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.
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.
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.
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.
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.
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.
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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