Generics, Fakes and Regulatory Incapacity

Noting an item in today's New York Times on cross-border regulation and generic pharmaceuticals.

The Times reports that India’s pharmaceutical industry supplies 40% of over-the-counter and generic prescription drugs consumed in the US, so increased scrutiny could have profound implications for US consumers.

F.D.A. investigators are blitzing Indian drug plants, financing the inspections with some of the roughly $300 million in annual fees from generic drug makers collected as part of a 2012 law requiring increased scrutiny of overseas plants. The agency inspected 160 Indian drug plants last year, three times as many as in 2009. The increased scrutiny has led to a flood of new penalties, including half of the warning letters the agency issued last year to drug makers. 

Ranbaxy, one of India’s biggest drug manufacturers, pleaded guilty to felony charges and paid a $500 million fine last year. 

Indian officials and executives are reportedly shocked by recent FDA export bans over adulterated generic versions of popular medicines such as the pain drug Neurontin and antibiotic Cipro that the FDA determined were adulterated. Some reportedly "take a very sinister view" of US inspections, suspecting that the US is protecting its domestic industry from cheaper imports. The article regrettably does not refer to or unpack the international expansion of generic manufacturers.

The Financial Times rather mordantly commented earlier this month that

Arun Sawhney wanted to be clear. “Ranbaxy is a different company today”, the chief executive of the Indian drugs group said shortly after the US Department of Justice imposed a $500m fine in May [2013] for distribution of adulterated medicines between 2004 and 2007. 

Mr Sawhney was drawing a line under the scandal. “All Ranbaxy products currently in the global market are safe and effective,” he said. The company had a new code of conduct for staff and clear accountability.

Less than a year later, Mr Sawhney’s words ring hollow. The US Food and Drug Administration has banned imports from another Ranbaxy facility for violating quality standards. This is a serious blow for the company, which now has all four of its Indian plants subject to US restrictions. It was left to express its disappointment and apologise to stakeholders. A key question is how these lapses have persisted under Daiichi Sankyo, Ranbaxy’s Japanese majority owner, given that country’s reputation for high-quality, precision manufacturing? 

For Daiichi Sankyo, the acquisition of a 64% stake in Ranbaxy for $4.7bn in 2008 was to be the road to globalisation. Five years on, many Mumbai-based analysts are struggling to explain the new owner’s failure to turn things round and the Indian workers’ still lackadaisical attitude towards data integrity and quality standards. 

Notes from the most recent FDA inspections at Ranbaxy’s facilities in Toansa and Mohali, for example, found that ingredients and drugs were being retested until acceptable results were obtained. Hygiene was also inadequate. FDA inspectors noted in its “483 report”, used to cite observations that can lead to regulatory action, that there were flies too numerous to count in the sample preparation room, cupboards holding sensitive equipment and agents were broken, and the refrigerator that stored samples was not working well, with melting ice causing pools of water inside. 

“If you see the kind of observations the FDA has made, they look quite basic,” said one Indian pharmaceutical industry analyst. “It’s more about the mindset of the company in the past and the way it was handled. If the Japanese management are not able to make changes in the company, who else will be able to?”

Concerns regarding quality and counterfeiting are longstanding, highlighted in works such as 'Counterfeit pharmaceuticals: Murder by medicine' by Peter Aldhous in (2005) 434(7030) Nature 132, 'Counterfeit and substandard quality of drugs: the need for an effective and stringent regulatory control in India and other developing countries' by Azhar Yaqoob Khan and N. M. Ghilzai in (2007) 39(4) Indian Journal of Pharmacology 206, 'Counterfeit anti-infective drugs' by Paul Newton, Michael D. Green, Facundo M. Fernández, Nicholas PJ Day, and Nicholas J. White in (2006) 6(9) The Lancet infectious diseases 602, 'Counterfeit Pharmaceuticals in China: Could Changes Bring Stronger Protection for Intellectual Property Rights and Human Health' by Dina Bronshtein in (2008) 17 Pacific Rim Law & Policy Journal 439, 'The other global drugs crisis: Assessing the scope, impacts and drivers of the trade in dangerous counterfeit pharmaceuticals' by Y. A Majid in (2008) 1(1) International Journal of Social Inquiry 151 and 'Parallel trade in pharmaceuticals: injecting the counterfeit element into the public health' by Bryan Liang in (2006) 31 North Carolina Journal of International Law & Commercial Regulation 847.

The New York Times continues that -

The F.D.A.’s increased enforcement has already cost Indian companies dearly — Ranbaxy, one of India’s biggest drug manufacturers, pleaded guilty to felony charges and paid a $500 million fine last year, the largest ever levied against a generic company. And many worry that worse is in store.

The unease culminated Tuesday when a top executive at Ranbaxy — which has repeatedly been caught lying to the F.D.A. and found to have conditions such as flies “too numerous to count” in critical plant areas — pleaded with Dr. Hamburg at a private meeting with other drug executives to allow his products into the United States so that the company could more easily pay for fixes.

In response to that delightful example of chutzpah the US representative "politely declined".

India’s drug industry is one of the country’s most important economic engines, exporting $15 billion in products annually, and some of its factories are world-class, virtually undistinguishable from their counterparts in the West. But others suffer from serious quality control problems. The World Health Organization estimated that one in five drugs made in India are fakes. A 2010 survey of Delhi pharmacies found that 12% of sampled drugs were spurious. 

In one recent example, counterfeit medicines at a pediatric hospital in Kashmir are now suspected of playing a role in hundreds of infant deaths there in recent years. 

One widely used antibiotic was found to contain no active ingredient after being randomly tested in a government lab. The test was kept secret for nearly a year while some 100,000 useless pills continued to be dispensed. 

More tests of hospital medicines found dozens more that were substandard, including a crucial intravenous antibiotic used in sick infants. … 

[C]onvictions of drug counterfeiters in India are extremely rare. ... Heather Bresch, chief executive of Mylan, which has plants in the United States and India, said regulatory scrutiny outside of the United States was long overdue. “If there were no cops around, would everyone drive the speed limit?” Ms. Bresch asked. “You get careless, start taking risks. Our government has enabled this.”

The US visit is

part of a long-running effort to create a global network of drug and food regulators to help scrutinize the growing flood of products coming into the United States, including 80% of the seafood consumed in the United States, 50% of the fresh fruit, 20% of the vegetables and the vast majority of drugs. 

She has gone to conclaves of regulators from Europe and elsewhere to coordinate policing, but Indian officials have so far not attended such meetings. 

Many of India’s drug manufacturing facilities are of top quality. Cipla, one of the industry’s giants, has 40 plants across the country that together can produce more than 21 billion tablets and capsules annually, and one of its plants in Goa appeared just as sterile, automated and high tech on a recent tour as those in the United States. 

Cipla follows F.D.A. guidelines at every plant and on every manufacturing line, and the company exports more than 55 percent of its production, said Yusuf Hamied, the company chairman. 

But Benjamin Mwesige, a pharmacist at the Uganda Cancer Institute in Kampala, said in an interview in July that the institute had stopped buying cancer drugs from India in 2011 because it had received shipments of drugs that turned out to be counterfeit and inactive, with Cipla labels that Mr. Mwesige believed were forged. ... Mr. Mwesige estimated that in 2011 about 20% of the drugs that the institute bought were counterfeit. 

Enforcement of regulations over all is very weak, analysts say, and India’s government does a poor job policing many of its industries. … India’s Central Drugs Standard Control Organization, the country’s drug regulator, has a staff of 323, about 2% the size of the F.D.A.’s, and its authority is limited to new drugs. The making of medicines that have been on the market at least four years is overseen by state health departments, many of which are corrupt or lack the expertise to oversee a sophisticated industry. Despite the flood of counterfeit drugs, Mr. Singh, India’s top drug regulator, warned in meetings with the F.D.A. of the risk of overregulation.

Importantly

 This absence of oversight, however, is a central reason India’s pharmaceutical industry has been so profitable. Drug manufacturers estimate that routine F.D.A. inspections add about 25% to overall costs. In the wake of the 2012 law that requires the F.D.A. for the first time to equalize oversight of domestic and foreign plants, India’s cost advantage could shrink significantly.

What's striking is the comment that

“If I have to follow U.S. standards in inspecting facilities supplying to the Indian market,” G. N. Singh, India’s top drug regulator, said in a recent interview with an Indian newspaper, “we will have to shut almost all of those.” 

From an Australian perspective that comment embodies a regulator's misunderstanding of costs, i.e. non-recognition of the costs (potentially death rather than merely paying for substandard or fake drugs) to Indian consumers from inadequate regulation, manufacture and distribution. Indian consumers have a lesser right to health than their Australian peers or are, in the mind of Indian bureaucrats, just more expendable?

Copyright Futures

In his Address At The Opening Of The Australian Digital Alliance ‘Fair Use For The Future: A Practical Look At Copyright Reform’ Forum [PDF] the Australian Attorney-General yesterday commented that

I firmly believe the fundamental principles of copyright law, the protection of rights of creators and owners, did not change with the advent of the internet and they will not change with the invention of new technologies. 

The principles and values underlying intellectual property law and the values which acknowledge the rights of creative people are not a function of the platform on which that creativity is expressed. 

However, this does not mean that I believe that Australia’s copyright laws are not in need of reform. Quite the contrary. The Copyright Act is overly long, unnecessarily complex, often comically outdated and all too often, in its administration, pointlessly bureaucratic. …  

As you all know, the key recommendation of the [ALRC] Report is that Australia adopt a ‘fair use’ exception to copyright, and the business of the day, for you today, is to consider the ‘fair use’ extension. 

I remain to be persuaded that this is the best direction for Australian law, but nevertheless I will bring an open and inquiring mind to the debate.

The A-G went on to state

As the Government considers what direction it wishes to take in response to the ALRC report, let me commit to a couple of things. 

First, when this process is finished, and it will be a through and exhaustive exercise in law reform, the Copyright Act, will be shorter, simpler and easier to use and understand. 

Secondly, the Act will be technology neutral - no more amusing references to videotapes as we find in current section 110AA. 

Thirdly, we will pay careful regard to the broader international legal and economic context, we all know that Australia’s laws cannot exist in a vacuum, they must operate efficiently within a global copyright system. That is particularly important as the Abbott Government continues, to number among its signature achievements, the negotiation of free trade agreements with our major trading partners, which, as you all know, contain important provisions concerning copyright and other intellectual property issues. 

We will do this in a way that ensures appropriate protection of copyright material in the digital age and encourages culturally and economically beneficial uses of material that do not undermine fundamental copyright principles. That of course is the balance to be struck and the merits do not lie entirely on one side of the scale or on the other.

Given lobbying after the iiNet and TvNow decisions it is unsurprising that the A-G went on to comment -

I want to use the opportunity of this address to make a few remarks about the issue of online piracy. 

While, as I said before, I do not believe the fundamental rationale of copyright changed with the internet, I am of the view that the internet poses a particular challenge in the area of online piracy. The illegal downloading of Australian films online is a form of theft. I say Australia films, but of course the illegal downloading of any protected content is a form of theft. 

Some stakeholders have sought the introduction of laws aimed squarely at the scourge of online piracy. 

While I am sympathetic to their views and am interested in examining new measures that will cut rates of online piracy in Australia, I am not unmindful of the policy challenges of developing the most efficacious regime to do so. 

Let me give you an example. The Great Gatsby, Australia’s most successful film at the local box office last year, is now centre stage after its haul of 13 AACTA Awards and an Oscar nomination. 

Unfortunately the success achieved by The Great Gatsby can lead to piracy of the film, placing the sustainability of our screen industry at risk. 

One area for potential reform of this problem may be section 101 of the Copyright Act. 

This provision provides that an entity which authorises the infringement of copyright without the copyright owner’s permission is liable for that infringement. 

It was thought that these provisions were ‘technology neutral’ and applied to internet service providers, marrying up with the ‘safe harbour scheme’. 

However, the High Court’s decision of 2012 in the iiNet case changed the position. The Government will be considering possible mechanisms to provide a ‘legal incentive’ for an internet service provider to cooperate with copyright owners in preventing infringement on their systems and networks. 

This may include looking carefully at the merits of a scheme whereby ISPs are required to issue graduated warnings to consumers who are using websites to facilitate piracy. 

This is a complex reform proposal, and how it is paid for is one of the principal unresolved issues. 

It should also be noted that Australia has international obligations on this point and that the Government will not be seeking to burden ISPs beyond what is reasonably necessary to comply appropriate domestic and international obligations. As well, I would like to emphasise that this would not put Australian ISPs at a disadvantage by comparison with their counterparts internationally as many overseas jurisdictions have the concept of authorisation liability, secondary liability or similar, which are intended to capture ISPs. 

Another option that some stakeholders have raised with me is to provide the Federal Court with explicit powers to provide for third party injunctions against ISPs, which will ultimately require ISPs to ‘take down’ websites hosting infringing content. 

Most importantly, in framing any enforcement reforms, my preference would be to facilitate industry self-regulation, as opposed to active and continuing government regulation. 

Industry participants are in the best position to develop a flexible, cooperative self-regulatory approach tailored to particular industry needs. Industry cooperation is a key element in tackling online piracy, and I will continue to encourage industry participants to work together to overcome the outstanding issues in contention.

Faces

'Anonymity, Faceprints, and the Constitution' by Kimberly N. Brown (2014) 21(2) George Mason Law Review 409-466 comments that

Rapid technological advancement has dramatically expanded the war- rantless powers of government to obtain information about individual citizens directly from the private domain. Biometrics technology — such as voice recognition, hand measurement, iris and retinal imaging, and facial recognition technology (“FRT”) — offers enormous potential for law en- forcement and national security. But it comes at a cost. Although much of the American public is complacent with government monitoring for security reasons, people also expect to go about daily life in relative obscurity — unidentifiable to others they do not already know, do not care to know, or are not required to know — so long as they abide by the law. The reality is quite different. The government and the private sector have the capacity for surveillance of nearly everyone in America. As one commentator puts it, “soon there really will be nowhere to run and nowhere to hide, short of living in a cave, far removed from technology.” 

FRT is a major contributor to the spectre of an Orwellian society.Facebook uses it to identify “friends” from uploaded photos, which are permanently affixed in cyberspace and accessible to the government. Federal and state authorities have their own databases of images collected from drivers’ licenses, public surveillance cameras, unmanned aerial drones, and tiny recording devices attached to police uniforms. Currently, the FBI is working on a $1 billion effort to expand its fingerprint identification system to crossreference FRT and other biometric data against a vast data repository that includes some 13 million criminal mug shot photos. With FRT, a federal agent or corporate marketer can convert any number of these facial images into algorithms, associate them with countless other bits of personal data accumulating throughout the global information network, and track the most intimate details of an unsuspecting person’s daily life. 

There is no recognized constitutional theory for placing boundaries on the government’s ability to engage in ubiquitous monitoring of citizens based on images snapped in public or posted online. The Supreme Court has made clear that the Fourth Amendment does not protect “[w]hat a person knowingly exposes to the public.” Nor does it cover information re- vealed to third parties. Thus, although corporations and individual citizens generate the largest storehouses of personal data today, the government — through its subpoena powers, contractual agreements, and public access to online data—can effectively bootstrap private information into its own domain without contending with the Constitution. 

As a consequence, technology has minimized the Constitution’s importance as a mechanism for protecting against arbitrary government tracking of one’s movements, habits, relationships, interests, and thoughts. This Article attempts to reassert the Constitution’s relevance when it comes to surveillance through FRT and related technologies in two ways. First, it argues for recognition of anonymity as a constitutional value that is both implicit in the Court’s Fourth Amendment jurisprudence and explicit in its First Amendment jurisprudence. Second, it suggests that a shift in technology’s intersection with data — from analysis of static bits of information in the pre-digital age to a “growing respect for correlations” among data in the digital age—warrants a fresh look at Fourth Amendment doctrine that excuses surveillance based on information obtained in public or from third parties. FRT allows users to correlate numerical faceprint algorithms with other data points to create new information relating to an individual’s past, present, and future life.Constitutional law must account for this modern capacity to manipulate data for predictive intelligence. To this end, the Article derives doctrinal guidelines for grappling with technology’s threat to the constitutional value of anonymity from a reconciliation of the Fourth and First Amendment law bearing on the issue. 

Part I defines anonymity and explains that respect for the capacity to remain physically and psychologically unknown to the government traces back to the Founding. With the advent and expansion of new technologies such as facial recognition technology (“FRT”), the ability to remain anonymous has eroded, leading to a litany of possible harms. 

Part II reviews the existing Fourth and First Amendment doctrine that is available to stave off ubiquitous government surveillance and identifies anonymity as a constitutional value that warrants more explicit doctrinal protection. Although the Fourth Amendment has been construed to excise surveillance of public and third-party information from its scope, the Court’s recent jurisprudence indicates a growing recognition that constitutional doctrine is out of step with modern surveillance technologies. The Supreme Court has expressly recognized a First Amendment right to anonymous speech, which should be taken into account in assessing the constitutionality of government surveillance systems under the Fourth Amendment. This Part accordingly draws a distinction between cases that arose in the pre-digital age, in which content was often collected through physical trespass or eavesdropping, and those arising in the digital age, in which correlations among disparate points of “big data” are used to make predictions. 

Part III argues that Fourth and First Amendment doctrine should be reconciled to address the manipulation — versus acquisition — of FRT data to derive new information about individuals which is exceedingly intimate and otherwise out of the government’s reach. This Part suggests that this qualitative shift in information gathering is constitutionally significant under existing doctrine. Part III also offers guidelines gleaned from the intersection of First and Fourth Amendment jurisprudence for consideration by lower courts and legislators as they address the threat of limitless surveillance which big data and new technologies present.

Space Junk

'An Inference about Interference: A Surprising Application of Existing International Law to Inhibit Anti-Satellite Weapons' by David A. Koplow in (2014) 35 University of Pennsylvania Journal of International Law states that it

presents a thesis that most readers will find surprising, in an effort to develop a novel, simultaneous solution to three urgent, complex problems related to outer space. The three problems are: a) the technical fact that debris in outer space (the accumulated orbital junk produced by decades of space activities) has grown to present a serious hazard to safe and effective exploration and exploitation of space; b) the strategic fact that many countries (notably the United States, China and Russia, but others, too) continue to demonstrate a misguided interest in pursuing anti-satellite weapons, which can jeopardize the security of space; and c) the political fact that attempts to provide additional legal regulation of outer space (via new bilateral or multilateral international agreements) have failed, with little prospect for prompt conclusion of meaningful new accords. 

The proposed solution is to adapt existing international law in an unforeseen way. Specifically, numerous current and historical arms control treaties provide for verification of parties’ compliance via “national technical means” (NTM) of verification, which prominently include satellite-based sensory and communications systems. These treaties routinely provide protection for those essential space assets by requiring parties to undertake “not to interfere” with NTM. The argument developed here is that additional tests in space of debris-creating anti-satellite weapons would already be illegal, even without the conclusion of any dedicated new treaty against further weaponization of space, because in the current crowded conditions of space, a new cloud of orbital debris would, sooner or later, impermissibly interfere with NTM satellites. 

If sustained, this thesis can provide a new rationale for opposition to the development, testing, and use of anti-satellite weapons. It a legal reinforcement for the political instincts to avoid activities that further undercut the optimal usability of outer space, and it demonstrates how creative re-interpretation of existing legal provisions can promote the advancement of the rule of international law, even in circumstances where the articulation of new treaties is blocked.

Freedom

Readers of this blog will recall that I'm unimpressed by the Office of the Australian Information Commissioner, an agency that hasn't meaningfully engaged with the community, has been permissive in belatedly responding to bad practice in the public and private sectors, and in responding to Freedom of Information applications has increasingly acted in ways that are contrary to its rhetoric about responsiveness and openness. As I indicated to the OAIC recently, it can hardly expect agencies to embrace that rhetoric when they see the OAIC, as champion of FOI, consistently relying on delays and under-resourcing to evade public access to information about privacy policy.

I was thus pleased to see 'Here's an office that's hardly free with information' by Michael West in today's Sydney Morning Herald.

West comments that

If the government was looking for some low-hanging fruit to make its budget savings, it might be tempted to cast a quiet eye over the Office of the Australian Information Commissioner. 

Were it do so, however, it might find that the Office of the Australian Information Commissioner was so low-hanging as to qualify not as fruit but rather as a root vegetable. 

Perusing the annual report for the office, one finds that the commissioners - of which there are three - ''delivered 59 speeches and presentations'' for the year to June 2013. 

Yet in the same period, the office managed only 89 ''information commissioner review decisions''. Of these, the office decided in favour of other government agencies seeking to keep publicly-funded information away from the public 65 per cent of the time. 

So it was that we posed a question to the office. As the head count had averaged 85.27 during the year, and as they had collectively made just 89 decisions, was it reasonable to assume that the rate of decisions equated to roughly one decision per staff member per year? 

Not at all, we were advised. 

The office has more functions than merely making decisions. Its mandate spans freedom of information, privacy matters and information policy. 

Although some staff work in only one of these three areas, many work across two or all three functions. The office estimates that 35 per cent of its resources are directed towards exercising its ''freedom of information functions''. 

The real strike rate then is 2.98 decisions per staff member per year. 

A cynic could be deluded into thinking, as this rate of decisions was in inverse correlation to the surfeit of speeches, reams of policy advice and the explosion in guidelines, that this was bureaucracy heaven. A cynic, however, would not understand the real demands of agency ''through-put''. 

Some 447 freedom of information requests were backed up in the system at year's end, up 25 per cent on the previous year. Of these, 105 had been filed at the office for longer than 12 months. 

However, the legendary Will Matthews FOI request was not among these. Matthews' Homeric campaign to wrest a straight answer out of government celebrates its 10th anniversary this year and is again bogged down in the Administrative Appeals Tribunal. ...  

But we digress. To its credit, the office does acknowledge a lack of breakneck speed: ''This level of delay has a detrimental effect on the FOI system,'' the annual report says. 

The blame, however, lies with government. The office has called for an increase in its $10 million funding. It wants more staff, not fewer. The feeling is not mutual, though, as staff turnover for the year was 24.7 per cent, roughly one in four. 

Nonetheless, some metrics are on the up. Wages and salaries rose 9 per cent and fees paid to consultants were up 20 per cent. 

(Note to self: tactfully refrain from snide comment here.) 

One person who has enjoyed the office experience says he was told straight away that it would be at least six months before a case officer would be assigned to his case. 

''If you question the delays,'' this person said, ''the message is: 'This is how we roll, everyone has to wait.' ''The office clock is different to the applicant's clock. When you get a letter you have to respond within two weeks. But when it's their turn to respond, time stands still. The seasons pass.'' ... 

Another metric tells the story: 95 of 419 applicants simply withdrew last year. ''The take away is 'don't bother asking' because you will be put in a queue so long or dealt with so slowly that giving up becomes the only logical course of action,'' the weary source said.

Note: I haven't been in contact with Mr West.

Reparation and citizenship

The New York Times features an item on proposals in Spain to offer dual citizenship to any person — self-identifying as Jewish or otherwise — whose Sephardic origins can be certified.

The proposal, not yet approved by Spain's legislature, is a reparation for the 1492 expulsion of Spain's Jews, removes some onerous existing requirements that include the need for applicants to renounce their current citizenship.

The NYT reports that

Leon Amiras, chairman of an association for immigrants to Israel from Latin America, Spain and Portugal, said this week that he planned to apply for Spanish citizenship and that many families had books or documents allowing them to trace and prove their ancestry. When his own grandmother and great-grandmother left Izmir, in Turkey, for Argentina, they were issued an identity document that was certified by the Spanish consul there at the time. … 

The Justice Ministry of Spain said this week that it had no estimate of how many Sephardic Jews might be eligible for Spanish citizenship. So far, the ministry has registered 3,000 applications, but a spokeswoman said that number should now increase. … 

In what appeared to be a reciprocal gesture, Natan Sharansky, chairman of the quasi-governmental Jewish Agency for Israel, estimated this week that there were millions of descendants worldwide of conversos, Jews who converted to Catholicism under duress in medieval Spain, including hundreds of thousands who are exploring ways of returning to their Jewish roots. “The state of Israel must ease the way for their return,” said Mr. Sharansky, who spent years in Soviet prisons for his human rights activities before arriving in Israel.

Grant of Spanish nationality will give the new citizens the right to move freely and work in any other country of the European Union.

Detail of course matters. A statement on the website of Spain's embassy in Canberra states -

The Spanish Council of Ministers approved a Draft Bill that simplifies considerably the administrative procedure of concession of the Spanish nationality to Sephardic Jews, whose ancestors were expelled from the Iberian Peninsula more than five centuries ago.

The Draft Bill must still follow the appropriate parliamentary procedure. 

The Draft Bill modifies the Civil Code, and will simplify the matter of proof of the condition of Sephardic Jew but furthermore, will not require that applicants give up their current citizenship. 

Those who wish to apply will have two years to do so after parliamentary approval. The Council of Ministers will be able to extend this period for another year. 

The alternative requirements established by the Draft Bill as sufficient proof for Sephardic Jews are: 

• A certificate from the competent rabbinic authorities legally recognised in their place of residence 

• Family surnames or family language (Ladino) 

• A certificate from the Spanish Federation of Jewish Communities confirming that the applicant is a Sephardic Jew 

• The inclusion of the name of the applicant or his/her direct descendants in the lists of Jewish families protected by Spain 

• Link or relationship of the applicant to a person or family as mentioned above

Although there are Sephardic communities in the five continents, and some of them keep alive the usage of the Spanish language spoken in the XV century, Ladino, it is expected that the proposed legal reform may have greater impact in Israel, given that it is estimated than more than 3.5 million, half of their population, is of Sephardic ancestry. 

As pointed out by Alberto Ruiz-Gallardón, Spanish Minister of Justice and driving force behind this initiative “after their forced expulsion, many Sephardic Jews kept and passed on from generation to generation the keys of their houses left behind in Spain. .… five centuries later, the door is reopened.”

The Spanish proposal is more generous that 'investor citizenship' (ius pecuniae) regimes elsewhere in Europe, Australia and other jurisdictions.

Malta is meanwhile attracting criticism within the EU over its move to a privately-managed fast-tracked, no-strings-attached Maltese citizenship offer. Pay 650,000 euros and you are in, with very few questions asked in a 'drive-by' citizenship program that will presumably be emulated in other parts of the world. New citizenship plus a couple of shelf companies in Tuvalu, Kiribati or the Caymans while you wait?

Lawyers and ASIO

The redacted Inquiry into the attendance of legal representatives at ASIO interviews, and related matters report [PDF] by Australia's Inspector-General of Intelligence and Security (IGIS) reflects a complaint from the Refugee Advisory and Casework Service (RACS) alleging inconsistent and arbitrary practices by the Australian Security Intelligence Organisation (ASIO) regarding the attendance of legal representatives at security assessment interviews.

RACS argued that that ASIO officers had no legal basis to exclude lawyers from interviews, as

•  there is no express statutory power in the Australian Security Intelligence Organisation Act 1979 (Cth) or Migration Act 1958 (Cth) to exclude legal representatives from security assessment interviews for protection visa applicants 
• the exclusion of a legal representative from a security assessment interview could amount to a denial of procedural fairness 
• there is no express power given to ASIO to require a lawyer who attends a security interview to sign a confidentiality undertaking 
• case law indicated that investigative bodies (for example, the National Crime Authority and the Australian Securities Commission) could exclude a particular lawyer, for example where the organisation was satisfied on reasonable grounds that the particular lawyer would prejudice the proceedings. 

IGIS comments that

ASIO provided me with detailed advice on the requirements of its current policies and procedures in respect of voluntary interviews, including security assessment interviews. The full text of these documents is afforded a national security classification and cannot therefore be included in this abridged report.

In summary, the guidance provides that ASIO officers cannot prevent an individual requiring the presence of their lawyer at a voluntary interview. Where an interviewee requires the presence of their lawyer, ASIO should request the contact details of the lawyer and their firm, as well as an undertaking of confidentiality. However, if interviewing officers assess that the presence of the lawyer is counterproductive to the conduct of the interview, they may inform the interviewee and, if appropriate, terminate the interview.

I understand the policy as instructing ASIO officers to work from a starting premise that the attendance of a lawyer will not be problematic, unless sound reasons exist for thinking otherwise.

I also understand that the attendance of legal representatives at ASIO interviews has not been a common occurrence, to date..

IGIS goes on to conclude that

• Having regard to the legal opinion provided to me by RACS and other relevant material provided by ASIO, I consider that ASIO’s internal guidance is both sound and appropriate in the circumstances.
• the attendance of a legal representative at an ASIO interview is not likely to be necessary on the basis of the vulnerability of an interviewee, but their presence could protect ASIO from claims of inappropriate questioning or conduct by ASIO interviewing officers.
• Recorded interviews showed that, on occasion, ASIO officers discussed the proposed presence of a lawyer at an interview, with the interviewee and/or the lawyer, for up to 30 minutes. More than one lawyer who provided statements to this inquiry claimed they felt that ASIO had placed significant pressure on them to discontinue their request to attend the interview with their client.
• I believe that ASIO has had an apparent practice of discouraging the attendance of lawyers at interviews, which seems inconsistent with the intent of its internal guidance. In my view this practice is inappropriate unless the interviewing officers have a specific basis for believing that the lawyer’s attendance may be of security concern.

IGIS also expressed concern regarding the written confidentiality agreement -

• the agreement sets out potentially relevant and complex statutory provisions, but is provided to the person at the interview who does not have time to consider it fully and understand obligations. 

• the document is incomplete. In particular, subsections 79(2) and 79(3) of the Crimes Act 1914 (Cth) make no sense without a definition of what is ‘prescribed’. In any event, a prudent lawyer would need to have regard to the provisions in context to understand their obligations. This problem would not be so acute if the undertaking was provided prior to the interview so that a person had some time to examine it. 
• as the confidentiality obligations are ongoing, there should be a clear requirement to provide the signatory with a copy so that they can continue to have regard to it. 
• In a preliminary draft of this report, I noted that the unsigned template is not a confidential or classified document and, in my view, there is no reason why it could not be made generally available before the interview. ASIO has subsequently undertaken to provide new guidance to its officers, stipulating that interviewing officers must provide sufficient time at the start of an interview for the legal representative to read, clarify and understand the agreement; and they must take duplicates of the document with them to enable one copy to be left with the signatory.

IGIS makes five recommendations (with ASIO agreeing to  R1 through 4 and in part to R5) -

R1: ASIO should work with the Department of Immigration and Border Protection (Immigration) to ensure that: (a) when making interview arrangements in Australia, visa applicants are specifically asked whether they want to have a legal representative attend (b) the lawyer’s personal details are obtained by Immigration and passed to ASIO (c) a decision is made about whether the lawyer may attend and is conveyed prior to the day of interview.

R2: ASIO should: (a) review its training to reinforce that the attendance of a lawyer at a security assessment interview is not to be considered problematic, unless sound reasons exist for deciding otherwise (b) ensure that decisions about whether a lawyer may attend an interview are considered and recorded on a case-by-case basis (c) ensure that in the absence of a specific cause for concern, interviews should commence without efforts by interviewing officers to discourage the attendance of a legal representative.

R3: ASIO should: (a) clarify the status of any person who wants to attend an interview to ascertain whether they are the interviewee’s legal representative (b) further consider whether migration agents should be accorded the same status as lawyers, with their attendance at interviews being addressed on a case-by-case basis.

R4: ASIO should: (a) provide guidance for interviewing officers on when a written or verbal confidentiality undertaking should be requested from a person (b) provide the template undertaking document to attendees before the interview commences (c) provide a copy of a written undertaking to the signatory.

R5: The details of this recommendation are afforded a national security classification and cannot be included in this abridged report. 

Disclosure

An Empirical Method for Materiality: Would Conflict of Interest Disclosures Change Patient Decisions? (Arizona Legal Studies Discussion Paper No. 14-02) by Roy G. Spece Jr., David V. Yokum, Andrea-Gale Okoro and Christopher T. Robertson comments

 The law has long been concerned with the agency problems that arise when advisors, such as attorneys or physicians, put themselves in financial relationships that create conflicts of interest. If the financial relationship is “material” to the transactions proposed by the advisor, then non-disclosure of that information may be pertinent to claims of malpractice, informed consent, and even fraud, as well as to professional discipline. In these sorts of cases, materiality is closely related to the question of causation, roughly turning on whether the withheld information might have changed the decision of a reasonable advisee (i.e., patient). The injured plaintiff will predictably testify that the information would have impacted his or her choice, but that self-serving testimony may be unreliable. The factfinder is left to speculate about the counterfactual world in which the information was disclosed. 

This Article shows how randomized vignette-based experimentation may be a valuable form of evidence to address these questions, for both litigation and policymaking. To demonstrate this method and investigate conflicts of interest in healthcare in particular, we recruited 691 human subjects and asked them to imagine themselves as patients facing a choice about whether to undergo a cardiac stenting procedure recommended by a cardiologist. We manipulated the vignettes in a 2×3 between-subjects design, where we systematically varied the appropriateness of the proposed treatment, which was described in terms of patient risk without the procedure (low or high), and manipulated the type of disclosure provided by the physician (none, standard, or enhanced). We used physician ownership of the specialty hospital where the surgery would be performed as the conflict of interest, disclosed or not, and the “enhanced” disclosure included information that such relationships have been associated with biases in prescribing behavior. 

We found that the mock patients were significantly less likely to follow the cardiologist's recommendation of surgical implantation of a drug-eluting stent when he disclosed a financial conflict of interest, regardless of whether the disclosure was standard or enhanced. We also found that the mock patients were more likely to choose the treatment when they faced greater risk without it. We did not, however, find that the disclosure made patients more discerning about the appropriateness of the procedure. 

We discuss the implications for law and policy. Mock patients seem likely to act upon such information, declining the low-value healthcare when conflicts are disclosed. This finding suggests that the information is material to such transactions, and that disclosures may be salutary for medical decisions. Arguably, therefore, physicians already have a duty under the common law to disclose the financial relationships they choose to accept. Other regulators and policymakers should recognize and clarify this duty, and courts should embrace this form of evidence. Methodologically, although this empirical approach has limits, it reduces speculation by factfinders and policymakers, focusing their attention on the right questions at least.

Kidney Transplants

Last year I noted I. Glenn Cohen's 'Transplant Tourism: The Ethics and Regulation of International Markets for Organs' in (2013) Journal of Law, Medicine & Ethics 269-285. 'Reverse Transplant Tourism' by Kimberly D. Krawiec and Michael A Rees in (2014) 77(3) Law and Contemporary Problems describes what the authors characterise as

 a novel form of kidney swap, which we label “Reverse Transplant Tourism.” This proposal has the potential to increase the number of successful transplants in the US at a time of great need, while reducing costs. It also will provide benefits to impoverished international patients with willing, compatible donors who otherwise would have no access to transplantation. Instead of non-US kidney donors being offered money through a black market middleman in exchange for one of their kidneys, Reverse Transplant Tourism would provide a legal and ethical exchange of living donor kidneys through kidney-paired donation. In this way, the donors will not receive money for their kidneys, but rather will receive a transplant for someone they love, while also helping a US pair who would otherwise be unable to transplant due to biological incompatibility.

The authors indicate that

The new approach involves cross-border kidney-paired donation, which we label “Reverse Transplant Tourism,” or “RTT.” Though RTT is currently still a hypothetical – to date, no RTT swaps have been performed – we argue that such a program, if properly structured, is both legal and ethical, and is a natural next step in the development of kidney exchange. 

Kidney exchanges, in which patients with willing but incompatible living kidney donors exchange their donor’s kidneys, have become common in the United States. RTT takes this approach a step further, by redefining incompatibility to include not only immunological barriers, but also a more prevalent incompatibility when transplantation is considered worldwide—the barrier of poverty. In the United States, there are many patients with kidney failure (end-stage renal disease, or “ESRD”) who have insurance to pay for a transplant, but whose donor has the wrong blood type or HLA antigens and thus is not immunologically compatible. In contrast, there are many poor patients outside of the United States with willing compatible living donors, who are not able to afford the immunosuppression necessary to sustain a renal transplant. In both these cases, the patients have barriers that prevent the transplant from moving forward. 

RTT, if properly structured, can provide an opportunity for impoverished foreign patients to overcome their financial barrier and for American recipients to overcome immunological barriers through an international exchange of kidneys. The use of biologically compatible pairs also expands the donor pool in important ways, with particular benefits for O blood type recipients and sensitized recipients. Moreover, RTT reverses some of the more pernicious effects of typical transplant tourism, in which a (comparatively wealthy) individual with ESRD travels abroad, normally to a comparatively poor country, to purchase organs for transplantation. These black market transactions have been widely condemned as a commercialization of organ transplantation that results in a net outflow of organs from the developing world to the developed (with accompanying cash flows in the opposite direction) under conditions that guarantee no protections for either donor or recipient. 

RTT, in contrast, leverages the donative intent and reciprocity of friends and family inherent in the kidney paired donation model to avoid the “organ deficit” of traditional transplant tourism – under RTT, organ flows out of each country are matched with inflows. RTT also extends the benefits of the US transplant system to impoverished nations, allowing patients who could never afford a kidney transplant to obtain one. The “reverse” in Reverse Transplant Tourism thus carries a double meaning, one geographic and the other figurative. 

Imperative to developing a proper structure for RTT will be to partner with countries that have enough infrastructure available to their citizens to ensure that ongoing transplant-specific medical care is available and local conditions are not hazardous to an immunosuppressed patient, so that the kidney transplant for the impoverished patient is not lost from preventable causes. Other safeguards could include patient screening protocols, standards and procedures to ensure organ quality, and firewalls between the non-profit funder and participating transplant centers and, eventually, between the nonprofit and any insurance and pharmaceutical companies that may provide funding. 

Part II introduces the concept of Kidney Paired Donation (“KPD”) and an increasingly common variant, Altruistically Unbalanced Kidney Paired Donation (“AUKPD”), arguing that RTT is less ethically controversial in some respects than AUKPD, because neither RTT pair could successfully transplant in the absence of a swap. Part III details our RTT proposal, illustrating the mechanics and expenses of the exchange. Part IV analyzes RTT’s permissibility under the National Organ Transplant Act (NOTA), concluding that RTT does not involve “valuable consideration” as contemplated by the statute. Part V considers the policy rationales that might motivate the ban against the exchange of valuable consideration for transplantable organs, concluding that RTT does not threaten any of these policy concerns and, in fact, improves on the status quo with respect to some concerns. Part VI discusses the numerous benefits of RTT, both to the individual patient participants and to the health care system more generally. Part VII discusses sustainability and safeguards, while Part VIII concludes.

'Trafficking in Persons for the Purpose of Organ Removal: International Law and Australian Practice' by Andreas Schloenhardt and Samantha Garbutt in (2012) 36(3) Criminal Law Journal 145-158 comments that

In international law, the Protocol to Prevent, Suppress and Punish Trafficking in Persons, especially Women and Children is the principal instrument to combat trafficking in persons for the purpose of organ removal. In 2011, Australia’s first investigation involving organ trafficking made headlines, raising questions about the application of relevant criminal offences and their compliance with international law. This article outlines international requirements and explores Australia’s legislative approach to criminalising organ trafficking in Div 271 of the Criminal Code (Cth). These offences are analysed in close reference to international law and best practice guidelines. The article concludes by developing recommendations to combat trafficking for the purpose of organ removal more effectively.

Food Labelling

I'm unpersuaded by 'The Magical Thinking of Food Labeling: The NLEA as a Failed Statute' from Diana R. H. Winters. It considers

the failures of the Nutrition Labeling and Education Act of 1990 (NLEA) and argues for its partial repeal. The NLEA was intended to improve the quality of information available to consumers about the food they bought and ate. At the time of its passage, awareness of the association between diet and health was increasing, and clear and accurate information about food was seen as a critical but simple way to provide people the opportunity to improve their health through nutrition. 

The Act has two parts. First, it mandates disclosure of certain nutrition facts — this includes the “Nutrition Facts” box that consumers have become used to seeing on packaged food. Second, it regulates claims made about how nutrients in the food affect human health (called “health claims,” and “nutrient content claims”) to ensure that such claims are based on scientific information. While the first part has succeeded in providing consumers with the mandated information, the second part has failed. Health claims on food are no more trustworthy than they were before the NLEA was passed, and may actually be less so. Indeed, health outcomes directly related to nutrition have worsened dramatically since 1990. 

The Act is ineffective and inefficient. The information available to consumers, even when presented in a manner compliant with the NLEA, is confusing and opaque. The Act and its regulations contain gaps that undermine the entire scheme. The amount of litigation regarding food labeling has increased, resulting in conflicting rulings regarding the continued vitality of state law in this arena. Moreover, the regulatory strategy of mandated information disclosure is itself weak. Even if the statute were perfectly written, so as to ensure that only claims supported by the best and most current scientific information were available to consumers, it is not certain whether the provision of clear and accurate nutritional information to consumers would actually be a factor in improving health. 

The Article advocates for the repeal of the health and nutrient content claim provisions of the NLEA. True policy improvement in the food-labeling scheme will not come about through incremental improvements to the NLEA’s health and nutrient content claims provisions. This problem should be dealt with by the states.

Revision of the statute, more vigorous enforcement,  better practice within industry and a wariness regarding the potential for regulatory arbitrage might of course be more effective.

'How Reliance on the Private Enforcement of Public Regulatory Programs Undermines Food Safety in the United States: The Case of Needled Meat' by Winters in (2013) 65(2) Maine Law Review considers meat labelling, commenting

“Mechanical tenderization,” or “blade tenderization,” or “needling,” or “hammering,” is a process where tiny cuts are made in beef by needles or blades, which cut the connective tissue and immediately tenderize the meat. When meat is mechanically tenderized, it becomes more susceptible to contamination by pathogens that cause foodborne illness because the needles can carry bacteria, such as E. coli, into the interior of the meat, where it is harder to kill by cooking. After more than a decade of documented foodborne illness outbreaks related to mechanically tenderized meat and repeated calls by consumer advocates for the labeling of such meat, it appears that the Department of Agriculture is finally poised to begin requiring the labeling of needled meat. 

The regulatory history of mechanically tenderized meat is a window into a much larger issue, that of regulatory inertia and the inadequacy of existing mechanisms to counter this stasis. This regulatory inertia is the subject of this Paper, and it does not have a simple cause, nor is it amenable to a simple solution. It cannot be reduced to a problem of agency capture, or a problem with agency incompetence. 

Telling the story of the ongoing conversation on mechanically tenderized meat among the United States Department of Agriculture (USDA), the meat production industry, and interest groups representing the consuming public is important for at least two reasons. First, the focus on a food safety problem that is not well known to the public illustrates the commonplace nature of regulatory inertia, demonstrating that such cases are not confined to high-profile issues with elusive solutions. 

Second, this story demonstrates the ineffectual nature of private enforcement. Private enforcement, in the form of agency-forcing suits, should act as a counterpoint to agency delay and dysfunction, by subjecting agency action to judicial review. We expect the judiciary to oversee the process of regulatory fermentation, and to ensure that an agency makes its decisions in a timely, appropriate manner. Here, however, government, industry, and advocacy groups representing the consuming public have been discussing this issue for a decade while individuals continue to get sick. 

There is no simple solution to this problem, although I suggest several in the Paper. First, Congress should increase its use of statutory hammers. Hammers are legislative mechanisms that impose consequences on an agency that fails to act in compliance with a statutory mandate. 

Second, as suggested by other scholars, interest groups, including both regulated industry and those representing the consuming public should be able to petition the Office of Information and Regulatory Affairs (OIRA), within the Office of Management and Budget, to review agency inaction. Simply put, OIRA, which provides centralized review to certain major regulations to assess compliance with cost-benefit principles, is theoretically positioned to assume a larger role in reviewing agency inaction.

Rationalising Fair Use in Australian Copyright Law

The report of the Australian Law Reform Commission Copyright and the Digital Economy inquiry into Copyright has been tabled in Parliament.

The report indicates that -

The overall effect of the recommendations in the Report will be a more flexible and adaptive copyright framework. The introduction of fair use will mean Australian copyright law can be applied to new technologies and new commercial and consumer practices, without constant recourse to legislative change. Fair use will promote innovation and enable a market-based response to the demands of the digital age. The reforms will enhance access to cultural material, without undermining incentives to create. The recommended exceptions are also intended to be more consistent with public standards of fairness. 

What do the recommendations have in common? The ALRC considers that exceptions to copyright, whether in the form of a specific rule or a general standard, should only permit the unlicensed use of copyright material where this would be fair. It should therefore not be surprising that fair use and each of its illustrative purposes, and the handful of specific exceptions recommended in the Report, have much in common. Generally, they permit the unlicensed use of copyright material if this would: 

• serve an important public purpose; 

• stimulate the creation of new works and the use of existing works for new purposes; and 

• not harm rights holders’ markets—ensuring exceptions do not undermine the crucial incentive to create and publish copyright material.

The ALRC recommendations are -

 The Case for Fair Use 

R4–1 The Copyright Act 1968 (Cth) should provide an exception for fair use. 

The Fair Use Exception 

R5–1 The fair use exception should contain: (a) an express statement that a fair use of copyright material does not infringe copyright; (b) a non-exhaustive list of the factors to be considered in determining whether the use is a fair use (‘the fairness factors’); and (c) a non-exhaustive list of illustrative uses or purposes that may qualify as fair use (‘the illustrative purposes’). 

R5–2 The non-exhaustive list of fairness factors should be: (a) the purpose and character of the use; (b) the nature of the copyright material; (c) the amount and substantiality of the part used; and (d) the effect of the use upon the potential market for, or value of, the copyright material.  

R5–3 The non-exhaustive list of illustrative purposes should include the following: (a) research or study; (b) criticism or review; (c) parody or satire; (d) reporting news; (e) professional advice; (f) quotation; (g) non-commercial private use; (h) incidental or technical use; (i) library or archive use; (j) (k) education; and access for people with disability. 

R5–4 The Act should be amended to repeal the following exceptions: (a) ss 40, 103C—fair dealing for research or study; (b) ss 41, 103A—fair dealing for criticism or review; (c) ss 41A, 103AA—fair dealing for parody or satire; (d) ss 42, 103B—fair dealing for reporting news; (e) s 43(2)—fair dealing for a legal practitioner, registered patent attorney or registered trade marks attorney giving professional advice; and (f) ss 104(b) and (c)—professional advice exceptions. The fair use or new fair dealing exception should be applied when determining whether one of these uses infringes copyright. 

The New Fair Dealing Exception 

R6–1 If fair use is not enacted, the Act should be amended to provide that a fair dealing with copyright material for one of the following purposes does not infringe copyright: (a) research or study; (b) criticism or review; (c) parody or satire; (d) reporting news; (e) professional advice; (f) quotation; (g) non-commercial private use; (h) incidental or technical use; (i) library or archive use; (j) education; and (k) access for people with disability. This provision should also provide that the fairness factors should be considered when determining whether the dealing is fair, along with any other relevant matter. Note: This consolidates the existing fair dealing exceptions and provides that fair dealings for certain new purposes ((f)-(k)) also do not infringe copyright. Importantly, unlike fair use, this exception can only apply to a use of copyright material for one of the prescribed purposes. The purposes are not illustrative. 

Statutory Licences 

R8–1 The Act should be amended to clarify that the statutory licences in pts VA, VB and VII div 2 do not apply to a use of copyright material which, because of another provision of the Act, would not infringe copyright. This means that governments, educational institutions and institutions assisting people with disability, will be able to rely on unremunerated exceptions, including fair use or the new fair dealing exception, to the extent that they apply. 

R8–2 The Act should be amended to clarify that the statutory licences in pts VA, VB and VII div 2 do not apply to a use of copyright material where a government, educational institution, or an institution assisting people with disability, instead relies on an alternative licence, whether obtained directly from rights holders or from a collecting society. 

R8–3 The Act should be amended to remove any requirement that, to rely on the statutory licence in pt VII div 2, governments must notify or pay equitable remuneration to a declared collecting society. Governments should have the option to notify and pay equitable remuneration directly to rights holders, where this is possible. 

R8–4 The statutory licences in pts VA, VB and VII div 2 of the Act should be made less prescriptive. Detailed provisions concerning the setting of equitable remuneration, remuneration notices, records notices, sampling notices, and record keeping should be removed. The Act should not require sampling surveys to be conducted. Instead, the Act should simply provide that the amount of equitable remuneration and other terms of the licences should be agreed between the relevant parties, or failing agreement, determined by the Copyright Tribunal. 

Quotation 

R9–1 The fair use or new fair dealing exception should be applied when determining whether a quotation infringes copyright. 

Private Use and Social Use

R10–1 The exceptions for format shifting and time shifting in ss 47J, 109A, 110AA and 111 of the Act should be repealed. The fair use or new fair dealing exception should be applied when determining whether a private use infringes copyright. 

Incidental or Technical Use and Data and Text Mining 

R11–1 The exceptions for temporary uses and proxy web caching in ss 43A, 111A, 43B, 111B and 200AAA of the Copyright Act should be repealed. The fair use or new fair dealing exception should be applied when determining whether incidental or technical uses infringes copyright. 

Libraries and Archives 

R12–1 Section 200AB of the Act should be repealed. The fair use or new fair dealing exception should be applied when determining whether uses by libraries and archives infringes copyright. 

R12–2 The exceptions for preservation copying in ss 51A, 51B, 110B, 110BA and 112AA of the Act should be repealed. The Act should provide for a new exception that permits libraries and archives to use copyright material for preservation purposes. The exception should not limit the number or format of copies that may be made.  

Orphan Works 

R13–1 The Act should be amended to limit the remedies available in an action for infringement of copyright, where it is established that, at the time of the infringement: (a) a reasonably diligent search for the rights holder had been conducted and the rights holder had not been found; and (b) as far as reasonably possible, the user of the work has clearly attributed it to the author. 

R13–2 The Act should provide that, in determining whether a reasonably diligent search was conducted, regard may be had to, among other things: (a) the nature of the copyright material; (b) how and by whom the search was conducted; (c) the search technologies, databases and registers available at the time; and (d) any guidelines, protocols or industry practices about conducting diligent searches available at the time. 

Education 

R14–1 The exceptions for educational use in ss 28, 44, 200, 200AAA and 200AB of the Act should be repealed. The fair use or new fair dealing exception should be applied when determining whether an educational use infringes copyright. 

Government Use 

R15–1 The parliamentary libraries exceptions in ss 48A, 50(1)(aa) and 104 of the Act should be extended to apply to all types of copyright material and all exclusive rights. 

R15–2 The Act should provide for a new exception for the purpose of the proceedings of a tribunal, or for reporting those proceedings.  

R15–3 The Act should provide for a new exception for the purpose of the proceedings of a royal commission or a statutory inquiry, or for reporting those proceedings. 

R15–4 The Act should provide for a new exception for uses where statutes require local, state or Commonwealth governments to provide public access to copyright material. 

R15–5 The Act should provide for a new exception for use of correspondence and other material sent to government. This exception should not extend to uses that make previously published material publicly available. 

Access for People with Disability 

R16–1 The fair use or new fair dealing exception should be applied when determining whether a use for access for people with disability infringes copyright. 

Retransmission of Free-to-air Broadcasts 

R18–1 In developing media and communications policy, and in responding to media convergence, the Australian Government should consider whether the retransmission scheme for free-to-air broadcasts provided by pt VC of the Copyright Act and s 212(2) of the Broadcasting Services Act 1992 (Cth) should be repealed. Note: This would effectively leave the extent to which retransmission occurs entirely to negotiation between the parties—broadcasters, retransmitters and underlying copyright holders. 

R18–2 If the retransmission scheme is retained, the scope and application of the internet exclusion in s 135ZZJA of the Copyright Act should be clarified. 

Broadcasting 

R19–1 In developing media and communications policy, and in responding to media convergence, the Australian Government should consider whether the following exceptions in the Act should be repealed: (a) s 45—broadcast of extracts of works; (b) ss 47, 70 and 107—reproduction for broadcasting; (c) s 109—broadcasting of sound recordings; (d) ss 65 and 67—incidental broadcast of artistic works; and (e) s 199—reception of broadcasts.  

R19–2 The Australian Government should also consider whether the following exceptions should be amended to extend to the transmission of linear television or radio programs using the internet or other forms of communication to the public: (a) s 47A—sound broadcasting by holders of a print disability radio licence; and (b) pt VA—copying of broadcasts by educational institutions. 

Contracting Out

R20–1 The Act should provide that any term of an agreement that restricts or prevents the doing of an act, which would otherwise be permitted by specific libraries and archives exceptions, is unenforceable. 

R20–2 The Act should not provide statutory limitations on contracting out of the fair use exception. However, if fair use is not enacted, limitations on contracting out should apply to the new fair dealing exception.

The Australian Copyright Council comments -

It is pleasing that ALRC has revised some of its earlier radical proposals in relation to statutory licensing. However we are concerned to see that the ALRC has maintained its recommendation for a broad fair use exception. We think that this new, very broad exception proposed by the ALRC could stifle rather than promote innovative business models and have a negative effect on the livelihoods of creators and the ability of consumers to access content.

Hot Assets and Proceeds of Crime

A recent post noted the large amounts of money potentially gained by drug traffickers.

Targeting the Illicit Profits of Drug Trafficking Through Proceeds of Crime Action (NDLERF Monograph 52) [PDF] by Michael McFadden, Martin O’Flaherty, Paul Boreham and Michele Haynes reports on a National Drug Law Enforcement Research Fund (NDLERF) project investigating whether Proceeds of Crime (POC) mechanisms are effective.

The report comments that

Because of the hidden nature of criminal enterprise, it is difficult to measure whether actions such as drugs seizures or proceeds of crime confiscations cause set-backs to the criminal business model, though logically, they must. 

The project had two main aims -

• To identify the disruptive effect of proceeds of crime action on criminal activity, and measure the disruptive effect by developing an economic model that estimated the multiplier impact of the reinvestment of the profits of drug trafficking. This measure can provide police with a more accurate estimate of the impact of their drug law enforcement activities, in turn improving accountability to both government and the community. 
• To identify factors associated with successful proceeds of crime action, to assist law enforcement to target those drug trafficking activities that are more likely to result in further criminal activity, and to provide a means for agencies to increase their seizures of criminal assets and proceeds of crime. 

The authors developed a business model of illicit drug trafficking and the development of a measure of the impact of POC action. They then carried out analyses of proceeds of crime data, examining 1,244 assets (cash, shares, boats, cars, residential and commercial property) associated with 269 cases opened from 1 January 2003 and closed by 30 June 2011, described in the AFP database.

The authors conclude that

• For every $1 of criminal proceeds confiscated, the short term impact (i.e. after a single lag of approximately 3 months) is a reduction in criminal funds of $2.20 for the Overall Model, and $3.50 for the Distributor Importer Producer Model. 
• In the medium term (after two periods of criminal activity, or about 6 months), these savings are $4.60 (Overall Model) and $11.90 (Distributor Importer Producer Model) for every $1 confiscated. 
• A reasonable estimate then of the impact of proceeds of crime action in Australia, is a multiplier of 3.5 to measure short term disruption and 11.9 to measure medium term disruption. For most practical applications, the authors recommend the use of the medium term estimate of 11.90.

The authors indicate that

Illicit drug trafficking is a source of funds for further trafficking and for supporting the lifestyles of criminals. Drug trafficking has been closely linked with organised crime and with social harms. ... There are two main audiences for the findings of this study. Senior police, police intelligence, policymakers and researchers will be interested primarily in measuring the disruptive effect of proceeds of crime action. Police responsible for managing proceeds of crime investigations and senior investigators will be interested in the practical applications of findings relating to success factors in financial investigations. 

The results of the project should improve agencies’ ability to target trafficking and increase the seizure of proceeds of crime. The proposed index of the disruptive effect of proceeds of crime action—the Proceeds of Crime Drug Disruption Index (POCDDI)—will also allow agencies to provide both the Government and the community with a more accurate assessment of the value of their proceeds of crime initiatives. 

Background to the study 

We conducted an extensive literature review, as well as collecting information from expert sources in Australia. .... It should be noted that in the wider literature proceeds of crime and money laundering are closely linked and issues relating to proceeds of crime are often dealt with under the broader heading of money laundering. As such, our review extended across both areas. 

The literature we surveyed was predominantly negative about the benefits of proceeds of crime/money laundering legislation. Various parties have raised concerns about the cost-effectiveness of anti-money laundering and proceeds of crime initiatives, their failure to target major crime figures and the infringement of civil liberties associated with implementation. We argue that very little attention has been paid to developing measures relevant to determining the success of these initiatives. Apart from the occasional comment, there has been little interest in the development of a coherent and explicit measurement framework for evaluation. Too often, studies have adopted measures that are readily available (eg arrests and forfeitures) rather than to develop measures that are truly appropriate for measuring the impact of proceeds of crime action upon the criminal enterprise and ultimately, through the disruption of crime, on the community. The business-for-profit nature of the majority of drug trafficking suggests that a proper evaluation should take place within the context of an appropriate business model. 

A business model of drug trafficking 

To derive a business model of drug trafficking, we modified an existing business model of people trafficking operations developed by the Organisation for Security and Co-operation in Europe (Aronowitz et al. 2010). An outline of the modified business model for drug trafficking is presented in Table 1. People trafficking operations have many features in common with the global movement of illicit drugs, employing similar techniques and similar resources. 

The consideration of drug trafficking as a business provides an entirely different perspective to that provided by the literature review. The literature review tended to be pessimistic about the potential for proceeds of crime and money laundering legislation to disrupt crime. 

One of the major concerns was the apparent lack of evidence of any impact on key organised crime figures. From a business model perspective, this might be expected. If modern organised crime is comprised of shifting allegiances and cooperation between individuals and cells in one or more broadly based criminal groups, then such a result is to be anticipated. The hypothesis that proceeds of crime action should be directed at major crime figures is based on the unstated assumption that organised crime exhibits a concrete, hierarchical structure. Such an assumption is not consistent with modern notions of the structure of organised crime. 

Adopting a business model of organised crime also gives us a clear indication of why proceeds of crime are important. All business models of organised crime assume that profit is the primary motive of such businesses, as it is with legitimate business enterprises. On that assumption, one would expect that successful proceeds of crime action would be disruptive to the business of crimes. Proceeds of crime action per se cannot be without value unless the business model of crime is wrong and that seems highly unlikely. If criticisms of proceeds of crime/money laundering efforts are to be sustained, they must be directed at the application of such regulations rather than the concept itself. 

In conclusion, recognition of the ‘business’ nature of organised crime refutes many of the criticisms met with in the literature which has, in our opinion, focused too narrowly on the technicalities of proceeds of crime and money laundering regimes rather than recognising the broader theoretical framework within which these regimes exist. The adoption of an appropriate business model also assists us to identify the point in the supply chain where proceeds action may be most effective. With imported drugs, the most vulnerable point would appear to be the transportation of illicit drugs across national borders. 

Factors relating to successful proceeds of crime investigation 

A second component of the research used proceeds of crime case data provided by the Australian Federal Police (AFP) to investigate factors associated with successful proceeds of crime investigations. Because the data are from AFP investigations, it is important to note that the findings presented here are not generalisable to state jurisdictions, which operate with both a different mix of cases and a different legal framework. 

We attempted to identify factors related to successful proceeds of crime investigations using both descriptive statistics and modelling techniques. First, the value of proceeds in financial investigations is heavily concentrated in the largest cases. The top 10 percent of cases contained 80 percent of the total value of proceeds (see Figure 1). This observation is consistent with the Pareto Principle or 80/20 rule, which suggests that 80 percent of the effects come from 20 percent of the causes. 

Conversely, as the value of a case increases, the proportion of assets forfeited tends to decline. In the ‘bottom’ 50 percent of cases (by value), two in three assets are forfeited, while in the ‘top’ 50 percent, one in two assets are forfeited. This suggests that law enforcement should continue to pursue straightforward lower value cases due to their higher success rate, while focusing the bulk of their effort on large investigations because most of the value is in these cases. 

More complex statistical methods were employed to identify factors in the successful outcome of financial investigations (see Chapter 5 for details). It should be noted that the number of cases available for drug- related proceeds of crime cases was insufficient to support the analysis. We decided to include proceeds of crime data from other crime types to increase the amount of data available for our statistical analysis. We tested our final model to evaluate whether the type of crime in any way influenced the factors related to success. Type of crime did not influence the model, which means that the types of factors that influence success in proceeds of crime action are the same for drug trafficking and other types of crime. A good financial investigation exhibits similar characteristics regardless of the predicate crime. The second major finding was that the duration of the financial investigation (as measured by the period from the restraint of an asset to its resolution) was statistically associated with the chance of success. The longer a financial investigation takes, the less likely it will be successful. For every year that passed, the odds of success were reduced by approximately one-third. 

The observed rate of decline could be useful in assisting financial investigation teams to assess the progress of individual cases. For example, where resources are scarce, this information would be helpful in weighing up whether to continue an ongoing case of some duration with a lower rate of success, as opposed to adopting a new case with a potentially higher chance of success. This finding may be of particular relevance as expert opinion confirmed that the main obstacle to pursuing proceeds of crime was lack of available resources in financial investigation teams. Third, our model also suggested that the type of asset restrained was associated with the chance of a successful outcome. Liquid assets and commercial property were more likely to be forfeited than residential property and other assets. There is potential to improve the overall effectiveness of financial investigations if the reasons for the lower success rate with respect to residential property and other assets could be identified.

Citizenship

The unpublished 'Unruly Beasts: Animal Citizens and the Threat of Tyranny' by Donaldson and Kymlicka - highlighted in a recent post - states that

In Zoopolis, we argue that domesticated animals are entitled not only to protection of their basic negative rights such as life and liberty. They should be recognized as citizens in a mixed human-animal democratic polis sharing rights of membership, representation, and participation in a shared cooperative scheme. Our argument for a duty to extend citizenship to domesticated animals (hereafter DAs) rests on three claims:

• DAs are de facto members of our political communities – physically present, and subject to human governance;

• through the process of domestication, DAs have been made dependent on human care, foreclosing any (immediate) option of a more independent existence outside of human communities; and

• within our political communities DAs form a dominated and exploited sub-class whose interests are systematically ignored by the political order.

In short, DAs are members of our communities; we have benefitted from, and enforced, their membership while systematically exploiting them, and these facts generate a moral obligation to extend citizenship. Justice demands that domination and hierarchy be replaced by relations of citizenship, and its accompanying ethos of equality, participation, consent and cooperation. We also argue that domestication makes co-citizenship possible. Citizenship is a cooperative relationship, calling on capacities for trust, communication, and physical proximity. We may not be able to enter such relations with all animal species on the planet, but there is no doubt that we can do so with DAs. Domestication presupposes and enhances capacities for sociability across species lines (Clutton-Brock 2012). One need only imagine sharing the demos with spitting cobras, blue whales or Bengal tigers to highlight the contrast. With DAs we can form bonds, engage in cooperative activity, and share physical space – preconditions for meaningful citizenship relations. 

This is just a sketch of the argument for DA citizenship, but we hope the underlying normative logic is clear and perhaps even has some intuitive appeal. Nonetheless, our proposal for animal citizenship has faced two broad criticisms: some critics question whether citizenship would in fact be good for DAs; while others question whether animal citizenship would be good for democracy. 

In this paper, we focus on the second concern, but it is important to keep the first in mind as well. We‘ve proposed citizenship as an emancipatory project that affirms the rights and interests of DAs, but some critics worry that citizenship will prove to be yet another way in which we discipline vulnerable and compliant DAs to fit our categories and practices. Since citizenship is a norm-governed relationship, ascribing citizenship to DAs would justify policing their behaviour to make them fit for human society - manipulating, coercing, and diminishing animals by failing to respect their differences from us, and placing unacceptable limitations on their flourishing (Nurse and Ryland 2013; Palmer 2014). In short, citizenship would be bad for animals. 

We have responded to this objection elsewhere (Donaldson and Kymlicka 2014). Citizenship does indeed involve socializing DAs to participate in norms of good citizenship, including norms of civility and contribution, but whether this is oppressive depends on whether these norms are mutually created, enabling all members of society to flourish, or whether they mold or relegate some members into a caste group to serve others. The aim of a citizenship approach is precisely to ensure that social norms are responsive to the good of DAs as well as humans. This would require creating conditions for DAs to safely explore alternative forms of cooperation with humans (and with other DAs) in order to determine what forms of cooperation (if any) they wish to engage in with us. Under these circumstances, we argue, citizenship would indeed be good for animals. In this paper we address the reverse question of whether animal citizens would be bad for democracy. 

In her article 'Democracy, Despots and Wolves', Emma Planinc argues that animals are fundamentally "unruly", unable to regulate their behaviour according to shared norms. Their participation would weaken the norms of reciprocity, self-restraint and civility that make democratic self-rule possible. She worries that because animals are "formless", "unbridled", "anarchic", "insatiable", "savage", "ravenous", "wanton" and "amoral" in their exercise of freedom, including them in the polis would weaken the commitment to moderation and justice on which democracy depends. 

We address this argument below, but it‘s worth noting the relationship between this critique and the first one. The first worries that DAs can too easily be compelled (through coercion or manipulative training) to comply with even the most exploitative norms, and so are inevitably vulnerable to domination. The second worries that animals will be insufficiently compliant with human-created social norms, and are therefore disruptive to the demos. While the two critiques differ in their predictions about the extent of DA compliance with social norms, they share the assumption that these norms can only ever be external impositions on DAs. The horizon of possibilities is either (docile) compliance or (unruly) non-compliance with human-created norms. What both ignore is the possibility of DA agency – their capacity not only to be trustworthy partners in cooperative activities with humans, but also to help create, negotiate and shape social norms. As we will see, this is what makes justice possible in relations between humans and DAs, and what makes a zoopolis consistent with the flourishing of all citizens, human or animal. 

This paper is structured as follows. First, we draw upon a growing body of evidence which shows that DAs, far from being "formless" and "anarchic" in their exercise of freedom, display capacities for learning, reflexivity, practical reasoning, and norm responsiveness rooted in a range of moral sentiments and pro-social tendencies. So far as we know, animals do not entertain propositions about pro-social norms and moral sentiments, nor do they consciously assent to such propositions. But this leads to the second step of our argument, which draws upon a growing body of evidence that human moral agency is not primarily a matter of rational scrutiny of, and self-conscious assent to, propositions. Human moral agency is grounded in pre-reflective moral sentiments and pro-social impulses that we share with many animals; it is largely intuitive and spontaneous; and it is embodied and socially embedded behaviour, not (or not primarily) the activity of a disembodied mind. Indeed, the stability of democratic life depends on this fact. 

In short, humans are continuous with other animals in our moral natures as much as other dimensions of our being, as indeed one would expect given the processes of evolution. Once we recognize this continuity, we must abandon the stereotype of unruly beasts versus sovereign humans, and instead consider how citizens, of all stripes, can be supported in the exercise of citizenship agency in ways that allow us to flourish together. This will require rethinking the spaces and places of citizenship to more fully realize fundamental democratic values. 

The final section of the paper explores a concrete example to flesh out the abstract arguments – namely, debates about dogs in public parks. This provides a fruitful microcosm for exploring the possibilities of DA citizenship, illuminating the potential for cross-species social norms and civility, the responsible exercise of freedom, and the fostering of social participation and inclusion. As we will see, there are good reasons to think that including DAs, far from threatening civic norms and democratic practices, could in fact promote and revitalize them.

Kymlicka and Donaldson's 'Animals and the Frontiers of Citizenship' (HLA Hart Memorial Lecture, University of Oxford, 2013) notes that

Citizenship has been at the core of struggles by historically excluded groups for respect and inclusion. Can citizenship be extended even further to domesticated animals? We begin this paper by sketching an argument for why justice requires the extension of citizenship to domesticated animals, above and beyond compassionate care, stewardship, or universal basic rights. We then consider two objections to this argument. Some animal rights theorists worry that extending citizenship to domesticated animals, while it may sound progressive, would in fact be bad for animals, providing yet another basis for policing their behaviour to fit human needs and interests. Critics of animal rights, on the other hand, worry that the inclusion of "unruly" beasts would be bad for democracy, eroding its core values and principles. We attempt to show that both objections are misplaced, and that animal citizenship would both promote justice for animals and deepen fundamental democratic dispositions and values.

They begin -

 In our recent book Zoopolis, we made the case for a distinctly “political theory of animal rights” 

In this Lecture, we attempt to extend that argument, and to respond to some critics of it, by focusing specifically on the novel idea of “animal citizenship”. 

To begin, let us briefly situate our approach in the larger animal rights debate. One of our goals in the book was to get beyond the traditional animal rights debate that has focused almost exclusively on one issue – the intrinsic moral status of animals. Many readers will be familiar with this 40-year debate, but just to remind you:

• animal rights theorists have claimed that because animals possess sentience or consciousness and therefore have a subjective good, they have the sort of moral standing that justifies certain inviolable rights – to life and liberty, and in particular the right not to be used as a means to human well-being. 

• In response critics have argued that to be a possessor of such inviolable rights requires something more than sentience or a subjective good. It requires some alleged higher capacity, typically a cognitive capacity such as rationality or autonomy or moral reasoning. And therefore only humans can be the bearers of such rights and, moreover, by virtue of possessing these higher capacities, humans have the right to use other beings who lack these capacities. 

• Animal rights theorists in turn have responded that restricting inviolable rights to those with a certain degree of cognitive complexity is both theoretically arbitrary and at odds with our actual practices. Indeed the evolution of the theory and practice of human rights in the last 60 years has been to repudiate any limitation based on the rationality or autonomy of the beings involved. Inviolable rights are first and foremost for the protection of the weak and vulnerable, not some sort of prize awarded to the most rational or cognitively complex.

To lay our cards on the table, we endorse the strong animal rights view – sentience is sufficient to qualify for inviolable rights – but we have little new to say on that question. Our focus instead is to show how it leaves unaddressed questions of what sorts of relations we should have with animals. We inevitably and rightly will have different relations with different groups such as wild animals, domesticated animals, and liminal animals (wild animals living amongst us), and these differing relationships generate different moral obligations. 

For example, consider wild wolves and domesticated dogs. Since dogs are domesticated wolves, they share the same intrinsic moral status, but we have very different relations with them. Through domestication we have brought dogs into our society, bred them to become dependent on us, and incorporated them into our schemes of social cooperation. These facts are morally significant – they create obligations to dogs that are different from those to wolves, despite their common intrinsic moral status. 

Our project in Zoopolis is not simply to emphasize the moral significance of these relational obligations, but also to argue that we can make sense of these different relations through the concepts and categories of political theory. 

To simplify, we argue that we can usefully distinguish three broad patterns of such relations:

• domesticated animals should be viewed as members of a shared society with us, and hence as having rights of membership. In political theory membership rights are typically theorized in the language of citizenship. We can therefore illuminate our distinctive obligations to domesticated animals by considering political theories of citizenship.

• Wilderness animals should be seen as having rights to their own territory and autonomy on that territory. In political theory rights to territory and autonomy are typically theorized in the language of sovereignty. We can therefore illuminate our distinctive obligations to wilderness animals by considering political theories of sovereignty. 

• Liminal animals (e.g. “urban wildlife”) – the non-domesticated animals who live amongst us - should be seen as having rights of residency without participating in a shared cooperative scheme with us. In political theory, ideas of denizenship have been used to capture this status of residency without citizenship, and these ideas can help illuminate our distinctive obligations to liminal animals. 

This is obviously a very schematic summary, but for this Lecture we want to focus on the first category – the idea of co-citizenship for domesticated animals - and to respond to some concerns that have been raised about it. 

To render the issues more vivid we will consider a specific case – one that some of you may be familiar with. It's the story ofBill and Lou, two oxen who worked at Green Mountain College in Vermont as part of the college's sustainable agriculture program. Last year, after 10 years plowing the fields at the college Lou injured his leg on the job, and Bill rejected the idea of continuing to work by being yoked with a new ox. The college deliberated and decided to kill Bill and Lou and process them into hamburgers to serve in the college cafeteria. There was outrage at this decision. A nearby sanctuary offered to take the oxen so they could have a peaceful retirement at no cost to the College. The College said no. They rejected the offer because left alive, Bill and Lou would violate the goal of sustainable agriculture -- the oxen would continue to consume resources and emit greenhouse gasses while no longer balancing the scales as petroleum-free tractors. 

The controversy about his case is unsurprising – Bill and Lou were known to many people as individuals, making their treatment stand out against the general background of our violence towards domesticated animals (hereafter DAs). Many animal rights (hereafter AR) advocates argued, correctly, that Bill and Lou have rights to life and liberty that were violated by the decision to kill them. But this doesn't seem to fully capture all of the perversities of the college's reasoning. In any event, for many traditional AR advocates the problem actually started much earlier, since they believe that Bill and Lou should never have been used as workers on the College farm in the first place. For these AR advocates – sometimes called “abolitionists” – any use of animal labour is inherently oppressive and exploitative. 

So on the one side, we have the College which feels entitled to kill the oxen who are no longer fulfilling their functional role, viewing them as "dispensable as rusty farm implements" in John Sanbonmatsu's words. And on the other side, we have AR advocates who think all use of domesticated animals must be abolished. What both are missing, we believe, is the possibility that Bill and Lou could be members of a just cooperative scheme at Green Mountain College. Our citizenship model is intended to illuminate this possibility.  

We will pursue the argument in three steps. First we will briefly recapitulate our argument for why DAs such as Lou and Bill are owed the status of co-citizens. Then we will consider two important objections that have been raised to this idea, one from defenders of AR who worry that extending citizenship to DAs, while it may sound progressive, will turn out to be bad for animals, providing yet another basis for policing their behaviour to fit human needs and interests. The second objection is from critics of AR, who argue that the inclusion of DAs like Bill and Lou would be bad for democracy, harming or diminishing the overall quality of our democratic life, and eroding the values and principles that we cherish in democratic citizenship.