29 November 2013

UnHeaven

Erasure, folding, normativity, animation, layering, relational, entanglement, spectral, project, subversion, displacement ...

 'The matter of displacement: a queer urban ecology of New York City’s High Line' by Darren J. Patrick in (2013) Social & Cultural Geography 1 engages in a "critical queering' of
gentrification through an ecological analysis of the redevelopment of New York City’s High Line. Taking the abandoned-queer-ecology-turned-homonormative park as a novel form of gay and green gentrification, I argue that the ‘success’ of the project must be critiqued in relational ecological terms. Intervening into the literature of gentrification, I begin to account for the material and symbolic aspects of ecological gentrification with the help of innovations in plant geography and queer ecology. To ground my analysis, I look to the process of ‘succession’, focusing, in particular,on one of the most established and successful plants growing on the abandoned High Line, Ailanthus altissima or the Tree of Heaven. Drawing on empirical insights, this account of the High Line’s redevelopment tracks relations between queers and plants.Through layers of sexuality, ecology, and geography, the matter of displacement becomes central to a consideration of ethico-political possibilities for a queer ecological critique of urban space. In conclusion, I argue for an ethics and politics of responsibility to and for abandoned spaces that calls us to pay closer attention to the queer, the ecological, and their ongoing entanglement.
Patrick explains that
I pursue a queer ecological critique of gay and green gentrification by way of considering entanglements of human sexuality and more-than-human agencies, specifically those of plants. Empirically, I focus on the redevelopment of New York City’s HighLine, a 1.45-mile-long (2.33km) linear urban park or promenade constructed in the formerly abandoned remains of an elevated railway on Manhattan’s West Side. Building on a foundation of semi-structured expert interviews and archival research, my effort is animated by photographic documentation of the vegetal landscape of the abandoned HighLine by the American photographer Joel Sternfeld. Reading his photographs through some key analytics of queer ecology, I think relationally with one of the former botanical inhabitants of the space, Ailanthus altissima, also known as the Tree of Heaven.
A. altissima’s biological capacities, along with its reputation as a so-called non native invasive species, offer some crucial insights into the political and ethical possibilities of a queered urban ecology. I emphasize both the material and symbolic role of A. altissima as an unruly actor whose ‘success’ as a species is inseparable from the continual anthropogenic production of waste spaces and successional ecological landscapes. I take A. altissima’s successional emergence in the abandoned ecology of the High Line, and its subsequent erasure from the planned landscape which replaced that ecosystem, as both metaphorically suggestive and literally entangled in the preservation-through-redevelopment effort spearheaded by Friends of the High Line (FoHL), the organization behind the effort to‘save’ the structure from demolition.
I am interested in A. altissima because of its status as an unruly figure, a literal weed, whose presence and adaptive capacities to produce space (i.e., to territorialize) involve (1) a geographic expression of its reproductive process and (2) its quasi-strategic capacity for‘self-recognition’ by way of a phenomenon called allelopathy. Perhaps uniquely among pioneering plant colonizers of the HighLine, A.altissima challenges us to consider the ways in which nonhuman displacement, in addition to reproduction and growth, plays an important role in the politics and ethics of ecological gentrification. Biological and ecological research on A. altissima retains a certain heteronormative attention to reproduction (i.e., reprocentricity). Even so, A. altissima’s reputation as an invasive species has prompted further exploration of the so-called ‘secondary metabolic’ processes that contribute to the plant’s success in urban ecologies. I read the latter alongside homonormativity, a term popularized by Duggan (2003) to critique the mainstreaming of metropolitan, white, bourgeois, and male gay sexuality in the neoliberal era. Duggan defines homonormativity as ‘a politics that does not contest dominant hetero-normative assumptions and institutions, but upholds and sustains them,while promising the possibility of a demobilized gay constituency and a privatized, depoliticized gay culture anchored in domesticity and consumption’(50). I extend the critique of homonormativity to geographic and urban ecological analyses of gentrification to demonstrate the political and ethical risks and opportunities of the ‘progress’ claimed by organizations such as FoHL.
From an ecological perspective, even as particular ecosystems ‘services’ are beginning to be ‘valued’ in political-economic terms, A. altissima’s ‘success’ in urban areas globally continues to symbolize blight and decay, often marking spaces as ripe for redevelopment.What might have been different if plants such as A. altissima had not been erased from landscape of the High Line? How might an insistence on ecological queerness as a domain of responsibility for and to unruly actors help to provide political power and ethical grounding for human inhabitants of cities who are opposed to or impacted by gentrification? Finally, what might the destructive territorializing capacities and successional strategies of A. altissima offer to radical queers seeking to critique the success of human organizations and strategies that use ‘gayness’ to immunize against meaningful political opposition?
Building on the history of gay territorialization of New York’s Lower West Side neighborhoods, FoHL’s political success relied on a selective and naturalized narrative of succession between waves of gentrifiers. This was accomplished, in part, through the proliferation of images, including Sternfeld’s, and discourses of ‘urban pastoralism’ (Cataldiet al. 2012:369). FoHL’s success in advocating preservation through redevelopment relied not only on a variety of classic neoliberal and gentrifying tactics, as the review of literatures of gay and green gentrification will demonstrate, but also on an implicit appeal to the notion of homo normative urban ecologies in which possibilities for political and ethical linkages between sexuality and urban nature were only expressed within the narrow limits set out by the exigencies of capitalist urban development. In this context, A. altissima becomes a spectral figure whose disappearance from the ‘revised’ landscape of the High Line bespeaks an insidious tendency to obscure the project’s negative impacts on vulnerable human communities.
My analysis of the abandoned landscape of the HighLine deploys queer ecological critique rooted in a notion of responsibility to and for abandoned urban spaces and the complex entanglements they enable and embody. In addition to invoking concepts of nonhuman agency (Cloke and Jones 2002, 2003; Jones and Cloke 2008), I look to the pioneering work of Sandilands, who, invoking one of her literary interlocutors, calls us to ‘[A]ssume responsibility for a place’ by pressing ourselves to‘look both backward at the burden of its history and forward at our responsibility for those parts of its future that lie under human control’(Grover, quoted in Sandilands 2005). Putting a notion of responsibility at the center of a temporal development of place, I introduce a grounded set of possibilities for political–ethical engagements of and in queer ecologies. This gesture connects to a more recent specificationof the significance of the ‘queer’ in ‘queer ecologies’ offered by Sandilands: ‘If “queer” is to mean anything at all, it must include a continual process of displacing the heterosexual couple at the center of the ecological universe’ (forthcoming, emphasis in original). In the case of the HighLine, FoHL’s insistence on the ‘gayness’of the space suggests that, at least in urban contexts, we must be attentive to the ways in which ecological argumentation must displace not just heteronormativity and its couples,but an increasingly insidious and naturalized urban homonormativity (Andersson 2011: 1093–1094). This is especially urgent where the latter silences or displaces issues of race and racialization, class,and gender by way of embracing white metronormative gayness (see Halberstam2005: Chapter 2).
My analysis unfolds four sections. First, I trace multiple threads of scholarly literature,which help to situate the redevelopment of the High Line as a novel instance of gay and green gentrification. With this theoretical scaffolding in place, I move on to a more substantial account of the history of the site’s redevelopment. My empirical insights demonstrate both the extent to which the High Line’s redevelopment exists as a case of gay and green gentrification, and the important lacunae that remain if we only deploy literatures addressing these phenomena in order to understand this case. Here, I make an initial gesture toward plant geography that I develop more fully in the third section, in which I elaborate the theoretical insights necessary to push the critique further by considering queer ecology and the agency of nonhuman actors. This leads, lastly, to an overview of political and ethical possibilities for understanding the complex dynamics of gentrification and displacement in queer ecological terms.

Pharma Regulation

Two US articles relevant to the Australian pharma regulation regime.

'The Money Blind: How to Stop Industry Bias in Biomedical Science, Without Violating the First Amendment' by Christopher T Robertson in (2011) 37 American Journal of Law and Medicine 358 argues that
The pharmaceutical and medical device industries use billions of dollars to support the biomedical science that physicians, regulators, and patients use to make healthcare decisions—the decisions that drive an increasingly large portion of the American economy. Compelling evidence suggests that this industry money buys favorable results, biasing the outcomes of scientific research. Current efforts to manage the problem, including disclosure mandates and peer reviews, are ineffective. A blinding mechanism, operating through an intermediary such as the National Institutes of Health, could instead be developed to allow industry support of science without allowing undue influence. If the editors of biomedical journals fail to mandate that industry funders utilize such a solution, the federal government has several regulatory levers available, including conditioning federal funding and direct regulation, both of which could be done without violating the First Amendment. 
Robertson's  'When Truth Cannot Be Presumed: The Regulation of Drug Promotion Under an Expanding First Amendment' in (2014) 94 Boston University Law Review argues that
 The Food, Drug, and Cosmetic Act (“FDCA”) requires that, prior to marketing a drug, the manufacturer must prove that it is safe and effective for the manufacturer’s intended uses, as shown on the proposed label. Nonetheless, physicians may prescribe drugs for other “off‐label” uses, and often do so, such that a large portion of U.S. healthcare spending is consumed by such unproven uses. Still, manufacturers have not been allowed to promote the unproven uses in advertisements or sales pitches. 
This regime is now precarious due to an onslaught of scholarly critiques, a series of Supreme Court decisions that enlarge the First Amendment, and a landmark Court of Appeals decision holding that the First Amendment precludes the Food and Drug Administration (“FDA”) from regulating off‐label promotional claims. These critiques strike at the very core of the FDCA, calling into doubt the constitutionality of the entire premarket approval regime, as a prior restraint on speech. 
This Essay makes three critical contributions, and offers a constructive approach to the regulation of drug promotion. First, this Essay reveals how the notion that “truthful” promotional claims enjoy First Amendment protection has been central to these scholarly and judicial critiques. However, those critiques have simply presumed the predicate of truthfulness – that the drugs are safe and effective for the newly intended uses, and further presumed that the FDA is acting paternalistically to protect the public from acting upon the truth. Second, this Essay clarifies that the truth is unknown, and this ignorance is itself the motivation for regulation. The FDCA incentivizes drugmakers to invest in producing that missing knowledge. Third, this Essay highlights the way courts currently use the Daubert doctrine to regulate scientific speech presented in their own courtrooms, noting that it is a prior restraint on speech that has received virtually no First Amendment scrutiny. 
Going forward, in FDCA enforcement actions, courts should defer to the FDA’s premarket approval process as the test for the truth of promotional claims, and thus their status under the First Amendment. Accordingly, courts should remain in epistemic equipoise until the drugmaker proves safety and efficacy. Nonetheless, if the courts refuse to defer to the coordinate branches in that established expert regulatory process, the courts should put the burden upon the drugmaker to prove its claims true in court. Even under this fallback position, drugmakers will remain incentivized to produce the epistemic basis to support their claims of safety and efficacy. Thus the FDCA can have a secure place even within an enlarged conception of the First Amendment.

28 November 2013

Polyversity

From the June 2013 LH Martin Institute research briefing by Hamish Coates, Daniel Edwards, Leo Goedegebuure, Marian Thakur, Eva van der Brugge and Frans van Vughton on Profiling diversity of Australian universities [PDF] -
 Rumour has it that a Federal Education Minister once claimed the country had just one university with around 220 campuses. More recently prominent vice chancellors have commented that all institutions are variations on a single theme—the comprehensive research university. But is our higher education system indeed so flat? Or do Australia’s institutions—universities as well as non- university providers—attempt to occupy differentiated positions in an increasingly complex landscape? Are salient differences of a strategic, marketing or intellectual nature? And, importantly, does it matter? 
This LH Martin Institute and ACER research briefing is intended to shift discussion of diversity in Australia’s higher education sector to a more considered level. We don’t promise neat solutions, but our analysis moves beyond extant sectoral partitionings to expose emerging dynamics and prospects for institutions, and hence for the system as a whole. We do this by using classification structures for institutional characteristics and performance that are being rolled out globally— namely U-Map (van Vught, 2009) and U-Multirank (van Vught & Ziegele, 2012). 
Our research builds on a discussion of diversity in the Australian higher education sector that has a fairly long history (for instance, see Meek, 1991; Meek & O’Neill, 1996) but remains inconclusive. The topic has featured prominently in several national reviews (e.g. West, 1998; Nelson, 2002; Bradley, Noonan, Nugent & Scales, 2008). A cogent recent analysis of policy implications is given by Coaldrake and Stedman (2013) in their latest book. In late 2012 the Hon John Dawkins (former Federal Education Minister) commented that the Unified National System—established under his leadership—was never intended to be a ‘uniform’ national system (Trounson, 2012). This has always been the government’s policy position but, as is well known, many of the policy drivers that have been put in place since the birth of the UNS have stimulated universities to pursue similar goals and activities. 
Caught in what would seem to be a semi-elastic web of conformity, the diversity debate so far has not been able to escape the ‘glass half full—glass half empty’ situation which reads, by-and-large, either that ‘all Australian universities are comprehensive research universities’ or that ‘...but clearly my university is different from yours’. There are two fundamental problems in this version of the debate. The first is that we are still struggling to come to terms with what diversity means for institutional positioning. The second is that because of this an authoritative set of indicators to underpin the discussion is absent. Our approach, built on the U-Map and U-Multirank transparency tools, offers a way out of this dilemma and provides new insights in the diverse Australian higher education landscape. But before delving into the details, let’s examine why diversity actually matters. 
Diversity rationales 
There is a good deal of consensus in the research literature that diversity in higher education is a good thing. Simply put, more diverse systems perform better than less diverse systems. Drawing from earlier conceptual and empirical work by Birnbaum (1983) and van Vught (2008) provides a succinct summary of the evidence. We review the major points.  
First, more diverse systems better meet the diverse needs of students. When systems expand and evolve from elite to mass to universal systems (Trow, 1979) as is happening across the globe, the student body itself by definition becomes more diverse. A diverse set of institutions allows students to choose the one that best reflects their preferences and abilities, thereby optimising the chances of successfully completing a higher education degree. 
Second, following from the above argument, a diverse system stimulates social mobility. There is no denying that for the large part the classic small higher education systems catered for the elite. Such systems were the perfect vehicle for keeping that elite ‘an elite’ by educating and socialising them in exclusive institutions. More diverse higher education systems allow for different access points and progression pathways and hence will allow for increased participation from the lower socio-economic strata and other equity groups. A third argument relates to better meeting labour market needs. Labour markets increasingly fragment and differentiate, thus requiring different types of graduates. A more diverse higher education system is better able to respond to these needs. 
Other benefits associated with diverse higher education systems relate to the potential for experimentation which, according to Jencks and Riesman’s (1968) analysis, will continuously lift the performance of higher education systems. Institutions try to differentiate in order to occupy niche markets. Once such niches prove viable, others will try to emulate, which in turn will lead to attempts to further differentiate, and so on. Australia’s geography, and the low mobility of our students (Edwards & van der Brugge, 2013), dampens such dynamic. 
The focus of our analysis 
Clearly, when taken seriously, institutional diversity grows quickly into a very complex discussion. In this contribution we seek to balance parsimony with due consideration to the inherent nuances of the matter. The next section touches briefly on key contexts, and on the value and methods of the profiles we have produced. At the heart of this briefing lies a presentation of the multidimensional profiles. The briefing closes by considering extensions to the indicator mix, to the population of institutions and level of analysis, and next steps that can be taken to further enhance transparency of the Australian university and, ultimately, tertiary education sector.

Inscriptionism

Latour and other theorists have argued that bureaucracies conceptualise - and by extension law gives recognition to - entities that fit into categories on forms. That is illustrated in an account in the Guardian earlier in the week regarding incident reports from detention centres managed by Serco.

The Guardian reports that
The birth of children and clinical depression are no longer being formally reported as incidents in Australian detention centres, while self-harm events have been downgraded from critical to major, according to new guidelines from the detention service provider Serco. 
The new guidelines were created in March this year, when the previous Labor government was in office. 
Incident reports are how Serco communicates with the immigration department about events in detention centres, such as births, deaths, assaults and escapes. 
The new reporting guidelines, which were obtained under freedom of information laws by Refugee Rights Watch, significantly alter the categories of incidents Serco is required to report to the immigration department. While some categories have been replaced or expanded, “birth of a child” and “clinical depression” have been removed, with no apparent replacements. 
The removal of the categories means it is unclear how the immigration department is now being informed about births in detention facilities. It also means that no performance audits in the form of “post incident reviews” would occur for childbirths. 
Serco issued a statement saying the department determined how an incident was categorised.
"The categorisation of incidents, that is, whether an incident is classed as minor, major or critical, is determined by the department. The categories relate to reporting timeframes. 
"We are required to report minor incidents within 24 hours, major incidents within one hour and critical incidents within 30 minutes.".... 
“It’s shocking to think that a birth behind bars doesn’t even rate a mention any more,” the Greens immigration spokeswoman, Sarah Hanson-Young, told Guardian Australia. 
“This change in protocol is very concerning. Will the department of immigration now plead ignorance when it comes to the number of babies born in detention? This government’s addiction to secrecy is becoming ridiculous and dangerous. 
... Among other changes to the guidelines are the downgrading of “self-harm – actual” and “assault – serious” from critical incidents to major incidents. This means Serco has more time to inform the department of when an incident has occurred. Bomb threats and unauthorised media presence have also been downgraded from critical to major. 
Some categories have been expanded to give more detailed reports. Assaults are broken down further so that incidents involving children are logged separately, and voluntary hunger strikes have been reclassified as “food/fluid refusal”. 
Sexual assault has been listed as a separate category. Guardian Australia had previously had to lodge freedom of information requests with Comcare to reveal the number of sexual assaults in detention centres, because the immigration department did not log this information as a separate category.
In thinking about the consequences of bureaucratic rationality - a box for everything (that matters) - I'm struck by 'Dead zones of the imagination On violence, bureaucracy, and interpretive labor (The Malinowski Memorial Lecture, 2006)' by David Graeber in (2012) 2(2) HAU: Journal of Ethnographic Theory 105 -

He comments that
one often finds a remarkable sympathy — dare one say, sense of affinity? — between scholars, who generally double as academic bureaucrats, and the bureaucrats they study. Consider the hegemonic role, in US social theory, of Max Weber in the 1950s and 1960s, and of Michel Foucault since the 1970s. Their popularity, no doubt, had much to do with the ease with which each could be adopted as a kind of anti-Marx, their theories put forth (usually in crudely simplified form) to argue that power is not simply or primarily a matter of the control of production but rather a pervasive, multifaceted, and unavoidable feature of any social life. I also think it is no coincidence that these sometimes appear to be the only two intelligent people in human history that honestly believed that bureaucracy is characterized primarily by its effectiveness. Weber saw bureaucratic forms of organization — public and private — as the very embodiment of impersonal rationality, and as such, so obviously superior to all other possible forms of organization that they threatened to engulf everything, locking humanity in a joyless “iron cage,” bereft of spirit and charisma (1958: 181). Foucault was more subversive, but in a way that made bureaucratic power more effective, not less. In his work on asylums, clinics, prisons, and the rest, bodies, subjects—even truth itself—all become the products of administrative discourses. Through concepts like governmentality and biopower, state bureaucracies end up shaping the parameters of human existence in ways far more intimate than anything Weber might have imagined. 
It’s hard to avoid the conclusion that, in either case, their popularity owed much to the fact that the American university system during this period had itself become increasingly an institution dedicated to producing functionaries for an imperial administrative apparatus on a global scale. During the Cold War, this was often fairly explicit, especially in the early years when both Boasians like Mead and Benedict and Weberians like Geertz often found themselves operating within the military-intelligence apparatus, or even funded by CIA fronts (Ross 1998). Gradually, over the course of the campus mobilizations of the Vietnam War, this kind of complicity was made an issue. Max Weber — or, to be more accurate, that version of Weber promoted by sociologists like Parsons and Shils (1951), which gradually became the basis for State Department “modernization theory” — came to be seen as the embodiment of everything radicals wished to reject. But it wasn’t long before Foucault, who had been whisked out of his retreat in Tunisia and placed in the Collège de France after the uprising of May 1968, began to fill the gap. One might even speak here of the gradual emergence of a kind of division of labor within American universities, with the optimistic side of Weber reinvented (in even more simplified form) for the actual training of bureaucrats under the name of “rational choice theory,” while his pessimistic side was relegated to the Foucauldians. Foucault’s ascendancy, in turn, was precisely within those fields of academic endeavor that both became the haven for former radicals, and were almost completely divorced from any access to political power — or, increasingly, from any influence on social movements as well. This gave Foucault’s emphasis on the “power/knowledge” nexus — the assertion that forms of knowledge are always also forms of social power, indeed, the most important forms of social power — a particular appeal. 
No doubt, any such pocket historical summary can only be a bit caricaturish and unfair. Still, I think there is a profound truth here. It is not just that we are drawn to areas of density, where our skills at interpretation are best deployed. We also have an increasing tendency to identify what’s interesting with what’s important, and to assume places of density are also places of power. The power of bureaucracy shows just how much this is often not the case.

Offensiveness, Language and summary offences law

'Time to define ‘The Cornerstone of Public Order Legislation’: The Elements of Offensive Conduct and Language under the Summary Offences Act 1988 (NSW)' by Julia Quilter and Luke McNamara in (2013) 36(2) UNSW Law Journal 537 addresses
a contradiction that has long been at the heart of the criminal law concerned with ‘public order’. Although crimes such as offensive conduct and offensive language are amongst the most frequently prosecuted offences in Australia, their legal nature is poorly understood and rarely the subject of judicial scrutiny or academic explanation. In the context of ongoing controversy over whether such offences have a legitimate place on the statute books, we confront this oversight. This article draws on the High Court of Australia’s decision in He Kaw Teh v The Queen to lay out a methodology for construing the elements of a statutory offence, and then employs this approach to produce a recommended interpretation of the elements of sections 4 and 4A of the Summary Offences Act 1988 (NSW). 
Brown et al have observed that:
The cornerstone of public order legislation is usually a provision that permits police to act where behaviour in a public place is regarded as offensive, insulting, abusive or indecent. Such provisions are inevitably vague and open-ended, with the characterisation of the behaviour left to the discretion of the police in the first instance, and subsequently to the discretion of magistrates. 
In New South Wales (‘NSW’), the ‘cornerstone’ is provided by sections 4 and 4A of the Summary Offences Act 1988 (NSW). Certainly the characteristics of vagueness and open-endedness, and susceptibility to discretion, to which Brown et al refer, are evident in the definitions of offensive conduct and offensive language. The legitimacy of these laws, and equivalent laws in other jurisdictions, has long been a topic of debate, and appropriately so.  
More than 40 years ago, Frank Walker MP (later Attorney-General of NSW) observed, in relation to the Summary Offences Bill 1970 (NSW):
One of the most arbitrary and dangerous aspects of the bill is the proliferation of vague, uncertain dragnet offences such as are to be found in ... the definition of unseemly words and later in the bill in provisions dealing with offensive behaviour. 
Any practising criminal lawyer will say that such terminology operates only to give the widest possible latitude to the police and the magistrates, and thereby constitutes a serious blow to the liberty of the citizen to be free from arbitrary arrest and arbitrary prosecution. I submit that this vague terminology is jurisprudentially unsound. Certainty is the very essence of the criminal law. Every man has the right to know whether his actions at a given time are or are not criminal. Sweeping, dragnet terminology means that a particular act will be legal or illegal according to the subjective opinions of the police officers and magistrates involved. 
A decade later, Doreen McBarnet coined the phrase ‘ideology of triviality’ to capture the air of relative unimportance that pervades the high volume lower courts of the criminal justice system. A related dimension of McBarnet’s analysis is the idea of ‘legal relevance’ – the assumption that ‘the offences dealt with in the lower courts do not involve much law or require much legal expertise or advocacy.’ As McBarnet counters: ‘[i]t is not in the nature of drunkenness, breach of the peace or petty theft to be less susceptible than fraud, burglary or murder to complex legal argument; it is rather in the nature of the procedure by which they are tried.’  
We would add to McBarnet’s list of ‘lesser’ crimes a pair that are amongst the most frequently prosecuted on the NSW statute books – offensive conduct and offensive language under sections 4 and 4A of the Summary Offences Act 1988 (NSW). During 2012,5612 charges for these two offences were finalised in the Local Court of NSW, and 6808 people were issued with a Criminal Infringement Notice (‘CIN’) in relation to alleged breaches of sections 4 and 4A. 
How is it that for two crimes that are enforced more than 12,000 times annually, and more than two decades after their current statutory formulation was endorsed by the NSW Parliament, it remains unclear what the elements of the crime are, and no comprehensive guidance on the elements of sections 4 and 4A has emanated from the Supreme Court of NSW? It is not our intention to lay blame at the feet of the judiciary or the ranks of criminal law practitioners. The ‘blind spot’ that motivates this article is also evident amongst academic lawyers. Public order offences are still routinely ignored in criminal law textbooks.In those works that do take offensive conduct and offensive language seriously as aspects of the criminal law to which students should be exposed, the tendency is to (rightly) problematise the operation of such laws, and to point, without offering solutions, to the uncertainty that exists.The scholarly literature that addresses the topic of offensive conduct and language crimes – much of which is excellent – tends to focus on the operation of these laws, often informed by illuminating historical, sociological and criminological perspectives, and with an explicit normative reformist agenda.  Sections 4 and 4A of the Summary Offences Act 1988 (NSW) have not, to this point, been the subject of close doctrinal analysis or exegesis, particularly in relation to fault (as opposed to conduct) elements.  
In this article we approach the neglected crimes of offensive conduct and language, influenced by the insights of scholars such as McBarnet, adopting a still critical, but also pragmatic, perspective, by asking the following questions: can we tolerate any longer the uncertainty that surrounds the parameters of charges under sections 4 and 4A that yield thousands of convictions every year, and that, in the case of offensive conduct, carries the possibility of incarceration? If the answer to this question is ‘no’ (and we believe it is), is it possible to articulate with greater precision the boundaries of this area of ‘criminality’? With courage and caution in equal measure, we assert that it is both possible and desirable to do so, and, in this article, we outline an approach to doing so.  
In our view, every criminal offence should be capable of clear articulation in terms of conduct and fault elements – especially offences that are charged in high volumes every year and which are controversial inclusions in the statute books. We are not naive about the possibility of achieving absolute clarity and certainty in this or, indeed, any other law. Such ‘perfection’ is unrealistic given, among many other considerations, the nature of legal language and the (often contested) processes of interpretation that are involved in deriving meaning,  and the effect of discretion in decision-making.  That said, certain unresolved ambiguities in the definition of offensive conduct and offensive language under the Summary Offences Act 1988 (NSW) can be remedied and ought to be. We are prepared to be bold in our proffered interpretations in the hope that, even if they are wrong, this article will nonetheless prompt wider engagement with questions that have escaped rigorous academic and judicial scrutiny for too long.  
The legitimacy of criminal offences such as those defined by sections 4 and 4A – that turn on the concept of offensiveness – has rightly been the subject of rigorous critique, including by eminent criminal law theorists.  For what it is worth, our own normative position is unambiguous: offensiveness has no place in Australian law as a basis for criminality and any offences that turn on an offensiveness standard (including sections 4 and 4A) should be abolished immediately. But it is not our aim in this article to prosecute this position; a position that has already attracted much scholarly attention. Rather, our aim is to confront the reality that sections 4 and 4A not only remain on the statute books in NSW, but they have been entrenched there for decades, and continue to be actively enforced. As long as this is the case, an attempt must be made to elicit judicial guidance in relation to the scope and elements of sections 4 and 4A of the Summary Offences Act 1988 (NSW). While our proposals for interpreting these offences do not deliver abolition, they do have the potential to at least provide a legal foundation for defending charges and narrowing the scope of sections 4 and 4A, thereby reducing (if not removing) the demonstrable risks of over-policing and over-criminalisation which have too often been realised in NSW.  
The body of this article is in three parts. Part II introduces the statutory provisions which define offensive conduct and offensive language, including a brief examination of the historical evolution of this form of public order offence. Part III deals with the operation of the laws, highlighting a number of concerns that have been raised about their reach in practice, including their disproportionate impact on Aboriginal people in NSW. Part IV sets out a methodology for construing statutory offences which we then apply to sections 4 and 4A of the Summary Offences Act 1988 (NSW) with reference to the known case law.

Resilience among law students

'Schooling the Blues: An Investigation of Factors Assoociated with Psychological Distress among Law Students' by Wendy Larcombe and Katherine Fethers in (2013) 36(2) UNSW Law Journal 391 [PDF] comments that
 There is now a growing body of empirical evidence confirming that lawyers and law students in Australia, as in the United States (‘US’), experience levels of psychological distress significantly higher than members of the general population and other professions. The landmark 2009 study by the Brain and Mind Research Institute (‘BMRI’), published as ‘Courting the Blues’,was not the first Australian study to investigate this issue, but it was perhaps the first to be heard as an alarm bell by legal professional bodies and law schools. The BMRI study reported that, on an internationally recognised measure, 31 per cent of solicitors, 17 per cent of barristers and 35 per cent of law students recorded elevated levels of psychological distress compared with 13 per cent of the general population. Subsequent studies with law students at the Australian National University and the University of Melbourne have produced very similar findings: both studies report that approximately 30 per cent of participating law students recorded elevated anxiety symptoms and a similar proportion recorded elevated depressive symptoms, compared with 13 per cent of the general population. 
As Townes O’Brien and her co-authors have observed, the BMRI report ‘hit Australian legal educators hard’, particularly as the decline in mental health appears to begin in law schools. Students are known to enter law schools with rates of wellbeing no different to, and even higher than, the general population. By the end of the first year of study in law, however, self-reported rates of psychological distress have increased significantly. The negative impact of legal education on first-year law students does not appear to abate across the degree, and distress levels are similar in legal practice, indicating that the nature and quality of the psychological distress experienced by law students and lawyers may be ‘fundamentally similar’. Law school thus appears to be an ideal site to develop and embed prevention and early intervention measures to address mental health difficulties that similarly affect law students and legal practitioners. 
The first step to designing effective and sustainable interventions is to better understand what happens to law students’ mental wellbeing in law school and the range of factors associated with high levels of distress. In particular, it is important for law schools to know whether it is legal education per se that triggers or exacerbates law student distress, or whether some interaction of ‘external’ sources of distress and personal characteristics mediates students’ responses to the law school environment. As explained below, Self-Determination Theory (‘SDT’) provides the most promising explanation of the environmental variables contributing to the documented increase in psychological distress experienced by first-year law students. However, more research is needed. Although law student mental wellbeing has been recognised as an issue for some decades in the US, and there is now ample evidence of the prevalence of distress among law students, there has been limited empirical research investigating course-related and institutional factors that may be contributing to high levels of psychological distress among law students. Without an improved understanding of the factors that adversely affect law student mental health, law schools could invest considerable effort in interventions that have little prospect of improving students’ wellbeing. 
It was in this context that the present study was designed to empirically investigate factors associated with high levels of psychological distress among a sample of Australian law students. An anonymous online survey was developed to explore a range of course-related variables that have been suggested in the research literature as potentially associated with law student psychological distress. The study also investigated some of the personal tendencies attributed to law students, as well as the stresses associated with the costs of higher education and an increasingly competitive job market. The study was undertaken in 2012 with a sample of law students from Melbourne Law School (‘MLS’), the University of Melbourne. This article reports the findings of that research, including the levels and forms of psychological distress recorded and the factors associated with elevated symptoms of depression, anxiety and stress. In doing so, it aims to provide a source of comparative data for subsequent empirical studies examining students’ elevated levels of mental distress in higher education, as well as contributing to an evidence-base for pedagogical development, curriculum reform and mental health intervention planning in law schools. 
Three general findings are noteworthy. First, all of the participant-related and course-related variables included in the study showed significant associations with elevated distress symptoms. By contrast, the only demographic variables that showed significant associations with elevated distress related to time commitments (paid work and family care). This strongly indicates that law student distress is mediated by students’ experiences, perceptions and cognitive constructs (as they interact with the law school environment), rather than by demographic variables. Second, different participant-related and course-related variables were found to be associated with the different forms of distress symptoms measured in the study – depression, anxiety and stress. Interventions to support student wellbeing will thus need to address the different forms of distress and their associated factors. Third, different variables were associated with different levels of distress symptoms, indicating that severe and extremely severe levels of distress have distinct triggers or risk associations. This is important information, indicating that programs and interventions tailored for the different forms and levels of distress measured in this study are likely to be most effective. 
The article is organised as follows. Part II outlines the available empirical research and explanations of law student distress that informed the present research and Part III details the methods used in the 2012 study conducted at MLS. Results on levels of psychological distress (Part IV) and the few associated demographic factors (Part V) are then reported. Parts VI–VIII report the results of tests investigating associations between the non-demographic variables in the study (participant- and course-related factors) and elevated depressive, anxiety and stress symptoms, respectively. Finally, we discuss the implications of these findings for the planning of mental health initiatives in law schools and offer suggestions for further research (Part IX).

Marrakesh

'Copyright Protections and Disability Rights: Turning the Page to a New International Paradigm' by Paul David Harpur and Nicolas Suzor in (2013) 36(3) University of New South Wales Law Journal argues that
 The dominance of international content industries in global copyright debates has historically confined disability rights to ad hoc limited exceptions to the general copyright monopoly. The United Nations Convention on the Rights of Persons with Disabilities the suggests that a paradigm shift is necessary to reframe accessibility debates. By introducing positive obligations on member states to ‘take all appropriate measures to ensure that persons with disabilities [can enjoy] access to cultural materials in accessible formats’, the CRPD requires states to move beyond ad hoc exceptions to copyright and towards internationally coordinated large-scale systematic attempts to reverse the book famine. The book famine in Australia and abroad should be a key policy priority, and the CRPD provides a clear positive obligation to address it. The Treaty to Facilitate Access to Published Works for Persons Who Are Blind, Visually Impaired, or Otherwise Print Disabled (Marrakesh Treaty) sets out a framework for international cooperation in this regard. The Marrakesh Treaty promises to level out some of the disparity of access between people in developed and developing nations and remove the need for each jurisdiction to digitise a separate copy of each book. This is a remarkable advance, and in combination with the CRPD, this suggests the beginnings of a possible paradigm shift in global copyright politics. While the Marrakesh Treaty is an important step forward, much more needs to be done. This article canvasses a number of potential measures that Australia might implement to comply with the CRPD and begin to remove the inequitable barriers that blind people face in accessing written works.

Cyberspace

The Australian Human Rights Commission released (in September this year) a discussion paper [PDF] on Human Rights In Cyberspace.

The paper states that
It is clear that the Internet provides unparalleled opportunities for the promotion and advancement of human rights, most centrally the right to seek, receive and impart information. The Special Rapporteur on that right has described the Internet as ‘one of the most powerful instruments of the 21st century for increasing transparency in the conduct of the powerful, access to information, and for facilitating active citizen participation in building democratic societies. He has accordingly stated that ‘facilitating access to the Internet for all individuals, with as little restriction to online content as possible, should be a priority for all States.’ 
However, the Internet also provides a new (and powerful) medium through which persons can (and do) publish hateful or discriminatory comments, and intimidate and harass others, in a manner which undermines the human rights of those who are targeted. 
Accordingly, societies’ use of the Internet raises challenging questions about the appropriate balancing of rights in cyberspace. Difficult questions of how to simultaneously protect potentially competing rights are not unique to the online environment. But the particular features of the Internet (its global (and therefore cross-jurisdictional) and instant reach; its creation of an effectively permanent record of communications, and the ability to communicate anonymously) present new obstacles for governments seeking to protect against harmful behaviour. 
These types of issues must be addressed in order for Australia to fulfil the theoretically simple (but practically very challenging) requirement that ‘the same rights that people have offline must also be protected online’. 
Questions for discussion 
There are two broad challenges regarding human rights and use of the Internet which emerge from the discussion in this paper, namely:
1. How do we as a society achieve an appropriate balance between competing rights in an online environment? 
2. What steps should be taken to address discrimination in terms of the ability of certain groups to access (and safely utilise) the Internet?
10.1 Addressing discrimination in terms of access to (and use of) the Internet 
The growing importance of the Internet to all aspects of life (including delivery of services by business and government) means that the ‘digital divide’ between those with effective access to the Internet and those without limits the latter group’s ability to enjoy a range of human rights. In order to effectively address this gap in enjoyment of rights (particularly the right to freedom of expression and information), consideration should be given to the following:
(a) What groups in Australia are affected by the ‘digital divide’? 
(b) To what extent does this impact on their enjoyment of rights? 
(c) What measures should be taken to address the difficulties that the following groups may experience in accessing the Internet: (i) people with disability (ii) older Australians (iii) Indigenous Australians (iv) Australians living in remote or rural areas? 
(d) To what extent would the ‘digital divide’ be addressed by ensuring access for all Australians to Internet facilities? How relevant are issues such as digital literacy and cyber-crime to the effective enjoyment of rights through the Internet for these groups?  
10.2 Balancing rights online
A key challenge in terms of ensuring that individuals’ rights are protected online is achieving an appropriate balance between protecting the right to freedom of opinion and expression in cyberspace, and protecting people from online bullying, discrimination and harassment which breaches their rights under the ICCPR. The types of issues which need to be explored include:
(a) How prevalent is online hate speech (i.e. racial vilification, hate speech against women, LGBTI people) - is it only a small minority who posts this extreme content, or is there a wider problem?
(b) Are online hate speech, discrimination and verbal abuse different to hate speech, discrimination and verbal abuse that occur in the offline world - does the potential reach and permanency of internet content change the impacts of these types of behaviours? 
(c) Are (reactive) legislative measures, rendering behaviour unlawful or criminal, an appropriate (and/or effective) way of achieving a balance between the competing rights in an online environment? 
(d) For the purposes of the application of anti-discrimination laws, what should be considered a ‘public’ vs. a ‘private’ space in the online world? 
(e) To what extent are (preventative) educative measures an effective way of addressing online hate speech and discrimination? 
(f) What type of laws, polices and/or practices do we need to create safe online environments for children, to ensure that they enjoy their rights in cyberspace (including the right to freedom of expression and to information)?
In discussing the "Right to privacy, family, home, correspondence, honour and reputation" the paper states that
Article 17 of the ICCPR states that:
1. No one shall be subjected to arbitrary or unlawful interference with his privacy, family, home or correspondence, nor to unlawful attacks on his honour and reputation. 
2. Everyone has the right to the protection of the law against such interference or attacks.
The HRC has indicated its view that ‘this right is required to be guaranteed against all such interferences and attacks whether they emanate from State authorities or from natural or legal persons.’
However, the Committee has also observed that ‘[a]s all persons live in society, the protection of privacy is necessarily relative.’ 
Balancing the rights to privacy and/or protection of reputation with the rights to freedom of information and expression presents challenges. It is clear however that measures to protect these rights which limit freedom of expression and information must comply with the requirements set out in article 19(3) of the ICCPR.

Taxonomies

'Taxonomy in Private Law—Furor in Text and Subtext' by Peter Watts in [2014] 1 New Zealand Law Review starts
with an overview of the debates that took place in the latter period of Peter Birks’s career over classification in private law. It does so by setting out the Birksian taxonomy and by collecting various extracts from Birks’s voluminous output, then contrasts those extracts with the views of a selection of his most prominent critics. The article next turns to a defence of Birks’s project and its aims of promoting rationality, the confinement of discretion, and modesty of function in the common law. The greater part of the article is devoted to showing how, in tort law particularly, New Zealand common law has lost its modesty and is intruding on personal freedoms. Instead of requiring an undertaking before a party becomes liable for nothing more than causing damage to another’s wealth, liability is being imposed from without by fudging the boundaries between contract and tort, and by using as tools nothing much sharper than “justice and fairness”. The final section of the article then turns to criticise, on similar grounds, the concept of unjust enrichment as promoted by Birks himself.
Watts comments that
Peter Birks’s clarion call, persisting from the early 1990s until his death in 2004, for a more orderly private law succeeded in creating a quite remarkable amount of academic disharmony. Not only have there been those who march in favour and those who waltz against, but amongst the rhythms has been a wide range of pitches, and instruments playing them. Although the noise has died down somewhat since Birks’s passing, it has not petered out. 
The bulk and range of the resulting literature is most daunting. A comprehensive review of it is not practicable. Anyway, the controversy rages from high jurisprudence to the small black letter details. In short, there was a text and a subtext to Birks’s campaign. Most people who disagreed with the campaign disagreed with both the text and the subtext, but some supported more or less the text but dissented from one or more parts of the subtext, and vice versa. If one has any interest at all in the controversy one is unlikely to be dispassionate. This passionate author agrees with most of the subtext but disagrees with some parts of the text.

27 November 2013

US Identity Scam

Where does charity money come from, how is it collected, how is it regulated and where does it go?

Having noted alleged misbehaviour by Mortenson in the lead-up to a book chapter on trust it is interesting to see Ken Stern's article on 'The Charity Swindle' at A25 in the 26 November 2013 NY Times -
By all outward indications, the U.S. Navy Veterans Association was a leader in the charitable community. Founded in 2002 to provide support to Navy veterans in need, the charity recorded astonishing financial success. In its first eight years, it raised around $100 million in charitable contributions, almost all of it through a direct marketing campaign. The organization, headed by Jack L. Nimitz, boasted of 41 state chapters and some 66,000 members. 
This would be a great story of charitable success, except for the fact that virtually everything about the association turned out to be false: no state chapters, no members, no leader with the name redolent of naval history. Instead, there was one guy: a man calling himself Bobby Thompson who worked from a duplex across the street from the Cuesta-Rey cigar factory in the Ybor City neighborhood of Tampa. 
But the money raised was real enough, generated by a series of for-profit telemarketers. The victims, by and large, were unsuspecting small-money donors who received urgent solicitations asking for support for needy naval veterans. Most of the money raised stayed with the fund-raisers, though plenty apparently dripped through to Mr. Thompson and a succession of Republican lawmakers who received generous contributions from the association’s political arm. But little ever made it to the intended beneficiaries. In 2010, the scheme was unwound by two reporters for what is now The Tampa Bay Times, but not before Mr. Thompson had fled the state of Florida. 
From June 2010, Mr. Thompson was on the run, the search for him hamstrung by the fact that no one had any real idea of who he was. Finally, on April 30, 2012, federal marshals tracked him down in Portland, Ore., finding him with a card to a storage unit containing $981,650 in cash and almost two dozen fake identity cards. 
Earlier this month in Ohio, where the charity’s registration documents had been filed, the man arrested as Bobby Thompson was convicted on 23 felony counts, including fraud, theft and money laundering. Authorities have identified him as John Donald Cody, a former Army intelligence officer and Harvard Law graduate. 
The most outrageous aspect of the case is that much of what Mr. Cody did was probably legal, or at least not specifically illegal. The principal beneficiaries were always the association’s for-profit fund-raisers. During the trial, one of them, Thomas Berkenbush of Community Support Inc., testified, apparently without fear of legal repercussions, that his company had kept 90 percent of the donations as a fund-raising charge. 
That, in and of itself, isn’t criminal. The alleged fraud was not that very, very little money ever went to Navy veterans. In fact, the fund-raising explicitly stated that a large portion of donations would go to cover telemarketing and other costs. Mr. Cody ran afoul of the law because he filed registration documents that contained false statements, because he stole the identity of the real Bobby Thompson, and because he pulled money from organizational accounts for his personal use. The irony is that he could have accomplished virtually his entire enrichment scheme without ever violating the law — and others have figured that out.
Thompson is elsewhere reported to have claimed to be a retired Naval commander, to have raised over US$100 million for his 'charity', gained funding from a "black box" CIA budget, and in court filings to have stated that he was working under "non-official cover" for the agency. He became a major Republican donor, reflected in twice having his photo taken with President George W. Bush.

26 November 2013

Kant and coalescence

One of my students - it's that time of the year - today noted the gibe by US Supreme Roberts in 2011 that
Pick up a copy of any law review that you see, and the first article is likely to be, you know, the influence of Immanuel Kant on evidentiary approaches in 18th Century Bulgaria, or something, which I’m sure was of great interest to the academic that wrote it, but isn’t of much help to the bar.
I was reminded of that somewhat misplaced criticism - the Supremes have of course benefitted on occasion from serious scholarship - in reading 'Copyright and Truth' by Maurizio Borghi in (2010) 12(1) Theoretical Inquiries in Law 1, which boldly
calls into question the primary meaning of copyright law. It argues that copyright is not primarily a legal instrument, but rather a fundamental mode of human existence. The starting point of the analysis is Kant’s definition of a book as a “public address” and of author’s rights as ultimately being grounded in the furtherance and maintenance of truth. Building on Kant’s argument, the Article defines the copyright primary subject matter as the act of speaking publicly in one’s own name, and the copyright sphere as the author-public coalescence that such act of speaking generates. This enables reaching a proper understanding of the scope of copyright and to characterizing its specificity as compared to its “fellow rights,” patents and trademarks.
Borghi comments that
some scholars have looked at copyright from perspectives that, albeit not always explicitly, call into question elements which cannot be simplistically reduced to interests in conflict. In various ways, these perspectives raise the awareness that copyright primarily, and not just secondarily, refers to a dimension that goes beyond any particular or even "general" interest. Copyright involves (as some have pointed out) matters such as democracy, a communicative sphere, or an ongoing dialogue between human beings. What all these different approaches have in common is that they overcome the binary language of the dominating paradigm and draw attention to a third and higher instance which is at stake in copyright. 
In this Article I argue that this third and higher instance, which is implicitly evoked by concepts like democracy, communication and dialogue, is better captured by upfront reference to truth. Kant’s notion of an author’s work as the act of speaking to the public, and the fundamental legal principles that arise from this elemental notion, represent the basis of my attempt to understand copyright as being grounded in the most fundamental need that human beings share when living in community with others, namely, the need for truth. In Part II  I consider Kant’s argument on the wrongfulness of reprinting, with the aim of arriving at a suitable definition of copyright subject matter. In Part II I analyze the intimate link between the subject matter of copyright and truth, and clarify what truth is in this context. The reflection developed by Hannah Arendt in the essay Truth and Politics will be of guidance in my analysis. In Part III I attempt to outline the specificity of copyright by comparing its own way of relating to truth with that of other so-called intellectual property rights, namely patents and trademarks. I conclude with some provisional remarks on the legitimate scope of copyright.
He concludes -
Truth as reliance is an instance at stake in all the three main directions of human existence that we have singled out, namely towards oneself, towards things, and towards other human beings. The whole of these three directions is what we call a world. When we relate to things we rely on reliance; when we relate to ourselves we need to represent reliance; and when we relate to others we elucidate reliance. In all these relations, and not only in the last one, man is coalescing with other men. The tone of this human coalescence is different in each of the three kinds of relation, and accordingly we find what we have termed a working, trading and thinking coalescence, respectively. All these forms are related to each other, and they are equal in rank. 
Nevertheless, the thinking coalescence, which articulates the relation of human existence to others, has a singular preeminence over the two other coalescences and their respective underlying relations. In a way, truth is first and foremost what men experience in thinking, and since, as has been shown, it belongs to the very nature of thinking to be carried out in common with others, it follows that truth is primarily apprehended by acts of speaking publicly in one’s own name. Such preeminence is not a priority in the sense that the other ways of experiencing truth depend on or are subordinated to acts of thinking. As a matter of fact, affairs of men, their working and trading, can run perfectly without the assistance of thinking. What thinking provides is just a gratuitous and perhaps unnecessary pivot. To use a pertinent Latin expression, we may say that what we have termed a "thinking coalescence" is a primum inter pares in the triad of human coalescences: it is primum, since it is pivotal to any human coalescence as such, but inter pares, since all other forms have equal rank and dignity. 
Accordingly, copyright is primum among its peer fellow rights. Nowhere is this preeminence clearer than in the institutions that define the permitted acts under copyright law, namely limitations and exceptions, the British doctrine of fair dealing and its American counterpart, fair use. It is disputed whether these institutions should be interpreted as restrictions to the author’s rights, that can be applied only negatively as a defense against infringement liability, or whether they define true and proper users’ rights, that can be positively asserted by any author’s counterpart. The reference to the truth as the proper "what-about" of copyright may suggest that copyright is neither author’s nor users’, but just, if I may say so, coalescence’s right. As far as the fair dealing defense is concerned, it might be argued that the "fairness" is nothing but the perfection of reciprocal acts aimed at furthering truth — acts which, so to speak, resonate with and enlighten each other, since it is in the very nature of copyright to withstand coalescence.

DTC

The US Food & Drug Administration (FDA) - counterpart of Australia's TGA - has sent a formal Warning to 23andme.

23andme is the dominant direct-to-consumer (DTC) genetic testing enterprise in a field where there has been controversy about privacy, data protection, the credibility of testing and the interpretation by consumers ... highlighted in publication with Dr Wendy Bonython (e.g. here in the Journal of Medical Ethics).

The FDA states that
The Food and Drug Administration (FDA) is sending you this letter because you are marketing the 23andMe Saliva Collection Kit and Personal Genome Service (PGS) without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act (the FD&C Act). 
This product is a device within the meaning of section 201(h) of the FD&C Act, 21 U.S.C. 321(h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body. For example, your company’s website at www.23andme.com/health (most recently viewed on November 6, 2013) markets the PGS for providing “health reports on 254 diseases and conditions,” including categories such as “carrier status,” “health risks,” and “drug response,” and specifically as a “first step in prevention” that enables users to “take steps toward mitigating serious diseases” such as diabetes, coronary heart disease, and breast cancer. Most of the intended uses for PGS listed on your website, a list that has grown over time, are medical device uses under section 201(h) of the FD&C Act. Most of these uses have not been classified and thus require premarket approval or de novo classification, as FDA has explained to you on numerous occasions. 
Some of the uses for which PGS is intended are particularly concerning, such as assessments for BRCA-related genetic risk and drug responses (e.g., warfarin sensitivity, clopidogrel response, and 5-fluorouracil toxicity) because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these. For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist. Assessments for drug responses carry the risks that patients relying on such tests may begin to self-manage their treatments through dose changes or even abandon certain therapies depending on the outcome of the assessment. For example, false genotype results for your warfarin drug response test could have significant unreasonable risk of illness, injury, or death to the patient due to thrombosis or bleeding events that occur from treatment with a drug at a dose that does not provide the appropriately calibrated anticoagulant effect. These risks are typically mitigated by International Normalized Ratio (INR) management under a physician’s care. The risk of serious injury or death is known to be high when patients are either non-compliant or not properly dosed; combined with the risk that a direct-to-consumer test result may be used by a patient to self-manage, serious concerns are raised if test results are not adequately understood by patients or if incorrect test results are reported.  
The FDA's belated response reflects the following paragraph -
Your company submitted 510(k)s for PGS on July 2, 2012 and September 4, 2012, for several of these indications for use. However, to date, your company has failed to address the issues described during previous interactions with the Agency or provide the additional information identified in our September 13, 2012 letter for (b)(4) and in our November 20, 2012 letter for (b)(4), as required under 21 CFR 807.87(1). Consequently, the 510(k)s are considered withdrawn, see 21 C.F.R. 807.87(1), as we explained in our letters to you on March 12, 2013 and May 21, 2013. To date, 23andMe has failed to provide adequate information to support a determination that the PGS is substantially equivalent to a legally marketed predicate for any of the uses for which you are marketing it; no other submission for the PGS device that you are marketing has been provided under section 510(k) of the Act, 21 U.S.C. § 360(k). ... 
we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses, which have expanded from the uses that the firm identified in its submissions. In your letter dated January 9, 2013, you stated that the firm is “completing the additional analytical and clinical validations for the tests that have been submitted” and is “planning extensive labeling studies that will take several months to complete.” Thus, months after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS. It is now eleven months later, and you have yet to provide FDA with any new information about these tests. You have not worked with us toward de novo classification, did not provide the additional information we requested necessary to complete review of your 510(k)s, and FDA has not received any communication from 23andMe since May. Instead, we have become aware that you have initiated new marketing campaigns, including television commercials that, together with an increasing list of indications, show that you plan to expand the PGS’s uses and consumer base without obtaining marketing authorization from FDA.

Patent Monetisation and Trolls

'Patent Demands & Startup Companies: The View from the Venture Capital Community' (UC Hastings Research Paper No. 75) by Robin Feldman  presents
a study of patent demands against venture-backed startups, conducted through members of the National Venture Capital Association and their portfolio companies. The results of surveying 200 venture capitalists and their portfolio companies provide strong indications of the impact that patent demands are having on the venture-backed community. Both the companies and the venture capitalists overwhelming believe that patent demands have a negative impact on the venture-backed community, with all or most of those assertions coming from entities whose core activity involves licensing or litigating patents. These impacts are described in terms of the specific costs expended by the companies and by the distraction to management, engineers, and other employees. Most important, participants described the human toll that patent demands have had on entrepreneurs. In addition, when making funding decisions, the vast majority of venture capitalists do not consider the potential for selling to assertion entities if the company fails. On the flip side, 100% of venture capitalists indicated that if a company had an existing patent demand against it, it could potentially be a major deterrent in deciding whether to invest. Finally, one venture capitalist provided an excellent summary of the impact of patent demands on venture-backed companies. When companies spend money trying to protect their intellectual property position, they are not expanding; and when companies spend time thinking about patent demands, they are not inventing.
Feldman reports -
  • 70% of the venture capitalists have portfolio companies that have received patent demands; and roughly one in three startup companies report receiving patent demands; 
  • Although 70% of the venture capitalists have experienced demands in the information technology sector, 30% also have experienced demands in the life science sector; 
  • The vast majority of patent demands against the startup companies come from entities that license or litigate patents as their core activity. (59% of the venture capitalists and 66% of the startup companies reported that all or most came demands come from such entities); 
  • 74% of the venture capitalists and 58% of the startup companies report that patent demands had a significant impact on a company; 
  • According to the vast majority of both the venture capitalists and the startup companies, the costs of preparing for and defending against patent demands exceed $50,000 per company, with a number of companies reporting costs in the millions of dollars. 
  • 64% of venture capitalists disagree with the statement, “as a venture capitalist, I consider the potential for selling patents to patent assertion entities if the companies fail.” 
  • When asked whether they see patent assertion as positive for startups and the startup community, 72% of venture capitalists disagree. 
  • 100% of venture capitalists indicate that if a company had an existing patent demand against it, it could potentially be a major deterrent in deciding whether to invest. Roughly half indicate that it would simply be a major deterrent on its face, and the other half indicate

25 November 2013

Advocacy, Naming and Vaccination

In Australian Vaccination Network Inc v Department of Finance & Services [2013] NSWADT 266 the NSW Administrative Decisions Tribunal has affirmed the decision by the Director General of NSW Department of Finance and Services to direct the controversial Australian Vaccination Network Inc (AVN) to adopt a new name.

The AVN is a legal entity under the Associations Incorporation Act 2009 (NSW).

The Director General made the direction on the basis that the AVN name is likely to mislead the public in relation to the AVN's nature, objects or functions, given the finding that AVN's "message is anti-vaccination and that the name does not reflect that message". The Director General also found that the name is "undesirable" and that "it suggests a connection with the Commonwealth government". The AVN applied to the ADT for a review of the decision.

The NSWADT generously comments that -
AVN's main object is the dissemination of information and opinions that highlight the risks of vaccinations. AVN is sceptical about vaccinations. The existing name, Australian Vaccination Network Inc, suggests that the association is pro vaccination or, at least, is committed to providing comprehensive information and opinions about the pros and cons of vaccination. The name should be changed so that it is not likely to mislead the public in relation to its main object. Although I do not have to decide this issue, a name that includes the word "risk" or "sceptic" such as Vaccination Risk Awareness Association Inc or Vaccination Sceptics Network Inc would, in my opinion, be acceptable. The name could also include the word "Australia" or "Australian" without suggesting a link to government. 
Controversy over the AVN, which has apparently endorsed the views of Andrew Wakefield, is noted here and here.

In  January 2013 the Director General had issued a direction to the AVN to change its name, on two grounds: that the name was"likely to mislead the public" and that the name was "undesirable." In February 2013 an internal review of the Director General's initial decision found that -
1) The Australian Vaccination Network Inc's message is anti-vaccination.
2) Its name does not reflect that message or its true nature, objects or functions.
3) Its name is likely to mislead the public. 
The AVN applied to the Tribunal for a review, meanwhile  gaining a stay subject to inclusion on its AVN's websites and Facebook page of a warning.

The NSWADT decision states that the Director General's decision
to direct AVN to adopt a new name is the correct and preferable decision. But my conclusion is not based on a finding that AVN's message is exclusively anti-vaccination, that the name suggests a connection with the Commonwealth government or that the name itself is undesirable. 
In essence, the AVN - under a rejigged name - remains free to engage in 'anti-vaccination advocacy' subject to provision of information from bodies such as the Friends of Science that is inconsistent with its ideology. Concentration on naming sidesteps the more intractable questions about advocacy that, as noted by critics, puts some people at unavoidable serious risk.

24 November 2013

3D Printers and patents

The UK Intellectual Property Office (IPO) has released a brief report [PDF] on 3D Printing: A Patent Overview.

The report's anodyne summary states that
It is important to comprehend the fact that the term “3D printing” can be considered an umbrella term for a number of related technologies that can be used to produce 3D objects. The current dataset has attempted to combine these technologies to provide information about 3D printing itself from a macroscopic perspective. The area of 3D printing has increased massively since 1980 (which constituted the date limitations of the current dataset). However, the fact that there is patent data from this era which is still relevant to this field of technology, is illustrative of the fact that this technology has existed in many forms for some time, and that it is only recently with advances in computing and software combined with large amounts of media interest, (plus the expiration of a number of useful patents) that has led to the current status regarding this technology.
A number of patents have been highlighted as being cited in other patents, perhaps providing an indication of the quality of the disclosures contained therein. There has been an increase in interest in this area, through an expansion of the numbers of academic papers, and increasing use of Internet search terms that can be related to 3D printing. Filings from the year 2000 onwards have demonstrated the largest increase in volume, despite the potential effects of the economic downturn in this time period. The UK does not appear to have a degree of specialisation in this area from the current patent filings. The UK does perform better in terms of the location of the inventor rather than as a location for filing of the application or the country from which priority is taken.
Most of the top applicants are US based companies. However, many of the inventors are not US based, but file their patents in this location. It is also evident from the data that the top applicant holds many patents in the area, but that these are older than those from other top applicants and will expire soon.
A review of landscape maps of this technology reveals that key areas of interest include biomedical applications, circuits and electrode fabrication.
Future work could take many forms given the diversity of the technologies contained within the dataset. It would to interesting to look at Trade Mark filings in this area to see if there is a relationship between this data and the current patent data.
Further work would encompass the analysis of particular parts of this dataset to provide analysis of patent data relating to particular technology areas such as biotechnology. Future work would also be envisaged in performing a more complete analysis of trade mark data in this area as well as consideration of data available from journal and conference proceedings.
The issue of intellectual property and 3D printing has not been fully considered in the current report but it remains an important issue in this field that is ripe for further consideration.
One commentator (Basiliere) put it well, in that he stated that consumer 3D printing is at the "peak of the hype cycle" It is difficult to determine if this comment is really true. However it is evident from the information in this report, that 3D printing is spreading across many technologies and has the potential to disrupt many of them.
There's much more bite in the body of report, which concludes with comments that -
The area of 3D printing has increased massively since 1980 (which constituted the date limitations of the current dataset). However, the fact that there is patent data from this era which is still relevant to this field of technology is illustrative of the fact that this technology has existed in many forms for some time, and that it is only recently with advances in computing and software combined with large amounts of media interest, (plus the expiration of a number of useful patents) that has led to the current status regarding this technology.
One dataset gives about 30,000 published patent applications since 1980 relating to 3D printing which cuts across many areas technology. Patenting activity in the area of 3D printing does not appear to have been affected by recent global economic crisis. The US appears to lead the way in this technology space with most applicants seeking patent protection there.
A number of patents have been highlighted as being cited in patents perhaps providing an indication of the quality of the disclosures contained therein. Looking at other sources of data either through non patent literature (NPL) and Internet search information has confirmed that there has been an increase in interest in this area through an expansion of the numbers of academic papers, and increasing use of Internet search terms, which can be related to 3D printing. Including these sources of data allows a fuller picture of this developing technology to be achieved.
Key conclusions for examining this data show that there has been a large increase in both the media interest and volumes of patent filings in this area of technology. The technology itself is not new (note the patents from 1980), but the tools which allow the underlying technologies to be exploited have undergone substantial improvement over this time frame. Filings from the year 2000 onwards have demonstrated the largest increase in volume, despite the potential effects of the economic downturn in this time period.
The UK does not appear to have a degree of specialisation in this area from the current patent filings. In looking at the patent data, Australia has been listed as a country with a high degree of specialisation, which can be linked back to the activity of a prolific inventor, Kia Silverbrook. The UK does perform well in terms of the location of the inventor rather than as a location for filing of the application or the country from which priority is taken.
Most of the top applicants are US based companies. However, many of the inventors are not US based, but file their patents in this location. Of the top applicants, most of those listed do not collaborate with others. It is also evident from the data that the top applicant holds many patents in the area, but that these are older than those from other top applicants and will expire soon.
There are a number of highly cited patents in this technology with some of them listed in the text. These patents are now relatively new and will expire soon. It will be interesting to see how the technology area evolves given this expiry. There is also increasing academic share of applications over the time period 2000-2012. A review of landscape maps of this technology reveals that key areas of interest include biomedical applications, circuits and electrode fabrication.