Abstract
BackgroundIn 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 FindingsWe performed a qualitative content analysis of documents outlining the constitutions and procedures of these two systems. We also gathered data from self-regulatory bodies on complaints, complainants, and rulings for the period 2004–2012. The qualitative analysis revealed similarities and differences between the countries. For example, self-regulatory bodies in both countries are required to actively monitor promotional items and impose sanctions on violating companies, but the range of sanctions is greater in the UK where companies may, for instance, be audited or publicly reprimanded. 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/week for each country. In Sweden, 430 (47%) complaints resulted from active monitoring, compared with only two complaints (0.2%) in the UK. In both countries, a majority of violations concerned misleading promotion. Charges incurred on companies averaged €447,000 and €765,000 per year in Sweden and the UK, respectively, equivalent to about 0.014% and 0.0051% of annual sales revenues, respectively. One hundred cases in the UK (17% of total cases in breach) and 101 (19%) in Sweden were highlighted as particularly serious. A total of 46 companies were ruled in breach of code for a serious offence at least once in the two countries combined (n = 36 in the UK; n = 27 in Sweden); seven companies were in serious violation more than ten times each. A qualitative content analysis of serious violations pertaining to diabetes drugs (UK, n = 15; Sweden, n = 6; 10% of serious violations) and urologics (UK, n = 6; Sweden, n = 13; 9%) revealed various types of violations: misleading claims (n = 23; 58%); failure to comply with undertakings (n = 9; 23%); pre-licensing (n = 7; 18%) or off-label promotion (n = 2; 5%); and promotion of prescription drugs to the public (n = 6; 15%). Violations that go undetected or unpunished by self-regulatory bodies are the main limitation of this study, since they are likely to lead to an underestimate of industry misconduct.ConclusionsThe 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.
Highlights
A string of whistleblower cases in the United States over the past decade has spotlighted the illicit marketing practices of pharmaceutical companies [1,2]
In stark contrast to the US, Europe has had few high-profile cases [3]. This invites the question whether illicit marketing is uncommon in Europe, or whether other factors may account for this disparity, such as lack of monetary incentives for whistleblowers, or other aspects of the European legal and regulatory framework
It has been suggested that industry may refrain from illicit marketing in Europe because in many countries industry is highly involved in policing marketing claims, which is purported to provide the industry with incentive to comply with rules [4,5]
Summary
A string of whistleblower cases in the United States over the past decade has spotlighted the illicit marketing practices of pharmaceutical companies [1,2]. In many European countries promotion is governed by a voluntary code of practice administered by the industry’s own system of self-regulation [5,6,7,8]. Such an arrangement differs from the US —and some European countries, e.g., France [5]—where regulatory agencies such as the Food and Drug Administration (FDA) directly regulate promotion [9]. 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. In many countries, including the US, government bodies regulate the promotion of medicines but in other countries, including many in Europe, the pharmaceutical industry self-regulates medicines promotion through voluntary codes of practice
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