New data analysis by University of Bath and Lund University academics reveals that public health in the UK could be undermined by a failing system of drug company self-regulation. The research shows that drug companies are consistently violating their industry code of practice in drug marketing. Not only are the code violations pervasive, but a fifth of the cases involve code violations that have been branded as “severe” by the industry’s self-regulatory body. These failings are compounded by significant delays in complaint processing—ranging on average from 7 to 9 months in recent years—which may allow unethical or unsafe marketing practices to continue for prolonged periods.

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 implementation of the industry’s trade body, the Association of the British Pharmaceutical Industry’s (ABPI) Code of practice.

Key Findings:

• Between 2004 to 2021, the PMCPA ruled on more than 1,100 cases where the ABPI code was breached. These cases involved as many as 159 companies.
• This means that there were, on average, 1.2 cases per week involving companies breaching their own code of conduct.
  
• Of the 1,100 cases ruled in breach of the code of conduct, 20% were issued with a Clause 2 ruling. This happens when the PMCPA thinks there has been severe misconduct that tarnishes the industry's reputation and diminishes the public’s confidence in its practices. On average, this translated to more than two Clause 2 rulings per month.
• Clause 2 rulings have become more frequent. The average stood at around 11 clause 2 rulings per year from 2004 to 2018, but there was a notable surge in 2019 (25 involving 14 companies), 2020 (30 involving 23 companies), and 2021 (23 involving 16 companies).
• While about 40% of the companies faced sanctions in only one year between 2004 and 2021 the majority were repeat offenders with twenty companies (12.6%) sanctioned in half or more of the 18 years covered by the study.
• There are huge and increasing delays in processing cases regarding company misconduct by the PMCPA. For complaints lodged in 2020 and 2021, the PMCPA took an average of almost 7 and 9 months, respectively, to conclude a case, in comparison to 2004, when it took an average of 3 months to complete a case.

Dr. Piotr Ozieranski, from the Department of Social & Policy Sciences, said: “By considering the industry’s own documents, we have revealed widespread and repeat offending among drug companies. This misconduct, alongside huge delays in complaint processing, poses serious consequences for patient health.”

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.”

Repeat offending

An example of a recent repeat offender is the Danish pharmaceutical company, Novo Nordisk. From 2019 to the end of 2023, the PMCPA adjudicated against Novo Nordisk a total of ten times for inappropriate marketing of its weight-loss drug Saxenda (liraglutide). In March 2023, it was suspended as a member of the ABPI for two years because of “serious breaches” of the organisation’s code of practice, which is the harshest penalty ever levied on a drug company. Its failings included disguised funding and providing heavily biased training of healthcare professionals that downplayed the drug’s side effects, potentially endangering patient safety.

In 2020 it had received another Clause 2 ruling for disseminating promotional materials targeted at healthcare professionals and patients during a British fertility conference. However, it did not adequately communicate that Saxenda should not be used when trying to conceive during pregnancy, or while breastfeeding due to safety concerns.

How Can The Industry Stop Unethical Drug Marketing?

The research authors want stronger safeguards against unethical marketing practices.

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.”

The research is published in Regulation & Governance and was funded by the Swedish Research Council, Sweden's largest governmental research funding body.

This analysis builds upon a previous investigation by the authors and The British Medical Journal Investigations Unit and the authors long-standing joint research on pharmaceutical industry regulation and marketing.