Shire Pharmaceuticals Ltd and Roche Products Limited named in advertisements for breaches of the ABPI Code of Practice
Shire Pharmaceuticals Ltd and Roche Products Limited 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 24 May 2013
For issuing a press release for VPRIV (velaglucerase alfa) (a prescription only medicine) that was misleading, inaccurate, disparaging, implied statistical and clinical significance from exploratory data and effectively promoted the medicine and encouraged patients to ask their health professionals to prescribe it, Shire was ruled in breach of the following clauses of the Code:
Clause 1.8 - Failing to comply with the Code.
Clause 2 - Bringing discredit upon, and reducing confidence in, the pharmaceutical industry.
Clause 4.1 - Failing to include prescribing information in promotional material.
Clause 7.2 - Making misleading claims.
Clause 7.3 - Making a misleading comparison.
Clause 8.1 - Making disparaging claims.
Clause 14.1 - Failing to certify promotional material before issue.
Clause 14.5 - Failing to certify promotional material before issue.
Clause 22.1 - Promoting a prescription only medicine to the public.
Clause 22.2 - Encouraging members of the public to ask their health
professional to prescribe a specific prescription only medicin
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.