scholarly journals Antitrust Law and Regulatory Gaming

2016 ◽  
Author(s):  
Mark Lemley
Keyword(s):  
Choice Theory ◽  
Regulatory System ◽  
Drug Formulation ◽  
Regulatory Agencies ◽  
Antitrust Law ◽  
Regulatory Structure ◽  
Regulatory Oversight ◽  
Private Behavior ◽  
Regulated Industries ◽  
Regulatory Decisions

Antitrust law promotes competition in the service of economic efficiency.Government regulation may or may not promote either competition orefficiency, depending on both the goals of the agency and the effects ofindustry "capture." Antitrust courts have long included regulatedindustries within their purview, working to ensure that regulatedindustries could not use the limits that regulation imposes on the normalcompetitive process to achieve anticompetitive ends. Doing so makes sense;an antitrust law that ignored anticompetitive behavior in any regulatedindustry would be a law full of holes.The role of antitrust in policing regulated industries appears to bechanging, however. A cluster of Supreme Court decisions in the past decadehave fundamentally altered the relationship between antitrust andregulation, placing antitrust law in a subordinate relationship that, somehave argued, requires it to defer not just to regulatory decisions butperhaps even to the silence of regulatory agencies in their areas ofexpertise.Absolute antitrust deference to regulatory agencies makes little sense as amatter either of economics or experience. Economic theory teaches thatantitrust courts are better equipped than regulators to assure efficientoutcomes in many circumstances. Public choice theory - and long experience- suggests that agencies that start out trying to limit problematicbehavior by industries often end up condoning that behavior and eveninsulating those industries from market forces. And as history has shown,relying on regulatory oversight alone without the backdrop of antitrust lawwould leave both temporal and substantive gaps in enforcement, whichunscrupulous competitors could exploit to the clear detriment of consumers.The mere existence of a competition-conscious regulatory structure cannotguarantee against abuses of that structure, or against exclusionarybehavior that falls just beyond its jurisdiction. Indeed - and perhapsironically - the very regulatory structure that exists to promotecompetition can create gaming opportunities for competitors bent onachieving anti-competitive goals. Such "regulatory gaming" undermines boththe regulatory system itself and the longstanding complementaryrelationship between regulatory and antitrust law.We argue that the risk of regulatory gaming provides an important exampleof the need for ongoing antitrust oversight of regulated industries. Wedefine regulatory gaming as private behavior that harnesses pro-competitiveor neutral regulations and uses them for exclusionary purposes. We identifythree possible instances of regulatory gaming: (1) product-hopping, inwhich the branded company makes repeated changes in drug formulation toprevent generic substitution, rather than to improve the efficacy of thedrug product; (2) manipulation of government standard-settingorganizations; and (3) claims of price squeezes by partially regulatedindustries.Our goal in this paper is not to persuade the reader that these particularexamples of regulatory gaming do or do not violate the antitrust laws.Rather, our point is that whether or not particular acts of regulatorygaming harm competition is and should be an antitrust question, not merelyone that involves interpreting statutes or agency regulations. Some levelof antitrust enforcement - with appropriate deference to firm decisionsabout product design and affirmative regulatory decisions that affectmarket conditions - provides a necessary check on behavior, such as producthopping, that has no purpose but to exclude competition.

The Council on Wage and Price Stability: A Retrospective

2015 ◽  
Vol 6 (2) ◽  
pp. 400-431 ◽  
Author(s):  
Thomas Hopkins ◽  
Laura Stanley
Keyword(s):  
Economic Analysis ◽  
Cost Analysis ◽  
Regulatory Agencies ◽  
Price Stability ◽  
Executive Order ◽  
Regulatory Oversight ◽  
White House ◽  
Benefit Cost Analysis ◽  
Benefit Cost ◽  
Regulatory Decisions

Applying benefit-cost analysis in the White House regulatory oversight process served as a basic mission of the Council on Wage and Price Stability (CWPS) during its seven-year lifespan (1974–1981). This paper reviews that CWPS experience, which involved filing comments in over 300 proceedings at more than 25 federal regulatory agencies. The paper draws on those CWPS public comments (filings), identifying persistent and pervasive deficiencies in the economic analysis regulators then and now often use as support for new regulation. CWPS filings fostered greater acceptance of benefit-cost analysis in regulatory decisions; such analysis is now required by executive order.

scholarly journals Regulatory Stewardship

2021 ◽  
Vol 17 (1) ◽  
Author(s):  
Jeroen Van der Heijden
Keyword(s):  
Life Cycle ◽  
Regulatory System ◽  
Regulatory Agencies ◽  
Collaborative Approach ◽  
Conceptual Clarity ◽  
Consistent Manner ◽  
System Life

Since 2013, New Zealand’s regulatory agencies have had a statutory obligation to carry out regulatory stewardship. They have been expected to adopt a whole-of-system, life cycle view of regulation, and to take a proactive and collaborative approach to the monitoring and care of the regulatory system(s) for which they have responsibilities. In 2021, after eight years, regulatory agencies have not managed to operationalise their shared regulatory stewardship obligations in a coherent and consistent manner. This article explores the challenges they face in operationalising regulatory stewardship, and provides some conceptual clarity that may aid these agencies in collaborating to develop and adopt the whole-of-system, life cycle view of regulation that is envisaged.

Lawsuits raise cost and existential risks for US tech

2021 ◽  
Keyword(s):  
Law Enforcement ◽  
Financial Risks ◽  
Business Practices ◽  
Regulatory Oversight ◽  
Content Type ◽  
Regulated Industries ◽  
Liability Risks ◽  
Laws And Regulations

Significance Plaintiffs range from users, customers, app developers, investors, competitors, employees (current and former), law enforcement and tax agencies. They are seeking redress for alleged harm across a gamut of the companies’ business practices, creating financial risks for many firms and existential risks for a few. Impacts Losing privately brought lawsuits will disadvantage tech companies’ efforts to rebuff enhanced regulatory oversight. Some tech companies will initiate litigation to contest laws and regulations they consider a restraint on their businesses. As app platforms penetrate regulated industries such as finance and healthcare, liability risks will rise.

Regulating European financial markets between crisis and Brexit

2019 ◽  
Vol 28 (4) ◽  
pp. 503-514
Author(s):  
Jakob Schemmel
Keyword(s):  
Financial Markets ◽  
Regulatory System ◽  
Second Step ◽  
European Law ◽  
Regulatory Structure ◽  
Content Type ◽  
European Regulatory ◽  
Recent Reform ◽  
Rule Making ◽  
Practical Implications

Purpose This paper aims to demonstrate how the European regulatory structure of the financial markets has changed after the financial crisis. Drawing from these findings, it discusses how the regulatory system might change and be adapted to a post-Brexit financial market. Design/methodology/approach The paper takes a systematic/legal approach. First, it analyses the recent reform against the background of European law and corresponding research. In a second step, it discusses the implications of Brexit by examining policy and legal contributions. Findings The changes to the European regulatory and supervisory structure of the financial markets have proven to be a pacemaker for European administrative and treaty law. Long-standing principles have fundamentally changed. Brexit, on the other hand, even though equally severe might not lead to similar results. Practical implications The paper proposes a limited reform to the existing regulatory structure to consolidate developments, ease constitutional frictions and enable the regulatory authorities to react quickly to volatile markets via rule making. Originality/value The paper draws attention to an almost unnoticed development in European law. It also illustrates the effects of Brexit on the European financial markets.

scholarly journals Emerging hybridity: comparing UK healthcare regulatory arrangements

2017 ◽  
Vol 31 (4) ◽  
pp. 517-528 ◽  
Author(s):  
Joy Furnival ◽  
Kieran Walshe ◽  
Ruth Boaden
Keyword(s):  
Design Methodology ◽  
A Priori ◽  
Healthcare Systems ◽  
Regulatory Agencies ◽  
Regulatory Oversight ◽  
Content Type ◽  
Regulatory Architecture ◽  
Healthcare Regulation ◽  
The Uk ◽  
Regulatory Models

Purpose Healthcare regulation is one means to address quality challenges in healthcare systems and is carried out using compliance, deterrence and/or improvement approaches. The four countries of the UK provide an opportunity to explore and compare different regulatory architecture and models. The purpose of this paper is to understand emerging regulatory models and associated tensions. Design/methodology/approach This paper uses qualitative methods to compare the regulatory architecture and models. Data were collected from documents, including board papers, inspection guidelines and from 48 interviewees representing a cross-section of roles from six organisational regulatory agencies. The data were analysed thematically using an a priori coding framework developed from the literature. Findings The findings show that regulatory agencies in the four countries of the UK have different approaches and methods of delivering their missions. This study finds that new hybrid regulatory models are developing which use improvement support interventions in parallel with deterrence and compliance approaches. The analysis highlights that effective regulatory oversight of quality is contingent on the ability of regulatory agencies to balance their requirements to assure and improve care. Nevertheless, they face common tensions in sustaining the balance in their requirements connected to their roles, relationships and resources. Originality/value The paper shows through its comparison of UK regulatory agencies that the development and implementation of hybrid models is complex. The paper contributes to research by identifying three tensions related to hybrid regulatory models; roles, resources and relationships which need to be managed to sustain hybrid regulatory models.

scholarly journals Spatial and temporal information processing in the sea urchin embryo: modular and intramodular organization of the CyIIIa gene cis-regulatory system

Development ◽  
1996 ◽  
Vol 122 (1) ◽  
pp. 333-348 ◽  
Author(s):  
C.V. Kirchhamer ◽  
E.H. Davidson
Keyword(s):  
Transcription Factors ◽  
Functional Organization ◽  
Specific Interaction ◽  
Regulatory Region ◽  
Regulatory System ◽  
Dna Interaction ◽  
Regulatory Function ◽  
Regulatory Structure ◽  
Spatial Expression ◽  
Target Sites

The CyIIIa cytoskeletal actin gene of Strongylocentrotus purpuratus is expressed specifically in the aboral ectoderm. In earlier work we identified a 2.3 kb cis-regulatory region that is necessary and sufficient for correct spatial and temporal expression of a CyIIIa.CAT gene. This region includes about 20 sites of specific protein-DNA interaction, at which at least nine different transcription factors may be bound. All except two of these factors have been cloned. In this work we have analyzed by deletion or mutagenesis each specific interaction. A specific function was identified for every binding site examined. These individual functions include control of amplitude and timing of expression at different phases of embryogenesis, and control of spatial expression. We show that particular negative regulatory interactions are required to repress expression of the CyIIIa.CAT construct in oral ectoderm and in skeletogenic mesenchyme at different stages. In further experiments we determined the overall functional organization of the CyIIIa cis-regulatory system, and we show that this system is modular in its regulatory structure. The ‘proximal module’ (with respect to the transcription start site) extends upstream for about 800 base pairs, and includes nine target sites serviced by six different transcription factors. Its major role is to establish CyIIIa expression in the aboral ectoderm territory as the blastomere founder cells are specified and the oral-aboral axis is determined, and to activate the CyIIIa gene late in cleavage. The ‘middle module,’ which lies upstream of the proximal module, acquires major control of CyIIIa function after the blastula stage. It includes six target sites, serviced by four different factors. The middle module is responsible for a sharp increase in expression occurring during gastrulation, mediated by the positively acting factors that bind within it. The middle module also includes sites at which two different negatively acting spatial control factors bind, the functions of which are required for correct spatial expression late in embryogenesis. The ‘distal module’ contains a number of sites at which a positively acting factor binds, but this module exercises no spatial regulatory function. Interactions within the distal module are required for the normal levels of function of both the proximal and middle modules.

A survey of reverse mergers in the Chinese stock market

2019 ◽  
Vol 9 (1) ◽  
pp. 5-21
Author(s):  
Qingquan Xin ◽  
Ruitao Li ◽  
Sonia Wong
Keyword(s):  
Stock Market ◽  
Stock Price ◽  
Regulatory System ◽  
Superior Performance ◽  
Chinese Stock Market ◽  
Regulatory Oversight ◽  
Content Type ◽  
Reverse Mergers ◽  
Regulatory Policies ◽  
Asset Quality

Purpose The purpose of this paper is to provide an introduction to the reverse mergers (RMs) conducted in the Chinese stock market by summarizing the regulatory system, surveying the literature on RMs and analyzing the major characteristics of 161 RM cases. Design/methodology/approach This paper introduces the characteristics and evolution of the regulatory framework governing RM activity in China. Then the paper reviews relevant academic studies on the RMs in China and other countries. Finally, the paper identifies and discusses the major characteristics of 161 RM cases in the Chinese stock market from 2006 to 2016. Findings Private companies that go public via RMs in China not only have superior asset quality but also demonstrate good accounting and stock price performance after listing, and these results are unlike those of studies on the quality of RMs in other countries. Research limitations/implications This paper is based on a survey of 161 RM cases in China’s stock market, with the major characteristics of the RMs being identified and analyzed. The limitations of previous studies and suggestions for further research are discussed. Originality/value This paper suggests that the relative superior performance of RMs in the Chinese stock market is caused by the interplay of market forces and regulatory oversight. The Chinese regulator’s pragmatic and flexible approach plays an important role in formulating regulatory policies that respond to the changing macroeconomic environment and financial markets.

Improving the Guardrails

2020 ◽  
pp. 191-210
Author(s):  
Michael A. Livermore ◽  
Richard L. Revesz
Keyword(s):  
Cost Benefit Analysis ◽  
Regulatory System ◽  
Cost Benefit ◽  
Regulatory Review ◽  
Regulatory Decision ◽  
Ex Post ◽  
Regulatory Decisions ◽  
Ex Post Analysis ◽  
Trump Administration

Future administration can begin undoing the mistakes of the Trump administration by reinstating prior norms concerning cost-benefit analysis and meaningful regulatory review. Several reforms can go even further and improve the regulatory system. One reform involves rethinking the role of ex-post analysis of regulation, to focus resources on identifying and addressing cross-cutting areas of uncertainty in regulatory decision making. A second area where improvements can be made is improving the quantification of costs and benefits that are currently left unquantified. A third area for improvement involves developing general guidelines for examining and weighing the distributional effects of regulatory decisions.

A Defense of Limited Regulation of Human Genetic Therapies

2018 ◽  
Vol 28 (1) ◽  
pp. 112-120 ◽  
Author(s):  
JAMES J. HUGHES
Keyword(s):  
United States ◽  
Human Subjects ◽  
The United States ◽  
National Institutes Of Health ◽  
Regulatory Agencies ◽  
Cultural Norms ◽  
Regulatory Oversight ◽  
Reproductive Freedom ◽  
Gene Therapies ◽  
Genetic Technologies

Abstract:There is a role for regulatory oversight over new genetic technologies. Research must ensure the rights of human subjects, and all medical products and techniques should be ensured to be safe and effective. In the United States, these forms of regulation are largely the purview of the National Institutes of Health and the Food and Drug Administration. Some have argued, however, that human genetic therapies require new regulatory agencies empowered to enforce cultural norms, protect against hypothetical social harms, or ensure that the human genome remains unchanged. Focusing on the United States, this essay will briefly review these arguments and argue that the current limited regulatory role over human gene therapies is sufficient to protect public health, bodily autonomy, and reproductive freedom.

Ethos and Economics: Examining the Rationale Underlying Stem Cell and Cloning Research Policies in the United States, Germany, and Japan

2005 ◽  
Vol 31 (1) ◽  
pp. 47-86 ◽  
Author(s):  
Angela Campbell
Keyword(s):  
Stem Cell ◽  
Embryonic Stem Cell ◽  
Embryonic Stem ◽  
The United States ◽  
Reproductive Technologies ◽  
Regulatory Structure ◽  
Regulatory Oversight ◽  
Policy Makers ◽  
Moral Ambiguity ◽  
Reproductive Science

The governance of reproductive science is fraught with controversy in nearly every jurisdiction across the globe. Worldwide, legislators and policy makers have struggled to craft meaningful and ethical parameters for the regulation of this new and evolving area of biotechnology. In most countries, it is agreed that some form of regulatory oversight over reproductive technologies is necessary. There is far less consensus, however, as to the type of regulatory structure that should be established. Recent debates over reproductive science have focused on two of the most controversial practices in this area: embryonic stem cell research and cloning technology. Specifically, interested parties have struggled over whether these practices are so egregious that they should be altogether prohibited, or whether they ought to be permitted, but subject to particular legislative limits and regulatory oversight.The difficulties that most countries have experienced in devising legislation pertaining to embryonic stem cell and cloning research emanate from the moral ambiguity that characterizes this area of science.

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