Ancestral Personhood

'Yoongoorrookoo: The emergence of ancestral personhood' by Alessandro Pelizzon, Anne Poelina, Afshin Akhtar-Khavari, Cristy Clark, Sarah Laborde, Elizabeth Macpherson, Katie O’Bryan, Erin O’Donnell and John Page in (2021) Griffith Law Review argues 

Since the momentous release of the Montecristi Constitution of Ecuador in 2008, which recognised Nature, or Pacha Mama, as a subject of rights, the rights of Nature movement across the world has gained exponential momentum, with numerous jurisdictions worldwide now recognising some form of legal subjectivity vested upon Nature. In particular, since 2017, river personhood has dominated news headlines around the world as one of the most recognisable forms of Nature’s novel subjectivity. The emergence of legal personhood for nature, however, has been far from uncontroversial, and numerous critiques have been advanced against the use of such a legal category – traditionally applied to humans and their abstract creations (such as States and corporations) – to the natural world, resulting in numerous calls for an alternative category of legal personhood (one that some rights of Nature advocates have termed an ‘environmental person’). Against the backdrop of this emerging debate, this paper acknowledges the work undertaken by the Martuwarra Fitzroy River Council (Martuwarra Council), which was established in 2018 in the Kimberley region of Western Australia by six independent Indigenous nations to preserve, promote and protect their ancestral River from ongoing destructive ‘development’. The Council believes it is time to recognise the pre-existing and continuing legal authority of Indigenous law, or ‘First Law’, in relation to the River, in order to preserve its integrity through a process of legal decolonisation. First Law differs markedly from its colonial counterpart, as its principles are not articulated in terms of rules, policies and procedures, but rather through stories. This paper, therefore, begins with a dialogical translation of one First Law story relating to Yoongoorrookoo, he ancestral serpent being,  to create a semantic bridge between two apparently distant legal worldviews. A dialogical comparative analysis is then followed to posit and explore the concept of an ‘ancestral person’ as a novel comparative tool that may be able not only to capture the idea of Nature as a legal subject, but also complex Indigenous worldviews that see Nature – in this case instantiated in the Martuwarra – as an ancestral being enmeshed in a relationship of interdependence and guardianship between the human and the nonhuman world. To instantiate and embody such relationships, the paper directly, and somewhat provocatively, acknowledges the River itself, the Martuwarra RiverOfLife, as the primary participant in such dialogue, an embodied non-human co-author who began a conversation then left to human writers to continue. 

As I have suggested in a forthcoming chapter and a monograph, a somewhat bleaker view would dissent from the notion of 'exponential momentum', especially momentum that has much impact in courts and in practice.

The authors refer to 

the clear emergence of a novel category of personhood that aims to transcend the existing Western dichotomic of natural and artificial personhood, but also to imagine a category of personhood capable of existing at the pluralist intersection of colonial and pre-colonial legal orders, that of an ancestral person. ... 

The idea of an ancestral person is thus proposed as a novel and intersectional category of legal personhood located at the encounter between colonial legal systems and First Law. It is important to note that this conceptual category is neither a creature of the colonial Western legal tradition nor of First Law, but rather is a conceptual tool to be negotiated as a bridge between the two. In order to establish the parameters of such negotiation, we want to begin by offering a few preliminary reflections. 

Indigenous rights to natural resources are often described as being ‘ancestral’ in nature, based on a deep spiritual connection between people and resources handed down across generations, placing an obligation on people to govern and care for the resources for present and future generations.  The term ‘ancestral’ is typically defined as meaning ‘relating to, or inherited from an ancestor’, and has underpinned conceptions of Indigenous rights in International treaties (such as the International Labour Organisation’s Convention 169 on the Rights of Indigenous and Tribal Peoples), as well as the Indigenous land rights jurisprudence arising from it. However, recognising pre-existing, ‘ancestral’ rights raises inevitable tensions around continuity, because of the period of time that has elapsed since colonisation. At times, this framing of Indigenous interests as ‘ancestral’ has been used by States to exclude Indigenous territorial claims that cannot be positively proven through continuous lines of succession since pre-colonial times, which has led to the ‘freezing’ of Indigenous territorial interests. An example of this is found in Chile, where Indigenous rights to water are framed as ‘ancestral rights’, and must be proved to have existed since ‘time immemorial’. The same problem occurs in the case of Australian native title rights to water, which must be proven pursuant to the maintenance and observance of traditional laws and customs that have been substantially maintained since the colonial claim to sovereignty. This restriction of ‘ancestral’ rights has led to the ongoing dispossession of Indigenous lands. 

In the Australian context, concerns have also been raised that a turn to rights of Nature discourse will result in the separation of land and waters from Indigenous people rather than respecting their sovereignty and empowering them to carry out their obligations to Country.  Other scholars have more broadly argued that the deployment of legal personhood for Nature has led to the law conceiving of Nature in distinctly human terms – and, relatedly, to conceiving rights in distinctively liberal terms. Tănăsescu emphasises that ‘the way in which we think of the entities that populate the law matters a great deal … [and] potentially stifles the politically radical act of extending the circle of entities recognized by the law’.  He then questions whether Indigenous ontologies, including a relational approach to Nature and selective ‘anthropomorphism can be aptly accommodated within the liberal concept of legal person’. 

Despite these critiques, many scholars ultimately adopt a nuanced approach to the strategic use of rights discourse. Here the question of whether to risk engaging with the system ‘partly comes down to an assessment of whether they have the power to effect genuine change through this kind of engagement’, which in turn depends on whether one adopts a centralist or pluralist approach to law. A pluralist approach, whereby legal norms are constructed by a multiplicity of actors, opens up the possibility of radical change, even when faced with the risk of deradicalization. Balakrishnan Rajagopal, for example, recognises the plurality of influences in the ongoing creation of legal norms in his argument for the production of an ‘international law from below’. Ultimately, Tănăsescu adopts a similarly nuanced approach by highlighting the New Zealand example of the Te Urewera Act of 2014, which establishes Te Urewera as a legal entity rather than person. He argues that this is one path of avoiding the pitfalls of allowing Indigenous law and ontology to become too entangled with liberal notions of personhood and rights. In this example, the Act is a vehicle through which the local Māori Iwi have been able to create space not only for a more relational ontological approach to Nature, but also to claim power through the governance structures and processes that have emerged from the Act. 

In Australia, one might ask whether the Native Title Act, for those Indigenous peoples who can meet the high threshold for proving connection to their ancestral lands noted earlier, can recognise a form of ancestral personhood, given that it provides for the recognition of traditional laws and custom in relation to land and waters. However, it is readily apparent that the Native Title Act (at least in its current form) does not deal well with legal pluralism; it is structurally and philosophically ill-equipped to give legal recognition to the concept of the ancestral person. Not only is the Act ultimately anthropocentric in its orientation, but also it is premised on a separation between land and waters, a premise which is antithetical to Indigenous world views. Rights and interests under traditional laws and customs can only be recognised by the Act insofar as they do not ‘fracture a skeletal element of our legal system’, and thus, accordingly, the Act inevitably reflects a colonial conceptualisation of the environment. Determinations of native title typically limit the recognition of water rights to a ‘non-exclusive right to take, use and enjoy that water’ or to take and use water ‘for personal, domestic and non-commercial communal purposes’ (or variations thereof). Moving away from these formulaic and anthropocentric descriptions of native title rights to water to encompass a more holistic conception of Country appears unlikely. In this sense, existing native title regime may be helpful in giving a voice to native title holders or claimants,  but despite recent judicial attempts to ameliorate some of its limitations,  is insufficient to capture the complexity of the normative and legal worldviews underpinning such regimes. 

The proposed concept of an ancestral person, therefore, is offered as a dialogical interface between distinct legal orders. To aptly reconcile the distinctive worldviews represented by this pluralist intersection, any conceptualisation of ancestral personhood cannot be derivative, but rather must necessarily be dialogical and co-creative. The aspirational desire of such a novel category is to reach a point of complementary harmony and collective wisdom, while maintaining ongoing awareness of the fact that the idea of the ancestral person as a comparative tool to establish a meaningful dialogue between ontologically distinct legal orders always operates within an asymmetry of power. The concept of an ancestral person as a novel legal category, undoubtedly presents colonial audiences – particularly colonial legal audiences – with a challenge. As an intersectional concept, it is more than a simple tertium genus of personhood. Rather it is a concept that can only emerge from the intersection among, and dialogue with, distinct legal traditions. Its complexities, however, are far more challenging for colonial legal systems than they are for Indigenous people. As a result, the burden is placed upon colonial legal scholars to develop the conceptual tools to fully approach the very idea of an ‘ancestral’ person as a legal concept.

The authors conclude 

The concept of the ancestral person presented in the previous section is an invitation to challenge the hegemonic and deeply held legal orthodoxy, while at the same time articulating First Law in terms that are recognisable within the colonial context. Once embraced in these comparative terms, law is no longer something that only humans engage with. Rather, law emerges from the endless interplay between humans and non-human ‘actants’, whereby rivers cease to be mere abstract legal persons, and instead become active participants in the very process of legal creation. The description of non-human beings as alive, sacred, emotional and vibrant, which has suffused this paper thus far, differs from current posthumanist, vitalist, materialist, or object-oriented scholarship that depart from traditional cartesian dualism, at least by gesturing toward an even less anthropocentric and more relational orientation. Rather, ancestral stories and First Law inform and shape the theoretical positioning of this paper, in explicitly maintaining the deep relational structures that these theories call upon. 

A practical instance of the application of the ancestral person to capture the plurality of worldviews that surround Nature is, we argue, the present story of the Martuwarra (or Fitzroy River) in the north-western Kimberly region of Australia. Against the normative message of the Yoongoorrookoo story, Anne Poelina and her colleagues describe more than 150 years of invasive colonial ‘development’ in the region. Indeed, the interest from the agro-pastoral sector in exploiting the waters of the Martuwarra-Fitzroy River has grown over the last decade, in particular since the publication of the Australian Government’s White Paper on developing Northern Australia.126 At present (in 2021), the government of Western Australia is preparing a water allocation plan for the Martuwarra-Fitzroy catchment as a basis for responding to water licensing requests. The express governmental aim of water allocation process is to maximise the water available for abstraction while maintaining the long-term integrity of the water resource. The ongoing water allocation planning process in the Martuwarra-Fitzroy catchment is, however, highly contentious, especially as Traditional Owners are only considered stakeholders while decision-making power about the future of the Martuwarra-Fitzroy River rests only with Government. The Yoongoorookoo story, the Martuwarra, and the depth of Aboriginal legal and normative traditions are all silenced within this modern water governance framework, despite a commitment from the State government to protect Indigenous cultural values. 

The Martuwarra and her peoples are thus left wondering when will the ‘colonial war’ end? In the words of late senior Elder, Butcher Wise, ‘you came, you took the land, you made us slaves and now you are back for the water; what is going to be left for Blackfellas [Aboriginal people]?’ The Martuwarra Fitzroy River Council (Martuwarra Council) was established in 2018 by six independent Indigenous nations to preserve, promote and protect their ancestral River from such ongoing destructive ‘development’. The Council believes it is now imperative to recognise the pre-existing and continuing legal authority of Indigenous law, or ‘First Law’, in relation to the River, in order to preserve its integrity through a process of legal decolonisation. First Law differs markedly from its colonial counterpart, as its principles are not articulated in terms of rules, policies and procedures, but rather through stories. The story with which this paper begins thus represents an opening into the normative and legal world of the Nyikina people, gesturing toward a host of legal and normative principles that can only be explored by applying an open and dialogical comparative legal methodology. 

Fundamental to First Law in the Martuwarra-Fitzroy Catchment is the role of the ancestors who create and populate the Country such as the Serpents (called Yoongoorrookoo in Nyikina language). These Serpents are guardians of the Country, strongly associated with water places.  The First Law Story of Yoongoorrookoo illustrates how the physical manifestations of the sacred ancestral being, Yoongoorrookoo, is entwined with ethics, values, custom, law, language, and inter-generational obligation, as water moves above ground, down rivers and permeates though groundwater systems. ... 

Today, the First Law of the Martuwarra, as well as culture and languages, remain fragile. New emerging storytellers are using modern technology to revive Bookarrarra Stories using multi-media, to reproduce stories in three-dimensional experience of sight, sound and ‘feeling’, or liyan. The concept of liyan incorporates at once a person’s spirit, moral compass and a conscious feeling that positions someone within the cultural landscape and grounds their intuition for ‘reading circumstances’, ‘reading people’ and ‘reading the Country’. First Law stories, such as Yoongoorrookoo Creator of the Law, create the opportunity to adapt them in order to keep them alive an in the hearts, minds and liyan of Martuwarra people as well as sharing with all people a complex set of values, ethics and the Law. These First Law stories, reimagined in a digital form, create a pathway for ‘freedom, ethics and civic courage’, an invitation to collective wisdom, cooperation, unity, information sharing and informed consent, the ‘cultural synthesis’ framed by Paulo Freire. 

The gift of the Yoongoorrookoo story, therefore, offers as an invitation to a legal dialogue among distinct legal orders, in the spirit of an emerging ‘Coalition of Hope’, whereby the renewed focus on First Law can provide a complimentary worldview encompassing an ethical framework that is able to ground justice and equity in a Law of relationships between human and non-human beings. This invitation is paramount to the possibility of imagining, discussing and conceptualising an ‘ancestral person’, whose ontological orientation is best exemplified by the Yoongoorrookoo story in relation to the Martuwarra. Far from leading to any pre-determined outcome, the negotiation of a novel category of personhood offers a creative space to counter the colonial risks of an unquestioned extension of legal personhood to Nature that Virginia Marshall aptly cautions against. 

The co-creation of an ancestral person as a novel legal category able to capture the nuances of First Law while speaking to the need of identifying a specific legal ‘subject’ that can be readily understood within the colonial framework inherited by the Western legal tradition is, in the present instance, instantiated in the Martuwarra. Importantly, the ideas discussed in this article were formally presented to the Martuwarra Council at the ‘Council of Wisdom’ workshop the Council held (partly remotely, due to the extant Covid19 restrictions) in June 2021. At the workshop, all present members of the Council endorsed the idea of an ancestral person as an instance of legal intersection worth pursuing and co-creating further. 

The Martuwarra Council’s understandings is that the Law is in the Land because it is from the stars and the earth that laws are grounded. It is therefore the Martuwarra’s peoples deep and continuing relationship with nature to witness and understand why these laws were created. No one is above the Law, according to First Law in the Martuwarra, everyone is equal under the Law, and stories show Yoongoorrookoo a living entity, a sacred ancestral being which continues to hold the Law from the Beginning of Time, Bookarrarra. The invitation to consider an ancestral person as a novel legal category, thus, may be read as a response to the pluralist opening to First Law as advocated by Yoongoorrookoo, ‘So all the people can see that the Spirit of the Law is just’.

'Removing the Veil from the ‘Rights of Nature’: The Dichotomy between First Nations Customary Rights and Environmental Legal Personhood' by Virginia Marshall in (2019) 45(2) Australian Feminist Law Journal 233-248 comments 

The legal concept of the creation of a legal entity is not trailblazing territory of itself, although introducing and advocating for the legal personality of a river may be. However, advocating for the rights of nature on grounds that all humans over-exploit, abuse and contaminate the environment is as misleading as it is untrue. The Indigenous peoples of Australia have a primary, unique and inherent obligation to ‘Care for Country’ according to the Indigenous rule of law; exercising the protection and management of the Aboriginal and Torres Strait Islander environment. The Indigenous rule of law and the obligation to ‘Care for Country’ stretches back many millennia yet Australian domestic laws and policies fail to properly support the exercise of such obligations by Indigenous Australians. In this article I argue, rather than embracing a ‘rights of nature’ property paradigm in Australia, we should instead empower First Nations people to take a pivotal, even primary, role in caring for Country.

Funerals

In Dann v Office of the State Coroner  [2020] WASC 486 the court considered an application for injunction to restrain a funeral, reflecting the right to arrange funeral, competing claims by members of the deceased's family and the significance of cultural, spiritual and religious factors.

The plaintiff commenced these proceedings by originating summons after her brother Jason Dann died suddenly. The second defendant is the Jason's estranged wife of Jason. The Supreme Court stated that the question arising in the proceedings is who should have the right to make the funeral arrangements: the plaintiff (his sister) or the second defendant (his wife from whom he was legally separated at the time of death). 

In December  the Coroner Stephen Sharratt issued a decision stating that he intended to issue a certificate under s 29(1) of the Coroners Act 1996 (WA), releasing Jason's body to the second defendant for burial. The plaintiff sought an order staying the Coroner's decision, restraining the release of the body to the second defendant, an order to release the body to the plaintiff and that the plaintiff have carriage of the funeral of Jason, and an order that the burial be at South Hedland Cemetery.

The judgment notes that 

 Jason was a proud Aboriginal man. Although he had lived in Broome from 2012 until he died, he had connections to the Nyul Nyul, Kariyarra, Ngarluma, Yindjibarndi and Banjima Countries, and had for a period of time, at least between 2006 and 2012, upheld a traditional way of life with the second defendant. During that time he lived on his ancestral homeland in the Dampier Peninsula, and sourced food, water, and shelter from the land. It must be accepted that he led a traditional way of life at other times. It is also clear that, in some respects of his life, Jason adopted a non‑traditional lifestyle, in that he was employed in a trade and that he used modern means of communication, such as the sending of text messages and email correspondence, through the internet. Jason and the second defendant married on 25 July 2009, at the Sacred Heart Church, Beagle Bay, in Broome. Jason and the second defendant have one child together, Jason Ashley Gregory Ignatius Dann Junior (Jason Jnr), who is now 16 years of age and resides with the second defendant in Perth. 

In or about September 2018, the second defendant separated from Jason and moved with Jason Jnr to Perth. Jason stayed in Broome and continued to work. He provided for Jason Jnr financially. At some time following the second defendant's move to Perth, the second defendant made an application to the Child Support Agency for Jason to support Jason Jnr, which appears to have been granted. 

The second defendant states in her affidavit that, whilst she has lived apart from Jason for two years, they remain married and maintained a good relationship. She claims that they never discussed divorce, and did not prepare or file an application for divorce. It is clear, however, that they did formally separate in 2018. 

The plaintiff in her second affidavit states that Jason and the second defendant had discussed divorce. The plaintiff in her second affidavit states that in her culture, Jason and the second defendant, having separated, were no longer married. I do not accept this contention. There is no explanation by the plaintiff as to why that would be so.  ... I am not satisfied that there was not a relationship of husband and wife between Jason and the second defendant at the time of his death. 

Jason's other surviving immediate family members include his father, George (73 years), and two older sisters, Georgina (51 years) and Rosalind (49 years). The plaintiff claims that Jason also has an adult son, Jawane Fairclough (23 years). However, the second defendant says that Jason did not admit the paternity of Jawane during his lifetime. After Jason died, the second defendant made unsuccessful attempts to contact Jawane. The plaintiff claims that Jason did accept paternity for Jawane in his lifetime, and that she accepts him as her nephew. The plaintiff states in her second affidavit that she has been able to locate Jawane and has informed him about her proposed funeral arrangements, and that he is supportive of those arrangements. I do not find it necessary to determine whether Jawane was recognised by Jason as his son in his lifetime in these proceedings, as it is clear from the affidavits filed on behalf of both parties that Jason had a reasonably close relationship with Jawane. In any event, I am unable to ascertain what his views are of this application, as there is insufficient information before the court.

The issues in dispute 

 The issues in dispute are narrow. Both the plaintiff and the second defendant agree that the funeral should be conducted in Port Hedland, and that Jason's body should be buried. The parties also agree that Jason should be buried in accordance with his wishes and the Nyul Nyul, Banjima, and Kariyarra traditions, which are that: (a) there should be a service conducted by a priest at St Cecilia's Catholic Church; (b) as part of Jason's family tradition, there should be a nine-day novena, which includes a series of prayers recited over nine days in honour of Jason. On the ninth day, Jason will be buried, and final prayers will be said at the gravesite; and (c) family from Beagle Way in the Kimberley will bring sand from Jason's Country, which will be placed with Jason when he is buried.  ... 

The plaintiff claims that, as the spokesperson of Jason's family, and in accordance with his wishes, she should be the person who should be entitled to take possession of Jason's body and proceed with the funeral arrangements that she has made on behalf of his family. The plaintiff states in her second affidavit that it is not culturally appropriate for Nyul Nyul, Banjima, Kariyarra, Ngarluma and Yindjibarni peoples to be buried on a Friday, and that the second defendant has disregarded their request for the funeral to occur on a Saturday rather than a Friday. The plaintiff also states in her second affidavit that in Nyul Nyul and Kariyarra custom: (a) it is for the father of the deceased to choose the pallbearers, which should not include children or nephews of the deceased, and if Jason's mother was still alive she would also be involved in making that decision; (b) the parents of the deceased should be the ones to travel in the car with the deceased to the funeral; and (c) there should not be photographs of the deceased in Tribute Books that are to be distributed at the funeral. The plaintiff in her second affidavit states that she has tried not to exclude Jason Jnr from the funeral arrangements, and has communicated directly with him following his father's death. 

The second defendant claims that she should be the person who should be entitled to take possession of Jason's body and proceed with the funeral arrangements, because it is important for her and Jason's son, Jason Jnr, to be a part of organising his father's funeral. The second defendant says that she is a woman of the Nanda people, and has a deep appreciation and respect for the customs and traditions of Jason's people and her people. 

The plaintiff claims that the second defendant is not Aboriginal. In her second affidavit, she states that she has searched the register on the website of the Office of the Registrar of Indigenous Corporations and ascertained that the second defendant is not a member of either the Nanda Aboriginal Corporation or the Barrel Well Community Nanda Corporation. Whilst that may be the case, I do not accept the plaintiff's contention that it necessarily follows because the second defendant is not on the register of either of those native title organisations that she is not Aboriginal. This is because there are many people who are part of a particular group of Aboriginal people who have not registered as a member of a particular Aboriginal corporation. Jason's father and sisters are recognised members of native title claim groups, including IBN, Gumala Aboriginal Corporation, and Australian Executor Trustees. ... 

Legal Principles 

This court has jurisdiction pursuant to s 4 of the Administration Act 1903 (WA), and inherent jurisdiction, to determine who should have carriage of a funeral, and where, and how, a body should be disposed of.[4] Pursuant to s 29(1) of the Coroners Act, the Coroner investigating a death must issue as soon as reasonably possible a certificate permitting burial, cremation, or other disposal of the body. The Office of the State Coroner points out in their written submissions that the equivalent duty to issue in the Coroners Act 1985 (Vic) has been interpreted as carrying with it, by necessary implication, the power to decide questions as to where, and by whom, the disposal will be carried out, which is essential to the effective discharge of the Coroner's functions. 

As counsel for the plaintiff points out, it is an established principle at common law that there is no property in a dead body, but executors are entitled to custody and possession of the body for the purpose of disposal of the body. The principles of law that apply in this State as to how this court is to determine who should have possession and control of the body of a deceased were recently set out by Archer J in Attwood v Office of the State Coroner as follows:

(a) If a person has named an executor in his or her will and that person is ready willing and able to arrange for the burial of the deceased's body the person named as executor has the right to do so. (b) A person with the privilege of choosing how to bury the body is expected to consult with other stakeholders, but is not legally bound to do so. (c) Where no executor is named the person with the highest rank to take out administration will have the same position as the executor in proposition (a). (d) The right of the surviving spouse or de facto will be preferred to the right of children. (e) Where two or more persons have equally ranking privilege, the practicalities of burial without unreasonable delay will decide the issue.

The propositions in (a) and (c) are to be regarded only as a common or usual approach, not an approach which is to be rigidly applied. It would have to be a rare case to depart from this common or usual approach. Where those claiming the privilege of burial have equally ranking rights for administration, the question turns largely to matters of practicalities, paying due regard to the need to have the body disposed of without unreasonable delay but with all proper respect and decency. Relevant factors Who is the party who has the highest ranking privilege to take out administration of Jason's estate? Whilst the second defendant and Jason were separated at the time of his death, until divorced, at law, the second defendant was still his wife at the time of his death. Pursuant to the table in s 14 of the Administration Act 1903 (WA), the second of defendant has the highest right to apply for administration of the estate of Jason, pursuant to s 25(1) of the Administration Act. 

The plaintiff contends that the legal principles that apply in determining whether a person was in a 'surviving de facto relationship' should be applied. In particular, the plaintiff argues that it is crucial to consider the nature of the Jason's relationship with the second defendant at the time of death, as a failure to do so would result in a situation whereby the carriage of the deceased's funeral would fall to somebody with whom the deceased's relationship had irretrievably broken down and was not 'marriage-like', 'in the nature of marriage', or of the 'required quality'. This could result in the deceased's wishes not being given all proper respect and decency and, in the present case, in him being buried in a manner that would offend his customs and traditions. This argument has no basis in law. The Coroners Act expressly contemplates that a senior next of kin can be a spouse of a deceased that does not live with the deceased. Also, the Administration Act does not contemplate, or require in any way whatsoever, that for a wife or husband of a deceased to be entitled to a distribution of property, or to apply for administration of a deceased estate, they must have lived with the deceased prior to the deceased's death or that their marriage had not broken down. 

Counsel for the second defendant argues that, pursuant to s 37(5) of the Coroners Act, the senior next of kin is the person who is entitled to take control of the deceased’s body for the purposes of burial. In determining who is the senior next of kin, siblings of a deceased are ranked below the legal spouse of the deceased. The Coroners Act even goes as far to distinguish between spouses who are residing together at the time of death, and those who are not residing together at the time of death. In both instances, a legal spouse outranks a sibling. Section 37(5) of the Coroners Act provides:

(5) In this section, unless otherwise prescribed, senior next of kin in relation to the deceased person means the first person who is available from the following persons in the order of priority listed ‑ (a) a person who, immediately before death, was living with the person and was either - (i) legally married to the person; or (ii) of or over the age of 18 years and in a marriage-like relationship (whether the persons are different sexes or the same sex) with the person; or (b) a person who, immediately before death, was legally married to the person; or (c) a son or daughter, who is of or over the age of 18 years, of the person; or (d) a parent of the person; or (e) a brother or sister, who is of or over the age of 18 years, of the person; or (f) an executor named in the will of the person or a person who, immediately before the death, was a personal representative of the person; or (g) any person nominated by the person to be contacted in an emergency.

On the basis that the second defendant outranks the plaintiff to apply for administration of the deceased estate, this is a factor that favours a grant in favour of the second defendant, as her right to apply to have carriage of the burial of Jason is higher than that of the plaintiff.

Wishes expressed by the deceased prior to death 

 The court may often give significant weight to the wishes of the deceased, particularly where those wishes are consistent with the established legal framework for resolving burials, and with the intentions of the person entitled to determine the form of burial. Both the plaintiff and her sister, Rosalind Jennice Dunstan, say that Jason told them that he wanted the plaintiff to 'handle his affairs' after his death. In her affidavit, Ms Dunstan states that she had various discussions with the deceased about what they wanted to happen to each of them after they passed away. The most recent discussion was when Jason last visited her home in Perth in September 2020. On that occasion, he told her that he wanted the plaintiff to handle his affairs when he was gone, that he wanted to be buried at the cemetery in South Hedland, and that he had pre‑booked a plot there, next to where their mother and brother are buried. 

The wishes of a deceased is a factor to be considered, but is not on its own determinative. The wishes of Jason do favour a grant to the plaintiff. In any event, even if an order is made in favour of the second defendant, it is clear his wish to be buried in his pre-booked plot should be honoured.

Cultural, spiritual and religious values of the surviving family 

 Unfortunately, there is animosity between the plaintiff and the second defendant. The cultural, spiritual and religious values of Jason and his surviving family should be given weight. For the reasons I have given, his surviving family include the second defendant, as she is his wife. Whilst the plaintiff makes much of the differences in the arrangements proposed by the second defendant, there is very little difference between them. The second defendant in her affidavit makes it clear that she intends to conduct a proper and decent burial of Jason in accordance with all of the traditions, and cultural and religious values, of Jason's peoples. Given that no firm date has yet been set for the funeral by either party, I see no reason why, if the second defendant is to have charge of the funeral, the day and date of the funeral could not be changed to a Saturday. I also see no reason why an order could not be made that no photographs be shown of the deceased at the funeral. The main issue appears to be whether Jason Jnr should be a pallbearer, and whether he should be allowed to travel in the funeral car with his grandfather and his father's body.

The Court states that the Coroner chose to release the body to the second defendant on the basis that she was the senior next of kin of Jason, as opposed to the plaintiff who was one of his next of kin.

 The senior next of kin is defined in s 37(5) of the Coroners Act to mean, in relation to a deceased person, the first person who is available in the order of priority listed in the following subsections. The second defendant answers the description of a person in s 37(5)(b) as she is a person who, immediately before death, was legally married to Jason. The plaintiff answers the description of a person in s 37(5)(e) as she is a sister of Jason who is over the age of 18 years. Consequently, the second defendant was the first person in the order of priority of s 37(5), and it was on this basis that the Coroner made his decision to issue a certificate to the second defendant, under s 29(1) of the Coroners Act, to permit the disposal of Jason's body. Significant weight should be given to the decision of the Coroner to grant the certificate to the second defendant.

The Court goes on to note that  

The wishes of the children of a deceased (whether or not they are a party to the proceedings) are relevant. In Reece v Little, Templeman J remarked in that matter that the wishes of the deceased's children carried very great weight. In this matter, it is clear that Jason has one biological child, Jason Jnr. It is less clear whether Jawane is also his biological child. I cannot determine whether he is or not. Although Jason Jnr is only 16 years old, his wishes should be respected. Even if Jawane is a biological child of Jason, it is not entirely clear exactly what the wishes of Jawane are. The only inference that can be drawn from the second affidavit of the plaintiff is that he is supportive of the funeral arrangements that the plaintiff has made. No further inference can be drawn from the plaintiff's account of her conversation with Jawane. In particular, in light of the fact that there is very little dispute about the funeral arrangements themselves, it cannot be inferred that he is of the view that only the plaintiff should have carriage of the funeral arrangements and not the second defendant. 

While the usual principles applied by this court are that the right of carriage of a burial by a surviving spouse is to be preferred to the right of children, the right of a child is generally to be preferred to that of a sibling of a deceased. As there is evidence before the court that Jason Jnr supports the orders sought by his mother that she should have carriage of the funeral arrangements, this is a factor that supports an order in favour of the second defendant. It appears that the plaintiff has the greater availability of immediate funds to pay for the funeral and the disposal of the body of Jason. However, the second defendant is willing to fund the cost of the funeral if funding cannot be obtained through an Aboriginal corporation. In any event, as counsel for the second defendant points out, the costs of the funeral is a cost to the estate, and can be recovered from the deceased's estate.

The conclusion was  

I appreciate that in this case, as in many of the cases that come before this court that involve families, in particular families of Aboriginal persons, to choose who should have the right within a family to have the carriage of the funeral of a much loved deceased causes much distress to the losing party. It is unfortunate that the parties to these proceedings have not been able to reach agreement as to who should have the carriage of the funeral arrangements when both parties put forward substantially the same arrangements. However, no agreement has been reached despite the fact that a registrar of this court has attempted to mediate an agreement between the parties this morning before this hearing. 

Regrettably, this court must decide who should have the right to arrange Jason's funeral and, in doing so, I must apply the established principles of law. Having considered all of the evidence filed on behalf of the parties, and the submissions made by their counsel, this case is not such a rare case that would warrant the court departing from the common or usual approach. When regard is had to all the relevant factors and considerations, I am of the opinion that the second defendant should have the carriage of Jason's funeral. This is because, when all relevant matters are considered on balance, the relevant factors are not such as to depart from the common or usual approach that the person who has the highest right to take out administration will have the right to arrange for the disposal of the deceased's body.

There is a similar dispute in Frail v Shorey & Anor [2021] NSWSC 122, with disagreement about cremation, smoking ceremonies and burial location.

Crypto and Ransomware

'Keys Under Doormats: Mandating insecurity by requiring government access to all data and communications' by Harold Abelson, Ross Anderson, Steven M. Bellovin, Josh Benaloh, Matt Blaze, Whitfield Diffie, John Gilmore, Matthew Green, Susan Landau, Peter G. Neumann, Ronald L. Rivest, Jeffrey I. Schiller, Bruce Schneier, Michael Specter and Daniel J. Weitzner in 2015 commented 

Twenty years ago, law enforcement organizations lobbied to require data and communication services to engineer their products to guarantee law enforcement access to all data. After lengthy debate and vigorous predictions of enforcement channels “going dark,” these attempts to regulate the emerging Internet were abandoned. In the intervening years, innovation on the Internet flourished, and law enforcement agencies found new and more effective means of accessing vastly larger quantities of data. Today we are again hearing calls for regulation to mandate the provision of exceptional access mechanisms. In this report, a group of computer scientists and security experts, many of whom participated in a 1997 study of these same topics, has convened to explore the likely effects of imposing extraordinary access mandates. 

We have found that the damage that could be caused by law enforcement exceptional access requirements would be even greater today than it would have been 20 years ago. In the wake of the growing economic and social cost of the fundamental insecurity of today’s Internet environment, any proposals that alter the security dynamics online should be approached with caution. Exceptional access would force Internet system developers to reverse “forward secrecy” design practices that seek to minimize the impact on user privacy when systems are breached. The complexity of today’s Internet environment, with millions of apps and globally connected services, means that new law enforcement requirements are likely to introduce unanticipated, hard to detect security flaws. Beyond these and other technical vulnerabilities, the prospect of globally deployed exceptional access systems raises difficult problems about how such an environment would be governed and how to ensure that such systems would respect human rights and the rule of law.

Their Executive Summary is - 

 Political and law enforcement leaders in the United States and the United Kingdom have called for Internet systems to be redesigned to ensure government access to information — even encrypted information. They argue that the growing use of encryption will neutralize their investigative capabilities. They propose that data storage and communications systems must be designed for exceptional access by law enforcement agencies. These proposals are unworkable in practice, raise enormous legal and ethical questions, and would undo progress on security at a time when Internet vulnerabilities are causing extreme economic harm. 

As computer scientists with extensive security and systems experience, we believe that law enforcement has failed to account for the risks inherent in exceptional access systems. Based on our considerable expertise in real-world applications, we know that such risks lurk in the technical details. In this report we examine whether it is technically and operationally feasible to meet law enforcement’s call for exceptional access without causing large-scale security vulnerabilities. We take no issue here with law enforcement’s desire to execute lawful surveillance orders when they meet the requirements of human rights and the rule of law. Our strong recommendation is that anyone proposing regulations should first present concrete technical requirements, which industry, academics, and the public can analyze for technical weaknesses and for hidden costs. 

Many of us worked together in 1997 in response to a similar but narrower and better- defined proposal called the Clipper Chip. The Clipper proposal sought to have all strong encryption systems retain a copy of keys necessary to decrypt information with a trusted third party who would turn over keys to law enforcement upon proper legal authorization. We found at that time that it was beyond the technical state of the art to build key escrow systems at scale. Governments kept pressing for key escrow, but Internet firms successfully resisted on the grounds of the enormous expense, the governance issues, and the risk. The Clipper Chip was eventually abandoned. A much more narrow set of law enforcement access requirements have been imposed, but only on regulated telecommunications systems. Still, in a small but troubling number of cases, weakness related to these requirements have emerged and been exploited by state actors and others. Those problems would have been worse had key escrow been widely deployed. And if all information applications had had to be designed and certified for exceptional access, it is doubtful that companies like Facebook and Twitter would even exist. Another important lesson from the 1990’s is that the decline in surveillance capacity predicted by law enforcement 20 years ago did not happen. Indeed, in 1992, the FBI’s Advanced Telephony Unit warned that within three years Title III wiretaps would be useless: no more than 40% would be intelligible and that in the worst case all might be rendered useless. The world did not “go dark.” On the contrary, law enforcement has much better and more effective surveillance capabilities now than it did then. 

The goal of this report is to similarly analyze the newly proposed requirement of exceptional access to communications in today’s more complex, global information infrastructure. We find that it would pose far more grave security risks, imperil innovation, and raise thorny issues for human rights and international relations. 

There are three general problems. First, providing exceptional access to communications would force a U-turn from the best practices now being deployed to make the Internet more secure. These practices include forward secrecy — where decryption keys are deleted immediately after use, so that stealing the encryption key used by a communications server would not compromise earlier or later communications. A related technique, authenticated encryption, uses the same temporary key to guarantee confidentiality and to verify that the message has not been forged or tampered with. 

Second, building in exceptional access would substantially increase system complexity. Security researchers inside and outside government agree that complexity is the enemy of security — every new feature can interact with others to create vulnerabilities. To achieve widespread exceptional access, new technology features would have to be deployed and tested with literally hundreds of thousands of developers all around the world. This is a far more complex environment than the electronic surveillance now deployed in telecommunications and Internet access services, which tend to use similar technologies and are more likely to have the resources to manage vulnerabilities that may arise from new features. Features to permit law enforcement exceptional access across a wide range of Internet and mobile computing applications could be particularly problematic because their typical use would be surreptitious — making security testing difficult and less effective. 

Third, exceptional access would create concentrated targets that could attract bad actors. Security credentials that unlock the data would have to be retained by the platform provider, law enforcement agencies, or some other trusted third party. If law enforcement’s keys guaranteed access to everything, an attacker who gained access to these keys would enjoy the same privilege. Moreover, law enforcement’s stated need for rapid access to data would make it impractical to store keys offline or split keys among multiple keyholders, as security engineers would normally do with extremely high-value credentials. Recent attacks on the United States Government Office of Personnel Management (OPM) show how much harm can arise when many organizations rely on a single institution that itself has security vulnerabilities. In the case of OPM, numerous federal agencies lost sensitive data because OPM had insecure infrastructure. If service providers implement exceptional access requirements incorrectly, the security of all of their users will be at risk. 

Our analysis applies not just to systems providing access to encrypted data but also to systems providing access directly to plaintext. For example, law enforcement has called for social networks to allow automated, rapid access to their data. A law enforcement backdoor into a social network is also a vulnerability open to attack and abuse. Indeed, Google’s database of surveillance targets was surveilled by Chinese agents who hacked into its systems, presumably for counterintelligence purposes. 

The greatest impediment to exceptional access may be jurisdiction. Building in exceptional access would be risky enough even if only one law enforcement agency in the world had it. But this is not only a US issue. The UK government promises legislation this fall to compel communications service providers, including US-based corporations, to grant access to UK law enforcement agencies, and other countries would certainly follow suit. China has already intimated that it may require exceptional access. If a British-based developer deploys a messaging application used by citizens of China, must it provide exceptional access to Chinese law enforcement? Which countries have sufficient respect for the rule of law to participate in an international exceptional access framework? How would such determinations be made? How would timely approvals be given for the millions of new products with communications capabilities? And how would this new surveillance ecosystem be funded and supervised? The US and UK governments have fought long and hard to keep the governance of the Internet open, in the face of demands from authoritarian countries that it be brought under state control. Does not the push for exceptional access represent a breathtaking policy reversal? 

The need to grapple with these legal and policy concerns could move the Internet overnight from its current open and entrepreneurial model to becoming a highly regulated industry. Tackling these questions requires more than our technical expertise as computer scientists, but they must be answered before anyone can embark on the technical design of an exceptional access system. 

In the body of this report, we seek to set the basis for the needed debate by presenting the historical background to exceptional access, summarizing law enforcement demands as we understand them, and then discussing them in the context of the two most popular and rapidly growing types of platform: a messaging service and a personal electronic device such as a smartphone or tablet. Finally, we set out in detail the questions for which policymakers should require answers if the demand for exceptional access is to be taken seriously. Absent a concrete technical proposal, and without adequate answers to the questions raised in this report, legislators should reject out of hand any proposal to return to the failed cryptography control policy of the 1990s.

The US Treasury Financial Crimes Enforcement Network (FINCEN) Financial Trend Analysis 'Ransomware Trends in Bank Secrecy Act Data Between January 2021 and June 2021' report comments

This Financial Trend Analysis focuses on ransomware pattern and trend information identified in Bank Secrecy Act (BSA) data. This report is issued pursuant to Section 6206 of the Anti-Money Laundering Act of 2020 (AMLA) which requires the Financial Crimes Enforcement Network (FinCEN) to periodically publish threat pattern and trend information derived from financial institutions’ Suspicious Activity Reports (SARs). FinCEN issued government-wide priorities for anti-money laundering and countering the financing of terrorism (AML/CFT) policy on 30 June 2021, which included cybercrime as a government-wide priority. FinCEN highlighted ransomware as a particularly acute cybercrime concern. The information contained in this report is relevant to the public, including a wide range of businesses, industries, and critical infrastructure sectors. The report also highlights the value of BSA information filed by regulated financial institutions. 

This Financial Trend Analysis is in response to the increase in number and severity of ransomware attacks against U.S. critical infrastructure since late 2020. For example, in May 2021, hackers used a ransomware attack to extort a multi-million dollar ransom, which also disrupted the Colonial Pipeline and caused gasoline shortages. Other recent attacks have targeted various sectors, including manufacturing, legal, insurance, health care, energy, education, and the food supply chain in the United States and across the globe. As Treasury Secretary Janet L. Yellen recently noted, “Ransomware and cyber-attacks are victimizing businesses large and small across America and are a direct threat to our economy.” 

FinCEN analysis of ransomware-related SARs filed during the first half of 2021 indicates that ransomware is an increasing threat to the U.S. financial sector, businesses, and the public. The number of ransomware-related SARs filed monthly has grown rapidly, with 635 SARs filed and 458 transactions reported between 1 January 2021 and 30 June 2021 (“the review period”), up 30 percent from the total of 487 SARs filed for the entire 2020 calendar year. The total value of suspicious activity reported in ransomware-related SARs during the first six months of 2021 was $590 million, which exceeds the value reported for the entirety of 2020 ($416 million). 

Trends represented in this report illustrate financial institutions’ identification and reporting of ransomware events and may not reflect the actual dates associated with ransomware incidents. 

FinCEN’s analysis of ransomware-related SARs highlights average ransomware payment amounts, top ransomware variants, and insights from FinCEN’s blockchain analysis: 

The 635 SARs filed during the review period include 458 SARs reporting transactions that occurred in the same timeframe. The remaining 177 SARs report transactions that occurred prior to 2021. 

Average Monthly Suspicious Amount of Ransomware Transactions: 

According to data generated from ransomware-related SARs, the mean average total monthly suspicious amount of ransomware transactions was $66.4 million and the median average was $45 million. FinCEN identified bitcoin (BTC) as the most common ransomware-related payment method in reported transactions. 

Top Ransomware Variants: 

Ransomware actors develop their own versions of ransomware, known as “variants,” and these versions are given new names based on a change to software or to denote a particular threat actor behind the malware. FinCEN identified 68 ransomware variants reported in SAR data for transactions during the review period. The most commonly reported variants were REvil/Sodinokibi, Conti, DarkSide, Avaddon, and Phobos. 

Insights from Blockchain Analysis: 

FinCEN identified and analyzed 177 unique convertible virtual currency (CVC) wallet addresses used for ransomware-related payments associated with the 10 most commonly reported ransomware variants in SARs during the review period. Based on blockchain analysis of identifiable transactions with the 177 CVC wallet addresses, FinCEN identified approximately $5.2 billion in outgoing BTC transactions potentially tied to ransomware payments. 

FinCEN Identified Ransomware Money Laundering Typologies: 

FinCEN identified several money laundering typologies common among ransomware variants in 2021 including threat actors increasingly requesting payments in Anonymity-enhanced Cryptocurrencies (AECs) and avoiding reusing wallet addresses, “chain hopping” and cashing out at centralized exchanges, and using mixing services and decentralized exchanges to convert proceeds. 

Scope and Methodology: 

FinCEN examined ransomware-related SARs filed between 1 January 2021 and 30 June 2021 to determine trends. The full data set consisted of 635 SARs reporting $590 million in suspicious activity. Of the 635 SARs filed during the review period, 458 report actual transactions that occurred during the review period worth $398 million. The remaining 177 SARs report transactions that occurred before 1 January 2021. FinCEN reviewed and verified each SAR to remove any suspicious activity amount unrelated to ransomware and to extract relevant indicators of compromise (IOCs). From this data, FinCEN identified the top 10 most common ransomware variants and analyzed their IOCs through commercially available analytics tools. This analysis allowed FinCEN to chart the flow of ransomware payments in BTC to identify which CVC exchanges and services ransomware actors used to launder their proceeds. USD figures cited in this analysis are based on the value of BTC when the transactions occurred. FinCEN also compared data gathered for 2021 to SAR data gathered in previous years in order to track ransomware trends. This data set consisted of 2,184 SARs reflecting $1.56 billion in suspicious activity filed between 1 January 2011 and 30 June 2021. 

Ransomware Filings in First Six Months of 2021 Exceed 2020 Total 

The total U.S. dollar value for ransomware-related transactions reported in SARs filed during the review period exceeds that of any previous year since 2011. In the first six months of 2021, FinCEN identified $590 million in ransomware-related SARs, a 42 percent increase compared to a total of $416 million for all of 2020 (see Figures 1 and 2). If current trends continue, SARs filed in 2021 are projected to have a higher ransomware-related transaction value than SARs filed in the previous 10 years combined, which would represent a continuing trend of substantial increases in reported year-over-year ransomware activity. This trend potentially reflects the increasing overall prevalence of ransomware-related incidents as well as improved detection and reporting of incidents by covered financial institutions, which may also be related to increased awareness of reporting obligations pertaining to ransomware and willingness to report. 

As noted in FinCEN’s 2020 Advisory on Ransomware, AECs reduce the transparency of CVC financial flows, including ransomware payments, through anonymizing features, such as mixing and cryptographic enhancements.

Burgers into cow?

Earlier this year I had an article in Canberra Law Review on the legal status of cryonics, ie the practice of what one critic mordantly likened to purportedly turning frozen hamburger back into a live cow, complete with the moo. In July, under the heading 'The Cryonics Industry Would Like to Give You the Past Year, and Many More, Back', the New York Times featured a characteristically uncritical article on cryonics - in other words cold storage of cadavers as the basis for eventual 'reanimation'. 

It states 

 The business of cryopreservation — storing bodies at deep freeze until well into the future — got a whole lot more complicated during the pandemic. 

When an 87-year-old Californian man was wheeled into an operating room just outside Phoenix last year, the pandemic was at its height and medical protocols were being upended across the country. 

A case like his would normally have required 14 or more bags of fluids to be pumped into him, but now that posed a problem. Had he been infected with the coronavirus, tiny aerosol droplets could have escaped and infected staff, so the operating team had adopted new procedures that reduced the effectiveness of the treatment but used fewer liquids. 

It was an elaborate workaround, especially considering the patient had been declared legally dead more than a day earlier. He had arrived in the operating room of Alcor Life Extension Foundation — located in an industrial park near the airport in Scottsdale, Ariz. — packed in dry ice and ready to be “cryopreserved,” or stored at deep-freeze temperatures, in the hope that one day, perhaps decades or centuries from now, he could be brought back to life. 

Alcor, which has been in business since 1972, adopted new rules in its operating room last year that restricted the application of its medical-grade antifreeze solution to only the patient’s brain, leaving everything below the neck unprotected. 

In the case of the Californian man, things were even worse because he had died without completing the normal legal and financial arrangements with Alcor, so no standby team had been on hand for his death. By the time he arrived at Alcor’s facility, too much time had elapsed for the team to be able to successfully circulate the protective chemicals, even to the brain.

Ouch 

That meant that when the patient was eventually sealed into a sleeping bag and stored in a large thermos-like aluminum vat filled with liquid nitrogen that cooled it to minus 320 degrees Fahrenheit (minus 196 Celsius), ice crystals formed between the cells of his body, poking countless holes in cell membranes.

Apparently that doesn't matter, with the article reporting that Max More, the 57-year-old former president of Alcor, said that the damage caused by the “straight freeze” could probably still be repaired by future scientists, especially if there was only limited damage to the brain, which is often removed and stored alone in what is known in the trade as a “neuro” preservation. 

 “The important stuff is up here as far as I am concerned,” he said, pointing to his sandy-blond crop of hair in a Zoom call. “That is where my personality lives and my memories are … all the rest is replaceable.” 

Presumably his consciousness resides in his head rather than the follicles. 

Onwards to another incident that rtaises questions about unconscionability and ethics, with the Times stating 

The relatives of one client failed to inform Alcor that he had died and instead had him embalmed and buried in Europe. When Alcor found out a year later, it confirmed that his contract said he wanted to be cryopreserved no matter how much time had elapsed, so the company got a court order and had the body returned to Arizona.

After embalming and a year in the ground we might be more than usually sceptical about the prospects of a sure and certain resurrection. 

 Russian cryo service KrioRus - which appears to be operating out of premises less impressive than my garden shed - has meanwhile been in the news, with Slate reporting

Two weeks ago, police in the Moscow region received a call about an unusual robbery and were ordered to stop a truck belonging to the suspect. On a platform attached to the vehicle, they found containers with frozen bodies. They belonged to people who agreed—and paid money—to be frozen after death in the hope of being revived in the future, a practice called cryonics. .... The woman who allegedly tried to steal bodies was Valeria Udalova, a former CEO of the cryonics company KrioRus, founded in 2006. The man who accused her of theft was her ex-husband, Danila Medvedev, also a former CEO of KrioRus. Both Udalova and Medvedev now own separate cryonics businesses and are in the midst of a battle over 81 bodies of KrioRus clients. 

It came to a head on Sept. 7, when Udalova reportedly broke into the cryostorage near Moscow, which is now under the control of Medvedev (though Udalova claims that she rents this facility). According to the Medvedev`s team, Udalova and her partners cut through a metal wall at the lab, dumped liquid nitrogen from containers with dead bodies, and loaded the containers, known in the industry as “dewars,” on the truck. When workers lifted the heavy vats, the dewars were bending like they were going to fall and break, as a leaked video shows; meanwhile, liquid nitrogen was pouring out and spilling on people. “Even paying much for your death in Russia can’t save you from being a part of the criminal conflict,” wrote one Facebook user who had watched the video. One of Medvedev’s partners, Dmitry Kvasnikov, claimed on Facebook on Wednesday that Udalova broke some equipment during the raid, so now it is hard to maintain dewars and refill them with liquid nitrogen. This put cryopatients “at some risk,” he said.

Hijinks about cadaver napping aside, the piece is of interest for reference to contracts 

KrioRus signs contracts with patients for 100 years; the founders believe, for some reason, that the technology to raise the dead will be discovered by the end of the century. Not just to revive them, but to return them to full health. ... But if such technology hasn’t been invented by the time the agreement comes to an end, it will be automatically extended for 25 years as many times as needed, the company promises.

Academia

The Supporting Staff Wellbeing in Higher Education report by Gail Kinman and Siobhan Wray examining working life in UK Higher Education institutions is based on a survey of 2046 academic and academic related staff regarding the psychosocial hazards they encounter, how they feel about the tasks they do and the availability and usefulness of support mechanisms to manage their wellbeing. The psychosocial safety climate of their institutions was also examined along with mental health and work-life balance. 

Key findings were 

•  Over three quarters (79%) of respondents said they need to work ‘very intensively,’ ‘often’ or ‘always.’ 
• Half (52%) said they experience unrealistic time pressures ‘often,’ or ‘always.’ 
• Many show signs of burnout, with 29% reporting feeling emotionally drained from work ‘every day.’ 
• More than two in ten academics work a further two working days per week. 
• Common barriers to obtaining support for wellbeing were lack of time due to a heavy workload and an inflexible schedule as well as lack of information about where to get it.

The authors offer a conclusion -

This study of UK HE employees has highlighted the initiatives that are currently available to support the wellbeing of employees and the type of support they find (or would find) most effective. The findings show that wellbeing related to key psychosocial hazards, i.e. job demands, support from managers and colleagues, role and relationships, in the higher education sector in the UK continues to be below minimum recommended standards. Moreover, the overall level of job control (an important resource for HE employees) has not improved over time. Reflecting the findings of the survey conducted in 2014, a high proportion of HE employees report being obliged to undertake tasks they consider to be unreasonable or unnecessary on a regular basis. Average working hours in the sector continue to be long, with more than two out of every ten respondents on academic contracts regularly working the equivalent of two extra days per week. Unsurprisingly, perceptions of the psychosocial safety climate in UK universities are typically poor – considerably more so than in studies of other organisations. The importance of improving the psychosocial safety climate in UK universities is intensified by the findings that the risk of burnout is high, and the level of self-reported mental wellbeing considerably lower than population norms. Interference between work and personal life is a common cause of stress and burnout and the findings of this study show that HE employees continue to have difficulties in achieving a healthy balance. 

 

The findings of this survey provide evidence that the psychosocial safety climate, and consequently staff wellbeing, may be improved if institutions take steps to reduce demands, increase support, control and role clarity, improve the quality of working relationships, and review tasks that might be considered unreasonable and unnecessary. Working with employees to identify opportunities for change and shape interventions will be particularly helpful. By highlighting employees’ support needs at the organisational and individual levels, the findings of this survey provide a foundation to help UK universities build a systemic and sustainable approach to wellbeing. As well as ensuring that individual support needs are met, it is crucial to promote a workplace culture where help-seeking is not stigmatised but encouraged and a range of interventions available that are fit for purpose and accessible to staff. These actions will help institutions meet the challenges of the COVID-19 outbreak and ‘build back better’ in terms of a healthy and more productive workforce. 

Key recommendations regarding support needs are - 

 Workplace culture, employee voice and communication 

• Prioritising staff wellbeing 

• Mechanisms to monitor the psychosocial safety climate 

• A culture of openness that normalises conversations about stress and mental health 

• Awareness of the risks of implementing individually focused solutions to structural problems 

• Training for all on equality, diversity and inclusion, including an awareness of neurodiversity 

• Policies and practices to identify and address bullying harassment and discrimination at an early stage 

• Opportunities to co-produce and evaluate support initiatives 

• Support initiatives that are fit for purpose, high quality and informed by evidence 

• Information on the available support initiatives that is centralised and accessible 

• Wellbeing and support policies that are put into action 

• A commitment to communicate and address the findings of staff wellbeing surveys and risk assessments 

• Mechanisms to formally assess the impact of change initiatives on staff wellbeing 

• A regular review of support initiatives to inform continuous improvement 

• Mechanisms to identify barriers to accessing support and how they can be minimised 

Managing workload 

• Mechanisms to identify the causes of workload pressure and manage this at source 

• Workload management initiatives that accurately reflect workload and working hours 

• Awareness of the risks of long working hours for staff wellbeing, work-life balance and performance 

• More autonomy and flexibility to enable staff to manage workload 

• More administrative support for routine tasks 

• Institution-wide policies for managing emails, including clear guidance on expectations for response 

• Support for early career staff to help them manage expectations regarding workload and wellbeing 

Psychological support and counselling 

• A counselling service for staff where the number of sessions is not capped, and counsellors have an understanding of the sector 

• Psychological support and counselling that can be accessed via different modes, such as face-to-face, telephone and online 

• A wide range of coaching and mentoring programmes 

• Improved support for staff with significant caring responsibilities and personal difficulties, such as bereavement 

• Psychological support for staff who feel socially isolated when working remotely 

• Guidance and support for staff to support students with mental health problems 

Support from managers 

• Awareness of the pressures of the job and how the responsibilities and requirements of the various roles can lead to overload 

• Training for managers to support staff wellbeing and how to access support, with regular opportunities for updating 

• Appraisal and supervision procedures that include questions about well-being, clear mechanisms for referral opportunities to revisit and monitor 

• Procedures to identify signs of struggle in remote workers and training on how to provide support • Initiatives to ensure staff feel appreciated, valued and respected 

• Support for line managers to protect their own wellbeing 

Wellbeing and work-life balance 

• A ‘tool-box’ of individual support initiatives to facilitate physical, mental and working health 

• Mechanisms to ensure that support initiatives are accessible to all staff 

• Guidance on work-life balance and healthy remote working, with particular focus on setting boundaries • Access to flexible working options (above the legal requirement) 

• A requirement for employees to take their full quota of annual leave 

• An awareness of the risks of presenteeism and provision of cover for staff who are on sick leave 

• Encouragement to take regular breaks from work during the day 

• A requirement to implement recommendations for reasonable accommodations from occupational health 

Social support 

• Support to promote positive working relationships, including informal opportunities to meet with colleagues 

• Mechanisms to identify and manage conflict at an early stage 

National support initiatives 

• Regular audits of the sector to monitor psychosocial hazards and employee wellbeing, assess change over time and identify areas of best practice and concern 

• Commitment to monitor the psychosocial safety climate in the sector and a consideration of including this as a Key Performance Indicator 

• Access to sector schemes or peer groups outside of the employing institution to communicate information about new initiatives, share best practice and discuss support needs and potential solutions 

• An independent ‘third-party’ that can evaluate how wellbeing services operate at an institution level and deal with staff concerns without fear of reprisals 

• An anonymous national hotline for reporting bullying/harassment

Recreational Genomics

The report of the UK parliamentary Science and Technology committee inquiry regarding Direct-to-consumer genomic testing states 

The human genome is the entire sequence of an individual’s DNA and is found in almost every cell in the human body. Genomic testing refers to techniques for measuring all or part of this DNA sequence. With the costs of some genomic testing technologies falling significantly in recent years, increasing numbers of genomic testing products have been developed and sold to consumers. These products are typically aimed at providing information about genealogy and ancestry, health, or ‘lifestyle’ (ranging from dietary advice to earlobe type). One company, 23andMe, had sold over 250,000 genomic testing kits in the UK as of June 2020. 

Following a public call for inquiry suggestions, our predecessor Committee launched an inquiry looking at genomic tests sold directly to consumers based on a proposal from the Nuffield Council on Bioethics. We took forward this inquiry. Over the course of our inquiry and our predecessor Committee’s inquiry, a range of potential benefits and risks associated with direct-to-consumer genomic testing were raised. These included potential benefits and risks for personal health, opportunities for research and economic growth, considerations of the possible impact on the NHS, and issues related to privacy and consent. Many, but not all, submissions to the inquiries argued that the existing regulations for direct-to-consumer genomic testing should be updated to seize some of these opportunities and address some of the concerns. In its national strategy for genomics, published in September 2020, the Government acknowledged the importance of maintaining public trust in genomics and said that it would “establish a gold standard UK model for how to apply strong and consistent ethical and regulatory standards”. 

In this Report, we discuss the main opportunities and risks of direct-to-consumer genomic tests in more detail, as well as the available evidence for both. We then present some of the main proposals discussed in the oral and written evidence for seizing opportunities and addressing risks, focusing on testing used for medically related purposes. 

Firstly, we recommend that the Government should require direct-to-consumer tests to be subject to greater pre-market assessment by an external body. Currently, most providers are able to self-declare their products’ conformity with the existing regulations, which the Medicines and Healthcare products Regulatory Agency suggested restricted its ability to ensure that genomic tests on the UK market provided reliable results. We suggest that any such external assessment should cover the test’s clinical performance (the extent to which a test can provide information about diagnosis, treatment, management or prevention of disease that will lead to an improved outcome), as well as its analytical performance (how well a test predicts the presence or absence of a particular gene or genetic change)—which is the focus of requirements on direct-to-consumer genomic tests currently. 

Secondly, we propose that the Government should work with Genomics England and the NHS to define clear technical standards for direct-to-consumer genomic testing that, if met, would enable the genomic data generated by the test to be used and trusted by Genomics England and the NHS. The development of such standards, which manufacturers of direct-to-consumer genomic tests could voluntarily meet, could: reduce the likelihood of false positive or false negative results; facilitate the sharing of data obtained from direct-to-consumer tests, which could potentially support research efforts; and reduce the need for the NHS to re-test individuals following a commercially-obtained test, potentially reducing the burden placed on the NHS by direct-to-consumer tests. They could also provide the means for consumers to discern tests of high quality. 

Next, we recommend that the Government should consider the case for amending the current regulation of direct-to-consumer genomic tests to revise the requirements on information and support provided to consumers. This could include requiring companies to inform consumers of the potential consequences of genomic test results for their relatives, or requiring external assessment of the information provided about the tests and results provided, including, for example, studies of consumer understanding. Medical supervision or the provision of genetic counselling could also be required for at least some types of genomic testing offered directly to consumers. The criteria used to determine which tests should require medical supervision could include the severity of the conditions being tested for, as well as the predictive power of the test. 

The Government should aim for the data protection framework governing genomic data in the UK to be world-leading. With technologies developing and more consumers using direct-to-consumer genomic tests, existing data safeguards may become less effective and the consequences for privacy more significant. The Government should review the adequacy of the UK’s data protection framework for direct-to-consumer genomic testing, including the risks and opportunities presented by technological developments and growing numbers of consumers using direct-to-consumer genomic tests. 

We also recommend that the Government should consider if any restrictions should be placed on the types of genomic tests that should be available directly to consumers for use on asymptomatic children or for prenatal testing. For example, the Government may wish to consider banning the provision of genomic tests for use on children that do not meet the criteria of the UK National Screening Committee. 

Finally, we recommend that the Government should consider the scope of regulation of direct-to-consumer genomic testing, specifically with respect to companies selling testing products to UK consumers but conducting testing outside of the UK, and companies offering analysis of genomic data obtained by third parties.

The  Committee states

Commercial genomic testing 

Genomic testing refers to techniques for identifying the content of an individual’s DNA, ranging from specific parts of the genome through to whole genome sequencing.  Based on the characteristics of the human genome as described in the previous section, genomic tests are typically used for one of three main purposes:

Genomic tests sold directly to consumers are most commonly used for genealogical purposes. Such tests are typically advertised as being able to provide information about genetic ethnicity or to identify existing relatives who have also used the product. 

Genomic testing can be used for a variety of health-related purposes. It can be conducted on patients exhibiting signs of disease (“symptomatic” individuals) to provide or confirm a diagnosis, or to guide treatment (if treatment exists).  Genomic testing can also be conducted on “asymptomatic” individuals—those not exhibiting any sign of disease. This is usually done to estimate a person’s predisposition to developing different conditions in later life. Other medical applications of genomic testing include “carrier testing”, which prospective parents can use to assess the risk of passing on an inherited disease, and prenatal testing, which screens fetuses for certain genetic conditions prior to their birth. The NHS has offered a growing variety of genomic tests for many years and plans to continue making increasing use of genomics,  but health-related genomic tests are also available for purchase by consumers.   

A third class of genomic tests available to consumers is sometimes known as ‘wellness’ tests.  These are intended to provide information related to an individual’s physical wellbeing or lifestyle. For example, tests are being advertised as providing genetically-tailored diets or exercise plans. 

Regulation 

A range of different regulations currently apply to genomic tests sold to consumers, including:

• the Consumer Protection Act 1987 and the Consumer Rights Act 2015 (which require products or services sold to consumers to be fit for purpose, as described and meet certain minimum standards, covering aspects such as quality and safety);

• the UK General Data Protection Regulation (which covers the collection, storage and use of data);  the Human Tissue Act 2004 (which effectively bans DNA analysis without appropriate consent); 

• the Advertising Codes (which ban adverts that are misleading, harmful, offensive or irresponsible, and are enforceable under the Consumer Protection from Unfair Trading Regulations 2008 and the Business Protection from Misleading Marketing Regulations 2008); 

• and for commercial genomic tests with a medical purpose, the Medical Devices Regulations 2002 (which set out essential requirements for in-vitro diagnostic devices placed on the market, such as requirements on safety for users and for performance to match the manufacturers’ claims).

Significant changes to the regulation of genomic tests with medical applications were planned by the previous Government. The European Union introduced the new ‘in vitro diagnostic medical device’ regulation (IVDR) in 2017, which is due to apply fully from May 2022. The previous Parliament passed the Medical Devices (Amendment … ) (EU exit) Regulations 2019, which would have caused the UK to adopt essentially the same regulations from May 2022. However, the Government has since introduced the Medical Devices (Amendment … ) (EU exit) Regulations 2020 that “revokes the [ … ] IVDR provisions for Great Britain, that would have been implemented” under the previous legislation.  As a result of these new regulations, the regulatory framework for commercial genomic tests will remain essentially as it is currently, but with the MHRA established as an independent regulatory body outside of the EU framework and provisions made to implement the Northern Ireland Protocol of the Withdrawal Agreement. 

The Government's response is

This response largely focuses on health-related DTC genomic tests, but the Government Chief Scientific Adviser will shortly publish a report on potential future uses of genomics beyond health and their implications, including in the DTC market. 

In June 2021, the House of Commons Science and Technology Committee published their report on DTC Genomic Testing, following an inquiry on commercial genomics launched in 2019. The inquiry was prompted by the rapid rise in genomics-based tests sold directly to the public, usually for ancestry or health and fitness purposes. They are also offered by private clinics for reproductive and fertility purposes. The inquiry focused on genomic tests sold directly to consumers (‘DTC genomic tests’), not those used in the NHS. 

The Committee’s report reviews a range of issues surrounding genomic tests sold directly to consumers, as well as the main regulatory changes suggested during the inquiry. There are seventeen recommendations for Government. Overall, the Committee has recommended improved regulation of DTC genomic tests and increased consumer protection, whilst recognising the potential positive impact the tests could have on the population’s health. 

The following response has been prepared by officials in the Office for Life Sciences (OLS), which is a joint unit between the Department for Business, Energy and Industrial Strategy (BEIS) and the Department for Health and Social Care (DHSC). OLS have engaged closely with the Medicines and Healthcare products Regulatory Agency (MHRA) given that the central theme of the report’s recommendations is to call for better regulation of DTC genomic tests, which is led by MHRA. OLS have also sought input from stakeholders across Government, the devolved administrations, and other relevant organisations, given the wide range of policies that the report’s recommendations cover. 

Overarching Government Response 

Through years of investment in scientific research, landmark infrastructure projects and world-leading healthcare initiatives, the UK has become a clear front-runner in genomics. The Government has committed to sustaining that position by “creating the most advanced genomic healthcare system in the world, underpinned by the latest scientific advances, to deliver better health outcomes at lower cost.” (Genome UK strategy, September 2020). 

We welcome the Committee’s report and the body of evidence collected as part of this inquiry. We recognise many of the issues raised and in some cases our responses to the Committee’s recommendations highlight activity already underway to tackle these concerns. 

Many of the recommendations made by the Committee relate directly or indirectly to improving the way that DTC genomic tests are regulated. The Committee’s report is therefore timely, given that the MHRA launched a public consultation on the regulation of in-vitro diagnostic devices (IVDs), the category in which DTC genomic tests fall under, on 16 September 2021. 

Post-EU Exit, the Government recognises that the MHRA will have a crucial role in supporting the effective development of innovative genomic tests, whilst maintaining the highest standard of safety. We are aware that the regulation of DTC genomic testing within the United Kingdom requires updating and will need further input from across the sector, including from consumers and manufacturers. 

Part of MHRA’s consultation explores the extent to which the issues related to the regulation of DTC genomic tests are specific to the genetic information analysed, or if they are applicable to DTC tests more broadly. The result of this will form a key part of future policy development regarding DTC genomic testing regulation. 

To help realise the UK’s ambitious vision for genomic medicine, the Government established the National Genomics Board (NGB). The Board is co-chaired by Lord Kamall, Parliamentary Under-Secretary of State for Health, with senior leaders in genomics on the board from across academia, the devolved administrations, the NHS, and industry. The NGB will ensure that the issues raised in the Committee’s report are kept under review and, if appropriate, matters will be discussed and further actions agreed by the board. 

Responses to the report’s individual recommendations 

Recommendation one: The Government should set out a specific timeframe in which it intends to review the case for introducing new regulations for genomic tests provided directly to consumers (‘direct-to-consumer genomic tests’). (Paragraph 34) 

The Government recognises both the opportunities and risks raised by direct-to-consumer genomic tests and is committed to ensuring effective and proportionate regulation. The MHRA is working to develop a robust, world-leading regulatory regime for medical devices that prioritises patient safety. 

The MHRA launched a public consultation on the 16 September 2021 into the regulation of IVDs, which covers DTC genomic tests, and new regulations are planned to follow in summer 2022. The consultation explores several matters raised in the Committee’s report and will be open for ten weeks. The Government is therefore unable to provide a detailed response to many of the report’s recommendations until the consultation has completed and the results have been analysed. 

Recommendation two: The Government should continue its support for genomic testing in the UK. (Paragraph 37) 

The Government welcomes the Committee’s recognition that the UK is world-leading in genomic testing. The Government will continue to support the UK’s genomic testing industry and recognises that it plays an important role in the UK’s thriving life sciences sector, bringing benefits for the population’s health and the economy. 

In July 2021, the Government launched its Life Sciences Vision, which was commissioned by the Prime Minister to outline the Government’s and the life sciences sector’s ambitions over the next decade. This vision demonstrates the Government’s commitment to growing the UK’s life sciences sector, including the DTC genomic testing industry. 

Furthermore, through its publication of Genome UK last year, and its subsequent Implementation Plan, the Government demonstrated a commitment to supporting the development of genomic technologies in an environment that promotes responsible, equitable and ethical patient care.

Implementation of Genome UK is supported by a robust governance system. This includes the Minister-chaired National Genomics Board, providing strategic oversight, as well as an Implementation Coordination Group (ICG) which monitors the delivery of Genome UK’s commitments more closely. These groups bring delivery partners and stakeholders together, with UK-wide representation. Progress against the delivery of Genome UK’s commitments has been made possible thanks to consistent government investment in Genomics England, the NHS Genomic Medicine Service, and the UK’s valuable research programmes, such as UK Biobank and Our Future Health. 

As part of the first Implementation Plan for Genome UK, the Government announced the roll-out of a world-first whole genome sequencing (WGS) programme to patients with a suspected rare disease and certain cancers in the NHS Genomic Medicine Service, in partnership with Genomics England. More broadly, the NHS continues to develop innovative testing strategies for the early detection of cancer and hereditary diabetes and high cholesterol, such as through the commercial agreement with the diagnostic company GRAIL announced in November 2020. 

Furthermore, Our Future Health (formerly known as the Accelerating Detection of Disease challenge) is helping to drive developments in the next generation of diagnostics and clinical tools, including the evaluation of polygenic risk scores (PRS). This ground-breaking research programme, supported by Government investment, will further enhance the genomic testing industry in the UK, whilst of course bringing health benefits to the UK’s population. 

We would like to thank the Committee for supporting the policies that have enabled the UK to become a world leader in genomics and life sciences. 

Recommendation three: The Government should require manufacturers of direct-to-consumer genomic tests to have the performance of their tests assessed by an external body prior to placing their products on the UK market. (Paragraph 41) 

The outcome of MHRA’s public consultation will help to inform future policy on how DTC genomic tests are regulated and in turn, how they are assessed prior to being placed on the UK market. 

Recommendation four: The Government should work with Genomics England and the NHS to define clear technical standards for direct-to-consumer genomic testing that, if met, would enable the genomic data generated by the test to be used and trusted by Genomics England and the NHS. The Government should also establish a mechanism by which providers of direct-to-consumer genomic tests could validate that their tests met these standards. (Paragraph 44) 

The Government acknowledges the critical importance of genomic test results meeting appropriate standards and requirements should they have the potential for use in the NHS. We acknowledge that there are a series of practical challenges relating to data standards and clinical validity of DTC genomic tests but believe this is predicated on having more effective scientific and clinical regulation of the devices themselves, before integrating their data into NHS and/or Genomics England (GEL) records. 

All NHS laboratories, including the seven NHS Genomic Laboratory Hubs (GLHs) are accredited and assured through the United Kingdom Accreditation Service (UKAS) under the ISO:15189 standard, which ensures quality and competency for all testing delivered in medical laboratories. The scientific and clinical specification of DTC genomic tests do not currently adhere to the same clinical standards as those used in the NHS. Until they do, for example through more effective regulation, bringing those results directly into health records may lead to undue confidence in those results, even if the technical data standards to integrate them had been reached. 

In time, NHS England and NHS Improvement will work with NHS laboratories, the NHS Genomics Clinical Reference Group, GEL, and others to agree a position on how comparable technical and reporting standards for DTC genomic testing should be developed and implemented. 

This will utilise the technical standards on how to describe and share human genetics and genomics data, developed by the international organisation the Global Alliance for Genomics and Health (GA4GH), which is supported by the UK’s National Institute for Health Research (NIHR) and Medical Research Council (MRC), along with other international funders. Both GEL and other key research datasets, such as UK BioBank, have commitments to implement GA4GH standards which will minimise harms and maximise research outcomes. 

There are also secondary data standards to consider, for instance that standardise the causal link between genetic information and specific diseases. This involves international collaboration between organisations such as the European Bioinformatics Institute (EMBL-EBI), National Centre for Biotechnology Information (NCBI), GEL, US National Institute for Health (NIH) and other clinical research institutes world-wide. Here the support from the UK Government to key institutions, including the support of EMBL-EBI (via UK Research and Innovation, ultimately via BEIS) and GEL (via the Office for Life Sciences) is key to an open, standard understanding of human health and disease which is kept up to date as knowledge progresses. 

The Government have established a Data Working Group under the Genome UK Implementation Coordination Group to consider the steps needed to implement the commitments under the “Data” theme in the Genome UK strategy. Part of this work will bring together key delivery organisations (such as GEL, NHS England and Improvement, and UK Biobank) to work through the practical challenges of implementing GA4GH standards into their systems. This expert group will keep the Committee’s recommendation in mind as we continue the implementation of Genome UK. 

Recommendation five: The Government should extend the scope of the performance requirements on direct-to-consumer genomic tests to explicitly cover clinical performance as well as analytical performance. (Paragraph 47) 

Performance requirements for IVDs, including DTC genomic tests, are explored as part of MHRA’s public consultation and will help to inform future policy related to this recommendation. 

The National Institute for Health Care Excellence (NICE) are also exploring the development of rapid, straightforward, trusted advice on important diagnostic, and digital technologies, such as at-home diagnostic tests which are directly accessible to patients/consumers. 

The Government encourages other well-placed partners, such as the independent UK National Screening Committee (UKNSC), to share their expertise with the MHRA on the validity and utility of DTC genomic tests, given that they have experience working with academic experts on the assessment of the validity and utility of other types of medical tests. 

Government will keep this recommendation under review following the outcome of MHRA’s consultation and will facilitate discussions between MHRA, NICE and the UKNSC, where appropriate. 

Recommendation six: In addition to pre-market validation of direct-to-consumer tests, the Government should consider requiring companies offering such tests to regularly update the evidence submitted to the external validation body, and for that body to review this, for example on an annual basis. (Paragraph 53) 

MHRA’s public consultation explores the pre-market requirements for devices placed on the UK market. 

Recommendation seven: The Government should consider the case for amending the regulation of genomic tests provided directly to consumers, to require medical supervision or the provision of genetic counselling for at least some types of genomic testing offered directly to consumers. Criteria used to determine which tests should require medical supervision could include the severity of the conditions being tested for, as well as the predictive power of the test. Requirements for supervision and genetic counselling should cover the qualifications of the medical intermediary required and minimum requirements on the content and format of the support or oversight provided. (Paragraph 64) 

MHRA’s public consultation explores requirements around the information provided to users of DTC genomic tests and the outcome of this will help to inform future policy on how the tests are regulated. 

Recommendation eight: The Government should consider the case for including reviews of the information provided to consumers prior to and after taking a direct-to-consumer test within any external validation required to place such tests on the market. This could, for example, include assessment of studies of consumer understanding of the information provided. (Paragraph 71) 

Several areas being explored as part of MHRA’s public consultation, including the potential to introduce new classification rules for IVDs, will help to inform future policy on this recommendation. 

Recommendation nine: Building on its review of advertising for non-invasive prenatal testing, the Advertising Standards Authority should review, within the next year, the marketing materials used by companies offering other genomic tests directly to consumers, focusing in particular on the clinical performance implied by the tests compared with their actual performance. (Paragraph 72) 

The Government has sought information from the Advertising Standards Authority (ASA), the UK’s independent advertising regulator who ensure that advertising is legal, decent, and truthful. The ASA respond to concerns and complaints raised by the public, assessing them against relevant UK advertising codes and taking action to ban advertisements which are found to be misleading, harmful, offensive, or irresponsible. The ASA also monitor advertisements across different sectors to ensure they are compliant with relevant advertising codes and conduct research to assess public opinion and identify where action is necessary to protect consumers. 

As referenced in the Committee’s report, in November 2019 the ASA published a series of rulings against advertisements for non-invasive prenatal testing (NIPT) for genetic conditions because the presentation of ‘detection rates’ was misleading. The ASA subsequently published an Enforcement Notice directed at the advertising of NIPT services, setting out the guidance and telling companies to take immediate action to ensure their advertising complied. Companies were encouraged to avoid quoting “detection rate” figures. If advertisers still chose to use “detection rate” figures then they had to be accompanied by a robust Positive Predictive Value figure and an explanation of both terms. Advertisers were also told not to use the claim “diagnostic” to describe NIPT. The Enforcement Notice made clear that if issues continued, targeted enforcement action would be taken which can include referral to the relevant professional regulatory body or Trading Standards who can consider legal sanctions. The full Enforcement Notice can be found here: https://www.asa.org.uk/resource/enforcement-notice-nipt.html 

The ASA ensures the outcome of upheld rulings—such as for NIPT testing – are complied with. They have not yet received any further complaints regarding NIPT advertising but have reassured Government that they will carry out swift action if made aware of any non-compliance. They are considering carrying out a ‘compliance sweep’ of NIPT advertising within the next year, which involves actively monitoring advertising to ensure companies are compliant with UK advertising codes. If advertising is found to break the relevant advertising codes, the ASA will ask advertisers to withdraw or amend their adverts. 

The ASA have also informed Government that they will continue to carefully consider any evidence of non-compliance of advertising for DTC genomic tests and take action where necessary. The Government will keep this recommendation under review and is supportive of the ASA’s work in this area. 

Recommendation ten: As the Government considers the requirements that should be introduced on the information provided to consumers using direct-to-consumers genomic tests, it should consider specific requirements for prenatal genomic testing to ensure that the information provided is balanced and non-directive, with accurate information on what might be expected from life for a child or adult with the condition being tested for. (Paragraph 76) 

This issue is addressed in MHRA’s consultation, as the information provided alongside such tests is a crucial part of their regulation. 

There may be a role for the UK National Screening Committee (UKNSC) in providing advice on regulation of prenatal genetic testing, given that they have experience exploring the use of prenatal genetic testing for Down’s Syndrome, Edwards’ Syndrome and Patau’s Syndrome, and appreciate the highly charged and contested debate in the public domain. The wider landscape of prenatal genetic testing is also changing rapidly, for example in recent years there has been a marked increase in the number of private clinics offering non-invasive prenatal testing (NIPT) to expectant mothers. As part of its inspection programme of baby scanning services, the Care Quality Commission (CQC) inspects NIPT services where they are offered in relation to Down’s Syndrome. In such services, CQC expect providers of NIPT to ensure that women using the service fully understand the procedure, understand that it is not a diagnostic test, are informed of the possible outcomes, and have appropriate support available when the test results are delivered. This includes facilitating access to counselling and other relevant services, as well as medical follow-up when needed. 

The Government will work with the UKNSC and MHRA to establish what actions are required to meet the recommendation, and with the CQC to understand if best practise can be transferred from private clinics to DTC genomic tests. 

Recommendation eleven: The Government should gather evidence on the current impact of direct-to-consumer genomic testing on the NHS, as well as the effectiveness of guidance and other support offered to NHS professionals encountering patients who have used such tests. If necessary, the Government should support the Royal Colleges and other relevant organisations to publish guidance for NHS professionals, as well as for consumers consulting the NHS following a direct-to-consumer genomic test, explaining the capabilities and limitations of those tests, how the NHS will act on results obtained from such tests and the reasons for the actions that the NHS will and will not take. (Paragraph 79) 

The Government agrees that it is important to gather more information on the impact of DTC genomic testing in the NHS. An NHS Genomics Workforce Survey, aimed at doctors initially, was launched on the 23 August 2021 across the NHS in England. It includes a question to quantify the proportion of doctors who have encountered patients seeking advice after taking a DTC genomic test, and whether doctors believe this will impact their future practice. This question will also be included in other versions of the survey that will be aimed at other healthcare professionals, for example, a survey aimed at pharmacists will be launched early next year. 

The Government also agrees that it is important that NHS professionals are well supported with guidance on DTC genomic testing. The British Society for Genetic Medicine (BSGM) and Royal College of General Practitioners (RCGP) have published a position and guidance statement on DTC genomic testing, issued in 2019 (https://www.rcgp.org.uk/policy/rcgp-policy-areas/genomic-position-statement.aspx). The NHS England and NHS Improvement Genomics Clinical Reference Group, which advises on clinical policy and strategy for genomics in the NHS, have considered and endorsed this guidance and continue to consider implications of DTC genomic testing on the NHS. 

This guidance notes that NHS patients may present to their GP or other NHS professionals requesting help with the interpretation of DTC genomic results and sets out recommendations on how NHS professionals should approach the management of these patients. It explains that the analytical validity, sensitivity, and clinical utility of DTC genomic testing may be lower than NHS standards and, for certain types of DTC genomic test results, there is a high chance of false positive or false negative results. This means that patients should be offered the NHS care which would otherwise have been offered (for example, family history and risk assessment, healthy lifestyle advice, or referral to specialist care) regardless of their DTC result. 

Furthermore, the Health Education England Genomics Education Programme (HEE GEP) will work with the Academy of Medical Royal Colleges, NHS England and NHS Improvement, and Government to build on this existing guidance. The HEE GEP is already working with the Royal College of GPs to develop resources to support GPs in understanding DTC genomic test results, managing conversations with patients who have taken such tests and managing required NHS care as appropriate, whilst adhering to the 2019 RCGP guidance outlined above. The HEE GEP will also explore the resources required to support other NHS professionals, such as nurses and midwives, encountering patients who have used DTC genomic tests. Resources and learning interventions will be evaluated by the HEE GEP to provide evidence of usage and impact. 

Recommendation twelve: The Government should continue to explore, with NHS England and NHS Health Education England, the opportunity for companies selling genomic tests directly to consumers to contribute to the costs of training genetic counsellors in the NHS. (Paragraph 82) 

Genomic counsellors play a key role in the genomic pathway and are an important but limited resource whose roles are first and foremost focused on activity commissioned by the NHS, covering referrals from NHS clinicians. As noted above, patients presenting to GPs after taking a DTC genomic test should be offered the NHS care which would otherwise have been offered (including referrals to genomic counselling services) regardless of their DTC result. NHS patients cannot access genomic counselling services in the NHS without a referral from an NHS clinician and a referral would not be made based solely on DTC genomic test results. Referrals to NHS genomic counselling services would only be made following the relevant NHS testing and/or assessment by an NHS clinician. Given this, DTC genomic tests are unlikely to be directly increasing demand for NHS genomic counselling services and therefore the NHS does not currently wish to seek contributions from DTC testing companies for the cost of training NHS genomic counsellors. 

Furthermore, if this recommendation were to be implemented, it would imply that NHS genomic counsellors could advise and support patients presenting with DTC genomic test results. There are several complex issues which would need to be addressed within the wider clinical pathway before this could be possible. This means that, at this stage, the NHS would not be able to implement this recommendation without additional funding and resource. For example: Data and results generated from DTC genomic testing would need to be validated and accredited appropriately so that they can be used by the NHS (see recommendation 4). This may involve re-validation within the NHS and additional laboratory work, including interpretation and confirmatory testing in line with NHS clinical and scientific standards. This would incur additional costs for the NHS; Allowing patients who have used DTC genomic tests to access NHS genomic counsellors would result in increased referrals to relevant services for patient management, including clinical genetics and oncology services, resulting in increased demand and pressure for these services; Appropriate data and information infrastructure would need to be developed to support the incorporation of DTC genomic test results into the NHS, including the development of an appropriate laboratory information management system (LIMS). As it stands, the DTC genomic test results would not be compatible with the NHS’ data infrastructure. 

Despite the difficulties in implementing this recommendation immediately, the Health Education England National School of Healthcare Science (NSHCS) does have prior experience of enabling private sector companies to fund the cost of training staff providing NHS services, for example in fertility services. Therefore, the Health Education England Genomics Education Programme will work with NHS England, the NSHCS, the professions (Association of Genetic Nurses and Counsellors) and Government to explore the feasibility of implementing this recommendation in the longer term. 

Recommendation thirteen: The Government should aim for the data protection framework governing genomic data in the UK to be world-leading. It should review the adequacy of the UK’s data protection framework for direct-to-consumer genomic testing, including the risks and opportunities presented by technological developments and growing numbers of consumers using direct-to-consumer genomic tests. The Government should also consider the case for requiring companies providing direct-to-consumer genomic tests to inform consumers, at the point of sale, of the potential consequences of genomic test results for their relatives. (Paragraph 88) 

The Government agrees that it is important to have a strong data protection framework governing genomic data in the UK. The Information Commissioner’s Office (ICO) is the regulator for the UK’s data protection law and it must be adhered to by DTC genomic testing companies. The law is based on high-level principles which are designed to be technology neutral. This means that new technologies, or existing technologies used in new and different ways, will still be subject to these principles. The principles can be applied successfully across any sector, including the DTC genomic testing sector. Therefore, data protection law in the UK can be applied in a proportionate manner to ensure that personal data generated by DTC genomic testing is in a lawful and fair manner, is kept securely, and is protected in line with the principles. There are a number of different guidance documents about the Data Protection and the UK General Data Protection Regulation on the ICO website here. 

For DTC genomic testing, the data being created is genetic data about the individual which is considered ‘special category data’. Special category data gets extra protections applied to it. This includes a requirement for ‘explicit consent’ from the individual for their personal data to be used. Although ‘explicit consent’ is a term used in data protection law, it has not been specifically defined. However, any explicit consent given by the individual for their personal data should be in line with the definition given to ‘consent’ as a minimum. In practice, the extra requirements for consent to be ‘explicit’ when processing special category data, such as genomic data, are likely to be: That explicit consent must be confirmed in a clear statement (whether oral or written), rather than by any other type of affirmative action; That it must specify the nature of the special category data that will be used; and That it should be separate from any other consents you are seeking – i.e. consent received for other types of personal data cannot be considered to apply to the special category data. A separate ‘explicit’ consent will need to be given by the individual for their special category data to be stored and used. 

For more detailed information on what constitutes a valid consent the ICO has published guidance here. 

In terms of DTC genomic testing, consideration needs to be given to the transparency information that must be provided. Individuals have the right to be informed about the collection and use of their personal data. Furthermore, the personal data must be used in a way that is fair to the individual and their situation. With regards to the potential consequences and inferences that can be made to and about others (such as relatives), when an individual gives explicit consent to their own personal genetic data being used/created through a DTC genomic testing firm, there is currently no specific requirement to inform individuals involved about these potential consequences. 

MHRA’s public consultation includes a question on whether the UK should introduce requirements for companies to inform consumers of the nature, significance, and implication of genomic tests. The results of this will help to inform future policy regarding this issue. 

In respect of the complexity and uncertainty around the future uses of genomic data, it should be noted that UK law requires that the purposes of processing personal data must be clear from the start. This requirement aims to ensure that the reasons for obtaining personal data, and any intended processing of that data are clear from the point of collection and remain in line with the reasonable expectations of the individuals concerned and goes some way to protecting potential scope creep around the use of collected genomic data. 

If an organisation intends to transfer an individual’s personal data, specifically in this instance their genomic samples, outside of the UK, UK law would restrict that, unless the rights of the individuals in respect of their personal data are protected in another way, or one of a limited number of exceptions applies. The Government will keep this recommendation under review and explore with the ICO whether further guidance in this area is necessary. 

Recommendation fourteen: The Government should consider which, if any, genomic tests for asymptomatic children should be able to be provided directly to consumers, including whether there should be a ban on the provision of genomic tests for use on children that do not meet the criteria of the UK National Screening Committee. (Paragraph 95) and Recommendation fifteen: The Government should consider if any restrictions should be placed on the conditions that prenatal genomic tests provided directly to consumers are able to test for. (Paragraph 99) 

Under the UK Medical Device Regulations 2002, the MHRA could only take action against the use of certain genomic tests if a compliance or safety issue associated with the device had arisen. The MHRA proactively investigate and review adverse incident reports for all medical devices placed onto the UK market and take necessary regulatory action where needed. 

The UKNSC is keen to be involved in any future discussions with MHRA to advise on policy relating to recommendation 14. The Government will encourage and facilitate these discussions where appropriate. 

Recommendation sixteen: The Government should consider requiring any manufacturer making genomic tests available to consumers in the UK to register a legal representative in the UK, with responsibility for ensuring that products supplied to consumers in the UK meet all relevant UK regulatory requirements. (Paragraph 101) 

MHRA’s public consultation explores the registration of medical devices in the UK and the outcome of this will help to inform future policy on this recommendation. 

Recommendation seventeen: The Government should consider extending the definition of products covered by the regulation of genomic tests to include software and other services offering analysis and interpretation of genomic test results obtained from third parties. (Paragraph 104) 

MHRA’s public consultation explores the scope of medical device regulations in the UK and the outcome of this will help to inform future policy on this recommendation.