01 September 2018

Consent and MyHR

'The European Union General Data Protection Regulation (EU 2016/679) and the Australian My Health Record Scheme – A Comparative Study of Consent to Data Processing Provisions' by Danuta Mendelson states
This study compares the concept, elements, and function of consent under the General Data Protection Regulation (EU 2016/679) of the European Parliament and of the Council on the protection of natural persons with regard to the processing of personal data and on the free movement of such data [GDPR] in the context of European Union [EU] national electronic health records schemes and the Australian national health record scheme called My Health Record [MHR]. The GDPR, which, as the name suggests, governs processing of data in any form, including data contained in the national electronic health systems, is binding on all 27 EU member countries. The analysis concentrates on consent as critical element in protecting individual patients’ rights with respect to the processing of their personal health data under GDPR and under the Australian MHR legislative scheme. The study does not examine individual EU member states’ national electronic health systems because, subject to derogation in limited circumstances, the GDPR governs all of them. Australia is a non-EU jurisdiction, and does not have the European Commission’s certificate of adequate level of data protection (GDPR Art 45 empowers the European Commission to determine whether a country outside the EU offers an adequate level of data protection, either by its domestic legislation or because of the international commitments it has entered into). One of the reasons for the absence of the certificate might be the less than impressive Australian notion of consent under the MHR scheme, and the virtual disregard for consent in its framework of protections for patients’ rights in relation to health and clinical data processing.

30 August 2018

Robot Love and AI Personhood

'Robot Love' by Margaret Ryznar in Seton Hall Law Review (Forthcoming) comments
Researchers have been developing a sophisticated humanoid robot that people in the future may want to marry. A human-robot marriage would pose all kinds of challenges for lawmakers—from the question of whether robots could be granted custody of children or access family bank accounts, to the basic question of free will. Any growing relationship between humans and robots, however, may pose challenges to the current understanding of family law. For skeptics of such a future, this remains an interesting thought experiment nonetheless. 
Ryznar argues
Sophia is a Saudi Arabian citizen with a wicked sense of humor. She has a very expressive face and blue eyes. Flaunting her charm, Sophia has made the media rounds, including 60 Minutes and the Tonight Show. She has graced magazine covers and been on a date with Will Smith. She also happens to be a social humanoid 4 robot developed by Hong Kong-based company Hanson Robotics. 
Technology has made inroads in many fields, including family law. Thus far, it has expanded how people may have children in their families. Soon, technology may revolutionize whom people marry. Already, many people marry those they matched in online dating. Dating robots has been increasingly discussed as a possibility in the near future. One computer expert contends that if current technological advances continue, “[R]obots will transform human notions of love and sexuality ... Humans will fall in love with robots, humans will marry robots, and humans will have sex with robots, all as ... normal extensions of our feelings of love and sexual desire for other humans.” Even more surprisingly, he predicts this will happen by 2050. In addition to the technology having advanced by then, people will likely continue to have trouble getting and staying married to other people, making robots more attractive. 
Robots have rapidly developed in recent years to improve people’s quality of life and welfare. They offer companionship and assistance around the house, such as vacuuming. Future robots will be able to cook. There are sex robots and those that offer companionship. If these traits are combined in one robot, it will embody the reason that many people marry in the United States. 
This potential future presents an opportunity to examine the meaning of family law—and its applicability to a changing world. Law often is a step behind the development of technology. The reasons may range from the extent to which family law is rooted in society’s philosophy or the slowness with which families change. The law eventually catches up to reality. This article is thus the first to consider the family law implications of romantic relationships that computer scientists are predicting and working to develop. 
Family law is the story of inclusion and exclusion. Certain relationships are excluded from recognition and others are included. For example, states prohibit polygamous marriages, marriages between some relatives, and marriages before a certain age. “The central dividing line in family law is marriage.” This article looks at how family law can apply to the marriage between humans and robots as predicted by researchers. For skeptics of such a future, it is an interesting thought experiment nonetheless. 
Accordingly, Part II of this article begins by examining the current family law framework, focusing on property division and child-related matters. Part III explores the applicability of the family law framework to potential relationships between humans and robots. This Part concludes that as difficult as it is to determine whether to allow such marriages, dealing with their aftermath is even more difficult, complicating the applicability of the current family law framework to robot marriage.
'Turing's People" Personhood, Artificial Intelligence and Popular Culture' by Bruce Baer Arnold and Drew Gough in (2018) Canberra Law Review asks
What is legal personhood? Many people understand personhood – and by extension law – through depictions in popular culture. The contemporary feature film for example provides a lens through which non-specialists (people without a background in information technology, philosophy and law) can make sense of humanoid robots and distributed artificial intelligence (AI), entities that perform as ‘human’. Such an understanding is increasingly salient as AI becomes a pervasive but under-recognised aspect of daily life, and continues to evolve in its sophistication and complexity, provoking questions about rights, responsibilities and regulation regarding artificial entities that are independent rather than autonomous. The article accordingly analyses depictions of personhood in films such as Ex Machina, WarGames, Alien and Alien Covenant, Forbidden Planet, RoboCop and AI. It suggests that popular culture has an uncertain grasp of legal personhood but provokes thought and tells us something useful about the difference between human animals, non-human animals, corporations and new artificial persons. Those differences will be legally and culturally contested in the emerging age of smart machines and governance by algorithm

ASIC reports on Insurance Selling

The Australian Securities and Investments Commission - which has been notable for regulatory incapacity regarding the finance sector - has released two reports on problems relating to the marketing of life insurance. It concludes
ASIC’s review of direct life insurance sales has found that sales practices and product design are leading to poor consumer outcomes.
ASIC Chair James Shipton states
 Life insurance is a long-term product but cancellation rates and poor claim outcomes show that people are being sold products they don’t want, can’t afford, or don’t perform as they expected
ASIC's Report 587  reveals that:
 Consumers are cancelling their policies in very high numbers:
  • one in five of all policies taken out were cancelled in the cooling off period 
  • one in four of all policies that remained in force beyond the cooling off period were cancelled within 12 months 
  • three in five of all policies sold were cancelled within three years. 
  • life insurance sold direct compares poorly with other channels when it comes to claims: 15% of claims are declined, with 27% of claims withdrawn. 
 Report 588  found consumers struggle with the direct life insurance sales experience and the complexity of the products, and consumer understanding of key features is often poor. ASIC  identified a failure by all surveyed firms to provide adequate information about important aspects of the cover, including key exclusions and future premium increases. Four firms were also found to engage in pressure selling techniques, including refusing to send out paperwork unless a consumer committed to buy.

Moreover, over half the firms had incentive schemes which encourage sales staff to prioritise closing a sale ahead of the needs of the customer, including bonus payments heavily focused on value or volume of sales.


The ACCC has reauthorised Ethical Clothing Australia’s Homeworkers Code of Practice for a further ten years.

That Code, soon to be renamed ‘Ethical Clothing Australia’s Code of Practice, Incorporating Homeworkers’, seeks to reduce the exploitation of textile, clothing and footwear (TCF) workers in Australia. It imposes obligations on participants in the supply chain to demonstrate that they provide award wages and conditions to TCF workers.

The ACCC comments that it regards the Code as being 'an important tool for incentivising businesses to observe their obligations to vulnerable workers in the TCF industry and take steps to manage legal and reputational risks in their outsourced supply chains'.
 “By increasing industry and consumer awareness about working conditions, businesses accredited under the Code are also able to promote their ethical credentials to consumers,” ACCC Deputy Chair Delia Rickard said. 
“The certification trademark for ethical textiles, clothing, and footwear, allows consumers to choose products with confidence that the businesses they are buying from aren’t exploiting workers.” 
“Consumers are becoming increasingly aware of the impact of unethical practices on vulnerable workers and some are changing their buying habits as a result.”
The ACCC examined the possibility that the Code could lead to anti-competitive detriment such as increased costs for businesses seeking accreditation. It concluded that
this risk of detriment is limited because the Code is voluntary. Retail signatories and accredited manufacturers are only able to agree to boycott other businesses that are not compliant with their legal obligations, and the Code contains safeguards against inappropriate accreditation or boycott decisions. 
 Accredited businesses can display the following ethical certification trademark on their signs and products to demonstrate their compliance.

The Homeworker Code Committee Incorporated is a not-for-profit organisation and registered charity. Homeworkers are individuals and employees who perform work in the textile, clothing and footwear industry from home or at other premises that would not commonly be regarded as business premises.

The ACCC notes that the Code Committee has made minor amendments to the Code since 2013, when the Code was last authorised by the ACCC. Further changes are planned.

 In order to gain accreditation under the Code, businesses must submit to audits undertaken by CFMMEU to verify that those businesses are complying with legal obligations to workers. Audits are also conducted along the supply chain of businesses seeking (or renewing) accreditation under the Code, to ensure that the accredited businesses are complying with their legal obligations to the workers involved at each stage of the production of TCF products sold by the accredited business.

Five Eyes Encryption Statement

The Five Eyes meeting noted in the preceding post has resulted in a 'Statement of Principles on Access to Evidence and Encryption', of interest given the Australia Government's Telecommunications and Other Legislation Amendment (Assistance and Access) Bill 2018 (Cth) noted here.

The Statement reads
The Governments of the United States, the United Kingdom, Canada, Australia and New Zealand are committed to personal rights and privacy, and support the role of encryption in protecting those rights. Encryption is vital to the digital economy and a secure cyberspace, and to the protection of personal, commercial and government information.
However, the increasing use and sophistication of certain encryption designs present challenges for nations in combatting serious crimes and threats to national and global security. Many of the same means of encryption that are being used to protect personal, commercial and government information are also being used by criminals, including child sex offenders, terrorists and organized crime groups to frustrate investigations and avoid detection and prosecution.
Privacy laws must prevent arbitrary or unlawful interference, but privacy is not absolute. It is an established principle that appropriate government authorities should be able to seek access to otherwise private information when a court or independent authority has authorized such access based on established legal standards. The same principles have long permitted government authorities to search homes, vehicles, and personal effects with valid legal authority.
The increasing gap between the ability of law enforcement to lawfully access data and their ability to acquire and use the content of that data is a pressing international concern that requires urgent, sustained attention and informed discussion on the complexity of the issues and interests at stake. Otherwise, court decisions about legitimate access to data are increasingly rendered meaningless, threatening to undermine the systems of justice established in our democratic nations.
Each of the Five Eyes jurisdictions will consider how best to implement the principles of this statement, including with the voluntary cooperation of industry partners. Any response, be it legislative or otherwise, will adhere to requirements for proper authorization and oversight, and to the traditional requirements that access to information is underpinned by warrant or other legal process. We recognize that, in giving effect to these principles, governments may have need to engage with a range of stakeholders, consistent with their domestic environment and legal frameworks. 
The Attorneys General and Interior Ministers of the United States, the United Kingdom, Canada, Australia and New Zealand affirm the following principles in relation to encryption. 
1. Mutual Responsibility 
Diminished access to the content of lawfully obtained data is not just an issue for Governments alone, but a mutual responsibility for all stakeholders.
Providers of information and communications technology and services - carriers, device manufacturers or over-the-top service providers -– are subject to the law, which can include requirements to assist authorities to lawfully access data, including the content of communications. Safe and secure communities benefit citizens and the companies that operate within them.
We are always willing to work with technology providers in order to meet our public safety responsibilities and ensure the ability of citizens to protect their sensitive data. Law enforcement agencies in our countries need technology providers to assist with the execution of lawful orders. Currently there are some challenges arising from the increasing use and sophistication of encryption technology in relation to which further assistance is needed.
Governments should recognize that the nature of encryption is such that that there will be situations where access to information is not possible, although such situations should be rare. 
2. Rule of law and due process are paramount 
All governments should ensure that assistance requested from providers is underpinned by the rule of law and due process protections. The principle that access by authorities to the information of private citizens occurs only pursuant to the rule of law and due process is fundamental to maintaining the values of our democratic society in all circumstances – whether in their homes, personal effects, devices, or communications. Access to information, subject to this principle, is critical to the ability of governments to protect our citizens by investigating threats and prosecuting crimes. This lawful access should always be subject to oversight by independent authorities and/or subject to judicial review. 
3. Freedom of choice for lawful access solutions 
The Governments of the Five Eyes encourage information and communications technology service providers to voluntarily establish lawful access solutions to their products and services that they create or operate in our countries. Governments should not favor a particular technology; instead, providers may create customized solutions, tailored to their individual system architectures that are capable of meeting lawful access requirements. Such solutions can be a constructive approach to current challenges.
Should governments continue to encounter impediments to lawful access to information necessary to aid the protection of the citizens of our countries, we may pursue technological, enforcement, legislative or other measures to achieve lawful access solutions.
The Five Eyes also released a 'Five Country Ministerial Statement on Countering the Illicit Use of Online Spaces' -
 We, the Homeland Security, Public Safety, and Immigration Ministers of Australia, Canada, New Zealand, the United Kingdom, and the United States, stand united in our commitment to protect our citizens from child predators, terrorists, violent extremists and other illicit actors. We are as determined to counter these threats online as we are to counter them in the physical world. We note with disappointment that senior digital industry leaders did not accept our invitation to engage on critical issues regarding the illicit use of online spaces at the 2018 Five Country Ministerial meeting. Nevertheless, we reiterate our determination to work together constructively to ensure our response is commensurate to the gravity of the threat. Our citizens expect online spaces to be safe, and are gravely concerned about illegal and illicit online content, particularly the online sexual exploitation of children. We stand united in affirming that the rule of law can and must prevail online. 
We are committed to an open, safe and secure internet; one that provides global connectivity, better access to services, and new ways to conduct business and share news and information. But we recognise that the anonymous, instantaneous and networked nature of the online environment has magnified the threats we face, and has opened up new vectors for harm. We are determined to ensure that the technologies that have been developed to enhance prosperity and freedom are not exploited by those who seek to promote terrorism and violent extremism; prey upon and exploit our children; or spread disinformation and discord to undermine our democratic institutions. 
The evolution of digital technology has created new opportunities for widespread transmission of child exploitation material, and for perpetrating the most abhorrent kinds of child sexual exploitation, such as live-streaming of abuse. And it is not only in the recesses of the dark web that such material is accessible. Much is hosted on the most common top‑level domains. Moreover, the growing sophistication of mobile technology has enabled offenders to target children, including through apps that can be used to recruit and coerce children to engage in sexual activity. The low financial cost, and the anonymised nature of this criminal enterprise, is contributing to a growth in the sexual exploitation of children. We must escalate government and industry efforts to stop this. 
We also affirm the need to build upon efforts to counter the use of the internet by terrorists and violent extremists who continue to exploit online spaces to share materials designed to radicalise and mobilise individuals to violence. These materials are used for recruitment, facilitation, training and financing purposes, often with devastating consequences. Governments and industry have made some progress in tackling this issue. However, the task is far from complete. Terrorists and violent extremists remain able to disseminate propaganda promoting violence, and to use online platforms to radicalise and recruit. And, despite concerted efforts, a great deal of terrorist and violent extremist content remains accessible online to anyone inclined to seek it out. We therefore call upon industry to go further in proactively and innovatively addressing the illicit use of their platforms and applications at pace. In this context we welcome and support the Global Internet Forum to Counter Terrorism (GIFCT). But we urge industry leaders to champion more rapid responses, both under the auspices of the GIFCT and beyond. Digital industry must take responsibility to reduce the availability of online terrorist and violent extremist content across all platforms and applications, and to do so comprehensively. Recognizing the G7 Interior Ministers' statement on terrorism and violent extremism, we echo and amplify their call to action, and we affirm that efforts must extend to all types of illegal and illicit online content. 
We are also increasingly seeing the use of online spaces to spread disinformation, sow division, and undermine our democratic institutions. The proliferation of interference activities and disinformation undermines the trust of citizens in online communications and information, delegitimizing the benefits and opportunities that communications and social media platforms create. We call upon industry to meet public expectations regarding online safety by:
  • Developing and implementing capabilities to prevent illegal and illicit content from ever being uploaded, and to execute urgent and immediate takedown where there is a failure to prevent upload. 
  • Deploying human and automated capabilities to seek out and remove legacy content. 
  • Acting on previous commitments to invest in automated capabilities and techniques (including photo DNA tools) to detect, remove and prevent re‑upload of illegal and illicit content, as well as content that violates a company's terms of service. 
  • Prioritising the protection of the user by building user safety into the design of all online platforms and services, including new technologies before they are deployed. 
  • Building upon successful hash sharing efforts to further assist in proactive removal of illicit content. 
  • Setting ambitious industry standards, and increasing assistance to smaller companies in developing and deploying illicit content counter-measures. 
  • Building and enhancing capabilities to counter foreign interference and disinformation. 
  • Preventing live streaming of child sexual abuse on all platforms.
We recognise that governments also have a major role to play in addressing the spread of illicit content online. We commit to build the capacity of non-'five eyes' countries to protect and defend the most vulnerable. We undertake to enhance information flows from government to industry, and work towards overcoming barriers to cross-sectoral collaboration. We agree to ensure our enforcement capabilities, including technical data such as hashes, can be shared with industry to support the development of scalable, Artificial Intelligence-driven solutions. Through the same innovation and cross-sectoral collaboration that has underpinned so many technological advances, the challenge of countering illicit online content is not insurmountable. 
To focus our collective efforts, we agree to establish a senior officials group charged with monitoring industry progress on the above actions on a quarterly basis and reporting back to us. We welcome digital industry Chief Executive Officers to future meetings of the Five Country Ministerial to update us on their efforts directly.

Five Eyes Communique

This week's Official Communiqué from the Five Country Ministerial 2018 reads
 We, the Homeland Security, Public Safety, and Immigration Ministers of Australia, Canada, New Zealand, the United Kingdom, and the United States met on the Gold Coast, Australia, on August 28-29 2018, to discuss how we can better collaborate to meet our common security challenges. We reaffirmed that the close and enduring five country partnership, developed following the Second World War, remains fundamental to the security and prosperity of our nations.
The 2018 Five Country Ministerial (FCM), which in previous years has achieved advancements in information and intelligence sharing on border protection and counter-terrorism, has matured to become the pre-eminent forum for collaboration among the five countries on domestic security issues. This year's FCM meeting recalibrated the forum to focus on tangible deliverables and practical collaboration on counter-terrorism, countering violent extremism, cyber security, countering foreign interference, protecting critical infrastructure, border management and law enforcement. 
A free, open, safe and secure internet
The internet and digital technologies are increasingly central to contemporary life and to the social and economic development of our societies. Global connectivity enables faster communication, better access to services, and new ways to conduct business and share news and information. We affirmed our vision for a free, open, safe, and secure internet, which is fundamental to our economic growth and prosperity.
Just as the internet provides many benefits, it also provides opportunities for people to carry out crimes and spread illicit content. Terrorism, child sexual abuse and exploitation, violent extremism, and coercive acts of interference and disinformation are enduring concerns of government. The anonymous, instantaneous, and networked nature of the online environment has magnified these threats and opened up new vectors for harm. Governments have a responsibility to protect those within our borders against both physical and digital threats, and to ensure that the rule of law prevails online, as it does offline. We have a responsibility to tackle these challenges in a coordinated and effective way. While senior digital industry representatives did not accept our invitation to participate in discussions on pressing issues regarding the illicit use of online spaces, we reiterated the need for digital industry to take more responsibility for content promulgated and communicated through their platforms and applications. We agreed to a Joint Statement on Countering the Illicit Use of Online Spaces, outlining our communities' high expectations of digital industry companies, with a focus on countering online child sexual abuse and exploitation, and violent extremist and terrorist material. We called for the further development and expansion of capabilities to prevent upload of illicit content, and to execute urgent and immediate takedowns. We reiterated the importance of industry investment in human and automated detection capabilities, underscoring the need for major companies to set industry standards and to help smaller companies deploy these capabilities to their platforms, including through the Global Internet Forum to Counter Terrorism (GIFCT). And we called for increased efforts to counter foreign interference and disinformation conducted via online platforms.
We also undertook to enhance feedback loops between government and industry on intelligence and information, including trends and sources of illicit content, with the aim of more comprehensively responding to malicious actors online, to facilitate faster identification and removal of illicit content, and increase public awareness of the sources of disinformation and other forms of malicious foreign interference. 
Countering the threat of terrorism 
Globalised terrorist networks and violent extremists pose a real and unabating threat to our communities. Ongoing efforts to bring about the decline and depletion of terrorist networks operating in the Middle East have created new risks as many foreign terrorist fighters return to their countries of origin or move to other regions, disseminating their capabilities. We committed to the expanded sharing of information about known or suspected terrorists between our national security and border protection agencies, reiterating that the detection of international movements of terrorists and their associates relies on the rapid sharing of information between partners. We re-affirmed that alerts and intelligence relating to the movement of known and suspected terrorists will be shared between all five partners quickly and effectively. And we committed to continue our cooperation to support effective whole of government efforts to identify and—where domestic laws allow—prosecute returning foreign terrorist fighters, and share best practices for rehabilitating and reintegrating their family members.
Building on the framework for cooperation in United Nations Security Council Resolution 2396, we committed to work together to build the capability of other States in border security and measures to monitor, screen, track, and share information on returning foreign terrorist fighters and local terrorist networks. The aviation environment continues to be seen as a high-value target by terrorist and criminal networks. We committed to establish a new group, the 'Aviation Security 5', to better share information about emerging threats in the aviation sector and support existing fora to raise global standards for aviation security. 
Cyber security and resilience of critical infrastructure 
The increasingly digitised and networked nature of all aspects of our economies and societies means that cyber security and resilience is of the highest priority. The cyber domain is a vector for threats posed by hostile state actors, criminals, terrorist networks and hacktivists. A cyber attack is an attack on our communities and our sovereignty. We affirmed our collective resolve to deter malicious cyber activity, including improving domestic resilience, and coordinating technical attribution and operational response policies to mitigate significant cyber incidents. We agreed to further strengthen connectivity between our cyber watch offices to enhance shared 24/7 monitoring of hostile cyber activity. We committed to work together to protect critical infrastructure and support the development of secure critical infrastructure supply chains that are advanced, affordable, reliable and trusted. We undertook to share risk assessments and certification practices on supply chains to underpin the continued resilience of our respective cyber networks and prepare for new and emerging technologies. 
Migration and border management 
The interconnection and interdependence of our economies and communities manifests in increasing volumes of people and goods moving across borders. Facilitating the legitimate movement of people and goods is essential to our economic prosperity. The five countries are at the forefront of emerging border technologies, with a history of driving new technologies to simultaneously enhance border security and achieve faster movement of lawful travellers and goods. We committed to work together with industry to build the 'touchless' border at ports of entry for legitimate travellers and trade. We agreed to a strategy to leverage our investments in emerging technologies, including digitalisation and artificial intelligence, to improve facilitation and mitigate risks through real-time intelligence and information sharing, while protecting privacy. Collectively, we are among the most generous countries on earth in terms of humanitarian aid and refugee resettlement. Given the increasing volume of irregular movements, resettlement alone will not solve the problem. We must work with government partners, international organisations, non-government organisations and the private sector to build capacity in countries of origin and their regions. We acknowledged the importance of safe and legal migration and asylum pathways, and migrants' awareness of these pathways, and reaffirmed the positive benefits that managed migration, settlement, and integration bring to our societies. We also reaffirmed our commitment to coordinated, global action to respond to large and irregular movements. We reiterated the sovereign right and responsibility of states to strong border management, consistent with international non‑refoulement obligations, to deter and detect those who seek to evade border controls. And we reaffirmed the responsibility of all states to accept the return of their nationals, agreeing to increase cooperation to support timely and effective removals of non-citizens who have no right to remain in our countries, including consideration of joint consequences.
We committed to strengthen efforts to combat the scourge of modern slavery, forced labour, and human trafficking, which devastate the lives of the most vulnerable across the globe. We undertook to establish a senior officials' taskforce to develop concrete measures to tackle these problems, including promoting transparency in global supply chains, and developing common approaches to engage industry on trafficking facilitated through the internet and other digital technologies. The taskforce will report back to Ministers in the first quarter of 2019. We further agreed to consolidate and strengthen intelligence sharing, investigative, and enforcement efforts, including deploying sophisticated national capabilities to local law enforcement.
We re-affirmed the need to effectively manage migration flows through the utilisation of enhanced screening techniques, sharing intelligence and more effectively reaching into new sources of data, consistent with civil liberty protections, including social media, to ensure foreign nationals who would do us harm cannot cross our borders. We agreed to enhance collaboration on targeting, analysis, and disruption operations to counter organised threats to our border and national security. 
Joint meeting of FCM and Quintet of Attorneys-General 
On 29 August, we were joined by our ministerial colleagues who met as the Quintet of Attorneys-General. Together we discussed emerging issues and collaboration in countering foreign interference, the challenges posed by ubiquitous encryption, criminal information sharing and addressing the financing of transnational crime and terrorism. 
Countering Foreign Interference 
We condemned foreign interference, being the coercive, deceptive and clandestine activities of foreign governments, actors, and their proxies, to sow discord, manipulate public discourse, bias the development of policy, or disrupt markets for the purpose of undermining our nations and our allies. Foreign interference threatens a nation's sovereignty, values and national interests — it can limit or shape the polity's ability to make independent judgements, erode public confidence in our political and government institutions, and interfere with private-sector decision making. We agreed the five countries would work collectively to counter foreign interference, protect our individual sovereignty, and ensure our values and interests are upheld. We agreed to draw upon the strengths of our cohesive societies, our public and private institutions, and our global partnerships to reduce the risk that foreign interference poses to domestic and global prosperity and stability. We committed to establish a mechanism for the five countries to share developments in our respective approaches to confronting the foreign interference challenge. We undertook to share information on foreign interference activities with a view to advancing our collective knowledge of how to counter such threats. In the event of a severe foreign interference incident within our sovereign nations, we agreed the five countries would coordinate on appropriate responses and attribution. 
Encryption is vital to the digital economy, a secure cyberspace and the protection of personal, commercial and government information. The five countries have no interest or intention to weaken encryption mechanisms. We recognise, however, that encryption, including end-to-end encryption, is also used in the conduct of terrorist and criminal activities. The inability of intelligence and law enforcement agencies to lawfully access encrypted data and communications poses challenges to law enforcement agencies' efforts to protect our communities. Therefore, we agreed to the urgent need for law enforcement to gain targeted access to data, subject to strict safeguards, legal limitations, and respective domestic consultations. We have agreed to a Statement of Principles on Access to Evidence and Encryption [featured here] that sets out a framework for discussion with industry on resolving the challenges to lawful access posed by encryption, while respecting human rights and fundamental freedoms. 
Criminal information sharing 
Increasing interconnection between serious and organised crime networks have globalised threats such as drugs, cybercrime, child exploitation, and financial crimes. Reaffirming our commitment to sharing criminal and law enforcement information, we tasked our senior officials to convene an extraordinary meeting of operational and policy agencies with responsibility for law enforcement, border protection, and criminal justice. Drawing on the work of the Five Eyes Law Enforcement Group, the Border Five, and the Migration Five, the meeting will advise Ministers on the necessary enhancements to information sharing and collaboration to support more effective responses to serious criminal threats.
Beneficial ownership and illicit finance
We agreed to support G20 and Financial Action Task Force (FATF) efforts to combat illicit finance by increasing the transparency of legal persons and arrangements, and enabling timely access to beneficial ownership information by law enforcement agencies. We also agreed to encourage collaboration between 'five eyes' financial intelligence units to enhance the sharing of intelligence and experience. And we agreed to work closely with the private sector to promote the adequate and accurate collection of beneficial ownership information. 
We affirmed today the importance of the five country partnership in addressing complex homeland and national security challenges. Our history of cooperation, our shared values, and our enduring friendship provide solid foundations to face the challenges and opportunities of the 21st century together. We are committed to building on this past cooperation and together pledge the commitments made today.

29 August 2018

Comparative Law Reform

'Paths to Social Change: Analyses of Decriminalization of Sodomy' by Udi Sommer and Victor Asal comments
 What variables lead judicial and non-judicial decision-making bodies to introduce policy change? In the theoretical framework proposed, the path dependent nature of law has a differential effect on courts and legislatures. Further, political institutions such as elections and accountability lead those bodies to introduce policy change under dissimilar circumstances. Global trends, however, affect both institutional paths equally. We test this theory with data for the repeal of sodomy laws in all countries from 1972-2002. Results from two disparate multivariate models overwhelmingly confirm our predictions. Uniquely positioned institutionally, courts of last resort are less constrained than legislatures by either legal path dependence or political accountability. Globalization, on the other hand, has an equal effect on both. This work is the first to offer a theoretical framework explaining policy change via different institutional paths, systematically test it comparatively and with respect to a policy issue still on the agenda in many countries.
The authors conclude
The goal of this study was to analyze policy change via different institutional paths. This question, which has been crucially important in the study of public policy, judicial politics and social movements, was examined here for the first time systematically in a cross-national framework over a period of several decades and with respect to a question still on the agenda in the majority of countries, namely the decriminalization of same-sex sex. While the debate in the literature is still unsettled (Dahl 1957; Funston 1975; Rosenberg 1991), the theory developed here suggests that policy change emanates from judicial as well as non-judicial bodies. 
The key message of this study, however, is not limited to this notion. Rather, we explain theoretically and then substantiate empirically that different sets of variables systematically explain policy change via disparate institutional venues. As such, this article makes significant contributions to our understanding of a range of topics from law, legal development and accountability to the effects of religiosity on policy change. 
The legalization of sodomy is only one piece of the puzzle. It is important to recognize that countries where same-sex sexual relations are legal are not necessarily places where members of the LGBT community are treated equally (Waaldijk 2000). Legalization of sodomy, hence, is not the ultimate measure of discrimination against sexual minorities. With that in mind, however, an examination of the repeal of sodomy laws is key to developing a better understanding of the rights of gays and lesbians crossnationally. Although legal change may not always precipitate change on the ground (Epp 1996), the repeal of sodomy prohibitions is still a meaningful policy choice that warrants explanation. While a court decision or a legal measure may fail to translate into full equality for the minority they aim to protect, such legal change has a declaratory value, is educational, and provides members of the minority group with venues to claim redress (Scheingold 2004; Waaldijk 2000; McCann 1994; Zemans 1983). 
This work sheds new light on the nature of legal and policy change as well as on decision making within judicial and non-judicial institutions. More specifically, the path dependent nature of legal development means that law is constituted within the political system. Accordingly, we argue and then demonstrate, legal precedent in a Common Law system limits the introduction of policy change via the political branches more than via courts of last resort, and particularly when such change proves contentious. On the other hand, legal path dependence in civil law countries makes it easier for policy change to emanate from the legislature. Indeed, whereas legislative repeal constitutes 97% of the cases where sodomy laws were revoked in Civil Law countries, 6 in every 10 repeals in Common Law countries between 1972-2002 were judicial. 
This finding lends support to the notion that political actors are more constrained by precedent than their judicial counterparts and that the effects of path dependence on decision making in supreme courts are commensurably weaker. More broadly, this finding also addresses a major criticism leveled against path dependence scholars concerning their inability to explain policy change. We contend that the judicial hierarchical structure enables courts of last resort to make policy changes. Indeed, courts of last resort may serve as important mechanisms of change, a relief valve of sorts, in theories of path dependence (Kahn 2006). 
Furthermore, political institutions such as accountability entail closer proximity between constituency will and decision making in the political branches. In contrast, we find courts are less affected by majoritarian elements, as demonstrated by the effect of religious groups, which is apparent on legislatures, but not on courts. Some forces on the domestic (e.g., democratic conditions) and global (e.g., globalization) levels affect repeal, notwithstanding its institutional venue. In a sub-sample of democracies, the effect of democratic conditions is diminished, but the effects of the other predictors remain largely unaffected. 
This work offers some important observations. While contested later (e.g., Funston 1975), Dahl (1957) posits that courts do not operate in a counter-majoritarian fashion. Consequently, Dahl questions the extent to which courts protect the rights of minority groups. Along the same lines, Rosenberg (1991) contends that the Supreme Court is a Hollow Hope for those who seek social change. Dependent on the political branches for implementation, save for in particular circumstances, courts are not likely venues for policy innovation. The theory proposed in this study (and its empirical support presented thereafter) directly engages this scholarship. As far as the protection of sexual minorities is concerned, the findings in this study indicate that judicial institutions may well be the ones to extend legal protection. We identify the variables that predict policy making in each institutional venue, explain their effects, and empirically confirm their systematic influences. The empirical confirmation is established on data for all the nations in the world for a period of three decades. It is based on two disparate sets of models (multinomial logit and GEE time-series cross-sectional regression) estimated separately for all countries and for democratic countries only. The results of all models are robust and the support they lend to our hypotheses unyielding. 
Under the right circumstances, policy change may originate from courts of last resort. The political stars align differently in dissimilar jurisdictions; when Common Law and strong religious constituencies are present in a polity, courts may be the venue of choice for those seeking social change. Indeed, the Canadian and South African cases described earlier are but two examples illustrating these dynamics. 
As far as predictors of social change are concerned, and in particular in the context of the rights afforded sexual minorities, the analytical advantage of examining disparate institutional paths is clear. For instance, despite failures to find effects for religiosity in past work (e.g., Frank and McEneaney 1999), our theory and empirical tests illustrate the critical importance of analytically treating disparate institutional paths in order to accurately assess the effects of independent variables such as religious constituencies. Further, the emphasis put on institutions (as opposed, for instance, to social movements) is not unique to this work (e.g., Wald et al. 1996; Cole 2005). 
Lastly, this work also offers some empirical predictions to be further developed and tested in future work. With respect to institutional paths to policy change, future work may wish to examine the introduction of other policies (related to sexual minorities or otherwise) via disparate institutional paths. The set of predictors offered in this paper may account, for instance, for the introduction of anti-discrimination policies in different countries. While some accounts in the literature claim that, in Europe for instance, the mere decriminalization of same-sex sex inexorably led to the introduction of antidiscrimination measures (e.g., Waaldijk 2000), the theory proposed here offers an alternative analysis. Considering institutional paths of policy change and their respective predictors including type of legal system, special constituencies, democratic conditions and globalization, our theory offers a rich framework for scholars studying those processes. Moving beyond sexual minorities, the findings here may serve future examinations of policy change relevant to additional minority groups and policy domains.


The Productivity Commission Rising inequality? A stocktake of the evidence report comments
Over nearly three decades, inequality has risen slightly in Australia 
In all societies some inequality occurs due to differences in ability, opportunity, effort and luck. Institutional and policy constructs can add to this, or detract from it. 
Moreover, excessive inequality and entrenched disadvantage can erode social cohesion and hinder growth. It can also sap investment in education and skills and slow productivity growth. Yet there is no precise causative relationship, let alone a consensus on how much inequality matters. It is a topic that continues to draw diverse and competing views. 
This study does not directly enter these debates. Rather, its purpose is to contribute a foundation to an informed discussion on inequality and its social impacts, bringing together and taking stock of the latest and most complete evidence measuring the level of and trends in inequality, poverty and disadvantage in Australia via multiple means. 
While comprehensive, this study is not exhaustive; other studies examine geographic, racial or gender inequality. 
Even this modest level of ambition is not without its challenges. No single metric is sufficient to give a definitive answer to the seemingly straightforward question: have inequality, poverty and disadvantage in Australia risen, fallen or remained steady in recent years? 
Our focus, therefore, eschews the specific and often self-serving use of any one measure of inequality. Instead we use an array of indicators that examine the distributions of household incomes, consumption and wealth, their composition and importantly, movement within the distributions over time, and in response to life events, such as transitions to work, divorce and retirement. For poverty and disadvantage our approach goes beyond the standard metrics, giving weight to measures that capture the experience of those households in the bottom part of the distribution.
The broader context for this study has been an evident reduction in global income inequality and poverty since the late 1980s, the time-frame we most often apply. At the same time, however, there has been rising inequality within many developed countries. We review the Australian experience, which is less dire than some would have it, but not exemplary.
Sustained growth has delivered significantly improved living standards for the average Australian in every income decile
What also distinguishes Australia from most other developed countries has been its unprecedented 27-year period of uninterrupted economic growth, prompting many to ask how the economic gains from growth have been shared. While growth is no guarantee against a widening disparity between rich and poor, we show that it has delivered for the average Australian household in every income decile significantly improved living standards. This is in contrast with the United States (which had a similar rate of increase in income inequality as Australia) where the distribution is much more uneven, with income growth in the lower deciles about a quarter of that for Australian households.
What matters more than economic growth for understanding trends in inequality are the sources of income growth (labour, capital and transfers). These fluctuate in ways that sometimes favour those on high incomes and sometimes favour those on low incomes. For example, the mining boom was a period that favoured high income earners and capital income, lifting measures of inequality. In contrast, the post-Global Financial Crisis period has benefited lower income groups, despite weak overall growth in labour income. Among the various forces acting on inequality and poverty, the one constant that matters is having a job.
Over recent decades income growth rates by age group have also varied substantially, but for the most part, the variation reflects overall trends in the strength of income growth. That is, when the economy is strong, all age groups tend to benefit from higher income growth and when the economy is weak, all age groups tend to experience lower income growth. But at different times, some age groups have benefited more or less than others. Most recently, young people’s incomes have grown relatively slowly. On average, however, each new generation has earned more income than the last at a given age, and reaches the same level of income earlier in life.
Examining more closely the demographics of the income distribution provides additional insights. We know for example that Australians in their prime working years are more likely to be in the middle and upper income deciles, whereas over-65 year olds are over-represented in lower income deciles, reflecting retirement and reliance on the Age Pension. We also know that individuals living in households where no person is in paid work are strongly concentrated in the lower deciles, especially if there are dependent children in the household. Similarly, households with dependent children and two or more income earners are over-represented in middle and upper income deciles, and working households without dependent children tend to be over-represented at the top of the distribution.
Australia’s progressive tax and highly targeted transfer systems substantially reduce inequality 
Another clear message from the data is that Australia’s progressive tax system and highly targeted transfer system substantially reduce income inequality. Income tax and government transfers have typically lowered the measure of overall income inequality (the Gini coefficient) by 30 per cent, an equalising effect that far outweighs the overall increase in the measure since the late 1980s. This equalising effect has fluctuated over time, but overall there has been no material change in the past thirty years. Redistributive tax policies can, however, also have unintended negative consequences on economic efficiency, for example, inciting a reduction in labour supply. 
While income is usually given prominence in debates about inequality, how evenly consumption is distributed is often a better measure, as consumption contributes most directly to wellbeing. Moreover, income patterns alone do not capture the importance of in-kind transfers from government, such as health, education, childcare subsidies and government housing. These in-kind transfers have an additional equalising effect, because people with low incomes (and households with children) receive the largest amount of in-kind transfers. When the more expansive measure of final consumption is used, overall inequality (the Gini coefficient) is about 30 per cent lower again than that for disposable household income. In-kind transfers can also bear on future inequality by opening doors to greater opportunities and lifting incomes later on. 
The distinction between income and consumption comes out most strongly in analysis by age. For example, while 25 to 34 year olds are over-represented in upper deciles for income, they are over-represented in lower deciles for final consumption. This reflects reduced reliance on the education and health system in this age group, as well as higher rates of savings. On the other hand, those aged 65 or older, who are strongly over-represented in lower deciles for income, are under-represented in lower deciles for final consumption. 
The distribution of wealth is relevant too. Household welfare depends not just on resources at a point in time, but over time as well, and wealth provides a sense of financial security. Wealth can also provide an important safety net for older Australians, many of whom have relatively low incomes but high wealth, in terms of managing aged care costs and longevity risk. 
Similar to income, growth in wealth has been spread widely across the population. On average, households in all but the bottom decile experienced real increases in wealth, predominantly in housing assets and superannuation balances over the past fifteen years. However, with the growth in wealth strongest in the upper deciles, some measures of wealth inequality have risen. While wealth distribution in Australia somewhat predictably is more unequal than income or consumption, Australia’s wealth distribution remains less skewed than in other countries. Among 28 OECD countries, Australia ranks eighth most equal, as measured by the Gini coefficient of wealth. 
The fact that inequality levels are so different among developed countries hints strongly at the scope for policies, institutions and political environments to shape inequality. 
Economic mobility is high in Australia, with almost everyone moving across the income distribution over the course of their lives … 
The standard inequality measures considered thus far give a snapshot of the distribution at a point in time. While they show some widening of the gap between households, that does not mean that the rich and the poor households at the beginning and the end of the period are the same households. 
The distinction is important because a society with a given level of inequality, and where household incomes are static over time, faces different and more serious policy challenges than a society with the same level of inequality but where household incomes are mobile. There are two types of mobility: intergenerational mobility and life course mobility. Intergenerational mobility refers to the relationship between a person’s economic position and that of their parents, and life course mobility refers to changes in a person’s economic position throughout their life. The limited timeframe of Australian longitudinal data limits our capacity to assess intergenerational mobility. Instead, we present original analysis on the degree of life course mobility in Australia using the HILDA dataset. In other words, how much people move across the distribution for income or wealth from year to year. 
It turns out that almost everyone moves across the income distribution over the course of their lives. Over a 16-year period, the average Australian was classified in five different income deciles; and for less than one per cent of people, the decile to which they belonged remained unchanged over the whole period. And nine per cent spent time in both the top and the bottom income decile. A lower, but still significant level of mobility was also apparent across the wealth distribution. This highlights the fluid nature of income and wealth: over time, any given decile consists of a different group of people — most of the people in the top decile today were not there fifteen years ago. 
Life events — such as transitioning from education into work, career advancement, household formation, having children, divorce and retirement — underpin some of the observed trends in economic mobility. Typically, income rises during the working years, though this can be interrupted by childbearing and other life events, such as ill health. Similarly, Australians accumulate wealth in their middle years, and draw on this wealth in retirement when their earnings drop. These changes in income and wealth allow people to ‘smooth’ their consumption. 
… but some Australians experience entrenched economic disadvantage 
While life course mobility affects households across the entire distribution, the ends of the distribution are ‘stickier’ than the middle. Households in the top and bottom two income deciles at the beginning of the period were the most likely to be in the same decile fifteen years later. About three per cent of households were stuck in one of the bottom two deciles throughout the period. Stickiness at the ends of the distribution is indicative of some entrenched inequality. 
Accordingly, the last chapter of this study updates earlier Commission research on the nature and extent of deep and persistent disadvantage in Australia. Disadvantage is a multidimensional concept that can take the form of low economic resources (poverty), inability to afford the basic essentials of life (material deprivation) or being unable to participate economically and socially (social exclusion). Because the elements of disadvantage encompass a diverse range of indicators, it is difficult to reach a single conclusion about the overall trend in disadvantage. 
Many Australians experience economic disadvantage at some stage in their lives, but for most, it is temporary. About nine per cent of Australians (2.2 million people) experienced relative income poverty (income below 50 per cent of the median) in 2015-16, with children and older people having the highest rates of relative income poverty. This aggregate figure has fluctuated since 1988-89 but, despite 27 years of uninterrupted growth, has not declined. Persistent and recurrent poverty affects a small, but significant proportion of the population. About three per cent of Australians (roughly 700 000 people) have been in income poverty continuously for at least the last four years. People living in single-parent families, unemployed people, people with disabilities and Indigenous Australians are particularly likely to experience income poverty, deprivation and social exclusion. For people in these circumstances, there is an elevated risk of economic disadvantage becoming entrenched, limiting their potential to seize economic opportunities or develop the skills with which to overcome these conditions. 
These risks are particularly elevated for children living in jobless households, which is a group that has stood out among the multiple measures of inequality and disadvantage. How the future of inequality in Australia evolves will depend on the opportunities that citizens have to improve their living standards today. For by far the largest number of us, sustained economic growth and reliable access to employment — complemented by skills and education improvements as specified in our 2017 report, Shifting the Dial — will offer these opportunities and the ability to embrace them. 
But for a significant albeit much smaller group, the challenges are much more complex. Growth and complementary improvements in skills and education policies will not be enough. In some previous research, we found that needs in housing or health policies could better be fashioned to address more directly than today quite specific needs — what might be termed ‘hand-made’ policy — as we look out towards a fourth decade of uninterrupted economic growth.

28 August 2018

Biobank Governance and genomic markets

'Biobank Governance: The Cautionary Tale of Taiwan Biobank' by Shawn H.E. Harmon, Shang-Yung Yen and Shu-Mei Tang in (2018) 15(1) SCRIPTed 103 comments
The importance of biobanks has long been mooted, and multiple models of development and operation can be found as a result of many actors founding biobanks (from institutions starting disease-specific banks to governments starting national population biobanks). Many countries began developing biobanks in the absence of national policies to aid in that formation. Taiwan was one such country. Believing that the unique genetic makeup, distinctive lifestyles, and disease-causing factors of the Taiwanese people deserved study, Taiwan took steps to create Taiwan Biobank. This paper examines Taiwan Biobank’s development and governance and focuses on two matters in particular which generated consternation during the development of Taiwan Biobank: the position adopted in relation to autonomy and ethnicity; and the approach toward transparency and internal governance. It concludes that Taiwan Biobank’s conflict-ridden evolution represents a cautionary tale, an example of how not to develop a flagship resource. 
 The authors state
 Shortly after the sequencing of the human genome, it was claimed that medical knowledge would be accelerated by the formation of ‘biobanks’, here defined as new repositories of human tissue and generated data (genetic, phenotypic, lifestyle, environmental, and demographic) together with associated health data (occupation, lifestyle, diet, and medical), which repositories are collective, inclusive, prospective, and purposively indeterminate. It was felt that large-scale longitudinal investigations into the interaction between common disease genes and environmental factors would be an optimal way to overcome common diseases and improve health. 
Therefore, many countries began developing national policies to aid in the formation of biobanks, or began developing biobanks in the absence of policies. Taiwan fell into the latter category. Believing that the unique genetic makeup, distinctive lifestyles, and disease-causing factors of the Taiwanese people deserved specific study, Taiwan took steps to create a national biobank. Proponents considered that, if the genes involved in common diseases could be defined and their risk quantified, new and improved treatments could be developed for Taiwan. Like many such banks, then, Taiwan Biobank’s conception was an exercise in promise; a leap into the scientific and policy unknown supported by claims that risks would be offset by advances in health and by valuable collaborations and commercial returns, the latter of which was not always clearly conveyed to or understood by the public. 
This paper examines the establishment, development, and governance of Taiwan Biobank. First, it reviews the historical evolution of Taiwan Biobank. Secondly, it examines two areas that generated significant controversy in this evolution, namely, positions adopted in relation to autonomy and ethnicity, and approaches in relation to transparency and internal governance. We propose that Taiwan Biobank’s problematic evolution represents a cautionary tale, highlighting pitfalls to avoid in developing a national flagship resource. 
2 The Development of Taiwan Biobank 
... Like many countries, Taiwan adopted a policy of sci-tech innovation as a means of achieving sustainable development and international competitiveness. Health technology innovation and the establishment of biobank infrastructure resources featured heavily in this policy:
1997: The Science and Technology Advisory Group (STAG) of the Executive Yuan held its first strategic review meeting on biotech policy, intending to promote national projects in genetic medicine and public health technology. Consequent projects included the National Genetic Medicine and the National Pharmacy and Biotech Projects. 
1998: A second strategic review meeting resulted in the National Development Fund investing NT$20 billion to support the development of the biotech industry, the emphasis being on technology innovation projects, strategic alliances, and enterprise creation, including the investment by state-owned enterprises in the biotech industry. 
1999: The Luchu Science Park was redeveloped with a Biomedicine District. 2001: Multiple regional ‘Biotech Hallways’ were created. 
2002: The Academia Sinica established the Taiwan Han Chinese Cell and Genome Bank Project, which relied on data collected randomly through the computerised household registration system. 
2004: The STAG argued that Taiwan should become an ‘island of biomedical technology’, and made a number of related recommendations.
In response to the STAG, the Taiwanese Government launched the Biomedical Technology Island Plan 2005, which comprised three main projects: the National Health Information Infrastructure Project; the Taiwan Clinical Services Project; and Taiwan Biobank. With respect to the latter, the National Science Council (NSC), predecessor to the Ministry of Science and Technology, asked Academia Sinica’s Institute of Biomedical Sciences (IBS) to plan a large-scale population biobank that would support biotechnology development and medical research in Taiwan. 
Adopting UK Biobank as its model, the IBS conceived of Taiwan Biobank, which would collect biological samples (blood, plasma, urine, and tissue) from some 200,000 healthy participants aged 30-70, and link those samples/data with their lifestyle, family history, and health information in an effort to determine the effects of genetic and environmental factors and interactions on common diseases, and to develop personalised medicine. Objectives included: determining the prevalence of specific genes and variations in the population; simplifying the procedure for searching for biological marker molecules; improving research into new curative medicines (especially for Taiwan-prevalent diseases); and simplifying disease-prevention and improving public health and hygiene decisions. Importantly, both Taiwan Biobank and its Pilot Study was structured around ethnicity; it aimed to build the resource by collecting samples from four target groups – the Hakka, the Minnan, the Han, and Aboriginals. 
2.2 Controversy and ethnicity during the Pilot Study (2003-2007)
Prior to commencement, Academia Sinica was tasked with performing a Pilot Study to test the scientific/technical feasibility of Taiwan Biobank. It had a target of 1,000 participants from three geographic regions: Miaoli (primarily Hakka); Chiayi (primarily Minnan); and Hualien (primarily Aboriginal). The ethnic foundation for the Pilot Study was not accompanied by any detailed or openly-discussed or accepted definition of each group, nor indeed by any explanation as to what or who counted as Aboriginal. Nonetheless, the Pilot Study Protocol was approved by Academia Sinica’s Institutional Review Board (IRB) in 2005. 
The process leading up to (and beyond) this approval has been described as a ‘development-first’ approach with decisions being made almost exclusively by policy and science elites in closed processes. Moreover, these decisions were sometimes based on misinterpretations of the course adopted in other countries, and they persistently exemplified either simplistic understandings of risk, or a complete disregard for the associated risks. And while there was some effort to encourage scientific discourses, there was no effort to be transparent or to undertake any public engagement. Indeed, it has been argued that the complexity of the project together with the exclusivity of its development hindered both public understanding and public debate. In short, there was no interest in social supervision. 
Eventually, and primarily after the academic community began to complain, the Pilot Study met with a maelstrom of public criticism, exemplified by a commentary in the China Times which raised questions about consent, confidentiality, and benefit-sharing, and which demanded that the plans for Taiwan Biobank be made public. One of the issues that was persistently raised was that of ethnicity. Given the poor record of Aboriginal treatment, the fragility of human subject protections, the circulation of stories about failures to meet consent standards, and the general absence of benefit-sharing models in Taiwan, the Taiwan Association for Human Rights made a formal request (in July 2006) that Academia Sinica publish its project processes online so as to improve transparency. That request was refused, and the Pilot Study continued unabated. 
2.3 Law-making, further controversy and recruitment (2007-2023) 
By 2007, and despite social outcry and non-engagement with social and ethical matters, the Pilot Study was viewed as having demonstrated feasibility. Thus, the Ministry of Health and Welfare (MOHW) directed the IBS to commence a Preparatory Study which would recruit 15,000 participants aged 30-70. The Preparatory Study dropped the overt emphasis on ethnic groups, but focused on Hakka, Minnan, and Aboriginal regions for its recruitment. As the study progressed, the number of participants was reduced to 8,000. During this time, the Executive Yuan took steps to legislate in the biobank setting so as to bring its regulatory environment more in line with international standards, adopting the Human Biobank Management Act 2010 (HBMA 2010), amending the Personal Information Protection Act 2010, and adopting the Human Subjects Research Act 2011 (HSRA 2011), more on which infra. 
In October 2012, Taiwan Biobank was formally approved by Academia Sinica’s IRB with the aims of preventing, diagnosing and treating a wide range of serious and life-threatening common complex diseases suffered by the Taiwanese people.  Country-wide recruitment commenced in late 2012, and over 77,000 participants have thus far provided 30ml of blood, 20ml of urine, specified physical measures, detailed information about themselves, and have agreed to have their health followed.  In accordance with Article 5 of the HBMA 2010, Taiwan Biobank established an Ethics and Governance Council (EGC) to act as an independent guardian of Taiwan Biobank’s Ethics and Governance Framework, and to advise the Competent Authority (the MOHW) on its revision from time to time. Very early in the EGC’s existence, however, Taiwan Biobank took steps to amend its Protocol so that, in addition to the 200,000 participants originally envisioned, it could collect 100,000 patient samples and data from Taiwan’s major hospitals, and it could focus on some specifically identified conditions (e.g., breast, lung, liver, colon, and rectum cancers, strokes, chronic kidney diseases, and Alzheimer’s Disease). This amendment was approved post facto by the EGC (in 2012). In early 2015, the MOHW recommended that hospitals share their banked resources with Taiwan Biobank.  However, on 30 September 2016, Academia Sinica’s IRB, which has authority to suspend or terminate any research that is not conducted in accordance with its requirements, or that has been associated with unexpected serious harm to subjects, held that it must approve any amendment to the Taiwan Biobank Protocol prior to its implementation. It therefore suspended Taiwan Biobank activities in response to this self-initiated inclusion of hospitals,  holding that Taiwan Biobank should be governed by the EGC and the IRB jointly, with the EGC responsible for ‘management’ and the IRB responsible for ‘research’. 
Taiwan Biobank responded that the EGC, not the IRB, is the main ethical governance structure for Taiwan Biobank. The MOHW countered that the Protocol should be submitted to and confirmed by the MOHW, which is the Competent Authority under the HBMA 2010.This dispute re-ignited criticism from a range of stakeholders, including the Taiwan Association for Human Rights, and led to delays in operations. While the jurisdictional conflict has not been resolved, the IRB did issue a Certificate of Approval on 2 March 2017, which states that (1) annual progress reports should be submitted to the IRB for review, (2) progress reports submitted to the MOHW should be copied to the IRB, and (3) all adverse events must be reported promptly to the IRB. This Certificate also seems to have approved the amendments to the Protocol, opening the way for hospitals to transfer their holdings to Taiwan Biobank. 
This rather tortured history highlights two matters which appear to have undermined the good governance of Taiwan Biobank in its early phases, and the general satisfaction with its development (though they cannot be said to have derailed its development). The first relates to its handling of ethnicity, including the special requirements that it imposes with respect to obtaining participant consent, and the second relates to the transparency (and accountability) around the undertaking’s governance.
'23andMe: a new two-sided data-banking market model' by Henri-Corto Stoeklé, Marie-France Mamzer-Bruneel, Guillaume Vogt† and Christian Hervé in (2016) 17(19) BMC Medical Ethics comments
Since 2006, the genetic testing company 23andMe has collected biological samples, self-reported information, and consent documents for biobanking and research from more than 1,000,000 individuals (90 % participating in research), through a direct-to-consumer (DTC) online genetic-testing service providing a genetic ancestry report and a genetic health report. However, on November 22, 2013, the Food and Drug Administration (FDA) halted the sale of genetic health testing, on the grounds that 23andMe was not acting in accordance with federal law, by selling tests of undemonstrated reliability as predictive tests for medical risk factors. Consumers could still obtain the genetic ancestry report, but they no longer had access to the genetic health report in the United States (US). However, this did not prevent the company from continuing its health research, with previously obtained and future samples, provided that consent had been obtained from the consumers concerned, or with health reports for individuals from other countries. Furthermore, 23andMe was granted FDA authorization on February 19, 2015, first to provide reports about Bloom syndrome carrier status, and, more recently, to provide consumers with “carrier status” information for 35 genes known (with high levels of confidence) to cause disease. 
In this Debate, we highlight the likelihood that the primary objective of the company was probably two-fold: promoting itself within the market for predictive testing for human genetic diseases and ancestry at a low cost to consumers, and establishing a high-value database/biobank for research (one of the largest biobanks of human deoxyribonucleic acid (DNA) and personal information).
Stoeklé et al argue
 Two major problems relating to autonomy are immediately apparent here: the problem of scientific literacy [30] and the lack of training of physicians in genetics [31, 32]. Indeed, it has been shown that more than half the individuals buying genetic tests online subsequently consult a physician to discuss the result [33]. It might therefore be a good idea to create a “direct-to-physician genetic reporting service”, or at least an optional service of this kind, effective before and after the purchase of the kit. Such a service would ensure that physicians were better trained in the interpretation and explanation of genetic tests and would ensure better counseling and follow-up for users, while providing users with greater autonomy. It would also make it possible for the test of- fered by 23andMe to be considered a real medical diag- nosis test rather than as simply providing information. This vision of autonomy differs from those prevailing in the UK and the US, in which all individuals wishing to have access to their genetic and medical data are free to do so, provided an agreement has been reached with the family in cases of clinical analysis, regardless of their level of genetic knowledge and the conditions of the service on offer [29, 34]. The press has reported incidents in which families requesting genetic tests via the Internet have learned, from the results obtained, that the presumed father was not the real biological father or in which the biological father has found that he has children that he didn’t know existed [35, 36]. 23andMe warns its clients in ad- vance of the possibility of such discoveries being made through its tests (see the website and blog of 23andMe) and seems to have resolved this problem. It nevertheless remains legitimate for civil society to pose the question as to whether private companies should be able to reveal such information through so-called “phylogeny” or “health report” genetic testing rather than through (offi- cial) paternity tests, particularly if they do not ensure, other than virtually, that this choice was consented to by all of the people concerned by the results and not just by the principal person concerned [34]. For preventive surgery, the best known case is undoubtedly that of an American actress who underwent a prophylactic double mastectomy following positive results in a genetic test for the breast cancer 1 (BRCA1) mutation [37]. In the wake of her decision, an increase was observed in the numbers of BRCA1 and 2 tests and of prophylactic double mastectomies carried out [38]. Over and above the principle of not doing harm, which is called into question by major, potentially traumatic surgery, this approach also raises questions about the principle of autonomy, because there may be a risk of abuse in the long term. Indeed, if such practices were to become systematic, insurers might have the right to oblige their clients to undergo testing if they have a family history of disease, particularly for genetic predispositions to cancer, due to the costly and debilitating nature of targeted treatments if the disease is diagnosed late. 
Ethical issues also arise within the testing company. These issues include the dematerialization and digitization of data, the anonymization of genetic data, the confidenti- ality of self-reported information and the storage of data and samples (Fig. 5) [39, 40]. Indeed, when informed consent forms and the commercial contract are signed digitally, the consumers provide the company with their names, together with a set of personal information about themselves and their families relating to health and ethni- city. The company states on its website that names, addresses, e-mail addresses and bank data will not be disclosed or used. Nevertheless, such information (Fig. 2) significantly increases the medical, scientific and financial value of the data. It is therefore unsurprising that the contract stipulates that data, DNA and biological samples will be kept and may be re-used in other research if the consumer consents. With the multiplication of this transaction by hundreds of thousands of individuals, the company is well aware that its consumers have not only paid a few hundred dollars each, on average, for genetic testing services, but have actually sold their samples and information for inclusion in a major biobank and database for use by scientists and doctors. But what are the conse- quences for the consumer? Can separate pieces of infor- mation about an individual be brought together? Particularly as concerns the consumer’s name and import- ant items of personal information? These issues have not been sufficiently explored by the company, which seems to safeguard its own interests more strongly than those of its consumers, although 23andMe received institutional review board approval for its research protocol and a revised consent document in 2010 (23andMe blog). Indeed, Genentech has paid $60 million (in total) for the WGS data of 3,000 23andMe consumers with Parkinson’s disease, with the aim of generating new therapeutic target leads [41]. However, despite large amounts of clear, illustrated information about the phenotypes and/or diseases revealed by their analyses, the robustness and accuracy of the chip used for testing are not perfect at individual level and not all of the mutations detected have been validated by Sanger sequencing (thereby potentially mixing false and true positives and negatives). A client may therefore unknowingly carry a deleterious mutation that may be reported in the information delivered by the company or may knowingly carry such a mutation that is not identified in the results delivered by the company. The risk of false- positive or false-negative results for these tests is the prin- cipal concern of the FDA and its approval process [42]. However, in the context of a study of several thousand people (carried out by GWA), missing a single SNP in an individual is not a problem because there are thousands of others. At an individual level, missing a SNP may have much greater consequences. The previous economic model was based on low prices to attract more consumers, providing more data and biological samples to be valorized and sold. The four rounds of investment in this company (Fig. 4) may have been designed to address the problem of the probable lack of benefit from this side of the market until the second market had been established (Fig. 3) [43]. This second market has now been established through the collaboration between 23andMe and Genentech. 
According to a French Agence de Biomédecine report on genetic tests published in 2014 [44], there is currently no consensus definition of a genetic test and very few countries have adopted specific legislation relating to genetic testing, the principal countries to have done so being Austria, Switzerland, Germany and Portugal. In the United States, genetic tests for medical purposes are accessible without a medical prescription and are billed by the laboratories concerned. However, 24 American states have prohibited divulgation of the results of genetic tests in the absence of a physician. Nevertheless, companies selling genetic tests via the Internet, such as 23andMe, at least before they were prevented from doing so by the FDA, report the results of their tests dir- ectly to their clients. According to an Institut National de la Santé et de la Recherche Médicale (INSERM) report on genetic tests dating from 2008 [45], this is per- mitted because genetic information is not considered to be particularly sensitive in the US. Instead, it is seen as ordinary personal information, unless supplied by a genetic test governed by the FDA. Nevertheless, increasing numbers of “genetic privacy” laws have been passed in the US in recent years, by contrast to Europe, which now seems to be moving in the opposite direction [44]. Indeed, the European Union (EU) is increasingly moving towards the broader and freer circulation of data for research purposes [44]. According to the French Agence de Biomédicine report published in 2014 [44], the UK has recently gone further, because the Human Genetics Commission responsible for providing the British government with expert advice now considers that it would not be desirable to ban tests bought over the Internet, simply because it would be impossible to police such a ban given the freedom of access to the Internet available today. However, it did recommend the estab- lishment of a certain number of guidelines concerning test quality, the information transmitted and the qualifi- cations of those carrying out the test. The proof of this shift in position is that 23andMe entered the British market in December 2014, about a year after it was banned by the FDA in the US [41, 46]. Ireland, Denmark, Finland, the Netherlands and Sweden have all accepted the sale of the 23andMe test in their territories (23andMe Europe). It might be possible for France to follow the same course of action. Most countries are currently facing a change in the definition of health data much more complex than any previously observed, which has been neglected for far too long. It is now possible to generate health data with non-certified medical technolo- gies as simple as a smartphone or any kind of connected object [47]. Is it really the fault of 23andMe for having understood this issue or that of the health authorities for not having thought sufficiently deeply about it? 
The data and samples that 23andMe “lend” to different research teams also raise two other ethical problems: the inequality of access to data and samples between research teams due to differences in financial resources or nationality, as the laws of some countries are not compatible with the patentability of human genes (Fig. 5.). One direct consequence is a significant bias in the race for publication and international tenders [39]. The issue of the patenting of human genes is far from resolved, particularly in the US and in European coun- tries, such as France. In the emerging world of targeted molecular therapies and genetic tests for diagnosis and prognosis, these questions will need to be addressed [39, 48]. There are already inequalities between research teams in terms of the production and use of scientific knowledge, through access to high-quality scientific pub- lications or various new technologies, probably due to significant qualitative and quantitative differences in resources between countries and between research teams in the same country. Should access to and use of knowledge be based on the financial clout of a team or its scientific intuition, particularly if society hopes for new ideas to emerge from science [49]? 
Another link that would merit closer scrutiny is that connecting 23andMe to Google. Google was one of the principal investors in all four rounds of financial invest- ment in this company. Google may be interested in the web behavior information for its search engine activity, and in the self-reported information and genetic infor- mation, which may be of use to subsidiary companies, (e.g., X, originally Google X lab) (Fig. 5). This idea raises other ethical issues due to the transhumanist vision of Google, with its growing monopoly on the emergence of new technologies, ultimately resulting in a lack of competition and, in some instances, a possible threat to democracy. Indeed, after five years of investigation, the European Commission accused Google of abusing its dominance of the market in April 2015 [50]. This example illustrates the difficulties inherent to companies attempting both to provide services and to relay information. 23andMe should therefore carefully consider the risks they face, because, in this instance, the products are biological materials and health data.


'Private Law, Analytical Philosophy and the Modern Value of Wesley Newcomb Hohfeld: A Centennial Appraisal' by Kit Barker in (2018) Oxford Journal of Legal Studies comments
Hohfeld is one of the best-known analytical philosophers to have written in the area of private law in western, common law legal systems in the twentieth century, but it is sometimes suggested that his scheme has had little impact on the law. One hundred years after his death, this article assesses the man and the impact of his work, noting a resurgence of interest in him amongst both commentators and courts. It suggests that there are two good reasons why his analytical philosophy is more relevant and useful today than ever – its potential to discipline and rationalise an increasingly insistent and ubiquitous rhetoric of rights; and the assistance it can provide in unpicking the complexity of the relationship between private law and the modern administrative state. 
Barker argues
 Wesley Newcomb Hohfeld died prematurely one hundred years ago of endocarditis, at the age of only 39. Although he is one of the best-known Western analytical philosophers to have written about private law, it is sometimes suggested that his work has had little real impact.1 My claim here is that his influence, whilst patchy, has nonetheless been profound and, more importantly, that, far from oxidising beneath the patina of time, or being buried by less ‘formal’ approaches toward law that developed through the legal realist and critical legal studies movements in the United States in the twentieth century, his approach is currently undergoing something of a renaissance amongst commentators and courts. I shall explore some possible explanations for this and identify the features of his thinking that continue to commend it. I shall also suggest some reasons why his approach is especially well-suited to the challenges faced by private law in the current age. 
Looking ahead, I shall propose three reasons why Hohfeld remains useful to us today. First – and this was genius in itself – he told us not what to think about legal rights, but ‘how’ to think about them. Because his approach does not predicate any particular set of values, or the use of the law to any particular end, it is more readily transmissible from one time to another and one jurisdiction to the next. He gave us a language to use in respect of rights, not a defined text to read. That is the beauty and the freedom of analytical philosophy. 
A second reason is that the world of law is now increasingly saturated with both the fact and ever-more-insistent rhetoric of rights. Often, the aim of this new rights-speak is strongly socially progressive, being directed at enhancing welfare and respect for fundamental human interests and realms of choice (human rights); sometimes, by contrast, it is associated with a more conservative political agenda that mandates judges not to use private law in welfarist ways. Either way, however, the exponential increase in rights discourse in recent years invites new controversy, as well as importing new concepts and, sometimes, a certain looseness of language. In such conditions, a stable method for understanding the way in which legal relationships are being reconfigured and what the reconfigurations might mean proves especially valuable. 
Thirdly, the rise of the administrative state throughout the twentieth century has made the modern relationship between private and public law extremely complicated. Unpicking this relationship – between the state and private interests; and between the state and private law systems of civil justice – requires a keen analytical intelligence. Hohfeld has much to offer in this process and his framework is useful, I shall argue, in understanding the modern dynamics between private and public law. 
Hohfeld’s modern relevance is hence in part, I shall suggest, a facet of the durable, scientific objectivity of his analytical technique and, in part, of its disciplining nature and utility at a point in time in which rights have become highly politically charged and the set of legal relationships existing between the state and its citizens is more intricate than ever. This is not to suggest that would be impossible to understand modern private law without Hohfeld, but his techniques are very well adapted to this end.