Novo Nordisk, Eli Lilly, Grünenthal and Napp breach the UK ABPI Code of Practice

Novo Nordisk Limited, Eli Lilly and Company Limited, Grünenthal Ltd and Napp Pharmaceuticals Limited named in advertisements

Novo Nordisk Limited, Eli Lilly and Company Limited, Grünenthal Ltd and Napp Pharmaceuticals Limited named in advertisements for breaches of the ABPI Code of Practice

Novo Nordisk Limited, Eli Lilly and Company Limited, Grünenthal Ltd and Napp Pharmaceuticals Limited have each breached the ABPI Code of Practice for the Pharmaceutical Industry. To highlight these breaches, all are the subject of advertisements in the medical, pharmaceutical and nursing press. In addition, Novo Nordisk has been publicly reprimanded in relation to two matters.

Novo Nordisk – Case AUTH/2234/5/09
For promoting Victoza prior to the receipt of its marketing authorization on a number of occasions, making claims and comparisons that were misleading, disguising promotional material and failing to provide information which reflected available evidence, Novo Nordisk was ruled in breach of the following clauses of the Code:
Clause 2 - Bringing discredit upon and reducing confidence in the
pharmaceutical industry.
Clause 3.1 - Promoting a medicine prior to the grant of its marketing
authorization.
Clause 7.2 - Making misleading claims.
Clause 7.3 - Using misleading comparisons.
Clause 7.9 - Failing to provide information about side-effects and reflect
available evidence.
Clause 9.1 - Failing to maintain high standards.
Clause 12.1 - Disguising promotional material.

Novo Nordisk was also publicly reprimanded by the Code of Practice Appeal Board.

Novo Nordisk – Case AUTH/2269/9/09
For failing to comply with an undertaking not to use material previously ruled in breach of the Code and for providing inaccurate information in that undertaking, Novo Nordisk 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.

Novo Nordisk was also publicly reprimanded by the Code of Practice Appeal Board.

Lilly – Case AUTH/2310/4/10
For promoting a medicine before the grant of the marketing authorization, Lilly was ruled in breach of the following clauses of the Code:
Clause 2 - Bringing discredit upon or reducing confidence in the
pharmaceutical industry.
Clause 3.1 - Promoting a medicine prior to the grant of the marketing
authorization.
Clause 7.2 - Making misleading claims.
Clause 9.1 - Failing to maintain high standards.

Grünenthal – Case AUTH/2330/7/10
For promoting an unlicensed indication for Versatis in the poster session of a meeting of the British Pain Society, Grünenthal was ruled in breach of the following clauses of the Code:
Clause 2 - Reducing confidence in the pharmaceutical industry.
Clause 3.2 - Promoting a medicine for an unlicensed indication.
Clause 9.1 - Failing to maintain high standards.

Grünenthal – Case AUTH/2332/7/10
For making cost comparisons for Versatis which were incorrect and misleading and failing to declare that a named author on a poster was one of its employees, Grünenthal was ruled in breach of the following clauses of the Code:
Clause 2 - Reducing confidence in the pharmaceutical industry.
Clause 7.2 - Making inaccurate and misleading cost comparisons.
Clause 9.1 - Failing to maintain high standards.

Napp – Case AUTH/2353/8/10
For providing business class air travel to delegates it had sponsored to attend an international congress and failing to certify overseas travel arrangements, Napp was ruled in breach of the following clauses of the Code:
Clause 2 - Bringing discredit upon or reducing confidence in the
pharmaceutical industry.
Clause 9.1 - Failing to maintain high standards.
Clause 14.2 - Failing to certify overseas travel.
Clause 19.1 - Providing excessive hospitality in the form of business class
air travel.

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 Nursing Standard on 15 December 2010 and the BMJ and The Pharmaceutical Journal on 18 December 2010.

The full case reports were published in the PMCPA November Code of Practice Review and are also available at www.pmcpa.org.uk.

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Notes for editors
For more information please contact: Vicky Edgecombe, Head of Communications – Tel: 020 7747 8884, Mob: 07920 863650 or email vedgecombe@pmcpa.org.uk.

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 the Director, Secretary and Deputy Secretary of the Authority, acting with the assistance of independent expert advisers where appropriate. 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.

via pmcpa.org.uk

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