WHO Genome Guidelines

This month's WHO 'Guidance for human genome data collection, access, use and sharing' notes  

Collecting, accessing, using and sharing genomic data from humans is fraught with ethical, legal, social and cultural issues. Nevertheless, the potential benefits of genomics can only be realized if such data is collected, accessed, used and shared. Consequently, the Science Council report set the promotion of ethical, legal, equitable, and responsible sharing of human genome data as a specific goal. 

This complementary document seeks to achieve that goal by outlining globally applicable principles for collecting, accessing, using and sharing human genome data. These principles serve as a compass to guide policy-makers, researchers, clinicians, and all those involved in human genome data, how they should collect, access, use and share human genome data in ways that advances genomics for individual and population health, protects individual and collective rights and interests, and fosters public trust. Equally, they provide individuals, their families and communities from whom human genome data is accessed with an understanding of the principles upon which their data will be collected, accessed, used and shared. The principles described recognize the importance and value of human genome data. Its use is critically important if we are to realize the promise of genomics for all, but this must be stewarded in such a way that identifies and mitigates the ethical, legal, social and cultural issues that are likely to arise. These principles offer normative guidance and serve as a call to action, urging all of those involved in the use of human genome data to uphold and implement them. 

1. INTRODUCTION 

The science and practice of genomics hold great promise and potential to improve individual and population health for present and future generations. To realize this potential, there is a need to enable the collection, access, use and sharing of human genome data within and across differing health and research sectors. Achieving this requires proactively addressing the ethical, legal, societal and cultural issues. It also requires acknowledging that there are risks associated with both the use of and the non-use of human genome data (1). Such risks must be balanced and mitigated to protect the interests of individuals, families and communities, while at the same time promoting the health and well-being of present and future generations. Efforts to scale up collection, access to, use and sharing of human genome data must recognize the related mistrust that can exist among some individuals, families and communities. This is an ongoing challenge, partly due to continuing exploitative practices, as well as capacity and power imbalances between the different stakeholders (2-4). The diversity of datasets and the under-representation of many populations in existing datasets must also be addressed to help reduce existing inequities, facilitate equitable access to the potential benefits of genomics, and advance global equity in genomics (5). However, addressing diversity and representation must be done in a way that does not perpetuate harms and protects privacy and confidentiality, if scientific quality and global equity in genomics are to be achieved. Consideration must also be given to the trans-generational impact of genomics, as decisions that are made today on collection, access, use and sharing could affect future generations. 

The integration of genomics into health systems requires a data life cycle approach, with guidance enabling collection, access to, use and sharing of human genome data within and across health and research sectors locally, nationally and internationally. To support research and the integration of genomics into health systems – and following the WHO Science Council 2022 report Accelerating access to genomics for global health (6) that recommended the promotion of ethical, legal, equitable and responsible use and sharing of human genome data – WHO has developed this document, which sets out principles for human genome data collection, access, use and sharing. 

2. PURPOSE AND SCOPE 

This document sets out globally applicable and inter-connected principles on the collection, access, use and sharing of human genome data, to promote human health and well-being, including responsible medical advances and scientific research. This document is rooted in human rights law (7-8). It complements and builds upon current laws, policies, frameworks and other guiding documents in this space (including 9-19) and encourages their development where none exist. 

The principles for human genome data collection, access, use and sharing are intended to:

•Promote social and cultural inclusiveness, equity and justice. •Promote trustworthiness within the data lifecycle •Foster integrity and good stewardship •Promote communal and personal benefits •Promote the use of common principles in laws, policies, frameworks and guidelines, within and across countries and contexts. 

In addition, these principles aim to build and strengthen capacity and awareness of individuals, families and communities from whom genome data are collected, to enable them to have more control over their genome data. 

Implementing these principles requires a comprehensive approach throughout the entire data life cycle. They apply to all prospective and retrospective collections of human genome data, and are designed to complement and inspire legal and ethical regulations, frameworks and guidelines at both the national and community- specific level (e.g. research community). WHO recognizes that the implementation of some of these principles may differ for retrospective data (e.g. secondary use of data). 

This document applies only to human genome data. Pathogen genome data (20) and microbiome data do not fall within its remit. 

Human genome data are typically linked with other health information that is critically important to its interpretation. WHO strongly encourages making other health data available with human genome data, subject to approval and mitigating any associated risks that may arise. It may be reasonable to apply these same principles to health data collection, access, use and sharing. Human genome data are obtained from biological samples thus these principles equally apply to them. Biological samples are a finite resource and have cultural significance in many contexts. Collecting, accessing, using, and sharing biological samples therefore may require additional considerations beyond those identified in this document (11). 

This document sets out principles that are intended to set normative standards in collection, access, use and sharing of human genome data. Each principle is followed by recommendations that can be used to guide the application and implementation of these principles in practice. The application of these principles in practice depends on giving careful attention to the health and research context in which human genome data are collected, accessed, used and shared. This will include: specific considerations of the individuals, families and communities providing the data; the purpose of collection, access and use; and the capacity, resources, skills and expertise of those collecting, accessing, using and sharing the data. Equally, national legal and ethical frameworks, as well as social and cultural values, impact the application of these principles. Individual and collective values may vary, giving rise to tensions when implementing these principles. In such circumstances, implementing these principles may require additional and careful deliberation and review. 

These principles are intended to be used by those responsible for governing, overseeing and managing human genome data, as well as stakeholders in the data life cycle within health and research contexts, including individuals, families and communities from whom human genome data originate, and the private sector. 

3. PRINCIPLES FOR HUMAN GENOME COLLECTION, ACCESS, USE AND SHARING 

3.1. To affirm and value the rights of individuals and communities to make decisions 

A commitment to affirm and value the rights and interests of individuals with capacity to make informed decisions about their human genome data throughout the data life cycle. In addition, a commitment to affirm the best interests of, and support for, individuals who do not have the capacity to make decisions for themselves. The use of human genome data has implications beyond the individual, and the relevant views of family members and communities on collection, access to, use and sharing of these data should be taken into account throughout the data life cycle.  

Recommendations: • Human genome data collection, access, use and sharing should be aligned with the needs, preferences and values of individuals, families and communities throughout the data life cycle. Informed consent is a critical component for the ethical use of human genome data and includes the right of and clear mechanism for an individual to withdraw, but there can be justified limitations to this right (e.g. when the results of the use of human genome data have been publicly shared). Any such limitations must be subject to approvals being in place and communicated clearly in advance. Informed consent should be as specific and granular as possible in relation to the potential uses (including by for-profit entities and the potential to share the data to train artificial intelligence), benefits and harms possibly resulting from the use of human genome data, the infrastructure hosting the data (including location and access modalities), and this information must be tailored to respect social and cultural contexts. The most appropriate informed consent model (e.g. specific, broad, tiered or dynamic informed consent) depends upon the individual/local context. Informed consent should be supported by governance frameworks and processes, and individuals should be informed of such processes. In circumstances where it is not possible to identify a specific purpose for human genome data use, informed consent to broad categories of human genome data collection, access, use and sharing may be permissible, provided such collection, access, use and sharing is subject to appropriate safeguards. 

These safeguards include, at a minimum, • • • • • governance frameworks and processes on the re-use of the data that should be informed by community engagement and oversight by a body such as a data access committee. Such a committee should ideally be independent and have responsibility for reviewing access requests and monitoring compliance with conditions set out in the access approval. The broader the informed consent, the more safeguards are required. Individuals, families and communities should have access to clear, transparent, accessible, understandable and ongoing communication about their human genome data collection, access, use and sharing, for those who wish to receive that information. This ongoing communication should, where possible, continue throughout the data life cycle. Individuals and their representative communities should be engaged in the governance and decision-making process regarding collection, access to, use and sharing of human genome data, including the development of appropriate informed consent models and processes. Children, when sufficiently mature to understand what is involved in their participation, should be given the opportunity to affirm the informed consent previously given on their behalf or to withdraw their consent from that point onwards. The right of the child to an open future (i.e. the right to know and the right not to know) should be given due consideration, when collecting, accessing, using and sharing human genome data from children. Measures regarding the protection of marginalized groups and populations, including individuals who are not able to consent or in need of additional support, protection or assistance, should be carefully thought out and implemented. 

3.2. Social justice 

A commitment to uphold individual and collective values and enable collection, access to, use and sharing of human genome data in ways that: (i) promote the highest attainable standard of health, individual and collective well-being; (ii) address the needs of underserved and marginalized individuals, families and communities, and those experiencing greater health burdens; (iii) reduce socioeconomic inequalities and health inequities; (iv) promote global equity; and (v) avoid individual and group discrimination and stigmatization. A commitment to enable access to adequate resources, skills, training, capacity building and capacity- strengthening for researchers, all health care professionals, genomic data administrators, policy-makers, individuals, families, communities and other stakeholders involved in human genome data collection, access, use and sharing. Fulfilment of this commitment requires greater effort in some countries and contexts than others due to existing inequities. 

Recommendations: • The purposes to be served by human genome data collection, access, use and sharing should give due consideration to local health needs and burdens, taking account of the interconnectedness between the local, national and international health ecosystems, which are critical to ensuring the global impact of genomics and improving global equity. 

• Return of results to individuals should be considered in cases where: results are clinically relevant and could be validated; return is feasible within the local health setting; and the return of results is legally and ethically permissible. 
• An approved policy should be developed for the return of individual results and should be in line with the individuals’ informed consent and respect the privacy and confidentiality of the individual. 
• Policies and procedures to protect individuals, families and communities from stigmatization and discrimination that can result from the association between genome data, community membership and health status should be developed in advance and regularly updated. They should be developed in collaboration with communities through meaningful community engagement, particularly those who may be at higher risk of stigmatization and discrimination. 

3.3. Solidarity 

A commitment to stand in solidarity with others by ensuring equitable access to human genome data and fair distribution of its benefits and burdens. This includes data collection, access, use and sharing, within and across communities, and acknowledges the need to address differences in capacity and existing inequities between different individuals, families or communities, countries and regions. 

Recommendations: • • The rights and interests of individuals, families and communities providing human genome data for collection, access, use and sharing should continue to be protected, particularly as efforts to scale up diversity and representation are increased. Decisions on human genome data collection, access, use and sharing should include an assessment of both the potential risks and potential benefits, and commitments to • • facilitating access to any resulting benefits for individuals, families and communities. Commercial interests should not unfairly limit collection, access to, use and sharing of human genome data. Governance processes should be introduced to clearly identify responsibilities and duties for all those involved in the data life cycle, and to specify sanctions in case of non-compliance. These sanctions should be sufficiently serious to act as deterrents to help avoid harm to individuals, families and communities. 

3.4. Equitable access to and benefit from human genome data 

A commitment to achieving equitable collection access to, use and sharing of human genome data and its resulting benefits. This means actively addressing power imbalances and inequities among different stakeholders that may hinder these efforts. A commitment to increase diversity and representation in datasets and decision-makers overseeing collection, access to, use and sharing of human genome data, without contributing to further harm for current and future generations. A commitment to ensuring that individuals, families and communities whose human genome data are collected, accessed, used and shared fairly benefit from its use. 

Recommendations: • Increasing representation of datasets across diverse populations is critical, but inclusion alone is insufficient to achieving equity. It must be paired with the meaningful participation of individuals, families and communities affected by decisions regarding the collection, access, use and sharing on their human genome data. Their involvement in decision-making and the development of governance frameworks is necessary, as differing cultural perspectives • • on human genome data can influence these processes. The equitable sharing of potential risks and benefits across and within communities, including affordable access to resulting benefits, should be considered in advance of collection, access, use and sharing of human genome data, and where possible and needed, informed by community engagement. Capacity building and strengthening should be considered as part of any collection, access to, use and sharing of human genome data. 

3.5. Collaboration, cooperation and partnership A commitment to promote mutually beneficial local, national and international collaboration, cooperation and partnership, including public–private partnership, between those involved in all aspects of human genome data collection, access, use, and sharing, acknowledging that to achieve this will require a rebalancing of power and representation between individuals, families, communities, countries, regions, and other stakeholders. 

Recommendations: • • • • Decisions on governance processes for human genome collection, access, use and sharing should be made collaboratively between all relevant stakeholders. Decisions on collection, access to, use and sharing of human genome data should include discussions on potential risks and benefits to individuals, families and communities from which the human genome data is collected. Policies should clarify that human genome data should be collected, accessed, used and shared with consideration for protecting and confidentiality to improve human health and wellbeing, with ethical safeguards. Ensure the interoperability of platforms to • facilitate collection, access, use and sharing of human genome data between institutions both nationally and internationally, and in the public and private sectors. To promote collaborative decision-making and effective partnerships, efforts should focus on building and strengthening capacity and improving health literacy on genomics and human genome data among all stakeholders. This includes both those contributing their data and those involved in making decisions about its collection, access, use, and sharing. It may incorporate targeted educational initiatives to increase public awareness and understanding of human genome data and the importance of and implications of its collection, access, use and sharing. 

3.6. Stewardship of human genome data A commitment to encourage, enable and sustain ethical, legal, socially and culturally appropriate, and responsible, human genome data collection, access, use and sharing by committing to: (i) develop processes to enable equitable collection, access to, use and sharing of human genome data; (ii) follow the current ethical practices on human genome data; (iii) identify and minimize potential risks in human genome data collection, access, use and sharing; and (iv) respect applicable laws and guidance, including laws on privacy and data protection. 

Recommendations: • Suitable models should be identified that provide equitable access to human genome data. They should be implemented in ways that best protect individuals, families and communities across different contexts. Efforts should be made to mitigate the environmental impact of data processing, storage and use. The collection, access, use and sharing • • of human genome data should align with other current relevant guidance, such as the Findable, Accessible, Interoperable, Reusable (FAIR) principles (21), the Collective Benefit, Authority to Control, Responsibility, Ethics (CARE) principles (22) and the TRUST code (23). Sufficient attribution should be given for the source(s) of human genome data. Timely access to human genome data should be granted, but justified, reasonable and • • • proportionate time delays can be permitted. To ensure that data collection and subsequent access, use, and sharing is in line with cultural and social priorities and considerations, community and stakeholder engagement should be ongoing throughout the data life cycle. Resources required to sustain the use of human genome data (e.g. financing, infrastructure, and personnel) should be considered at the outset of human genome data collection and also reviewed through the data life cycle. Specific guidelines, policies and frameworks should be put in place to ensure that current ethical, legal, privacy, data protection, and security standards and practices are followed, recognising that they may be informed by standards and practices on health data • • generally. This may require the establishment of data governance structures and oversight mechanisms (e.g. data access committees). Such standards and practices may need to evolve over time to reflect advances in technology, the state of the art, and societal norms. Robust data security measures should be implemented to safeguard genetic information from unauthorized access, breaches or misuse. This might include encryption, access controls, regular security audits, and compliance with data protection regulations. Provide training and resources to all those involved in the data life cycle on ethical data handling, privacy protection, and responsible data stewardship practices for human genome data. 

3.7. Transparency 

A commitment to provide openly available and easily accessible information on policies and processes that describe human genome data collection, access, use and sharing, including how the data are to be protected. A commitment to transparency also includes making research findings readily accessible to individuals, families, communities and other stakeholders who shared genomic data. 

Recommendations: • Publicly available policies should describe the criteria for deciding on collection, access to, use and sharing of human genome data, the processes for decision-making, how human genome data is protected, and how such policies were developed. 

• These policies should describe how the right to privacy is protected and who is responsible for ensuring respect to this right throughout the data life cycle. 

 

• Systems and mechanisms should be put in place to enable communication with individuals, families and communities about the use of their human genome data, and related research results. This should include plain language summaries of key insights and education materials and should be openly available to all. Individuals, families and communities should be informed about how they can exercise their rights related to their human genome data. 

3.8. Accountability 

A commitment to establishing processes that enable and promote responsible collection, access, use and sharing of human genome data and that prevents human genome data misuse, accompanied by mechanisms that hold individuals, institutions and other stakeholders accountable for failure to adhere to such processes. 

Actions: • Establish mechanisms that assign roles and responsibilities to those involved throughout the collection, use and sharing of human genome data, including for cases related to negligence or data misuse. Responsible stakeholders should be identified prior to human genome data collection, access, use and sharing. 

 • Mechanisms, including regulations and policies, should be put in place to guard against the misuse of human genome data. This includes limiting collection, access to, use and sharing of human genome data with stakeholders who cannot adequately protect the data. Such policies should, at a minimum, support the right to privacy, prohibit collection, access to, use and sharing of human genome data that stigmatize or discriminate against the individual, their family or their community. They should also prohibit any attempt to re-identify the individual, and prohibit the unauthorized collection, access to, use and sharing of such data. 

 

 • Mechanisms should be put in place to ensure that stakeholders use human genome data in a secured and trustworthy manner, and that those responsible for human genome data misuses are held to account. Human genome data collection, access, use and sharing should be subject to checks on the purpose of data use. Data audit trails and systems for tracking and auditing data collection, access, use and sharing should also be implemented to monitor compliance with data sharing agreements, regulatory requirements, and ethical guidelines.

Pricing and Privacy

The US Federal Trade Commission has launched action against the three largest prescription drug benefit managers (PBMs) —Caremark Rx, Express Scripts (ESI), and OptumRx —a nd their affiliated group purchasing organizations (GPOs) for engaging in anticompetitive and unfair rebating practices that have artificially inflated the list price of insulin drugs, impaired patients’ access to lower list price products, and shifted the cost of high insulin list prices to vulnerable patients. 

The FTC states 

The FTC’s administrative complaint alleges that CVS Health’s Caremark, Cigna’s ESI, and United Health Group’s Optum, and their respective GPOs—Zinc Health Services, Ascent Health Services, and Emisar Pharma Services—have abused their economic power by rigging pharmaceutical supply chain competition in their favor, forcing patients to pay more for life-saving medication. According to the complaint, these PBMs, known as the Big Three, together administer about 80% of all prescriptions in the United States. 

 

The FTC alleges that the three PBMs created a perverse drug rebate system that prioritizes high rebates from drug manufacturers, leading to artificially inflated insulin list prices. The complaint charges that even when lower list price insulins became available that could have been more affordable for vulnerable patients, the PBMs systemically excluded them in favor of high list price, highly rebated insulin products. These strategies have allowed the PBMs and GPOs to line their pockets while certain patients are forced to pay higher out-of-pocket costs for insulin medication, the FTC’s complaint alleges. 

 

“Millions of Americans with diabetes need insulin to survive, yet for many of these vulnerable patients, their insulin drug costs have skyrocketed over the past decade thanks in part to powerful PBMs and their greed,” said Rahul Rao, Deputy Director of the FTC’s Bureau of Competition. “Caremark, ESI, and Optum—as medication gatekeepers—have extracted millions of dollars off the backs of patients who need life-saving medications. The FTC’s administrative action seeks to put an end to the Big Three PBMs’ exploitative conduct and marks an important step in fixing a broken system—a fix that could ripple beyond the insulin market and restore healthy competition to drive down drug prices for consumers.” 

 

Insulin medications used to be affordable. In 1999, the average list price of Humalog—a brand-name insulin medication manufactured by Eli Lilly—was only $21. However, the complaint alleges that the PBMs’ chase-the-rebate strategy has led to skyrocketing list prices of insulin medications. By 2017, the list price of Humalog soared to more than $274—a staggering increase of over 1,200%. While PBM respondents collected billions in rebates and associated fees according to the complaint, by 2019 one out of every four insulin patients was unable to afford their medication. The FTC’s Bureau of Competition makes clear in a statement issued today that the PBMs are not the only potentially culpable actors – the Bureau also remains deeply troubled by the role drug manufacturers like Eli Lilly, Novo Nordisk, and Sanofi play in driving up list prices of life-saving medications like insulin. Indeed, all drug manufacturers should be on notice that their participation in the type of conduct challenged here raises serious concerns, and that the Bureau of Competition may recommend suing drug manufacturers in any future enforcement actions. ... 

 

The PBMs’ financial incentives are tied to a drug’s list price, also known as the wholesale acquisition cost. PBMs generate a portion of their revenue through drug rebates and fees, which are based on a percentage of a drug’s list price. PBMs, through their GPOs, negotiate rebate and fee rates with drug manufacturers. As the complaint alleges, insulin products with higher list prices generate higher rebates and fees for the PBMs and GPOs, even though the PBMs and GPOs do not provide drug manufacturers with any additional services in exchange. 

 

The complaint further alleges that PBMs keep hundreds of millions of dollars in rebates and fees each year and use rebates to attract clients. PBMs’ clients are payers, such as employers, labor unions, and health insurers. Payers contract with PBMs for pharmacy benefit management services, including creating and administering drug formularies—lists of prescription drugs covered by a health plan. ... 

 

Insulin list prices started rising in 2012 with the PBMs’ creation of exclusionary drug formularies, the FTC’s complaint alleges. Before 2012, formularies used to be more open, covering many drugs. According to the complaint, that changed when the PBMs, leveraging their size, began threatening to exclude certain drugs from the formulary to extract higher rebates from drug manufacturers in exchange for favorable formulary placement. Securing formulary coverage was critical for drug manufacturers to access patients with commercial health insurance, the FTC alleges. Competition usually leads to lower prices as sellers try to win business. But in the upside-down insulin market, manufacturers—driven by the Big Three PBMs’ hunger for rebates—increased list prices to provide the larger rebates and fees necessary to compete for formulary access, the FTC’s complaint alleges. According to the complaint, one Novo Nordisk Vice President said that PBMs were “addicted to rebates.” While PBMs’ rebate pressures continued, insulin list prices soared. For example, the list price of Novolog U-100, an insulin medication manufactured by Novo Nordisk, more than doubled from $122.59 in 2012 to $289.36 in 2018. 

 

The complaint alleges that even when low list price insulins became available, the PBMs systematically excluded them in favor of identical high list price, highly rebated versions. As described in the complaint, one PBM Vice President acknowledged that this strategy allowed the Big Three to continue to “drink down the tasty … rebates” on high list price, highly rebated insulins. 

 

The PBMs Caused the Burden of High Insulin List Prices to Shift to Vulnerable Patients, the FTC Alleges 

 

According to the complaint, as insulin list prices escalated, the PBMs collected rebates that, in principle, should have significantly reduced the cost of insulin drugs for patients at the pharmacy counter. Certain vulnerable patients, such as patients with deductibles and coinsurance, often must pay the unrebated higher list price and do not benefit from rebates at the point of sale. Indeed, they may pay more out-of-pocket for their insulin drugs than the entire net cost of the drug to the commercial payer. Caremark, ESI, and Optum knew that escalating insulin list prices and exclusion of low list price insulins from formularies hurt vulnerable patients—yet continued to pursue and incentivize strategies that shifted the burden of high list prices to patients, the FTC’s complaint alleges. 

 

Caremark, ESI, and Optum and their respective GPOs engaged in unfair methods of competition and unfair acts or practices under Section 5 of the FTC Act by incentivizing manufacturers to inflate insulin list prices, restricting patients’ access to more affordable insulins on drug formularies, and shifting the cost of high list price insulins to vulnerable patient populations, the FTC’s complaint alleges.

Earlier this month the FTC announced 'Refunds to Consumers Deceived by Genetic Testing Firm 1Health.io Over Data Deletion and Security Practices'. 

 The Federal Trade Commission is sending refunds to more than 2,400 consumers related to a settlement with 1Health.io, formerly known as Vitagene, over allegations the genetic testing company left sensitive genetic and health data unsecured, deceived consumers about their ability to get their data deleted, and unfairly changed its privacy policy retroactively. 

The FTC’s June 2023 complaint alleged that 1Health.io’s security failures put consumers’ sensitive data at risk, contrary to the company’s promise to exceed industry-standard security practices. The complaint also alleged that the company promised consumers they could delete their personal information at any time when, in fact, the company's failure to maintain a data inventory meant that the company could not always honor that promise. 

The complaint further alleged that, in 2020, the company unfairly changed its privacy policy by expanding the types of third parties with whom it could share health and genetic data that consumers had already provided the company, without notifying consumers or obtaining their consent. 

The FTC is sending payments totaling more than $49,500 to 2,432 consumers. Most consumers will get a check in the mail. Recipients should cash their checks within 90 days, as indicated on the check. Eligible consumers who did not have an address on file will receive a PayPal payment, which should be redeemed within 30 days. ... 

The Commission’s interactive dashboards for refund data provide a state-by-state breakdown of refunds in FTC cases. In 2023, FTC actions led to $324 million in refunds to consumers across the country.

Biodiversity

'No basis for claim that 80% of biodiversity is found in Indigenous territories' by Álvaro Fernández-Llamazares, Julia Fa, Dan Brockington, Eduardo S Brondízio,  Joji Cariño, Esteve Corbera, Maurizio Farhan Ferrari, Daniel Kobei, Pernilla Palmer, Guadalupe Yesenia H Márquez, Zsolt Molnár, Helen Tugendhat and Stephen T Garnett in (2024) Nature comments 

For the past 20 years or so, a claim has been made in all sorts of outlets, from reports and scientific publications to news articles, that 80% of the world’s biodiversity is found in the territories of Indigenous Peoples. Those using this figure invariably aim to highlight the essential roles that Indigenous Peoples have in conserving biodiversity, and seem to have quoted it in the belief that it is based on solid science. 

Numerous studies demonstrate that Indigenous Peoples and their territories are indeed key to safeguarding biodiversity for future generations. But the claim that 80% of the world’s biodiversity is found in Indigenous Peoples’ territories is wrong. 

The continued use of this number by United Nations agencies, non-governmental organizations (NGOs), journalists, conservation biologists and Indigenous activists and advocates, among others, could damage the exact cause that it is being used to support. Efforts to draw on and prioritize Indigenous Peoples’ knowledge in biodiversity conservation, and to protect their governance and rights, could be undermined if the credibility of individuals and organizations who make this claim is questioned. 

The global conservation community must abandon the 80% claim and instead comprehensively acknowledge the crucial roles of Indigenous Peoples in stewarding their lands and seas — and must do so on the basis of already available evidence. ... 

The 80% claim is based on two assumptions: that biodiversity can be divided into countable units, and that these can be mapped spatially at the global level. Neither feat is possible, despite important advances in measuring biodiversity. In fact, according to the Convention on Biological Diversity — a multilateral treaty to develop strategies for the conservation and sustainable use of biological diversity, involving nearly 200 countries — biodiversity is the “diversity within species, between species and of ecosystems”. It is not something that can be easily quantified. 

Even if researchers resorted to using the number of species present as a measure of biodiversity — a narrow yet common proxy — there are still millions of species that have not been described. Furthermore, there is debate over the proportion of described taxa that represents valid species, and knowledge about the geographical distributions of most species is lacking or incomplete. Data on species counts and distributions are especially likely to be missing for Indigenous Peoples’ lands and seas. 

The 80% claim seems to stem from misinterpretations of previously published statements. As advocates for Indigenous Peoples (three of us identify as Indigenous), we have had discussions about this figure over several years with Indigenous leaders at policy forums, on field visits and in research projects. To track its origins and assess how frequently it has been cited in the literature and in what contexts, we searched for combinations of the words ‘Indigenous’, ‘80%’ and ‘biodiversity’, as well as for combinations of their variants, such as ‘eighty’, ‘percent’ and ‘biological diversity’. We conducted our search using Google Scholar and Clarivate’s Web of Science, and included literature published up to 1 August this year. 

Our search found no reference to the 80% assertion before 2002. A report that year by the UN Commission on Sustainable Development, a body tasked with assessing progress on the commitments agreed at the 1992 UN Conference on Environment and Development in Rio de Janeiro, Brazil, stated that Indigenous Peoples “nurture 80% of the world’s biodiversity on ancestral lands and territories”. Over the next six years, similar unattributed statements were made in four other reports (see Supplementary information). However, judging by how commonly the number is cited, it seems to have been a 2008 World Bank report that contributed most to its widespread adoption in the academic literature.

PBR

'New Genomic Techniques and Intellectual Property Law: Challenges and Solutions for the Plant Breeding Sector ‒ Position Statement of the Max Planck Institute for Innovation and Competition: Munich, 8 January 2024' by Daria Kim, Michael A Kock, Matthias Lamping, Pedro Henrique D Batista, Reto M Hilty, Peter R Slowinski and Miriam Steinhart in (2024) 73(4) GRUR International 323–339 comments 

On 5 July 2023, the European Commission proposed a regulation aiming to ease the requirements for the marketing authorisation of plants obtained through certain new genomic techniques (NGTs) within the European Union (EU). While NGTs are expected to become more attractive to breeders and farmers, the complexity of the intellectual property (IP) landscape surrounding these techniques and resulting products may negatively impact technology diffusion and innovation. Given numerous concerns related to IP protection for NGTs and NGT-derived plants, this Position Statement from the Max Planck Institute for Innovation and Competition presents a set of policy recommendations for facilitating access to and utilisation of IP-protected NGTs and NGT-derived products in the breeding sector. 

New genomic techniques (NGTs) have the potential to transform traditional plant breeding, resulting in significant social benefits, in particular, by improving global food security and mitigating the impact of climate change. However, NGTs also pose new legal challenges, especially in terms of safety regulation and intellectual property (IP) regimes. 

The recent Proposal by the European Commission (hereinafter ‘the Commission’) for a Regulation on plants obtained by certain NGTs and their products4 envisages treating NGT-derived plant varieties largely as products derived from conventional (random) mutagenesis. This is expected to make NGTs more attractive to breeders and farmers, as well as increase competition among companies utilising NGTs. As a result, the need for access and usage rights in IP-protected NGTs and NGT-derived plant varieties is likely to become more urgent. Notably, the Commission has acknowledged concerns related to IP protection, in particular, raised by ‘breeders and farmers’ organisations regarding the need to ensure breeders’ access to patented genetic material and access by […] farmers to [plant reproductive material] from NGT plants’. 

This Position Statement addresses some of the concerns regarding patents and plant variety protection for NGTs and NGT-derived plants, focusing on the plant breeding sector and the applicable EU legal framework. Most of the proposed solutions can be implemented through clarifications of existing legal provisions, while some may require legislative measures or private ordering coordination. Overall, these solutions aim to mitigate the deterrence effect caused by the complexity of the IP landscape surrounding NGTs and NGT products, in particular, by facilitating the allocation of access and usage rights.

Genomics and life insurance underwriting

The Treasury Department's consultation paper 'Use of genetic testing results in life insurance underwriting' comments 

Over recent years, the use of genetic testing results in life insurance has been the subject of significant public debate. In 2018, a report by the Parliamentary Joint Committee on Corporations and Financial Services expressed concerns that the use of genetic tests in underwriting life insurance was adversely impacting participation in health research projects involving genetic testing. In 2019, Australia’s life insurance industry introduced a partial moratorium on the requirement to disclose genetic test results. The Moratorium was introduced in response to concerns that individuals would not undertake genetic testing for fear of negatively impacting their ability to obtain affordable life insurance. 

In June 2020, a $500,000 grant was awarded to researchers at Monash University to monitor the impact of the Moratorium, its effects on the uptake of genetic testing, and its impacts on genetic discrimination. The subsequent 2023 Australian Genetics & Life Insurance Moratorium: Monitoring the Effectiveness & Response (A-GLIMMER) report documented stakeholder concerns and experiences with genetic test results and life insurance. The report found that the existing moratorium continues to discourage consumers from participating in both established clinical genetic testing, which may identify a need for potentially life-saving treatment, and medical research involving genetic testing. Addressing these concerns requires review of the regulatory framework for the use of genetic testing in life insurance underwriting. This consultation paper seeks feedback on both the impacts of life insurers using genetic test results in underwriting on genetic testing and research, as well as a range of potential policy responses. 

Life insurance can be individually risk-rated 

Life insurance is a mechanism for consumers to aggregate and distribute the costs associated with mortality and morbidity risks. Pooling risk benefits the insured by spreading the significant costs associated with death, illness and injury amongst all the people insured. 

There are four main types of life risk insurance products in Australia:

1. Life cover (also known as term life insurance or death cover), which pays a lump sum in the event of the death of the policy holder. 

2. Total and permanent disability (TPD) insurance, which pays a lump sum to help with rehabilitation and living costs if the policy holder becomes totally and permanently disabled because of illness or injury. 

3. Trauma insurance, which pays a lump sum amount if the policy holder suffers a critical illness or serious injury (e.g., cancer, a heart condition, major head injury or stroke, but not mental health conditions). 

4. Income protection insurance (often referred to as individual disability income insurance or IDII), which pays a portion of the policy holders’ income if they can’t work due to illness or injury.

Life Insurance, like insurance products other than health insurance, is ‘risk-rated’ not ‘community-rated’. Risk-rating gives effect to the principle that insurance premiums should reflect individual risk. By contrast, community rating is the basis of Australia’s health insurance system. The Private Health Insurance Act 2007 requires private health insurers to offer community-rated health insurance, which means all policy holders pay the same premiums for the same policy, regardless of their gender, age or health status. The results of an individual’s genetic tests therefore have no direct bearing on their access to or the price of a complying health insurance product. 

Underwriting is a process where life insurers individually assess a person’s unique risk of illness, injury and death to determine the level of risk to be covered and enable the accurate pricing of premiums. This process ensures that the cost of the cover is proportionate to the risks that the individual concerned presents. Key factors taken into account during the underwriting process include an applicant’s personal medical history, age, smoker status, occupation, family history, lifestyle and pursuits. 

In Australia, default insurance provided through a superannuation fund or employer is not individually underwritten. However, voluntary insurance, including life insurance purchased from an insurer, via a financial adviser or a voluntary increase in group superannuation will generally be individually underwritten. 

As life insurance is a guaranteed renewable product, once a policy has been underwritten and commenced, the life insurer cannot change or cancel a person’s cover, provided they pay all future premiums when due. However, life insurers can generally increase premiums across a risk pool if claims are higher than was initially anticipated. 

Genetic testing can indicate potential for individual health risks 

Genetic testing investigates a person’s genetic variants and changes, some of which may contribute to the risk of developing a health condition . Genetic variants that are disease-causing can be inherited (called germline variants), acquired through the lifespan, or can be found in cancers (called somatic variants). There are over 5000 conditions known to be caused by germline variants, including some conditions which predispose individuals to a higher risk for certain cancers. 

The results from genetic testing can be used to identify the genetic origin of a disorder, diagnose rare inherited diseases more efficiently, or predict both the risk of individuals developing a genetic condition and their need for, or likely response to, specific treatments. Medical research involving genetic testing can be used to identify new links between genetic variants and health conditions, as well as develop new treatment methods. Consequently, there are significant medical and public health benefits associated with the use of genetic testing by individuals, as well as ongoing medical research involving genetic testing. 

There are various types of genetic test purposes, including diagnostic, predictive (of risk for future disease) and presymptomatic testing. In many cases, genetic testing is used to confirm a diagnosis when a particular condition is suspected based on current physical signs and symptoms. Clinical diagnostic genetic testing is used to identify or rule out a specific genetic or chromosomal condition in an individual with features that may have either a genetic or non-genetic origin. The results of a diagnostic genetic test can also inform the individual’s prognosis and influence a person's choices about health care and the management of their disorder. Where a person is experiencing symptoms of a diagnosed condition, they may be required to disclose this to the life insurer, regardless of whether that diagnosis is the result of a genetic test or other medical test. 

Predictive and presymptomatic testing is used to detect gene variants associated with heritable disorders that appear after birth, often later in life, but are not clinically detectable at the time of testing. Predictive testing of the general, currently unaffected population can identify variants that increase a person's risk of a developing disorder with a genetic basis. Presymptomatic genetic testing can determine whether or not a person is at risk of a condition that may have already been identified in other family members, or is likely to develop signs and symptoms of the condition in the future. The results of predictive and presymptomatic hereditary disease testing can differentiate between pre-symptomatic genetic diagnosis (which may result in future disease), asymptomatic carrier status (with the majority having no future adverse personal health consequence) or non-carrier status. Depending on the condition identified, a genetic diagnosis may not always result in clinical signs and the degree of severity may vary among those who do develop disease. This variability in risk may not be readily predicted from the genetic test findings alone. 

Genetic testing can be used for a range of other purposes, including diagnostic prenatal testing where a fetus is at risk for a heritable genetic condition, newborn screening to determine if a baby has one of a selected number of severe heritable genetic conditions that requires early management, cascade testing of family members once a heritable genetic condition is identified in a family member and carrier testing to determine risk of the condition in offspring. In the context of life insurance, the most relevant uses of clinical genetic testing are for diagnostic, predictive and pre-symptomatic testing, as well as for research purposes, where a genetic condition or risk for a genetic condition is identified in an individual. 

Recent Government initiatives in genetic testing and research include a $500.1 million investment to the Genomics Health Futures Mission, and a $28.1 million investment to develop a new government body to guide the future translation of genomic research and trials into clinical practice.  

Life insurers can request genetic testing results 

Under the Insurance Contracts Act 1984, consumers must take reasonable care not to make a misrepresentation to life insurers when entering into contracts, including failing to answer a question or providing an obviously incomplete or irrelevant answer to a question. Consumers have a responsibility to provide information requested by life insurers, including any genetic testing results. Life insurers can subsequently use this information, including, for example, when considering any offer to provide insurance to a consumer. 

While the Disability Discrimination Act 1992 makes discrimination on the grounds of disability (including a disability that may exist in the future because of a genetic predisposition) unlawful in many areas of public life, there are exceptions relating to the provision of insurance. Under section 46 of the Disability Discrimination Act 1992, discrimination in insurance and superannuation products (including life insurance) is permitted in the following circumstances:

• where the discrimination is based on actuarial or statistical data on which it is reasonable for the discriminator to rely; and the discrimination is reasonable having regard to the data and other relevant factors; or 

• where no such actuarial or statistical data is available and cannot reasonably be obtained – the discrimination is reasonable having regard to any other relevant factors. 

Consequently, provided the conditions above are satisfied, life insurers can request details regarding family medical history, and regularly use that information in the same manner. Life insurers are also able to request and use genetic testing results to inform their life insurance underwriting. Consumers can provide favourable genetic test results to life insurers, for example, to demonstrate that they are not at risk of developing certain health conditions despite previous family history. 

Consumers who believe they have been unlawfully discriminated against because of a genetic diagnosis, or risk for a heritable genetic condition, can make a complaint to the Australian Human Rights Commission, which has the power to investigate and attempt to conciliate complaints of discrimination. If the conciliation is unsuccessful, in certain circumstances a complainant may commence legal proceedings in the Federal Court of Australia or the Federal Circuit and Family Court of Australia. 

Concerns about the impact on participation in medical research involving genetic testing 

In 2016, the Parliamentary Joint Committee on Corporations and Financial Services conducted an inquiry into the life insurance industry. Part of the inquiry focused on use of genetic testing results in life insurance. In its final report, released in 2018, the Committee expressed concerns that the use of genetic tests in underwriting life insurance was adversely impacting the public’s willingness to participate in health research projects that involved genetic testing. The Committee made a number of recommendations directed towards the Financial Services Council (FSC), the then peak industry body representing the life insurance sector. These included that the FSC:

• in consultation with the Australian Genetic Non-Discrimination Working Group, assess the consumer impact of imposing a moratorium on life insurers using predictive genetic information, unless the consumer provides genetic information to a life insurer to demonstrate that they are not at risk of developing a disease; and 

• make any updates required to the relevant Standards to support the above recommendation.

The Committee further recommended that if the FSC and life insurers adopt a moratorium on the use of predictive genetic information as outlined above, that the Government continue to monitor developments in genetics and genetic testing to determine whether legislation or another form of regulation banning or limiting the use of genetic information by the life insurance industry is required. 

Moratorium on the use of genetic tests in life insurance 

Following the inquiry, the FSC introduced a moratorium on the use of genetic testing in life insurance. The updated standard, known as FSC Standard 11: Moratorium on Genetic Tests in Life Insurance, came into force on 1 July 2019. The standard aimed to facilitate an efficient life insurance industry, while also recognising a social responsibility to not hinder the adoption of new medical technologies that could improve health outcomes. 

Under the Moratorium, life insurers could only request or use the results of a genetic test if the total amount of cover a person would have – including both the cover being applied for and any existing individual and group insurance cover with any life insurers – was more than:

• $500,000 of lump sum death cover 

• $500,000 of total permanent disability cover 

• $200,000 of trauma and/or critical illness cover 

• $4,000 a month of any combination of income protection, salary continuance or business expenses cover.

For example, under the Moratorium, a consumer with no existing insurance applying for $300,000 worth of death cover would not be required to disclose any genetic testing results. Conversely, a consumer with $300,000 worth of existing death cover, seeking to apply for an additional $300,000 worth of cover (with either their existing or an alternative insurer), would be required to disclose any genetic testing results if asked. 

These limits compare to APRA data that suggests that the average sum insured of individual policies, exclusive of any group cover, is:

• $713,959 of lump sum death cover 

• $849,128 of total permanent disability cover 

• $207,414 of trauma and/or critical illness cover 

• $7,706 of disability income insurance.

There is currently no data available on the average sum insured via group cover. The extent of cover will generally vary by superannuation fund and the age of the fund member. 

The Moratorium also stated that regardless of the amount of cover sought, life insurers would not require or encourage applicants to take a genetic test as part of their life insurance application. Similarly, applicants would not be required to disclose results of genetic tests taken as part of medical research where the applicant would not receive the results. 

In February 2022, the FSC released a statement outlining the effectiveness of the Moratorium. Data released alongside the statement indicated that of the 846 applications for cover received by life insurers which included a genetic test result in the six months to 30 June 2021:

• In 653 cases (77 per cent) the genetic test result had no influence. 

• 73 cases (9 per cent) were adversely impacted by a genetic test result, all of whom were seeking cover above the FSC Moratorium limits. 

• 111 cases (13 per cent) were positively influenced by a genetic test result (i.e., the premium offered was lower than it would have otherwise been). 

Importantly, these statistics do not capture instances where consumers may have chosen not to apply for cover above the limit because they were aware that the FSC Moratorium only applies up to certain amounts of cover. 

In October 2022, the FSC undertook a review of the Moratorium, and subsequently announced the following changes: 

• The removal of the sunset clause (previously the FSC Moratorium was due to sunset in June 2024). 

• Immunity for genetic tests taken before, or while, the FSC Moratorium was in place. 

• The indefinite extension of the Moratorium, and its incorporation into the Life Insurance Code of Practice (from 1 July 2023). 

In June 2022, the Council of Australian Life Insurers (CALI) was established as the life insurance industry’s new representative body. As of October 2023, CALI’s 19 members represent 99 per cent of the life insurance market and all reinsurers in Australia. From 29 September 2023, CALI took over ownership of the Life Insurance Code of Practice from the FSC. 

The prevalence of genetic testing is increasing 

Over the last decade, the number of Medicare Benefits Schedule (MBS) genetic and genomic pathology services, as well as the amount of benefits paid, has trended upwards (Figure 1). This reflects both advances in genomic medicine and the addition of new genetic and genomic services to the MBS in response to Medical Services Advisory Committee (MSAC) recommendations. With ongoing advances in technology, and associated decreases in cost, the scope and utilisation of genetic testing is expected to increase significantly over the coming years. ... 

Concerns about effectiveness of Moratorium: The A-GLIMMER report In June 2020, a Medical Research Future Fund Genomics Health Futures Mission grant was awarded to researchers at Monash University. The researchers sought to monitor the impact of the FSC Moratorium, its effects on the uptake of genetic testing, and its impacts on genetic discrimination (the A-GLIMMER Report). 

The A-GLIMMER final report was released in June 2023. The report drew upon consultation with consumers, patients, health professionals and financial advisers to assess views on the effectiveness of the Moratorium. 

Key issues raised in the report included that:

• People who have genetic tests that indicate a predisposition to a condition are experiencing difficulties accessing life insurance. 

• People are not undertaking genetic tests or participating in scientific research due to concerns about obtaining affordable life insurance. 

• Stakeholders have concerns about the life insurance industry’s self-regulation of the Moratorium, as well as a low level of confidence in the effectiveness of the Moratorium. Many stakeholders were also concerned about the absence of any Government oversight. 

• Life insurers are not complying with the Moratorium, including asking applicants about genetic test results despite applications falling below the financial thresholds. 

• The Moratorium’s financial limits were too low. 

• There was poor awareness and knowledge about the Moratorium amongst some stakeholders.

The A-GLIMMER Project’s overall assessment was that the Moratorium is inadequate to address and prevent genetic discrimination in life insurance, and that self-regulation is an ineffective regulatory model to address genetic discrimination. The Final Report recommended that: 

• The Government amend the Disability Discrimination Act 1992 to prohibit insurers from using genetic or genomic test results to discriminate between applicants for risk-rated insurance, and consider amendments to the regulation of financial services to ensure insurers are subject to a positive duty to not discriminate. 

• The Government allocate responsibility and appropriate resources to the Australian Human Rights Commission (‘AHRC’) to enforce, promote, educate and support individuals and all relevant stakeholders to understand and meet the new legal obligations under the Disability Discrimination Act 1992.  

Options for regulatory intervention 

Genetic testing provides significant public health benefits, both through individual testing and when undertaken as part of medical research. Similarly, life insurance plays an important role in assisting Australians through some of their most challenging moments. Individuals should not be forced to decide between undertaking genetic testing and obtaining life insurance. 

However, there are concerns that the current moratorium is deterring individuals from potentially life-saving genetic testing, as well as from participation in genetic research, for fear that it might impact their ability to obtain affordable life insurance. As genomic technologies evolve, there will likely be improvements in the accessibility and affordability of genetic testing. This will lead to more Australians undertaking some form of testing and will likely exacerbate these concerns. As a result, regulatory intervention may be needed to enable consumers to access affordable life insurance, while simultaneously ensuring that the potential benefits of genetic testing are fully realised. In assessing regulatory interventions, appropriate consideration must be given to potential risks and market consequences. The primary risk of further restrictions on the use of genetic test results is the occurrence of ‘adverse selection’. Adverse selection occurs when a consumer, who is aware of a genetic test result indicating that they are at high risk of an early death or disablement, seeks a life insurance policy or level of cover that they otherwise would not have. The issues presented by adverse selection are likely most acute when insurers do not have access to the same information as the consumer (i.e., the genetic test result), as the insurer is unable to accurately assess the risk of a claim. At its most extreme, adverse selection has the potential to threaten the viability of a market, or lead to insurers amending product offerings to moderate any impacts. Where insurer offerings remain unchanged, an increase in coverage attributable to people acting in response to genetic tests may be reflected in increased premiums. 

There is mixed evidence on the impact of adverse selection on the behaviour of consumers or the risk exposure of life insurers. A US study found that consumers were up to five times more likely to purchase long-term insurance after a positive test for Huntington’s Disease. Conversely, the Canadian Privacy Commissioner commissioned several actuarial reports on the likely impact of a ban on using genetic test results in life insurance underwriting, which concluded that a ban would have negligible market impact at the time. Similarly, a 2022 Report commissioned by the UK Government found no evidence of a current risk to insurers as a result of restricting the use of genetic testing results by life insurers. 

A range of options for regulatory intervention are outlined below. For those options involving legislative action, the nature of any amendments or intervention (e.g., the specific Act or Acts to be amended) are not canvassed, as the options focus on the outcome of any proposed intervention. Any approach eventually adopted would be subject to periodic reviews to ensure there is flexibility and that the approach remains fit for purpose. Stakeholders are welcome to provide feedback on any implementation considerations that they may wish to raise. 

• Option 1: No Government intervention: Under this option no action would be taken by the Government. Instead, the use of genetic testing results by life insurers would continue to be governed by both the Disability Discrimination Act 1992, and the Life Insurance Code of Practice. This approach would limit the scope for additional adverse selection. Additionally, there would be no further regulatory burden placed on industry, as insurers would not be required to update existing policies or procedures. 

Conversely, this approach would fail to address the concerns outlined in the A-GLIMMER report. As outlined above, APRA data suggests that the monetary limits of the Moratorium are below the average sum insured of individual policies. Barring any voluntary action from the life insurance industry, both the disincentives to undertaking genetic testing and impacts on public health would remain as they currently are. Additionally, the Council of Australian Life Insurers has stated that the industry now supports government regulation of the use of genetic tests by life insurers to give Australians peace of mind. 

While not a matter for Government, options for industry-led action include increasing or otherwise altering the thresholds within the Moratorium, and submitting the Life Insurance Code of Practice to ASIC for approval as a code of conduct under s1101A of the Corporations Act 2001. 

• Option 2: Legislating a ban: Under this option, the Government would legislate a total or partial prohibition on the use of adverse genetic testing results by life insurers. 

Under a total ban, life insurers would be prohibited from requesting or utilising any adverse genetic testing results to inform their underwriting calculations. This approach would partially reflect the recommendations of the A-GLIMMER report, and align with the Canadian approach to the use of genetic test results by life insurers, as outlined in the Genetic Non-Discrimination Act. 

Under a partial ban, life insurers would be prohibited from requesting or utilising any adverse genetic testing results to inform their underwriting decision, subject to certain exemptions. This approach would broadly align with the United Kingdom approach, whereby insurers cannot use predictive genetic test results, except for those for Huntington’s disease, and only then in certain applications. A process for determining the nature and extent of any exemptions would need to be delivered to support this approach. 

A total or partial ban would provide increased certainty to consumers and medical professionals that undertaking genetic testing, or participating in medical research involving genetic testing, would not impact the ability of consumers to obtain life insurance. These approaches would address many of the concerns raised in the A-GLIMMER report. 

Conversely, in the event that a ban on the use of genetic testing is implemented, the information asymmetry between consumers and insurers may give rise to adverse selection. If insurers cannot use adverse genetic tests in any capacity, it is possible for a consumer who has knowledge of a condition to take out a level of cover that they otherwise would not have. Insurers would be unable to accurately assess the risk of a claim by that consumer. There are concerns that this may impact the viability of the life insurance industry, for example due to consumers with adverse test results attempting to take out very large amounts of cover. However, there is limited evidence that such concerns have eventuated in jurisdictions with similar restrictions. This option would also require life insurers to update relevant policies and procedures. Additionally, implementing only a partial ban may result in the disincentives to undertaking genetic testing remaining unaddressed. Consumers may not be aware of the existence of any limitations, and may lack clarity as to the exact circumstances in which life insurers may rely on the exceptions. Additionally, genetic test consultations, consent form, and research recruitment process will still have to involve a conversation regarding financial implications and life insurance, which may impact participation rates. 

• Option 3: Legislating a financial limit: This option proposes to legislate a financial limit, below which insurers cannot request or utilise adverse genetic testing results in their underwriting. This result broadly reflects the current limitations on the use of adverse genetic testing results by life insurers, as detailed in the Life Insurance Code of Practice. The financial limit may apply to the total cover held by an applicant (in line with Life Insurance Code of Practice), or be restricted to the cover sought under each individual application. Any financial limit developed under this option would exceed the existing thresholds detailed in the Life Insurance Code of Practice, and would be subject to regular and ongoing reviews to ensure they remain at an appropriate level. For example, the limit on death benefit covered could be increased to $1.5 million. 

This approach would ensure that consumers could obtain a certain level of cover, while limiting the scope for additional adverse selection. However, as demonstrated in the A-GLIMMER report, consumers are often unaware of the existence of financial limitations. A prescribed limit may also not reflect the needs or specific circumstances of individual consumers. Additionally, if consumers are aware that the financial limits may be revised in the future, they may continue to avoid genetic testing for fear of what implications might arise in future, once it is too late to choose not to have the genetic test. 

Effective enforcement is vital to ensuring consumer confidence in the protections afforded to them. While the most appropriate enforcement body may ultimately depend on the nature of the limitations adopted, options for enforcing a legislated regime covering the way life insurers utilise adverse genetic test results could include: 

• Option 1: The Australian Human Rights Commission (AHRC): The A-GLIMMER report recommends that the AHRC be given responsibility to enforce, promote, educate and support individuals and stakeholders to understand and meet any new obligations regarding genetic testing in life insurance. The report notes that the AHRC has extensive experience addressing, resolving, and seeking to prevent significant claims of discrimination in relation to insurance. 

• Option 2: The Australian Securities and Investments Commission (ASIC): As part of its regulation of life insurers, ASIC could be given responsibility for enforcing any new obligations regarding genetic testing in life insurance. ASIC has extensive experience regulating the conduct of life insurers, and a high level of familiarity with their operations. Under this approach, consumers would have the option of making a complaint to the Australian Financial Complaints Authority (AFCA).

Forensics

The Queensland Government has today accepted the two recommendations of the Commission of Inquiry to examine DNA Project 13 Concerns. The media release states 

 The Commission of Inquiry found Project 13, which introduced automated DNA extraction methods to the Queensland Health forensics laboratory, was a ‘fatally flawed’ project, with scientifically sound methodologies sacrificed for speed while the laboratory was under pressure to accelerate DNA processing, when it was introduced more than 16 years ago. ... 

The recommendations relate to retesting some samples that were previously tested using the flawed Project 13 methodology between 2007 and 2016. 

A total of 103,187 casework samples were extracted using the automated DNA extraction method during that period. A single case can have multiple, sometimes hundreds, of samples. The existing ‘legal-led review’ process will determine which cases need their samples retested, and the priority order. 

Forensic Science Queensland will lead implementation, with efforts rolled into the existing program of work implementing First Commission of Inquiry recommendations. 

Given the findings of both Inquiries, amendments to the rules around the disposal of samples in the Police Powers and Responsibilities Act 2000 will be considered by Parliament next week. Currently, samples taken from a suspect in an indictable offence are to be destroyed after a year if proceedings have not been brought against the person in that time. 

The amendments will extend that time period to three years to ensure testing can be conducted. Additionally, some historical records which were not destroyed by the laboratory in line with the one-year disposal schedule, will have three years to be reviewed. 

A Bill will also be introduced into Parliament next week to give effect to recommendation 121 of the First Commission of Inquiry, to establish the position of Director of Forensic Science Queensland and the supporting Forensic Science Queensland agency. 

The interim FSQ and interim Advisory Board was created administratively within Queensland Health following the First Commission of Inquiry. The Bill will allow formal establishment of FSQ within the justice portfolio, which is expected to be in July 2024. 

Government will take steps to ensure the laboratory has the resources necessary to fulfill its obligations and restore public confidence in its operations.

Plant Breeders

'Propagating materials and harvested materials: clarifying the scope of plant variety or breeder’s rights' by Charles Lawson in (2023) 18(9) Journal of Intellectual Property Law & Practice 655–672 comments 

Plant breeding faces the inherent problem of ensuring that there are no disincentives that might hamper breeders from delivering improved plant varieties to growers and bringing superior produce to consumers. Plant variety or breeder’s rights is one means of addressing these concerns, regulating for an incentive for plant breeders to develop these improved varieties. The International Convention for the Protection of New Varieties of Plants done, most recently, at Geneva on 19 March 1991 (UPOV 1991) provides a framework agreement consistent with the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights. UPOV 1991 provides for exclusive rights (variously called a variety right or a breeder’s right) for ‘propagating material’ and then extends this to ‘harvested material’ and the products of ‘harvested material’. The key effect of these regulated exclusive rights is to facilitate a royalty on new varieties by limiting the dealings with that variety as a reward and incentive to breed improved varieties — the virtuous cycle facilitating new and better varieties into the market for the benefit of consumers. The problem addressed by this article is the extension of the exclusive rights for ‘propagating material’ to ‘harvested material’ and the products of ‘harvested material’. This is essentially an issue about the meaning of ‘harvested material’, and specifically, that ‘harvested material’ that is also ‘propagating material’ should be considered ‘propagating material’ per se for the purposes of UPOV 1991 and national implementing laws.

'Access to biodiversity for food production: Reconciling open access digital sequence information with access and benefit sharing' by Brad Sherman and Robert J Henry in (2021) 14(5) Molecular Plant comments 

Over the last 40 years or so, a complex web of international legal agreements was developed that regulate the access, transfer, and use of plant genetic resources. These include the Convention on Biological Diversity (CBD), the Nagoya Protocol, and the International Treaty on Plant Genetic Resources (Figure 1). In developing these legal regimes, policy makers struggled to balance a number of conflicting demands. These included ensuring that access providers share in the benefits that arise from the use of their genetic resources; that users who value-add to genetic resources can protect their innovations via intellectual property; and, at the same time, that scientists and breeders have ongoing access to genetic resources. While there are problems with the existing regimes, they have reached an uneasy compromise of sorts. 

[graphic omitted] 

In recent years, dramatic changes in the life sciences have threatened to undermine this complex and fragile balance (Unamba et al., 2015). These changes have been facilitated by new genomic technologies such as gene editing and synthetic biology (McDaniel and Weiss, 2005), by improved and cheaper sequencing technologies (Shaffer, 2007) that rapidly increased the availability of DNA sequence data, and advances in whole-genome sequencing (Figure 1). Genomics is now a major source of data, rivalling big data disciplines like astronomy in the pace of data acquisition, storage, and analysis (Stephens et al., 2015). Open access international data repositories, such as GenBank, the DNA Databank of Japan, and European Molecular Biological Laboratory, that house a huge amount of DNA sequence-related data (estimated at over 1.5 billion sequences) (WiLDSI, 2020) facilitate the sharing and use of digital sequence information (DSI) (Ad Hoc Technical Group on Digital Sequence Information, 2020). The scientific value of public databases largely comes from the aggregation of data that allow scientists to identify patterns across the stored sequences (WiLDSI, 2020).