Otsuka Pharmaceuticals Europe Ltd and Indivior UK Ltd named in advertisements for breaches of ABPI Code and Otsuka Pharmaceuticals Europe Ltd and AstraZeneca publicly reprimanded

Otsuka Europe – Cases AUTH/3041/6/18 and AUTH/3123/11/18

For failing to implement timely changes to summaries of product characteristics (SPCs) and make consequential changes to its promotional material, Otsuka Europe was publicly reprimanded by the Code of Practice Appeal Board⁽²⁾, which considered that the company’s failures had the potential to impact patient safety (see May 2019 Code of Practice Review). 

Otsuka Europe was also required to be audited.  At the consideration of the audit reports the Appeal Board⁽²⁾ noted that Otsuka Europe had previously not provided it with accurate information.  Self-regulation relied, inter alia, on the provision of accurate information.  The Appeal Board⁽²⁾ subsequently publicly reprimanded Otsuka Europe for a second time and required a re-audit of its procedures in relation to the Code.

 

Otsuka Europe – Case AUTH/3151/1/19

For internal distribution of incorrect prescribing information which omitted important safety information and for a lack of oversight and process in relation to creation and revision of prescribing information for Jinarc (tolvaptan), Otsuka Europe 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.

 

Otsuka Europe – Case AUTH/3153/1/19

For using and failing to certify an advertisement which had been withdrawn and for multiple errors in the certification of a large number of pieces of material used at, or in relation to, a congress including the use of some material prior to certification, Otsuka Europe 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 14.1    - Failing to certify material.

 

Otsuka Europe – Case AUTH/3169/3/19

Otsuka Europe voluntarily admitted that it had failed to clearly communicate changes to the summaries of product characteristics (SPCs) for Jinarc (tolvaptan), consistently apply the company’s process and comply with an undertaking given in a previous case and 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 29       - Failing to comply with an undertaking.

 

Otsuka Europe – Case AUTH/3174/3/19

For failing to correctly classify a meeting as promotion for Jinarc (tolvaptan) and for undermining the Code and self-regulation in relation to failing to encourage open dialogue about compliance, Otsuka Europe 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 12.1- Disguising promotional material.

 

AstraZeneca – Case AUTH/3013/1/18

For failing to certify an advisory board meeting that involved travel outside the UK AstraZeneca was ruled in breach of the following clauses of the Code:

Clause 9.1   - Failing to maintain high standards.

Clause 14.2 - Failing to certify a meeting involving travel outside the UK.

After initial publication of the case report, further information was received which appeared to come from the original complainant suggesting that AstraZeneca had not provided the Code of Practice Panel with complete information. 

The Panel reconvened to consider the further information and although it was concerned about AstraZeneca’s approach to the provision of information to the Panel it decided not to report the company to the Code of Practice Appeal Board⁽²⁾ on this occasion. However, on receiving an update, the Appeal Board’s⁽²⁾ view was that further sanctions should be considered and following receipt of comments from AstraZeneca it publicly reprimanded the company for failing to provide complete and accurate information in an open and transparent way.  

 

Indivior – Case AUTH/3138/12/18

For failing to disclose transfers of value made directly or indirectly to health professionals and healthcare organisations located in the UK, Indivior was ruled in breach of the following clauses:

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

Clause 9.1   - Failing to maintain high standards.

Clause 24.1 - Failing to disclose transfers of value.

Clause 24.4 - Failing to disclose transfers of value in the required timeframe.

The public reprimands, interim and full case reports are available at www.pmcpa.org.uk. The public reprimand appears on the front cover of the May 2020 Code of Practice Review  and on the PMCPA website.

For more information contact Elly Button ebutton@pmcpa.org.uk  07920 863650