TRIPS Waiver

'The COVID-19 TRIPS Waiver Process in Critical Review: An Appraisal of the WTO DG Text (IP/C/W/688) and Recommendations for Minimum Modifications' by Siva Thambisetty, Aisling McMahon, Luke McDonagh, Hyo Yoon Kang and Graham Dutfield comments

The original TRIPS waiver proposal made by India and South Africa in October 2020 was based on the need for affordable access to medical products for the prevention, containment of treatment of COVID-19 during the pandemic. That proposal sought to bring into force a waiver of WTO States’ TRIPS obligations with regard to patents, copyrights, industrial designs and undisclosed information as they relate to COVID-19 health technologies. In May 2021, we set out the legal and political case for this principles-based TRIPS waiver. Subsequent negotiations over the waiver have been difficult and protracted. Only in May 2022 did an apparent ‘compromise’ text emerge from the WTO Director General (DG), but without the explicit support of the waiver’s main proponents, India and South Africa, leading to concern over the scope and effectiveness of the DG text. In this paper we provide a short commentary that critiques the WTO DG text’s deficiencies and spells out the minimum modifications necessary for a meaningful workable text for use in the COVID-19 emergency context.

Fictions

‘The Talented Mr. Mallory’: literary scammers, pain-for-profit, and selves made of others' by Alyson Miller in (2021) 18(2) New Writing: The International Journal for the Practice and Theory of Creative Writing 197-212 comments 

In 2019, Dan Mallory, book editor turned author of the enormously successful thriller, The Woman in the Window, was exposed as a pathological dissembler. Faking cancer, an Oxford PhD, a prestigious career, and tragic family deaths, Mallory constructed a distressing history in order to gain authority and influence. Examining the complexities of the fraud in relation to other contemporary fakes, this paper contends that impostors expose the value systems of power, especially those situated within gatekeeping institutions that enable grifters to thrive. It asserts that despite humiliating exposure, or the excoriation of outraged readers, the impostor invariably succeeds, perpetuating an exclusive monoculture in which the same voices, both real and imagined, are heard and received. The Mallory controversy emerges within a succession of impostures fixated on crossing boundaries from privilege to disadvantage and trauma, revealing an identity politics located within the commodification of the marketable ‘other’. The hunger for narratives of ‘authentic’ suffering comes to represent a form of literary virtue signalling which exploits ‘otherness’ to satisfy middle-class stereotypes and prejudices. Imbricated with issues of appropriation and theft, the fake treats suffering as an object to be possessed, yet also functions to uncover a sequence of literary and cultural fault-lines. 

 Miller states 

 Invariably described as charming, handsome, and clever, Dan Mallory, book editor turned novelist, is also a pathological dissembler (Parker 2019). With the release of The Woman in the Window (Finn 2018), a psychological thriller about an alcoholic agoraphobe, Mallory garnered extraordinary literary success: the manuscript sold in a two-million-dollar two-book deal, entered the Times bestseller list at number one, and has recently been adapted for film, starring Amy Adams and Gary Oldman (Parker 2019). A ‘hodgepodge’ (Crispin 2019) re-imagining of Alfred Hitchcock’s Rear Window (1954) and Jon Amiel’s Copycat (1995), The Woman in the Window nonetheless attracted enormous industry support, lauded by Stephen King as ‘unputdownable’, for example, whilst Gillian Flynn pronounced the novel an addictive and ‘mesmerising … noir for the new millennium’, with ‘stunning twists’ and ‘beautiful writing’. Yet it is in the extra-textual emplotments in which Mallory’s talent for fictivity evolved into ‘Nabokovian game-playing’ (Parker 2019). Via a contradictory series of bizarre autobiographical claims, Mallory constructed a complex alternate double-life, including significant traumas such as surviving a brain tumour and the death of a brother by suicide, alongside more aggrandising fabrications: modelling for Russian Vogue; working as an editor at prestigious publishing houses; and achieving a doctorate from Oxford. In line with the scandal surrounding James Frey, after a New Yorker exposé revealed the extensive, if not dichotomous, narrative of suffering and brilliance to be a sequence of cynical and calculated deceptions, Mallory was denounced as a Mr. Ripley performance artist, a charismatic impostor with a long history of ‘duping … with false stories about disease and death’ (Parker 2019). In a response statement, Mallory confessed to yet further suffering, claiming to be ‘afflicted with severe bipolar II disorder’, and experiencing ‘crushing depressions, delusional thoughts, morbid obsessions, and memory problems’: ‘It’s been horrific, not least because, in my distress, I did or said or believed things I would never ordinarily say or do – things of which, in many instances, I have absolutely no recollection’ (qu. ABC 2019). 

As Christopher L. Miller observes in Impostors, ‘deception is fundamental to literature’ (2018, 3), whilst the fraud – or the hoax, imposture, or forgery – is as old as writing itself. Surrounded by ‘screens, fakes, avatars, simulacra, and all manner of imitation’, contemporary audiences arguably attend less to the Platonic exhortation against the gap between mimesis and ‘true reality’, than to the Aristotelian enticement to revel in the fictional and the virtual, to embrace the pleasure of the unreal (3-4). The recognition of language as a form of creative play and of the mimetic as being ‘capable of so much more than truth-bearing’ (5) also frees the literary work, particularly in terms of its attachment to the figure of the author. Indeed, Roland Barthes argues that by removing an insistence on the role of the ‘Author-God’, and understanding text not ‘as a line of words releasing a single “theological” meaning … but as a multi-dimensional space in which a variety of writings, none of them original, blend and clash’, both fixed meaning and signifying limits are rejected and refused (1977, 146–147). If the identity of the author is obsolete, and there is, Miller contends, ‘no origin to steal’, language itself reigns and hoaxing is not only ‘utterly inconsequential’ but also ‘entirely permissible’ (2018, 6). Certainly, it is rhetoric adopted by Mallory, who repeatedly, if not conveniently, insists on the irrelevance of the life of the writer: ‘I am not especially interested in author bios. I am buying their novel, not their memoir. I view it as a sign of respect not to want to know too much’ (qu. Benedictus 2019). Barthes thus asserts that the separation of a text and its author results in liberation from singular or ‘ultimate meaning’ which, as a ‘tissue of signs, an imitation that is lost, infinitely deferred’, is now constituted by the reader (1977, 147). Yet in the context of literary fakes, the clarity of such a borderline is radically unsettled, complicating not only ideas about the construction of self, but also the consequences of imposture. Whilst the manoeuvrings of a fraudulent author are often framed in terms of the enactment of a postmodern vision of identity, defined by a protean urge towards reinvention, the scandals surrounding fakery are also trapped within a ‘crossfire between play and truth’ (Miller 2018, 7). 

The effect, as this paper contends, is less concerned with arguments for the possibilities of an endlessly transforming selfhood; rather, it is about the revelation of a series of anxieties about privilege, representation, and power, in which the politics of identity are located within the marginalisation and commodification of the marketable ‘other’. Certainly, the fabrications created by Mallory seem fixed on obscuring ideas about stable subjectivities, suggesting a blurring of distinctions between real and unreal selves. Rooted in complex layers of literariness, and defined by gothic tropes of haunting, doubling, and liminality – augmented by admissions of mental illness – such a strategy alludes to notions of subjectivity as a series of narrative constructions that might be re-visioned in profound or shocking new formulations. It is an undoubtedly tempting proposition, yet in the context of fakes, also deeply problematic, imbricated with issues of appropriation and theft, of the plagiary of bodies as ‘raw material to be moulded, made up, made us of, and made off with’ (Young 2017, 434). As Kevin Young argues in Bunk, whilst the fraud or hoax ‘once meant to glorify’, the modern desire to ‘horrify’ denotes a radical shift through which suffering and trauma are regarded as objects to be possessed (98). Indeed, the rationale employed by impostors that suggests authenticity is little more than a façade or performance to be enacted is, as Cathy Park Hong contends, borrowing from James Baldwin, often a ‘delusion of whiteness’ that wilfully denies the systemic and material inequalities which inform the realities of ‘self’ and ‘other’:

The avant-garde's ‘delusion of whiteness’ is the specious belief that renouncing subject and voice is anti-authoritarian, when in fact such wholesale pronouncements are clueless that the disenfranchised need such bourgeois niceties like voice to alter conditions forged in history. The avant-garde's ‘delusion of whiteness’ is the luxurious opinion that anyone can be ‘post-identity’ and can casually slip in and out of identities like a video game avatar, when there are those who are consistently harassed, surveilled, profiled, or deported for whom they are. (2014)

Indeed, the Mallory imposture exposes the perverse capitalisation of marginality by fakes, who utilise discourses of ‘otherness’ as a vehicle through which to gain status and celebrity – representing a level of success traditionally denied to those who exist outside centres of power but made interesting and appealing by those whose performances neatly align with the expectations of majority culture

Searches

iTnews reports that the Australian Border Force conducted over 41,410 warrantless (legal) searches of electronic devices at the border between 2017 and 2021. 

The FOI-based report  indicates that travellers do not have to be informed of their rights by border officials, including that "travellers have no legal obligation to provide a password/passcode or provide assistance to access an electronic device at the border." The ABF "may" advise travellers of their rights but there is no policy requiring them to do so. Its broad search powers authorise device searches for a range of reasons, including on suspicion that a traveller has or intends to engage in work prohibited by their visa. Searches are also made on behalf of, and copied data shared with, other federal agencies. 

iTnews notes that inconsistencies in the way data is recorded preclude itemisation of the type of device searched, nor whether the device belonged to Australian citizens. 

The FOI indicates that between May 2020 and the end of 2021, 951 phones were searched. The remaining 40,459 searches - conducted between 2017 to 2021 - may have been smartphones or laptops or removable hard drives. There were probably more searches in the period, as the 41,410 searches does not capture instances where travellers refused to provide their passcode. 

Device searches peaked at 14,927 in 2019, dropping to 3447 in 2020. iTnews states the ABF could not confirm whether this was related to the drop in air travel or other reasons. 17,085 of the 40,459 examinations to May 2020 were recorded as impacting Australian citizens; the ABF subsequently stopped recording nationality. 

 The ABF indicates that it "retains data on the number of searches, and the details of those searches".  It would not say if it had accessible data on how many of the 41,410 searches resulted in an outcome - such as the discovery of prohibited items, arrests or convictions - nor if that data could be released. 

 The ABF indicated that "travellers have no legal obligation to provide a password/passcode or provide assistance to access an electronic device at the border." Presumably that will changes.

Devices can be taken offsite for forensic 'examination'.  If a traveller exercises their right to refuse to provide a passcode, the device can be taken from the border and given to the ABF's digital forensic team for examination. “Most devices held for examination are returned to the traveller within 14 days, and often sooner if no material is found to warrant further investigation”, with "some devices may need to be held for longer but only under exceptional circumstances, such as for technical reasons or for those devices that contain vast amounts of data.”

Gangs

Regulatory approaches to preventing organised crime among outlaw motorcycle gangs' by Christopher Dowling and Anthony Morgan (AIC Trends and issues in crime and criminal justice 652, 2022) comments 

Australia’s response to organised crime has relied on the criminal justice system, using strong enforcement and legal regimes to dismantle criminal groups, and deter or imprison offenders (Ayling 2017, 2014). Outlaw motorcycle gangs (OMCGs) have been the most visible target of these measures, given their prominence in Australia’s organised crime landscape. Many Australian states and territories have adopted suites of laws which criminalise OMCGs and the association of their members. These laws have been introduced alongside dedicated police operations focused on disrupting the operation of OMCGs through high-intensity, low-tolerance enforcement activity. 

Regulatory approaches rooted in civil and administrative law, meanwhile, are being increasingly used against organised crime in Europe (for a review, see Spapens, Peters & Van Daele 2015). These approaches focus on reducing opportunities for organised crime by blocking groups and offenders from elements of the legitimate economy that can enable it. This typically includes restrictions on the issuing of licences, permits, contracts, subsidies or grants, and the denial of real estate and other assets. Such measures can be critical to cutting off offenders from the funding streams, physical and technical infrastructure and mechanisms for concealing illicit revenue that facilitate organised crime. 

Early examples of these approaches are evident in Italy (Calderoni & Di Stefano 2015; La Spina 2014) and Japan (Reilly 2014), which have long histories of private and public sector infiltration by mafia and yakuza crime organisations, respectively. More recently, the whole-of-government OMCG strategy introduced in the Netherlands best exemplifies the implementation of a regulatory approach to this offender population (van Ruitenburg 2020). Although it incorporates criminal justice measures as well, this strategy takes a broad view of disruption, with interventions coordinated across government targeting all of the conditions necessary for OMCGs to operate, including employment, finances and location. 

There are recent examples of regulatory measures having been introduced in Australia, although they have typically been implemented within a broader criminal justice framework (Ayling 2017). Many Australian states and territories have now established regimes of judicial orders which restrict the activities of individuals with histories of organised crime related offending, including engagement in certain industries and financial activities. Recent changes to the Transport Security Amendment (Serious Crime) Act 2021 aim to prevent exploitation of the aviation and maritime transport sectors— an enabler of organised crime—by introducing more stringent eligibility criteria for people applying for a card that would allow them to work in Australia’s airports and seaports. 

Regulatory approaches, used alongside criminal justice approaches, open up a wider variety of angles from which to target organised crime and particularly its enablers. Nevertheless, there is little local or international evidence to support the impact of these measures. Where research has been undertaken, it was often not able to completely disentangle specific regulatory interventions from other measures, making it difficult to infer the true source of any change. This is evident in a recent evaluation of the whole-of-government approach to OMCGs in the Netherlands (Klement and Blokland 2021). While results show that the introduction of this approach led to a gradual reduction in the rate of recorded organised crime offending by OMCG members, the wide range of criminal justice and regulatory measures incorporated make it challenging to identify the specific mechanisms at work.

Regulation

'Inherited regulation for advanced ARTs: comparing jurisdictions’ applications of existing governance regimes to emerging reproductive technologies' by Walter G Johnson and Diana M Bowman in (2022) 9(1) Journal of Law and the Biosciences comments 

Over the past 5 years, advanced assisted reproductive technologies (ARTs), such as mitochondrial replacement therapies (MRTs) and heritable human genome editing (HHGE), have raised global policy concerns and fears of ‘unregulated’ proliferation. Yet, few innovations are ever truly unregulated and more often fall within the scope of one or more pre-existing regulatory regimes, a process referred to as ‘inherited regulation’. While the United Kingdom has enacted new legislation to specifically authorize and closely regulate MRTs, many jurisdictions will likely default to current oversight systems to manage advanced ARTs. This article evaluates and compares how several jurisdictions have already used four types of inherited regulatory regimes to manage MRTs and HHGE. Cases are drawn from jurisdictions where inherited regulatory interventions on advanced ARTs have taken place (USA, Greece, Ukraine, China, and Russia) and include jurisdictions closely connected with those cases (Mexico and Spain). When accounting for political, cultural, and religious contexts, many of these inherited regimes offer promise as starting points for governance of advanced ARTs, yet each will require further adjustments and tailoring to adequately manage the benefits and risks of these powerful innovations.

The authors argue 

Technology has long influenced how and when human reproduction can occur, transforming and being transformed by everything from social values to economic structures in the process. Yet, over the past four-and-a-half decades, the actual or potential role of technology in reproduction has rapidly expanded. The birth of Louise Brown in 1978 through in vitro fertilization (IVF) catalyzed the clinical application of assisted reproductive technologies (ARTs) around the world as well as ethical and policy debates around their use. Incremental innovation in ART methods now occurs continuously, aiming to increase the success rates of pregnancy and live births through established fertility treatments. However, more radical or ‘seismic’ innovations in ARTs have also occurred since the turn of the millennium, making novel reproductive options possible with corresponding policy implications. 

These advanced ART techniques move beyond IVF and related methods by manipulating gametes, embryos, or even somatic cells at the organelle, genomic, or gene expression levels, ultimately producing a viable embryo biologically related to the intended parents. Advanced ART techniques began to arise over two decades ago with reproductive cloning and ooplasmic transfer, although the controversies they provoked resulted in legislative and regulatory actions to block their use in many jurisdictions. Unlike earlier advanced ARTs, which lack direct health benefits for the resulting children, newer advanced ARTs promise significant benefits to at least a small number of families who otherwise would be unable to have a healthy, biologically related child. Such techniques, including mitochondrial replacement therapies (MRTs) and heritable human genome editing (HHGE), have not yet achieved widespread use. Yet, the healthy births of multiple children from MRTs across a handful of jurisdictions and a single use of HHGE yielding three children in China foreshadows a coming time where the technologies may become more widely adopted. 

In this article, we trace how multiple states have already used available regulatory systems to steer the use of, or prohibit, certain advanced ART techniques. Scholars have already begun to make comparisons of several states’ approaches to one type of advanced technique, MRTs, addressing the matters of how jurisdictions conceptualize and categorize the technology or whether states have or will enact novel regulatory regimes. This article takes a different approach by comparing oversight responses to both MRTs and HHGE that are grounded in existing rules and regulatory authorities (rather than novel frameworks) and examining the type of regulatory regime applied in each case, assuming that the regulation of one form of advanced ART will undoubtedly inform decision-making around others. By focusing on how jurisdictions can use existing oversight mechanisms, conceptualized here through the lens of inherited regulation, we aim to illustrate how these advanced ARTs are not truly ‘unregulated’ and explore the normative dimensions of wielding inherited regulation in this space. As global debates continue over how states and the international community should respond to MRT and HHGE, comparative analysis and a recognition that advanced ARTs can trigger inherited regulatory regimes may offer insights relevant to policymakers and stakeholders more broadly. 

In this article, we find evidence of jurisdictions taking multiple different approaches to using existing regulatory structures and instruments to manage advanced ARTs, and we argue that effectively using these regimes will require policymakers to thoughtfully, and incrementally, tailor their requirements to advanced ARTs. For some jurisdictions, this will require coordinating multiple inherited regimes, potentially at multiple levels of government. Section II provides an overview of two nascent advanced ARTs, which have already seen clinical use, before Section III introduces the theoretical framework of inherited regulation. Five case studies of inherited regulatory interventions on advanced ARTs are presented in Section IV, followed by a comparison and discussion of these cases in Section V. Concluding thoughts and implications for policy strategies around advanced ARTs and inherited regulation are set out in Section VI.

Informatics

'Family informatics' by Enrico Coiera, Kathleen Yin, Roneel V Sharan, Saba Akbar, Satya Vedantam, Hao Xiong, Jenny Waldie and Annie Y S Lau in (2022) 29(7) Journal of the American Medical Informatics Association 1310–1315 comments 

While families have a central role in shaping individual choices and behaviors, healthcare largely focuses on treating individuals or supporting self-care. However, a family is also a health unit. We argue that family informatics is a necessary evolution in scope of health informatics. To deal with the needs of individuals, we must ensure technologies account for the role of their families and may require new classes of digital service. Social networks can help conceptualize the structure, composition, and behavior of families. A family network can be seen as a multiagent system with distributed cognition. Digital tools can address family needs in (1) sensing and monitoring; (2) communicating and sharing; (3) deciding and acting; and (4) treating and preventing illness. Family informatics is inherently multidisciplinary and has the potential to address unresolved chronic health challenges such as obesity, mental health, and substance abuse, support acute health challenges, and to improve the capacity of individuals to manage their own health needs. 

The authors state

 A family is a network of individuals that may share obligations, needs, behaviors, routines, and rituals that can shape individual health choices. Family members may have a shared genetic, environmental, or socioeconomic context and together have emergent needs that may supersede those of the individual. 

Healthcare services in the main focus on the needs of individuals and see families as a support mechanism for the individual. Families for example can have a collective responsibility for managing geriatric, pediatric, and mental health conditions of their members. However, a family itself is a health unit, and different families exhibit different degrees of ‘health’. Serious illness in one family member may create psychological burden on others. In a pandemic, one infected family member may force all to isolate with heightened risk of infection. Resource- or time-poor families may put collective needs (such as securing financial income) above any impact on the health of individuals. Family coping styles such as adaptability may contribute to positive health outcomes for family members but some family behaviors can be obstructive and create barriers to health management. Family influences may affect the management of acute and chronic conditions, and play a significant role in preventative health. 

There is a similar focus on individuals in health informatics. Information services typically support individual clinician decision making about individual patients or populations. Consumer informatics also mainly focuses on supporting the health needs of individuals through self-care.  While there has been early and promising attention paid to understanding the information needs of families, it is still largely ignored by the mainstream. 

In this paper, we argue that family informatics is a necessary evolution in the scope of health informatics. If we are to comprehensively deal with the health needs of individuals, we must ensure our technologies account for and exploit the role of families. If we are to address the unique health needs of families, we may need new classes of digital service. 

To better understand these opportunities, we use the lens of social networks to conceptualize the structure, composition, and behavior of families. We examine the unique tasks that fall to families and describe possible categories of family-focused digital interventions that could meet these needs.