Sanofi and Otsuka named in advertisements following breaches of the ABPI Code of Practice for the Pharmaceutical Industry

​Sanofi and Otsuka have each breached Clause 2 of the Code and are subject to advertisements in the medical, pharmaceutical and nursing press. In addition Sanofi was publicly reprimanded.

Press Release 05 June 2015

Sanofi and Otsuka have each breached Clause 2 of the Code and are subject to advertisements in the medical, pharmaceutical and nursing press. In addition Sanofi was publicly reprimanded.

Case AUTH/2620/7/13

For failing to comply with an undertaking by using a claim about Lyxumia (lixisenatide) in a journal supplement similar to one previously ruled in breach of the Code, Sanofi 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
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The Code of Practice Panel ruled breaches of the Code and noted that this was the second time that Sanofi had breached the undertaking given in Case AUTH/2604/5/13.

The Panel was very concerned that Sanofi appeared not to have paid sufficient attention to ensure that its materials were comprehensively reviewed following the provision of an undertaking. The Panel reported Sanofi to the Code of Practice Appeal Board for it to consider whether further sanctions were warranted.

The Appeal Board decided to require an audit of the company’s procedures in relation to the Code. Two further reaudits were required by the Appeal Board. On consideration of the second reaudit the Appeal Board noted that progress had been made and, on the basis that it was maintained, no further action was required.

Case AUTH/2736/9/14

Sanofi voluntarily admitted its failure to disclose and document its interactions with numerous patient organisations. Sanofi 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 14.3 Failing to certify

Clause 23.3 Failing to have written agreements with patient organisations (Second 2012 Edition of the Code)

Clause 23.7 Failing to make publicly available a complete and accurate list of patient organisations to which it provided support (Second 2012 Edition of the Code)

Clause 23.8 Failing to make publicly available a complete and accurate list of patient organisations it had engaged to provide significant, contracted services (Second 2012 Edition of the Code)

Clause 24.3 Failing to have written agreements with patient organisations (2014 Edition of the Code)

Sanofi voluntarily admitted breaches of the Code in relation to its conduct and disclosure of interactions with patient organisations in 2013 and 2014. The company also voluntarily admitted a potential breach of the Code concerning its support of scientific meetings organised by patient organisations.

The Code of Practice Panel appreciated that Sanofi had voluntarily admitted its failings in process and procedure, however given the time period and the extent to which such failings had gone undetected, it considered that the matter warranted consideration by the Code of Practice Appeal Board. The Appeal Board was extremely concerned that such a long term systemic failure across the entire Sanofi business regarding multiple payments to multiple patient organisations had occurred. The arrangements in place at Sanofi at the relevant time were shambolic and shocking. Given its extreme concern about the breadth and scale of the failings the Appeal Board decided to publicly reprimand the company.

The Appeal Board also decided to require an audit of Sanofi’s procedures in relation to the Code. On consideration of the audit report, the Appeal Board noted its concern about some of the company’s activities and considered that Sanofi should address the matters raised as a priority. On the basis that this work was completed, progress was continued and a company-wide focus and responsibility for compliance was maintained, the Appeal Board decided that no further action was required.

Case AUTH/2752/3/15

For the inappropriate conduct of a senior employee, Otsuka was found 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 22.1 Provision of inappropriate hospitality

The Panel was concerned about the conduct of a senior male Otsuka employee who, during the course of an evening following a dinner at a meeting partly funded by the pharmaceutical industry, organised the purchase of drinks at the hotel bar for a female delegate who was obviously intoxicated. The Panel considered that overall the matter brought discredit upon and reduced confidence in the pharmaceutical industry.

Notes to Editors:

The full case reports are published in the May edition of the Code of Practice Review​​​​ and are available at pmcpa.org.uk. The public reprimand is published in the May edition of the Review which is also available on the website.

The advertisements will appear in the 6 June editions of the BMJ and The Pharmaceutical Journal and the 10 June Nursing Standard.

For more information please contact Elly Button 0207 747 8884, mobile 07920863650