Grunenthal, Boehringer Ingelheim, Eli Lilly, AstraZeneca UK and Janssen-Cilag named in advertisements following breaches of the ABPI Code

All five companies have brought discredit upon, and reduced confidence in, the pharmaceutical industry. In addition Boehringer Ingelheim and Eli Lilly and Company were required to issue a corrective statement.

Grünenthal – Case AUTH/2823/2/16

For failing to comply with its previous undertaking, failing to brief its representatives correctly regarding call rates and failing to agree written contracts in advance of engaging health professionals, Grünenthal was ruled in breach of the following clauses of various editions of the Code:

​Clause   2            Bringing discredit upon, and reducing confidence in, the pharmaceutical industry.

Clause   9.1         Failing to maintain high standards.

Clause 15.4         Failing to be sufficiently clear to representatives about the differences between call and contact rates.

Clause 15.9         Producing representatives' briefing material that was likely to lead to them breaching the Code.

Clause 20.1         Engaging health professionals in consultancy arrangements without agreeing a written contract in advance. (2015 Code)

Clause 23.1         Engaging health professionals in consultancy arrangements without agreeing a written contract in advance. (2016 Code)

Clause 29           Failing to comply with an undertaking.

 

Boehringer Ingelheim and Eli Lilly and Company – Cases AUTH/2825/3/16 and AUTH/2826/3/16

For distributing a letter regarding Jardiance (empagliflozin) that prepared the market for an anticipated licence extension, Boehringer Ingelheim and Lilly were ruled in breach of the following clauses of the Code:

Clause   2             Bringing discredit upon, and reducing confidence in, the pharmaceutical industry.

Clause   3.2         Using material that was inconsistent with the summary of product characteristics and promoted an unlicensed indication.

Clause   9.1         Failing to maintain high standards.

Clause 12.1         Disguising promotional materials.

The Code of Practice Panel reported Boehringer Ingelheim and Lilly to the Code of Practice Appeal Board(2) which subsequently required both companies to issue a corrective statement to recipients of the item at issue.

The case report, which includes the wording of the corrective statement, is available at www.pmcpa.org.uk.

 

AstraZeneca – Case AUTH/2842/4/16

For facilitating the use by independent speakers of uncertified presentations which were misleading as to the licensed indication for Duaklir Genuair (formoterol/aclidinium), AstraZeneca was ruled in breach of the following clauses of the Code:

Clause 2              Bringing discredit upon, and reducing confidence in, the pharmaceutical industry.

Clause 3.2           Implying a use for a medicine which was inconsistent with its summary of product characteristics.

Clause 7.2           Being misleading as to the licensed indications of medicines.

Clause 9.1           Failing to maintain high standards.

 

Eli Lilly and Company – Case AUTH/2849/6/16

For distributing a publication which included an error regarding the dose of Vitamin B12 which must be given with Alimta (pemetrexed), Lilly was ruled in breach of the following clauses of the Code:

Clause 2              Reducing confidence in the pharmaceutical industry.

Clause 7.2           Giving inaccurate and misleading information.

Clause 7.4           Using unsubstantiated information.

Clause 9.1           Failing to maintain high standards.

 

Janssen – Case AUTH/2871/8/16

For material sent by Janssen Europe to UK health professionals that promoted Stelara (ustekinumab) for an unlicensed indication and failing to certify such material, Janssen voluntarily admitted breaches of the following clauses of the Code:

Clause   2            Bringing discredit upon, and reducing confidence in, the pharmaceutical industry.

Clause   3.2         Promoting a medicine in a manner inconsistent with its summary of product characteristics.

Clause   9.1         Failing to maintain high standards.

Clause 14.1         Failing to certify promotional material.