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.

Affiliation

Another instance of contested, if not appropriated, affiliation. 

The Guardian and CBC report controversy over claims by University of Saskatchewan academic Carrie Bourassa of Indigenous ancestry.  Bourassa has described herself as having Métis, Anishinaabe and Tlingit heritage and on occasion very publicly identified herself as “Morning Star Bear” (“I’m Bear Clan. I’m Anishinaabe Métis from Treaty Four Territory”).

 CBC television alleged that Bourassa was entirely of European descent, with a study of genealogical and other records indicating that her ancestors were of Russian, Polish and Czechoslovakian descent. As with much disagreement about affiliation, colleagues had expressed disquiet about her account of her ancestry and some appear to have undertaken genealogical searches (confirmed and deepened by CBC).

Bourassa states that she had been adopted as Métis by a friend of her grandfather and had subsequently been adopted into Tlingit and other communities. CBC was accused of running a “smear campaign", with  Bourassa stating she was “shocked and dismayed at the recent attack on my identity”. She indicated that she identified as Métis and that elders who supported her did not rely on “blood quantums” to assess Indigenous identity. 

CBC quotes a University of Toronto academic of Métis heritage as saying “It makes you feel a bit sick [t]o have an impostor who is speaking on behalf of Métis and Indigenous people to the country about literally what it means to be Métis … that’s very disturbing and upsetting and harmful.” 

Another colleague states 

 early on in Bourassa’s career, she only identified as Métis. But more recently, Tait said, Bourassa began claiming to also be Anishinaabe and Tlingit. Tait said she also began dressing in more stereotypically Indigenous ways, saying the TEDx Talk was a perfect example. 

“Everybody cheers and claps, and it’s beautiful,” said Tait. “It is the performance that we all want from Indigenous people — this performance of being the stoic, spiritual, culturally attached person [with] which we can identify because we’ve seen them in Disney movies.”

Authority aside, Bourassa may have benefited from scholarships as a Métis student.

In my forthcoming monographs on identity I note that 'identity states' rely on registers and tags. CBC states

On her Facebook page, Bourassa says she’s a member of First Indigenous Riel Métis Local #33 (FIRM 33). 

Wendy Gervais, the elected representative for the Métis Nation–Saskatchewan (MN-S) in the Regina region where FIRM 33 is located, says that organization is not connected to the Métis Nation. “They are not a recognized, legal local,” said Gervais. “They’re not part of our governing body.” 

Gervais said in Saskatchewan, proving you are a Métis person is relatively simple — you just show you are on the provincial citizenship registry. 

“If someone were questioning who I am, here’s my citizenship card, here’s my genealogy. This is who I am,” said Gervais. “Any person carrying a Métis citizenship card has produced their documentation to prove who they are.” 

In fact, during a 2012 address to a House of Commons committee examining Métis identity, Bourassa acknowledged she didn’t qualify for the registry. 

“I can have my local membership, but I know I am not eligible for that provincial registry,” Bourassa said.

A critic comments that

sidelining genealogical proof is alarming at a time when Indigenous people are fighting for their rights and their land. 

 

“That’s opening the doors to every Tom, Dick and Harry to claim Indigeneity,” she said. “Then suddenly out of the woodwork, everybody’s Indigenous because they feel like it.”

Equity

Rereading 'The Intersection of Companies and Trusts' (Harold Ford Memorial Lecture 2019) by Melbourne Chief Justice Allsop AO. 

The CJ states

 The intersection of companies and trusts is statute and equity. The focus of what I wish to discuss tonight was the subject of an influential (and still well-read) article which Professor Ford wrote in 1981. The article was entitled "Trading Trusts and Creditors' Rights". The article appeared to have been spurred by the then recent High Court decision in Octavo Investments and the growing development, at least from the 1960s for fiscal reasons, of the use of the so-called trading trust as a vehicle for the conduct of business, in apparent preference to the limited liability company in its own right and in its own interests. This union of trust and company and the interaction of statutory and equitable rules led Professor Ford to refer to the hybrid as a "commercial monstrosity". 

More recent growth of superannuation savings, managed superannuation funds and the statutory and the regulatory frameworks of superannuation trusts, as well as managed investments schemes, mandate close attention to equitable principle and to relevant statutes, and to the inter-relationship between the two. 

For 38 years, with an intervening Australian Law Reform Commission report, the "commercial monstrosity" has given life to a body of jurisprudence requiring the careful conceptualisation and expression of legal, statutory and equitable concepts. Judgments have been written by eminent commercial and equity judges. The High Court has, on a number of occasions, contributed to the development of the jurisprudence. Recently, in Carter Holt, in an appeal from a five member bench of the Victorian Court of Appeal, in three separate but broadly conforming judgments, the High Court has settled, hopefully once and for all, the major disputes which divided Supreme Courts in the 1980s and 1990s, which appeared to be settled by the end of the first decade of the 21st century, and which then erupted once again in the second decade of this century. 

Equity, equitable principle and statute lie at the heart of company law. The genius of the 19th century development of the limited liability company as an institution that mixed contract, fiduciary loyalty and capitalist risk-taking has always called for a command of legal skills that encompass the common law, equity and statute. 

Equity and equitable principle have a justification and coherence that is not merely historical and rooted in the organisation of English courts of centuries past. A conception of equity is an inhering part of any civilised system of law and justice. It involves the adaption of the general rule to the circumstances of the case informed by equity's principles. As a body of law directed to, and concerned with, the conscience of parties, in particular with fraud, accident and mistake, equity maintained, through particular application to the relationships of the parties before it, the requirements of justice, fairness, and conscionable conduct. 

The distinctiveness of equity is a reflection of law's inherent societal and human character, affected by the deep and complex relationships of rule, principle and values. Equity is the part of the legal fabric which ameliorates hardship of rule, that accommodates structure to justice, and which provides the flexibility of rule and principle to the sometimes competing demands of the occasion, certainty, and changing values. As a matter of history in our legal system, equity had a separate existence in a separate body of courts, and so, clear separate institutional coherence. That should be recognised still, not to maintain outdated organisational structures, but to recognise the true sources of different parts of our law, which recognition assists in coherent legal development. 

For instance, I venture to suggest that many of the commercial problems of corporate and financial regulation exposed in the recent Royal Commission would be made more ruthlessly manageable by a full understanding and a daily application of the fiduciary principle, rather than by ever more detailed regulation which has as its (false) working assumption the ability exhaustively to define good faith, fiduciary responsibility, and behaviour in good commercial conscience. 

Equity and its doctrines are built on maxims and principles. Its informing norms are timeless. They arise from a view as to what ought be the case: equity regards as done, that which ought to be done; fairness and equality: equality is equity. Notions of fairness and justice and a demand on the person before the court to act, or to have acted, in good conscience, are reflected in equity's concern with fraud, accident and mistake, and with the strength of the demands for faithfulness and confidence in the fiduciary relationship. Its doctrines reflect the interplay of personal obligation, trust and confidence, and the translation of known circumstances and relationships that are subject to doctrine and personal obligation into rights that are expressed and recognised as proprietary in character. Thus, the interest of the cestui que trust was assignable by the early 16th century when an assignment of a chose in action was illegal on the ground of maintenance. 

Considerations of the nature of equity affect the technique of its application, as expressed by two masters of equity (Dixon CJ and Kitto J) in Jenyns v Public Curator which emphasised the precise identification of all relevant facts being every connected circumstance relevant to the justice of the case. 

The passage should not be misunderstood. Equity is not to be viewed as based on personal choice, or mere intuitive human or personal responses. It is a body of doctrine and rules with thematic coherence, directed often at subjects that are abstracted and intricate, but even then equity and any intricacies or subtleties in doctrine will be informed by the practical realities of the problem at hand, by underlying principles and their purposes, and by the values that underpin them. This relationship of rule, principle, and values, especially fairness, justice in the notion of conscience, is no better expressed than by another master of equity, Deane J, in Muschinski v Dodds and his demand for the application of principle and doctrine, not the formless void of individual moral opinion. Yet he recognised that notions of fairness and justice "remain relevant to the traditional equitable notion of unconscionable conduct which persists as an operative component of some fundamental rules or principles of modern equity".