“Persistent and severe misconduct” by pharma companies in the U.K. shows the inadequacy of existing self-regulation of marketing, according to researchers who analyzed complaints from 2004 to 2021.
The analysis, details of which were published in the journal Regulation & Governance, looked at almost 1,800 complaints against pharma companies in the U.K. The goal of the research was to understand the effectiveness of self-regulation by looking at changes in metrics over time and by comparing U.K. data to figures from elsewhere in Europe.
Analyzing the U.K. data revealed repeat offenders. Self-regulatory body the PMCPA ruled 159 companies had breached the rules over the analyzed period. Twenty of the companies received sanctions in at least half of the analyzed years. The PMCPA sanctioned 10 companies in 14 or more years.
The researchers tracked changes in the severity of the sanctions. From 2004 to 2018, the PMCPA issued 11 Clause 2 rulings a year, on average. Clause 2 is a severe sanction reserved for companies that the body believes has brought discredit to and reduced confidence in the pharma industry.
After averaging 11 rulings a year, the PMCPA issued 25 Clause 2 rulings in 2019. The surge was sustained, as the PMCPA issued 30 Clause 2 rulings in 2020 and another 23 in 2021. Around half of the 81 recipients of Clause 2 rulings were repeat offenders, receiving the severe sanction in at least two years. Sixteen companies received Clause 2 warnings in four to nine of the analyzed years.
The researchers said “the widespread recidivism” underscores the ineffectiveness of self-regulation in deterring misconduct. Yet, the U.K. compared favorably to the European Union. The researchers said the U.K. “appears more adept at identifying potential breaches compared to most other countries, suggesting significant underdetection or underreporting of drug company misconduct in Europe.”
While the researchers found fault with Europe, they still see value in looking overseas for inspiration about how to enhance oversight in the U.K. Piotr Ozieranski, a University of Bath researcher and co-author of the paper, outlined an alternative to the current U.K. model in a statement.
“We envision a system akin to the U.S. model, where government regulators can impose substantial financial penalties for repeat or serious offenses,” Ozieranski said. “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.”