Chiesi Ltd and Vifor Pharma UK Limited named in advertisements for breaches of the ABPI Code of Practice.
Chiesi Ltd and Vifor Pharma UK Limited have each breached the ABPI Code of Practice for the Pharmaceutical Industry and brought discredit upon, and reduced confidence in, the pharmaceutical industry. In addition, Chiesi was publicly reprimanded.
Press Release 22 March 2013
Chiesi – Case AUTH/2435/8/11
For promoting Fostair for an unlicensed indication and breaching a previous undertaking given in that regard, Chiesi was ruled in breach of the following clauses of the Code:
Clause 1.8 - Failing to comply with all applicable codes, laws, and regulations.
Clause 2 - Bringing discredit upon, and reducing confidence in, the
pharmaceutical industry.
Clause 3.2 - Promoting a medicine for an unlicensed indication.
Clause 9.1 - Failing to maintain high standards.
Clause 25 - Failing to comply with an undertaking.
The Code of Practice Panel was concerned about the difficulty in obtaining the relevant information from Chiesi and the inconsistency of that information. The Panel reported Chiesi to the Code of Practice Appeal Board which decided to publicly reprimand Chiesi for its failure to provide complete and accurate information at the outset. It also required an audit of Chiesi’s procedures.
Vifor – Case AUTH/2529/9/12
As Vifor Global issued three advertisements which bore a claim similar to one which had previously been ruled in breach of the Code, Vifor in the UK was considered to have failed to comply with an undertaking and 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 February 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 23 March 2013 and The Nursing Standard on 27 March 2013.
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. 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. For the consideration of any case, independent members from outside the industry, including the Chairman, must be in a majority. Details of the Appeal Board’s composition can be found on our website.