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 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.
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.
In a document analysis, Shai Mulinari and colleagues examine the evidence for promotion and self-regulation by the pharmaceutical industry in the UK and Sweden.
Making and selling medicines is big business. In 2013, the global
revenue of pharmaceutical companies was nearly US$1 trillion. And every year, a large proportion of this revenue—maybe as much as one-third—is spent on drug promotion. The pharmaceutical companies claim that drug promotion (for example, advertisements in journals and visits from pharmaceutical sales representatives) helps to inform and educate health care professionals about the risks and benefits of medicines. However, drug promotion also has the potential to encourage health care professionals to prescribe inappropriate or needlessly expensive drugs and to encourage the public to buy unnecessary over-the-counter (OTC) drugs (medicines that, unlike prescription drugs, can be bought without a written instruction from a physician or other licensed health care professional). 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.
Why Was This Study Done?
Over the past decade, several whistleblower cases have spotlighted the illicit marketing practices of pharmaceutical companies in the US but relatively few similar cases have been brought in Europe. The reason for this discrepancy is unclear but one possibility is that the wider use of self-regulation in Europe encourages the industry to comply with drug promotion rules and deters illicit conduct. To date, however, self-regulation of medicines promotion has been poorly studied. Here, the researchers undertake a quantitative (numerical) and qualitative (descriptive) study of pharmaceutical self-regulation in the UK and Sweden, two countries often cited as places where self-regulation is effective. In both countries, the rules on medicines promotion are codified in the Code of Practice of the national industry trade group and are overseen by self-regulatory bodies that operate independently of the trade groups; the Swedish code applies to the promotion of both prescription and OTC drugs whereas the UK code applies only to the promotion of prescription drugs.
What Did the Researchers Do and Find?
The researchers first undertook a qualitative content analysis of the documents outlining the rules and procedures governing the self-regulatory bodies overseeing medicines promotion in the two countries. Both bodies, they report, are required to actively monitor promotional items and to impose sanctions on companies that violate the rules. However, a wider range of sanctions, which includes the audit and public reprimand of offending companies in addition to economic sanctions, can be imposed in the UK than in Sweden. Analysis of numerical data collected by the self-regulatory bodies on complaints, complainants, and rulings revealed that between 2004 and 2012 the Swedish and UK bodies ruled that 536 and 597 cases, respectively, were in breach of the country’s rules on medicines promotion; many of the violations in both countries concerned misleading claims about a drug’s effects. In Sweden, nearly half the complaints resulted from active monitoring of promotional items compared to only 0.2% in the UK. Charges incurred by companies because of violations of the medicines promotion code were equivalent to about 0.014% and 0.0051% of annual sales revenue in Sweden and the UK, respectively. Notably, nearly 20% of the cases in breach of the code of practice in both countries were serious breaches, and seven companies were in serious violation more than ten times each in the two countries combined.
What Do These Findings Mean?
These findings indicate that, between 2004 and 2012, there were numerous violations of the pharmaceutical industry codes regulating medicines promotion in both the UK and Sweden. That is, there was a clear discrepancy between the ethical standard codified in the pharmaceutical industry Codes of Practice in these two countries and the actual conduct of the industry. Importantly, the discrepancy may be larger than reported here because the researchers only considered violations that were detected and punished by the self-regulatory bodies in their analysis; some violations that occurred during the study period probably went undetected or unpunished. Given their findings, the researchers suggest that regulatory reforms, including pre-vetting of promotional materials, intensified active monitoring of promotion, larger fines, and the introduction of other sanctions such as greater publicity following rulings, may help to improve the quality of medicines information for health care professionals and the public in Sweden, the UK, and other countries where the pharmaceutical industry self-regulates drug promotion.
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001785.
Wikipedia provides information on pharmaceutical marketing (mainly in the US) (note that Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
The US Food and Drug Administration Office of Prescription Drug Promotion aims to protect the public health by assuring prescription drug information is truthful, balanced, and accurately communicated; the FDA’s Bad Ad Program aims to educate health care professionals about the role they can play in ensuring that drug advertising and promotion is truthful and not misleading
Information on the UK regulatory framework is available from the UK Medicines and Healthcare Products Regulatory Agency (MHRA); the MHRA website also includes information on MHRA vetting of advertising material.
Information on the UK self-regulatory body, the Prescription Medicines Code of Practice Authority (PMCPA), is available; the PMCPA website includes information about the UK Code of Practice for medicines promotion
Details of the Swedish Code are also available; codes for other European countries are provided by the European Federation of Pharmaceutical Industries and Associations
Healthy Skepticism is an international non-profit membership association that aims to improve health by reducing harm from misleading health information
The World Health Organization provides information about drug promotion and attitudes to it in “Drug Promotion—What We Know, What We Have Yet to Learn—Reviews of Materials in the WHO/HAI Database on Drug Promotion”