Cryo

'Cryopreservation and current legal problems: seeking and selling immortality' by Alexandra Mullock and Elizabeth Chloe Romanis in (2023) 10(2) Journal of Law and the Biosciences comments 

 Cryonics, the ‘freezing’ of the human body after death in the hope of reanimation in the future, remains a remote possibility, and yet it is becoming a more popular choice. There has been much academic discussion of the ethics of cryopreservation; however, the legal problems have received little attention. There are, however, several potential current conflicts that might arise, as was illustrated by the case of JS in England, in which a 14-year-old girl who sought cryopreservation against her father’s wishes. In the USA, there have been disputes within families about cryonic preservation, and between cryonics organizations and loved ones of the deceased when there is negligent preservation. Cryopreservation raises questions concerning the law on death and posthumous interests, property in the body, contract law, and (potentially) negligence. We argue that, in the absence of proper regulation, cryonics organizations may be able to exploit the dying and dead. The potential legal problems that we have identified in relation to the law in England and Wales demonstrate that the law is ill-equipped to protect the interests of the dead and their next of kin. 

Waking the dead after cryopreservation remains science fiction. While freezing human cells and tissue is well established in medicine—particularly freezing gametes or embryos for fertility treatment—life after death via cryopreservation remains impossible. Despite the state of the science, people are opting for this technology and entrusting their ‘remains’ to cryonics companies, and interest in doing so is increasing. Individuals can arrange for either their entire body or their head to be frozen after death, and thereafter preserved with the hope that reanimation (and cure) is eventually possible. The question of whether such a hope will ever be fulfilled is not our concern and this article does not attempt to engage with unknown futures and science fiction. Rather we are concerned about the current legal uncertainty over preserving the dead in this way and the potential for legal conflict this raises for the living relatives of the deceased in the present. In this paper, we consider the legal uncertainties in the jurisdiction of England and Wales. 

An example of conflict over cryopreservation was seen in Re JS, in which a 14-year-old-girl with a rare form of terminal cancer successfully sought a court order to allow her body, after death, to be cryonically preserved without the approval of her estranged father. While this case set no precedent approving or encouraging cryonics, questions about the way the process would be handled prompted Jackson J to conclude that proper regulation of cryonics was needed. As JS illustrated, the current law is struggling to accommodate the cryonic process, the interests of those preserved and their relatives. The conflict in JS reveals how those with an interest in what happens to the body of a deceased relative may seek to prevent cryopreservation. Moreover, because the process and maintenance of cryonics involves an ongoing obligation to preserve the body of the deceased, whose legal rights died with them, questions arise, and are addressed in this paper, over the nature of any legal obligations to the next of kin and importantly, who has the legal right to possess the preserved body or head in the event of a dispute. 

While the ethics of cryonics have been considered in some depth, the legal questions have received less attention. Perhaps this is unsurprising. Conway takes the view that so few people in the UK are choosing cryonic preservation that regulating to address such rare needs is ‘not such an urgent task’. However, we believe that examining the issues to better inform the debate before regulation becomes a more urgent task is a worthwhile exercise. Some people are already using this technology, and the potential for legal problems and conflict is significant. Many of the legal issues we explore in this article are speculative, but such an investigation is necessary to consider what may be problematic about cryonics, and to consider potential legal solutions. Furthermore, because of the importance attached to respecting the wishes and the remains of the dead, and the logistics of preserving and storing the dead in this context, cryopreservation raises particularly sensitive and potentially disturbing issues. Such issues require thorough consideration before a court is compelled to resolve a dispute concerning cryopreservation. 

There is nothing to prevent individuals in England and Wales from choosing cryonic preservation after death, provided they can pay for it and make the necessary arrangements to be frozen and stored at a cryonics organization. There is, however, somewhat of a legal vacuum when it comes to the potential legal problems or conflicts between interested parties surrounding cryonic preservation. Consequently, it is important to examine problems that have arisen — in Re JS and in the USA — and to speculatively consider foreseeable legal problems related to use of technology in advance of such conflicts materialising in the jurisdiction of England and Wales. 

In this article, we first consider how the initial arrangements are conducted with the relevant organizations and the challenges of ensuring that cryopreservation ensues, particularly in England and Wales. These complications may arise while the person intending to become a cryon is still alive/dying and thus is a legal person. We then discuss ‘conflicts about cryopreservation’— namely, what happens where family members oppose cryopreservation (even though favored by the dying/dead individual), or where the state has requirements for bodily treatment/investigation after death, or, if a problem arises with the process immediately after death. We then consider ‘conflicts in preservation’—namely, disputes between the dead/their next of kin and cryonics organizations where there is a failure to cryonically preserve a body, or the process is in some way negligent. All these disputes are complicated because they often occur once the person who had wanted to be preserved is no longer alive, and thus no longer a legal person. Finally, we consider ‘disputes after preservation’—these are primarily questions of who, in the event of a dispute, has the right to possess, or perhaps ‘own’ a cryopreserved body when that body (definitively no longer a legal person) effectively becomes a chattel. While the general rule is that the body is not property, we argue that cryonic preservation could transform human remains into property. While the family initially has a strong claim in deciding what happens to the body in terms of how the body is disposed of, once the cryonic organization takes possession and exercises skill in preserving the body, the issue of ownership becomes unclear. 

As Re JS illustrated, people may opt for cryopreservation as a way of dealing with or processing their death, perhaps as a means of obtaining some comfort and hope about the end of their life. Our analysis demonstrates that this choice makes them incredibly vulnerable in several ways. We highlight how, without proper regulation in a number of areas, cryonics organizations are able to exploit the dying and dead, and potentially also create significant legal problems, with associated emotional distress, for the family of the deceased person.

Biometrics

'Glukhin v. Russia' by Monika Zalnieriute in (2023) 117(4) American Journal of International Law 695-701 comments 

 Glukhin v Russia is the first ECtHR decision on the use of FRT; it portends a strong foundation for further restricting how governments use FRT. For two reasons, however, there is little certainty as to the future of the ECtHR’s approach to mass FRT-surveillance in public spaces. First, the ECtHR tends to focus heavily on procedural safeguards - what I have called its procedural fetishism; and second, the case concerned Russia – a former Member State of the Council of Europe. In this case note, I argue that ECtHR’s trend towards procedural fetishism is particularly dangerous, for it legitimizes mass FRT-surveillance in public spaces, including when used to tackle protest movements globally. 

On July 4 2023, the Third Section of the European Court of Human Rights (ECtHR) ruled in Glukhin v Russia, that administrative conviction for a protester’s failure to notify Russian authorities of his intention to hold a solo demonstration, and the use of facial recognition technologies (FRT) to convict the protester, violated his rights to a private life and freedom of expression, guaranteed under Articles 8 and 10 of the European Convention on Human Rights (‘the Convention’ or ‘ECHR’). The use of FRT enabled authorities to track down the Russian national and arrest him within seven days of the alleged offence. Mr Glukhin was arrested, with CCTV and social media footage being used in administrative proceedings against him. The ECtHR found that the Russian Government’s actions violated Articles 8 and 10 of the Convention. 

This is the first ECtHR decision on the use of FRT; it portends a strong foundation for further restricting how governments use FRT. For two reasons, however, there is little certainty as to the future of the ECtHR’s approach to mass FRT- surveillance in public spaces.

Zalnieriute's 'Against Procedural Fetishism: A Call for a New Digital Constitution' in (2023) 30(2) Indiana Journal of Global Legal Studies argues 

Digital constitutionalism, to date, has been proceduralist; it has assumed that transparency and due process can temper power and attain justice for people vis-à-vis the automated state and powerful tech companies. So far, digital constitutionalism has also been very soft and blind to its own coloniality: Instead of deploying hard law, we are still looking for ways to pressure digital behemoths to self-regulate. We downplay US dominance, colonial exploitation, and environmental degradation caused by digital imperialism. Meanwhile, the power of tech companies has escalated. They now influence many aspects of our public and private lives, from elections to our own personalities and emotions, to environmental degradation. To be successful, the project of digital constitutionalism must resist a corporate agenda of procedural fetishism, a strategy to redirect the public from more substantive and fundamental questions about the concentration and limits of power to procedural microissues. Such diversion merely reinforces the status quo. 

To rectify the imbalance of power between people and tech companies, a new digital constitution must therefore try something different. It must shift its focus from soft law initiatives to tangible legal obligations by the tech companies. We must redistribute wealth and power not only by breaking and taxing tech companies, fortifying regulatory enforcement, increasing public scrutiny, and adopting prohibitive laws but also by democratizing big tech by making them public utilities and giving people a say how these companies should be governed. Crucially, we must also decolonize digital constitutionalism through recognition of colonial practices of extraction and exploitation and paying attention to the voices of Indigenous peoples and communities of the so-called Global South. With all these mutually reinforcing efforts, a new digital constitution will debunk the corporate and state agenda of procedural fetishism and will establish the new social contract for the digital age.,

Regulating AI

'Licensing high-risk artificial intelligence: Toward ex ante justification for a disruptive technology' by Gianclaudio Malgieri and Frank Pasquale in (2024) Computer Law and Security Review comments 

The regulation of artificial intelligence (AI) has heavily relied on ex post, reactive tools. This approach has proven inadequate, as numerous foreseeable problems arising out of commercial development and applications of AI have harmed vulnerable persons and communities, with few (and sometimes no) opportunities for recourse. Worse problems are highly likely in the future. By requiring quality control measures before AI is deployed, an ex ante approach would often mitigate and sometimes entirely prevent injuries that AI causes or contributes to. Licensing is an important tool of ex ante regulation, and should be applied in many high-risk domains of AI. Indeed, policymakers and even some leading AI developers and vendors are calling for licensure in the area.  

To substantiate licensing proposals, this article specifies optimal terms of licensure for AI necessary to justify its use. Given both documented and potential harms arising out of high-risk AI systems, licensing agencies should require firms to demonstrate that their AI meets clear requirements for security, non-discrimination, accuracy, appropriateness, and correctability before being deployed. Under this ex ante model of regulation, AI developers would bear the burden of proof to demonstrate that their technology is not discriminatory, not manipulative, not unfair, not inaccurate, and not illegitimate in its lawful bases and purposes. While the European Union's General Data Protection Regulation (GDPR) can provide key benchmarks here for ex post regulation, the proposed AI Act (AIA) offers a first regulatory attempt towards an ex ante licensure regime in high-risk areas, but it should be strengthened through an expansion of its scope and substantive content and through greater transparency of the ex ante justification process. 

Regulating AI is difficult. Complex technology, under-resourced regulators, substantial economic consequences, and high risks for fundamental rights all contribute to this difficulty. Thanks to the well-recognized “black box” problem, identifiable AI abuses are only the tip of an iceberg of problems.1 AI systems can be opaque, nonlinear, and unpredictable, and they evolve rapidly. This makes it difficult to keep ex post, reactive regulations up to date with the latest technological advances. Years-long litigation will also often fail to set relevant precedents and standards before major damage occurs. Meanwhile, many AI developers either lack legal expertise, or ignore potential legal problems, and they often have vastly more resources than the authorities supposedly monitoring and regulating them. 

These asymmetries cause many problems, pressuring governments to prioritize innovation (however destructive its effects) at the cost of fundamental sacrifices of societal values. Since jobs and growth are often far easier to quantify than, say, the negative effects of discrimination or disinformation (amongst the many harms unregulated AI can cause), inadequate regulations and enforcement are endemic to the field. In addition, AI regulatory frameworks cannot guarantee a good level of accountability of AI providers if they foresee small fines in case of AI misuse. A small dent in profits is not enough to deter bad behaviour; rather, it is treated as a cost of doing business. This can incentivize companies to take risks with their AI systems and prioritize profits over safety and ethical considerations. This would be understandable if AI were only a concern of a small number of scientists and laboratories. But it is now evident that the use of AI in business, policing, administration, and beyond, poses high risks to fundamental rights, such as privacy and equality, and can perpetuate and even amplify biases and discrimination, which can have a significant impact on individuals in a situation of vulnerability. 

This paper will criticise policymakers’ over-reliance on ex post legal measures, including fines and penalties, and will advocate for AI licensure, taking inspiration jointly from the European Union's General Data Protection Regulation and the proposed AI Act, but going well beyond these approaches. Their approach might not prevent harm from occurring in the first place. A more proactive approach, ex ante rather than ex post, would require companies to meet certain safety and ethical standards before deploying AI systems, would be more effective in preventing harm and ensuring accountability. While the GDPR has essential principles for AI justification (including fairness and purpose limitation), it is generally more based on an ex post approach, since there is no requirement for prior administrative authorisation for high risk data processing. On the other hand, the proposed AI Act is based on an ex ante model (conformity assessment before commercialisation), but that model might prove limited in its scope (the rigid list of high-risk AI systems might be not adequate), substance (the proposed draft does not refer to, e.g., a fairness principle) and transparency (there is no duty to disclose the ex ante justification statement to the public). 

A key regulatory tool for an ex ante regime is licensure. Under a licensing system, products, services, and activities are unlawful until the entity seeking to develop, sell, or use them has proven otherwise. High-risk AI's documented and potential harms indicate a strong case for a licensure regime here. Under our proposal, to obtain a license, a high-risk AI provider must certify that its AI system meets clear requirements for security, non-discrimination, accuracy, appropriateness, and correctability before it is commercialized. Such a standard may not seem administrable now, given the widespread and rapid use of AI at companies of all sizes. But such requirements could be applied, at first, to the largest companies’ most troubling practices, and then gradually to other applications of AI. Under such a regime, AI providers may, for example, be required to demonstrate basic practices of fairness, accuracy, and validity once they have used an AI system in use by, or affecting, over 1 million people. Since government often charges fees for licenses, this system may also prove effective at providing much-needed resources to regulatory bodies now struggling to keep up with the AI revolution. 

Our proposal builds on existing scholarship and regulatory proposals and practices. Scholars have argued that certain data practices should not be permitted; licensure would help ensure that they are indeed prohibited. Rather than expecting underfunded, understaffed regulators to overcome monumental black box problems after harm has been done, responsibility could be built into the structure of data-driven industries via licensure schemes that require certain standards to be met before large-scale data practices expand even further. Licensure should spur fundamental quality improvements in the realm of product-based and services-based AI, including automobiles, aircraft, logistics, smart infrastructures, financial and employment recommendations, and scoring. There is increasing concern about the validity of the data used in AI and the algorithms it is based on. Rather than addressing all these concerns in an ex post way via tort-based judicial actions or audits and litigation by regulators, the ex ante approach of licensure must be part of the regulatory armamentarium. There are some wrongs that can arise out of AI that are too serious to be recompensed ex post. 

In addition, a solely ex post approach can create unnecessary risks for fundamental rights of consumers and end-users. Suppose that after a period of time of intensive use of an AI system (e.g., an App) by a massive number of consumers, regulators find that AI-driven app violates the law. A possible sanction might be to block the app and prevent those people to continue using that system. However, considering the period when the app was largely used, people might experience the need of that app, based on a psychological, economic or functional dependency from that AI system. Such harms occurred after the Italian ex post prohibition of Replika and ChatGPT, where many users experienced emotional distress and similarly significant adverse effects after that the Italian DPA prohibited those AI-driven systems. To be sure, the Italian moves here were warranted. Nevertheless, regulators’ ex post approach created the paradox that both keeping an AI system in use and prohibiting it risked either harming or reducing the utility of individuals. By contrast, conditioning the burden of proof on AI providers to provide a justification of fairness, safety, non-discrimination, and integrity ex ante would prevent such troubling double binds, and many other problems. 

Beyond its value in preventing avoidable harms and double binds for regulators, a licensure regime for AI would also enable citizens to democratically shape technology's scope and proper use, rather than resigning themselves to forces beyond their control. To ground the case for more ex ante regulation, Part 2 catalogues the limitations of ex post approaches in the regulation of AI, while Part 3 examines the substantive foundation of licensure models by elaborating a jurisprudential conception of justification. Part 4 addresses the institutional dimensions of our licensure proposal and addresses objections. Part 5 concludes with reflections on the opportunities created by AI licensure frameworks and potential limitations upon them. This paper focuses mostly on the EU law. However, when formulating its proposal, it makes a necessary comparison with other legal systems, where the models of ex ante prohibition and licensures are already a reality or where the legal discussion can already offer some important food for thought.

Indicia

'Fraud, Trusts and Trusting: Enforcing Crown Forfeitures in Equity, c.1570–1620' by David Foster in (2023) The Journal of Legal History comments 

Conveyances with informal agreements to hold for the benefit of the transferor initially proved efficacious in avoiding statutory forfeiture provisions. In the late sixteenth century, the equity side of the Exchequer developed a capacious doctrine of revenue fraud designed to capture such informal arrangements and to subject the transferor to liability for crown forfeitures. Initially drawing inspiration from the ‘badges of fraud’ in the Statute of Fraudulent Conveyances 1571, the Exchequer quickly lowered the evidentiary threshold required to prove a conveyance fraudulent. A key badge of fraud was an ‘entrusting’ of the transferee by the transferor. The presence of a conveyance ‘in trust’ eventually became the sole evidence required to hold certain conveyances fraudulent under the statute. In the longer term, these cases became the precedential basis for holding the beneficiary’s right under a trust liable to forfeiture as a matter of doctrine. 

Those who expected to find themselves liable to crown forfeitures might take steps to conceal their property in the name of another. From the medieval period, statutory forfeiture provisions had been passed to capture property hidden by means of a use or trust, but these provisions proved difficult to enforce where property was conveyed subject to an informal agreement to reconvey or to hold ‘in trust’ for the transferor. Notwithstanding the succession of statutes designed to prevent the avoidance of legal rights by feoffments to uses, we find in the preamble to the Statute of Uses 1536 the continuing complaint that, by uses, ‘the king’s highness hath lost the profits and advantages of the lands of persons attainted’.  From the late sixteenth century, the case law increasingly focused on so-called ‘fraudulent conveyances’ which had the effect of defeating the crown of its forfeitures. The expansive approach to fraud adopted on the equity side of the Exchequer proved effective in protecting crown revenues flowing from forfeitures. Litigation touching fraudulent conveyances made ‘in trust’ arose in the context of forfeitures for outlawry, recusancy, departure from the realm without licence, and treason. By the second decade of the seventeenth century, the case law had coalesced into a relatively stable body of rules governing crown rights in equity. 

This article considers the case law in the period c.1570–1620 and the emergence of clear principles governing crown forfeitures on the equity side of the Exchequer. As we shall see, references in the cases to ‘conveyances in trust’ left ambiguous the technical form of the disputed conveyance; whether a mere informal ‘entrusting’ or a more formally drafted ‘trust’ in the form of an active use or use upon a use.The fluidity of the language of trusts and trusting would prove fertile ground for subsequent developments – particularly as later jurists came to regard these early cases as determining the incidents of the beneficiary’s right under a trust.

Pharma Markets

'In the Name of Transparency: Organizing European pharmaceutical markets through struggles over transparency devices' by Susi Geiger and Théo Bourgeron in (2023) 44(11) Organization Studies comments 

The controversies surrounding the heavily redacted contracts between the European Commission and Covid-19 vaccine producers have highlighted ‘transparency’ as a hotly debated concept in the pharmaceutical market. We combine research on transparency with literature on the organization of markets to investigate how such struggles over competing visions of transparency end up shaping markets and their politics. Focusing on the case of the European pharmaceutical market, we demonstrate how market transparency was implemented through devices that enacted specific visions of transparency and produced distinct market organizations over time: transparency for states (until about 1990), transparency for corporations (ca. 1990 to 2010) and transparency for state coalitions (since 2010). We discuss how the specific instrumentations and materializations of such visions of transparency play a crucial role in market politics. This debate also highlights why engaging in controversies over transparency has become increasingly important for those contesting the market status quo – in pharmaceutical markets and beyond. ... 

Why aren’t markets more transparent? During the Covid-19 pandemic, this issue was a lively point of debate as activists and politicians questioned the opacity in which Covid-19 treatments and vaccines were ordered, priced and distributed (Centre for Global Development, 2021; Londeix & Martin, 2022). In May 2019, a few months before the virus started to spread, a resolution had already been passed at the World Health Assembly (WHA, 2019), which ordered member-states to ensure transparency in pharmaceutical markets. Making visible a push for transparency by state actors themselves, the resolution aimed to reduce the spaces of opacity in which high prices for medicines were said to proliferate (Shaw & Mestre-Ferrandiz, 2020). Yet, while states, corporations and civil society all agreed on the benefits of ‘more transparency’, its very definition was a contested one. Shortly after the WHA, a pharmaceutical spokesperson published a column suggesting an alternative vision of transparency, one that focused on making the decision-making processes of payers more transparent to corporations (Roedinger, 2019). How do such contestations around visions and definitions of transparency act to reorganize markets, and to whose benefit? 

Once the exclusive concern of stock market regulators and neoclassical economists looking for markets emanating ‘correct’ informational signals, transparency has become a ubiquitous issue in public debate in markets ranging from pharmaceuticals, capital markets, international trade, raw materials and housing to food (BEUC, 2018; EPHA, 2021; Transparency International, 2016). This practical concern over market transparency as a governance ideal arises at a time when organization studies have started to illuminate how the notion of transparency is put to use by policymakers, civil society and corporations (Hansen & Weiskopf, 2021; Heimstädt & Dobusch, 2020; Reischauer & Ringel, 2023; Weiskopf, 2023). This research highlights the constitutive qualities of transparency, where ‘transparency as a form of ordering’ (Flyverbom, 2015, p. 168) shapes organizations and actor conduct. 

We transpose this constitutive view of transparency into the context of markets, demonstrating how shifting meanings of transparency have concrete organizational consequences as they become translated into socio-material market arrangements. We highlight that visions of transparency are materialized through what Harvey, Reeves and Ruppert (2013) called transparency devices, and we investigate the role that these devices play in the organization of markets. Our study contributes to research that moves beyond normative views of market transparency (Roscoe, 2022; Roscoe & Willman, 2021) by analysing the struggles that occur around competing visions of transparency and, crucially, by tracing how these struggles shape markets. 

Investigating such struggles, we claim, is vital to understand market politics. Focusing on the evolution of the European pharmaceutical market, we highlight how the strategic deployment of arrangements that promote selective visions of transparency is a key mechanism to reorganize markets and direct funding to specific actors. In this perspective, a lack of transparency is not the outcome of ill-designed markets – in the pharmaceutical market at least, our investigation shows how (shifting) definitions of transparency were carefully organized with political objectives in mind. Our paper highlights certain moments in time in which transparency assumed a ‘post-political’ role in markets. In post-politics, superficially consensus-based regulatory norms such as transparency are used to ‘hide fundamental differences in interests and power resources’ behind technical settlements (Garsten & Jacobsson, 2013, p. 422; Wilson & Swyngedouw, 2014). In our case, such settlements worked to conceal fundamental conflicts between corporations, states and patients. However, by focusing on transparency’s technical implementation through devices, we also expose the politics around this post-political concept, emphasizing how it has become not only a consensual key organizing principle but also a technocratic battlefield for promoting alternative market organizations. By highlighting these market politics, our discussion offers insights into how civil society and state activists currently reclaim transparency to challenge the market status quo, in pharmaceutical markets and beyond.

'Building the weak hand of the state: tracing the market boundaries of high pharmaceutical prices in France' by  Théo Bourgeron and Susi Geiger in (2022) 27(5) New Political Economy 837-850 comments

Prices for new medications have strongly increased over the last decades, reaching levels that could endanger healthcare insurance systems. Focusing on the French case, this article builds on the structural approach of business power and investigates how this situation results from the construction of market boundaries that created unassailable spaces for high pricing. Starting from the 1990s, it traces how high drug prices relied on the construction of a market setting first designed to increase pharmaceutical prices, in which the negotiating position of the state was deliberately weakened. But the politics of maintaining such high drug pricing quickly required reshaping the boundaries of the pharmaceutical market and concentrating the favourable negotiation framework on a small number of innovative medicines. Most recently, the spiralling of prices for these medicines have necessitated yet another revisiting of these market boundaries. High drug prices do not result from direct business power by the pharmaceutical sector; rather, the pharmaceutical sector depends on boundary-work performed in cooperation with state institutions to carve out domains for favourable market pricing. Emphasising the politics of this boundary-work thus ultimately also signals its potential reversibility. 

In 1989, the French Minister of Health was defending its ‘New Pharmaceutical Policy’ bill. This bill was essential, he argued, because it would ‘ensure the conditions of growth for the pharmaceutical industry’ by rebalancing the negotiations between pharmaceutical companies and the state, allowing the former to obtain higher prices to be competitive on the European single market.  In 2019, Chantal Delorgey, the head of the French health agency Haute Autorité de la Santé (HAS), was wondering whether the relationship between public payers and pharmaceutical manufacturers had become too unbalanced (EPHA 2019). This time, pharmaceutical firms were accused of being in the strong position, building their negotiating power on a market structure that pushed the prices of new medicines to unsustainable highs. This article draws up a history of what happened in the intervening 30 years and describes the intense institutional construction that has shaped the positions of public payers and private firms in the French pharmaceutical market over time. 

Digging into this history reminds us that current high prices for medicines result from political struggles mediated by contested market mechanisms. High prices have become an integral part of the pharmaceutical business model, allowing manufacturers to sustain high levels of profit (Froud and Sukhdev 2006). Past research has investigated how these levels of profits allow pharmaceutical firms to adopt a financialised business model that involves the reconfiguration of biochemical compounds, intellectual property, clinical trials, and the pharmaceutical ecosystem towards profit-making (Dumit 2012, Rajan 2017, Lazonick et al. 2019, Bourgeron and Geiger 2022). These value-extraction strategies fundamentally rely on pharmaceutical companies’ ability to achieve high prices for their pharmaceuticals (Roy 2020), with some analyses predicting how an imbalance between states and multinational pharmaceutical companies may ultimately jeopardise universal access to medicines even in high-income countries (Tansey and Ainger 2019, EPHA 2020). This makes it crucial to understand the political economy determinants of high drug prices, an issue that has not been the topic of much scholarship, despite significant interest in pharmaceutical prices in general (Busfield 2006, Nouguez 2016, Nouguez and Benoît 2017) and in specific cases of high drug pricing (Roy and King 2016). Building on structural approaches of business power, we draw up a political economy of high drug prices by outlining, through the case of France, how their construction results from intense market boundary-work by policymakers and pharmaceutical companies. In our analysis, the weak negotiating position of European states results from the deliberate action of public authorities, who endorsed successive reforms of the boundaries of the pharmaceutical market aimed at replacing direct support to pharmaceutical firms through state aids with indirect support through prices, facilitated by favourable negotiation frameworks. This however loosened the state’s control on pharmaceutical companies and led to disputes over which medicines should enjoy such high prices. As healthcare activists and budget holders all over the EU struggle to maintain universal access to medicines, our perspective is crucial to map the boundaries of high pharmaceutical prices and understand where contestation opportunities lie. 

This article proceeds as follows. We first elaborate on the difficulties raised by high drug prices and explain how this calls for a conceptual background that combines a structural approach of business power with an attention to how the boundaries of markets are transformed. We then detail our methods and the complicated landscape of pharmaceutical price negotiation in France. This brief overview is followed by our historical study. It shows how the initial construction of pharmaceutical prices as market-based prices aimed at weakening the state in the negotiations with companies to help French manufacturers compete at the European level (1989-2003). It then highlights the boundary-work that led this market to be split into differentiated markets, where some medicines were allocated low prices through administrative procedures and others enjoyed favourable market pricing (2003-2011). Finally, it describes how high prices for innovative medicines negotiated through markets have become unsustainable for public payers, leading to further boundary-work and proposals to implement administrative caps on the highest-priced medicines (2011-2020)

Neurodiversity

The Senate Community Affairs References Committee report Assessment and support services for people with ADHD states 

This report of the Senate Community Affairs References Committee inquiry into barriers to consistent, timely and best practice assessment of attention deficit hyperactivity disorder (ADHD) and support services for people with ADHD draws on 700 submissions, and the evidence of 79 witnesses attending three days of public hearings across Australia. 

The committee thanks all those who made contributions to our deliberations. The committee has been moved by the personal experiences and openness of the hundreds of submitters and witnesses who have shared their ADHD experiences. It appreciates the time invested by the ADHD community and notes the ways the health, education, employment and justice systems have let people down. 

Over one million—or an estimated one in 20—Australians have ADHD. The committee has heard the experiences of many people with ADHD who have not been able to access the healthcare and supports that they need. This has had lifelong impacts on them and their families, including on their self-esteem, health, relationships, education, employment and financial situation. 

The committee notes that not all people with ADHD define their experience through medical models of understanding and acknowledges that understandings of ADHD are constantly evolving. The committee further acknowledges that identity in the ADHD community is a varied and deeply personal experience. People with ADHD may or may not identify with their diagnosis, as members of the disability community, or as neurodivergent people. 

Over the course of the inquiry, the committee found that barriers to people with ADHD accessing assessment, diagnosis and support services include:

• Lack of services—limited availability and long wait times for healthcare professionals to diagnose, and provided medication and other supports to people with ADHD, lack of services in the public health system, especially for adults with ADHD and insufficient services in rural, regional and remote areas. 

• High costs of services—including insufficient coverage under Medicare, the Pharmaceutical Benefits Scheme (PBS) and the National Insurance Disability Scheme (NDIS). 

• Poor consumer experiences—caused by lack of reliable information about ADHD, overly bureaucratic processes, fragmented care, inconsistent prescribing regulations, and stigma and variable quality of healthcare associated with ADHD, as well as use of stimulants. 

• Lack of supports in schools, out-of-home care and correctional facilities. 

• Specific challenges for key groups including girls, women and gender-diverse people, First Nations peoples and people from culturally and linguistically diverse backgrounds. 

Having considered the considerable and varied evidence provided, the committee is of the view that more can be done to remove barriers for people with ADHD so that they can receive the assessments, healthcare and support they need. The costs of the current system are too high, given the costs to the healthcare, education and justice systems, as well as to employers. However, above all these costs are the significant personal health, wellbeing and financial costs to people with ADHD and their families and carers. 

Overwhelmingly, people with ADHD want more accessible support to help them thrive and reach their best potential—in their relationships, in their studies and in their work. The committee has made its recommendations to the Senate and looks forward to receiving the government response to the concerns raised during this inquiry. 

Recommendations 

1  The committee recommends the Australian Government considers funding and co-designing a National Framework for ADHD, together with people with ADHD as well as ADHD advocacy and community organisations. 

2 The committee recommends the Australian Government consult with people with lived experience of ADHD, healthcare colleges and organisations to identify additional supports to improve access to ADHD healthcare and support. This should encompass reviewing bulk billing incentives to reduce out-of-pocket expenses for diagnosis and ongoing support, shared care models, telehealth, and improving access in rural, regional and remote areas. 

3  The committee recommends the Australian Government review the Medicare Benefits Schedule with a view to improving the accessibility of assessment, diagnosis and support services for people with ADHD. 

4  The committee recommends the Australian Government review the Pharmaceutical Benefits Scheme (PBS) to improve the safe and quality use of medications by people with ADHD. This review should give consideration to the requirements for a diagnosis to access some medications, age restrictions, dosage restrictions and the scope of practice for clinicians prescribing medications. 

5  The committee recommends that the Commonwealth expedite the development of uniform prescribing rules to ensure consistency between state and territory jurisdictions, through the Ministerial Council on Health. 

6 The committee recommends the Australian Government, in collaboration with people with ADHD and ADHD advocacy and community organisations, develop a dedicated government ADHD information portal. 

7  The committee recommends the Australian Government implement, through the Department of Health and Aged Care, a neurodiversity-affirming public health campaign to shift social attitudes and stigma associated with ADHD and to improve public awareness and promote education. 

8 The committee recommends the National Disability Insurance Agency improve the accessibility and quality of information around the eligibility of ADHD as a condition under the National Disability Insurance Scheme (NDIS). 

9 The committee recommends that the Department of Social Services provide ongoing funding for disability advocacy organisations, including ADHD advocacy organisations, to support people with ADHD. 

10 The committee recommends the Australian Government works to improve training on recognising and meeting the needs of ADHD people in a variety of settings, such as in education, institutional settings and the workplace, including considering setting minimum standards for neurodiversity training. 

11 The committee recommends that the Australian Government work towards improving specialised health services in institutionalised settings, including for people with ADHD. 

12 The committee recommends the Australian Government, through the current ‘Scope of practice review’ and in collaboration with healthcare colleges, develop pathways which could include an expansion of the range of healthcare professionals who are able to provide ADHD assessment and support services, particularly General Practitioners and Nurse Practitioners, and improve the skills of all healthcare professionals who interact with people with ADHD. 

13 The committee recommends all levels of government consider investing in the implementation of the Australian ADHD Professionals Association’s Australian evidence-based clinical practice guideline for ADHD, along with funding to promote the guideline to healthcare professionals and healthcare policy-makers. 

14  The committee recommends that the Australian Government consider investing in ADHD lived experience non-profit support, disability and advocacy organisations. Such funding would enable these organisations to provide community-based and targeted services to people with ADHD, such as an advice and support helplines, legal aid, financial counselling and assistance in finding assessment, treatment and support pathways. 

15 The committee recommends the Australian Government support further research, through the Australian Government’s Medical Research Endowment Account (administered by the National Health and Medical Research Council) and the Medical Research Future Fund (administered by the Department of Health and Aged Care), to better understand ADHD, and ways to address stigma. The committee suggests that further research is needed into:

• support available to people with ADHD, including evidence-informed clinical care and peer support; 

• addressing the stigma that people with ADHD experience including in healthcare, education and the community; 

• non-hyperactive presentations of ADHD and gender bias; 

• ADHD in First Nations, culturally and linguistically diverse and LGBTQIA+ communities

Bioethics

'Equality-enhancing potential of novel forms of assisted gestation: Perspectives of reproductive rights advocates' by Elizabeth Chloe Romanis in (2023) Bioethics comments 

Novel forms of assisted gestation—uterus transplantation and artificial placentas—are highly anticipated in the ethico-legal literature for their capacity to enhance reproductive autonomy. There are also, however, significant challenges anticipated in the development of novel forms of assisted gestation. While there is a normative exploration of these challenges in the literature, there has not yet, to my knowledge, been empirical research undertaken to explore what reproductive rights organisations and advocates identify as potential benefits and challenges. This perspective is invaluable. These organisations/individuals have an awareness not only of the needs of individuals but also of the political landscape in which regulatory decisions are made and which individuals navigate when seeking reproductive assistance. In this study, data was generated from two semi-structured focus groups (n = 11). Reflective thematic analysis was used to examine the views raised by study participants in these focus groups. This paper explores two of the themes constructed in the data. First, the equality-enhancing potential of assisted gestation exploring the multifaceted ways in which assisted gestation has structural benefits for marginalised groups. Second, realising the equality-enhancing potential of assisted gestation explores the intersecting barriers to access to reproductive technologies and how they may impede the benefits of these technologies in practice. These results can enhance conceptual understanding of the importance of novel forms of assisted gestation and ensure that attention is paid to practical barriers in further normative research.  

 

For people unable to gestate, whether for biological, social or psychosocial reasons, assisted gestation affords them the opportunity to become biological parents. Assisted gestation has long existed in surrogacy. However, novel reproductive technologies that make possible different forms of assisted gestation are on the horizon and are highly anticipated for the specific experiences they could afford people who cannot gestate. This article reports results from an empirical research project seeking the views of reproductive rights advocates in Great Britain about the benefits and limitations of novel forms of assisted gestation. 

 

Uterus transplantation (UTx) presents the possibility of enabling those without a uterus of their own (whether they were born without it or have had a hysterectomy) to gestate—experiencing pregnancy and birth. Since the first report of a live birth from a successful UTx in Sweden in 2014, approximately one hundred transplants have been successfully performed worldwide. While the procedure is not yet widely available and is yet to be performed in the United Kingdom (at the time of writing), it is described as an ‘emerging therapy that is transitioning from an experimental phase to an established clinical practice’. To date, the transplant has only been performed on people with physiology assigned female at birth (AFAB). However, one team of research surgeons have concluded that despite being challenging ‘there is no overwhelming clinical argument against performing UTx’ on a person with physiology assigned male at birth. 

 

A more futuristic endeavour is the artificial placenta, capable of facilitating gestation outside of the body (‘ectogestation’). Speculation about the possibility of gestation outside the body has increased since the publication of successful animal studies demonstrating proof of concept in 2017. There are now more teams working on the prospect, and promising results of animal testing continue to be published worldwide. These devices all have a similar design—a sealed system of warm amniotic fluid (in which the subject is located), with a cannula acting as an umbilical cord to deliver oxygen and nutrients and remove waste, and a pumpless oxygenator circuit. Researchers have indicated that they hope to begin testing on human subjects in the immediate future. Equity financing for clinical translation was secured in 2022 by the team working in Philadelphia. These devices are being designed specifically as a means of improving outcomes from extremely premature birth. Artificial placentas have the potential means of enhancing reproductive decision-making by ‘taking over’ gestation for people undertaking dangerous pregnancies. The technology, in its current iteration, can facilitate only partial ectogestation (since the technology is reliant on the subject having foetal physiology). In the future, artificial placentas might have further choice-enhancing potential by offering the ability to make decisions about what degree of bodily gestational labour individuals are willing to undergo in becoming a parent in a broader range of circumstances, for example, by enabling people to opt out of performing a complete gestation, or, even of undertaking gestation at all. 

 

There is a growing body of normative ethical literature that explores the benefits and potential limitations of both UTx and artificial placentas; however, this literature can be considered somewhat disjointed. These technologies are most often explored in isolation and while it is important that we consider what is different about each technology, considering forms of assisted gestation collectively can help us see the implications of arguments made about novel technologies in their broader context. Moreover, considering the genus of assisted gestation (and thus several technologies encompassed within it) can improve our conceptual understanding of the technologies. While these technologies work in different ways, there are some obvious synergies in their potential uses to aid people who cannot gestate, and they might be thought of as alternative options to address an inability to gestate by potential service-users. Thus, in this study, multiple forms of assisted gestation were considered. The study sought to ascertain the views of reproductive rights advocates about novel forms of assisted gestation—UTx and artificial placentas—drawing together experiences and reflections connected to each. 

 

To my knowledge, before this study, there had been no empirical research conducted exploring reproductive rights advocates’ perspectives on novel forms of assisted gestation. Empirical research with individuals working with or for reproductive rights organisations is key because they have an awareness of the experiences of different people who cannot gestate or who have experienced difficulties during gestation and birth and of the political landscape. Their insights are consequently invaluable in highlighting how individuals may want to access and use novel technologies, as well as some of the challenges they may face. This article reports results from a focus group study exploring these perspectives that was analysed using a reflexive thematic analysis approach. These results have utility in helping enhance the understanding of why assisted gestation is important, and what the potential access barriers are for individuals, in further normative research.