest in and awareness of an unlicensed medicine, Grünenthal was ruled in breach of the following clauses of the Code in 2010:
For the manner in which its health economic liaison managers raised interest in and awareness of an unlicensed medicine, Grünenthal was ruled in breach of the following clauses of the Code in 2010:
Clause 2 - Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
Clause 3.1 - Promoting a medicine before the grant of a marketing authorization
Clause 9.1 - Failing to maintain high standards.
Clause 3.1 - Promoting a medicine before the grant of a marketing authorization
Clause 9.1 - Failing to maintain high standards.
The Code of Practice Panel reported the company to the Code of Practice Appeal Board. During its consideration of this matter, the Appeal Board noted that Grünenthal had provided misinformation in its response to recommendations following an audit. For providing misinformation Grünenthal was publicly reprimanded by the Appeal Board.
Vifor – Case AUTH/2442/10/11
For failing to comply with an undertaking to withdraw two press releases which bore similar claims to material which had previously been ruled in breach of the Code, Vifor 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.
For failing to comply with an undertaking to withdraw two press releases which bore similar claims to material which had previously been ruled in breach of the Code, Vifor 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 have been published in the PMCPA May Code of Practice Review and are also available on this website.
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 7 July 2012 and The Nursing Standard on 11 July 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.