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

Mulinari, Shai; Davis, Courtney; Ozierański, Piotr

doi:10.1177/2631309x20970477

Cited by 18 publications

(21 citation statements)

References 22 publications

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“…77 , 81 However, studies of the self-regulation of drug promotion have documented significant discrepancy between industry codes and the actual conduct of the industry or specific companies. 79 , 82 - 84 …”

Section: Introductionmentioning

confidence: 99%

Tip of the Iceberg? Country- and Company-Level Analysis of Drug Company Payments for Research and Development in Europe

Ozierański

Martinon

Jachiet

et al. 2022

Int J Health Policy Manag

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Background: Creating new therapies often involves drug companies paying healthcare professionals and institutions for research and development (R & D) activities, including clinical trials. However, industry sponsorship can create conflicts of interests. We analysed approaches to drug company R & D payment disclosure in European countries and the distribution of R & D payments at the country and company level. Methods: Using documentary sources and a stakeholder survey we identified country-regulatory approaches to R & D payment disclosure. We reviewed company-level descriptions of disclosure practices in the UK, a country with a major role in Europe’s R & D. We obtained country-level R & D payment data from industry trade groups and public authorities and company-level data from eurosfordocs.eu, a publicly available payments database. We conducted content analysis and descriptive statistical analysis. Results: In 32 of 37 studied countries, all R & D payments were reported without named recipients, following a self-regulatory approach developed by the industry. The methodological descriptions from 125 companies operating in the UK suggest that within the self-regulatory approach companies had much leeway in deciding what activities and payments were considered as R & D. In five countries, legislation mandated the disclosure of R & D payment recipients, but only in two were payments practically identifiable and analysable. In 17 countries with available data, R & D constituted 19%-82% of all payments reported, with self-regulation associated with higher shares. Available company-level data from three countries with self-regulation suggests that R & D payments were concentrated by big funders, and some companies reported all, or nearly all, payments as R & D. Conclusion: The lack of full disclosure of R & D payments in countries with industry self-regulation leaves considerable sums of money unaccounted for and potentially many conflicts of interests undetected. Disclosure mandated by legislation exists in few countries and rarely enhances transparency practically. We recommend a unified European approach to R & D payment disclosure, including clear definitions and a centralised database.

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Section: Introductionmentioning

confidence: 99%

Tip of the Iceberg? Country- and Company-Level Analysis of Drug Company Payments for Research and Development in Europe

Ozierański

Martinon

Jachiet

et al. 2022

Int J Health Policy Manag

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“…However, the sums underreported by industry have been, on balance, smaller (Ozieranski et al, 2020), probably reflecting a single approach to disclosure (ABPI, 2019), contrasted with disparate ethical codes adopted by some patient organisations without central standards or oversight (Jones, 2008; Rickard et al, 2019). Failure to disclose by companies may also involve sanctions by the ABPI’s self‐regulatory body (Mulinari et al, 2020). Therefore, we chose drug company reporting to calculate the amount of funding received, although it only represents a minimum level of financial dependency.…”

Section: Methodsmentioning

confidence: 99%

A ‘patient–industry complex’? Investigating the financial dependency of UK patient organisations on drug company funding

Ozierański

Pitter²,

Rickard

et al. 2021

Sociology Health & Illness

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We examined the minimum extent of dependency of UK patient organisations on pharmaceutical industry funding using drug company disclosure reports and patient organisation financial accounts from 2012 to 2016. We used linear regression to explain the overall share of industry funding (‘general dependency’) and top donor funding (‘company‐specific dependency’) in organisations’ income. Predictors included patient organisations’ goal; having members and volunteers; geographical scope of activity; headquarter location; expenditure/income ratio; and disease area. The prevalent low levels of general dependency (IQR, 0.1%–6.0%) and company‐specific dependency (IQR, 0.1%–4.3%) made a widespread capture of patient organisations unlikely, though only if one excludes the possibility of significant payment under‐reporting. However, organisations with considerably higher dependency than others might be more prone to co‐optation by industry. Of the 398 organisations, 18 (4.5%) and 8 (2.0%) had general and company‐specific financial dependency over 50%, respectively. However, the shares of outliers exceeding the third quartile plus 1.5 times IQR were 51 (12.8%) and 56 (14.1%) for each dependency type. Certain characteristics including activity profile (advocacy) or indicating limited access to resources (remote location) made organisations vulnerable to developing financial dependency. Future research should examine both financial and non‐financial links between the two sides and their impact on patient organisations’ activity.

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“…There is a substantial literature that endorses responsive regulation across sectors and industries including human services and social work (Burford & Adams, 2004;Burford, Braithwaite & Braithwaite, 2019), taxation (Braithwaite, 2007;Job et al, 2007), the pharmaceutical industry (Mulinari et al, 2020), criminology (Braithwaite, 1989), corporate crime (Braithwaite, 2008;Schell-Busey et al, 2016;Tombs, 2015) and child welfare/child protection (Burford, Braithwaite & Braithwaite, 2019;Harris, 2011). Responsive regulation has also proven appealing to regulators and policymakers (Job et al, 2007;Parker, 2013), and efforts to decentralise governments (Tombs & Whyte, 2013).…”

Section: Ca L L I Ng For a Gr E At Er Foc Us On R E Sponsi V E R Egu ...mentioning

confidence: 99%

“We don’t want you to come in and make a decision for us”: Traversing cultural authority and responsive regulation in Australian child protection systems

Hamilton

Maslen

Farrant

et al. 2021

Aust J Social Issues

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The Ngulluk Koolunga Ngulluk Koort (Our Children Our Heart) project conducted extensive Elder and community consultation to develop principles and practice recommendations for child protection governance in Western Australia. We explore these principles and practice recommendations and highlight the need for culturally safe community consultation and governance with a focus on repairing damage incurred by the Aboriginal and Torres Strait Islander community from past child protection policies. We argue that using principles of responsive regulation and the inclusion of Elder voices in child protection decision making is critical to closing the gap between current practice and what is "best practice" for Aboriginal children and families. We also identify important considerations for preventing further harm through consultation processes, and issues of authority.

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

Cited by 18 publications

References 22 publications

Tip of the Iceberg? Country- and Company-Level Analysis of Drug Company Payments for Research and Development in Europe

Tip of the Iceberg? Country- and Company-Level Analysis of Drug Company Payments for Research and Development in Europe

A ‘patient–industry complex’? Investigating the financial dependency of UK patient organisations on drug company funding

“We don’t want you to come in and make a decision for us”: Traversing cultural authority and responsive regulation in Australian child protection systems

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