Re-evaluating Regulatory Capture: The Limits of Industry Influence in Pharmaceutical and Consumer Financial Regulation

Lead Research Organisation: University of York
Department Name: Politics

Abstract

Regulation has become an increasingly important tool of government for safeguarding the public interest. As public services have become privatised, government regulation has been introduced to ensure that public goals are realised through private companies. Moreover, as risks from consumer goods have become more well-known, such as health risks arising from foods and medicines, governments have increasingly regulated markets to ensure consumer safety. As a consequence, we have seen a large increase in regulatory agencies that are staffed by experts and that operate independently from the rest of government. Expert institutions are thus taking many decisions that have a direct bearing on society. However, regulatory agencies are often accused of a phenomenon called 'regulatory capture'. Capture is the idea that private business interests excessively influence government regulation thereby diverting the ability of government to work in the public interest. Scholarship on the subject has been dominated by theoretical accounts that are rooted in so-called 'public choice' and 'principal-agent' theories. These are underpinned by the assumption that government regulatory officials are inherently prone to being captured since they have many incentives to shirk from the responsibilities given to them by elected leaders. For example, in this line of thought it is often argued that regulatory officials want to favour the businesses they are meant to regulate because this helps them to get lucrative jobs in the private sector after leaving their government job. This theoretical work has been complemented by mainly quantitative empirical work, especially in the US context, that shows that there are correlations between the decisions taken by government regulators and the presumed interests of regulated businesses.

This project shines a critical light on this scholarship and suggests that regulatory capture may be far less common than often assumed. It suggests that existing literature has insufficiently taken into account scholarship on the actual behaviour of regulatory officials: this literature has demonstrated that public officials usually have a strong belief in the societal value of their work and that their belonging to a professional group provides them with resilient norms and incentives to resist capture. For example, scientists working for a government regulator have strong incentives to follow principles of good scientific work in order to maintain their reputation among colleagues. The main objective of the project is to demonstrate that regulatory capture is not inevitable, and to provide a hitherto missing understanding about the conditions under which the professionalism of regulatory officials acts as bulwark against capture. To avoid the tendency to equate any regulatory decision that appears congruent with industry interests with capture, this research project suggests that we need to define capture as industry influence that results in the shifting of regulatory decisions away from the public interest towards special interests. In this light, studying capture requires the use of qualitative process-tracing analysis that, in contrast to existing quantitative research on regulatory capture, is uniquely suited to the identification of causation. This has been neglected in capture scholarship that mainly demonstrates correlations, not causation between industry interests and regulatory decisions. The project tests its novel theory of capture by comparatively tracing regulatory decision-making processes in two fields of regulation that are widely assumed to be vulnerable to capture: pharmaceutical market approvals and financial product consumer protection over four decades (from 1970 to 2010) in the United Kingdom.

Planned Impact

The project benefits government regulators, consumer advocacy and civil society groups by helping them to prevent capture. It also aims to benefit the wider public by informing public discourse on regulatory agencies.

The project benefits UK government regulators by providing a cross-sector forum for discussion about the difficult topic of regulatory capture. This is of benefit to them as it allows them to share best practices on how to avoid capture, as well as being introduced to the state-of-the-art of social sciences scholarship on how to prevent capture. Preventing capture is not only beneficial to the reputation of regulators. Rather, preventing capture is ultimately beneficial to society as it diminishes the undue influence of special interests and enhances the public legitimacy of government. To ensure that regulators -and society- will be impacted in these beneficial ways the project will host a workshop for regulators to be held in September 2021. This workshop is crucial for informing regulatory agencies in the UK about the aims, objectives and findings of the research project and the larger research agenda attached to it. The workshop focuses on short presentations of regulators about internal safeguards they have in place to prevent capture (or why these do not exist in their organisation), followed by a plenum discussion about 'best practices'. The plenum discussion will be guided by succinct policy briefs that highlight under which conditions industry can skew regulatory decision-making away from the public interest, based on the findings of the research project. The workshop also serves as a basis for co-design of research into regulatory capture by providing regulators with an opportunity to input into a future, cross-country and cross-sector research project on regulatory capture. Representatives of sixteen UK regulators are invited to the workshop. Next to the avenue of engaging directly with regulators, I will also contribute to any government consultations and Select Committee inquiries on regulatory agency reform to provide input on how to prevent capture through agency design.

The project will benefit consumer advocacy groups by empowering them to contribute to the prevention of capture. The scholarly literature on regulation widely assumes that third parties, such as consumer advocacy groups and other civil society groups, play a key role in safeguarding the public interest from undue private interests in regulatory processes. Based on the findings of the research project, specific information bulletins targeted at these groups will be created which will outline action points for effective intervention. These will be shared with groups via e-mail and the website with an invitation for personal meetings to discuss the project in September 2021. The focus of this one-to-one meeting approach will be the Money Advice Service, Citizens Advice, Which?, The Patients Association, National Rheumatoid Arthritis Organisation and the Stroke Association. These were selected in order to represent some umbrella consumer advocacy organisations as well as specialised organisations that stand in direct relationship with the case studies covered in the project. Empowering third parties is crucial in order to realise the wider societal benefits of preventing capture referred to above.

The project also aims to be of benefit to the wider public by raising awareness about government regulation and capture. Ultimately, the project aims to bring the enormous impact regulators have on society into sharper public focus. This has the potential to enhance the public accountability of regulators. To realise this impact, the public-facing part of the project website will include information bulletins and videos that outline the project's aims and findings. The Principal Investigator will also regularly contribute to media discussions on the topic of regulation.

Publications

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Description Government agencies are often accused of a phenomenon called 'regulatory capture'. Capture is the idea that private business interests excessively influence government regulation thereby diverting the ability of government to work in the public interest. Scholarship on the subject has been dominated by theoretical accounts that are underpinned by the assumption that government officials are inherently prone to being captured since they have many incentives to shirk from the responsibilities given to them by elected leaders. This project has created an alternative theoretical framework to this type of thinking. This project's theoretical work is based on the insights that public officials usually have a strong belief in the societal value of their work and that their belonging to a professional group provides them with resilient norms and incentives to resist capture. The ongoing empirical work of the project is beginning to reveal that regulatory capture is less common than has been widely assumed. It is also starting to unveil the complexity of evidencing regulatory capture through empirical research, thus shining a highly critical light on the low evidentiary standards used in other research on the subject. These findings have so far emerged from studying the decision-making of the British pharmaceuticals regulator in relation to three products that were authorised to the market and subsequently withdrawn due to causing severe side effects in patients (Lipobay, Vioxx and Avandia), and regulatory decisions on two financial products which turned into mis-selling scandals (endowment mortgages and Payment Protection Insurance). It is commonly assumed that such 'faulty' decision-making by regulators is caused by undue influence of pharmaceutical companies. However, the in-depth, process-tracing methodology used in this project highlights that decision-making on these cases was far more complex than that: under conditions of high scientific uncertainty in pharmaceuticals regulation, the regulator continuously took the risks associated with these products seriously and did take action once clear evidence of harmfulness of the products emerged. In financial consumer regulation, regulators tried to establish the nature and scale of the problem, and continuously tried to alter the behaviour of the industry. Nevertheless, the case studies also highlight a large degree of, potentially misplaced trust, in the regulated companies. Moreover, the comparative approach of the project is starting to highlight key differences in decision-making in the the two different areas of regulation: while shared norms of scientific rigour provided a check on regulatory capture in pharmaceutical regulation, in financial consumer regulation capture was mainly limited by the important role played consumer advocacy organisations. No detailed studies of the three cases of withdrawn medicines exist so far, and no comparisons have been drawn to decision-making in financial consumer regulation. So the project is contributing important new knowledge on the subject. At this stage of the project, it is too early to say whether the project's key hypothesis -that higher degrees of professionalism of regulatory agencies leads to lower degrees of capture- is supported by empirical evidence. To be able to shed light on the main hypothesis empirical research work on regulator decision-making on the final case of a mis-sold financial product is currently ongoing. All case studies together will provide a hitherto non-existing history of regulatory failures in pharmaceuticals and financial product consumer protection in Britain over four decades (from 1980 to 2020) in the United Kingdom.
Exploitation Route The findings of the project can be put to use by public administration scholars in order to emphasise that government agencies are, more often than not, a force for good in society. There is an increasing awareness in this academic discipline that increasing public distrust in expert government institutions is undermining democratic institutions, and that scholars in the field need to be more proactive in countering populist narratives about the expert institutions of government. The project will also benefit government regulators, consumer advocacy and civil society groups by helping them to prevent capture. The empirical work of the project is starting to uncover important differences in mechanisms of industry influence on regulatory agencies in different policy sectors. These crucial findings will be shared with regulatory officials and consumer advocacy groups once the empirical work of the project is completed. The project also aims to benefit the wider public by informing public discourse on regulatory agencies. Ultimately, the project aims to bring the enormous impact regulators have on society into sharper public focus.
Sectors Government, Democracy and Justice

URL https://capturerevisited.org/
 
Description I was invited to speak as an expert panellist about how to detect and prevent regulatory capture at the regulatory conference of the Australian Competition & Consumer Commission and the Australian Energy Regulator in 2022. This is part of an ongoing impact strategy to engage directly with regulatory authorities, with further plans to engage with agencies in the UK in similar formats. Specific impacts will be discussed here as they emerge. I have also promoted a shift in the debate about regulatory agencies, focusing on the positive role they play in society by developing free educational resources for school pupils, which have been used by secondary school teachers. This is also an ongoing activity and specific impacts will be discussed in detail here as they develop.
First Year Of Impact 2022
Sector Education,Government, Democracy and Justice
Impact Types Societal,Policy & public services

 
Title Analytical process-tracing framework for regulatory capture research 
Description The PI has developed a step-by-step analytical process-tracing method designed specifically for researching excessive industry influence on regulatory agencies. The analytical guide avoids the common mistakes made in a lot of regulatory capture research, which has suffered from the problem of confirmation bias. The analytical framework developed for this project focuses on chronological analysis of a set of pre-defined data sources in a specified order. Following this guide requires the researcher to consult all relevant evidence without deliberately or accidentally focusing exclusively on evidence that supports the theory of capture. It also requires the reader to understand regulatory processes from the beginning, rather than interpreting all evidence through the lens of a known outcome of the regulatory process. An additional benefit of the guide is that it makes the research process replicable by other researchers, which can be difficult to achieve in qualitative research. 
Type Of Material Data analysis technique 
Year Produced 2020 
Provided To Others? No  
Impact The analytical guide is used to structure the research process of all case studies on this project. Initial findings of the case studies show that capture has been misdiagnosed in most cases due to a lack of systematic causal process-tracing. 
 
Title Comparative theoretical framework of mechanisms of regulatory capture 
Description Based on a comprehensive literature review of all research on regulatory capture, the PI has developed a theoretical framework of different causes and mechanisms of regulatory capture. The framework requires the researchers to gather data on all driving factors and mechanisms of regulatory capture identified in the academic literature. This then enables systematic comparative analysis of regulatory processes across case studies in order to identify if and how capture was a consequence of a particular set of underlying factors. It also provides for the replicability of the research conducted for this project. 
Type Of Material Data analysis technique 
Year Produced 2020 
Provided To Others? No  
Impact The framework has the potential to identify why capture occurs in some regulatory processes and not in others, something that we currently lack knowledge on. Such insights have the potential to be beneficial for policy-makers and regulatory agencies in helping them to prevent capture. It is too early in the project to reach firm conclusions and achieve impact on this, but early case study findings indicate that causes and mechanisms of regulatory capture differ in different sectors of regulation. This is significant because advice on how to prevent capture has been dominated by 'one size fits all' approaches. 
 
Description York Regulation Network 
Organisation University of York
Department Department of Sociology
Country United Kingdom 
Sector Private 
PI Contribution As part of this research project, I took the lead in setting up a research network on regulation and governance at the University of York in collaboration with colleagues from the School for Business and Society and the Law School. The network now brings together researchers from six departments across two faculties, and will be expanded further in due course.
Collaborator Contribution Colleagues from the School for Business and Society and the Law School have contributed to organising events for the network and in securing additional funding (this is an ongoing effort).
Impact The network has hosted one research workshop and one practitioner seminar in the first three months of its existence. Two further research seminars and one guest speaker event are planned for the academic year 2022/23 (with more events to be organised in the following year).
Start Year 2022
 
Description York Regulation Network 
Organisation University of York
Department York Law School
Country United Kingdom 
Sector Academic/University 
PI Contribution As part of this research project, I took the lead in setting up a research network on regulation and governance at the University of York in collaboration with colleagues from the School for Business and Society and the Law School. The network now brings together researchers from six departments across two faculties, and will be expanded further in due course.
Collaborator Contribution Colleagues from the School for Business and Society and the Law School have contributed to organising events for the network and in securing additional funding (this is an ongoing effort).
Impact The network has hosted one research workshop and one practitioner seminar in the first three months of its existence. Two further research seminars and one guest speaker event are planned for the academic year 2022/23 (with more events to be organised in the following year).
Start Year 2022
 
Description Animation for wider public, students and school pupils 
Form Of Engagement Activity Engagement focused website, blog or social media channel
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact Online dissemination of an animation that explains what regulatory agencies are and showcases how their work affects our everyday lives. The animation discusses the main objectives of the research project and highlights that regulatory agencies are less influenced by industry than is often believed. The video was shared via Youtube, where it was viewed more than 2,800 times in the six months after posting.
Year(s) Of Engagement Activity 2021
URL https://futurumcareers.com/Political-Science-with-Dr-Eva-Heims.mp4
 
Description Article for international news website 
Form Of Engagement Activity Engagement focused website, blog or social media channel
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact More than 2000 people read this online article about the impact of the 'revolving door' on regulatory agencies. The main purpose of the article is to challenges the idea that the 'revolving door' results in excessive industry influence on government agencies among members of the public, professional practitioners and academics. The article received a number of comments from members of the public, professional practitioners and academics, thus promoting a debate on the issue.
Year(s) Of Engagement Activity 2020
URL https://theconversation.com/there-is-a-revolving-door-between-industry-and-regulators-but-does-that-...
 
Description Expert panellist at Practitioner Conference 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Several hundred representatives from government regulators and business/industry attended the panel 'Ethical business regulation - a panacea for regulatory capture?', in which I presented my work and view on regulatory capture as an expert panellist. The panel was organised as part of the 2022 Regulatory Conference of the Australian Competition & Consumer Commission and the Australian Energy Regulator.
Year(s) Of Engagement Activity 2022
URL https://www.accc.gov.au/about-us/conferences-and-events/accc-aer-regulatory-conference#2022-conferen...
 
Description Project article and activity sheet for secondary school pupils 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Schools
Results and Impact Online publication of a free education and careers resource for secondary school pupils and their teachers. It highlights that industries have less influence over regulators than the media have us believe. It also showcases the importance of comparison in the study of politics and aims to inspire pupils to study political science and to become researchers by providing a first-hand insight into the field.

The resources have been shared on teaching platforms, such as Tes, and were downloaded more than sixty times in the first six months after publication. It also received a five-star rating on Teachers pay Teachers, in which a teacher who used the material with Year 10-12 students commented that the material engaged pupils and provided for diversity and versatile learning strategies. The material also received more than 1500 likes on social media in the six months after publication.
Year(s) Of Engagement Activity 2021
URL https://futurumcareers.com/do-industries-influence-government-regulatory-agencies
 
Description Project website 
Form Of Engagement Activity Engagement focused website, blog or social media channel
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact The project website aims to engage a number of audiences (the public, practitioners, policy-makers and academics) by providing easily accessible information on research about industry influence on regulatory agencies. This engagement activity is currently ongoing as content is added to the website as the project develops.
Year(s) Of Engagement Activity 2020,2021
URL https://capturerevisited.org/