24 November 2012

WGS

From the critique by Mark Rothstein in 25(5) GeneWatch (2012) 15-16 of the US Presidential Commission for the Study of Bioethical Issues Privacy and Progress in Whole Genome Sequencing report (noted here).

Rothstein comments that -
The report places too much emphasis on research and not enough on clinical applications. The research issues are relatively uncontroversial, because there is widespread societal recognition of the desirability of research utilizing WGS, so long as there is informed consent, data security, and other traditional protections. The clinical applications are less easily resolved. Certain uses of WGS are undoubtedly valuable, including for analyzing rare disorders, performing tumor genome sequencing, and determining pharmacogenomically appropriate medications. For other uses, however, such as predictive risk assessment for common, complex disorders in asymptomatic individuals, there is little current clinical utility and therefore WGS is difficult to justify.
Another weakness of the report is that it underestimates the potential harms that individuals may suffer as a result of WGS. Except for observing the burden of knowing about a condition for which there is no effective treatment, the report focuses solely on tangible harms, such as discrimination. Nevertheless, many individuals currently experience various psychological and social harms from traditional genetic testing (e.g., depression, anxiety), and the massive scope of WGS is likely to increase the number and severity of these intangible problems.
The discussion of privacy, the main focus of the report, is incomplete. By emphasizing the risk of unauthorized uses of genomic information the report overlooks the substantial issue of lawful uses of information pursuant to compelled authorizations. This occurs when individuals are required to sign a broad authorization (releasing substantially all of their health records) as a condition of applying for a job, various forms of insurance, government benefits, or other matters. Each year in the U.S. individuals sign at least 25 million compelled authorizations, and the adoption of interoperable, comprehensive, and longitudinal electronic health records greatly increases the scope of disclosure and therefore the privacy risks. Unless these risks are addressed it is impossible to protect genetic privacy -- or more broadly, informational health privacy.
The report also contains an inadequate (and, in places, incorrect) discussion of applicable laws. For example, it states (on pages 66-67) that GINA “does not address the use of or access to genetic data. In other words, GINA is an anti-discrimination law; it does not provide comprehensive privacy protections.” This statement is incorrect. Section 202 of GINA prohibits an employer from requiring or requesting an individual to undergo genetic testing or disclose genetic information as a condition of employment. In theory, an employer cannot discriminate if it does not have genetic information; also, individuals will be more willing to undergo beneficial testing if the results will not be available to employers. The problem is that there is no practical way for custodians of health records to comply with a request to disclose everything except genetic information (which, under GINA, includes family health information). By calling attention to this problem, the Commission could have helped to hasten the development of necessary privacy-enhancing technologies.
Although the report is limited to broadly defined “privacy” issues, it is impossible to study privacy concerns without understanding the context in which WGS will be used. The adoption of WGS technology has the capacity to overturn numerous established practices in clinical genetics, and the report’s failure even to mention these applications is unfortunate. Three examples follow.
First, genetic screening of newborns and children is now limited to conditions for which medical intervention in childhood is necessary and potentially beneficial. The rationale for limited testing in childhood is that for adult-onset disorders that cannot be ameliorated in childhood (e.g., Huntington disease, Alzheimer’s disease), the child should be able to decide upon reaching maturity whether to undergo genetic testing. Routine, population-wide WGS of newborns and children would fundamentally alter this established policy. Such a change could have significant psycho-social implications, including privacy implications, and therefore requires thoughtful analysis.
Second, as the cost difference between a single genetic test and WGS is reduced to nominal levels, there will be pressure to undergo WGS in every situation where only a single test is needed initially. This “might as well” sequencing could be promoted by public or private payers as being more efficient than multiple tests, as well as by clinicians who believe the additional genomic information has clinical value. WGS will generate numerous incidental findings that would necessitate genetic counseling, surveillance, and privacy controls. It also could lead to a significant psychological burden that needs to be considered.
Third, the report does not address direct-to-consumer WGS. In addition to numerous regulatory issues, direct-to-consumer WGS raises such fundamental ethical issues as the conflict between autonomy and paternalism, nonmaleficence, justice, and privacy.

23 November 2012

Gore

In R v Borg [2012] VSC 565 the Supreme Court of Victoria has sentenced a man to 23 years' imprisonment with a 19 year non-parole period for what one friend describes as "a good old-fashioned lipsmacking tabloid headline crime".

Borg had come to the false conclusion that his victim had informed police of the man's hydroponic marijuana cultivation activities. He wasn't happy. Quite soon, neither was his victim

Borg had shot the victim and then dismembered the body and burnt the remains. He then placed the remnants of the body into a tub of acid, disposed of various items in bush land and poured the contents of the tub into the ocean.

Alas, the victim had not been the informant. An anonymous female had informed the police of the marijuana crop via the Crimestoppers line and the man's co-offender made a complete confession which led to the man's arrest.

Lasry J noted that
according to what you told [associate] Spiropoulos, you picked [victim] Peter Rule up from his house and took him out for dinner. After dinner, you took him to a factory occupied by Corey Small in Campbellfield. You told Peter Rule that there was a gun hidden somewhere in the factory and that they should look for it. During the course of the search for the gun which you had described to Peter Rule, you produced the gun and shot him a number of times. You told Spiropoulos that you shot him six times in the head and four times in the chest.
You later rang Spiropoulos and told him to purchase 15 bottles of bleach, some garbage bags and rags which Spiropoulos then did. This was late on a Sunday night. You later directed Spiropoulos to meet you at a factory in Campbellfield owned by Corey Small and to bring the items that Spiropoulos had purchased. 
You and Spiropoulos then spent an hour and a half or more cleaning up at Corey Small’s factory following the killing of Peter Rule. The body of Peter Rule was in the boot of your motor car and you had finished at the factory in Campbellfield you then drove to the factory in Thomastown. By this time is was the early morning of the following day and you instructed Spiropoulos to return to the Thomastown factory the following day and he did so. By the time he arrived you had set about burning the body of Peter Rule to the extent that only ashes were left. During that process a chain saw had been purchased to assist with dismembering Peter Rule’s body. The process of destroying Peter Rule’s body lasted as long as three days. Part of that process also involved placing the remnants of Peter Rule’s body into a black tub and then mixing acid into it. After the process had been completed you and Spiropoulos travelled to the area of the Great Ocean Road in the vicinity of Anglesea and Lorne where various items were disposed of by being concealed in the bush and the contents of the black tub were washed into the ocean. New clothes were purchased in Lorne at a menswear shop which could be linked to both you and Spiropoulos. After returning from that area, there was then cleaning of motor vehicles and later, to conceal any trace of what had happened at the Thomastown factory the floor was washed and repainted.
In conclusion Lasry J commented that -
The murder of Peter Rule was a planned, calculated killing and was particularly callous. You have denied you were involved in the killing and continue to do so. The jury’s verdict means they rejected your denials and so do I. Peter Rule was enticed to a location where you had planned to kill him and you did so. This was a killing with a significant amount of premeditation and planning involved and those factors in themselves make it bad enough. But the brutal degradation of Peter Rule’s body, which I accept was for the purpose of concealing what you had done, was dreadful and is a significant aggravating factor as your counsel properly conceded. 
In addition, this was a killing which occurred for the purpose of preserving your hoped for income from the illegal growing of cannabis. Had it not been for the fact that Michael Spiropoulos could not cope with his own conscience, the whereabouts of Peter Rule’s remains might never have been known. I respectfully agree with the submission made by the prosecutor that this is very serious offending and requires clear denunciation of what you have done. As for deterrence both specific and general, both you and the community needs to be reminded that the law will not tolerate individuals resorting to behaviour involving gross violence like yours to protect expected financial benefits from other illegal activity.

22 November 2012

Holymoly

I'm waiting on news of trade mark litigation in Denmark, where ultra conservative Roman Catholic religious institution Opus Dei is suing a small board games maker that - presumably influenced by the very same forces of darkness that are manifest in this blog - markets a game titled Opus-Dei: Existence After Religion.

Dema Games, which has a Danish trade mark for its product, is responsible for an atheist-flavoured "philosophy-themed, strategy-based game" in which - but of course - the player with the most points wins. The religious institution is apparently seeking damages - probably enough to shut down Dema - along with an end to the game and the associated mark.

The games company won a UK domain name dispute in 2009 in an arbitration judgment [PDF] that is worth reading.

In Australia the local branch of Opus Dei - the Prelature of the Holy Cross and Opus Dei in Australia - complete with an Australian Company Number (ACN 053818929) has the Opus Dei mark in four classes:
Class 9: Computer, Electrical and Scientific Products - Electronic publications, educational films, tapes, cassettes and other electronic material 
Class 16: Paper Goods and Printed Material - Printed matter, newspapers and periodicals, books and other printed publications, instructional and teaching materials 
Class 41: Education, Sport, Culture - Religious, spiritual, theological, philosophical, community and social educational, information and training services 
Class 42: Computer, Software and Scientific Services - Religious, spiritual, theological, philosophical and spiritual research and services including pastoral counselling 
Would unwary consumers be confused and mistake the offerings of the prelature with the card game?

Pharma Patent Questions

The Pharmaceutical Patents Review noted in a previous post has released a Background and Issues Paper.

The paper asks eleven questions -
1: Is the breadth of pharmaceutical patents eligible for an extension of term appropriate? 
2: Is the length of the extension of term provided for appropriate? 
3: Are the recent amendments to increase the thresholds for the grant of an Australia patent appropriate in the context of pharmaceuticals? If not, why not and what further changes are necessary? 
4: Do the systems for opposition and re-examination provide appropriate avenues for challenging the granting and validity of a pharmaceutical patent? 
5: Do interlocutory injunctions, as the law is currently applied, provide appropriate relief in cases involving pharmaceuticals? 
6: Is Australian law on contributory infringement appropriate in relation to pharmaceuticals? 
7: Are the current timeframes in which infringement proceedings must commence appropriate for pharmaceutical patents? 
8: Are follow-on patents being used to inappropriately extend protection for pharmaceuticals? If so, how? And, if they are, is this sound policy and what changes, if any, are needed? 
9: Is the law on data exclusivity appropriate? 
10: Are the laws on patent certificates appropriate? 
11: Are the laws on copyright of product information appropriate?

21 November 2012

Williams

'The Executive Power of the Commonwealth of Australia' article by Peter Gerangelos noted in the preceding post features a supplementary note on Williams v Commonwealth [2012] HCA 23 -
The decision of the High Court in Williams v Cth is the most recent case on executive power. This supplementary note will refer to those aspects of the decision most relevant to the principal concerns of this article. The case no doubt will be the subject of further detailed analysis. 
The decision affirmed, inter alia, the following aspects of Pape: An appropriation pursuant to s. 81 is not a source of spending power; and s. 61 is a source of inherent executive power based on ‘nationhood’ considerations beyond what may be permitted by those executive powers (both ‘prerogative’ — in the narrow sense — and ‘capacities’) recognized by the common law. The discussion in this article relating to the principal issue of inherent content to s. 61 remains unaffected, except in the aspects discussed below. 
The precise issue raised by the facts was the extent to which the Commonwealth, absent statutory authorization, could enter into contracts and to spend moneys in performance thereof; in this case entering an agreement to fund chaplaincy services in State schools. The agreement and spending in issue were held to be invalid. The ambit of the prerogative, in the narrow sense, was not in issue. A majority (French CJ, Gummow, Bell and Crennan JJ) held that s 61 permitted Commonwealth contracting and spending without statutory authorization (subject to appropriation) only in the following circumstances: when it is a) reasonably necessary for the execution and maintenance of the provisions of the Constitution and valid laws made thereunder; b) in the exercise of the Commonwealth’s prerogative powers (in the narrow sense); c) in the exercise of those powers which derive from the inherent executive nationhood power (which is not amendable to exhaustive definition); and d) in the ordinary course of administering a recognized part of the Commonwealth government, carrying out recognized functions of government, which is analogous to the power to administer government departments pursuant to s 64 of the Constitution. Excepting these circumstances (hereinafter ‘the recognized exceptions’), the Commonwealth could not validly contract and spend unless authorized by legislation. As the impugned funding agreement did not come within these ‘recognized exceptions’, it was held invalid. 
Although the facts related more precisely to executive ‘capacities’, the reasoning of these majority judges manifested a move away from previous understandings and assumptions relating to s 61, the full implications of which may not become apparent until further cases are brought. This is revealed most clearly by contrasting the approach of this majority in Williams with the general approach based on breadth/depth analysis, previously dominant despite differing views as to the existence and ambit of inherent content based on ‘nationhood’. Applying the latter approach, the funding agreement would be regarded as an exercise of that executive capacity shared with natural persons, recognized by the common law and incorporated by s. 61, to enter into contracts. It clearly thus fell within the depth component of Commonwealth executive power, satisfying the first step for constitutional validity. It was then necessary to determine whether the terms of the contract, the matters it provided for, satisfied the breadth requirement; that is, whether they were within the permissible sphere of Commonwealth executive power determined by reference to the ambit of Commonwealth legislative competence, express and implied. If they were, then no further statutory authorization was required (subject to appropriation). 
Heydon J (in dissent) came closest to this approach, commending Winterton’s breadth/depth distinction as ‘not only neat but illuminating’. The depth requirement was met because the act of contracting and spending was a recognized executive capacity authorized by s 61, albeit one not unique to the Commonwealth. The breadth requirement was satisfied by s 51 (xxiiiA) which provided, inter alia, that the Parliament could make laws “with respect to ... benefits to students”, adopting a broad interpretation thereof to included the provision of chaplaincy services. 
This approach does not suggest that the Executive Government of the Commonwealth could do anything in relation to which the Parliament of the Commonwealth could make a valid law. The breadth/depth approach would say rather that the government can only do those things, engage in those activities, encompassed by the executive prerogatives and capacities at common law, and — following Pape — by the ‘nationhood’ executive power, and then, only within the sphere defined by Commonwealth legislative competence, express and implied. 
None of the majority judges adopted this approach. Rather, they appear to have considered first the ambit of s 61 executive power; and in relation to which they eschewed an exhaustive definition. They proceeded to determine (without reliance on breadth/depth) whether the funding agreement in issue was a valid exercise of s 61 power. Applying the holding in Pape — that s 81 is not a spending power — they proposed that, prima facie as a general rule, the Commonwealth does not have power to contract and spend without prior statutory authorization. The next step was to determine whether the executive action in issue came within one of ‘the recognized exceptions’ above-mentioned. None of these, however, gave implicit recognition to a general executive capacity, at common law and incorporated by s. 61, to contract and spend. That is, the majority appear not to have given explicit recognition to a general capacity (shared with natural persons) to contract and spend (depth) so long as this was exercised within the sphere of Commonwealth legislative competence (breadth). Of course, if the Commonwealth were not a federation, and its Parliament had plenary legislative competence, there would be no need to consider the element of breadth. Validity would simply be determined by the question of depth. Indeed, they appear almost to be rejecting that there is an executive ‘capacity’ to contract and spend, based on the character of the Commonwealth as a juristic person and recognized at common law. Instead the focus appears to have shifted to the ‘recognized exceptions’ as restraints on that capacity. Under the previous approach, apart from meeting the breadth requirement, this capacity may have been restrained by considerations relating to the requirement that its exercise be subject to the general law, that it not impinge on the rights of others, that it not involve coercion, and by a certain sensitivity relating to the different quality attached to a ‘capacity’ when exercised by government as opposed to the private citizen (eg, secret government telecommunications surveillance being quite different to private eavesdropping.) However, following the majority reasoning, a general power to contract and spend which does not come within these exceptions now requires statutory authorization, and is thereby no longer an executive ‘capacity’ at all. Will this approach be extended to include, and thus limit, what were hitherto regarded as ‘capacities’ beyond the power to contract and spend? Is there potential for this approach be extended to limit the ‘prerogatives’ in the narrow sense? Future cases will need to clarify this. 
The new criteria for determining the ambit of these capacities, as reflected in the nature of the ‘recognized exceptions’ (especially the last one) would appear to be based on issues of accountability (requiring legislation for the exercise of any former ‘capacity’ implementing new policy beyond the recognised functions of government) and a more vigorously asserted need to protect State executive power from federal encroachment. 
There were some further specific instances of disenchantment with the breadth/depth approach, possibly based on a misunderstanding thereof. Gummow and Bell JJ  focussed on a broad proposition, which they rejected, that the executive might do anything which Parliament might do by an enactment; and yet seem not to have distinguished this from the breadth/depth approach. The latter approach does not suggest that the executive may do anything at all which could be permitted by legislation. Rather, it stands for the proposition that whatever the prerogatives and capacities recognized at common law, as well as (post-Pape) the inherent executive nationhood power, may permit the Commonwealth to do (depth), it may only take that permitted action within the sphere of Commonwealth legislative competence (breadth). And yet French CJ queried the usefulness of the concept of breadth:
The subject matters of legislative power are specified for that purpose [to determine the validity of legislation], not to give content to the executive power. Executive action, except in the exercise of delegated legislative authority, is qualitatively different from legislative action.
The meaning of ‘not giving content’ is difficult to determine. For the concept of the content of executive power is more meaningfully applied when examining depth. Reference to subject matters of legislative competence merely determines the sphere in which the content of the executive power may operate. Executive action is, in the main, qualitatively different to legislative action and it is for this reason that a determination of its constitutional validity it is not as straightforward as determining the validity of legislation. But this does not justify impugning the concept of breadth. On the contrary, this difference explains and justifies the discrete method applied by breadth/depth analysis, properly understood, to executive action, distinguishing it from that applied to the determination of the validity of legislation pursuant to the Constitution. 
The above would indicate that there has been a further shift away from existing approaches and principles in relation to executive power. There is a possibility that the above issues may be re-examined and amended when revisited by the Court. This potential for reconsideration is reinforced by the view of at least one the justices, due to a significant shift of the position of some of the parties on a fundamental legal issue after the hearing had commenced, that the fullest consideration of that issue may have been hindered. That issue, referred to as the ‘common assumption’, was ‘that the executive power of the Commonwealth included a power to enter contracts without statutory authority as long as the Commonwealth had legislative power to give it statutory authority.’ This is broadly in conformity with the orthodox breadth/depth analysis. Heydon J was concerned by the rejection of this common assumption by the plaintiff after oral argument had commenced, ‘raising the possibility that the case may not have been argued and considered with the degree of thoroughness that no doubt would have been applied to it if the common assumption had been clearly impugned by the plaintiff from the very outset.’ After referring to other vicissitudes of litigation which hindered a fuller examination of this fundamental question, his Honour concluded:
This case is not an appropriate one in which that question should be answered. ... It is important that points of fundamental significance such as the one that this case belatedly raised be pondered by counsel for years – as they often are when appeals come to this Court – or at least for months – as is usual when matters in the original jurisdiction are brought to the Full Court. Above all, they need to be considered calmly. Radical changes in the construction of the Constitution should not be made without better assistance than the unpredicted conspiracy of circumstances permitted counsel to provide in this case.
The final episode relating to these questions may thus yet to be played out.

Nationhood

'The Executive Power of the Commonwealth of Australia: Section 61 of the Commonwealth Constitution, ‘Nationhood’ and the Future of the Prerogative' by Peter Gerangelos in 12(1) Oxford University Commonwealth Law Journal (2012) 1-35 comments that
Section 61 of the Australian Constitution provides for the general executive power of the Commonwealth. It has traditionally been regarded as incorporating the prerogative as the yardstick of its ambit. There has, however, been a drift away from sole reliance on the prerogative toward a conception of s 61 as incorporating inherent power to meet the imperatives of a modern, independent national government. This has created a tension between those who would maintain that the prerogative alone can ensure against undue aggrandizement of executive power and those who see in an executive ‘nationhood’ power the only appropriate criterion by which to interpret s 61 to meet the needs of a modern government. The trend toward ‘nationhood’ has now been supported by the High Court of Australia. It is therefore presently urgent to address the issue of limitations to this power. It will be argued that this can only be achieved by maintaining an appropriate role for the prerogative, albeit the concept itself may need to evolve as part of the Australian common law and a written federal constitution.

Bibliometrics

'Are more senior academics really more research productive than junior academics? Evidence from Australian law schools' by Vinod Mishra and Russell Smyth in (2012) Scientometrics1-15 examines
the relationship between academic seniority and research productivity through a study of a sample of academics at Australian law schools. To measure research productivity, we use both publications in top law journals, variously defined, and citation metrics. A feature of the study is that we pay particular attention to addressing the endogeneity of academic rank. To do so, we use a novel identification strategy, proposed by Lewbel (Journal of Business and Economic Statistics 30:67–80, 2012), which utilises a heteroscedastic covariance restriction to construct an internal instrumental variable. Our main finding is that once endogeneity of academic rank is addressed, more senior academics at Australian law schools do not publish more articles in top law journals (irrespective of how top law journals are defined) than their less senior colleagues. However, Professors continue to have greater impact than Lecturers when research productivity is measured in terms of total citations and common citation indices, such as the h-index and g-index.
'Academic Inbreeding and Research Productivity in Australian Law Schools' (Monash Department of Economics Discussion Paper 46/12) [PDF] by Mishra and Smyth compares
 the research productivity of inbred and non-inbred faculty employed at Australian law schools. The sample consists of 429 academics, employed at 21 law schools. To measure research productivity we use both articles and pages published in top law journals, defined in six different ways, as well as total citations and two different citation indices. We report results including, and excluding, publications in the home law review. We find evidence that silver-corded faculty outperform other faculty on one of the measures of research productivity, once the endogeneity of academic seniority and grant history is addressed, but this finding is not robust across alternative measures of research productivity. We find that there is no statistically significant difference between the research productivity of inbred and non-inbred faculty. This finding is robust to a range of different ways of measuring research productivity and alternative econometric approaches, including using two-stage least squares to address the endogeneity of academic seniority and grant history.
The authors conclude -
The main finding in this study is that there is no significant difference in the research performance of inbred and non-inbred staff. Hence, there is no support for either of the competing hypotheses presented earlier. While there are conceptual arguments suggesting that academic inbreeding could have a positive or negative relationship with research performance, and the existing empirical findings are not unanimous, intuitively we expected to find that academic inbreeding would have a negative effect on research performance. As Eisenberg and Wells (2000, p. 310) put it, when they told colleagues that they found a negative relationship between academic inbreeding and research performance in US law schools, “no-one seem[ed] surprised by the result”. 
Our findings are surprising in the sense they are negative results and refute popular (mis)conceptions about academic inbreeding. Over the last few years there has been increased recognition that scientific progress in several disciplines has been hampered by researchers‟ tendencies to confine negative results to the file-drawer (see Gumpenberger et al., 2012). An example in the empirical legal studies literature is the debate on capital punishment, in which Donohue and Wolfers (2005) have argued that “reporting bias” has distorted the debate by producing a situation where primarily only studies reporting a deterrent effect get published. We believe that our findings have value in that we use a rigorous methodology to reach results contrary to many recent studies on the relationship between academic inbreeding and research productivity and we do so in a different institutional context. 
Most recent studies which have found a negative relationship between academic inbreeding and research productivity have used data from countries and disciplines in which the proportion of inbred staff is relatively high (see eg. Horta et al., 2010; Inanc & Tuncer 2011). Even in the Eisenberg and Wells (2000) study, the proportion of academic inbreeding was high in the Ivy League schools. By contrast, the degree of academic inbreeding is relatively low in Australian law schools and findings in this setting add to the literature. 
Almost three decades ago, Wyer and Conrad (1984) published one of the first studies on this topic to use a multivariate model and also reached the conclusion that there was no statistical difference in the research productivity of inbred and non-inbred staff. Given that finding was “contrary to most previous results” the authors considered it “appropriate to summarize the methodological strengths of [their] study” (at p. 224). We do likewise. First, our results are robust to a number of alternative ways of measuring research productivity. Second, we focus on publications in top journals, variously defined, and citations to measure impact. This contrasts to most previous studies which have focused on the quantity, and not quality, of research. Third, we control for a number of factors likely to be correlated with research productivity. Fourth, the results are robust to the inclusion, or exclusion, of publication in the home law review. Fifth, we corrected for the endogeneity of seniority and grant history and the findings for inbreeding were robust. 
Thus far, studies of the academic inbreeding-research productivity nexus outside of the US have tended to focus on disciplines and countries in which there is a high prevalence of academic inbreeding. In terms of future research, there need to be more studies for countries and disciplines in which academic inbreeding is not as prevalent to verify the results here. The relationship between academic inbreeding and research productivity is just one aspect of the broader debate around academic inbreeding. There is also much speculation around the organizational effects of inbreeding. Compared with the larger literature on the relationship between academic inbreeding and research productivity, few studies have examined the organizational effects or institutional implications of academic inbreeding (Horta et al. 2010 is a recent exception). This is a topic that could usefully be the subject of future research.

20 November 2012

Twits

The 62 page 'Guilty as Tweeted: Jurors Using Social Media Inappropriately During the Trial Process' (UWA Faculty of Law Research Paper No. 2, 2012) by Marilyn Kravitz comments that
Social media is ubiquitous, millions of people use it worldwide. However, some of these people (albeit a small proportion) are jurors. If jurors use social media during a trial inappropriately, it can have devastating repercussions to an accused’s right to a fair trial. For example, the juror’s impartiality may be affected. This article examines why jurors use social media inappropriately. It also provides recommendations tailored to the Australian courts about how to prevent jurors from using social media inappropriately and how to contend with the relevant juror. Given the high number of Australians that use social media, the courts should seriously consider this issue.
She begins with the statement -
Picture this: you are a criminal lawyer. You worked night and day for several months to represent your client, who was charged with conspiracy to supply heroin and conspiracy to supply amphetamines. Eight co-accuseds were also charged with similar offences. At the beginning of the trial, the judge instructed the jury not to use the internet to read about anything connected with the trial. He also instructed them to base their verdict on the information that they hear in court and nothing else. The judge repeated these instructions consistently during the trial.
The jury subsequently deliver verdicts for some of your client’s co-accuseds: some are found guilty and some are found innocent. A verdict has not yet been delivered for your client. You then receive some startling news: one of the jurors in the trial chatted with a co-accused who was found innocent yesterday. Their conversation occurred entirely on Facebook messenger and they discussed the trial.
You are outraged on behalf of your client about what the juror did. You are left wondering about what you should do as a result of the juror’s actions. You also wonder what the Court will do when it finds out.
The above scenario is based on a real trial in the United Kingdom: Attorney-General v Fraill. In this case, the court sentenced the juror to eight months imprisonment as a result of her using social media inappropriately. ....
Juror misconduct due to inappropriate use of social media is an old problem in a new form. Historically, if a judge told jurors not to discuss their case, then there was little chance that a juror would be caught talking to others about it. However, social media is different. Many people, including jurors that use social media, treat social media as if it were their own personal and confidential conversation with another person or people. However, in reality, their social media use can be broadcast to a very large audience. According to Niehoff, ‘the faux intimacy of social media seduces users into believing that their communications are like hushed confessionals when they are actually more like full-throated shouts.’
There are over a dozen cases of jurors using social media inappropriately in the United States, two in the United Kingdom and one in Australia, as of the date of this article. It is possible that many jurors are inappropriately using social media in Australia, but the courts do not know about it because no one is reporting it. Alternatively, if they are not, it is highly likely that jurors will use social media inappropriately in the future due to the high number of Australians that use social media. For example, eleven million Australians use Facebook. Nine million Australians visit the site weekly and over 7 million visit it daily. The most popular Australian on Twitter is former Prime Minister and former Foreign Minister Kevin Rudd: over a million people follow him. Further, various Australians recently announced that they intend to research the area of social media and the courts. Researchers from three Australian universities, Bond University, Monash University and the University of Canberra, seek funding from the Australian Research Council to research social media and the courts. The Victorian Attorney General, Robert Clark, announced that he will create a working group to find solutions to the availability of information prejudicial to an accused on social media. The group will include people working in social media, the police and judicial officers.
The purpose of this article is to explore the current knowledge surrounding jurors using social media inappropriately. After a short description of the history of the jury and the principles underlying it, this article will explore the problems associated with jurors using social media inappropriately. It will then explore why jurors engage in this form of misconduct, along with recommendations about how to prevent this form of misconduct from occurring. The article will also examine how the courts should contend with the juror and the trial itself when it discovers that a juror used social media inappropriately.

Defamation and Reporting

'Appropriate Reforms to Defamation and Protection Laws' (UWA Faculty of Law Research Paper No. 1, 2012) by Michael Gillooly was an Invited Submission to the WA Government St Andrew's Hostel Inquiry in June this year. It is relevant to the forthcoming national Royal Commission into child abuse involving arms of the Roman Catholic Church in Australia and other institutions, and to the NSW and Victorian inquiries in the same area.

Gillooly notes that
This is an advice to the Government of Western Australia made as part of its inquiry into the conduct and response of relevant public officials and government agencies in relation to allegations of sexual abuse at St Andrew's Hostel in Katanning, and related organisations.
It addresses what might be appropriate reforms to current WA defamation or protection laws in respect of:
1. Allowing a person who reports child sexual abuse, believing it to be true, to have statutory protection from defamation proceedings.
2. Whether designating additional positions or authorities for this purpose would be appropriate (consistently with the currently designated mandatory reporters, the Department for Child Protection or Western Australia Police).
3. Whether the Public Interest Disclosure Act 2003 (WA) can be suitably amended, or alternatively, provides an appropriate model for that purpose.
4. Any other mechanisms or protections that could be considered to ensure that those who have a valid complaint of child sexual abuse can disclose it appropriately.
He goes on to comment that
There is no doubt that reports about child sexual abuse, whether actual or suspected, which are made to an appropriate person, honestly and in good faith, would be protected by the defence of qualified privilege. Nonetheless, the long standing existence of that protection proved an insufficient inducement to members of the hostel community to come forward and voice their concerns about the activities of the Warden. It is submitted that the reason is the common law nature of the defence. Because the defence is rooted in the common law, it suffers from certain deficiencies as a form of encouragement to potential complainants:
First, the defence can only be stated in the broad terms of general principle. The virtue of this generality is that qualified privilege is flexible enough to apply in a multitude of different situations. In this regard it can be contrasted with its distant cousin, absolute privilege, which only applies in a narrow range of specifically enumerated circumstances. However, the defence’s generality and flexibility are also its major weaknesses for present purposes, for there may be some element of uncertainty attaching to the precise scope of its application. Hence, it fails to provide a potential reporter with a clear and specific statement of his or her immunity from action.
Second, the defence is not readily accessible to non-lawyers. Its existence and elements are to be found in the interstices of the common law, and considerable specialist knowledge is required to grasp its full implications.
Third, like all common law principles, the defence is open to change retrospectively and without notice by judicial decision.
Gillooly makes several recommendations -
Amendments to the Children and Community Services Act 2004
1. That a specific and explicit right to report child abuse for members of the public be enacted. The insertion into Part 4 Division 9A of provision along the following lines is suggested:
Section XXX. Voluntary reporting of child sexual abuse
(1) A person, who believes or suspects that a child has been, is being or will be the subject of sexual abuse, may report that belief or suspicion to the CEO of the Department of Child Protection, the Commissioner of Police or any of their officers.
(2) A person making a report under subsection (1) shall state their reasons for forming the reported belief or suspicion.
2. That the subsection 129(2) protection be extended to cover reporters exercising the new right enacted pursuant to Recommendation 1. The insertion into s 129(1) of a new paragraph along the following lines is suggested:
Paragraph 129(1)(exxx) (exxx)
makes a report under section XXX;
3. That special provisions relating to defamation proceedings be enacted in order to: (i) cast the onus with respect to good faith under the new defence on the plaintiff; (ii) enable a defendant to obtain a declaration of falsity in an appropriate case; and (iii) penalise the use of defamation proceedings to deter good faith reporting of child sexual abuse.
The insertion, after s 129, of a new section along the following lines is suggested:
23 Section129XXX. Provisions relating to defamation proceedings
(1) In any proceedings for defamation, when a defence under s 129(1)(exxx) and (2) is relied upon, the defendant need not prove that he or she acted in good faith, but the onus of proof lies on the plaintiff to establish the defendant’s lack of good faith in order to defeat the defence.
(2) Where defamation proceedings fail due to successful reliance by a defendant on a defence under s 129(1)(exxx) and (2), and the plaintiff proves the falsity of the defamatory imputations conveyed by the report made under s XXX, the court may make a declaration of the falsity of those imputations.
(3) A person shall not threaten or foreshadow the initiation of defamation proceedings in order to deter or dissuade a person from making a good faith report under s XXX.
Penalty: a fine of $6000
Amendments to the Public Interest Disclosure Act
 4. That section 5 be amended to make the Public Sector Commissioner the “one stop shop” for the initial receipt of public interest disclosures.
The insertion into section 5 of provisions along the following lines is suggested:
Paragraph 5(3)(j)
(j) where the information relates to any of the matters referred to in any of the preceding paragraphs of this subsection, except for paragraph (g) 43 – it is made to the Commissioner.
Subsection 5(3A)
Where a disclosure is made to the Commissioner under s5(3)(j), the Commissioner shall refer the disclosure to the relevant “proper authority” and is not subject to the obligations set out in Part 2, Division 2 with respect to that disclosure.
Administrative Recommendation
5. That the Public Sector Commissioner be asked to consider the preparation of guidelines under s 21 to facilitate the identification of the person within a public authority who has been designated to receive public interest information disclosures
I have been rereading 'Republication of Defamation under the Doctrine of Reportage - The Evolution of Common Law Qualified Privilege in England and Wales' (UNSW Law Research Paper No. 2010-20) by Jason John Bosland, which examines -
the ‘doctrine of reportage’ - a particular application of the ‘Reynolds’ qualified privilege defence to defamation recognised by the House of Lords in Reynolds v Times Newspapers Ltd. The doctrine of reportage provides protection for the neutral reporting (republication) of defamatory allegations made by others in the context of a dispute or controversy of public interest. It is argued in this paper, however, that this emerging defence is doctrinally distinct from the privilege recognised in Reynolds and that its jurisprudential basis needs to be reconsidered. Moreover, the development of the defence under the guise of Reynolds privilege has led to confusion, both by courts and by commentators, as to its potential breadth. It is suggested that the public interest justifications underpinning the reportage defence need to be explicitly re-examined by the courts in order to define its proper scope. Following an examination of these public interest justifications, it is argued that a broad interpretation of the defence should be rejected.

19 November 2012

Wine GIs and Broccoli

'Geographical Indications and the International Trade in Australian Wines' by Michael Blakeney in (2012) 18(1) International Trade Law & Regulation 70-78 comments that
Australia has been regarded as a 'New World' opponent of attempts under the TRIPS Agreement to extend the European system of GIs protection to the wider world. It also joined with the USA in instituting a successful TRIPS dispute against the EU’s GIs procedures. However, the extensive Australian trade in wines to the EU has obliged Australia to embrace a European-style GIs system for its own wines. This article describes the evolution of the Australian – EU Wine Agreements of 1994 and 2009 and the consequential development of the Australian wine GIs system. It calls into question as over-simplified the Old World/New World dichotomy in relation to GIs.
Another perspective is provided in his 30 page 'Geographical Indications and TRIPS', which considers "the international negotiations concerning the extension of the special protection for the geographical indications for wines and spirits provided in the WTO TRIPS Agreement to agricultural and handicraft products".

Blakeney's 'Patenting of Plant Varieties and Plant Breeding Methods' in (2012) 63(3) Journal of Experimental Botany 1069-1074 considers
the relationship between patenting and plant variety rights protection, through a detailed analysis of the recent determination by the Extended Board of Appeal of the European Patent Office that methods for breeding broccoli and tomatoes were not patentable. It concludes that the right to patent agricultural innovations is increasingly located within a political context. 
Blakeney's lucid commentary states that
The determination of the EBA was that a process for the production of plants which is based on the sexual crossing of whole genomes and on the subsequent selection of plants, in which human intervention, including the provision of a technical means, serves to enable or assist the performance of the process steps, is excluded from patentability as being essentially biological within the meaning of Article 53(b) EPC. Thus the EBA confirmed that classical plant breeding is excluded from patentability. On the other hand, if a process of sexual crossing and selection includes within it an additional step of a technical nature, which step by itself introduces a trait into the genome or modifies a trait in the genome of the plant produced, so that the introduction or modification of that trait is not the result of the mixing of the genes of the plants chosen for sexual crossing, then that process leaves the realm of the plant breeding and, consequently, is not excluded from patentability. This principle applies only where the additional step is performed within the steps of sexually crossing and selection, independently from the number of repetitions, otherwise the exclusion of sexual crossing and selection processes from patentability could be circumvented simply by adding steps which do not properly pertain to the crossing and selection process, being either upstream steps dealing with the preparation of the plant(s) to be crossed or downstream steps dealing with the further treatment of the plant resulting from the crossing and selection process. The EBA noted that, for the previous or subsequent steps, per se patent protection was available. This will be the case for genetic engineering techniques applied to plants which differ from conventional breeding techniques as they work primarily through the deliberate insertion and/or modification of one or more genes in a plant.
It is important to note that the EBA disallowed the patenting of methods of plant breeding. It has been pointed out that the products of plant breeding remain patentable (Then and Tippe, 2011). An analysis of the examination reports for recent patent applications at the EPO indicate that claims in relation to the breeding of plants would have to be deleted, but that the plants themselves [sunflowers (see note 18) and coreless tomatoes (see note 19)] were patentable. Because of this, civil society representatives have ‘a clear legal prohibition on granting patents on plants and animals, on processes for breeding, relevant biological material and the food derived’ (see note 20).
This litigation emphasizes for plant breeders and botanists the political dimension of their activities, which had hitherto been treated as a matter of technical science. The environmentalist NGO, Greenpeace, is cofounder of ‘No Patents on Seeds’, and has taken the lead in building public awareness of the issue. Similarly, the NGO, ETC Group, has led a campaign over many years opposing the ‘patenting of life’. An illustration of the strength of feelings on this issue was the destruction by Greenpeace activists in July 2011 of a GM wheat crop being grown at a government experimental station in Australia (see note 21). The attack followed the refusal of a Freedom of Information request for more information about the trials. The GM trials were part of experimentation into the development of drought resistant crops. Underpinning the opposition to this science is the concern of NGOs that the independence of small independent farmers and breeders is threatened by powerful life sciences corporations.
A 2008 study by the ETC Group identified 55 patent ‘families’ (see note 22) (a total of 532 patent documents) that were applied for and/or granted to a number of biotechnology companies on so-called ‘climate-ready’ genes at patent offices around the world (ETC, 2008). Its 2010 update of this study ‘examined patents containing claims concerned with abiotic stress tolerance (ie traits related to environmental stress, such as drought, salinity, heat, cold, chilling, freezing, nutrient levels, high light intensity, ozone, and anaerobic stresses’. It noted a dramatic upsurge in the number of patents published (both applications and issued patents) related to ‘climate-ready’ genetically engineered crops from 30 June 2008 to 30 June 2010, identifying 262 patent families and 1663 patent documents. The 2010 report of the ETC contrasted the ownership of 9% patent families by public sector institutions (9% of the total) with the private sector which holds 91% of the total. The 2010 report points out that ‘just three companies — DuPont, BASF, Monsanto — account for two-thirds (173 or 66%) of the total’. This level of market concentration gives cause for concern for those who espouse the positive role of competition, but also a concern about the sort of biotechnological research which is undertaken. For example, to what extent will the dominance of private corporations in biomedical and agricultural research direct that research towards Northern concerns away from Southern food priorities. It has been estimated that only 1% of the research and development budgets of multinational corporations is spent on crops of interest that would be useful in the developing world. Almost entirely neglected by these corporations are the five most important crops of the poorest, arid countries — sorghum, millet, pigeon pea, chickpea, and groundnut.
This disputation over the patenting of the products of plant breeding, as well as plant breeding methods themselves, emphasizes the increasingly politicized environment in which experimental botany is occurring. Current research into the influence of climate change upon the development of weeds, insect pests, and crop diseases and the ways in which plants can be engineered to withstand salinity and aridity is increasingly going to be undertaken in a political context.
The Canberra Greenpeace activists (or eco-vandals) noted by Blakeney have meanwhile received nine-month suspended sentences for destroying a CSIRO genetically modified wheat crop. The activists had destroyed the crop in July last year; Greenpeace then sought publicity by contacting the ABC and releasing vision of the protest.  Greenpeace has since paid more than $280,000 in compensation to the CSIRO.

Penfold J in the ACT Supreme Court indicated that the action was motivated by deeply held beliefs and altruistic intentions but the law had been deliberately broken. She criticised Greenpeace for allowing two junior staff members to be exposed to the consequences of breaking the law.

Greenpeace reportedly responded that the two activists knew what they were getting themselves into.
"The crop that we targeted was one that we had cause to believe would be used in trials, including human trials. We were very concerned about the lack of transparency around that trial," .... "As the judge noted, we have made a number of Freedom of Information requests in the month leading up to our action, seeking further details about the trials and the CSIRO refused to provide that information to us."
Mr Pearson says despite the charges and fine, the conservation group would not rule out undertaking similar acts in the future.
"Look Greenpeace will never resile from undertaking acts of civil disobedience, we simply will not do that. We won't walk away from that now or in the future," he said.
"It's not a matter of saying would we do that particular action again, it's a matter of whether we would engage in civil disobedience again and we certainly will if we believe it's necessary."
Ben Pearson says while it is a large amount, Greenpeace members will continue to support the organisation. "Well Greenpeace paid it on behalf of the activists in recognition of the fact that they had, while undertaken the activity in their own personal capacity," he said. "Greenpeace supporters give us money exactly because we undertake these kind of activities, because we actually physically stand up to environmental harm and those causing it.

WA Bar Demographics

'A Cultural Challenge for the Western Australian Legal Profession: A Lack of Diversity at the WA Bar?' by Jill Howieson and Tomas Fitzgerald in 36(1) University of Western Australia Law Review (2012) reports that
 At the request of the Western Australian Bar Association, the authors undertook a study into issues of diversity at the Western Australian Bar. Members of the Association had noticed, but not specifically studied, various demographic imbalances in the Bar’s constitution. A review of the literature revealed that there was a paucity of statistical analysis of the makeup of Australian barrister associations generally, let alone into any specific reasons as to how and why a demographic imbalance might exist. Recognizing that a clearer picture of the breakdown of the demographics of the Western Australian legal profession and of the specific cultures that might exist at the Bar was needed, the authors undertook a study that examined whether there was an existing legal monoculture at the Bar, and if so what some of the reasons for this might be. The authors conjectured that being ignorant as to how to become a barrister and having a sense of isolation from the legal profession generally, might be reasons for the cultural imbalance (if it indeed existed) and then set about to investigate this empirically. The results revealed that there might be hidden barriers that work to inhibit a broad range of legal professionals from progressing to the Bar. In particular, a knowledge of how to become a barrister, how legal professionals and students feel that they ‘fit in’ to the local legal culture and the various myths that exist about life at the Bar might be inhibiting the progress of a diverse demographic of people from joining the Bar. This article explores the research findings and makes the call for a dedicated research agenda to confirm the study results and to investigate how Australia might best prepare to achieve a diverse and balanced Bar, Bench and legal profession.

Copyright and Consecration

'Towards a Critical IP Theory: Copyright, Consecration & Control' by John Tehranian in Brigham Young University Law Review (2012) 1237-1296 comments
Intellectual-property jurisprudence increasingly informs the way in which social order is maintained in the twenty-first century. By regulating cultural production and patrolling the dissemination of knowledge, copyright law mediates the exercise of important social, political, and economic rights, thereby playing a critical role in the construction of our information society. In theory, ostensibly neutral ground rules guide the vesting, enforcement, and adjudication of rights pertaining to creative works in a way that best advances the constitutionally mandated purpose of the copyright regime: progress in the arts. But, in reality, copyright law’s procedural and substantive doctrines do more than just advance “progress in the arts” and can serve as powerful tools for the regulation, control, and manipulation of meaning. This Article identifies and builds on an emerging literature—one that it refers to as “critical intellectual- property” scholarship—to introduce a framework for studying just how copyright transcends its small corner of the legal universe by shaping social structures and regulating individual behavior as part of a larger hegemonic project. 
As John Fiske writes, “Popular culture always is part of power relations; it always bears traces of constant struggle between domination and subordination, between power and various forms ofresistance to it or evasions of it . . . .” Thus, it is not surprising that intellectual-property laws that control access to and use of popular culture are a function of power relations. In the early 1970s, sociologist Pierre Bourdieu introduced the concept of cultural reproduction to explain the processes through which the dominant class retained its power. Drawing on the example of schooling in modern society, he argued that educational institutions function largely to preserve hegemonic interests by perpetuating the reproduction of the cultural and social values of the dominant class. 
Bourdieu’s work on cultural reproduction has inspired waves of scholarship in the social sciences, but it has not generated as much interest in the field of intellectual property. Yet the notion of cultural reproduction is instrumental to understanding the consequences of intellectual-property laws on knowledge–power systems. Bourdieu’s work and the scholarship it has inspired suggest that the inviolate recitation of the cultural production of dominant social forces is a profound vehicle for the inculcation of a set of values and symbols that consolidate existing power structures. If that is the case, the act of imperfect reproduction, or of customization, of cultural production can translate into an act of subversion or reproduction of the existing social order in a particular form. These acts of differentiation and similitude, or the acts of imperfect reproduction and customization, are carefully regulated by intellectual-property laws. And the selective protection granted to cultural production under the guise of copyright reveals the role of intellectual-property law in molding identities, enforcing dominant values, and controlling expressive rights. In short, user and creator rights are determined byintellectual-property laws that can help both maintain and perpetuate existing social structures. Copyright’s procedural and substantive rules therefore serve as a key vehicle for the discursive exertion of knowledge–power systems on individuals. 
Part II of this Article examines the link between intellectual- property rights and knowledge–power systems. Specifically, it frames the theoretical underpinnings of this study of copyright law in cultural studies. A growing body of scholarship has begun to analyze the relationship between trademark, copyright, and patent doctrines and wider power struggles by assessing the myriad ways in which our intellectual-property regime reflects and even accentuates traditional race-, gender-, orientation-, and class-based divides. Although this literature has not received a collective appellation, it has made a vital contribution to understanding the broader implications of intellectual-property law from a perspective informed, at least implicitly, by critical theory. This Article therefore identifies this nascent scholarship as developing a ‘critical intellectual-property’ theory. This Article then situates this critical intellectual-property scholarship in relation to the extant literature in the more mature movements of critical legal studies and critical race theory. 
Building on this critical intellectual-property scholarship, this Article turns its attention towards constructing a theoretical model for assessing the broader impact of intellectual-property protections on hegemonic practices. It does so both to elucidate the relationships among present contributions in the field and to provide a framework for future work. Specifically, this Article recognizes three primary moments of analytical interest for critical intellectual- property queries: (1) the vesting of rights, (2) the assertion of rights, and (3) the adjudication of rights. Decision-making in these three theaters of operation reveals the intricate way in which ostensibly neutral laws have combined to create hierarchies of informational and cultural rights that patrol relations between sovereigns and their subjects, corporations and individuals, and entrenched interests and surging parvenus. 
Thus, Part III focuses on the genesis of rights and the way in which the vesting of copyright protection beatifies certain forms ofcultural production. To illustrate this point and to provide a historical analysis of intellectual-property law as a hegemonic battleground, the Article examines the origins of the derivative-rights doctrine as a response to tensions over access to cultural content. Specifically, the example of William Shakespeare and the opera— surprisingly populist works in the nineteenth century that transformed into the fodder of only the elite in the twentieth century—helps trace the development of cultural hierarchy and chart the interplay between norms and the law in the process of sacralizing creative content. Part III concludes by examining the works of The Beatles, as embodied in both the musical Love and Danger Mouse’s The Grey Album, to demonstrate how modern copyright law patrols acts of cultural reproduction and semiotic disobedience. 
Part IV turns its attention to the assertion of rights. Specifically, it examines the power dynamics at play in determining how and when rights are enforced and the resulting impact that selective enforcement has on the semiotic influence of cultural content. To illustrate this point, the Article considers the unauthorized use of sound recordings by the federal government at American detention facilities at Guantanamo Bay and the conspicuous silence about the practice by the music industry. Part IV contrasts this state of affairs to the aggressive, high-profile enforcement tactics that the music industry has used to fight the scourge of individual file sharing on the Internet. In the process, we witness how copyright, and its selective enforcement, can mediate the relationship between sovereigns and their subjects. 
Finally, Part V focuses on how copyright interests are vindicated in the adjudicative process. Specifically, it charts how both the procedural and substantive aspects of copyright doctrine create hierarchies of protection and impact broader social, economic, and political rights. With respect to procedure, copyright’s seemingly innocuous registration rules create a vast disparity in the effective protections from infringement enjoyed by sophisticated versus non- sophisticated creators. Thus, procedural niceties reflect and perpetuate a broader societal project establishing cultural hierarchy and the consecration of sacred texts. With respect to substantive adjudication, Part V builds on a body of literature that has highlighted the impact that aesthetic judgments have in courts’ weighing of copyright claims. Specifically, aesthetic judgments reflect subtle, value-laden determinations about the place of creative content in our cultural hierarchy. To illustrate this point, an exegesis of two recent cases involving unauthorized send-ups of classic American novels—Gone with the Wind and The Catcher in the Rye— demonstrates how courts can abandon a rhetorical commitment to aesthetic neutrality in conducting their fair-use analyses and how implicit, but powerful, judgments about a work’s worth—in a sociopolitical context—can influence the outcomes of suits. To paraphrase George Orwell, while the law may tell us that all copyrighted works are created equal, it turns out that some are more equal than others.

18 November 2012

DTC Genetics

Three perspectives on regulation of the direct-to-consumer (DTC) genetic testing market.

'Regulating the Use of Genetic Tests: Is Dutch Law an Example for Other Countries with Regard to DTC Genetic Testing?' by R.E. Van Hellemondt, A.C. Hendriks and M.H. Breuning in (2011) 3(1) Amsterdam Law Forum 14 notes that
Several European countries are considering the regulation of Direct-To-Consumer genetic tests via internet in order to protect the public. This paper addresses the question whether the Dutch Act on Population Screening, an internationally widely praised piece of legislation, could serve as an example for other European countries. While the Act adequately protects individuals against (potential) harmful screenings programmes, it falls short when it comes to offering protection against genetic tests offered to the public through the internet by commercial firms. The Act should therefore be amended, also to secure consistency with European legal standards. 
… a broad consensus exists among professionals in genetics that the implications of DTC genetic tests are far reaching and complex. Such testing should not be left to the free forces of the market, but should be accompanied by adequate information, and informed consent. There is – also in view of these concerns expressed by professionals – not only a need to revise the Dutch Act; it is above all important to elaborate on the emerging body of European legal standards applicable to DTC genetic screening. Offering genetic tests directly to individuals via internet raises complex legal questions that can not merely be answered by individual States. National measures can, moreover, easily be bypassed by making use of cross border constructions. Adequately protecting individuals against questionable testing kits therefore calls for international vigilance and comprehensive measures by the international community, in Europe to start with the Council of Europe and the European Union.
'Test at Your Own Risk: Your Genetic Report Card and the Direct-to-Consumer Duty to Secure Informed Consent' by Deepthy Kishore in (2010) 59(6) Emory Law Journal 1553 comments that
 On June 26, 2000, President Bill Clinton and Prime Minister Tony Blair announced that new gene sequencing techniques had accelerated the progress of the Human Genome Project; for the first time ever, scientists had completed a “rough draft” of the human genome. The announcement inspired a worldwide debate about cloning and genetic engineering, prompting both public curiosity and fierce debate about the nebulous science of predicting one’s lifespan and assessing the likelihood for developing disease. A host of companies, some of which market their services over the Internet, have since made genetic testing available directly to consumers. 
The emergence of direct-to-consumer (DTC) genetic testing raises important questions about how best to protect consumers from misinterpreting the meaning of their genetic makeup and has sparked discussion about how much and what kind of information a company should disclose to adequately warn consumers of the risks of undergoing genetic testing. Moreover, recent news events suggest that the Food and Drug Administration (FDA) will soon attempt to regulate DTC genetic testing: In May 2010, CVS drugstores and sixty thousand Walgreens drugstores suspended their plans to sell genetic test kits after the FDA announced that it would investigate DTC genetic testing companies. 
Selling access to individual genetic information has transposed the physician-patient relationship into a company-consumer context, calling for a novel examination of how consumer and patient protections overlap and where federal regulation ends and tort law begins. This Comment applies principles of products liability and informed consent to argue that tort liability, rather than greater regulation of genetic tests, is the best way to protect consumers of DTC genetic testing. It demonstrates that without professional assistance, consumers risk misinterpreting the meaning of their genetic test results and may even be driven to take drastic actions based on that information. Thus, this Comment asserts that where genetic testing services are marketed directly to consumers, the required level of disclosure should be the same as that under the doctrine of informed consent: Courts should impose a duty on companies engaged in DTC genetic testing to provide complete warnings, akin to the warnings physicians must provide patients in accordance with informed consent. The ultimate goal of the duty of disclosure proposed by this Comment is to protect and promote the autonomy of the consumer-patient.
'Genetic testing legislation in Western Europe - a fluctuating regulatory target' by Sirpa Soini in (2012) 3(2) Journal of Community Genetics 143–153  notes that
 Rapid developments of biomedical science have initiated different fora to take stand on the protection of human rights and human dignity. In front of the new genomic era with the completion of the Human Genome Project in 2003, a plethora of instruments addressing human genetic testing emerged, some looking suspiciously like legal acts. The notion of genetic exceptionalism was characteristic to the normative reactions in the legal acts, but it can be questioned how justified this is. Despite the critique on genetic exceptionalism, it is argued that in certain situations detection of a serious genetic anomaly may cause extra anxiety in a person tested, if the knowledge has a great significance also to family members. Regulative needs should depend on the context and purpose of the test. This review examines the legal framework governing the use of genetic tests in the clinical setting in Western Europe. Five countries have enacted genetic specific laws, and three have comprehensive provisions pertaining genetic testing in their biomedical legislation. Central provisions cover informed consent, autonomy and integrity of the person tested, further uses of tests results, quality requirements of the personnel and facilities involved. Moreover, contemporary challenges related to whole genome sequencing, direct-to-consumer genetic tests and insurance are briefly discussed. 
Soini concludes that
The expression ‘geneticisation’ has been used to describe a kind of a genetic hype, over-emphasis of genetic component in human life and identity based on the perception that genomic knowledge is exceptional, and determines the course of one’s life, diseases, energy levels, happiness and career. For instance, as Rothstein (2005) points out, a mutation or other impairment in DNA may rather be a symptom of a disease, instead of being a cause for it. Thus, environment along with social conditions have also a huge impact on how our genes express themselves. 
Many have argued against raising genetic data into stricter category of health data (Gostin and Hodge 1999; Laurie 2002; Rothstein 2005; Krajewska 2009). In an in-depth analysis, Gostin and Hodge (1999) argue that the hypothesis underlying genetic exceptionalism is flawed and it is not ethically and legally justified to distinct genetic data from other health data. Discrimination on other grounds may at least as devastating to a person. Clinical observations, lifestyle, family history and biometrics provide means to detect and predict a person’s current and future health. The basic rule about non-disclosure of sensitive personal data should apply here as well. Anna Krajewska has suggested that the term genetic information be replaced by the term biological information (Krajewska 2009 p. 25). Moreover, many acts stipulate the right-to-know and not-to-know about the results of genetic tests. The classic medical ethics and patient rights regimes govern the same issue, and I wonder why should there be a need for special provisions. If a person does not want to be informed of her medical condition, be it cancer diagnosis, HIV testing, or a genetic diagnosis, same approach and rules respecting the patient’s self-determination should apply. 
Despite the critique regarding genetic exceptionalism, I argue that in certain situations genetic data has elements superseding other health conditions, and may thus generate more anxiety in a person tested. This is the case particularly in serious clear conditions that have great significance for the close relatives. Indeed, the need to pay attention to the interests of the kin is acknowledged in many of the examined legislations, while some stick to strict confidentiality and deny all access of third parties to information without a consent of the person tested. 
Given the difficulty of defining the notion of ‘genetic testing’ and rapidly accumulating and sometimes also radically changing scientific knowledge, the regulatory task is not easy. Fear of eugenics is of course understandable cause for regulatory demands due to the rather recent eugenic policies in the beginning of twentieth century, and this history is clearly reflected in the regulation. However, claims of eugenics in the context of contemporary genetics seem to lack profound reasoning about the concept and its meaning (Harper 2008, p. 405-427). The purpose of today’s medical genetics is to alleviate individual suffering which is rather distinct from a coercive state policies targeted against certain groups and populations (WHO 2003, p. 10). 
Genetic testing should, as any other healthcare measures, be of appropriate quality and utility. Clinical validity and utility of the research findings shall be held important before consideration of their clinical application (PGH Foundation 2010). This would also need improvement of legislation in this field, as currently research is strictly regulated in Europe, but introduction of genetic tests into clinical practice lack sufficient control. However, some balancing will be needed as a strict scrutiny would raise costs and delay introduction of tests in practice (Cassiman 2011). Appropriate mechanisms for approval of tests for clinical purposes and quality assurance for laboratories and personnel should take place along with oversight mechanisms. Still, regulation should not be too detailed to be flexible in the course of scientific progress. The approach adopted in the Austrian, German and Swiss legislation to leave assessment of the state-of-the-art to an independent multidisciplinary committee established by law seems to provide an evolutionary and responsive mechanism in front of rapidly developing science. 
The role of the regulation can be seen as to facilitate practises and secure community interests by setting appropriate conditions and providing a structured framework for the activities in the field of genetics (Morgan and Yeung 2007, p. 4-7). Thus, it serves to provide public confidence. 
Asymmetry on information regarding genetic information both among lay people and general practitioners should be given a due regard. This goal is mentioned, for instance in the OECD Guidelines (2007). Use of a parliamentary normative process is likely to ensure the democratic decision making that reflects national attitudes and values. It could be enhanced by deliberative democracy by involving citizens to open discourse at the early stage of the normative process. If norms are developed outside the democratic process, for instance, in the expert instances, the process is not necessarily transparent, the values may not meet those of the citizens, and consequently, they may not be welcomed. Awareness raising and accurate information are crucial for maintaining public trust in science in general and genetics in particular. Approval of genetic applications is hence also a matter of reception.

Monsters and others

From Steve Dow's critique of Prime Minister Gillard's stance on the marriage of 'other' people, ie the maintenance of a civil disability on same-sex couples
Gillard reiterated her opposition to same-sex couples tying the knot, saying "we should find other ways of recognising the value of other relationships".
The Prime Minister's use of ''other'' is telling. A trained lawyer who idolises teachers now as she did when young, she must surely be aware of the implication of her language. 
Otherness has been applied to gender, race, religion, class, political ideology, place of birth: psychoanalysts to feminists to postmodernists have theorised ''the other'' as a label by which those in power relegate another group, sometimes but not always a minority, as not belonging, as inferior.
Gay men and lesbians, in particular, continue to be subjected to a load of othering. When her leader labelled ''other'' the likes of Wong's long-term relationship with her partner Sophie Allouache - who gave birth to the couple's daughter, Alexandra, last December - what must have run through the Finance Minister's head?
Might she have been tempted to respond, as she did to applause on the Q&A program in May, "I know what my family is worth"?
… It takes my breath away that Gillard can be proud her speech attacking the Opposition Leader for misogyny has had an international impact, but be unable to explain her internationally isolated moral blind spot, in the developed world at least, on a policy that causes violence to the psyche of her same-sex attracted constituents. A policy that says: you are inferior, you don't belong. 
If Gillard takes pride in Australia's international standing, consider this: by developed-nation standards we're starting to look stupid, a bigoted backwater. Same-sex marriage is legal in an increasing number of countries, among them Argentina, Belgium, Canada, Denmark, Iceland, the Netherlands, Norway, Portugal, South Africa, Spain and Sweden. Sure, there are ''other'' forms of recognition of ''other'' relationships: there are same-sex civil unions or registered partnership schemes in, among other countries, France, Germany, New Zealand (from where my partner hails) and Switzerland. 
But on a national level, we don't even have an equivalent to those civil schemes yet. And separate is not equal, hence several of these countries are upgrading their gays and lesbians: England and Wales, for instance, will likely have same-sex civil marriage by 2015. Our Kiwi neighbours across the ditch will get there before we do.
A different perspective on norms, boundaries and otherness is provided in 'Making Monsters: The Polygraph, the Plethysmograph, and Other Practices for the Performance of Abnormal Sexuality' by Andrew Balmer Ralph Sandland in 39(4) Journal of Law and Society (2012) 593-615
 This article addresses the use of the polygraph, penile plethysmograph, and other practices for the management of sexual offenders as part of the ‘Containment Approach’, a strategy increasingly common in the United States which is, in part, being trialled in the United Kingdom. The polygraph has a tangled history with abnormal sexuality, as we describe in the context of homosexuality in the 1960s. We examine how these strategies target sex offenders as malleable in regard to sexual performances but also, through notions of risk management, paradoxically constitute offenders as fundamentally incurable and thus permanently risky. Using Foucault's notion of the ‘abnormal’, we investigate the implications of this risk management/ performance paradox. We conclude that it reveals a certain anxiety about the relationship between abnormal and normal sexual behaviour in contemporary sex‐offender management discourse, which can help explain the emergence of these practices.
'US, EU & UK Employment Vetting as Strategy for Preventing Convicted Sex Offenders from Gaining Access to Children' by James Jacobs & Dimitra Blitsa in European Journal on Crime, Criminal Law & Criminal Justice (Forthcoming) notes that
 Fear and anxiety about sexual predators who target children has stimulated legal initiatives in the US, EU and UK to encourage/require background screening for public and private sector job applicants and volunteers for positions that afford access to children. This Article examines the political, legal and logistical challenges that such initiatives have and are facing in three important legal regimes. 
The authors comment that
Horrific sex crimes against children in the US, continental Europe and the UK have led to extensive legislative and administrative efforts to prevent convicted sex offenders from committing future crimes against children. One of the most important preventative strategies has been to disqualify previously convicted sex offenders from holding jobs and volunteer positions affording close contact with children. Political reality makes it very difficult to reject this strategy, at least in principle. 
The US policy is much simpler than the EU’s or the UK’s. Federal and state online sex offender registers allow any member of the public to identify convicted sex offenders who live anywhere in the US. All employers (not just those providing children’s services) can search court and other public records for current and prospective employees’ past convictions. Certain child services employers are required by federal or state law to conduct criminal background checks. Except for some state laws that prohibit convicted sex offenders from occupying certain occupations and positions, employers and volunteer organisations can decide for themselves which (not only sexual) convictions render a job applicant or employee unsuitable for certain positions. Employers prefer this regime because it gives them control over hiring and allows them to take steps they think necessary to avoid potential civil liability caused by employees who injure a client, customer or fellow employee. The disadvantage from the continental European perspective is that it violates the convicted person’s privacy and hinders rehabilitation. 
The EU, although committed to the confidentiality of criminal records, is encouraging Member States to commit to pre-employment sex offender vetting, while pursuing its long-term goal of better criminal record information sharing. The EU has sought to ensure: 1) that convicted sex offenders may be identified and barred from working with children, and 2) that child sex offence convictions in any EU Member State should be accessible to employers working with children in every Member State. Progress towards these goals has been slow, but steady. Many legal, practical and political obstacles remain. The UK is the EU Member State that has gone furthest in trying to implement such a regime. A public body is responsible for determining which positions should be closed to sex offenders. Employers and volunteer organisations have a duty to check the criminal background of those applying for positions affording close contact with children. Employers and volunteer organisations are prohibited from hiring individuals barred from working with children. 
There is good reason to believe that current employment vetting regimes are going to continue evolving. Every employment vetting scheme faces tough policy choices. Which convictions should be disqualifying and for how long? How much access to children should render a job or volunteer position subject to vetting? Should only sex offence convictions be disqualifying? What about pending charges? What about police intelligence? Should only convictions for prior sex crimes against children be disqualifying? Should a prior sex crime conviction against an adult victim disqualify the perpetrator from later working with children? What about non-sex crimes against children? And what about drug trafficking? 
Is it likely that a fully established employment vetting scheme will remain limited to protecting children? Should it be? The US and the UK have already expanded their employment vetting schemes to cover positions affording close contact with other vulnerable groups, e.g. the elderly and the handicapped. There is inexorable pressure to extend employment vetting to more professions, occupations and positions. Should persons who have been convicted of fraud be screened from working as financial advisers? Should persons who have been convicted of drunk driving be disqualified from driving school buses or piloting aeroplanes? 
Finally, the logic of employment vetting scheme should lead to vetting job seekers’ convictions in foreign countries. A day care job applicant previously convicted of sexually abusing a child in an Asian country should be of as much concern to a US, UK, or EU employer as a job applicant with a similar conviction in the home jurisdiction. In the future, because information technology will make foreign convictions much more accessible, we should expect steady pressure to expand employment vetting to foreign convictions. However, this will require solutions to very difficult legal and logistical problems.