12 December 2015

DTC Genomics regulation in Europe

'Current developments in the regulation of direct-to-consumer genetic testing in Europe' by Louiza Kalokairinou, Heidi C. Howard and Pascal Borry in the latest Medical Law International comments
Over the past years, direct-to-consumer (DTC) genetic testing has provoked controversy regarding its still questionable risks and benefits. The safety and performance of such devices, when entering the European market, are currently regulated by the Directive 98/79 EC of the European Parliament and of the Council on in vitro diagnostic medical devices. In September 2012, a new Regulation was proposed to replace this Directive, and the legislative process is still ongoing. This article presents the main points of the European Commission’s proposal for the new Regulation and the subsequent amendments voted by the European Parliament, aiming to evaluate the potential contribution of the proposal for a more effective regulation of DTC genetic testing in Europe. In this regard, the proposal seems to enhance the current regulatory framework by further elucidating the scope of the Regulation and by establishing a risk-based classification system that guarantees increased pre-market scrutiny of the tests. Furthermore, the proposal attempts to establish higher safety and performance requirements and to enhance transparency. In addition, the European Parliament introduced amendments according to which appropriate genetic counselling is required in the context of genetic tests, and such tests are classified as prescription only, banning, at the same time, their DTC advertising. These developments have already provoked controversy among stakeholders and, if eventually adopted, they may lead to a radical change in the European DTC genetic testing landscape. In this light, the political decisions that will be taken imminently will be determinant.
In introducing the article they state
Even though proponents of [direct-to-consumer (DTC) genetic] tests claim that they enhance the autonomy of consumers and promote their education regarding genetics, there is great concern among policymakers, professional groups and scientists regarding various ethical, social and regulatory aspects associated with such services. These concerns include, among others, issues regarding the questionable validity and utility of DTC genetic tests and the often poor and misleading information accompanying them, as well as concerns regarding the privacy of results and the possible stigmatization and discrimination resulting from a privacy breach. In addition, it is feared that the absence of adequate medical supervision and genetic counselling in this context may lead to inappropriate health decisions and unnecessary burden on the healthcare system if consumers request and obtain unnecessary consultations with medical professionals. Moreover, the effectiveness of regulation regarding DTC genetic testing has been widely debated, both in Europe and in the United States, and it is further complicated by such tests being mostly marketed through the Internet, rendering the enforcement of relevant legislation more challenging.
The aim of this article is to outline exactly how regulation of DTC genetic testing in Europe is likely to be affected by the proposed Regulation on In Vitro Diagnostic Medical Devices, which is currently under discussion in a trialogue between the European Parliament, the Council of the European Union (EU) and the European Commission. More specifically, after providing a brief introduction to the historical background of the proposed regulation, the proposed amendments will be summarized and assessed, focusing especially on the scope of protection provided by the proposed regulation, the risk classification of devices, the regulation of self-tests, clinical evidence and clinical utility, transparency and truth in labelling, canalization and advertising of genetic tests and, finally, regarding genetic counselling and informed consent.
The authors conclude
Adopting the current proposed Regulation and the amendments introduced by the Parliament will mean that a very broad range of genetic tests, including tests for both health-related and lifestyle purposes may fall within the scope of the Regulation, regardless of the jurisdiction in which the manufacturer is established, as long as they are offered to people residing in EU Member States. Furthermore, DTC genetic tests will be subject to additional requirements set for self-testing devices, whilst, according to the new risk-based classification system, (DTC) genetic tests will have to go through a pre-market assessment by independent notified bodies. In this respect, the proposed Regulation and the amendments voted by the European Parliament improve upon the current regulatory framework and may raise the standards of safety and performance for genetic tests entering the European market. Nevertheless, the lack of definition and requirements for the assessment of clinical utility might render its inclusion in the pre-market evaluation of IVD devices meaningless and/or burdensome for the notified bodies.
Furthermore, the European Parliament’s amendments make mandatory the involvement of health-care professionals in the process of genetic testing by requiring appropriate genetic counselling for every type of genetic test as well as by classifying all genetic tests as prescription only and banning DTC advertising for such tests. A full implementation of these provisions would mean, in theory, that genetic testing companies will have to redirect the provision of their products and their marketing campaigns to health-care professionals since directly accessing consumers in the EU will be illegal. In this way, the amendments attempt to bring genetic testing back to the traditional, physician-centred model of healthcare, despite the recent shift to a model focusing on consumer empowerment, as initiated by DTC genetic testing companies.
Even though requiring genetic counselling and the involvement of health-care professionals in the genetic testing process might mitigate the risks stemming from particular subsets of tests, the competence of the EU to regulate clinical practice in such detail has been contested. There are concerns that the very broad definition of genetic tests provided by the proposal, in combination with particularly strict requirements for pre-market approval, without taking into account risks and benefits associated with each type of test, would be overly restrictive and stifle innovation and competitiveness in Europe. Hence, it may be important for the restrictions imposed on the tests to be proportionate with the potential risks stemming from such tests in order to achieve an appropriate balance between the protection of public health and the right of the individuals for self-determination and access to their genetic information.
As a general comment, it may be noted that the amendments introduced by Parliament emphasize medical supervision and genetic counselling in order to address some of the risks potentially stemming from DTC genetic testing. At the same time, an opportunity to establish robust criteria of clinical validity is being missed, whilst the inclusion of clinical utility in the pre-market assessment is not likely to have any impact on DTC genetic tests. In this regard, it may be argued that the medical prescription model and the mandatory pre- and post-test genetic counselling have been valued more than ensuring the good quality of the tests. This policy choice might prove to be problematic since it shifts responsibility to health-care professionals who may often not be adequately equipped to assume the role of gatekeepers.
The Council, on the other hand, seems to move closer to the position of the Commission and attempts to ensure that IVD devices are thoroughly assessed when entering or being put into service in the European market and they are adequately surveyed after that.
When it comes to DTC genetic testing, the approaches adopted by the Parliament and the Council are divergent. It remains to be seen how this opportunity to change the DTC genetic testing landscape will be handled on the political level and on which side the pendulum will settle.
Finally, it should be kept in mind that the Regulation is still a long way from implementation. A trialogue among the Commission, the Parliament and the Council started in October 2015. This procedure might last for several months. Taking into account that the proposal of the Parliament provides a 3-year transition period before implementation of the Regulation, whilst the Commission and the Council propose a 5-year period, and given the rapid developments in the DTC industry, it is not clear to what extent the reforms will impact the DTC genetic testing market.
'Should Extinction be Forever? Restitution, Restoration, and Reviving Extinct Species' by Christian Diehm in (2015) 37(2) Environmental Ethics comments
 “De-extinction” projects propose to re-create or “resurrect” extinct species. Perhaps the most common justification offered for these projects is that humans have an obligation to make restitution to species we have eradicated. There are three versions of this argument for de-extinction—one individualistic, one concerned with species, and one that emphasizes ecological restoration—and all three fail to provide a compelling case for species revival. A general critique of de-extinction can be sketched that highlights how it can both facilitate inattentiveness to biological and ecological boundaries and foster a managerial mentality toward the natural world.
'Towards a Law of the Mammoth? Climate Engineering in Contemporary EU Environmental Law' (Tilburg Law School Research Paper No. 07/2015) by Han Somsen comments
 In an article that made waves when it was first published in 1996, judge Easterbrook scorned the idea that the technological reality of cyberspace justified talk about or a need for ‘Cyber Law’. Just as there is no need for a ‘Law of the Horse’ merely because horses give rise to legal claims, he argued, conventional legal principles and reasoning are sufficiently accommodating to absorb new legal challenges that arise in the wake of cyberspace. We may likewise doubt the need for a ‘Law of the Mammoth’, even though technologies emerge that harbour the prospect of bringing back the woolly mammoth from extinction, reversing climate change, and creating new life forms. Cyber Law is now firmly established, of course, and Easterbrook also appears to have lost the academic debate from the likes of Lawrence Lessig. That fact notwithstanding, the onus to show that the time has come for a Law of the Mammoth clearly is on those staking the claim. 
The purpose of this article essentially is to prepare the ground for that argument, with particular but by no means exclusive reference to climate engineering. Instead of framing the question as one of a confrontation between environmental law and climate engineering, a multitude of technologies instrumental in intentionally enhancing the environment suggests that it is appropriate more generically to consider the introduction of a novel concept in environmental law that captures the essence of such efforts. In the same vein as ‘human enhancement’ has come to be distinguished from ‘medical therapy’, in view of novel environmental policy uses of technologies it is submitted that we should consider the virtues of distinguishing environmental ‘enhancement’ from environmental ‘improvement’.

Occupations

The De-Licensing of Occupations in the United States by Robert J. Thornton and  Edward J. Timmons in (2015)  Monthly Labor Review comments
Occupational licensing directly affects nearly 30 percent of U.S. workers today and continues to grow in density and scope. In this article, we identify and analyze those rare instances when occupational licensing laws have been eliminated — what we refer to as “de-licensing.” We also discuss recent examples in which courts decided to limit the scope of occupational licensing laws, and we analyze recent efforts (almost uniformly unsuccessful) of a few states to de-license groups of occupations. The reason proposed for most of these efforts is that excessive levels of licensing have hindered job creation, especially for people with lower levels of education. We argue that the paucity of successful de-licensing efforts is due to intense lobbying by associations of licensed professionals as well as the high costs of sunset reviews by state agencies charged with the periodic review of licensing and its possible termination. ...Addressing de-licensing is important because it raises several questions. Once an occupation is licensed, is it likely to remain licensed, or do effective mechanisms exist to periodically reevaluate whether the continued licensing of the occupation is in the public interest? What effects has de- licensing had or could be expected to have on the numbers of practitioners and earnings levels in the de-licensed occupation? Various studies have found that licensing, much like unions, can reduce practitioner numbers while increasing earnings. Does de-licensing cause converse effects? That is, would de-licensing increase the number of practitioners while decreasing earnings? If so, how sizable are these effects and how rapidly would they occur? These questions are particularly important because the extent to which job regulation (such as licensing) inhibits job growth and the potential for deregulation to promote job growth have recently become important national issues.

11 December 2015

Hohfeld

'How To Do Things With Hohfeld' by Pierre Schlag in (2015) 78(1/2) Law and Contemporary Problems 185-233 comments 
Wesley Newcomb Hohfeld’s 1913 'Fundamental Legal Conceptions as Applied in Judicial Reasoning' is a brilliant article.  A thrilling read it is not — more like chewing on sawdust. The arguments are dense, the examples unwieldy, and the prose turgid. As for Hohfeld’s project—the identification of fundamental legal conceptions — it seems to promise all the aesthetic charm of standard nineteenth-century juristic science.  Taxonomic activity will be happening. There will be classification. And jurisprudence by subdivision.
Oh, joy.
Yes. It’s that article. And yet, conceding all this (in fact, insisting on it), I hold to my claim: The full significance of Hohfeld’s article is hardly evident upon a first (or even second) read. And yet, as I try to show here, it can fundamentally alter the way one thinks about law. The taxonomic ambitions of Hohfeld’s style render his work suspect—at least to those who consider themselves postrealist or postmodern or post- whatever. I get it. I too am generally put off by this sort of thing. In my case, the aversion is a result of getting burned once too often: a legal philosopher proposes to offer a new classification scheme; he assures that great things will follow (the achievement of conceptual clarity is almost always involved); then after much arduous reading and repeated encounters with ethereal abstractions, nothing happens. Well, Hohfeld is not like that. Hohfeld redeems his conceptual taxonomy at great, though admittedly not always reader-friendly, length. He repeatedly shows the practi cal usefulness and theoretical power of his analyses even if he does not fully recognize or exploit all of their ramifications.
One of the most striking aspects of Hohfeld’s work is how much its architecture and arguments remain relevant—even bitingly so—today. Here I want to celebrate Hohfeld’s work and show how his thinking remains a powerful corrective to common errors in contemporary legal thought. More than that, I want to show how his work continues to serve as an extremely useful platform for intellectual, economic, and political insight into contemporary law. Where the full usefulness and power of Hohfeld’s analyses are not explicit, I will be pushing hard to show what can be done with his platform—specifically as regards its economic and political implications for law.
Strikingly, even the most objectionable aspects of Hohfeld’s work, for instance, his atomism, nonetheless yield extremely useful insights. Like any truly great work of legal scholarship, Hohfeld’s work not only helps us understand what it sets out to explore, but also serves to map out the problems it leaves unresolved. The upshot is that we learn not just from its successes but from its limitations. Hence it is that, more than a hundred years after its publication, there are many implications to Hohfeld’s work yet to be fully elaborated. 
To put it trenchantly, without Hohfeld, one simply misses a lot. In my view (and no, this is not the occasion in which I come out as a pragmatist), the great virtue of Hohfeld’s approach is not so much that Hohfeld’s analyses are right, but rather that they are useful and thought-provoking.

Accidents and Ambos

'ACT Workcover and the Failed 1997 Implosion: A Case Study of the Role of the Inspectorate' (National Research Centre for OHS Regulation Working Paper No. 91) by Patricia Healy comments
The failed implosion of the old Canberra Hospital buildings on Sunday 13 July 1997 resulted in an explosion which blasted masonry and steel debris beyond the 200 metre exclusion zone to where thousands of spectators stood watching on the shore of Lake Burley Griffin. A young spectator, Katie Bender, was killed instantly when struck by a fragment of that debris.
At the Bender Inquest the Coroner, Mr Shane Madden, described the implosion project as having failed systemically. He attributed the failure to: the Project Manager’s and contractors’ lack of appropriate competencies; the absence of input from independent engineers and explosives experts; inappropriate action by the ACT Chief Minister’s Office and Department in promoting the implosion as a public event; and failure of the regulatory agencies to properly discharge their functions.
It is clear, in retrospect, that the wholesale underestimation of the risk to public safety was a significant factor in this litany of failures. The public safety risk inherent in the implosion project as it was implemented, was unrecognized, discounted or underestimated by all the parties involved at all stages of the project. This study, with the great benefit of hindsight, examines why this occurred and how it affected the role of ACT WorkCover and those inspectors directly involved. Specifically it examines how the particular circumstances of the implosion project combined with the situation and practice of WorkCover to influence the inspectors’ assessment of the inherent risks and the exercise of their regulatory enforcement powers.
The 2nd Reading Speech for the Transparency in Government Bill 2015 (Vic) meanwhile states
This bill is an important step towards promoting regular public reporting of performance data by Victoria's ambulance and fires services, and Victoria's public hospitals. It establishes a new statutory framework to facilitate the regular release of ambulance and fire services' response times to emergency incidents; the mandatory annual release of important performance agreements, known as a statement of priorities, between the government and the boards of Ambulance Victoria, public health services and denominational hospitals; and the regular release of performance data by public health services and denominational hospitals.
The bill will deliver upon the government's commitment to ensure greater  transparency in the delivery of public health and emergency services. It will also address the need to improve the public reporting of emergency services' response times, as outlined in the 2015 Victorian Auditor-General's Office Emergency Service Response Times report..
The information required to be reported under this bill is about the performance of public services that are of critical importance to Victorians. Victorians have a right to clearly understand the performance of these services, and have a right to do so without having to go through a Freedom of Information process to access this information. This bill will ensure the enduring and easy access to this information for the public..
This  government is committed to providing greater transparency about the way that these crucial services operate. The men and women who work in these agencies perform an invaluable service for our community and we are grateful for it. The need for greater transparency arises precisely because their service is of such importance to Victorians. Victorians are entitled to understand how their critical services are performing..
The bill provides a framework for the release of three different kinds of information:
  • Response times for Ambulance Victoria, the Country Fire Authority (CFA) and the Metropolitan Fire and Emergency Services Board (MFESB); 
  • Statements of priorities agreed to by Ambulance Victoria, public health services and denominational hospitals; and 
  • Performance data for public health services and denominational hospitals against the performance indicators in their statements of priorities.
Response times for Ambulance Victoria, the CFA and MFESB will be published online every quarter for prescribed emergency incidents, providing the 50th and 90th percentile response times to an emergency incident in a municipal district or local government area and thereby ensuring "that Victorians have an accurate impression of historical response times in their community". Total response times will be included, providing an understanding of the time it takes from the point at which the Emergency Services Telecommunications Authority (ESTA) receives a call for assistance to the first arrival at the scene by the relevant agency. 
The government acknowledges that response times are not the sole indicator of how effective or how well an agency is performing and that a range of factors can affect an agency's response time performance, such as geographical and seasonal variations. For this reason, the bill expressly clarifies that further information can be included in these reports, to promote greater transparency by contextualising the information and providing meaningful commentary. This will ensure that, if necessary for the public to clearly understand response times in their context, agencies will be able to provide the necessary contextual information to the public.
The bill recognises that there are likely to be times when the resources of an emergency service are devoted to addressing a major emergency, such as major bushfires during the fire season. In such circumstances, the  bill allows the minister to delay the publication of quarterly reports until a major emergency has been sufficiently addressed before reporting is resumed. The bill also recognises the potential impact of sustained and prolonged industrial action on the ability to collect and prepare response time data, and also allows for delayed publication in such circumstances. The  bill ensures that there is transparency when these exceptions are relied on by requiring the minister to publish a statement so that the public is aware that a report will be delayed.
The Speech indicates that the Bill will introduce
 a requirement for all statements of priorities for Ambulance Victoria, public health services and denominational hospitals to be published online by 1 November each year.
Statements of priorities are important documents that outline an annual agreement between the board of a health service and the relevant minister. They set out strategic priorities and agreed objectives for each financial year in terms of financial sustainability, services access and performance, safety and quality and service delivery, with accompanying performance indicators and performance targets.
Denominational hospitals are not legislatively required to agree to a statement of priorities, but where they choose to do so, the bill also requires their publication.
If a statement of priorities is not agreed in time to be published by 1 November for the relevant year, the bill ensures that the minister will publish reasons for the delay, and will ensure the publication of the statement of priorities as soon as practicable after agreement is reached.
Public health services and denominational hospitals with statements of priorities will be required to publish quarterly performance reports against specificperformance indicators in those statements.
These indicators are to be chosen from the prescribed performance categories, such as safety and quality performance or access and timeliness performance. In some cases, it will not be practical for certain performance indicators to be reported against on a quarterly basis. For example, data for a particular performance indicator might be collected by an independent contractor on a yearly basis. The bill enables the minister to specify an alternative reporting timetable, and requires publication of the reasons for the variation.
Where a public health service or denominational hospital has not agreed on a statement of priorities, the bill facilitates the reporting of health performance data by allowing the minister to publish a quarterly performance report against the performance indicators specified in the notice issued by the minister. If the public health service or denominational hospital later agree to a statement of priorities, the minister will publish a quarterly performance report based on the performance indicators in the agreed statement of priorities and that have also been specified in the notice issued by the minister.
The devil is in the detail, with the Speech indicating that minister responsible for administering the Health Services Act 1988 (Vic) will be permitted to delay reporting of hospital performance data in cases where it would unreasonably divert resources from a major emergency (ie the escape clause increasingly used by Commonwealth agencies in relation to the Freedom of Information Act) or as a result of prolonged or sustained industrial action.

Fiduciaries

'Accommodating Loyalty' by Andrew S. Gold in Paul B. Miller and Andrew S. Gold (eds.) Contract, Status, and Fiduciary Law (Oxford University Press, 2016) comments
 Legal and extra-legal conceptions of loyalty often diverge, most notably in fiduciary law. Some consider this divergence problematic because they see loyalty duties as moral duties, or because they see loyalty as a moral virtue. This chapter raises doubts about a moralistic view of fiduciary loyalty, in part due to difficulties in legal enforcement. Rather than seek to bring the law into a closer fit with moral understandings of loyalty, this chapter will instead suggest that the law should accommodate extra-legal conceptions of loyalty – that is, it should make space for loyal individuals to take on obligations that match their understanding of what it is to be loyal.
'The Collective Fiduciary' by Lauren Roth comments 
Can fiduciaries be made to serve public goals? The movement under the Patient Protection and Affordable Care Act (‘ACA’) towards universal access to health insurance requires us to focus on the fiduciary relationships between large organizations providing access to healthcare and the populations they serve. These relationships have become a collective undertaking instead of a direct, personal relationship.
In this Article, I introduce the concept of the collective fiduciary in response to the shift towards uniform, national goals in the realm of health insurance and healthcare. Only through a collective approach can we hold fiduciaries accountable for the welfare of many instead of one or a few individuals. While other scholars have focused on the individual whose fortunes or health are controlled by a fiduciary, this has made it difficult to collect information about fiduciary actions and obtain consistent and coherent decisions from fiduciaries. My argument here is that this is not a problem that can be fixed at the level of the individual fiduciary or individual beneficiary.
I examine the expansion of the role of the fiduciary as a result of growing demand for private welfare benefits in the United States. My concern here is with the expansion of health insurance and the administration of health benefits. If patients are denied benefits, then they are effectively denied access to service providers. In a space where the government has been, until now, largely absent both by choice and because of a lack of agreement on policy direction, individual decisions by fiduciaries add up to the only large scale policy existing for private benefits. Fiduciaries can and will undo the goal of expanding access to healthcare under the ACA unless ERISA’s fiduciary regime (the example I focus on in this Article) is altered. Though I explore several possible solutions, I ultimately argue that fiduciary duties are only meaningful when denials of benefit claims are supervised and capped by government actors. 

Patent Litigation

'The First Patent Litigation Explosion' by  Christopher Beauchamp in Yale Law Journal (Forthcoming)  comments
The twenty-first century “patent litigation explosion” is not unprecedented. In fact, the nineteenth century saw an even bigger surge of patent cases. During that era, the most prolific patent enforcers brought hundreds or even thousands of suits, dwarfing the efforts of today’s leading “trolls.” In 1850, New York City and Philadelphia alone had ten times more patent litigation, per U.S. patent in force, than the entire United States in 2013. Even the absolute quantity of late-nineteenth-century patent cases bears comparison to the numbers filed in recent years: the Southern District of New York in 1880 would have ranked third on the list of districts with the most patent infringement suits filed in 2014 and would have headed the list as recently as 2010.
This Article reveals the forgotten history of the first patent litigation explosion. It first describes the rise of large-scale patent enforcement in the middle of the nineteenth century. It then draws on new data from the archives of two leading federal courts to trace the development of patent litigation from 1840 to 1910 and to outline the scale, composition, and leading causes of the litigation boom. Finally, the Article explores the consequences of this phenomenon for the law and politics of the patent system. The effects of the litigation explosion were profound. The rise of large-scale patent assertion provides a new explanation for patent law’s crucial shift from common law to equity decision making in the middle of the nineteenth century. And at its height, the litigation explosion produced a political backlash that threatened to sweep away the patent system as we know it. Recovering the history of patent law during this formative and turbulent era offers fresh perspectives on the patent reform debates of today.

Governance

'Ideals of the Corporation and the Nexus of Contracts' by Ewan McGaughey in ((2015) 78(6) Modern Law Review 1057 asks 
What is 'the fundamental nature of the laws' that govern ‘public corporations in the United States and the United Kingdom’? This review article explores the 'nexus of contracts' view of the corporation, against its critique by Marc Moore in Corporate Governance in the Shadow of the State (2013). While the nexus of contracts theorists are usually thought to align the corporation to the private sphere, and seek to limit government interference, Moore suggests that corporations ought to be regarded as public. His analysis seeks to demonstrate that corporate laws of the United States and United Kingdom are essentially public. This article adds a further level, that the majority view of the corporation has been that it is a social institution. This stands in stark contrast to the nexus of contracts approach, whose roots lie in comparative German-American scholarship from the 1930s. In substance, this approach illegitimately privileges the claims to govern for a 'leadership' body of directors, asset managers, or banks, all of whom gain voice with 'other people's money'.
McGaughey comments
What is ‘the fundamental nature of the laws’ that govern ‘public corporations in the United States and the United Kingdom’? To basically similar questions, Frank Easterbrook and Daniel Fischel once famously answered, ‘Who cares?’ ‘Divergence between private and social interest,’ they wrote, ‘is rare’. So it did not matter what goals large corporations pursued: profit, social welfare, or charity. It did not matter whether corporations acted long-term or short-term, because a corporation was simply a set of ‘private agreements’. The only reasons to not enforce private agreements were force, fraud, lack of mental capacity, external effects on third parties, or maybe to alleviate poverty. But those goals were all achieved in the general law of contract, or tort, or specific regulation outside corporate law. Corporate law itself was just sub-category of contract law where, according to them, the aim is to enforce private bargains. Often the express terms of the ‘corporate contract’ run out. Then, corporate law makes default rules for what the parties ‘would have wanted’ (and only that) had they thought about it, and had they had no transaction costs. But if you officiously enquired about the fundamental nature of corporate law, the testy reply was just: ‘Who cares?’
Probably for this reason alone, but also for many others, Corporate Governance in the Shadow of the State is an important contribution to literature on ideals of business regulation. Evidently, Moore does care about the nature of the company. The basic question he poses is whether regulation of large listed corporations is more ‘public law’ or ‘private law’. His case studies are the major ‘Anglo-American’ models, represented by a Delaware ‘Inc’ (as modified by federal US regulation), and a UK ‘plc’. But the ‘private or public’ debate is not an end in itself. It is a route to the normative question of how large corporate structures ought to function: a profound question if, as Moore says, the ‘dominant academic paradigm’ does indeed ‘trickle down into the so-called ‘real world’.’

CEDAW

'Why Do National Court Judges Refer to Human Rights Treaties? A Comparative International Law Analysis of CEDAW' by Christopher McCrudden in American Journal of International Law (Forthcoming) reports 
An analysis was conducted of 325 national judicial decisions across 55 jurisdictions, in which CEDAW was referred to in the reported decision. Despite predictions to the contrary based on previous scholarship, significant variations between courts in their interpretation of CEDAW occurred relatively infrequently, courts referred relatively seldom to interpretations of CEDAW by other national courts, and there was little evidence of transnational dialogic approaches to judging. An analysis of these results suggests that domestic judges invoking CEDAW act primarily as domestic actors who use international law in order to advance domestic goals, rather than acting primarily as agents of the international community in applying CEDAW domestically, or contributing to the transnational shaping of international law to suit national interests. The Article suggests an understanding of the domestic implementation of a human rights treaty as not only law, but as a unique kind of law that performs a particular function, in light of its quality as something akin to hard and soft law simultaneously.

Feminist Theory and Paternalism

'Legal Feminism and the Post-Racism Fantasy' by Rakhi Ruparelia in (2014) 26 Canadian Journal of Women and the Law 81-115 comments
In 1993, the Canadian Journal of Women and the Law published a special issue on racism in an effort to “shift paradigms” in feminist legal scholarship in Canada. This article examines scholarship published in the journal since that time to evaluate to what extent this aspiration has been realized. Although some progress has been made, feminist theorizing around racism and colonialism is not being undertaken as a matter of course. Rather, this theorizing is pursued most often when an issue has obvious significance to racialized women. The author explores why feminists, and white feminists in particular, still do not regularly integrate the impact of racism and colonialism into their writing and the potential consequences of this choice. She argues that ignoring the role of racism and colonialism in legal scholarship perpetuates systems of domination, which feminism should be aggressively dismantling and thus impedes the feminist project. The author ultimately questions whether theorizing without meaningful analysis of the role of racism, colonialism, and other sites of oppression can still be considered feminist.
'The Dark Side of Nudging: The Ethics, Political Economy, and Law of Libertarian Paternalism' by Christopher McCrudden and Jeff King in Alexandra Kemmerer, Christoph Möllers, Maximilian Steinbeis, Gerhard Wagner (eds.)  Choice Architecture in Democracies, Exploring the Legitimacy of Nudging  (Hart and Nomos, 2015) argues
Libertarian paternalism, as advanced by Cass Sunstein, is seriously flawed, but not primarily for the reasons that most commentators suggest. Libertarian paternalism and its attendant regulatory implications are too libertarian, not too paternalistic, and as a result are in considerable tension with ‘thick’ conceptions of human dignity.
We make four arguments. The first is that there is no justification for a presumption in favor of nudging as a default regulatory strategy, as Sunstein asserts. It is ordinarily less effective than mandates; such mandates rarely offend personal autonomy; and the central reliance on cognitive failures in the nudging program is more likely to offend human dignity than the mandates it seeks to replace. Secondly, we argue that nudging as a regulatory strategy fits both overtly and covertly, often insidiously, into a more general libertarian program of political economy. Thirdly, while we are on the whole more concerned to reject the libertarian than the paternalistic elements of this philosophy, Sunstein’s work, both in Why Nudge?, and earlier, fails to appreciate how nudging may be manipulative if not designed with more care than he acknowledges. Lastly, because of these characteristics, nudging might even be subject to legal challenges that would give us the worst of all possible regulatory worlds: a weak regulatory intervention that is liable to be challenged in the courts by well-resourced interest groups. In such a scenario, and contrary to the ‘common sense’ ethos contended for in Why Nudge?, nudges might not even clear the excessively low bar of doing something rather than nothing.
Those seeking to pursue progressive politics, under law, should reject nudging in favor of regulation that is more congruent with principles of legality, more transparent, more effective, more democratic, and allows us more fully to act as moral agents. Such a system may have a place for (some) nudging, but not one that departs significantly from how labeling, warnings and the like already function, and nothing that compares with Sunstein’s apparent ambitions for his new movement.

Copyright and computer-authored work

'There's No Such Thing as a Computer-Authored Work – And It's a Good Thing, too' by James Grimmelmann in Columbia Journal of Law and the Arts (Forthcoming) comments
Treating computers as authors for copyright purposes is a non-solution to a non-problem. It is a non-solution because unless and until computer programs can qualify as persons in life and law, it does no practical good to call them "authors" when someone else will end up owning the copyright anyway. And it responds to a non-problem because there is nothing actually distinctive about computer-generated works.
There are five plausible ways in which computer-generated works might be considered meaningfully different from human-generated works: (1) they are embedded in digital copies, (2) people create them using computers rather than by hand, (3) programs can generate them algorithmically, (4) programmers as well as users contribute to them, and (5) programs can generate them randomly. But all of these distinctions are spurious. Old-fashioned pen-and-paper works raise all of the same issues. A close look at the creative process shows how little really changes when authors use digital tools. The problems posed for copyright by computer-generated works are not easy, but they are also not new.

08 December 2015

Heideggeroids and Legal Realists

From Thomas Sheehan's 'What if Heidegger were a Phenomenologist' in Mark Wrathall (ed) The Cambridge Companion to Heidegger's Being and Time (Cambridge University Press, 2013) 381-402 at 381
Paid-up Heideggerians – call them Heideggeroids – are addicted to speaking in the idiosyncratic code that Heidegger himself concocted, an often perplexing idiom that Karl Jaspers once called Heideggergegacker, “Heidegger cackling.” Not unlike the American Derridoids, who follow their own mystagogue (“Everyone say oui, oui”), Heideggeroids are deeply devoted to channeling the Master’s voice from the Great Beyond, a practice that follows from the Doctrine of Heideggerian Exceptionalism. 
According to his devotees, the Master was attuned to mysteries that had never before been seen or heard (cf. Paul’s ἄρρητα ῥήματα, ineffable sayings: II Corinthians 12:4), and he bequeathed these secrets to a small conventicle of initiates in an esoteric language that they alone, using their secret decoder rings, are able to understand. (Philosophers of other persuasions are so totally jealous.) And only by speaking in that secret cipher can Heideggeroids avoid the pitfalls of “metaphysical language” and the disasters attendant upon it.
''Legal Theory,' Strategies of Learned Production, and the Relatively Weak Autonomy of the Subfield of Learned Law' by Bryant Garth and Yves Dezelay in Justin Desautels-Stein and Christopher Tomlins (eds.) In Search of Contemporary Legal Thought (Cambridge University Press) (Forthcoming) comments 
 This chapter focuses on the relationship between learned or scholarly law and economic and political power. It begins by introducing Pierre Bourdieu’s writings on the role of law and legal theories, which provide a general sociological framework, and then it draws on that approach to examine the role of learned law in the United States. The first part examines a key period in the genesis of the U.S. legal field and its hierarchies -- the outsourcing of the reproduction of lawyers and the compilation of legal knowledge to the law schools late in the nineteenth century. Law professors and their theories were quite marginal in the US legal field at that time. The second part examines the Legal Realist “coup” of the law professors against the dominance of the elite judges and corporate lawyers in the 1930s. The third part discusses similar challenges to the place of elite lawyers and judges in the 1960s from the left and more recently from the right. In each case, we show that legal academics and their theories are part of a larger story of adaptation and relegitimation of the enduring hierarchies of the U.S. legal field. A major theme, which these histories make clear, is the relatively weak autonomy of the field of learned law in the United States. Within this larger story, however, we point out the factors that created what looks in retrospect like a “golden age” of academic theory in the 1980s.

07 December 2015

ADF Speech and the Constitution

From Gaynor v Chief of the Defence Force (No 3) [2015] FCA 1370 regarding judicial review against termination of Gaynor's commission as an Army Reservist in the Australian Defence Force after repellent public comments -
272 ... it seems to me that the decision to terminate was based on the fact that the applicant expressed his views publicly while he was still a member of the ADF. That conclusion is reinforced by CDF’s substantive concluding paragraph:
25. I have also given some weight to the additional information you have provided in your submissions relating to the impact of the termination of your service on your employment prospects and your desire to continue serving in the Australian Army. However, I do not consider that these factors constitute a change in circumstance that would affect my conclusion that your retention is not in the interest of the Australian Army. In particular, they do not excuse your behaviour, nor do they diminish the seriousness of your behavioural shortcomings having regard to the standard of behaviour expected of members of the Army both permanent and Reserve.
273 This appears to me to postulate (I intend no criticism) a standard of behaviour involving conformity and compliance with stated ADF values and philosophies which did not depend on the terms of particular publications and statements. Although the applicant’s public statements were the reason for consideration of his conduct, the expected standards of behaviour against which his conduct was measured did not turn on whether at particular times he had identified himself as a member of the ADF, but rather whether he was at those times a member of the ADF.
274 I, therefore, do not accept the respondent’s second line of argument, or that termination of the applicant’s commission turned on his identification of himself as a member of the Army Reserve.
275 There is no suggestion that the applicant published any official information in his public statements. However, there is no real doubt that his published statements infringed the prohibition in item 19 of DI(G) ADMIN 08-2, even if not s 60 of the Defence Discipline Act. But this was not the basis (certainly not the only basis) of the termination of his commission; it was just one element of the matters under consideration and, as CDF emphasised in his Minute of 22 August 2013, questions of “technical” breach of this DI(G), and of DI(G) ADMIN 08-1, were to be given less weight than CDF’s conclusions that:
7. … a. your public comments (evidenced in reference A) demonstrate attitudes that are demeaning and demonstrate intolerance of homosexual persons, transgender persons, and women, and are contrary to the policies and cultural change currently being undertaken within the Army and Defence; and b. your comments critical of ADF and Government policy (evidenced in reference A) demonstrate a conflict of interest between your personal interests and your obligations to serve the Army that cannot be reconciled.
276 All of his comments were made while the applicant was not on duty, not in uniform and not doing anything connected with the ADF except criticising it and certain of its members. It is clear from the Quick Assessment Report that the applicant had made no particular contribution to his unit since November 2011 and was not really expected to do so again.
277 In my view, the applicant’s commission was, in substance, terminated for two reasons. The first was that he made public comments critical of the ADF while a member of the ADF. Those comments were in contravention of Defence instructions but much more important to their assessment was their tone and content, which was viewed within the ADF, and by CDF, as wholly unacceptable. The second reason was the applicant’s defiance of direct orders by his superiors, a circumstance which is anathema in military service.
278 I am not to be taken as indicating any criticism of either of those judgements, the persons who made them, the persons who share them or the military standards which sustain them.
279 However, in my view the circumstance that the comments were made in a personal capacity, unconnected with the ADF except by the ongoing formal circumstance of ADF membership, and that the comments were made in the form of communications about political matters which satisfy the first limb of the Lange test, raises for resolution whether the decision to terminate the applicant’s commission exceeded the statutory authority under reg 85(4) of the Personnel Regulations because it was, in its effect, not reasonably appropriate and adapted to the legitimate end served by reg 85.
280 Consideration of that issue, against the facts which I have discussed, requires attention to the explanation given in McCloy of the stages of consideration of proportionality. I regard it as appropriate to ask whether a regulation (or other legislation or legislative instrument), which directly prohibited the applicant’s conduct, would be valid if it was based on the same matters as the findings of CDF in the Termination Decision. In my view it would not.
281 That conclusion turns on the third element of the test distilled in McCloy.
282 I accept that there is a need for discipline, obedience to orders and adherence to standards in the ADF by its members. A restriction on public comment of the kind I am considering (i.e. termination of a commission) was a “suitable” response to infringement of those requirements.
283 I cannot conceive of another obvious and compelling means of achieving the objective in the face of conduct such as that of the applicant, which was defiant and intractable. I will accept that the response was therefore “necessary” in that sense.
284 However, in my view the response did not meet the third element of the test of proportionality stated in McCloy. It was not “adequate in its balance” having regard to the fact that the applicant’s conduct involved the expression of political opinion, effectively as a private citizen. A contrary view would accept that ADF members have lost that freedom of political expression, even when not serving in any active capacity, nor likely to do so again.
285 In my view, the burden on the exercise by the applicant of his freedom of political communication was considerable by reason of its consequence, whatever might be said against the manner of its expression or its content. I cannot accept that the right to exercise that freedom was lost only because the applicant remained a member of the ADF.
286 I should add, for completeness, that my view about the second limb of the Lange test is the same, with or without the application of the refinements discussed in McCloy.
287 Membership of the ADF, while on service in one form or another, undoubtedly carries with it obligations of obedience to lawful commands, and all the rigour and restrictions of military service but it does not seem to me that it extinguishes either freedom of belief or, while free from military discipline, freedom of expression. It may be the case that members of a full time regular service are rarely (if ever) free to publicly express opinions against the policies of the ADF or the decisions of their superiors but the same cannot always be said about members of Reserves. Such persons are often not on duty. They are private citizens, in substance, when not on duty and not in uniform. Military discipline under the Defence Discipline Act does not apply to them. In my view, their freedom of political communication cannot be burdened at those times.
288 There may be other grounds upon which the applicant’s commission may have been terminated. It does not appear as though the applicant was making a useful contribution to the ADF in other respects, or was likely to in the future. Termination may have been justified on some only of the grounds which CDF considered. I say nothing about those possibilities. My task is to review the grounds which were used, paying particular regard to the reasons for decision published on 10 December 2013.
289 When I do that, I conclude that the applicant’s commission was terminated because of the publication of his private views about political matters. The fact that those publications were at variance with ADF or government policy, or were in terms of which some may strongly disapprove, or were critical of ADF policies or instructions, does not appear to me to be sufficiently connected with any legitimate legislative aim to displace the freedom of political communication implied in the Constitution.

06 December 2015

Copyright

'Copyright Paternalism' by Kevin J. Hickey argues 
The dominant justification for copyright is based on the notion that authors respond rationally to economic incentives. Despite the dominance of this incentive model, however, many aspects of existing copyright law are best understood as motivated by paternalism. Termination rights permit authors to rescind their own earlier assignments of copyright. The elimination of formalities protects careless authors from forfeitures of copyright if they fail to register the copyright or place appropriate notice on their works. The law limits how copyrights can be transferred, when rights in emerging media can be assigned, and which works can be designated as “made for hire” by contract. Thus, while the basic model of copyright presumes that authors are rational actors, many of its actual provisions suppose that authors are not capable of understanding or protecting their own economic interests. This Article highlights and seeks to understand the tension between these two different conceptions of the author.
Building on recent critiques of copyright’s incentive model and on the insights of behavioral law and economics, this Article envisions what a more unabashedly paternalistic copyright regime might look like. Such a view accepts that authors are not rational actors; they are short-sighted, lack bargaining power, and respond weakly to distant and uncertain economic incentives. If we take this account seriously, copyright’s existing paternalistic provisions are inadequate solutions to the behavioral failures that they purport to remedy. Instead, a truly paternalistic copyright regime would provide meaningful protections for authors against one-sided copyright transfers, and rely on more tailored and direct incentives for artistic creation.