The Prescription Medicines Code of Practice Authority (PMCPA) is the self-regulatory body which administers the Association of the British Pharmaceutical Industry (ABPI) Code of Practice for the Pharmaceutical Industry:
PMCPA Case number: AUTH/3847/11/23
This case was a voluntary admission by Novo Nordisk concerning undisclosed transfers of value of approximately £7.8 million over a three-year period selected by Novo Nordisk as part of its internal investigation (2020-2022). The failures to disclose related to approximately 500 transfers of value to over 150 different vendors and represented between 10-14% of each year’s total transfers of value.
The outcome under the 2019 Code was:
| Breach of Clause 2 | Bringing discredit upon, and reducing confidence in, the pharmaceutical industry |
| Breach of Clause 9.1 | Failing to maintain high standards |
| Breach of Clause 23.2 | Failing to publicly disclose details of the fees paid to consultants in the UK for certain services rendered by them |
| Breach of 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 |
| Breach of 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 |
| Breach of Clause 27.7 | Failing to make publicly available a list of patient organisations which it supports |
| Breach of Clause 27.8 | Failing to meet the disclosure requirements when engaging patient organisations |
| No Breach of Clause 23.4 | Requirement that fees, expenses and the like due to consultants must be disclosed. |
The outcome under the 2021 Code:
| Breach of Clause 2 | Bringing discredit upon, and reducing confidence in, the pharmaceutical industry |
| Breach of Clause 5.1 | Failing to maintain high standards |
| Breach of Clause 24.4 (x2) | Failing to disclose annually details of the fees and expenses paid to UK individuals, organisations etc for contracted services |
| Breach of Clause 24.6 (x2) | Failing to meet the disclosure requirements for fees and expenses for contracted services |
| Breach of 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 |
| Breach of 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 |
| Breach of Clause 29.2 | Failing to meet the disclosure requirements for the provision of donations, grants or sponsorship to a patient organisation |
| Breach of 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 |
| Breach of 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 |
Personal thoughts on this case:
Given the seriousness of this matter I am left wondering what form of ‘public reprimand’ the PMCPA has imposed upon this pharmaceutical company for breaching its codes of practice. I only came across this because it was in the BMJ and have come across no mention of it in mainstream media.
With this current system of self-regulation, how can we be assured that breaches like these are not happening more widely in the UK? Furthermore, will ‘public reprimand’ be a sufficient penalty to ensure that such behaviour is not repeated?