25 January 2014

Citizenship Markets

How much for the nicest passport and tax-favourable regime?

Previous posts have noted questions about the market for citizenship (eg gaining citizenship in Australia and other nations by investing on the requisite scale). 'Should Citizenship Be for Sale?' (Robert Schuman Centre for Advanced Studies Research Paper No. 2014/01) edited by Ayelet Shachar and Rainer Baubock indicates that
On 12 November 2013 the Maltese Parliament decided to offer Maltese and European citizenship at the price of € 650,000, but implementation of the law has been postponed due to strong domestic and international critiques. On 23 December, the Maltese government announced significant amendments, including a higher total amount of € 1,150,000, part of which has to be invested in real estate and government bonds. Several other European states have adopted ‘golden passport’ programmes. Should citizenship be for sale? In November 2013 EUDO CITIZENSHIP invited Ayelet Shachar of the University of Toronto Law School to open a debate on these controversial policies. Twelve authors have contributed short commentaries, most of which refer to the initial law adopted by the Maltese Parliament. 
Bauböck comments that
The EUDO CITIZENSHIP forum “Should citizenship be for Sale?” has collected comments representing a wide range of views and some highly original arguments. They can be summarised by distinguishing global, European and national perspectives.
(1) Global questions
From a global perspective, several authors argue that citizenship has become primarily a resource for mobility. Globalisation has already deeply undermined national citizenship as a bond between individuals and states and the sale of passports is just a symptom of an irreversible commodification of citizenship (Spiro). The primary value of citizenship lies in the mobility rights attached to passports. The high price put by the Maltese Parliament on Maltese passports reflects the instrumental value of free movement rights attached to EU citizenship for the wealthy and mobile global elites.
Some authors defend the sale of citizenship by pointing out that it less arbitrary and more transparent than other ways of acquiring citizenship (e.g. Kochenov), while others suggest that giving the ultra-rich privileged access to “global mobility corridors” (Barbulescu) raises concerns about fairness and justice (e.g. Owen). Instead of offering their citizenship for money, democratic states could bestow it on persons who are threatened by persecution or who fight for democratic values as a means of protection or exit option (Paskalev).
(2) European questions
Several comments emphasize that selling EU passports amounts to free-riding on the shared EU assets of free internal movement and external visa-waiver agreements created jointly by all Member States (e.g. Magni-Berton). Investor-citizenship programmes are, however, not the only instance. Many EU countries offer privileged access to EU citizenship to large populations outside the EU territory on grounds of distant ancestry or co-ethnic identity, obliging thereby all other Member States to admit immigrants from third countries to their territories and labour markets as EU citizens (e.g. Shaw).
Since EU citizenship is derived from Member State nationality and determining the latter remains an exclusive competence of Member States, EU law does not provide much leverage against either the sale of EU passports or other policies of creating new EU citizens without genuine links to any EU country. Several authors raise, however, the question whether the principle of proportionality established by the Court of Justice of the EU if withdrawal of Member State nationality leads to a loss of EU citizenship could also be applied to national rules regulating the acquisition of citizenship (Shaw, Shachar, Swoboda).
Independently of the issue of legality these authors suggest that the European Parliament is the institution that is best suited for addressing the issue. Instead of asking for intervention against particular Member States, they call for a broader debate on shared principles that ought to guide Member State policies in matters of citizenship.an overview over the main questions raised in our forum.
(3) National questions
Most authors in our forum defend a conception of citizenship as membership in a democratic community. From this perspective, selling membership seems odious in the same way that selling the franchise in elections is (Shachar, Bauböck). Citizenship is considered as the kind of good that money should not be able to buy (Ochoa). Magni-Berton argues, however, that monetary investment can be a way of contributing to the common good of a political community and should therefore not be summarily dismissed as a legitimate reason for acquiring citizenship. In his view, the high price indicates the real problem, which is artificial scarcity created through exclusionary rules for access to national citizenship.
Authors disagree on whether citizenship acquisition based on purchase or investment is more arbitrary than the common rules of ius sanguinis, ius soli or residence-based naturalisation. Some consider all of these membership mechanisms as essentially arbitrary or discriminatory (e.g. Armstrong, Kochenov), whereas Bauböck defends them as supporting equal membership in intergenerational communities.
From a global justice perspective, “golden residence programmes” that provide investors with privileged access to permanent residence status seem to be just as unfair towards the poor as “golden passport programmes”. From a democratic citizenship perspective, however, the former are less problematic since they maintain a condition of residence and thus a “genuine link test” for access to citizenship (e.g. Dzankic, Shachar, Owen).
Other authors acknowledge that states have legitimate interests in “inviting the rich, the beautiful and the smart” (Kochenov) and that investor citizenship is not essentially different from the widespread practice of offering citizenship to prominent sportsmen and –women (Owen). Chris Armstrong observes that some states offer citizenship to foreigners who have served in their army or have otherwise provided exceptional service to the country. If investors really help to save a country from financial breakdown, offering them citizenship may be justified on grounds of emergency relief. Other authors are, however, sceptical that those who are only interested in additional mobility rights can be made to invest their wealth permanently and productively (Dzankic).
Apart from the lack of a “genuine link” criterion, a global market for citizenship status is also seen as corrupting democracy by breaking down the wall the separates the spheres of money and power. Several contributions argue that there is a broader trend towards relinking citizenship acquisition to social class, which manifests itself, on the one hand, in offering citizenship to the rich and, on the other hand, in income and knowledge tests for ordinary naturalisations of foreign residents (Shachar, Barbulescu, Dzankic, Bauböck, Owen, Swoboda).

Tobacco and the TPPA

'Safeguards for Tobacco Control: Options for the TPPA' by Robert Stumberg in (2013) 39 American Journal of Law & Medicine 382 [PDF] comments that
With tobacco trade, the past is prologue. In the 1980s, the U.S. government used domestic trade remedies (“Super 301”) to pry open markets for U.S. tobacco companies. The targets included Japan, South Korea, Taiwan, and Thailand. A grateful tobacco industry donated a renovation of the Treaty Room in the U.S. Department of State, declaring at the dedication: “Tobacco is intimately and historically associated with American diplomacy.”  Thailand responded by banning imported cigarettes on grounds that the imports were more addictive and marketing of imports was driving up consumption. The United States then challenged Thailand for violating the General Agreement on Tariffs and Trade (GATT). The GATT panel ruled against Thailand, finding that the import ban failed to satisfy the health exception of GATT Article XX.
Studies showed that liberalizing tobacco trade in the 1990s resulted in lower tariffs, lower prices, aggressive marketing, and greater tobacco use—in the range of ten percent for all four countries. The same results held true for China, India, Indonesia, Malaysia, Pakistan, and the Philippines. By 1997, the mounting evidence of a “tobacco epidemic” — and the overt connection with trade agreements — prompted an apparent shift in U.S. policy. The U.S. Congress adopted the Durbin and Doggett Amendments, which prohibit federal agencies from promoting “the sale or export of tobacco or tobacco products” or seeking “the reduction or removal by any foreign country of restrictions on the marketing of tobacco or tobacco products, except for restrictions which are not applied equally to all tobacco or tobacco products of the same type.” In 2001, President Clinton issued Executive Order 19393 to make clear that this policy applies to all executive agencies and “the implementation of international trade policy.” Limiting trade negotiators aimed to promote coherence between health and trade policy.
In 2003, congressional leaders documented how the Office of U.S. Trade Representative (USTR) negotiated Korean tariff reductions on behalf of Philip Morris International (PMI), agreed to zero tobacco tariffs on the last day of negotiations on the U.S.-Chile Free Trade Agreement (FTA), and proposed ten of eleven amendments sought by PMI to weaken the draft Framework Convention on Tobacco Control (FCTC). Since the Doggett Amendment has been in effect, the USTR has negotiated with eighteen countries to eliminate tariffs on processed tobacco leaf and cigarettes. The United States continued to expand market access for tobacco-related services and extended investor rights to tobacco companies. Writing for the Council on Foreign Relations, Thomas Bollyky summarizes the legacy of twentieth century trade policy for tobacco: Tobacco companies are aggressively exploiting trade and investment agreements to expand their market in low- and middle-income countries. Lower tariffs reduce the price of imported cigarettes in countries without good taxation systems to compensate. Multinational tobacco companies use dispute resolution . . . to block tobacco marketing and labeling regulations far more modest than those in the United States. Young women, who have historically smoked less than men in most parts of the developing world, are a major target of industry marketing campaigns.
Now the U.S. government is leading negotiations among eleven countries on a Trans-Pacific Partnership Agreement (TPPA), “a true 21st century trade agreement” that “will reflect U.S. priorities and values.” The open question is whether a priority is to support tobacco trade as it contributes to 6 million deaths per year—one billion deaths in a twenty-first century epidemic. The TPPA has six chapters that might provide material support to the tobacco industry.
As trade agreements evolve through regional negotiations, the first global health treaty is emerging as a force to exercise, rather than restrict, regulatory authority. The FCTC does not directly regulate; it obligates countries to achieve a common foundation of taxes and tobacco-control measures. A stream of recent work makes a strong case that trade agreements provide the “flexibilities” that governments need to implement the FCTC. This Article accepts that premise.
Yet the frameworks for trade promotion and tobacco control intersect with many points of overlapping coverage. At most of these intersections, the tobacco industry lobbies or litigates to shrink the policy space to regulate. This Article explores options for protecting that space: Part II outlines how the TPPA might strengthen the trade framework to the benefit of the tobacco industry. It also highlights the role of international litigation in the industry’s campaign to chill implementation of tobacco-control measures. Part III explains the options for Trans-Pacific Partnership (TPP) countries to safeguard tobacco-control measures—exclusions and exceptions—and how to evaluate them. Parts IV and V walk through the syntax of those safeguards. For each element of a safeguard, it parses the purpose, shortcomings, and alternatives to current practice. The focus is on the WTO’s baseline health exception and alternatives for a tobacco exception, including one vetted by U.S. negotiators. The conclusion highlights the simplicity and effectiveness of exclusions compared to exceptions.
Stumberg concludes
Six chapters of the TPPA potentially threaten tobacco-control measures. They expand market access or protect the industry with WTO-plus rules that can be used in later rounds of litigation:
1. Investment—expands investor-state arbitration for U.S.-based tobacco companies.
2. Intellectual property—adds a new right to use trademarks with a place name (e.g., Marlboro).
3. Cross-border services—expands the service sectors to which trade rules apply (e.g., packaging, distribution, and advertising); potentially limits domestic regulation.
4. Regulatory coherence—promotes industry stakeholder participation in decision-making; promotes regulatory impact assessments that the industry uses to litigate.
5. Technical barriers to trade—potentially limits how governments cooperate in setting standards or guidelines for tobacco control.
6. Tariffs—expands market access in countries with high tobacco tariffs (Vietnam).
Six elements of the GATT/GATS exception create a complex formula for defending tobacco measures:
1. Scope—Based on the U.S. model for free trade agreements, the baseline health exception applies to selected chapters of the agreement, but not to specific rules being used to litigate against tobacco-control measures (including the investment chapter, among others).
2. Protection—Tobacco investors use MFN to incorporate rules from outside the primary agreement that provide more favorable treatment. The draft TPPA investment chapter excludes procedural treatment from MFN, but MFN would still apply to substantive investor rights.
3. Deference—There are no terms of deference to non-WTO treaties in the WTO exception.
4. Nexus—The necessity test creates uncertainty with stages that enable litigation to challenge the contribution of a measure, weigh that contribution against its trade restrictiveness, and identify less restrictive alternatives. Some scholars predict that investment arbitrators would apply the necessity test with less deference than trade panels.
5. Objective—Some measures serve multiple purposes, including non-health purposes like revenue or business licensing; their connection to protecting health may be indirect.
6. Additional restrictions—Even a “necessary” measure can be challenged as having a discriminatory effect in the market as applied. This works against incremental change and measures that freeze the market at its current stage of development.
The exception provides opportunities to litigate each element. Win or lose, the threat of costly litigation has long been part of the tobacco industry’s strategy to constrain implementation of tobacco-control measures.
To create a safe harbor for its agency regulations, the United States informally proposed a tobacco exception. This, however, does not protect legislation or measures adopted by tax, licensing or customs authorities. In place of the necessity test, it requires scientific evidence, a burden of proof that necessity does not require. The U.S. proposal would not protect against the WTO dispute the United States lost, the WTO claims against Australia, or the investment claims against Australia or Uruguay.
This article identifies alternatives for each element in the U.S. proposal. Here is the original summary compared to alternative elements in several possible combinations:
Original summary of the U.S. proposal— Language in the general exceptions chapter that allows health authorities to adopt regulations on specific tobacco products or classes that impose origin-neutral, science-based restrictions in order to safeguard public health.
Alternatives - several of many possible combinations— Nothing in this Agreement prevents a party from adopting or enforcing . . .   measures that contribute or aim to reduce use of tobacco products or its harms. . . . measures that it considers appropriate for science-based protection of public health. . . . measures that it considers appropriate to reduce use of tobacco products or its harms. Nothing in this Agreement applies to measures that contribute to or aim to reduce tobacco use or its harms.
Additional interpretive clauses – For greater certainty, . . . this exception applies in addition to other exceptions; it has no effect on operation of those exceptions. . . . this exception applies to all obligations including any duty to compensate for direct or indirect expropriation. . . . if this exception applies to a measure, it is consistent with MFN treatment.
The more elegant alternative to a complex exception is to simply exclude tobacco-control measures. An exclusion is better protection than a defense; it contains litigation. If the political will is lacking for a full exclusion, there are several ways to draft a partial exclusion. TPP countries could follow Australia’s lead by opting-out of ISDS (generally or with respect to tobacco-control measures), and countries can take reservations from rules on market access and discrimination in the chapters on services and investment.
Even if Uruguay and Australia win their trade and investment disputes, the precedent will not end such litigation. Defenses that rest on trade flexibilities or exceptions flex in both directions; they provide a defense and also an opportunity to to balance trade against health interests. Further, the tobacco industry will continue to have an advantage in resources to litigate for the purpose of chilling or diverting tobacco-control measures.
Whether it supports or opposes effective safeguards for tobacco control, the U.S. government will play a decisive role. Upon passage of Tobacco Control Act in 2009, President Obama committed his administration to work with the WHO and other nations “to fight this epidemic on a global basis. He acknowledged the “constant and insidious barrage of advertising.”  Yet in the years since, U.S. negotiators have worked to expand market access for advertising and distribution, expand trademark protections, reduce tariffs, and expand investor rights—all to the benefit of tobacco companies at home and abroad. The TPP is an opportunity to strike a balance in favor of health and against tobacco litigation.

23 January 2014

SPOT the terrorist?

Devotee of The Mentalist? The US Government Accountability Office (GAO), counterpart of Australia's ANAO, last year released a 99 page report that cautioned about enthusiasm regarding behavioural profiling at transport notes.

The report [PDF] states that
Available evidence does not support whether behavioral indicators, which are used in the Transportation Security Administration's (TSA) Screening of Passengers by Observation Techniques (SPOT) program, can be used to identify persons who may pose a risk to aviation security. 
GAO reviewed four meta-analyses (reviews that analyze other studies and synthesize their findings) that included over 400 studies from the past 60 years and found that the human ability to accurately identify deceptive behavior based on behavioral indicators is the same as or slightly better than chance. 
Further, the Department of Homeland Security's (DHS) April 2011 study conducted to validate SPOT's behavioral indicators did not demonstrate their effectiveness because of study limitations, including the use of unreliable data. Twenty-one of the 25 behavior detection officers (BDO) GAO interviewed at four airports said that some behavioral indicators are subjective. TSA officials agree, and said they are working to better define them. 
That's an issue because
TSA began deploying the SPOT program in fiscal year 2007 - and has since spent about $900 million - to identify persons who may pose a risk to aviation security through the observation of behavioral indicators. In May 2010, GAO concluded, among other things, that TSA deployed SPOT without validating its scientific basis and SPOT lacked performance measures.
Apart from indications that the behavioural detection is no more effective than guesswork (US$1bn on guesses?) SPOT is contentious because of claims of racial or other profiling. The GAO notes that behavior detection officers must apply the SPOT behavioral indicators to passengers without regard to race, color, religion, national origin, ethnicity, sexual orientation, or disability. Problems with data meant that the researchers were unable to determine whether discriminatory profiling was taking place.

The report indicates that the GAO
analyzed data from fiscal years 2011 and 2012 on the rates at which BDOs referred passengers for additional screening based on behavioral indicators and found that BDOs' referral rates varied significantly across airports, raising questions about the use of behavioral indicators by BDOs. To help ensure consistency, TSA officials said they deployed teams nationally to verify compliance with SPOT procedures in August 2013. However, these teams are not designed to help ensure BDOs consistently interpret SPOT indicators. 
TSA has limited information to evaluate SPOT's effectiveness, but plans to collect additional performance data. The April 2011 study found that SPOT was more likely to correctly identify outcomes representing a high-risk passenger--such as possession of a fraudulent document--than through a random selection process. However, the study results are inconclusive because of limitations in the design and data collection and cannot be used to demonstrate the effectiveness of SPOT. For example, TSA collected the study data unevenly. In December 2009, TSA began collecting data from 24 airports, added 1 airport after 3 months, and an additional 18 airports more than 7 months later when it determined that the airports were not collecting enough data to reach the study's required sample size. Since aviation activity and passenger demographics are not constant throughout the year, this uneven data collection may have conflated the effect of random versus SPOT selection methods.
Further, BDOs knew if passengers they screened were selected using the random selection protocol or SPOT procedures, a fact that may have introduced bias into the study.
TSA completed a performance metrics plan in November 2012 that details the performance measures required for TSA to determine whether its behavior detection activities are effective, as GAO recommended in May 2010. However, the plan notes that it will be 3 years before TSA can begin to report on the effectiveness of its behavior detection activities. Until TSA can provide scientifically validated evidence demonstrating that behavioral indicators can be used to identify passengers who may pose a threat to aviation security, the agency risks funding activities that have not been determined to be effective.  
The GAO accordingly recommends that
Congress should consider the absence of scientifically validated evidence for using behavioral indicators to identify threats to aviation security when assessing the potential benefits and cost in making future funding decisions for aviation security. GAO included this matter because DHS did not concur with GAO’s recommendation that TSA limit future funding for these activities until it can provide such evidence, in part because DHS disagreed with GAO’s analysis of indicators. GAO continues to believe the report findings and recommendation are valid.
The report is useful as a lens for understanding the TSA and for engagement with prior research such as
  • M. Hartwig and C. F. Bond, Jr., 'Why Do Lie-Catchers Fail? A Lens Model Meta- Analysis of Human Lie Judgments' (2011) 137(4) Psychological Bulletin
  • P. K. Davis, W. L. Perry, R. A. Brown, D. Yeung, P. Roshan, and P. Voorhies, Using Behavioral Indicators to Help Detect Potential Violent Acts: A Review of the Science Base (RAND Corporation, 2013)
  • C. F. Bond Jr. and B. M. DePaulo, 'Accuracy of Deception Judgments' (2006) 10(3) Personality and Social Psychology Review
  • A. Vrij and P. Granhag, 'Eliciting Cues to Deception and Truth: What Matters Are the Questions Asked' (2012) 1 Journal of Applied Research in Memory and Cognition
  • M. A. Aamodt and H. Custer, 'Who Can Best Catch a Liar? A Meta-Analysis of Individual Differences in Detecting Deception' (2006) 15(1) The Forensic Examiner
  • B. M. DePaulo, J. J. Lindsay, B. E. Malone, L. Mehlenbruck, K. Charlton and H. Cooper, 'Cues to Deception' (2003) 129(1) Psychological Bulletin
  • A. Vrij, P. Granhag and S. Porter, 'Pitfalls and Opportunities in Nonverbal and Verbal Lie Detection' (2010) 11(3) Psychological Science in the Public Interest
  • C. F. Bond, Jr., and B. M. DePaulo, 'Individual Differences in Judging Deception: Accuracy and Bias' (2008) 134(4) Psychological Bulletin 
  • L. Sporer and B. Schwandt, 'Moderators of Nonverbal Indicators of Deception, A Meta-Analytic Synthesis' (2007) 13(1) Psychology Public Policy, and Law

Professional Negligence

'Uncovering the Silent Victims of the American Medical Liability System' by Joanna Shepherd in (2014) 67(1) Vanderbilt Law Review 151 argues [PDF] that
A frequently overlooked problem with the current medical liability system is the vast number of medical errors that go uncompensated. Although studies indicate that 1% of hospital patients are victims of medical negligence, fewer than 2% of these injured patients file claims. In this Article, I explain that many victims of medical malpractice do not file claims because they are unable to find attorneys willing to take their cases. 
I conducted the first national survey of attorneys to explore medical malpractice victims’ access to the civil justice system. The results from the survey indicate that the economic reality of litigation forces many contingent fee attorneys to reject legitimate cases. In fact, over 75% of the attorneys in my survey indicate that they reject more than 90% of the cases that they screen. The attorneys explain that insufficient damages and high litigation expenses are their primary reasons for rejecting cases and that several tort reforms have reduced their willingness to accept cases. Moreover, the majority of the attorneys report that they have threshold damage values below which they will not even consider accepting a case. Indeed, over half of the attorneys responded that they will not accept a case unless expected damages are at least $250,000 – even for a case they are almost certain to win on the merits. For a case in which winning is less certain, most attorneys require minimum expected damages of $500,000 to accept the case. Because of the high cost of medical malpractice litigation, contingent fee attorneys simply cannot economically justify taking cases with damages below these thresholds. 
To understand the extent of this access-to-justice problem, I use private-industry claims data to show that 95% of medical malpractice victims will find it extremely difficult to find legal representation unless their damages are significantly larger than the typical damages for their types of injuries. Thus, the medical liability system silences many legitimate victims of medical malpractice.

Dump the dead goldfish

The Wall Street Journal reports that the US Justice Department on Wednesday accused Investigations Services LLC (USIS), the national government's largest private security background checker, of a multi-million dollar fraud by filing over 660,000 flawed background investigations. USIS is part of the Altegrity private security conglomerate.

The contentious vetting is 40% of the investigations by USIS for the government over a four year period, including vetting used by the Defense Department, Department of Homeland Security and over 100 other federal agencies.

Justice Department unhappiness was foreshadowed here.

The WSJ indicates that the Department has filed a 25 page civil complaint to join a whistleblowers' lawsuit against USIS in Alabama. The filing accuses USIS of using close ties with the government 'to conceal the so-called practice of dumping or flushing background checks, i.e. sending the government cases that didn't have proper review. USIS notes that it "was formed through the privatization of the Office of Personnel Management’s Federal Investigation Service in July 1996, so it is not surprising that the majority of our services and solutions are provided to government clients.

One of the Justice media releases indicates that the whistleblower is seeking qui tam recognition, potentially important given indications that USIS has gained over US$4bn in federal contracts over the past decade.

The filing reportedly quotes one USIS executive as informing two quality control officers in 2010 that he "Flushed everything like a dead goldfish", presumably contrary to the USIS statement that "integrity and excellence are core values" and that
The alleged conduct referenced in the civil complaint is contrary to our values and commitment to exceptional service. These allegations relate to a small group of individuals over a specific period of time and are inconsistent with the strong service record we have earned since our inception in 1996.
The organisation's Corporate Code [PDF] features the stirring CEO statement that -
I am very pleased to be a part of a company that is deeply founded on the principle of integrity. Integrity is not only one of Altegrity’s Core Values, it is truly woven throughout the corporation at every level. We treat each other, as well as our customers, with the utmost respect—and we uphold the highest degree of honesty and trust in all our business interactions. 
As is true with all great companies, Altegrity has a Code of Conduct and Business Ethics policy that helps guide our day-to-day business contacts and dealings. Following the Code helps uphold our corporate culture that is so focused on integrity, but also ensures we comply with national and international laws and regulations that govern our businesses. 
It is important that every employee—at every level—understands our Code of Conduct and complies with the Code every day, in all dealings within and outside our company. Even more importantly, we must uphold the spirit of the Code, for those situations or scenarios that may arise that are not specifically addressed. We should always conduct ourselves in a way that supports Altegrity’s reputation. It is imperative that we use good judgment to guide our actions and seek assistance should we encounter an ethical dilemma that we cannot resolve on our own.
Obviously someone wasn't reading the rhetoric the right way.

The Altegrity site indicates that
Altegrity is a coined name derived from Altus, Latin for high, suggesting altitude, achievement, success, and perspective, and Integrity, the critical foundation of our businesses and our work that revolves around sound judgment and rigorous adherence to the highest principles. Altegrity signifies a company whose work with people is of the highest integrity and suggests efficiency, disciplined processes, accuracy in what we do, and completeness or thoroughness of our solutions. Altegrity is a company that always strives to achieve the heights of integrity.
Altegrity encompasses 10,500 employees in 30 countries. Apart from USIS its subsidiaries include Kroll Advisory Solutions ("the global leader in risk mitigation and response", offices in 29 cities across 17 countries), Kroll Ontrack ("legal technologies, data recovery and information management solutions", with 30 offices worldwide, inc Australia) and HireRight ("a leading provider of on-demand employment background screening, drug and health screening, and employee eligibility solutions that help employers automate, manage, and control screening and related programs").

The latter claims relationships with over one-third of the Fortune 500 and that it "screens more than 6 million applicants annually", including "pre-integrated employment screening services through enterprise e-recruiting solutions from top providers such as Oracle, Taleo, Kenexa, SAP, Silkroad, PeopleAdmin, HealthcareSource and HRsmart" (some of which operate in Australia).

USIS is described by Altegrity as the U.S. government's largest supplier of background investigations and provides diverse investigations to all levels of government and law enforcement agencies", including. This includes

  • health care fraud site visits, criminal background checks and fingerprinting 
  • physical/personnel/facility security, investigative analytics, intelligence analysis, construction surveillance and security convergence
  • litigation support, records management and information support services for the government. 
  •  site verification visits, electronic fingerprint collection and FBI channeling, fraud investigations and medical payment claims validation to combat fraud, waste and abuse
  • secure, proprietary IT systems to conduct its investigation processes, ensuring information security and real-time tracking of performance. 
  • construction surveillance to several secure government construction projects. 
  • customized records, information, and document management solutions for the federal government, including the U.S. Securities and Exchange Commission, Department of Justice, Department of Homeland Security and Federal Deposit Insurance Corporation and more. 
  • litigation support, including drafting motions and briefs, conducting legal research, supporting discovery and assisting in trial or negotiation preparations. 


Students have noted my cruel comments - or merely incredulity - about "wild krill oil" (alongside their suggestions that we start breeding docile and oh so domesticated non-wild krill on campus) and regulation in Australia of nutraceuticals.

 The New York Times reports that a study of 30 top-selling fish oil supplements, identifying levels of omega-3 fatty acids, found that six of the products contained levels that were on average 30 percent less than stated on the label.

The Times indicates that fish oil products reportedly generate some U$1.2 billion in annual sales but "like most supplements" they are "largely unregulated", given that there is no requirement for registration with the Food and Drug Administration or provision of proof that the capsules and liquids "contain the ingredients on their labels and the doses advertised".

In Australia I trust that we'd invoke the Competition & Consumer Act 2010 (Cth) regarding misrepresentation and presume that products from local manufacturers are consistent with what's claimed in the advertising.

The  Times indicates -
 In the current analysis, researchers carried out detailed tests to assess the supplements’ omega-3 content, their levels of mercury, and the extent to which they showed any signs of rancidity or deterioration. Samples of each product were either purchased online on sites like Amazon or bought off the shelves in stores and tested immediately. Then they were ranked according to quality and value. ... 
several of the products it tested compared favorably to Lovaza, the prescription fish oil marketed by GlaxoSmithKline that can cost hundreds of dollars for a one-month supply. Lovaza is a prescription drug held to strict regulations, so it is subjected to regular quality control tests. But some of the products analyzed by LabDoor contained similar or greater levels of omega-3s at a fraction of the cost. 
The analysis showed, however, that mislabeling was not uncommon, affecting at least a third of the supplements tested. One of the products had only half the amount of DHA advertised, for example, and another contained only two thirds, said Neil Thanedar, the chief executive of LabDoor. There were also several products that did not mention DHA content on their labels at all.
DHA is docosahexaenoic acid, one of the omega-3s especially promoted for "brain and heart health". The tests noted by the Times indicates showed that at least six products contained DHA levels that were, on average, 14 percent less than listed on their packaging

22 January 2014

Protests and Move-on Directions in Victoria

The Summary Offences and Sentencing Amendment Bill 2013 (Vic), expected to be passed next week, amends the Summary Offences Act 1966 (Vic) to
provide for additional circumstances in which police members and protective services officers (PSOs) may direct a person to move on from a public place and clarifies the operation of those powers. The Bill also creates a new move-on-related exclusion order scheme within the Summary Offences Act 1966. The scheme will permit police members to apply to a court for an exclusion order in circumstances where a person has repeatedly been directed to move on from a particular public place. The order would have the effect of banning that person from the specified public place for up to 12 months.
It has unsurprisingly attracted attention as a mechanism for inhibiting protests and pickets.

Clause adds new circumstances in which police members and protective service offices (PSOs) may direct a person to move on from a public place under section 6 of the 1966 Act, i.e.—
  • the person has or persons have committed, within the last 12 hours, an offence in the public place; or
  • the conduct of the person or persons is causing a reasonable apprehension of violence in another person; or
  • the person is or persons are causing, or likely to cause, an undue obstruction to another person or persons or traffic; or
  • the person is or persons are present for the purpose of unlawfully procuring or supplying, or intending to unlawfully procure or supply, a drug of dependence; or
  • the person is or persons are impeding or attempting to impede another person from lawfully entering or leaving premises or part of premises.
The police and PSOs must have regard to the duration of the obstruction; and the conduct that is causing the obstruction. PSOs will only be able to use the powers in designated places such as train stations.

The amended s 6(4) of the 1966 Act will provide that police members and PSOs may give a move-on direction to "a person or persons". It enables police and PSOs to give one direction to a group rather than having to individually direct each person in the group to move on.

A new s 6A will enable arrest by police or PSOs of a person those officials reasonably believe has failed to comply with a move-on direction without a reasonable excuse. It is similar to s 458 of the Crimes Act 1958 (Vic) but goes beyond that provision in enabling a police member or PSO to arrest a person whom they reasonably believe has previously contravened a move-on direction even where the person was not caught "in the act" of contravening the exclusion order. A PSO who arrests a person must hand the individual into the custody of a police member as soon as practicable. An arrested person must not be detained unless the detention is necessary to ensure the attendance of the arrested person before court, to preserve public order, to prevent the continuation or repetition of the contravention of a move-on direction, or for the safety or welfare of members of the public.

The new section 6B deals with identity. It enables a police member to request a person to state their name and address where the member intends to direct the person to move on. It is an offence to comply such a request without a reasonable excuse. However, 6B(8) provides that the offence does not apply where a person who is requested to provide their name and address is not told that it is an offence to fail to comply with the request.

A person requested by a police member to state his or her name and address may request that member to state his or her name, rank and place of duty. It is an offence for the police member to fail to comply with such a request or to gives false details.

If a police member suspects on reasonable grounds that a person has provided a false name or address to them in response to a request made under s 6B(1), the member may request the person to produce evidence of their name or address. Section 6B(7) makes it an offence to fail to comply with such a request without a reasonable excuse. The exception in s 6B(8) noted above also applies to this offence.

Section 6D provides that a member of the police may apply to magistrates court for an exclusion order under s 6E, to be served on the respondent by ordinary service (consistent with s 394 of the Criminal Procedure Act 2009 (Vic)) as soon as practicable after filing with the Court. The order must state the name of the person to whom the order applies, the ground on which it was made, a description of the public place or part of the public place which the person must not enter, when the order takes effect, the period of the order and any conditions imposed.

Section 6E provides that the court may make an exclusion order if satisfied on the balance of probabilities that -
  • the person has repeatedly been directed to move on from the same public place or part of that place; and 
  • an exclusion order has not previously been made in respect of the person in relation to the specific directions relied upon in the application; and 
  • an exclusion order may be a reasonable means of preventing the person from engaging in further conduct in the public place, or part of the public place, that could form the basis for another move-on direction. 
In determining reasonableness the court may take into account -
  • the nature and gravity of the person's conduct that formed the basis for any of the previous directions to move on; 
  • whether the person has previously been the subject of an exclusion order; 
  • the likely impact of the exclusion order on the person, any other person affected by the conduct that formed the basis of any of the previous directions to move on, and public safety and order; and 
  • any other matter that the Court considers relevant.
Section 6E(5) enables the court to allow a person to enter the place for a specified purpose on a discretionary basis
This discretion to make conditions ensures that the operation of the orders do not have unintended consequences. For example, it may be appropriate to allow a person subject to an order to pass through an area if he or she would otherwise be prevented from entering their home, or to enter an area to visit family, or for work. It is also intended that the Court could limit the times that the person could enter the public place for such a purpose, such as by only allowing the person to enter on specific days, during specific times in the day or a certain number of times in a given period. The person would still be prohibited from entering the public place for any other purpose.
Usefully the Bill provides that the Chief Commissioner of Police must prepare a report for inclusion in the Victoria Police annual report as a guide regarding the extent to which the move-on related exclusion orders are being used, including the number of applications for exclusion orders in the financial year, the number of exclusion orders made in the financial year; and the number of people found guilty of contravening an exclusion order in the period.

IP Enforcement

'Provocations and Challenges Concerning Enforcement and Civil Procedure in IP' (Sydney Law School Research Paper No. 14/03 ) by Kimberlee G. Weatherall is concerned with
 international developments in intellectual property enforcement and, in particular, with increasingly specific provisions found in international instruments relating to civil procedure in IP. Apart from highlighting the need for academic attention to the trend, the paper analyses the obligation, found in recent instruments such as the Anti-Counterfeiting Trade Agreement (ACTA) and drafts for the Trans-Pacific Partnership Agreement (TPP), that enforcement procedures must be 'fair and equitable'. It examines the genesis of this obligation in TRIPS, the extent to which it has content beyond the specific rules in TRIPS, how effective and enforceable it is likely to be, and, using some examples drawn from recent developments, whether broader conceptions of the right to a fair trial in international human rights instruments can help us interpret when procedures are 'fair' or 'equitable'.


Dr Tissot must be smiling.

A century after fin-de-siecle enthusiasm for cold showers, prayer, the Boy Scouts and YMCA as solutions for self-abuse (supposed cause of same-sex affinity, insomnia, inability to catch a ball or become a successful accountant, hairy palms, premature baldness, ringworms, knobbly knees and other ills) an item in Macleans states that
Earlier this year, Armando, a 23-year-old technician from Oklahoma (who didn’t want to give his last name), was browsing the online news and discussion board Reddit when he clicked a button called “random.” It took him to a forum filled with guys his age discussing what guys his age tend to discuss on the Internet: porn. Only, this forum wasn’t dedicated to sourcing the most explicit sites, but to how people could wean themselves off porn forever. Participants were asked to challenge themselves by giving up porn and masturbation for at least a week. Those who had done so claimed it gave them more energy and confidence and boosted their self-esteem, something they dubbed “superpowers.” 
For Armando, who had recently broken up with his girlfriend, it sounded worth a try. His first attempt to give up what he considered a casual daily habit of surfing the web for porn lasted three days. So did his second and third. By his fourth attempt, Armando says he had come to the realization that what had once seemed like a perfectly normal pastime might not be so healthy after all. He’s been porn-free for two months. He has also remained “master of his own domain,” in Seinfeld parlance (after the episode where Jerry, George, Elaine and Kramer have a contest over who can refrain from masturbation the longest). He reads more and works out twice as hard at the gym. One day, after he’d read a book, exercised and taken two cold showers, he dug out the violin he hadn’t played since high school. 
Alas, no indication that a test reveals his IQ has risen by ten points and his acne has quite disappeared!
He’s now aiming to quit porn forever, convinced that his porn habit was responsible for the failure of his past two relationships. “It really messes up your mind for what sex is actually supposed to be,” he says. “It sets the hopes too high for normal men and women to be able to perform at that level. I believe that’s causing a lot of relationship problems among my peers.” He’s also gained enough confidence in his willpower to take on a new challenge: to stop smoking. 
Armando is part of “NoFap,” a growing online movement among young men who pledge to give up both guilty pleasures for a period of time in hopes of improving their lives. (“Fapping” is Internet slang for masturbation.) When it started two years ago, it was a lighthearted experiment to test whether giving up porn for a week could make you more productive. Today, NoFap has grown to more than 80,000 members, many of whom pledge to swear off porn entirely, saying it contributed to low self-esteem, problems with women and lack of career ambition. Recent forum discussions include a debate on the effectiveness of male chastity belts (yes, they exist) and the best software to block Internet porn pop-ups. One post from a college freshman says giving up porn suddenly made him want to cuddle with a girl. “I just want to lie in bed, fully clothed . . . holding hands and being really close,” he writes.

e-Safety Commissioner

The Australian Government has released a discussion paper [PDF] regarding a Enhancing Online Safety for Children: Public consultation on Key Election Commitments as part of the 'Policy to Enhance Online Safety for Children' that encompasses establishment of a Children's e-Safety Commissioner, development of "an effective complaints system, backed by legislation, to get harmful material down fast from large social media sites" and examination of "existing Commonwealth legislation to determine whether to create a new, simplified cyber-bullying offence".

The document is probable because it under-recognises the resilience of children (not all of whom are wrapped in cotton wool), fails to recognise concerns regarding treatment of all "cyberbullying" as equally serious, and sidesteps any evaluation of the effectiveness of existing programs. Such an evaluation would be useful, given questions about the effectiveness of particular initiatives over the past decade, especially those that were inspired to appease certain constituencies.

The paper follows calls in the Victorian Law Reform Committee report on sexting noted here.

In discussing the mooted e-Safety body the paper states that
As part of the election campaign in September 2013, the Government committed to appoint a senior Commonwealth official as a Children’s e-Safety Commissioner (the Commissioner), supported by existing resources re allocated from existing locations within the public service. The Commissioner will be a single point of contact for online safety issues for industry, Australian children and those charged with their welfare. The Commissioner will also take the lead across government in implementing policies to improve the safety of children online. The need for an accessible and centralised point of contact to deal with online safety has been recognised by policy makers in a range of contexts. For example, on 5 November 2013 the New Zealand Government introduced the Harmful Digital Communications Bill, which proposed the appointment of an Approved Agency under a new civil enforcement regime to handle complaints about harmful digital communications and assist in dispute resolution. The Victorian Law Reform Committee also recommended the establishment of a Digital Communications Tribunal.
Functions of the Commissioner
The Government’s election policy commitments indicate that the Commissioner will have responsibility for the following:
  • implementing the proposed scheme for the rapid removal of material that is harmful to a child from large social media sites; 
  • working with industry to ensure that better options for smartphones and other devices and internet access services are available for parents to protect children from harmful content; 
  • establishing an advice platform with guidelines for parents about the appropriateness of media content; 
  • establishing a research fund to consider the effects of internet use on children, how support services can be provided online and how to mitigate children’s online risks; 
  • establishing a voluntary process for the certification of online safety programmes offered within schools; and 
  • establishing a funding programme for schools to deliver online safety education.
In addition to the functions outlined above, there are a range of existing Australian Government online safety resources and programmes which could be transferred to the Commissioner’s control. ... 
The clear policy intent of the Government is to have a single organisation which takes the lead in relation to online safety for children, allowing for greater efficiency and addressing duplication and overlap. There may, however, be some offsetting considerations in weighing up which programmes should be transferred to the Commissioner’s control. For instance, while some resources and research projects specifically target online safety for children (such as the Cybersafety Help Button and Australian Children’s Cybersafety and E-security Project), other resources are intended for improving the online safety of people of all ages and therefore may not be suited to a Children’s e-Safety Commissioner. For example, the Australian Federal Police’s (AFP) ThinkUKnow programme involves the delivery of public safety messages to students, teachers and parents, which are bolstered by the law enforcement role that the AFP has within the community. The ‘Report Abuse’ function of the ThinkUKnow programme is used to report online grooming behaviour. Consideration should be given to whether the ‘Report Abuse’ function should also remain with a law enforcement body. 
In cases where any agencies retain their online safety programmes, the Commissioner would be expected to establish strong working relationships to ensure consistent messaging in online safety initiatives, and to avoid duplication with the delivery of other online safety programmes.
They would say that, wouldn't they … cooperation in a positive and forward looking way, no duplication, happy surrender of resources (at a time of ongoing budget cuts) "re allocated" from "existing locations".

The next page features the usual motherhood statements -
A range of options are available for establishing the Commissioner. Best practice principles for establishing a new government position are outlined in the Governance Arrangements for Australian Government Bodies published by the Department of Finance, which include some of the following key principles:
  • There should be no unnecessary proliferation of government bodies, therefore a new function, activity or power should be conferred on an existing body, unless there is a persuasive case to form a new body. 
  • Existing governance structures allow for well-understood lines of responsibility to operate, including the clear application of other accountability laws and processes. 
  • A departmental status works well for functions of government that require close ministerial involvement, direction and responsibility. 
  • Additional set-up and ongoing administrative costs for the body should be minimised to reduce demands placed on public sector resources. 
  • A balance needs to be struck between establishing a body’s independence while at the same time still enabling government to govern efficiently.
It is a key objective that the Commissioner will maintain a high public profile to provide visible leadership on enhancing online safety for children.
Visible leadership is especially important in the lead-up to an election and the annual budget wars between competing agencies.

The paper identifies four options for creation of the Commissioner -
1 – establishment of an independent statutory authority 
This option would see the creation of a new independent statutory authority, separately staffed and resourced to support the Commissioner and its functions. While this option would provide the greatest level of independence for the Commissioner to carry out his/her functions, it is also the most costly option. 
2 – establishment of an independent statutory office, with administrative support from an existing government agency 
This option would establish a Commissioner as an independent office, and provide that office with administrative support from an existing government agency (an approach recently taken by the Australian Energy Regulator, which was established as an independent Statutory Board with administrative resources sourced from the Australian Competition and Consumer Commission). Administrative support could be provided by the ACMA, with relevant existing ACMA powers delegated and resources transferred to the Commissioner. Alternatively, administrative support could be provided by the Department of Communications. This would provide some synergies in policy development activities between the Commissioner and the Department, but may give the impression that the Commissioner is not sufficiently independent from government. 
3 – designation of a Member of the ACMA as the Commissioner 
This option would involve appointing an existing member of the ACMA Board to be the Commissioner, with legislative amendments to the Australian Communications and Media Authority Act 2005 to permanently place the role of the Commissioner within the ACMA Board, with distinct functions and powers to achieve the Commissioner’s intended purpose. One benefit of this approach is that it would be possible to temporarily appoint an ACMA Member to act as the Commissioner while legislative arrangements are established for the permanent Commissioner and his/her functions (including legislation for the proposed scheme for rapid removal of material that is harmful to a child from social media sites – see Chapter 2). Having interim arrangements would enable a more rapid transition to the new arrangements, as the interim Commissioner could be closely involved in setting up the legislative arrangements for the new Commissioner. A variant of this option would see the appointment of an Associate Member of the ACMA as the Commissioner, with distinct functions and powers to achieve the Commissioner’s intended purpose. An advantage of this variant is that the appointment could be made without legislative amendment to the ACMA Act. 
4 – designation of a non-government organisation with expertise in online child safety 
This option would involve establishing a legislated framework for appointing an expert non-government organisation (NGO) to undertake the role of the Commissioner. The NGO would be selected on a competitive basis and would operate under contractual arrangements with government. The contract would set out the quantity and quality of outputs the selected NGO would deliver. This option is similar to an approach being proposed in New Zealand under the new Harmful Digital Communications Bill. The key advantage of this option would be the greater flexibility that NGOs have in terms of their:
  • operating cost structure; 
  • capacity to work with industry, including generating additional income; and 
  • capacity to work with state and territory agencies, including law enforcement and education agencies.
A potential disadvantage may be limits on the range of ‘enforcement’ functions that an NGO is allowed to take on. This may require the selected NGO to work closely with local police.

Health Data Mining

Last year I noted the Caldicott report [PDF] on governance of personal data in the UK, in particular plans for sharing of information through the National Health Service.

There is increasing concern - some unfounded, some substantive - over plans by the UK Government to market bulk anonymised data to the private sector through entities such as the national Health and Social Care Information Centre (HSCIC), a 'safe haven' that will offer life sciences researchers "strictly controlled" access to data collected from hospitals and general practitioners.

From an Australian perspective (or that of my membership of the OECD Working Party on Health Information Infrastructure) there are several concerns.

One is the notion of consent regarding use of the data, with questions about the ease of opting out (the default is that information from patients will be held by HSCIC and potentially provided to for example pharmaceutical companies).

Another is the scope for deanonymisation in the world of big data, a scope that has been traditionally under-appreciated by data custodians in the public and private sectors.

A third concern is inept communication, with health administrators failing to simultaneously persuade people of benefits - which are potentially significant - and allay concerns.

That failure is fostering activism by MedConfidential, a civil society group that brings together Privacy International, Big Brother Watch, NO2ID and FIPR.

An editorial in Nature comments that -
The key, as always, is consent. The information at stake here is not genomic clues to future health risks — already the subject of fierce debate — but sensitive data on past and current medical conditions. What the government leaflet fails to highlight is the real threat to privacy and the possible consequences. Worse, the public-relations exercise carried out by the government to stress the programme’s benefits has if anything increased the backlash from privacy campaigners, who are now highlighting the risks and urging people not to participate. An unfortunate false choice has been established, between scientific progress on one side and protection of privacy on the other. 
The government did not initially intend even to allow individuals to opt out of having their data centralized in this way, which would have flown in the face of the most basic principles of privacy and informed consent. The leaflet now states, “You have a choice”, but the government seems to have made it as difficult as possible for people to exercise that right. They must explicitly contact their local doctor to opt out — a requirement that seems a sure way to make certain that most won’t bother, and so will be opted in by default. UK medical charities, including the Wellcome Trust, have launched their own advertising campaign in support of care.data, which, although it validly highlights many of the research opportunities of such big data, also fails to mention sufficiently prominently that an opt-out option exists, and indeed seems intended to try to reduce the number of people who opt out. 
Maximizing the number of people entering the programme is clearly a noble goal. But one cannot help but get the uncomfortable impression that, in their enthusiasm to amass these data, the authorities are using sleight of hand and paying lip service to the principles of informed consent. Inconvenient as it may be, and even if it has some negative effects on the utility of the database, the opt-out option to care.data should be prominently displayed, and facilitated.

21 January 2014

Cancer Voices and BRCA

'The Empire of Cancer: Gene Patents and Cancer Voices' by Matthew Rimmer in (2013) 22(2) Journal of Law, Information and Science argues
Increasingly, an important theme in the history of cancer is the role of law, particularly in the field of intellectual property law. It is striking that a number of contemporary policy debates over intellectual property and public health have concerned cancer research, diagnosis, and treatment. In the area of access to essential medicines, there has been much debate over Novartis’ patent application in respect of Glivec, a treatment for leukaemia. India’s Supreme Court held that the Swiss company’s patent application violated a safeguard provision in India’s patent law designed to stop ever greening. In the field of tobacco control, the Australian Government introduced plain packaging for tobacco products in order to address the health burdens associated with the tobacco epidemic. This regime was successfully defended in the High Court of Australia. In the area of intellectual property and biotechnology, there have been significant disputes over the Utah biotechnology company Myriad Genetics and its patents in respect of genetic testing for BRCA1 and BRCA2, which are related to breast cancer and ovarian cancer. The Federal Court of Australia handed down a decision on the validity of Myriad Genetics’ patent in respect of genetic testing for BRCA1 in February 2013. The Supreme Court of the United States heard a challenge to the validity of Myriad Genetics’ patents in this area in April 2013, and handed down a judgment in July 2013. Such disputes have involved tensions between intellectual property rights, and public health. 
This article focuses upon one of these important test cases involving intellectual property, public health, and cancer research. In June 2010, Cancer Voices Australia and Yvonne D’Arcy brought an action in the Federal Court of Australia against the validity of a BRCA1 patent — held by Myriad Genetics Inc, the Centre de Recherche du Chul, the Cancer Institute of Japan and Genetic Technologies Limited. Yvonne D’Arcy — a Brisbane woman who has had treatment for breast cancer — maintained: ‘I believe that what they are doing is morally and ethically corrupt and that big companies should not control any parts of the human body.’   She observed: ‘For my daughter, I've had her have [sic] mammograms, etc, because of me but I would still like her to be able to have the test to see if the mutation gene is in there from me.’ 
The applicants made the following arguments:
Genes and the information represented by human gene sequences are products of nature universally present in each individual, and the information content of a human gene sequence is fixed. Genetic variations or mutations are products of nature. The isolation of the BRCA1 gene mutation from the human body constitutes no more than a medical or scientific discovery of a naturally occurring phenomenon and does not give rise to a patentable invention.
The applicants also argued that ‘the alleged invention is not a patentable invention in that, so far as claimed in claims 1–3, it is not a manner of manufacture within the meaning of s 6 of the Statute of Monopolies’. The applicants suggested that ‘the alleged invention is a mere discovery’. Moreover, the applicants contended that ‘the alleged invention of each of claims 1–3 is not a patentable invention because they are claims for biological processes for the generation of human beings’. The applicants, though, later dropped the argument that the patent claims related to biological processes for the generation of human beings. 
In February 2013, Nicholas J of the Federal Court of Australia considered the case brought by Cancer Voices Australia and Yvonne D’Arcy against Myriad Genetics. The judge presented the issues in the case, as follows:
The issue that arises in this case is of considerable importance. It relates to the patentability of genes, or gene sequences, and the practice of “gene patenting”. Briefly stated, the issue to be decided is whether under the Patents Act 1990 (Cth) a valid patent may be granted for a claim that covers naturally occurring nucleic acid — either deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) — that has been “isolated”. In this context, the word “isolated” implies that naturally occurring nucleic acid found in the cells of the human body, whether it be DNA or RNA, has been removed from the cellular environment in which it naturally exists and separated from other cellular components also found there. 
The genes found in the human body are made of nucleic acid. The particular gene with which the patent in suit is concerned (BRCA1) is a human breast and ovarian cancer disposing gene. Various mutations that may be present in this gene have been linked to various forms of cancer including breast cancer and ovarian cancer.
The judge held in this particular case that Myriad Genetics’ patent claims were a ‘manner of manufacture’ under s 6 of the Statute of Monopolies and s 18(1)(a) of the Patents Act 1990 (Cth). The matter is currently under appeal in the Full Court of the Federal Court of Australia. 
This article interprets the dispute over Myriad Genetics in light of the scholarly work of Nobel Laureate Professor Joseph Stiglitz on inequality. Such work has significant explanatory power in the context of intellectual property and biotechnology. First, Stiglitz has contended that ‘societal inequality was a result not just of the laws of economics, but also of how we shape the economy — through politics, including through almost every aspect of our legal system’. Stiglitz is concerned that ‘our intellectual property regime … contributes needlessly to the gravest form of inequality.’ He maintains: ‘The right to life should not be contingent on the ability to pay.’ Second, Stiglitz worries that ‘some of the most iniquitous aspects of inequality creation within our economic system are a result of “rent-seeking”: profits, and inequality, generated by manipulating social or political conditions to get a larger share of the economic pie, rather than increasing the size of that pie’. He observes that ‘the most iniquitous aspect of this wealth appropriation arises when the wealth that goes to the top comes at the expense of the bottom.’ Third, Stiglitz comments: ‘When the legal regime governing intellectual property rights is designed poorly, it facilitates rent-seeking’ and ‘the result is that there is actually less innovation and more inequality.’ He is concerned that intellectual property regimes ‘create monopoly rents that impede access to health both create inequality and hamper growth more generally.’ Finally, Stiglitz has recommended: ‘Government-financed research, foundations, and the prize system … are alternatives, with major advantages, and without the inequality-increasing disadvantages of the current intellectual property rights system. 
This article provides a critical analysis of the Australian litigation and debate surrounding Myriad Genetics’ patents in respect of genetic testing for BRCA1. First, it considers the ruling of Nicholas J in the Federal Court of Australia that Myriad Genetics’ patent was a manner of manufacture as it related to an artificially created state of affairs, and not mere products of nature. Second, it examines the policy debate over gene patents in Australia, and its relevance to the litigation involving Myriad Genetics. Third, it examines comparative law, and contrasts the ruling by Nicholas J in the Federal Court of Australia with developments in the United States, Canada, and the European Union. Fourth, this piece considers the reaction to the decision of Nicholas at first instance in Australia. Fifth, the article assesses the prospects of an appeal to the Full Federal Court of Australia over the Myriad Genetics’ patents. Finally, this article observes that, whatever happens in respect of litigation against Myriad Genetics, there remains controversy over Genetic Technologies Limited. The Melbourne firm has been aggressively licensing and enforcing its related patents on non-coding DNA and genomic mapping


'Unmanned Aerial Vehicles: Emerging Policy and Regulatory Issues' by George Cho in (2013) 22(2) Journal of Law, Information and Science argues
Unmanned aerial vehicles (UAVs) provide a new and exciting platform for remote sensing and other applications. However, the added technological capabilities have produced policy and regulatory challenges. There is a need to understand the technology and infrastructure in the context of national and international laws. This contribution is an attempt to develop an understanding of the use of UAVs and their policy and regulatory implications. The deployment of UAVs might be more restricted and restrictive than at first envisaged. Such considerations as the sharing of domestic airspace, air navigation rules, public safety and national security are pertinent. There is a pressing need to address legal obligations and responsibilities and related issues such as privacy rather than just be concerned with the technology. Particular restrictions such as the export of the technology, the transmission of geospatial data across borders and international agreements are as important. 
 Cho concludes
This paper is about the policy, legal and privacy implications of the use of UAVs and UASs generally in civilian environments. The survey provided a background for an understanding of the various names used to describe these aircraft from drones to attack drones and disaster drones. Pilotless aerial vehicles have been used since the turn of the century, for instance, in the two World Wars. 
A summary table was used to help conceptualise the scale and breadth of different configurations of UAVs. The table underscores the myriad sizes, scales and functional capabilities of selected UAVs whether in the civilian or military use. While mass is a surrogate measure for a classification system, it seems that a better criterion is to use kinetic energy impact levels as a taxonomic tool. A feature of such comparisons is that vehicles with a mass of less than 150 kg — classed as small UAV — is becoming an attractive platform for many civilian applications. Whether this becomes a standard configuration will depend largely on policy and regulatory considerations. Public awareness of UAVs and the political understandings of UAVs are thought to be paramount if there is to be support and acceptance of the technology and its future development. The introduction of UAVs to domestic airspace raises safety and integration issues. The lack of a ‘detect and avoid’ system is a key technology that is still missing in the use of UAVs. The current ban on commercial use of UAVs other than the provision of services, such as aerial photography, may have an influence on further research and development. 
The regulation of UAVs is nascent and poses several legal and regulatory challenges. Different jurisdictions have approached such challenges in particular ways depending on national objectives and priorities. Examples from the US, UK and Australia show that air navigation safety is the top-ranked concern that has attracted close attention. Other regulatory challenges include minimising risk for all users of navigational airspace, compliance with air navigation rules and benchmarking between nations to share best practices in the unmanned aerial vehicle industry. 
The use of UAVs for surveillance purposes has produced much opposition and debate everywhere as well as court litigation. Precedents from the common law suggest that after trespass and nuisance, constitutional guarantees of an expectation of privacy may become the dominant source of litigation. In particular, the focus on surveillance cases in the US involving aircraft and violations of the Fourth Amendment has highlighted the evolution of the law and the changes to court opinions that guarantee the expectations of privacy of American citizens. Preliminary conclusions from this section on privacy are that UAVs engender both disquiet and discomfort given the unconscious feeling that there are ‘eyes in the sky’ observing and recording activities of private citizens. While having become acclimated to their presence, unlike closed circuit televisions (CCTV), current versions of UAVs emit an audible buzz and a reminder of their presence in the air. 
The final section discussed technical and operational issues on the use of UAVs. Vehicular autonomy and the safety of operations featured prominently in the discussion. Attention to these issues may provide the framework for the unmanned aerial vehicle industry and its development. However, this is not to detract from its civilian and military use and the restrictions on its manufacture and export in a global context. 
The contribution of this paper on the use of UAVs and UASs generally in civil applications has drawn out the major implications on policy, law, privacy and its technology and operations. First, it has identified that definitional issues need immediate resolution. 
Second, this paper has identified the regulatory challenge for all jurisdictions is the assurance of an equivalent level of safety for the operation of UAVs in the national airspace. There is a crying need for the development of harmonised international air navigation rules. This should not discriminate between mass, size and any other criterion. However, much research in terms of detailed, cross-county comparisons is needed to ensure that the best practice of any jurisdiction can become a feature of an international rule or regulation. 
Third, this paper has identified that the many shades of privacy concerns across jurisdictions. In particular, the court cases provide guidance on the legal bases of the violation of privacy and the expectations of privacy. 
Finally, many issues remain unresolved. Definitions of UAVs can be problematic as is the lack of a truly autonomous system for integration into national airspace because the technology is still evolving. A truly national aviation system, which integrates UAVs seamlessly, may be difficult to establish. The difficulties stem from the standards of airworthiness that are acceptable for civilian purposes, the development of capabilities of ‘sense and avoid’ systems and pilot or operator training and certification. Unmanned aerial vehicles are unique and call for unique solutions to the problems and challenges of this new industry.

Spent Convictions

Following announcement by the Victorian Government of plans to expunge some criminal convictions for same sex activity the South Australian Government, in me too mode, has announced that it got there first -
South Australian Labor Minister, Ian Hunter, has welcomed announcements from Victorian Premier, Denis Napthine, and New South Wales Member of Parliament, Alex Greenwich, that they will introduce legislation to expunge historical gay sex convictions. 
“It’s great to see other States following the lead of the South Australian Government by seeking to remove historical gay sex convictions,” Mr Hunter said. 
The Spent Convictions (Decriminalised Offences) Amendment Act 2013 commenced on 22 December 2013, allowing convictions of historical homosexual offences to be spent for all purposes. 
“While some people with convictions for historical homosexual offences could already apply to a Qualified Magistrate for their conviction to be spent, those sentenced to a term of imprisonment could not,” said Mr Hunter. “Following our reforms, a person can now apply to a Qualified Magistrate for their conviction to be spent regardless of the penalty they received.” 
“The South Australian Government has ended the victimisation of those convicted under historic homophobic laws,” said Mr Hunter. “This continues the strong legacy of social reform by Labor Governments in South Australia.” 
The Dunstan Labor Government made South Australia the first State to decriminalise homosexuality in 1975, but Mr Hunter says that those convicted under the laws continued to suffer from the stigma associated with having a criminal record. 
“I have no doubt that those convicted were prevented from participating fully in society. Such offences being on their records would have continued to impact their employability and their ability to engage with volunteer organisations,” said Mr Hunter. “These reforms will finally bring the suffering of those convicted to an end.”

20 January 2014

PBR in the South

'How Argentine Farmers Overpowered Monsanto: The Mobilization of Knowledge-users and Intellectual Property Regimes' by Felipe Amin Filomeno in (2013) 5(3) Journal of Politics in Latin America 35–71 comments that
Since the 1980s, governments and transnational corporations from core countries led by the United States have driven a global upward ratchet of intellectual property protection. In agriculture, this has meant strengthening the rights of seed companies over the plant varieties they develop and curtailing the rights of farmers over the seeds they cultivate. Exceptionally, from the 1990s to 2013, Argentine soy growers overcame the pressures from the seed industry, guaranteeing the right to freely save seeds of proprietary varieties from their own harvests for future cultivation. Based on a comparative historical analysis of conflicts over intellectual property on seeds in Argentina, Brazil, and Paraguay from the 1990s to 2013, this study suggests that a successful mobilization of knowledge-users in struggles over intellectual property depends on (1) the organizational stability of their political representation, (2) the coordination between the organizations that rep-resent them, (3) the existence of independent channels for the representation of knowledge-users most sensitive to royalty payments, and (4) their ability to produce a public discourse capable of drawing support from a broad coalition.
The author argues that
Since the early 1980s, governments and transnational corporations from core countries led by the United States have driven a global upward ratchet of intellectual property (IP) protection (Chang 2001; Drahos 2002). In agriculture, this has meant strengthening the rights of seed companies over the plant varieties they develop and curtailing the rights of farmers over the seeds they cultivate. During this period, two international treaties have raised minimum standards for the protection of IP in agricultural biotechnology: the 1991 Act of the UPOV Convention (i.e., the International Union for the Protection of New Varieties of Plants; UPOV 1991) and the World Trade Organization’s 1994 Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).
UPOV was created in 1961 to provide an effective system of plant variety protection based on plant breeders’ rights. Its convention was amended in 1972, 1978, and 1991. Among other changes, the act of 1991 extended the minimal protection period for most species from 15 to 20 years and made the protection of farmers’ right to save seeds from their own fields for future cultivation optional for states. For rural communities, saving seeds is a millenary tradition whose legitimacy derives from the fact that rural producers have contributed to the creation, conservation, and improvement of genetic resources in agriculture for centuries. For seed companies, however, the practice of saving seeds is a “residue” of older forms of agriculture; it also limits corporate profits, because farmers who save seeds are less dependent on seed companies and may even act as their competitors when they exchange or sell saved seeds. TRIPS, in turn, states in article 27 that member governments may exclude the following from patentability:
plants and animals other than microorganisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof.
The strengthening of private IP in agriculture is associated with a major transformation in the development and distribution of agricultural technology that also started in the 1980s. Private corporations replaced the public sector as the leading actor in agricultural technology, which became largely conditioned by the quest for profit and market share. “The trend [has been] to privatize the means and sources of knowledge production and to deploy strategies to enclose knowledge commons through intellectual property right regimes” (Parayil 2003: 974). Transnational seed companies have pressured states to design and enforce IP regimes that allow them to maximise the appropriation of economic returns from their R&D investments. The main focus of their pressure has been the right of rural producers to save seeds. If this right is suppressed, rural producers will have to buy new seeds on the market every year, for which they will have to pay royalties (usually included in the price of each bag of seed).
In the 1980s, Monsanto – a transnational corporation based in St. Louis, Missouri – was among the first to genetically modify a plant cell and to conduct trials with genetically modified (GM) crops. Among its chief products are the herbicide Roundup® – based on glyphosate – and Roundup Ready® (RR) soybeans – a GM variety of soybeans resistant to glyphosate. RR soybeans are advantageous for rural producers not because of superior yields per cultivated area, but because glyphosate is less expensive, less toxic, and easier to apply than herbicides used on conventional soybeans. The easier management of RR soybeans also favors the use of non-tillage sowing methods, which are more efficient and cause less erosion to the soil. Since RR soybeans started to be cultivated on a large scale in the United States, Argentina, and other countries in the 1990s, Monsanto has tried to obtain recognition and protection for IP rights on the RR technology around the world. Being an autogamous plant, soy can reproduce through self-fertilization, and its seeds retain their agronomic qualities from one generation to another. This allows rural producers to save soybean seeds for future cultivation, including those of RR varieties, which turns the right to save seeds into a problem for Monsanto.
In Argentina, the corporation has unsuccessfully tried to obtain recognition for the IP rights it claims to have over RR soybeans. Not only does Argentine legislation allow rural producers to save seeds from their own fields for future cultivation without consent from or payment to seed com- panies, but the Argentine Supreme Court denied Monsanto a patent on RR soybeans in 2000, arguing that the technology no longer matched the requisite of novelty when the corporation filed its application for a patent. This severely reduced Monsanto’s capacity to appropriate part of the economic gains generated by the RR technology, prompting the company to retaliate by suspending its R&D activities in Argentina and filing a lawsuit against exporters of Argentine soybean products in Europe. In the meantime, Monsanto and other seed companies operating in Argentina had also proposed changes to national legislation on IP, demanding restrictions on the right to save seeds. To date (as of September 2013), all these attempts have been unsuccessful, with the core of Argentine legislation on IP on plant varieties remaining the same since the 1970s.
The case of Argentina stands in sharp contrast to that of the United States, where Monsanto has used private contracts, lawsuits, and inspecting activities to suppress the right of farmers to save seeds. It also differs from the reality of Brazil and Paraguay, where the corporation implemented a private mechanism of royalty collection for RR soybeans that virtually eliminated the right of rural producers to freely save seeds. More broadly, the case of Argentina defies the global upward ratchet of IP protection initiated by the U.S. government around 1980. How can this cross-national variation be explained?

Academic Butterflies

'Make the butterflies fly in formation? Management of copyright created by academics in UK universities' by Andreas Rahmatian in (2014) Legal Studies argues that
Universities have increasingly become aware of the fact that the intellectual property (IP) rights that attach to the work of their academics could become significant and valuable assets to the university as an institution and economic organisation. The study involved analysis of the copyright and intellectual property policies of universities in the UK and the interviewing of specialised representatives of universities in relation to the policies of their respective institutions. The principal question of the study was the way in which university policies deal with the issue of ownership of copyright generated by academic staff, which proved to be a sensitive area. University policies presume that, by default, they own all work that academics create as their employees. There seems to be insufficient appreciation of the differentiated legal interpretation of the employees’ copyright rule. At least in relation to core academic work (scholarly books and journal articles in particular), initial copyright ownership by the university, by virtue of the statutory employee- copyright rule, is highly doubtful. As a result of the universities’ principal position with regard to ownership, university IP policies have resorted to complicated and artificial assignment and licencing provisions, with questionable enforceability. 
Rahmatian comments that
In all probability, most universities have issued intellectual property (IP) policies directed particularly at patents and copyright, because these are the most relevant IP rights that arise from the activities of university academics. It is therefore worth looking at university policies on IP rights created by academics, taken from a representative sample of universities in the UK. This study investigates whether universities as employers claim ownership over the IP rights in their policies, how restrictive this claim is with regard to further use, whether this claim complies with the law and whether one can detect a broadly coherent IP policy across different universities. The study is confined to copyright; this is not only to keep the study within manageable proportions, but also because copyright is the most important IP right for a legal conceptualisation of academic output. Copyright, the most far-reaching and almost all-encompassing IP right, concerns every item of academic output, whether in the arts and humanities, the social sciences or the hard sciences, while patents arise only in a science and engineering environment. (Currently, patents are com- mercially more relevant for universities than copyright.) The study also wanted to examine the ways in which a copyright policy is enforced in reality within the university, whether the policy’s intention is reflected in the actual wording and how the role of the policy is perceived by its administrators in the broader context of university management. 
The last point raises an important issue. It seems that the growing concern about IP rights generated within universities has gone hand in hand with the rise of the emergence of university managerialism in the 1990s. The phenomenon of managerialism has been defined as ‘a general ideology or belief system that regards managing and management as being functionally and technically indispensable to the achievement of economic progress, technological development, and social order within any modern political economy’. ‘Management’ can be regarded as an abstracted social practice and design for a comprehensive set of ideas for rationally coordinating and controlling collective action. University managerialism seems to be a type of neoliberal managerialism, which emerged in the late 1990s in particular, when the New Labour government came into power in the UK. This form of managerialism has quickly come to dominate public-sector entities. It characteristically replaces political debate with detailed continuous bureaucratic work control at the micro-level, implemented by accountability and performance processes and technologies. Universities, though formally not subject to central government agencies, have increasingly come under pressure to adopt this regime of ‘new managerialism’ and have moved towards an entrepreneurial and market-driven outlook, with the effect that academics have largely lost their importance in university governance and have been replaced by managers or academics-turned-managers. Several factors have fundamentally contributed to the changing culture in universities over the past 40 years, including, in particular, the growing size of the higher education sector and the incessant reduction of public funding by the state. Today, the state is less the financial provider for the universities but, rather, the regulator of their internal affairs (through the requirement for external auditing of teaching and research standards). In such a climate, the emergence of a market- oriented ‘knowledge economy’ or ‘knowledge society’ ideology, implemented through ‘knowledge management’ practices within the institutional university structure, cannot come as a surprise. This ideology demands that the knowledge creation and output be evaluated, monitored and audited in a seemingly objective/ standardised and near-commercial manner (‘business metrics’). The language of university management reveals this economist’s approach: therefore, it has been suggested that institutional decision making is to be complemented by the ‘principle of externality’, a concept borrowed from economics in the context of market (equilibrium) inefficiencies. All that ties in with the idea that universities are just businesses in the service industry and the students are their most important customers. A management scheme following these parameters will try to measure and improve academic staff performance, and will seek to create wealth for the university as an economic entity. Intellectual property rights, particularly copyright, can be of great assistance in such a scheme. 
The connection between copyright (or copyright ownership) and managerialism has apparently not yet been made explicitly in the academic literature, but the higher education sector is a good example that can demonstrate the workings of this alliance. The intellectual achievements and services (in a broad sense) of an academic become more measurable if they can be translated (or packaged) into IP rights, above all copyright. In this way, the person’s work can be expressed as a sum of proprietary units, detached from the individual and capable of being assessed and priced for the purpose of evaluation and auditing as part of the university’s management framework. Thus copyright can be a legal vehicle for turning the academic’s intellectual creations into alienable products which (a) enable management to conceptualise an individual as a commodified or objectified ‘human asset’, and (b) create capital for the univer- sity as a ‘business’ organisation by virtue of the separable value of the product (or copyright-property). The latter objective benefits particularly from ownership rules that vest copyright from the outset in the university as employer. It goes beyond the scope of this study to provide empirical evidence of the use of copyright in the rise of university managerialism, but some of possible contributing factors to such a development – copyright policies and ownership rules – will be examined.