Recently, four companies received violations from the Prescription Medicines Code of Practice Authority (PMCPA) in London for advertising violations, including Novartis, Pfizer, Otsuka, and Novo Nordisk. The PMCPA is a division of the Association of the British Pharmaceutical Industry (ABPI). The ABPI Code of Practice for the Pharmaceutical Industry provides standards for the promotion of medicines for prescribing to health care professionals and provision of information to the public about prescription medicines. The main sanction given by PMCPA is publicity.
Novartis
Novartis was found in violation for failing to update and recertify two documents hosted on a Novartis website to include up-to-date prescribing information for Entresto and for the length of time one of the documents had been available with out-of-date prescribing information. The out-of-date prescribing information had the potential to impact patient safety.
The complainant was a health professional who was directed to view the Novartis website by a company representative. Upon reviewing the website, they were “shocked to see that the documents available to download compromised the safety of patients,” including outdated and missing prescribing information for Entresto.
Novartis was in breach of the following clauses of the 2021 Code: Clause 2, for bringing discredit upon, and reducing confidence in, the pharmaceutical industry; Clause 5.1, for failing to maintain high standards; and Clause 12.1, for failing to include up-to-date prescribing information.
Pfizer
Pfizer was in violation of the Code for promoting an unlicensed vaccine, including to members of the Public, on Twitter. The tweet was posted by a US-based Pfizer employee and retweeted by a senior UK employee in November 2020. The tweet remained visible and related to a Pfizer and BioNTech press release announcing the conclusion of the Phase 3 Study of Pfizer’s COVID-19 vaccine candidate, which had met all primary efficacy endpoints. The tweet allegedly included relative efficacy rates without any information about absolute efficacy rates and without including any information about safety data or safety information.
Pfizer was in breach of the following clauses of the 2019 Code: Clause 2, for bringing discredit upon, and reducing confidence in, the pharmaceutical industry; Clause 3.1, for promoting an unlicensed medicine; Clause 7.2, for making a misleading claim; Clause 7.9, for making claims that did not reflect the available evidence regarding possible adverse reactions; and Clause 9.1, for failing to maintain high standards.
Otsuka
Otsuka was in violation of the Code for failing to disclose relevant information in its response to a previous 2015 case. Additionally, interviewees were not given the opportunity to sign witness statements produced as a record of their interviews and submitted to the PMCPA.
The complainant in this case was a former employee of Otsuka who had given a statement during an internal investigation. The former employee alleged that Otsuka failed to disclose all relevant information to the PMCPA, that Otsuka did not allow witnesses to see or sign the statements submitted to PMCPA (and that Otsuka had removed information from them, rendering the witness statements untruthful), and that three whistleblower employees were forced out of the industry.
Otsuka was in breach of the following clauses of the 2015 Code: Clause 2, for bringing discredit upon, and reducing confidence in, the pharmaceutical industry; and Clause 9.1, for failing to maintain high standards.
Novo Nordisk
Novo Nordisk was found in violation of multiple clauses under both the 2019 Code and the 2021 Code for its failure to disclose transfers of value of roughly £7.8 million, relating to more than 150 bodies from 2020 to 2022.
Novo Nordisk was also publicly reprimanded for its failings to disclose transfers of value over a sustained period.
Novo Nordisk was in breach of the following clauses of the 2019 Code: Clause 2, for bringing discredit upon, and reducing confidence in, the pharmaceutical industry; Clause 9.1, for failing to maintain high standards; Clause 23.2, for failing to publicly disclose details of the fees paid to consultants in the UK for certain services rendered by them; Clause 24.1, for failing to document and publicly disclose annually certain transfers of value made directly or indirectly to health professionals, other relevant decision makers and healthcare organizations; Clause 24.4, for 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, for failing to make publicly available a list of patient organizations to which it provides supports; and Clause 27.8, for failing to meet the disclosure requirements when engaging patient organizations.
Novo Nordisk was in breach of the following clauses of the 2021 Code: Clause 2, for bringing discredit upon, and reducing confidence in, the pharmaceutical industry; Clause 5.1, for failing to maintain high standards; Clause 24.4, for failing to disclose annually details of the fees and expenses paid to UK individuals, organizations, etc. for contracted services; Clause 24.6, for failing to meet the disclosure requirements for fees and expenses for contracted services; Clause 28.1, for failing to document and publicly disclose annually certain transfers of value made directly or indirectly to health professionals, other relevant decision makers and healthcare organizations; Clause 29.1, for failing to make publicly available annually, a list of patient organizations 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, for failing to meet the disclosure requirements for the provision of donations, grants or sponsorship to a patient organization; Clause 30.1, for 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; and Clause 31.1, for 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.