Health Data Opacity

'The Big Data Regulator, Rebooted: Why and How the FDA Can and Should Disclose Confidential Data on Prescription Drugs and Vaccines' by Amy Kapczynski and Christopher J. Morten in (2021) 109(2) California Law Review 493 comments 

Medicines and vaccines are complex products, and it is often extraordinarily difficult to know whether they help or hurt. The Food and Drug Administration (FDA) holds an enormous reservoir of data that sheds light on that precise question, yet currently releases only a trickle to researchers, doctors, and patients. Recent examples show that data secrecy can be deadly, and existing laws such as the Freedom of Information Act (FOIA) cannot solve the problem. We present here a wealth of new evidence about the urgency of the problem and argue that the FDA must “reboot” its rules to proactively disclose all safety and efficacy data for drugs and vaccines with minimal redactions, deploying data use agreements to ensure the most sensitive data is handled appropriately. In line with the literature that has been critical of simplistic calls for “transparency,” we urge a more contextual form of “data publicity.” We also show that clinical trial data publicity can be achieved without legislative reform, while respecting privacy, protecting any legitimate trade secrets, and maintaining or improving incentives to innovate. The FDA must adapt to protect and expand structural accountability and to protect the public and its trust. The model we offer here could guide similar action at other regulatory agencies as well, enabling better oversight of information-intensive industries and helping safeguard the agencies themselves. 

The authors argue 

Few issues are more important to the American public than the quality and safety of our medicines. About half of all Americans take one or more prescription drugs, and medicines represent a startling 2% of total U.S. gross domestic product (GDP) each year. Life as we know it relies on vaccines that prevent dangerous diseases. But there is a structural problem at the heart of our system for the development and assessment of therapeutics and vaccines: a problem of secrecy in the age of big data. 

The problem of data secrecy is especially visible in the shadow of the COVID-19 pandemic. As we complete this in the summer of 2020, governments around the world are taking unprecedented measures to promote the development of a COVID-19 vaccine. Billions of dollars of public money are being invested, with dozens of potential vaccines in development. But researchers have raised an outcry, pointing out that they have no access to some of the most basic and important information about the design and outcomes of the most promising COVID-19 vaccine trials. Access to this information could enable scientists to understand key clinical trial decisions in time to influence them, to evaluate the quality of the evidence as it emerges, and to protect against mistakes and misconduct, such as changes in trial endpoints that produce spurious results. Researchers could also make novel uses of the data collected, advancing our understanding of COVID-19 at a critical time. Under pressure, several companies (as of this writing) have begun to release some such data voluntarily.  This is a positive step and a proof of concept. But there are important gaps in what has been provided and no systems in place to be sure that they will be remedied, despite the extraordinary stakes. 

The inability to access data related to COVID-19 vaccine development sheds light on the problems caused by systemic data secrecy in clinical trials. Therapeutics and vaccines are complex products. We cannot know whether they hurt or help without rigorous clinical trials, whose conduct and interpretation are highly complicated. Today these trials, particularly at later stages, are typically conducted by companies with strong financial interests in the outcomes. This is a key justification for our drug regulatory system: independent experts are needed to protect the public by examining and validating data about the effects of medicines. But our drug regulatory bodies are under-resourced, and recent examples show that outside expert analysis can reveal concealed risks of medicines. 

The rise and fall of the painkiller rofecoxib (Vioxx) offers a stark example of the harms of data secrecy. The drug was promoted as being safer than aspirin and became a blockbuster. It earned $2 billion each year for Merck before it was abruptly removed from the market because it caused heart attacks, strokes, and heart failures. The evidence only became known to outside experts through litigation. Later independent research showed that signals of these risks were present in data held by the FDA nearly 3.5 years before the drug was withdrawn from the market. That evidence did not reach doctors or patients because the data was not made available to the scientific community. An FDA official later estimated that tens of thousands of people died as a result. 

Data secrecy also causes harm by undermining our health care system. Secrecy prevents us from making the best allocation of scarce resources and obscures avenues for systematic reforms at the FDA and in the pharmaceutical industry. Data secrecy may also undermine trust. The American public, for example, expressed widespread hesitancy about any COVID-19 vaccine that was to be rushed to market before the November 2020 U.S. election. Sharing safety and efficacy data on drugs and vaccines—including COVID-19 vaccines—would help to secure public trust in the FDA review process and in the products that emerge from it and would help to protect the scientific integrity of the FDA review process from political pressure.  

There is, accordingly, an emerging consensus that independent researchers need better access to clinical trial data to keep both the industry and regulators honest and accountable. Yet existing tools for an independent assessment of clinical trial data are inadequate. What remains missing is an effective legal and regulatory framework for the release of this data within the United States. For several years, working closely with medical researchers and a legal team, we have worked to maximize the potential of existing strategies for clinical trial data disclosure. This Article sets out a key lesson of that work: existing tools are inadequate for the task. If researchers are to have systematic access to the clinical trial data needed to help spot unsafe and ineffective medicines, the FDA will have to make clinical trial data available proactively. 

We show that the agency can, consistent with existing law, make clinical trial data available proactively. We describe how the FDA can do so while navigating the two main challenges of data sharing: protecting the privacy of individuals who participate in trials and addressing claims that company data should remain confidential. Drawing on examples of successful data sharing in other countries and at other agencies, we also show that the process can be done effectively and manageably. Our central contribution is a wealth of new evidence about the significance of the problem and an updated argument for proactive disclosure that can be achieved without legislative reform. We reveal the flaws in arguments that comprehensive proactive disclosure is prohibited under U.S. federal statutes  or, if permitted, will require expensive compensation to the industry for intellectual property violations. 

This Article is centrally aimed at solving an important public health problem, but it also contributes to two broader literatures. The first is the literature on transparency and the implications of freedom of information laws. Transparency as an ideal has been rightly criticized recently as having taken on a formalistic, decontextualized quality. As an ideal, transparency does not appropriately recognize that “freedom” at times requires more than unfettered, standardless exchange and does not appreciate how freedom of information laws can be weaponized to undermine public interests. We show here that the implications of data sharing turn on and should be sensitive to a broader political-economic context. Data sharing can serve public interests because of a wider ecology that provides researchers with the necessary resources to analyze the data and includes publications and norms (of the “open science” tradition in academic medicine, for example) that help generate and validate important new insights and challenge false claims. Data itself does not produce these insights, and a context that enables trustworthy analysis is essential if data sharing is to work well. 

To this end, we argue that data use agreements will be an important component of data disclosures in our “big data” age. They provide a means to navigate issues of privacy and commercial interest—issues that can otherwise shut down data sharing, rightly or wrongly—and a mechanism to develop and impose other publicly minded conditions. The role of these agreements here illustrates the importance of contract as a tool to facilitate information exchange and innovation. Decontextualized demands for “openness” have gained traction in recent decades and might suggest that in every instance we need unfettered data exchange that treats all parties equally, including companies. We argue instead that the FDA should prioritize health researchers over industry actors and that it should use data use agreements to ensure those researchers protect legitimate public interests. These contracts are possible only with proactive disclosure and are inconsistent with reactive FOIA requests. 

We join other scholars in suggesting that the future of freedom of information, if it is to achieve its aims, lies in the development of robust proactive disclosure systems. In part to mark these distinctions, we call what we seek here not data transparency, but data “publicity.” The term as we use it, which draws upon early progressive traditions, marks the need for attention to context, power, and resources if data sharing is to serve the public. We also seek to contribute to the broader literature on the future of the regulatory state and the conditions of democracy broadly understood. Today, we live in an extraordinarily information-intensive age. Decades of dramatic advances in technologies for information processing have transformed the core of the modern economy and enabled the emergence of massively complex new industries and firms. This means that not only pharmaceuticals but also products like cars, insurance, airplanes, and phones are far more informationally intensive today than they were twenty years ago. Informationally intensive products and systems are complex, opaque, and dynamic. Systems that are improperly or fraudulently designed — think here about Volkswagen’s deceptive “defeat device” to evade emissions testing, or Boeing’s defective automated flight software for the 737 Max — generate serious social and individual harms. Regulators face growing challenges in this environment, and we need structures to allow the public to hold both regulators and the industry accountable. Yet the same barriers that appear in this context—issues of privacy, corporate claims to trade secrecy and confidentiality, and difficulties with reactive data release models (FOIA especially)—will reappear throughout the administrative state. Our Article thus can help inform a wide variety of regulators who face related issues, whether in the area of consumer products, environmental protection, or artificial intelligence. Data publicity will have plausible benefits elsewhere, and regulators can learn from how it can be achieved at the FDA. But they must also learn from the fertile conditions in the pharmaceutical and medical context that allow clinical trial data publicity to inform the public. It is not open data alone, but data publicity in a context where resources and expertise exist to enable intelligible uses of such data, that furthers democratic accountability. 

 We begin in Part I by describing the need for proactive disclosure of safety and efficacy data  and why existing legal avenues, such as FOIA, fail to create adequate data publicity. In Part II, we show that, contrary to the conventional wisdom and the (usual) view of the FDA itself, federal law does not prohibit the FDA from disclosing such data, even from the moment of drug or vaccine approval. Consistent proactive disclosure, however, will require revisions to the FDA’s current regulations, corrections to its interpretations of certain statutes, and, for the most sensitive data, data use agreements. We also show that the move should not hurt and may improve innovation, nor should it require compensation under the Takings Clause. If the agency does not act, Congress can and should, as we describe in Part III. 

Identity

The Australian Human Rights Commission Ensuring health and bodily integrity: towards a human rights approach for people born with variations in sex characteristics report responded to Terms of Reference requiring it to 'inquire into, and report on, how best to protect the human rights of people born with variations in sex characteristics in the context of medical interventions, including surgical and non-surgical interventions'.  The inquiry considered the 2013 report of the Senate Standing Committee on Community Affairs on involuntary or coerced sterilisation of intersex people, the Victorian Decision-Making Principles for the Care of Infants, Children and Adolescents with Intersex Conditions; 2017 Darlington Statement by Australian and New Zealand intersex organisations and independent advocates; and decisions of the Family Court of Australia. 

The report states that The Commission notes that terminology in this area is contested, and inappropriate language use can have harmful consequences. The Commission is committed to consulting on this issue, with a view to adopting the most appropriate terminology in this project. The Commission’s use of the term ‘people born with variations in sex characteristics’ is intended to refer compendiously to the people whose human rights are the focus of this project. Other terms are also used in this context, and the Commission remains committed to further consultation on terminology. 

 The Commission comments that 

 People born with variations in sex characteristics in Australia have increasingly raised concerns with the Australian Human Rights Commission (the Commission), the Australian Government and the United Nations, about human rights violations in relation to medical interventions conducted without the full and informed consent of the person involved. These interventions are of particular concern in relation to infants and children. 

The  Report provides 

recommendations for how Australia should protect and promote the human rights of people born with variations in sex characteristics in the context of medical interventions to modify these characteristics. These recommendations are framed by principles derived from international human rights law. 

 Applying a human rights analysis to medical interventions in relation to people born with variations in sex characteristics has three principal benefits: 

 • it promotes compliance with international and domestic law 

• the human rights framework provides a near-universal set of norms by which to answer questions regarding medical interventions in relation to people born with variations in sex characteristics • it provides a framework to consider the claimed benefits of performing these medical interventions without a person’s personal consent, against any impingement on human rights. 

These principles are set out in Chapter 2: 

• Bodily integrity principle: All people have the right to autonomy and bodily integrity. Medical interventions on people without their personal consent have the potential to seriously infringe these rights. 

• Children’s agency principle: Children and young people have the right to express their views in relation to decisions that affect them, and those views must be given due weight in accordance with their age and maturity. The ability of children to consent to medical interventions generally increases as they grow older. Children and young people who are able to understand fully the nature and consequences of proposed medical interventions should be able to make their own decisions about whether those interventions proceed. 

• Precautionary principle: Where safe to do so, medical interventions to modify the sex characteristics of a child born with variations in sex characteristics should be deferred until a time when the child is able to make their own decisions about what happens to their body. 

• Medical necessity principle: In some cases, to protect the child’s rights to life or health, it may be medically necessary for a medical intervention to modify the sex characteristics of a child born with variations in sex characteristics to occur, before a child can make their own decision. An intervention will be medically necessary if it is required urgently to avoid serious harm to the child. 

• Independent oversight principle: Given the risk of making a wrong decision, decisions about whether a medical intervention to modify the sex characteristics of a child born with variations in sex characteristics is medically necessary should be subject to effective independent oversight. 

 The Commission recommends new legislative protections, guidance and oversight processes when there is consideration of medical interventions for people under the age of 18 years born with variations in sex characteristics. Legislation should enforce a general requirement that medical interventions take place only with the prior, informed, personal consent of the person concerned – subject to an exception in the case of medical necessity. 

 (a) Consent and decision making 

Under international human rights law, a medical intervention may only take place without the individual’s personal consent where this is a medical necessity or medical emergency. The Commission recommends that this approach be taken in relation to medical interventions for people under the age of 18 years who are born with variations in sex characteristics. This general legal rule reflects a person’s rights of autonomy and agency over their body. A range of practical problems regarding obtaining consent to medical interventions are considered in Chapter 4. To address these problems, the Commission recommends the development of new guidance setting out what is required to obtain informed consent from people under the age of 18 years before performing a medical intervention for a person born with variations in sex characteristics. This guidance should ensure that • medical interventions are proposed only when medically necessary • consent in all cases is fully informed, and • children and younger people are empowered to participate in decision making in a manner consistent with their evolving capacities. Questions raised in this report regarding adequacy of current oversight mechanisms are not intended to suggest parents or doctors are not acting in good faith. Stakeholder submissions indicate quite the opposite. However, as the High Court observed in Marion’s case, good intentions may not be enough to protect children. 

 (b) Medical necessity 

The Commission recommends that medical interventions in relation to a person under the age of 18 without their personal consent should only take place where the intervention is required urgently to avoid serious harm to the person concerned (the ‘medical necessity’ principle). An intervention is ‘required urgently’ if it cannot be deferred without a significant risk of serious harm. The Commission notes (in more detail at 2.3 Applicable human rights), the various UN treaty body committee comments to Australia to limit intervention without personal consent to circumstances of medical necessity. Chapter 5 considers the different rationales put forward for medical interventions in relation to children born with variations in sex characteristics and concludes that such medical interventions should only be permissible if all of the following factors are present: • the medical intervention is required urgently to avoid serious harm • the risk of harm cannot be mitigated in another less intrusive way, and intervention cannot be further delayed • the risk of harm outweighs the significant limitation on human rights that is occasioned by medical intervention without personal consent. Chapter 5 applies the principle of medical necessity to the situation of medical interventions for people born with variations in sex characteristics. The Commission concludes that some rationales used to justify medical interventions are not consistent with this principle including, for example, psychosocial rationales based on ‘normalising’ genitalia. 

(c) Clinical practice and new National Guidelines 

The Commission recommends the development of new National Guidelines to guide decision-making processes to ensure that medical interventions modifying sex characteristics are not undertaken unless intervention is a medical necessity. These are considered in Chapter 6. The recommended National Guidelines should include guidance on • obtaining informed consent and ensuring affected children and younger people are involved in decisions (see Chapter 4) • the application of human rights principles in determining whether a medical intervention is a medical necessity (see Chapter 5) • requirements for independent authorisation of certain medical interventions (see Chapter 7). The Commission recommends that the National Guidelines be developed by a national multidisciplinary expert group convened by the Australian Government and should complement legislative reforms recommended in Chapter 7. The National Guidelines should also promote the best standards of clinical care generally. The national multidisciplinary expert group should develop clinical guidelines and best practice and treatment protocols, including in relation to the provision of psychological and peer support. 

 (d) Oversight of medical interventions 

The Commission recommends the establishment of Independent Panels to provide appropriate oversight of medical interventions in relation to children born with variations in sex characteristics, through the application of a human rights framework. Chapter 7 discusses how a human rights framework for decision making about medical interventions should be incorporated into Australian domestic law and policy, and what independent oversight mechanisms should be established. Oversight, in this context, refers to mechanisms by which an independent decision maker determines whether a medical intervention may be carried out on a person under the age of 18 without personal consent. The Commission recommends reform of oversight mechanisms by legislation by • establishing Independent Panels with responsibility to decide whether to authorise medical interventions in respect of people born with variations in sex characteristics • defining the circumstances in which interventions without personal consent may be authorised, which should be limited to circumstances of medical necessity • recognising that in emergency situations there should be an expedited authorisation process or, where this still does not provide time to deal with the emergency, a requirement for subsequent notification of the Independent Panel. 

 (e) Enforcement 

The Commission recommends legislation to prohibit medical interventions in relation to people under the age of 18 years born with variations in sex characteristics otherwise than in accordance with the medical necessity principle. Additionally, there should be appropriate criminal penalties for carrying out a relevant intervention without authorisation from an Independent Panel. Chapter 8 discusses how obligations placed on health practitioners and others to apply to an Independent Panel prior to performing medical interventions might be enforced in practice, under criminal law, and through regulation of health professionals. 

 (f) Support, health records and data collection People affected by medical interventions modifying sex characteristics need adequate support. Stakeholders raised concerns about records having been destroyed, failure to appropriately share records between treating health professionals, and inadequate record security. The Commission recommends in Chapter 9 that governments provide sufficient public funding for peer support organisations, comprehensive psychological and psychiatric health services, and comprehensive and up-to-date consumer resources for people born with variations, and their parents or guardians. While support for individuals born with variations is central, supports for parents or guardians is also crucial to enable families to best understand all the considerations in caring for a child born with a variation. Australian governments should also consult on establishing and funding coordinator positions to integrate care across multiple specialties and institutions. The Commission considers that there is a need for long-term, longitudinal data on past and current practices to better understand the health and psychosocial effects of different interventions. The Commission therefore recommends the Australian Government facilitate the establishment of a national databank to assist research on the frequency of variations in sex characteristics and the effects of medical interventions and non-intervention. The Australian Government and state and territory governments should also fund and facilitate collaborative medical, psychological, health and wellbeing research, and socio-economic research to tackle stigma and disadvantage as relates to exclusion in schooling and employment.

The Report states 

In 2013, the Senate Community Affairs References Committee (Senate Committee) conducted an inquiry into the involuntary or coerced sterilisation of intersex people in Australia (Senate Committee Inquiry). In its final report, the Senate Committee made a number of recommendations to better protect the human rights of intersex people. In its formal response in May 2015, the Australian Government welcomed the report and recognised the harm experienced by many people subjected to forced sterilisation. It committed to raising with the states and territories the Senate Committee’s recommendations regarding the legal framework regulating sterilisation for people with disability, with a view to promoting consistency between Australian jurisdictions. In respect of ‘involuntary or coerced sterilisation of intersex people’, the Government acknowledged the report’s main recommendations and specifically noted the benefit of further research on the desirability of ‘bringing the medical treatment of intersex variations into the jurisdiction of guardianship tribunals’ and/or the Family Court of Australia, but did not support amending the Family Law Act 1975 (Cth) to expand the Family Court’s role at that time. Broadly speaking, the Australian Government has emphasised the responsibility of the states and territories and has not committed to the implementation of particular reform in this area. 

During the Commission’s inquiry, state governments had also been considering how to better protect the rights of people born with variations in sex characteristics and provide better support to them and their families. In July 2021, the Victorian Government committed to prohibiting deferrable medical interventions on intersex people without personal consent, and introducing an oversight panel to ensure compliance with the prohibition. The Commission welcomes this commitment. In July 2021, the report (i) Am Equal: Future Directions for Victoria’s Intersex community, outlined a collaborative approach that importantly includes people born with variations in sex characteristics and their advocacy and peer support organisations. Its three main focus areas – Future Intersex Resourcing, Future Intersex Health and Wellbeing Centre, and Improving Future Treatment – are consistent with the Commission’s views reflected in this Report. The proposals to develop: a mechanism to prohibit deferrable medical interventions modifying a person’s sex characteristics without personal consent; an oversight panel to ensure compliance with the prohibition; provisions which ensure the collection of data and transparency over what treatments are being performed and support for the development of National Guidelines, are welcome and consistent with key recommendations in this Report. 

The Commission also welcomes the ACT Government’s work to protect the rights of people born with variations in sex characteristics and provide better support to them and their families. In October 2019, the ACT Government committed to developing a plan for managing deferrable medical interventions for people born with variations in sex characteristics. This has involved consulting with intersex people and experts in the field; reviewing the existing literature and initiatives in other countries; and testing key issues with stakeholder individuals and organisations. The Commission has engaged with the ACT’s efforts to formulate a proposal to develop such protections. There is congruence in the approach proposed by the ACT Government and that of the Commission’s, as articulated in this report.

The Commission's Recommendations are 

1: Laws and practices concerning medical interventions to modify the sex characteristics of people born with variations in sex characteristics should be guided by a human rights framework based on the following principles.

1. Bodily integrity principle: All people have the right to autonomy and bodily integrity. Medical interventions on people without their personal consent have the potential to seriously infringe these rights. 

2. Children’s agency principle: Children and young people have the right to express their views in relation to decisions that affect them, and those views must be given due weight in accordance with their age and maturity. The ability of children to consent to medical interventions generally increases as they grow older. Children and young people who are able to understand fully the nature and consequences of proposed medical interventions should be able to make their own decisions about whether those interventions proceed. 

3. Precautionary principle: Where safe to do so, medical interventions to modify the sex characteristics of a child born with variations in sex characteristics should be deferred until a time when the child is able to make their own decisions about what happens to their body. . 

4. Medical necessity principle: In some cases, to protect the child’s rights to life or health, it may be medically necessary for a medical intervention to modify the sex characteristics of a child born with variations in sex characteristics to occur before a child can make their own decision. An intervention will be medically necessary if it is required urgently to avoid serious harm to the child. 

5. Independent oversight principle: Given the risk of making a wrong decision, decisions about whether a medical intervention to modify the sex characteristics of a child born with variations in sex characteristics is medically necessary should be subject to effective independent oversight. 

2: The development of new resources to increase awareness of variations of sex characteristics in the community, educational, service and employment settings, and to reduce the associated stigma. To undertake this, the Australian Government and state and territory governments should fund community organisations led by people born with variations in sex characteristics to . 

3: New National Guidelines on medical interventions for people born with variations in sex characteristics (see Recommendation 6) should set out what is required to obtain informed consent before performing a medical intervention for a person born with variations in sex characteristics. This guidance should require that:

(a) Treating practitioners provide accurate, up-to-date, evidence-based medical information including about: (i) the variation in question (ii) the exact nature of any proposed intervention, why it is medically necessary, and the degree of any risk from the intervention (iii) what alternatives exist, including other medical interventions or delaying or deferring the proposed intervention (iv) the likely long-term effects and outcomes if the proposed intervention is carried out immediately, at a later time, or if the intervention is not carried out (v) what uncertainty, if any, exists in relation to the current state of medical knowledge underpinning any recommended intervention (vi) any diversity of medical opinion about the proposed intervention (vii) the benefits of peer support, and contact information for relevant groups. 

(b) Treating practitioners document fully the information provided, how they have included children in decision-making processes and the steps they have taken to effectively communicate the information, taking into account the age, decision-making ability or other characteristics of the person. 

(c) people born with variations in sex characteristics and, where they are children, their parents and other family members, are provided information in clear, accessible, non-technical language that they can understand 

(d) Treating practitioners refer people born with variations in sex characteristics, and where relevant their parents and other family members, to peer support and advocacy organisations, and services such as psychologists and social workers, who can provide further information to help inform their decision-making. 

(e) children are included in decision making in an age-appropriate way, including by being given support to understand any medical advice and to express their views, with due weight being given to those views according to their age and capacity. Where a child has sufficient understanding, the child’s informed consent should be sought. Where the view is formed that the child does not have sufficient understanding for their consent to be sought, the reasons and evidence for this should be documented along with a description of any attempts made to seek the views of the child 

(f) people with variations in sex characteristics and, where they are children, their parents and other family members, are provided with adequate time to make treatment decisions, with access to necessary support, to ensure they do not feel undue pressure to consent.

 4: Medical interventions modifying sex characteristics of children may be conducted without personal consent only in circumstances of medical necessity. Circumstances of medical necessity exist only where all of the following factors are present:

(a) the medical intervention is required urgently to avoid serious harm 

(b) the risk of harm cannot be mitigated in another less intrusive way, and intervention cannot be further delayed 

(c) the risk of harm outweighs the significant limitation on human rights that is occasioned by medical intervention without personal consent. 

5: All people born with variations in sex characteristics should have access to comprehensive, appropriately qualified multidisciplinary care, with input from mental health and other key professionals, and other people with variations. Care should be available across their lifespan and regardless of where they live. 

6: (a) The Australian Government should convene and fund a national multidisciplinary expert group to develop National Guidelines on medical interventions for people born with variations of sex characteristics (National Guidelines), with input from specialist clinicians and health professional bodies, people with lived experience and their parents and carers, advocacy and peer-support groups, and human rights organisations. (b) The National Guidelines should reflect human rights principles including in relation to medical necessity (see Recommendation 4) and the provision of adequate information for informed consent (see Recommendation 3), as well as include best practice and treatment protocols for the management of different variations in sex characteristics and reviews of existing and emerging evidence-based research. (c) The National Guidelines should be reviewed periodically, to ensure guidance is based on the best available data and evidence. 

7: (a) The Australian Government and state and territory governments should legislate to establish one or more independent panels with responsibility to decide whether to authorise medical interventions modifying sex characteristics of people under the age of 18 years born with variations (Independent Panels). (b) Whenever a clinician or clinical treatment team intends to make such a medical intervention, they should be required to apply to an Independent Panel prior to performing the intervention. (c) Independent Panels should be constituted by members with expertise that includes relevant clinical expertise, lived experience of being born with variations in sex characteristics, and human rights. 

8: (a) An Independent Panel should only authorise a medical intervention for a person under the age of 18 years where it is satisfied that the person concerned either: (i) has the ability to provide personal consent and has provided such consent, or (ii) is not able to provide personal consent and the intervention is a medical necessity. (b) In rare emergency situations, where there would be a real risk of serious and irreparable harm to the person if the intervention were not carried out immediately, the Independent Panel should have an expedited process to consider the request for authorisation. Only where this still does not provide enough time to address the emergency, should an intervention proceed without authorisation. In those circumstances the relevant Independent Panel must be notified promptly following the conduct of the medical intervention. (c) Independent Panels, in determining whether a medical intervention is authorised, should be informed by the National Guidelines on medical interventions for people born with variations of sex characteristics. 

9: The Australian Government and state and territory governments should legislate to prohibit medical interventions for people born with variations in sex characteristics otherwise than in accordance with Recommendations 7 and 8. There should be appropriate criminal penalties for breaching this legislative prohibition. 

10: The Australian Government and state and territory governments should provide sufficient public funding for: 

(a) sustainable operation of advocacy and peer support organisations led by people born with variations of sex characteristics 

(b) comprehensive psychological and psychiatric health services, for people born with variations of sex characteristics, their parents and other family members 

(c) improved access to peer support and health services, including online and by telephone 

(d) comprehensive and up-to-date consumer resources for people born with variations in sex characteristics, their parents and other family members informed by clinical, peer support and human rights experts.

The Australian Government and state and territory governments should also consult on establishing and funding coordinator positions to integrate care across multiple specialties and institutions. 

11: The Australian Government should facilitate the establishment of a national databank to assist research on: 

(a) the frequency of variations in sex characteristics, including specific variations 

(b) the short-, medium- and long-term effects of medical interventions and non-intervention. 

12: The Australian Government and state and territory governments should fund and facilitate collaborative research, co-designed by community organisations led by people born with variations of sex characteristics, including:

(a) medical, psychological, health and wellbeing research, across the lifespan, that affirms human rights norms and helps people born with variations of sex characteristics to flourish 

(b) socio-economic factors that put people born with variations in sex characteristics that risk leading to stigma and disadvantage, including emerging issues such as social exclusion in schooling and employment. 

(c) any research that investigates the circumstances and needs of all sexual and gender minorities should disaggregate data on people born with variations of sex characteristics.

Conscription and Political Pamphlets

The discussion of 'civil conscription' as part of today's judgment in Kassam v Hazzard; Henry v Hazzard [2021] NSWSC 1320 regarding COVID public health orders

Civil Conscription 

Section 51(xxiiiA) of the Constitution confers on the Federal Parliament legislative power to make laws for the peace, order and good government of the Commonwealth with respect to:

“[t]he provision of maternity allowances, widows pensions, child endowment, unemployment, pharmaceutical, sickness and hospital benefits, medical and dental services (but not so as to authorise any form of civil conscription, benefits to students and family allowances; …” (emphasis added)

This legislative power was inserted into s 51 with effect from 19 December 1946 by the Constitution Alteration (Social Services) Act 1946 following its passage in a referendum. The historical events that lead to the passage of this provision in this particular form are described in Wong v The Commonwealth (2009) 236 CLR 573; [2009] HCA 3 at [18] to [55] per French CJ and Gummow J, at [174] to [191] per Hayne, Crennan and Kiefel JJ and, to an extent, by Heydon J at [271] to [277] (“Wong”). It suffices to note two matters about that history. 

First, the phrase “civil conscription” has its origins in the debate about whether “industrial conscription”, that is, the use of compulsory civilian labour, would or would not be deployed in the war effort, as it eventually was (Wong at [31] to [40]; see Reid v Sinderberry (1944) 68 CLR 504). 

Second, the carve out from the referendum proposing the grant of legislative power so as to not authorise any form of civil conscription was suggested by the then opposition and agreed to by then government (Wong at [50] to [51]) and no doubt helped secure its passage. It stands in contrast to the nationalisation of medical services that took place in the United Kingdom around the same time (Wong at [274]). Thus, the phrase “civil conscription” was deployed so as to preclude compulsory service by medical professionals which might not answer the description “industrial conscription” (Wong at [50]). 

Bearing that in mind, two aspects of the concept of civil conscription of s 51(xxiiiA) should be noted. First, the preclusion on authorising civil conscription only qualifies a (Commonwealth) law for the “provision” of “medical or dental services” (the BMA Case at 254 per Rich J, at 261 per Dixon J, at 282 per McTiernan J, at 286 per Williams J, contra per Latham CJ at 253 and Webb J not deciding at 292; Alexandra Private Geriatric Hospital Pty Ltd v Commonwealth (1987) 162 CLR 271 at 279; [1986] HCA 6; “Alexandra”). 

Second, civil conscription is directed to compulsive service in the provision of medical services. In the BMA Case a majority, Latham CJ, Rich, Williams and Webb JJ, Dixon and McTiernan JJ dissenting, upheld a challenge to the validity of a legislative requirement for pharmacists to write scripts for medicines on a particular form regardless of whether the medicine was to be obtained for free by the patient under the Pharmaceutical Benefits Scheme. The widest reading of the majority’s conclusion was that the prohibition on civil conscription in relation to medical and dental services strikes down any “compulsion of law requiring that men … perform work in a particular way” (at 249 per Latham CJ). Dixon J in dissent concluded that nothing in the impugned provision compelled the rendering of medical services to patients in any capacity whether regularly, occasionally, for a short period or intermittently (at 278). His Honour’s approach was effectively adopted in the General Practitioner’s Case (1980) 145 CLR 532 at 556-557 per Gibbs J. at 563 per Stephen J, at 564 per Mason J and 571 to 572 per Wilson J; Wong at [195]). In Wong, Hayne, Crennan and Kiefel JJ also applied the approach of Dixon J in the BMA Case while accepting that civil conscription can arise from the practical and not just legal effect of a legislative provision (at [209]). Even so, their Honours concluded that the practical effect of the scheme for the payment of medical benefits in the Health Insurance Act did not amount to civil conscription in that it did not compel a medical practitioner, legally or practically, to provide a service on behalf of the Commonwealth or at all to treat any patient or particular patient ([id]). Their Honours also concluded that, accepting that the practical effect of the Health Insurance Act was to require doctors who wish to practise to participate in the Medicare scheme (at [224]), a requirement to comply with a standard of practice is not a form of civil conscription (at [226]). 

Similarly, after reviewing the history of s 51(xxiiiA), French CJ and Gummow J in Wong reached the same conclusion. In so doing, their Honours described the meaning of “civil conscription” in s 51(xxiiiA) as follows (at [60]): 

“The legislative history and the genesis of s 51(xxiiiA) supports a construction of the phrase "(but not so as to authorize any form of civil conscription)" which treats "civil conscription" as involving some form of compulsion or coercion, in a legal or practical sense, to carry out work or provide services; the work or services may be for the Commonwealth itself or a statutory body which is created by the Parliament for purposes of the Commonwealth … it also may be for the benefit of third parties, if at the direction of the Commonwealth.” (emphasis added) 

The effect of the Kassam plaintiffs’ written submissions was that Order (No 2) effected a form of civil conscription because it effectively required unvaccinated persons to obtain a COVID-19 vaccine. [157] This wrongly assumed that s 51(xxiiiA) proscribes the compulsory acquisition of medical services which it does not. In oral submissions, counsel for the Kassam plaintiffs, Mr King, was pressed on how any doctors or any other medical professional was compelled to provide a medical or dental service. He contended that [158]

“…the effect of the order is what is critical in our respectful submission, and the effect of that order is to conscript both patients and doctors, their doctors, to obtain a double vaccination, or in relation to the earlier orders a single vaccination, as the price of giving up their employment and their right to protect and look after their families.” 

This contention was repeated in a written submission filed on 4 October 2021. [159] Nothing in any part of Order (No 2) or the PHA involves any element of coercion on a doctor or other medical provider to vaccinate anyone. Otherwise, this submission simply repeats the wrong assertion that s 51(xxiiiA) operates on the acquisition of a medical service as opposed to its provision. 

In his submissions, Dr Harkess contended that a medical or dental service was provided by a person who received a COVID-19 vaccine because theycontribute to the eventual establishment of “herd immunity”. He submitted that it follows that those who were “compelled” to be vaccinated were civilly conscripted to provide dental and medical services. [160] It suffices to state that contributing to the general health of the community by adding to herd immunity is not providing a medical service. 

Wong establishes that s 51(xxiiiA) is to be interpreted according to its historical purpose as explained above. On any sensible reading of the authorities the impugned orders do not impose any form of civil conscription as referred to in s 51(xxiiiA).

Points of note include paras [147]-[148] -

In his affidavit Professor Borody asserts that the Federal Minister for Health wrote to him on 27 August 2020 and “specifically instructed me that doctors in Australia can prescribe ivermectin and other components of ‘off label’.  He annexes that letter. The letter does not contain any instruction that doctors in Australia can prescribe ivermectin and other components off label. In fact, what the Minister stated was:

“Whilst shown to be effective in the lab environment, ivermectin cannot be used in humans for COVID-19 until further testing and clinical trials have been completed to show that it is safe and effective in humans. 

… I acknowledge some physicians are prescribing ivermectin off label. As you would know the practice of prescribing registered medicines outside their approved indications is not regulated nor controlled by therapeutic goods Association as it is at the discretion of a prescribing physician.”

The balance of the letter encourages Professor Borody to seek funding for trials of ivermectin. It suffices to state that nothing in Professor Borody’s report provides any assistance for the Kassam plaintiffs claim that the impugned orders are unreasonable.

Elsewhere the Court states

Finally on this topic, I note that the Henry plaintiffs relied on the dissenting judgment of Deputy President Dean of the Fair Work Commission in an unfair dismissal case that addressed whether an employee who objected to being vaccinated could be reinstated to work at an aged care centre (Kimber v Sapphire Coast Community Aged Care Ltd [2021] FWCB 6015). In particular, they relied on various passages in the Deputy President’s judgment to the effect that “vaccine mandates” embodied in the various public health responses to COVID-19 amount to a form of coercion that violates a person’s right to bodily integrity (at [115] to [129]). 

Given the very different jurisdictions being exercised by the Fair Work Commission and this Court, I would not ordinarily address the reasoning in their decisions (and I doubt they would address the reasoning in mine). However, as the Henry plaintiffs sought to rely on the reasoning it is necessary to record why that judgment is of no assistance. 

First, the relevant parts of the decision relied on by the Henry plaintiffs do not address the case law concerning consent to a medical treatment. 

Second, the passages relied on and passages to similar effect throughout the judgment appear to contain assertions about the efficacy and safety of COVID-19 vaccines and other aspects of the public health response to COVID-19 that were not reflected in the evidence that I found persuasive in this case and as far as I can ascertain were not the subject of evidence in that case. 

Third, elsewhere in her reasons, the Deputy President considered it necessary to opine on matters affecting either the validity or the appropriateness of making the Aged Care Order under the PHA (at [147] to [173]). The function of determining its validity is for this Court to discharge and the function of determining whether it should have been made is for the political process. The Fair Work Commission has neither function. 

Fourth, the Deputy President’s judgment concludes with a number of clarion calls imploring “all Australians” to do things such as “vigorously oppose the introduction of a system or medical apartheid and segregation” (at [182]) and “vigorously oppose the ongoing censorship of any views that question the current policies regarding COVID” (at [183]). Political pamphlets have their place but I doubt that the Fair Work Commission is one of them. They are not authorities for legal propositions. 

In the end result, provisions such as clause 4.3 and 5.8 do not amount to a violation of anyone’s right to bodily integrity but instead impede their freedom of movement which has consequential effects on their ability to work. Freedom of movement is undoubtedly important, although it is not necessarily some form of positive right. Regardless, the PHA is clearly directed to limiting that freedom, sometimes severely.

Dumps

Another 'we didn't bother to clear the filing cabinets' inciodent, with the ABC reporting 'confidential documents including child protection information were dumped at a Darwin tip last week when the Northern Territory Families department threw out old filing cabinets'. 

 The documents were inside old filing cabinets discarded by Territory Families during an office clean-out Members of the public who find any of the documents are urged to come forward It is possible some of those documents are now out in the community after some cabinets were sold from the tip's on-site shop over the weekend. 

Territory Families, Housing and Communities has since launched an investigation into how the sensitive information ended up at Darwin's Shoal Bay Waste Management facility. Nicole Hurwood, acting chief executive of Territory Families, said the agency believed the documents were thrown out on October 7 during an office clean-up when leftover or broken office cabinets were dumped at the tip. 

She said it became aware of the mistake on Monday and arranged to have the office cabinets immediately secured and then searched to retrieve any documents. Territory Families was now working to identify and contact anyone whose private information may have been dumped at the tip by accident ... 

"Agency officers have discovered a range of different documents [at the tip], including corporate documents and some child protection documents," Ms Hurwood said on Friday. "What we do know at this stage is there [was] information relating to about six families and some lists with child protection information on them." 

She said the agency did not know if any of the the private documents have ended up in public hands, adding "there were cabinets sold from the Shoal Bay Recycling Centre over the weekend". "We will be relying on the public or the people who find those documents to come forward," she said, saying they should contact Territory Families' complaint line.

Hurwood indicates that Territory Families was undertaking an internal investigation to "minimise that risk from occurring again". The efficacy of that review is uncertain, given  that Territory Families lost dozens of confidential documents — including a child protection investigation, a child death file and other documents regarding clients and staff dating back to 2009— at the Alice Springs tip i. They were located in filing cabinets and pedestal drawers accidentally sent to the tip during an office relocation.

Identity Crime

The ABC reports the arrest on the Gold Coast of a 45 year old woman, charged under the Health Practitioner Regulation National Law with pretending to be a doctor.

She had been issuing fake COVID-19 "medical exemption" certificates, allegedly issuing around 600 false certificates. 

 Police issued a search warrant on Wednesday morning for an address in Labrador and arrested the woman, who is from Darling Heights in the Toowoomba region. 

She was charged under Health Practitioner National Law with five counts of taking a title indicating a person is a health practitioner.

In this instance there is coverage under Health Practitioner Regulation National Law (Queensland) ss 113, 115, 116, 117 and 118 alongside associated advertising provisions.

The first conviction under the National Law was in 2014, with Jayne Walton being prosecuted by the Australian Health Practitioner Regulation Agency (AHPRA), found guilty of using the title ‘psychologist’ and claiming to be a registered psychologist, and ordered to pay fines totaling $20,000. Other health practitioner title offences - a form of identity crime - are noted elsewhere in this blog, for example here.

The woman is reported as having charged $150 per fake certificate and claim that "her interpretation of the legislation" authorises her to issue the certificates even thougfh she is not a registered practitioner. It is unclear if people who paid for the certificates were aware they were not genuine; purchasers who were aware that the certificates were fake could potentially be charged with fraud-related offences. 

Subsequent reports indicate that the woman recently gained a doctorate in Professional Research (Addiction) at the University of Southern Queensland, claims experience as a patient in psychiatric institutions in four countries and is a "spiritual insights" and recovery coach. 

Her Amazon books profile states 

She now spends her days with her life partner and spiritual advisor, Venerable Monk Xu. They have joined forces to ensure their mission reaches a higher purpose and together have opened a small sanctuary that seeks to spiritually enlighten, train (body mastery), teach and coach hundreds of people to turn away from addiction and live a life of dedication and purpose. 

She continually fills her mind with self-development, educational and academic pursuits of excellence and just recently completed her Master of Public Health (MPH) at University of Queensland (Ranked 47th Best University in the World). Her passion, Coaching With Substance is a registered Public Benevolent Institution with a charitable vision to eradicate the harms caused by addiction, addictive behaviours and co-morbid mental illnesses, one client at a time. As the Founder, she spends her waking moments dedicated to her cause & life purpose.

Hacking

'The Simulation of Scandal: Hack-and-Leak Operations, the Gulf States, and U.S. Politics' by James Shires in (2020) 3(4) Texas National Security Review 10–29 comments 

Four hack-and-leak operations in U.S. politics between 2016 and 2019, publicly attributed to the United Arab Emirates, Qatar, and Saudi Arabia, should be seen as the “simulation of scandal" — deliberate attempts to direct moral judgment against their target. Although “hacking” tools enable easy access to secret information, they are a double-edged sword, as their discovery means the scandal becomes about the hack itself, not about the hacked information. There are wider consequences for cyber competition in situations of constraint where both sides are strategic partners, as in the case of the United States and its allies in the Persian Gulf. 

Hack-and-leak operations (HLO) are a new frontier in digital forms of foreign interference, epitomized by the success of Russian intelligence agencies in obtaining and disseminating documents from the Democratic National Committee (DNC) during the 2016 U.S. presidential election campaign.1 HLO and other information operations are widely seen as a severe threat to liberal democratic structures and U.S. policymakers have mobilized significant resources in response, including threat intelligence and cyber security protections, increased election and voting security, legislative pressure on social media companies, and even offensive cyber attacks. 

This “whole-of-nation” approach is largely based on the events of the 2016 U.S. election, and specifically Russian interference in the election process. However, it is hard to pinpoint the exact impact of the Russian disinformation operations. Controversial candidates, a combative and polarized media environment, and entrenched economic and social divisions were all key factors in the 2016 election result. Furthermore, foreign interest in the U.S. election was not limited to the Russian government; other state and nonstate actors also sought to influence candidate campaigns in their favor. The danger is that academic and policy understandings of HLO are over-reliant on a single case. This article therefore asks: How do other HLO cases alter our understanding of this new phenomenon, including motives, means, and consequences? 

HLO occur frequently worldwide, but their political contexts vary widely and have uncertain implications for U.S. politics.6 Consequently, this article expands our understanding of HLO through a detailed qualitative analysis of four operations that targeted political figures in the United States in the period following the DNC operation (October 2016 to January 2019), thus keeping the political and media environment constant as far as possible. These cases replicate many of the striking features of the DNC operation: access through phishing, the release of large collections of emails, publication in national media outlets, and even direct references to “DCLeaks,” the identity assumed by the Russian intelligence agencies to disseminate the DNC documents. These cases have been publicly attributed to governments in the Middle East, namely Qatar, Saudi Arabia, and the United Arab Emirates (UAE), and thus broaden conceptions of digital foreign interference to allies as well as adversaries. 

This article argues that HLO are the “simulation of scandal”: deliberate attempts to direct public moral judgment against their target. The success of HLO depends on the shifting power dynamic between the scandal-maker and the scandal-subject, referred to in Arabic as kāshif and makshūf, respectively. At the center of this dynamic are the digital technologies used to obtain and release secret information. These hacking tools are a double-edged sword, as their discovery often means the scandal becomes about the hack itself, not about the hacked information; in other words, the kāshif becomes the makshūf. These cases also highlight other overlooked aspects of HLO: the utility of “activist” cover, the involvement of new actors such as public relations (PR) agencies and law firms, and the leaker’s wary reliance on mistrustful relationships with traditional media. Finally, the article identifies wider consequences for cyber competition in situations of constraint where both sides are strategic partners. In such situations, HLO offer a powerful but indirect and unpredictable means of influence. 

The first section places HLO within the literature on cyber conflict and information operations. The second section draws on sociological accounts of mediatized and digitalized leaks to explore the simulation of scandal. The rest of the article concerns the four case studies: The third section provides an overview of each case; the fourth analyzes their coverage in prominent media outlets; and the fifth discusses reasons behind their differing effects. A conclusion places this discussion in a broader strategic context, highlights limitations, and suggests further work.

GDPR and CCPA

'Catalyzing Privacy Law' by Anupam Chander, Margot E. Kaminski and William McGeveran in (2021) Minnesota Law Review comments 

When the General Data Protection Regulation (GDPR) took effect in May 2018, it positioned the European Union as the world’s privacy champion. A flurry of emails updating privacy policies landed in in-boxes across the globe, attesting to the international reach of the European rule.  A month later, California enacted the California Consumer Privacy Act (CCPA), establishing the nation’s most stringent omnibus privacy protections, effective as of January 1, 2020. California, the home of many of the world’s largest data-based enterprises, emerged as a dark horse contender in the privacy regulator race. In the past year, state after state considered broad data privacy legislation, and eleven comprehensive federal privacy bills were introduced in Congress. 

What is catalyzing U.S. privacy law? The conventional wisdom holds that Europe is setting the global standard for information privacy. There is much truth to this—some 142 countries and counting now have a broad data privacy law, typically modeled on the GDPR. Scholars writing insightfully about the global race to information privacy have tracked the spread of data privacy laws across the world, noting Europe’s influence on these developments.  In a recent article, Paul Schwartz observes that the European Union pioneered international privacy law to enable commerce among nations within the bloc itself. He argues that other countries largely adopted the European Union’s data privacy model, reflecting its “success in the marketplace of ideas.” 

Schwartz cites the CCPA as an example of Europe’s success in spurring other jurisdictions to enact similar laws. Journalists reporting on the CCPA’s enactment, too, have frequently referred to it as “GDPR lite” and “California’s version of GDPR.” And as the push for federal legislation intensifies, many characterize it as a national response to the GDPR. 

This Article challenges this emerging consensus. Despite decades of European privacy law, the United States showed little appetite until now for broad privacy legislation.  Instead, norm entrepreneurs in California helped establish a new privacy framework that, as we show, differs significantly—and consciously—from the European model. Our close comparison of the new California and European laws reveals that the CCPA is not simply GDPR-lite: it is both more and less demanding on various points. It offers a fundamentally different regime for data privacy. And the numerous legislative proposals in state houses show greater fealty to California’s model than to the European antecedent.  Bills pending before Congress reflect pressure not from Brussels, but from Sacramento. 

Thus, California has emerged as a kind of privacy superregulator, catalyzing privacy law in the United States. Rather than the supranational EU, the subnational state of California — and, more specifically, a small network of determined individuals within that state — is now driving privacy in a significant part of the world. The emergence of the CCPA demonstrates the central role of local networks and norm entrepreneurship, contesting on the ground of what we call “data globalization.”  

We are thus witnessing a paradigm shift in the policy conversation around data privacy law. Until now, the rules of transatlantic privacy rested on awkward negotiated mechanisms to transfer data between two seemingly irreconcilable regimes. Now we are witnessing what might be characterized as a regulatory race on both sides of the ocean. 

This Article is the first to critically evaluate the relationship between California’s privacy law, Europe’s data protection regulation, and possible future state and federal privacy law.  This study is also of practical interest, answering questions for individuals and businesses alike: For businesses, whose laws should I follow? For individuals, who will protect my privacy? Studying these questions leads, in turn, to another set of inquiries about the ways in which catalysis from the GDPR and CCPA govern privacy outside either Europe or California. When Europe’s laws meet California’s, who wins? If indeed European or Californian regulation will be applied globally de facto, why then should anyone else legislate? 

The answers to all of these questions have implications not only for the shape of information privacy law but for understanding inter-jurisdictional regulatory dynamics in the digital economy. While data shares some characteristics with cars, pollution, and corporate charters—all the subject of prior globalizations of legal compliance and legal rules — it also differs because of its simultaneous and instantaneous global effects. Data disobeys borders and operates at Internet speed. Equally important, the answers to these questions shed light on the prospects of countries across the world as they vie for advantage in the information age. Ultimately, our account of privacy catalysis tests the operation of both federalism and international regulatory competition in the twenty-first century. Our analysis proceeds as follows. Part I situates our discussion of regulatory catalysis in data privacy within the broader frame of the theory of regulatory competition, borrowing lessons from areas such as corporate and environmental law. Part II compares the substance of the GDPR and the CCPA and the ways in which their structures promote catalysis in other jurisdictions. Part III turns to the race for data privacy law. We are the first to disentangle the catalytic effects on U.S. federal and state laws coming from both Brussels and Sacramento and to show that the resulting proposals are distinctly American and owe a greater debt to the CCPA than to the GDPR. As it once did with pioneering environmental regulation, California has emerged as a super-regulator again, this time with respect to data in the information age.