Novel data analysis released by the University of Bath and Lund University has highlighted that public health could be at risk due to a faulty system of drug company self-regulation.
The research shows that drug companies are violating their industry code of practise during drug marketing, with many being outed as repeat offenders.
According to the investigators, a fifth of the associated cases involve 'severe' code violations, as judged by the industry's self-regulatory body. These failings are only made worse by significant delays to the complaint processing procedure — which is estimated to take between seven to nine months.
The study
Dr Piotr Ozieranski at the University of Bath and Dr Shai Mulinari from Lund University examined 1,776 complaints against drug company misconduct made in the UK over 18 years (2004 – 2021).
The complaints were made to the drug industry’s self-regulatory body — the Prescription Medicines Code of Practice Authority (PMCPA) — which oversees the Association of the British Pharmaceutical Industry’s (ABPI) Code of practice.
While around 40% of companies faced sanctions in one instance, the majority were repeat offenders
The prevalence of code breaches
Between 2004 to 2021, the PMCPA ruled on more than 1,100 cases which involved breaches in the ABPI code; with as many as 159 companies implicated.
On average, there were 1.2 cases a week involving companies who were seen to be breaching their own code of conduct.
Of the 1,100 cases considered to breach the ABPI's code of conduct, 20% were Clause 2 rulings — which encapsulates the cases with severe misconduct that could tarnish the industry's reputation, as well as diminishing the public's confidence in pharmaceutical organisations.
This amounted to more than two Clause 2 rulings per month on average, which has experienced a notable surge since 2019.
While around 40% of companies faced sanctions in one instance, the majority were repeat offenders, with 20 companies sanctioned in 50% or more of the 18 years the study spanned.
Delays in complaints processing
The study also highlights the significant delays in processing company misconduct cases, and the researchers say this is only increasing.
Complaints that were submitted during 2020–2021 were found to take an average for seven to nine months to reach any conclusion, whereas they approximately took three months in 2004.
Dr Shai Mulinari said: “By allowing unethical drug promotion to carry on for extended periods, patients' health is in jeopardy. These findings underscore the urgent need for stricter enforcement and quicker resolution of complaints to ensure the safety and well-being of patients.”
Dr Piotr Ozieranski emphasised the need for rigorous regulation: “We envision a system akin to the US model, where government regulators can impose substantial financial penalties for repeat or serious offenses. Moreover, we want regulators to take a proactive and adversarial stance, actively monitoring drug company misconduct instead of relying mainly on complaints from well-informed insiders. Another crucial recommendation is to expand protections for whistle-blowers.”
