26 January 2019

Prosecco Geographical Indication

Geographical Indications (GI), one of those areas of intellectual property law that delight the more advanced IP students and bewilder populists or tired journalists. There's a delicious piece out this month for people considering the current Prosecco controversy. Who knows, it might even feature in a tutorial this semester!

'In Vino Veritas? The Dubious Legality of the EU’s Claims to Exclusive Use of the Term ‘Prosecco’' by Mark Davison, Caroline Henckels and Patrick Emerton coming up in Australian Intellectual Property Law Journal comments 
The European Union (EU) maintains that the word “Prosecco” is a geographical indication for a type of wine made in Northern Italy, rather than a grape variety. This position has been relied on by the EU to ban the importation of any wine labelled as Prosecco into the EU, and into other countries with which the EU has free trade agreements. Moreover, the EU is demanding that Australian wine producers be prohibited from marketing wine labelled Prosecco in Australia, as a condition of its entry into a bilateral trade agreement. Based on a detailed historical analysis of the use of the term Prosecco in Italy, this article argues that that the EU’s characterisation of the term is erroneous and is intended to operate to protect Italian Prosecco producers from international competition. By implication, the EU regulation is likely to contravene Article 20 of the World Trade Organization’s Trade Related Aspects of Intellectual Property Agreement (which prohibits governments from unjustifiably encumbering the use of trademarks) and Article 2.1 of the Agreement on Technical Barriers to Trade, (which prohibits, inter alia, technical regulations pertaining to terminology and labelling that unjustifiably discriminate between similar domestic and imported products). Furthermore, a prohibition on the use of the word Prosecco on Australian products in the Australian market may be inconsistent with the Australian Constitution, which prohibits the acquisition of property by government on other than just terms. These issues also point to a more fundamental question: namely, whether and if so to what extent domestic legal systems may permissibly be used to generate claims to intellectual property that are then used to leverage international protection for that intellectual property.

24 January 2019

Mammoths Again

'Won’t Somebody Please Think of the Mammoths? De-extinction and Animal Welfare' by Heather Browning in (2019) Journal of Agricultural and Environmental Ethics 1-19 comments
 De-extinction is the process through which extinct species can be brought back into existence. Although these projects have the potential to cause great harm to animal welfare, discussion on issues surrounding de-extinction have focussed primarily on other issues. In this paper, I examine the potential types of welfare harm that can arise through de-extinction programs, including problems with cloning, captive rearing and re-introduction. I argue that welfare harm should be an important consideration when making decisions on de-extinction projects. Though most of the proposed benefits of these projects are insufficient to outweigh the current potential welfare harm, these problems may be overcome with further development of the technology and careful selection of appropriate species as de-extinction candidates.
Browing argues
 There are three methods through which de-extinction can be achieved: selective breeding, cloning and genetic engineering (Cohen 2014; Shapiro 2015). Each of these has different benefits and drawbacks and is useful for different cases. The first of these methods is selective breeding, or back-breeding. In this process, current relatives are selectively bred for those characteristics that defined the extinct species. For example, in order to re-create mammoths, elephants could be successively bred for their larger and hairier variations, until something closely resembling a mammoth is created. There are currently a few programs using back-breeding to attempt to recreate extinct species—projects attempting to bring back the quagga are selectively breeding zebras (Cohen 2014), and to bring back Auroch through selective breeding of modern-day cattle (Shapiro 2017). The process is limited by the availability of sufficiently similar relatives that are still capable of expressing the desired traits. 
The second method is somatic cell nuclear transfer (SCNT), or cloning. This requires the nucleus of a cell taken from a recovered member of the species to be implanted into an egg cell of a related surrogate species. This creates a zygote genetically identical to the donor animal of the target extinct species. The zygote is then gestated and birthed by the surrogate animal. A famous example of the use of this process was in the creation of ‘Dolly’ the sheep. This has also been attempted for de-extinction purposes, in the cloning of the Pyrinean ibex, or Bucardo, where a clone was made of the last living individual; though this clone did not survive long after birth (Cohen 2014). There has reportedly been some success in using this technique for creating new embryos of the extinct gastric-brooding frog (Cohen 2014). This process is only possible where entire cells of the extinct species are available, which is only the case for very recent extinctions, and where appropriate surrogate species can be identified (Shapiro 2017). 
The third de-extinction method is genetic engineering. Here, DNA is recovered from preserved specimens of the extinct species. As it is almost never entirely intact, it is spliced with the DNA of a related species to create the closest possible genetic match to the original target. The spliced genetic material is then used to create a zygote to be gestated and birthed by an extant surrogate animal. Most current work on de-extincting mammoths is using this method, as the remaining mammoth DNA exists only in fragments. It is also the primary method in use for de-extinction of the passenger pigeon (Cohen 2014). This is what Shapiro (2017) considers the “most likely route to de-extinction” (2017, p. 4) as it only requires fragmentary DNA from the target species, which can then be expanded into a whole genome. It is limited primarily through availability of preserved DNA, which rules out long-extinct species, and like the cloning techniques, requires the use of closely related living species both for use of their DNA for gene editing, and as surrogate mothers (Shapiro 2017). 
All of these methods for de-extinction are being used in current projects on various species, and each presents potential animal welfare problems, which I will detail in the “Welfare Issues” section. This is not merely hypothetical—de-extinction projects are happening now, and the welfare concerns for the animals thus created should be the focus of attention when evaluating these projects. ... 
In the past few years, de-extinction has become the centre of increasing scientific and philosophical focus, with a number of books and papers published on the scientific feasibility of and ethical issues surrounding such projects. I will summarise these here, before moving on in the next section to examine the animal welfare concerns, which have not yet been given much attention in the literature. 
Firstly, there is the question of whether or not the animals created through these methods count as members of the original species. Although they will be genetically similar to the target species, they will still have some differences in genotype, phenotype and development, that may rule them out as part of the species (Shapiro 2017). It is thus uncertain whether the species can really be said to have been brought back from extinction, or whether we have simply created a new, similar species to fill the same role. This question, and its implications, will be discussed further in the “Weighing Up Potential Benefits” section. 
Another set of issues relate to scientific feasibility; whether the breeding and cloning methods can even work. Further, if animals are intended for reintroduction, this raises questions as to how we should select species such that they have the highest chance of success when reintroduced (Jones 2014). There are concerns as to whether the necessary environments for release still exist, and whether the animals can undergo the required behavioural training for release (Blockstein 2017). There are also legal issues, as to what the status of the de-extinct and re-introduced animals would be (e.g. native or introduced) and how this would affect conservation and protection legislation (Camacho 2015). 
A number of papers have also addressed the ethical concerns of de-extinction projects, across a range of issues. For example, whether this sort of targeted ‘precision’ conservation is in conflict with a more wholistic form of ecosystem conservation (Adams 2017). There are suggestions that resources spent on de-extinction programs could result in decreased support for conservation of extant species, through loss of actual or potential sources of funding (Bennett et al. 2017). Campagna et al. (2017) are concerned that the discussion of de-extinction could “give the impression that extinction is reversible” and will therefore “diminish the gravity of the human annihilation of species” (2017, p. 48). Davis and Moran (2016) express concern that release of de-extinct species carries the risks of “invasiveness, disease transmission, and unforeseen species interactions” (2016, p. 3) and call for field research using similar surrogate species in order to minimise these risks. Another criticism of the process is that it is ‘unnatural’—both in terms of the technologies that are used to recreate the species, and in terms of the nature of the species thus created (Mason 2017). All these questions have already been well-explored and will not be re-examined further here; instead I will now turn to the issues of animal welfare arising from de-extinction projects. 
Welfare Issues 
Until recently, what has been absent in discussions of de-extinction is an exploration of the issues relating to the welfare of the animals created through these projects. Although mentioned briefly in many of the papers discussing ethical issues, animal welfare concerns are typically given only a few lines. These usually indicate that these issues are important but should not be difficult to work out, as they are the same sorts of issues that show up in other projects involving scientific research and species reintroduction. For example, Cohen (2014) brings up harm to animals as a potential source of negative utility in considerations of de-extinction projects but concludes “there is no reason to think de-extinction will cause a large animal welfare problem” (2014, p. 175). Sandler (2014) considers animal welfare concerns as a potential ethical reason against de-extinction projects but concludes “compared with the number of animals already used in research … conservation cloning does not pose a special or very large animal welfare problem” (2014, p. 358). Although he acknowledges that research should take care to minimise suffering caused, he thinks “the animal welfare concerns it raises do not significantly differentiate it from many other research and conservation practices involving animals” (2014, p. 358). Rohwer and Marris (2018) point out that “creating a mammoth is morally permissible … provided that suffering is minimal” (2018, p. 2, italics in original), and go on to describe some of the concerns with cloning, surrogacy and rearing; though again, follow Sandler in dismissing these as not much different from those in other similar conservation practices. Greely (2017) describes the potential welfare problems associated with cloning technology but considers that “the risks of de-extinction are not substantively different from those associated with gene editing” (2017, p. 34). Friese and Marris (2014) briefly describe some of the welfare concerns in the creation and rearing of de-extinct animals, and argue that “questions regarding animal care need to be understood as a crucial part of de-extinction experimentation, rather than downstream concerns” (2014, p. 2), however they conclude that these issues can be addressed through “a social science approach based upon the current realities of cloning, genetic engineering, back breeding, and species preservation today” (2014, p. 3). 
Only Kasperbauer (2017) has really emphasised the importance of animal welfare considerations in making decisions about de-extinction programs, labelling it as “the most critical challenge for de-extinction” (2017, p. 1). He argues that “the current state of de-extinction technology provides good reasons to think the lives of de-extinct animals will indeed be full of suffering” (2017, p. 6) due to problems with cloning technology and reintroduction, and briefly outlines some of the ways in which these potential harms could come about. Here I will examine in detail exactly how and why these situations are likely to be harmful to animal welfare. 
Although it is true that many of the welfare issues are continuous with those affecting other areas of animal research and conservation, I argue that de-extinction creates special issues for animal welfare that need to be considered when evaluating such projects. Welfare issues can affect the de-extinct animals, other animals used in the process (e.g. surrogate mothers) and the wild animals that will be impacted through reintroduction (Cohen 2014). In particular, there are welfare issues surrounding the cloning procedures when these are used, and in the process of captive rearing and reintroduction, beyond those usually faced by zoos or conservation bodies doing this sort of work. This is in large part due to the lack of knowledge about these species and their requirements.

Good Data and Genomics

'Not as Good as Gold? Genomics, Data and Dignity' by myself and Dr Wendy Bonython' in Good Data (2019) edited by Angela Daly, Monique Mann and S Kate Devitt - published today - comments
Genomics enables us to read individuals and populations as abstractions – repositories of genetic data rather than persons. Through that lens it is tempting to regard ‘good data’ as a matter of what is big (comprehensive) and better (more accurate), rather than considering whether it is beneficial to or respectful of its human contributors. As nations move swiftly to whole-of-population data collection, analysis and sharing, this chapter suggests that construing bigger and better data as necessarily beneficial to people is contrary to the dignity that is central to personhood. From both a bioethics and legal perspective we are often asking the wrong questions about ‘good data’. The chapter critiques contemporary genomic initiatives such as the Genographic Project, Ancestry.com, deCODE and 23andMe in arguing it is imperative to consider meaningful consent regarding data collection and use, alongside establishment of a genomic commons that addresses problems inherent in propertization of the genome through patent law. Public and private goods can be fostered through regulation that ensures data quality and an information framework centred on public education about genomic data, encouraging responsible use of data within and across national borders. If the genome is ‘the book of life’ we must ensure that ‘good’ data is available to all and is understood rather than monopolized, mishandled or misread.
We state
The genomics revolution – opening, understanding and manipulating ‘the book of life’ – results in fruitful questions about ‘good data’, dignity, ethics and law. 
They are fruitful because they require engagement with issues that extend beyond diagnostics, therapeutic practice and the interaction of life-sciences research with business. They are also fruitful because they can be addressed through reference to past philosophical inquiries by figures such as Kant and Locke and to instances such the exploitation of vulnerable people in Nazi Germany and Jim Crow America where scientific ends were deemed to justify outrageous means. 
We live in a world where there is excitement about genomic tools such as CRISPR, where governments are endorsing the establishment of population-scale health databases to facilitate advances in public health while strengthening national champions in an emerging global bioeconomy, where corporations such as Myriad are exploiting genomic patents, and where consumers are unwarily gifting familial data to private sector initiatives such as 23andMe or Ancestry.com. 
In that world it is pertinent to examine assumptions about the nature, derivation and use of genomic data. Such an examination offers an opportunity for thinking about ways in which potential harms can be minimized, so that data functions as a social good rather than as a commodity subject to data stripmining. It also offers an opportunity to think about personhood. Most saliently, in an age of Big Data and algorithmic governance are individuals people who must be respected, or commodities that can be mined by the artificial persons that we characterize as corporations and governments, creations that exist to foster our flourishing? 
This chapter accordingly considers ‘good data’ – and good data practice – through a lens of genomics. The chapter initially discusses genomics as a way of seeing that enables us to read individuals and populations as abstractions: repositories of genetic data (and hence potential susceptibilities, disorders and even behavioural traits) rather than persons. Through that lens it is tempting for the researcher to regard ‘good data’ as a matter of what is big (comprehensive) and better (more accurate) and commodifiable through law that provides patent holders with exclusive rights. As nations move swiftly to whole-of-population data collection, analysis and sharing, the chapter suggests that construing bigger and better as necessarily beneficial to people is contrary to the dignity that is central to personhood. From both a bioethics and legal perspective, typically centred on property rights, we are often asking the wrong questions about ‘good data’. ‘Bigger’ and ‘better’ may be beneficial from a data perspective; without an adequate ethical and legal framework, however, those benefits will not necessarily be extended to its human contributors. 
The chapter accordingly critiques contemporary genomic initiatives such as Ancestry.com, National Geographic’s Genographic Project, deCODE and 23andMe in arguing it is imperative to consider meaningful consent regarding data collection and use, alongside establishment of a genomic commons that addresses problems inherent in propertization of the genome through patent law. Public and private goods can be fostered through regulation that ensures data quality and an information framework centred on public education about genomic data, encouraging responsible use of data within and across national borders. 
The chapter concludes by arguing that if the genome is ‘the book of life’ we must ensure that ‘good’ data is available to all and is understood rather than monopolized, mishandled or misread. Goodness may be fostered by respectful clinical protocols, best practice on the part of research funders/regulators and enhanced awareness on the part of consumers rather than merely by exclusions under intellectual property law or an international agreement regarding genetic privacy and genomic rights.
'What Is (in) Good Data?' by Monique Mann,. S Kate Devitt  and Angela Daly offers an overview of the book.

The editors comment
In recent years, there has been an exponential increase in the collection, aggregation and automated analysis of information by government and private actors. In response to this there has been significant critique regarding what could be termed ‘bad’ data practices in the globalised digital economy. These include the mass gathering of data about individuals, in opaque, unethical and at times illegal ways, and the increased use of that data in unaccountable and discriminatory forms of algorithmic decision-making. 
This edited collection has emerged from our frustration and depression over the previous years of our academic and activist careers critiquing these dystopian ‘Bad Data’ practices. Rather, in this text on ‘Good Data’ we seek to move our work from critique to imagining and articulating a more optimistic vision of the datafied future. We see many previous considerations of Bad Data practices, including our own, as only providing critiques rather than engaging constructively with a new vision of how digital technologies and data can be used productively and justly to further social, economic, cultural and political goals. The objective of the Good Data project is to start a multi-disciplinary and multi-stakeholder conversation around promoting good and ethical data practices and initiatives, towards a fair and just digital economy and society. In doing so, we combine expertise from various disciplines and sectors, including law, criminology, justice, public health, data science, digital media, and philosophy. The contributors to this text also have expertise in areas such as renewable energy, sociology, social media, digital humanities, and political science. There are many fields of knowledge that need to come together to build the Good Data future. This project has also brought together academic, government and industry experts along with rights advocates and activists to examine and propose initiatives that seeks to promote and embed social justice, due process rights, autonomy, freedom from discrimination and environmental sustainability principles.

21 January 2019

Biometrics Project Management

The ANAO has damned the Australian Criminal Intelligence Commission(ACIC) for comprehensive mismanagement  of the Biometric Identification Services Project, concerned with the national fingerprint database and the Commonwealth's ever-expanding facial biometric vision. That administration is characterised as "deficient in almost every significant respect".

The Australian Criminal Intelligence Commission’s Administration of the Biometric Identification Services Project report states
ACIC did not effectively manage the BIS project with its approach characterised by:
  • poor risk management; 
  • not following at any point the mandated process in the contract for assessing progress against milestones and linking their achievement to payments; 
  • reporting arrangements not driving action; 
  • non adherence to a detailed implementation plan; and 
  • inadequate financial management, including being unable to definitively advise how much they had spent on the project.
ANAO comments that
The objective of this audit was to assess the effectiveness of the Australian Criminal Intelligence Commission’s administration of the Biometric Identification Service project. ... 
On 1 July 2016, the Australian Criminal Intelligence Commission (ACIC) was created through the merger of the CrimTrac agency (CrimTrac), the Australian Crime Commission (ACC) and the Australian Institute of Criminology (AIC). 
Prior to the merger, CrimTrac had commenced planning and initial administration of the Biometric Identification Services project (the BIS project or BIS). 
BIS was a $52 million project with two key goals: replacement of the existing National Automated Fingerprint Identification System (NAFIS); and addition of a facial recognition capability to enhance law enforcement’s biometric capabilities. 
A Biometric Identification Solution Contract was signed on 20 April 2016 between NEC Australia (NEC) and CrimTrac, just prior to ACIC’s creation. 
The BIS project encountered difficulties at an early stage. Despite intervention by the executive of ACIC and ultimately unsuccessful negotiations between ACIC and NEC, the ACIC CEO announced on 15 June 2018 that the project had been terminated. 
 When it became apparent that BIS would not be completed prior to the expiry in May 2017 of ACIC’s contract with Morpho, the company that operated NAFIS, ACIC extended its contract with Morpho (for a substantially higher price). The NAFIS contract is now due to expire in May 2020. ACIC has yet to decide the future of NAFIS. 
Rationale for undertaking the audit 
The audit was requested by ACIC’s Acting Chief Operating Officer on behalf of ACIC on 14 February 2018; and the BIS (and the system it was to replace, NAFIS) are critical enabling systems for Commonwealth and state law enforcement. A threat to the availability of this capability would be of significant concern to the Australian Government. 
Audit objective and criteria 
The objective of this audit was to assess the effectiveness of ACIC’s administration of the BIS project. 
The audit criteria were: Was the procurement process for the BIS project conducted in accordance with the Commonwealth Procurement Rules?; and Has ACIC effectively managed the BIS project to achieve agreed outcomes? 
While CrimTrac’s management of the BIS procurement process was largely effective, the subsequent administration of the BIS project by CrimTrac and ACIC was deficient in almost every significant respect. The total expenditure on the project was $34 million. None of the project’s milestones or deliverables were met. 
The procurement was designed and planned consistent with the Commonwealth Procurement Rules and ICT Investment Approval requirements and the tender assessment process supported value for money. However, two critical requirements were overlooked in the requirements gathering phase and the approach to negotiating and entering the contract did not effectively support achievement of outcomes. This was a result of the contract not explaining the milestones and performance requirements in a manner that was readily understood and applied. 
ACIC did not effectively manage the BIS project with its approach characterised by: poor risk management; not following at any point the mandated process in the contract for assessing progress against milestones and linking their achievement to payments; reporting arrangements not driving action; non adherence to a detailed implementation plan; and inadequate financial management, including being unable to definitively advise how much they had spent on the project.
The approach to negotiating and entering the contract did not effectively support achievement of outcomes because the contract did not explain the milestones and performance requirements in a manner that was readily understood and applied. 
Management of the project 
The governance framework for BIS was not effective. Risk registers established for the project were not used effectively. External reviews in June and November 2017 identified the absence of a robust governance structure. ACIC’s Audit Committee was not informed of the status of the project. 
Contract management was not effective. The stipulated contract process by which progress against milestones and deliverables was to be assessed was not followed at any stage and ACIC thus had no way of assuring itself that it got what it paid for. ACIC agreed to more than $12 million in additional work. Documentation showed that some of this work may have been unnecessary and other work may have already been covered under the contract. ACIC ‘inherited’ the former CrimTrac and ACC Electronic Document and Records Management Systems (EDRMS), leading to duplication and ineffective record keeping. Further, many staff did not use any EDRMS, instead keeping records on their own computers, in uncurated network drives or in email inboxes. While a Benefits Management Framework was developed and evidence showed that a benefits realisation and documentation process was intended, it was not implemented. An internal audit report had found that ACIC did not have an effective contractor management framework. 
ACIC established appropriate arrangements for reporting to stakeholders. However these were not fully effective because they did not result in sufficient action being taken and the external stakeholders felt that reporting dropped off over time. 
The contract provided an implementation plan including Solution Delivery and Solution Design, with more detail for Solution Delivery. The agreed schedule was not adhered to and was repeatedly extended before BIS was terminated in June 2018. In order to maintain the uninterrupted availability of a national fingerprint capability for law enforcement, ACIC was obliged to renegotiate the existing NAFIS contract at a significantly increased cost. 
Financial management of the BIS project was poor. ACIC’s corporate finance area had no responsibility for management of the financial aspects of the BIS project; neither did the project team have a dedicated financial or contract manager. ACIC was unable to advise definitively how much they had spent on the project. 
ACIC made a ‘goodwill’ payment of $2.9 million to NEC which was not linked to the achievement of any contract milestone. ACIC was not able to provide details of how the quantum of this payment was calculated.

Genomic Identity and the ancestry industry

Readers of works such as Kim TallBear's 2013 'Native American DNA: Tribal belonging and the false promise of genetic science' and 'Genomic articulations of indigeneity' in (2013) 43(4) Social Studies of Science 509-533 or Jonathan Kahn's Race in a Bottle: The Story of BiDil and Racialized Medicine in a Post-Genomic Age (Columbia University Press, 2014) will be unsurprised by 'Constructing identities: the implications of DTC ancestry testing for tribal communities' by Hina Walajahi, David R. Wilson and Sara Chandros Hull in (2019) Genetics in Medicine.

The authors comment
 Direct-to-consumer (DTC) genetic ancestry companies have rapidly increased in popularity, with top testing services maintaining genetic databases of several million consumers. While genetic ancestry tests are often characterized as recreational, companies invoke deeply personal concepts of individual identity, group membership, and kinship when marketing their services. In particular, many companies claim to be able to determine Native American heritage, claims that are not supported by the state of the science and may have significant cultural and political consequences for US tribal communities. This study aims to fill the gaps in empirical work on this issue and characterize how genetic ancestry companies articulate indigenous identity through their marketing strategies. 
We conducted a qualitative content analysis of the public facing websites for 25 DTC genetic ancestry companies that offer services measuring Native American ancestry. xxx Our findings describe how genetic ancestry companies promote a causal relationship between genetics and self-identity through marketing language such as “Discover Yourself” and “Are you Native American?” and how this may affect US tribal communities. 
Genetic ancestry company claims regarding genetic ancestry, personal identity, and cultural membership are problematic and challenge how US tribal nations currently identify and create potential obstacles for tribal sovereignty.
The use and misuse of DTC genomics for 'ancestral belonging' was highlighted last decade in 'The Science and Business of Genetic Ancestry Testing' by  Deborah A. Bolnick, Duana Fullwiley, Troy Duster, Richard S. Cooper, Joan H. Fujimura, Jonathan Kahn, Jay S. Kaufman, Jonathan Marks, Ann Morning, Alondra Nelson, Pilar Ossorio, Jenny Reardon, Susan M. Reverby and Kimberly TallBear in (2007) 318(5849) Science  399-400.

It commented
At least two dozen companies now market “genetic ancestry tests” to help consumers reconstruct their family histories and determine the geographic origins of their ancestors. More than 460,000 people have purchased these tests over the past 6 years, and public interest is still skyrocketing. Some scientists support this enterprise because it makes genetics accessible and relevant; others view it with indifference, seeing the tests as merely “recreational.” However, both scientists and consumers should approach genetic ancestry testing with caution because (i) the tests can have a profound impact on individuals and communities, (ii) the assumptions and limitations of these tests make them less informative than many realize, and (iii) commercialization has led to misleading practices that reinforce misconceptions. 
The Impact of “Recreational Genetics” 
Although genetic ancestry testing is often described as “recreational genetics,” many consumers do not take these tests lightly. Each test costs $100 to $900, and consumers often have deep personal reasons for purchasing these products. Many individuals hope to identify biological relatives, to validate genealogical records, and to fill in gaps in family histories. Others are searching for a connection to specific groups or places in Eurasia and Africa. This search for a “homeland” is particularly poignant for many African-Americans, who hope to recapture a history stolen by slavery. Others seek a more nuanced picture of their genetic backgrounds than the black-and-white dichotomy that dominates U.S. racial thinking. 
Genetic ancestry testing also has serious consequences. Test-takers may reshape their personal identities, and they may suffer emotional distress if test results are unexpected or undesired. Test-takers may also change how they report their race or ethnicity on governmental forms, college or job applications, and medical questionnaires . This could make it more difficult to track the social experiences and effects of race and racism. Genetic ancestry testing also affects broader communities: Tests have led African-Americans to visit and financially support specific African communities. Other Americans have taken the tests in hope of obtaining Native American tribal affiliation (and benefits like financial support, housing, education, health care, and affirmation of identity) or to challenge tribal membership decisions. 
The authors comment
It is unlikely that companies (and the associated scientists) deliberately choose to mislead consumers or misrepresent science. However, market pressures can lead to conflicts of interest, and data may be interpreted differently when financial incentives exist. For scientists, these incentives include paid consultancies, patent rights, licensing agreements, stock options, direct stock grants, corporate board memberships, scientific advisory board memberships, media attention, lecture fees, and/or research support. Because scientific pronouncements carry immense weight in our society, claims must be carefully evaluated when scientists have a financial stake in them. Unfortunately, peer-review is difficult here, because most companies maintain proprietary databases. 
As consumers realize that they have been sold a family history that may not be accurate, public attitudes toward genetic research could change. Support for molecular and anthropological genetics might decrease, and historically disadvantaged communities might increase their distrust of the scientific establishment. These tests may also come up in medical settings: Many consumers are aware of the well-publicized association between ancestry and disease, and patients may ask doctors to take their ancestry tests into consideration when making medical decisions. Doctors should be cautious when considering such results. 
We must weigh the risks and benefits of genetic ancestry testing, and as we do so, the scientific community must break its silence and make clear the limitations and potential dangers. Just as the American Society of Human Genetics recently published a series of recommendations regarding direct-to-consumer genetic tests that make health-related claims, we encourage ASHG and other professional genetic and anthropological associations to develop policy statements regarding genetic ancestry testing.
'In the blood: the myth and reality of genetic markers of identity' by Mark A. Jobling, Rita Rasteiro and Jon H. Wetton in (2016) 39(2) Ethnic and Racial Studies 142-161 comments
The differences between copies of the human genome are very small, but tend to cluster in different populations. So, despite the fact that low inter-population differentiation does not support a biological definition of races statistical methods are nonetheless claimed to be able to predict successfully the population of origin of a DNA sample. Such methods are employed in commercial genetic ancestry tests, and particular genetic signatures, often in the male-specific Y-chromosome or maternally-inherited mitochondrial DNA, have become widely identified with particular ancestral or existing groups, such as Vikings, Jews, or Zulus. Here, we provide a primer on genetics, and describe how genetic markers have become associated with particular groups. We describe the conflict between population genetics and individual-based genetics and the pitfalls of over-simplistic genetic interpretations, arguing that although the tests themselves are reliable, the interpretations are unreliable and strongly influenced by cultural and other social forces.

20 January 2019

Organ Trafficking

Last month's Compassion, Not Commerce: An Inquiry into Human Organ Trafficking and Organ Transplant Tourism by the Human Rights Sub-Committee of the Joint Standing Committee on Foreign Affairs, Defence and Trade comments
Organ trafficking, the unethical removal, transfer or commercialisation of human organs for transplantation outside legal frameworks poses severe risks for both organ recipients and donors. It is an illicit trade that changes over time with developments in transplantation surgery techniques, the availability of medical infrastructure, uneven economic development, migration patterns, demographic trends, socio-economic exclusion, and the evolution of national multinational criminal networks. .... The organ trade has evolved and continues to evolve under the influence of forces of demand and supply as well as changes in national and international regulation and law enforcement. Judgements made about the extent and geographical focus of organ trafficking and transplant tourism a decade or more ago may have limited validity in relation to present trends and circumstances, and this report demonstrates that without the collection of accurate data, solutions will be difficult to create. This report examines the global prevalence of human organ trafficking and the scope of Australian participation within this illicit trade. The report further considers international frameworks to combat organ trafficking and organ transplant tourism and specifically recommends that Australia sign and ratify the Council of Europe Convention against Trafficking in Human Organs. The report further recommends that the Australian Government pursue a range of measures to strengthen Australia’s involvement in international efforts to combat human organ trafficking, improve relevant data collection, support public health education programs, strengthen Australia’s legal prohibitions on organ trafficking, and thoroughly investigate reforms that would enhance Australia’s domestic organ donation program. ix With regard to the last issue it should be noted that surveys show the majority of Australians – 69 per cent - are willing to donate their organs and/or tissue when they die. In Australia, 90 per cent of families say yes to donation when their loved one is a registered donor. Despite this apparent support for organ donation, and a majority of Australians believing that registering is important, only one in three Australians are registered as donors. While 71 per cent of Australians think it is important to talk about organ donation with their family, only half – 51 per cent -of Australians have held this discussion about whether they want to be a donor with their loved ones. This report largely deals with measures that are aimed at suppressing human organ trafficking and transplant tourism.
The Subcommittee's  recommendations are
Organ trafficking and organ transplant tourism in the global context 
Recommendation 1 The Sub-Committee recommends that the Australian Government pursue through the United Nations the establishment of a Commission of inquiry to thoroughly investigate organ trafficking in countries where it is alleged to occur on a large scale. 
Recommendation 2 Given the contention and ongoing debate around transplant practices in China, the Sub-Committee recommends that the Australian Government:  monitor the transplantation practices of other countries with regard to consistency with human rights obligations, including with regard to the use of the organs of executed prisoners;  seek the resumption of human rights dialogues with China;  continue to express concern to China regarding allegations of organ trafficking in that country; and  offer to assist with the further progression of ethical reforms to the Chinese organ matching and transplantation system. 
Australian involvement in organ trafficking and transplant tourism 
Recommendation 3 The Sub-Committee recommends that the Australian Government meets international best practice standards by establishing a comprehensive organ donation data collection repository, based possibly on the ANZDATA model, but comprising a single point of access to data regarding all organ transplantations in Australia, including outcomes of treatment, deaths, travel overseas for treatment, cross referencing against waiting lists and other relevant information. 
Recommendation 4 The Sub-Committee recommends that the Australian Government ensures that suitably-anonymised data regarding the participation by Australians in overseas commercial transplants, or those involved in organ procured from a non-consenting donor overseas, be shared with appropriate international partners, in order to combat transnational organ trafficking through cross-jurisdictional intelligence sharing. 
Recommendation 5 The Sub-Committee recommends that the Australian Government works with the States and Territories, transplant registries, and the medical community, to consider the appropriate parameters, protections, and other considerations, to support a mandatory reporting scheme whereby medical professionals have an obligation to report, to an appropriate registry or authority, any knowledge or reasonable suspicion that a person under their care has received a commercial transplant or one sourced from a non-consenting donor, be that in Australia or overseas.  
International frameworks to combat organ trafficking and organ transplant tourism 
Recommendation 6 The Sub-Committee recommends that the Australian Government sign and ratify the Council of Europe Convention against Trafficking in Human Organs, and works with the States and Territories to make the requisite amendments to Commonwealth and State and Territory legislation and ensure non-legislative obligations are met. 
Australian legal and policy issues 
Recommendation 7 The Sub-Committee recommends that the Australian Government amend the Criminal Code Act 1995 and any other relevant legislation insofar as offences relating to organ trafficking:
  • include trafficking in human organs, including the solicitation of a commercial organ transplant; 
  • apply to any Australian citizen, resident or body corporate; 
  • apply regardless of whether the proscribed conduct occurred either within or outside of the territory of Australia; 
  • apply regardless of the nationality or residence of the victim; and 
  • apply regardless of the existence, or lack thereof, of equivalent laws in the jurisdiction in which the offending conduct occurred. 
Recommendation 8 The Sub-Committee recommends that the Australian Government establishes a multi-lingual public health education program that:
  • addresses the legal, ethical and medical risks associated with participation in organ transplant tourism; 
  • includes a stream for educating frontline staff such as medical professionals about how to best identify possible cases of organ harvesting and support both vulnerable victims and desperate patients, based possibly on the Anti-Slavery Australia e-learning model; 
  • is multi-lingual; and 
  • is designed in particular to educate Australians who were born in, or have family associations in, countries where human organ trafficking is known or suspected to occur. 
Recommendation 9 The Sub-Committee recommends that the Australian Government includes information on trafficking in human organs and transplant tourism on relevant government websites, including on the SmartTraveller.gov.au website, on country-specific pages of countries where human organ trafficking is known or suspected to occur. 
Recommendation 10 The Sub-Committee recommends that the Australian Government
  • work with medical professionals, and other relevant stakeholders, to examine the impact of non-specialist prescribing of immunosuppressant medication on the efficacy of post-operative care and; 
  • examine ways to implement capture of data relating to the prescribing of immunosuppressant medication including that relating to transplants occurring overseas. 
Recommendation 11 The Sub-Committee recommends that the Australian Government seeks to improve organ donation rates through a number of approaches including:
  • consultation with the relevant agencies, continue the promotion of organ donation including education and awareness campaigns. 
  • ongoing funding of the Supporting Leave for Living Organ Donors program and the Australian Paired Kidney Exchange Program (AKX). 
  • further investigation of other countries donation programs, including Opt-Out organ donation programs to determine whether such a program could be appropriate for the Australian health system. 
Case study on alleged human tissue trafficking 
Recommendation 12 The Sub-Committee recommends that the Australian Government works with the States and Territories, as a matter of priority, to ensure that any person or body corporate importing human tissue into Australia for commercial purposes produces verifiable documentation of the consent of the donor person or their next-of-kin. This could include appropriate legislative changes at the Commonwealth or State and Territory level where required.
The report states
 On the 21 June 2017 the Human Rights Sub-Committee was tasked by the Joint Standing Committee on Foreign Affairs, Defence and Trade, to undertake an inquiry into the organ trafficking and transplant tourism. 
The terms of reference required the Sub-Committee to examine this broad issue including what Australia is doing to prevent and deter the practice of organ trafficking and transplant tourism both in Australia and overseas. In addition the Sub-Committee was asked to consider, whether it would be desirable or practical for Australia to accede to the 2014 Council of Europe Convention against Trafficking in human organs. 
There are a number of key terms relating to organ trafficking and transplant tourism relevant to this inquiry. This section outlines definitions for each of these terms, as they will be used within this report. 
Organ trafficking 
‘Organ trafficking’ encompasses two related types of activity: trafficking in human organs; and the trafficking of persons for the purpose of organ removal.1 ‘Trafficking in human organs’ refers to the unethical or illegal removal, transference or commercialisation of human organs, outside of  the governance system of the relevant jurisdiction. Where trafficking in human organs is a crime, the object of that crime is the organ.  The Australian Government considers ‘trafficking in human organs’ to mean: …the illicit trafficking in human organs, tissues or cells obtained from living or deceased donors and transacted outside the legal national system for organ transplantation. 
‘Trafficking of persons for the purpose of organ removal’ refers to the recruitment of a person, transportation of a person, or transference of a person to the control of another person, for the purpose of removal of an organ, outside of the governance system of the relevant jurisdiction. Where the trafficking of persons for the purpose of organ removal is a crime, the object of that crime is the trafficked person. 
It is important to note that organ recipients or donors may travel internationally legitimately, outside of commercial arrangements. For example, a recipient may travel to another country were a relative is a tissue match and has volunteered to donate kidney or a partial liver without any commercial transaction having taken place. 
Organ trafficking is defined in several international instruments. These instruments will be discussed in detail in chapter 4 of this report. The United Nations Protocol to Prevent, Suppress and Punish Trafficking in Persons Especially Women and Children supplementing the United Nations Convention against Transnational Organized Crime (the Palermo Protocol which is discussed further in Chapter 4) defines organ trafficking in the context of the broader prohibition on trafficking in persons, defining ‘trafficking in persons’ as: …the recruitment, transportation, transfer, harbouring or receipt of persons, by means of the threat or use of force or other forms of coercion, of abduction, of fraud, of deception, of the abuse of power or of a position of vulnerability or of the giving or receiving of payments or benefits to achieve the consent of a person having control over another person, for the purpose of exploitation. Exploitation shall include…the removal of organs…the consent of a victim…shall be irrelevant… 
The Council of Europe Convention against Trafficking in Human Organs (the Council of Europe Convention, this is discussed further in Chapter 4) was  established in part in response to a definitional gap in the Palermo Protocol identified by a joint United Nations and the Council of Europe study. The joint study established that the Palermo Protocol addressed only trafficking of persons for the purpose of organ removal, without consideration as to trafficking in human organs themselves. The Council of Europe Convention sought to address this gap, defining ‘trafficking in organs’ as the “illicit removal of human organs…without the free, informed and specific consent of the living or deceased donor” or where a “donor, or a third party, has been offered or has received a financial gain or comparable advantage” or the “transportation, transfer, receipt, import [or] export” of organs removed under these circumstances. 
The Declaration of Istanbul on Organ Trafficking and Transplant Tourism (the Declaration of Istanbul, this is discussed further in Chapter 4) is a set of principles and proposals towards the prevention of organ trafficking, developed by representatives of international scientific and medical bodies. Agreed at a gathering convened by the Transplant Society and the International Society of Nephrology, the declaration defines organ trafficking as: …the recruitment, transport, transfer, harbouring or receipt of living or deceased persons or their organs by means of the threat or use of force or other forms of coercion, of abduction, of fraud, of deception, of the abuse of power or of a position of vulnerability, or of the giving to, or the receiving by, a third party of payments or benefits to achieve the transfer of control over the potential donor, for the purpose of exploitation by the removal of organs for transplantation. 
Organ transplant tourism 
The term ‘organ transplant tourism’ refers to the cross-border travel of a person to facilitate an organ transplant. While there is no legal definition of transplant tourism under Australian law, the Australian Government considers the term to mean: …a prospective organ recipient voluntarily travelling to a foreign country for the purpose of undergoing organ transplantation. The organ may be acquired through legal, illegal or unethical means, including without the full and free consent of the donor. 
The World Health Organization (WHO) and the Declaration of Istanbul provide a shared definition, considering transplant tourism to be a subset of ‘travel for transplantation’: Travel for transplantation is the movement of organs, donors, recipients or transplant professionals across jurisdictional borders for transplantation purposes. Travel for transplantation becomes transplant tourism if it involves organ trafficking and/or transplant commercialism or if the resources (organs, professionals and transplant centers) devoted to providing transplants to patients from outside a country undermine the country’s ability to provide transplant services for its own population. 
The Law Council of Australia notes that while the WHO/Declaration of Istanbul definition is not binding, it is “internationally accepted and hence instructive.”10 The importance of the WHO/Declaration of Istanbul definition, as the basis of a common framework between international standards bodies and the international medical community, is highlighted by the United Nations, which has noted that the previous lack of an agreed definition “made it more difficult to understand and analyse the problem and its extent, and eventually to take appropriate countermeasures at the national, regional and international levels.” 
Origins and conduct of the inquiry 
The inquiry of the Joint Standing Committee on Foreign Affairs, Defence and Trade, Human Rights Sub-Committee into Human Organ Trafficking and Organ Transplant Tourism arose from a series of private briefings. 
The Human Rights Sub-Committee was approached by the Falun Dafa Association of Australia who provided a private briefing together with authors David Matas and David Kilgour on 22 November 2016 regarding the alleged ‘harvesting of organs’ sourced from political prisoners, prisoners of conscience, and those sentenced to execution by China. 
Kilgour, Matas along with fellow author Ethan Gutman had published an update to an earlier account of the alleged trafficking of organs in China entitled: Bloody Harvest/The Slaughter - An Update. This publication examines information concerning the transplant programs of hundreds of   hospitals in China and claims that the Chinese government has been performing 60,000 to 100,000 transplants per year since the year 2000 (as opposed to the official Chinese claim of approximately 10,000 per year) and the primary source for transplanted organs were imprisoned Falun Dafa practitioners. 
It is outside the capacity of the Sub-Committee to prove or disprove these allegations. However given the importance of this issue, the SubCommittee wished to establish how extensive the practice of organ trafficking may be with regard to Australian and what Australia might do to combat the illicit sale and purchase of human organs. 
A briefing was requested from the Department of Health, the Department of Foreign Affairs, and the Attorney-General’s Department to discuss organ trafficking predominantly from an Australian perspective. 
The Sub-Committee also held a private briefing involving academics specialising in organ transplant medicine and international organ trafficking on the 9 May 2017 which was interrupted by business in the Parliament on the day. Witness were invited back on the 13 June 2018 to complete this briefing. These witnesses discussed the extent of organ trafficking participated in by Australians, allegations brought by the Falun Dafa Association against China, and the issue of organ transplant trafficking and tourism more broadly. 
The Sub-Committee was concerned with the allegations raised by the Falun Dafa Association and by the apparent growth in this trade worldwide. The Sub-Committee wished to ascertain if Australian measures to deter and prevent organ trafficking in Australia and by Australians have kept pace with this growing trade. 
...  The Committee referred the inquiry to the Human Rights Sub-Committee to undertake with the following terms of reference:
The Committee will have regard to the offence of Organ Trafficking under division 271 of the Criminal Code and whether it would be practicable or desirable for:
  • this offence to have extraterritorial application; and 
  • Australia to accede to the 2014 Council of Europe Convention against Trafficking in Human Organs.15 
Outline of report 
Chapter 2 assesses the global prevalence of organ trafficking, international legal frameworks and the risks of organ transplant tourism for donors and recipients. 
Chapter 3 examines the scope of Australian participation in organ trafficking and transplant tourism and the adequacy of the data available on organ trafficking by Australians. 
Chapter 4 examines international frameworks to combat organ trafficking and organ transplant tourism and considers the question of whether Australia should sign and ratify the European Convention against Trafficking in Human Organs. 
Chapter 5 examines the current Australian legal framework relating to participation in organ trafficking, and considers whether or to what degree extraterritorial jurisdiction should be extended. 
Chapter 6 examines as a case study of alleged human tissue trafficking, the issues relating to the Real Bodies commercial anatomical exhibition on display in Australia during the course of this inquiry


'Approaching Ecological Sustainability in the Emerging Insects-as-Food Industry' by ├ůsa Berggren, Anna Jansson and Matthew Low in (2019) Trends in Ecology and; Evolution comments
The emerging insects-as-food industry is increasingly promoted as a sustainable alternative to other animal protein production systems. However, the exact nature of its environmental benefits are uncertain because of the overwhelming lack of knowledge concerning almost every aspect of production: from suitable species, their housing and feed requirements, and potential for accidental release. If ecological sustainability is to be a hallmark of mass insect rearing for consumption, ecologists need to engage in research related to sustainability criteria that are directly linked to key elements of the development of the industry. There is more to this subject than simply comparing feed-conversion ratios (FCRs) of insects to traditional livestock production, and we highlight areas where research needs to be immediately focused.
The Emerging Insects-as-Food Industry 
As the global appetite for animal protein increases, we need new approaches for its production if we want to avoid further biodiversity losses and environmental degradation (e.g., sustainable intensification of agriculture). One idea that is gaining increasing attention is growing insects for mass consumption. Aside from the curiosity value of eating insects (at least from a western perspective), the main reasons why insect mass rearing is being taken seriously is the nutritional value of the insects and their resource efficiency when converting organic matter into protein. It is this efficiency that has sparked the most interest, with it having major implications for the economics and environmental sustainability of this fledging industry (especially relative to many livestock systems).However,for insect rearing to have a noticeable impact on the sustainability of worldwide protein production, mass intensive rearing will be needed at levels dwarfing the current wild-harvest and small-scale production. It is in the details of this upscaling of production that the true environmental impact of this industry will be largely determined. While it is true that insects may offer significantly better FCRs and a smaller land-use footprint compared to traditional livestock systems, this does not guarantee that the insects-as-food industry will be environmentally friendly. It is now, during inception of the industry, that critical discussions about sustainability need to be undertaken and initiation of the science needed to identify the factors driving its environmental impacts. Otherwise we risk creating an industry that replaces one environmental problem with another (e.g., as occurred with biofuel). Thus, our aim in this paper is not to provide a comprehensive review of the state of the industry (for that see), but rather to highlight a number of pressing issues related to sustainability where ecologists can be at the forefront of discussions and research about this production system. From this, we suggest priority areas where research attention is needed if we want evidence-based decisions to drive policy and industry development towards environmental sustainability goals.