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Pharma firms violate marketing regulations every week, claims study

UK and Sweden said to act unethically more than once a week

UK flagA new study claims that pharma companies in the UK and Sweden are adopting unethical marketing practices "on average more than once a week."

The report by researchers at the University of Lund in Sweden says its findings show that the industry is failing to adhere to its own system of self-regulation on marketing of medicines and that the penalties imposed on violations are inadequate.

The authors - Anna Zetterqvist, Juan Merlo and Shai Mulinari - carried out an analysis on the self-regulation schemes operating in the UK and Sweden along with data from the overseeing bodies on complaints, complainants and rulings between 2004 and 2012.

In total, Swedish and UK bodies ruled that 536 and 597 cases, respectively, were in breach, equating to an average of more than one case per week for each country.

Over half of the cases related to misleading promotion, for instance when claims were made about drugs that lacked medical evidence. In other examples, the violation concerned marketing of prescription medications, which is prohibited in the EU.

One hundred cases in the UK (17% of total cases in breach) and 101 (19%) in Sweden were highlighted as "particularly serious", according to the research, which is published in the journal PLoS Medicine.

"Many were repeat offenders - including some of the largest pharmaceutical companies in the world," they write. Among the companies with multiple serious violation rulings across both countries during the period are Pfizer (19), Bayer (16), GlaxoSmithKline (13) and Novartis and Novo Nordisk (with 12 apiece).

The authors also suggest the numbers cited may be an under-estimate, given that it is "implausible" that all instances are picked up by the overseeing bodies, even assuming they are overseeing matters comprehensively, and a number of incidents deemed minor do not progress to become full cases. 

In addition, the UK regulations do not cover breaches involving over-the-counter (OTC) drugs, so any of these would not be included in the tally.

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

Moreover, while unethical advertising does lead to fines, the sums are very low in proportion to the pharmaceutical industry's revenue at around 0.01% of annual sales in Sweden and 0.005% in the UK.

Regulatory reforms such as pre-vetting of promotional materials and intensified active monitoring of promotion may help to improve adherence to ethical practices, the reports suggests.

Higher fines and more publicity of the judgments could also serve as an incentive to the pharmaceutical industry to improve its behaviour, according to Mulinari, but he also feels that doctors should take action. 

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

Article by
Phil Taylor

18th February 2015

From: Regulatory

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