Novartis, Pfizer, Otsuka and Novo Nordisk named in advertisements for breaches of the ABPI Code

 

Novartis – Case AUTH/3725/1/23

For failing to update and recertify two documents hosted on a Novartis website to include up-to-date Entresto (sacubitril/valsartan) prescribing information, for the length of time one of the documents had been available with out-of-date prescribing information, and because the out-of-date prescribing information had the potential to impact patient safety, Novartis was ruled in breach of the following clauses of the 2021 Code:

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

Clause 5.1 - Failing to maintain high standards

Clause 12.1 - Failing to include up-to-date prescribing information

Pfizer – Case AUTH/3741/2/23

For promoting an unlicensed vaccine, including to members of the public on Twitter, Pfizer was ruled in breach of the following clauses of the 2019 Code:

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

Clause 3.1 - Promoting an unlicensed medicine

Clause 7.2 - Making a misleading claim

Clause 7.9 - Making claims that did not reflect the available evidence regarding possible adverse reactions

Clause 9.1 - Failing to maintain high standards

Otsuka – Case AUTH/3757/3/23

For failing to disclose relevant information in its response to a previous case in 2015, and because interviewees had not been given the opportunity to agree and sign the witness statements produced as a record of their interviews and submitted to the PMCPA, Otsuka was ruled in breach of the following clauses of the 2015 Code:

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

Clause 9.1 - Failing to maintain high standards

Novo Nordisk – Case AUTH/3847/11/23

For its failure to disclose transfers of value of approximately £7.8 million, relating to over 150 different bodies, across a three-year period (2020-2022) selected as part of its voluntary admission, Novo Nordisk was ruled in breach of the following clauses of the 2019 Code and 2021 Code:

2019 Code

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

Clause 9.1 - Failing to maintain high standards

Clause 23.2 - Failing to publicly disclose details of the fees paid to consultants in the UK for certain services rendered by them

Clause 24.1 - Failing to document and publicly disclose annually certain transfers of value made directly or indirectly to health professionals, other relevant decision makers and healthcare organisations

Clause 24.4 - Failing to make disclosures annually in respect of each calendar year in the first six months after the end of the calendar year in which the transfers of value were made

Clause 27.7 - Failing to make publicly available a list of patient organisations to which it provides supports

Clause 27.8 - Failing to meet the disclosure requirements when engaging patient organisations

2021 Code

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

Clause 5.1 - Failing to maintain high standards

Clause 24.4 - Failing to disclose annually details of the fees and expenses paid to UK individuals, organisations etc for contracted services

Clause 24.6 - Failing to meet the disclosure requirements for fees and expenses for contracted services  

Clause 28.1 - Failing to document and publicly disclose annually certain transfers of value made directly or indirectly to health professionals, other relevant decision makers and healthcare organisations

Clause 29.1 - Failing to make publicly available annually, a list of patient organisations to which it provides donations, grants or sponsorship or with whom it has engaged to provide contracted services over the reporting period

Clause 29.2 - Failing to meet the disclosure requirements for the provision of donations, grants or sponsorship to a patient organisation

Clause 30.1 - Failing to make publicly available annually details of the fees for certain contracted services paid to members of the UK public, including patients and journalists

Clause 31.1 - Failing to make disclosures annually in respect of each calendar year in the first six months after the end of the calendar year in which the transfers of value were made.

The Code of Practice Appeal Board required Novo Nordisk to be publicly reprimanded for its failings with regards to its failure to disclose transfers of value over a sustained period.

The case reports and the public reprimand are available at www.pmcpa.org.uk. 

 

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