Abstract
“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.
Highlights
The interrelated issues of pharmaceutical industry regulation, crime control and ethics compliance were key concerns in John Braithwaite’s (1984) corporate criminology classic “Corporate Crime in the Pharmaceutical Industry.” When Braithwaite and colleagues revisited these issues 30 years later, they diagnosed what they saw as “a worsening crisis” since the 1990s, concluding that “corporate crime in the pharmaceutical industry appears to be on the rise” (Dukes et al, 2014, p. 275)
Its main purpose is to act as a threatening element in the background. This regulatory approach is advocated by its proponents in the belief that if regulators resist “the temptation to crowd out corporate ethics with excessive criminalization” they will be “more effective in reducing corporate crime in the pharmaceutical industry” (Dukes et al, 2014, p. 271)
If Braithwaite and colleagues are correct that corporate crime in the pharmaceutical industry has been growing, this seems to put in question responsive regulation because, over the last decades, the pharmaceutical sector has implemented many of the structures and strategies proscribed by the proponents of responsive regulation (Francer et al, 2014)
Summary
The interrelated issues of pharmaceutical industry regulation, crime control and ethics compliance were key concerns in John Braithwaite’s (1984) corporate criminology classic “Corporate Crime in the Pharmaceutical Industry.” When Braithwaite and colleagues revisited these issues 30 years later, they diagnosed what they saw as “a worsening crisis” since the 1990s, concluding that “corporate crime in the pharmaceutical industry appears to be on the rise” (Dukes et al, 2014, p. 275). Responsive regulation involves the concept of an “enforcement pyramid” whereby regulators seek to motivate compliance in the first instance through use of less punitive, self-regulatory strategies involving education, persuasion and negotiation, and by appeal to the intrinsic ethical and social values of a company. If these “softer” measures fail, regulators respond by progressively moving up the enforcement pyramid—but only as far as necessary. If Braithwaite and colleagues are correct that corporate crime in the pharmaceutical industry has been growing, this seems to put in question responsive regulation because, over the last decades, the pharmaceutical sector has implemented many of the structures and strategies proscribed by the proponents of responsive regulation (Francer et al, 2014)
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