Regulatory Justification Research Articles

Regulatory justifications: regulating European medicines to maximise market potential

ABSTRACTThe justification for regulating is generally considered to rely on benefitting interested groups. Whereas the traditional view is that regulators act as impartial arbiters balancing competing public and private interests, modern accounts consider regulation to be dominated by single interests, such as those of industry. This article challenges these theories by arguing that regulators are substantively (not just procedurally) motivated to justify their actions according to the goals set for them by the bodies that empower them. In consequence, regulators understand their goals as market-based objectives, prompting them to focus on maximising market potential. This is demonstrated in the context of regulating medicines in Europe, through the European Patent Organisation, the CJEU, and the European Medicines Agency. The analysis identifies that regulating to achieve market benefits is a better predictor of regulatory behaviour, but this behaviour frustrates goal-achievement (relating to effective and affordable medicines) and only incidentally enables benefits to accrue to specific groups.

To Breathe or Not to Breathe: Negative Data on Ozone and Vascular Function in an Established Research Model

To Breathe or Not to Breathe: Negative Data on Ozone and Vascular Function in an Established Research Model

A Deference to Protocol: Fashioning a Three-Dimensional Public Policy Framework for the Internet Era

A Deference to Protocol: Fashioning a Three-Dimensional Public Policy Framework for the Internet Era

Public Interest Law: Facing the Problems of Maturity

This article discusses the history and current status of public interest law. It examines the seminal work of the 1970s that established public interest law and contrasts the early period with the complexities and challenges today. It opens with a discussion of the key aspects of enterprise in the 1970s: creation of a new institutional form, the new role of public interest lawyer, the business plan for financing the firms and the economic, institutional regulatory justification. That the project has succeeded and public interest law has become a permanent part of the U.S. legal system. Looking at where we are today however there are two unfinished projects: inequality in society and the limits of the regulatory process. Lawyers today are redesigning the 1970s concepts to meet the challenges. They are engaging in collaborative practices, utilizing new roles as collaborators and facilitators, locating additional compensation and participating in public interest endeavors around the world.

A Brief Educational Intervention May Increase Public Acceptance of Emergency Research Without Consent

We hypothesized that knowing the regulations regarding emergency research without consent would increase public support for this type of research. Randomized controlled trial. Consecutive patients presenting during eight 24-h periods received one of two interviews; the intervention interview included an educational paragraph. There were 473 (74% of eligible) patients who participated: 51% (95% confidence interval [CI] 46-55) were willing to be enrolled in a study using exception to informed consent; 84% (95% CI 80-87) believed that current therapy for cardiac arrest offers ≥ 50% chance of full recovery, and these patients were less willing to enroll (odds ratio [OR] 0.5, 95% CI 0.3-0.9). The educational intervention increased willingness to enroll (OR 1.3, 95% CI 1.0-1.6, p = 0.03). A brief educational intervention had only a modest effect on willingness to participate in emergency research without consent. It may be more important to educate patients on the shortcomings of current therapy than on the ethical and regulatory justifications for such research.

Re-imagining the Role of Trade Unions after WorkChoices

No system where interests collide can proceed without a means to break deadlocks or redress major asymmetry of market power.--(Gardner 2008: 40) A focus on asymmetry of market power emerges as a central theme within three of the four plenary papers examining the future shape of Australia's federal industrial relations system. Gardner, Hancock and McCallum all affirm the inherent power imbalance existing in the common law employment contract as a continued justification for regulation in the arena of industrial relations. Yet, imbalance of power is not unique to the employment relationship, (2) a factor which has contributed to many commentators seeking a broader regulatory justification for intervention. (3) This approach is not incompatible with recognition of the existence and effect of power imbalance in the context of employment and the role of regulation in correcting power imbalance. It does, however, seek to establish a broader justificatory basis for the regulation of work, a project which may help the discipline of labour law move beyond the contract of employment as the locus of regulation. The rationale behind the impetus to extend the principles underpinning labour regulation clearly emerges in the acknowledgement made in each of the plenary papers of the declining role of trade unions and strike action within the modern federal industrial relations system. If collectivism is in decline, alternate methods of regulating the relationship of employees and employers should be adopted. This discussion will consider two of the central themes emerging from the plenary papers: power imbalance; and the impact of the shift in regulating trade unions as representatives of workers generally in favour of the regulation of trade unions as representatives or agents of individual union members. Gardner suggests that the causes of the declining influence of trade unions in Australia have been misrepresented as social rather than legal. Commenting on the impact of the amendments made to the federal legislation by the Keating Government in 1993 and the Howard Government in 1996, Gardner observes that 'the diminution of collective representation and influence looked like a societal change not a legislatively induced one'. The discussion will consider the ongoing role of trade unions and collective action within the Australian industrial relations framework in light of the history of industrial relations in Australia and the pessimistic assessment of the future of collective representation that emerges within some of the plenary papers. For example, Hancock argues that '[i]t may well be unrealistic to expect the unions to turn around the secular decline in their penetration of the work force'. However I believe this focus on the decline in union density is unhelpful in the Australian context. It is possible to imagine a rejuvenated role for trade unions as representatives of workers generally if we consider the role of unions in Australia within their historical context. In his plenary paper, McCallum reminds us of the origins of employment regulation and the transformation of the master and servant relationship from service to contract at the time of the industrial revolution. McCallum emphasises that the contractual relationship is characterised by command and obedience, wherein the employee submits to the control of the employer in return for payment. The underlying capital and managerial power of the employer is reinforced at common law by the terms of the contractual bargain which require the employee to obey lawful and reasonable commands, upon threat of summary termination. This emphasis on the contractual basis of the individual employment relationship serves to illustrate the inadequacy of the common law to redress the unequal position of an individual employee against the pre-existing capital power of the employer. It is also a useful tool for teaching students who have never studied industrial relations or labour law. …

Residential energy contracts and the 28 day rule

What measures are needed to protect customers when a utility market is first opened to competition? In the UK, residential (domestic) customers must be able to terminate energy contracts at 28 days' notice. This rule was introduced as a transitional protection for customers and for competition. However, the regulatory justification for the rule seems to have evolved over time. Removing the rule could have a number of advantages, including the development of fixed-price fixed-term contracts. The advantages of retaining the rule are questionable. In other retail sectors there is no regulatory concern or requirement of this kind. UK electricity suppliers have begun to offer capped prices for specified periods of time, suggesting that there is a growing customer demand for this. Fixed-price fixed-term contracts are a common form of competition in Scandinavia. The 28 day rule no longer seems necessary to protect customers and is more likely to distort than to protect competition. In retrospect, it would have been preferable not to introduce the rule in the first place.

Book Review: Social Citizenship in the Shadow of Competition: The Bureaucratic Politics of Regulatory Justification, by Bronwen Morgan. (Aldershot: Ashgate, 2003)

Book Review: <i>Social Citizenship in the Shadow of Competition: The Bureaucratic Politics of Regulatory Justification</i>, by Bronwen Morgan. (Aldershot: Ashgate, 2003)

Morgan: Social Citizenship in the Shadow of Competition: The Bureaucratic Politics of Regulatory Justification

Morgan: Social Citizenship in the Shadow of Competition: The Bureaucratic Politics of Regulatory Justification

The weakest link: demonstrating the inconsistency of "appropriate levels of protection" in Australia-Salmon.

In Australia-Salmon, the WTO Appellate Body found Australia to be in violation of the WTO SPS Agreement based on the inconsistency of the "appropriate level of protection" underlying various SPS measures. Article 5.5 of the SPS Agreement prohibits arbitrary or unjustifiable distinctions in "appropriate levels of protection" if such distinctions result in discrimination or a disguised restriction on international trade. In Australia-Salmon, Canada challenged Australia's import ban on salmon. Australia permitted the entry of other fish products that were known to host some of the same diseases cited by Australia in justifying its salmon import ban. The distinction in the "appropriate levels of protection" between Australia's regulation of salmon and its treatment of these other fish products was found to be "arbitrary or unjustified" and to have "resulted in a restriction on international trade."Australia-Salmon was the first WTO decision to find an Article 5.5 violation. Canada successfully made a "weakest link" argument to undercut Australia's regulatory justification. The decision rests on the relationship between the risk purportedly justifying the salmon import ban and the risk seemingly ignored in Australia's treatment of other fish products-the regulatory "situations" compared concerned the identical pathogens with the identical potential consequences. As such, Australia-Salmon may be an example of a category of regulatory "chains" that are peculiarly exposed to Article 5.5 challenge. In responding to the Appellate Body's ruling, Australia reduced its limits on salmon and imposed new restrictions on the other fish products. The outcome suggests that a challenge of one SPS measure under Article 5.5 may lead to the imposition of new restrictions on other imported products-an unexpected result for the free trade regime.

The Weakest Link - Demonstrating the Inconsistency of 'Appropriate Levels of Protection' in Australia-Salmon

In Australia-Salmon, the WTO Appellate Body found Australia to be in violation of the WTO SPS Agreement based on the inconsistency of the appropriate level of protection underlying various SPS measures. Article 5.5 of the SPS Agreement prohibits or unjustifiable distinctions in appropriate levels of protection if such distinctions result in discrimination or a disguised restriction on international In Australia-Salmon, Canada challenged Australia's import ban on salmon. Australia permitted the entry of other fish products that were known to host some of the same diseases cited by Australia in justifying its salmon import ban. The distinction in the appropriate levels of protection between Australia's regulation of salmon and its treatment of these other fish products was found to be arbitrary or unjustified and to have resulted in a restriction on international trade. Australia-Salmon was the first WTO decision to find an Article 5.5 violation. Canada successfully made a weakest link argument to undercut Australia's regulatory justification. The decision rests on the relationship between the risk purportedly justifying the salmon import ban and the risk seemingly ignored in Australia's treatment of other fish products - the regulatory situations compared concerned the identical pathogens with the identical potential consequences. As such, Australia-Salmon may be an example of a category of regulatory chains that are peculiarly exposed to Article 5.5 challenge. In responding to the Appellate Body's ruling, Australia reduced its limits on salmon and imposed new restrictions on the other fish products. The outcome suggests that a challenge of one SPS measure under Article 5.5 may lead to the imposition of new restrictions on other imported products - an unexpected result for the free trade regime.

A theory of the theory of public goods

The article critically examines the traditional theory of public goods, it is an established part of the theory of public finance. The author shows that this theory in the form in which it is treated by its creators and authors of modern textbooks, can serve no empirical explanation for the production of a good in the public sector, no regulatory justification for such production. Then, the article developed political economy concept that the fact that some goods are produced and provided by the state, is due to the interests of the state, seeking to build up their own wealth and political power. In this context, the very theory of public goods and its promotion are explained as part of a system of institutions, ensuring the preservation and expansion of the power and influence of the state in society.