Improving Pharmaceutical Self-Regulation

Conduct needs to match ethical standards for pharmaceutical industry in Europe, study finds.

Ethical standards and actual conduct within the pharmaceutical industry in Europe needs to be more closely aligned, a recent study indicated.

Published in the journal PLOS Medicine, the study finds an existing discrepancy between the ethical standard that is codified in pharmaceutical industry Codes of Practice and the conduct of the pharmaceutical industry in the UK and Sweden.

The researchers reached this conclusion after performing qualitative content analysis of documents that outline rules and procedures that govern the self-regulatory bodies who oversee medication promotion both countries. The study utilized numerical data that was collected by self-regulatory bodies on complaints, complainants, and rulings.

The researchers found that between 2004 and 2012, the Swedish and UK regulatory bodies ruled 536 and 597 cases, respectively, were in breach of each country’s existing rules on medication promotion. The study noted that many of the violations in the two countries involved misleading claims about the effects of various treatments.

Companies were charged due to medication promotion code violations, which were equivalent to approximately 0.014% and 0.0051% of annual sales revenue in Sweden and the UK, respectively. Furthermore, almost 20% of cases that were in breach of the code of practice in both countries were regarded as serious breaches.

Seven companies were found to be in serious violation more than 10 times each in both countries combined. The researchers noted that the actual number of violations may be even greater than reported because the study only included violations that were detected and punished by self-regulatory bodies in their analysis.

"Policies that might improve the quality of medicines information include intensified pre-vetting and active monitoring efforts in conjunction with larger fines, as well as greater publicity following rulings,” the study authors concluded.