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Pharmaceutical companies violate own regulations

Shai Mulinari
Shai Mulinari

A new report from Lund University in Sweden shows how the pharmaceutical industry time and again violates regulations on the marketing of drugs. The study has been published in the journal PLOS Medicine.

In order to avoid unethical marketing, the pharmaceutical industry has a well-established system of self-regulation. There are individual national systems, but they are very similar in many European countries.

An interdisciplinary research group comprising researchers in social science and medicine have investigated judgments from the self-regulation bodies in the UK and Sweden over the years 2004 to 2012. The study revealed 597 and 536 cases respectively of marketing that violated the industry’s own regulations.

This means that unethical marketing of pharmaceutical drugs happens on average more than once a week in both the UK and Sweden.

Over half of cases related to misleading marketing. For instance, claims made about drugs were found to lack medical evidence. In other cases, the violation concerned marketing of prescription medications, which is prohibited in the EU.

In 20 per cent of cases, the violation of the regulations was judged to be severe.

“There is clearly a discrepancy between the ethical rules and what companies are actually doing”, said Shai Mulinari, a researcher in both social sciences and medicine who led the study.

Unethical advertising does lead to fines, but the sums are very low in proportion to the pharmaceutical industry’s revenue: 0.01% of annual sales in Sweden and 0.005% in the UK.

Dr Mulinari believes that higher fines and more publicity of the judgments could serve as an incentive to the pharmaceutical industry to improve its behaviour. However, he also feels that doctors should take action:

“It is important that doctors report impropriety, otherwise all responsibility is left to the industry.”

 Shai Mulinari
+46 737 34 33 16
shai [dot] mulinari [at] soc [dot] lu [dot] se

Publication: Complaints, Complainants, and Rulings Regarding Drug Promotion in the United Kingdom and Sweden 2004–2012: A Quantitative and Qualitative Study of Pharmaceutical Industry Self-Regulation