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
Authors: Anna V. Zetterqvist, Juan Merlo, Shai Mulinari
Abstract
Background
In many European countries, medicines promotion is governed by voluntary codes of practice administered by the pharmaceutical industry under its own system of self-regulation. Involvement of industry organizations in policing promotion has been proposed to deter illicit conduct, but few detailed studies on self-regulation have been carried out to date. The objective of this study was to examine the evidence for promotion and self-regulation in the UK and Sweden, two countries frequently cited as examples of effective self-regulation.
Methods and Findings
We conducted a qualitative content analysis of documents outlining the constitutions and procedures of the two systems under study. Additionally, we collected data from self-regulatory bodies regarding complaints, complainants, and rulings spanning the period from 2004 to 2012. Through the qualitative analysis, we identified both similarities and differences between the countries. For instance, self-regulatory bodies in both countries have a mandate to actively monitor promotional items and impose sanctions on companies that violate the regulations. However, the range of sanctions is more extensive in the UK, where companies may face audits or public reprimands. In total, the Swedish and UK bodies identified 536 and 597 cases, respectively, as breaches, averaging more than one case per week for each country. Notably, 430 complaints (47%) in Sweden were a result of active monitoring, whereas the UK only reported two complaints (0.2%). Misleading promotion constituted the majority of violations in both countries. The financial charges imposed on companies averaged €447,000 and €765,000 per year in Sweden and the UK, respectively, corresponding to approximately 0.014% and 0.0051% of their annual sales revenues. Among the cases identified, 100 in the UK (17% of total breaches) and 101 in Sweden (19%) were deemed particularly serious. In total, 46 companies in the combined two countries were found in breach of the code for a serious offense at least once (36 in the UK and 27 in Sweden), with seven companies repeatedly violating the code more than ten times each. Analyzing serious violations related to diabetes drugs (UK: 15; Sweden: 6; 10% of serious violations) and urologics (UK: 6; Sweden: 13; 9%) through qualitative content analysis, various types of violations were identified, including misleading claims (23 cases; 58%), failure to comply with undertakings (9 cases; 23%), pre-licensing (7 cases; 18%) or off-label promotion (2 cases; 5%), and promotion of prescription drugs to the public (6 cases; 15%). It is important to note that undetected or unpunished violations by self-regulatory bodies are the main limitation of this study, as they may lead to an underestimation of industry misconduct.
Conclusions
The prevalence and severity of breaches testifies to a discrepancy between the ethical standard codified in industry Codes of Conduct and the actual conduct of the industry. We discuss regulatory reforms that may improve the quality of medicines information, such as pre-vetting and intensified active monitoring of promotion, along with larger fines, and giving greater publicity to rulings. But despite the importance of improving regulatory arrangements in an attempt to ensure unbiased medicines information, such efforts alone are insufficient because simply improving oversight and increasing penalties fail to address additional layers of industry bias.
Citation: Zetterqvist AV, Merlo J, Mulinari S (2015) 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. PLoS Med 12(2): e1001785. doi:10.1371/journal.pmed.1001785
Academic Editor: Aaron S. Kesselheim, Harvard University, Brigham and Women's Hospital, UNITED STATES
Received: July 24, 2014; Accepted: December 29, 2014; Published: February 17, 2015
Copyright: © 2015 Zetterqvist et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited
Data Availability: All relevant data are within the paper and its Supporting Information files.
Funding: Swedish Research Council, www.vr.se, nr. 2013-1268 (SM); Riksbankens Jubileumsfond (Bank of Sweden Tercentenary Foundation) www.rj.se, nr. P09-0281:1-E (SM), and Stiftelsen Rektor Nils Stjernquists forskningsfond, http://www5.lu.se/o.o.i.s/4241, nr. RFv2013-0356 (SM). AVZ and JM did not receive specific funding for this work. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Competing interests: The authors have declared that no competing interests exist.
