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.