Pharmaceuticals, Corporate Crime and Public Health

Dukes, Graham; Moloney, Jayson

doi:10.4337/9781783471102

Cited by 46 publications

(55 citation statements)

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“…As argued here, reforms that may improve the quality of medicines information include intensified pre-vetting and active monitoring efforts in conjunction with fines that effectively deter industry from illicit promotion, as well as greater publicity following rulings. This list is not exhaustive (for example, see [ 62 ] for additional suggestions). Such reforms could have relevance for other countries as well [ 19 ] although more analyses of promotion regulatory systems are needed to substantiate this contention.…”

Section: Discussionmentioning

confidence: 99%

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

2015

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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. ...

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Section: Discussionmentioning

confidence: 99%

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

2015

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“…Through detailed analysis of the Astellas case, this article seeks to address two gaps in the corporate criminology literature on the pharmaceutical industry. The first is that most of the examples of illicit marketing and criminogenic cultures drawn on by Braithwaite and colleagues (Dukes et al, 2014) to support their contention of a "worsening crisis" pertain to the USA where companies have been subject to criminal prosecution rather than self-regulation (Mulinari, 2016). This is important because it is possible, but not proven, that the adversarial and punitive US system has failed to deter corporate crime in contrast to European self-regulatory systems, which would lend support to a responsive regulatory approach.…”

Section: Responsive Regulation In the Uk Pharmaceutical Sectormentioning

confidence: 99%

Failure of Responsive Regulation? Pharmaceutical Marketing, Corporate Impression Management and Off-Label Promotion of Enzalutamide in Europe

Mulinari

Davis

Ozierański

2020

Journal of White Collar and Corporate Crime

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“Responsive regulation” has been proposed to offset pharmaceutical industry illicit behavior in areas such as drug marketing based on self-regulation backed up with threats of government sanctions. We explore the efficacy of responsive regulation by tracing recent investigations by the UK pharmaceutical industry self-regulatory authority into the firm Astellas’s illicit promotion of a top-selling prostate cancer drug. Using documentary data, we reveal a ruthless company culture reflected in the illicit, so-called off-label promotion across Europe and the deceptive “impression management” by company managers during the course of investigations in the UK. We argue for a more probing, adversarial and government-led regulatory approach instead of the self-regulatory approach that shields breaching companies from enforcement actions and associated public scrutiny.

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“…The remedy advanced here is to make it also academically prestigious (prize-winning, income-generating, citationgenerating) to come up with one of the best preventive diplomacy ideas based on one's detailed knowledge of a particular country. The other thing that appeals to us about it is that, as we have seen with the prevention of disease (Dukes et al 2014), universities taking back leadership in applied research excellence from closed bureaucracies could put it on a more ethical footing. While it is open to an intelligence agency like the CIA to propose to its political leaders that its best idea is to deploy drones on missions of extrajudicial assassination in countries against which the United States has not declared war, or to establish an institution like the School of the Americas in Panama, such proposals could not possibly win prizes on an open-source preventive diplomacy wiki led by university professors.…”

Section: The Preventive Diplomacy Wiki Proposalmentioning

confidence: 99%

Cascades of Violence: War, Crime and Peacebuilding Across South Asia

D’Costa¹

2018

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Pharmaceuticals, Corporate Crime and Public Health

Cited by 46 publications

References 0 publications

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

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

Failure of Responsive Regulation? Pharmaceutical Marketing, Corporate Impression Management and Off-Label Promotion of Enzalutamide in Europe

Cascades of Violence: War, Crime and Peacebuilding Across South Asia

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