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

2020 ◽  
pp. 2631309X2097047
Author(s):  
Shai Mulinari ◽  
Courtney Davis ◽  
Piotr Ozieranski

“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.

2002 ◽  
Vol 33 (4) ◽  
pp. 1-12 ◽  
Author(s):  
D. Harker ◽  
S. Cassim

The regulation of advertising is a controversial and difficult process, and many schemes around the world opt for a self-regulatory approach to curb unacceptable advertising. However, when schemes are established or reformulated, most countries learn from other, more established, regimes. Whilst Australia and South Africa commenced the advertising self-regulation (ASR) process at similar times and based their systems on the UK model, two attempts have been made in Australia over the past three decades to produce more acceptable ads, whilst South Africa’s system has endured in its original form. This paper reviews the ASR systems in these three countries, using a macro framework for analysis which contextualises advertising in society. The systems have the fundamental process of handling complaints about advertising in common, however there are advantages and disadvantages of each and these are discussed with a view to providing some guidance for Australia’s fledgling, reformulated, system. Important insights for the development of regulation of advertising are presented.


Author(s):  
Simeon J. Yates ◽  
Eleanor Lockley

This chapter reviews prior work on technology acceptance and then reports on a nationally representative survey of UK employees exploring both employee’s personal experiences of digital technologies at home and work and their evaluations of the effectiveness of the technologies and the “digital culture” in their organization. Presenting the results of 3040 UK workers, it seeks to explore the factors that influence digital roll-outs by focusing on the experiences and perceptions of the UK workforce as a whole, with the expectation that introducing new technology alone isn’t enough. This research explores how “digitally ready” organizations are in the UK in terms of people, processes, and company culture. It concludes that a large proportion of the UK workforce are not seeing the benefits of digital technologies. Importantly, there is a need for organizations to understand that making digital solutions a success is a process of cultural change in their organization.


1987 ◽  
Vol 41 ◽  
pp. 559-629
Author(s):  
Edward A. Johnston

1.1 A paper about the Appointed Actuary is essentially a paper about prudential supervision of life insurance companies. The system which has operated in the UK since the mid-1970's is only partly one of Government supervision. Through the professional role of the Appointed Actuary, it also contains elements of a system of self-regulation with the Institute and Faculty of Actuaries standing in place of SRO's. Unlike the self-regulatory arrangements of the Financial Services Act. though, this second part of the system has grown up by custom and practice and in certain respects it is not codified. However it enables the Insurance Companies Act to be operated successfully.


2017 ◽  
Vol 9 (8) ◽  
pp. 1325 ◽  
Author(s):  
Séverine Saintier

The rise of renewable energy sources (RES) comes with a shift in attention from government and market energy governance to local community initiatives and self-regulation. Although this shift is generally welcome at domestic and EU level, the regulatory dimension, at both levels, is nevertheless not adapted to this multi-actor market since prosumers are not empowered and energy justice is far from achieved. The rise, in the UK, of Community Interest Companies (consumers and local actors’ collectives) in the energy sector provides an interesting perspective as it allows a whole system’s view. Research was conducted with six energy community organizations in the South West of England in order to evaluate their role and identity and assess whether this exemplar of “the rise of a social sphere in regulation” could be used as a model for a more sustainable social approach to the governance of economic relations. Findings illustrate that such organizations undoubtedly play an important role in the renewable energy sector and they also help to alleviate some aspects of “energy injustice”. Yet, the failure to recognize, in terms of energy policy, at domestic and EU level, the importance of such actors undermines their role. The need to embed and support such organizations in policy is necessary if one is to succeed to put justice at the core of the changing energy landscape.


2020 ◽  
Vol 10 (1) ◽  
pp. 59-69
Author(s):  
Edmund C. Levin

Background: Screening adolescents for depression has recently been advocated by two major national organizations. However, this practice is not without controversy. Objective: To review diagnostic, clinical, and conflict of interest issues associated with the calls for routine depression screening in adolescents. Method: The evaluation of depression screening by the US Preventive Services Task Force is compared and contrasted with those of comparable agencies in the UK and Canada, and articles arguing for and against screening are reviewed. Internal pharmaceutical industry documents declassified through litigation are examined for conflicts of interest. A case is presented that illustrates the substantial diagnostic limitations of self-administered mental health screening tools. Discussion: The value of screening adolescents for psychiatric illness is questionable, as is the validity of the screening tools that have been developed for this purpose. Furthermore, many of those advocating depression screening are key opinion leaders, who are in effect acting as third-party advocates for the pharmaceutical industry. The evidence suggests that a commitment to marketing rather than to science is behind their recommendations, although their conflicts of interest are hidden in what seem to be impartial third-party recommendations.


2019 ◽  
Author(s):  
Leon Y. Xiao

Loot boxes represent a popular and prevalent contemporary monetisation innovation in video games that offers the purchasing player-consumer, who always pays a set amount of money for each attempt, the opportunity to obtain randomised virtual rewards of uncertain in-game and real-world value. Loot boxes have been and continue to be scrutinised by regulators and policymakers because their randomised nature is akin to gambling. The regulation of loot boxes is a current and challenging international public policy and consumer protection issue. This paper reviews the psychology literature on the potential harms of loot boxes and applies the behavioural economics literature in order to identify the potentially abusive nature and harmful effects of loot boxes, which justify their regulation. This paper calls on the industry to publish loot box spending data and cooperate with independent empirical research to avoid overregulation. By examining existing regulation, this paper identifies the flaws of the ‘regulate loot boxes as gambling’ approach and critiques the alternative consumer protection approach of adopting ethical game design, such as disclosing the probabilities of obtaining randomised rewards and setting maximum spending limits. This paper recommends a combined legal and self-regulatory approach: the law should set out minimal acceptable standards of consumer protection and industry self-regulation should thrive to achieve an even higher standard.


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