Transgender inclusion within policy is critical yet often missing. We propose a policy tool to assesses human rights, access to resources and opportunities, language, and implications for transgender and nonbinary individuals. Acknowledging trans communities as standard policy practice can serve as an essential practice to shift dialogue and norms.

Despite a recent wave in global recognition of the rights of transgender and gender-diverse populations, referred to in this text by the umbrella label of trans*, international law continues to presume a cisgender binary definition of gender — dismissing the lived realities of trans* individuals throughout the world. This gap in international legal recognition and protection has fundamental implications for health, where trans* persons have been and continue to be subjected to widespread discrimination in health care, longstanding neglect of health needs, and significant violations of bodily autonomy.

Mitochondrial replacement therapy (MRT), also called nuclear genome transfer and mitochondrial donation, is a new technique that can be used to prevent the transmission of mitochondrial DNA diseases. Apart from the United Kingdom, the first country to approve MRT in 2015, Australia became the second country with a clear regulatory path for the clinical applications of this technique in 2021. The rapidly evolving clinical landscape of MRT makes the elaboration and evaluation of the responsible use of this technology a pressing matter. As jurisdictions with less strict or non-existent reproductive laws are continuing to use MRT in the clinical context, the need to address the underlying ethical issues surrounding MRT’s clinical translation is fundamental.

Vaccine mandates played a critical role in the success of New York City’s COVID-19 response. By relying on evidence as a substantive basis for the mandates and adhering to procedural requirements and precedent, New York City leveraged its position and expertise as a local governmental authority to devise mandatory vaccine policies that withstood numerous legal challenges. New York City’s experience highlights the role of municipal government in mounting a meaningful public health response, and the strategies adopted by NYC may provide a blueprint for municipalities around the world facing the ongoing COVID-19 pandemic and the threat of future public health emergencies.

Many transgender people need specific medical services to affirm their gender. Gender-affirming health care services may include mental health support, hormone therapy, and reconstructive surgeries. Scant information is available about the utilization or costs of these services among transgender people, which hinders the ability of insurance regulators, health plans, and other health care organizations to plan and budget for the health care needs of this population and to ensure that transgender people can access medically necessary gender-affirming care. This study used almost three decades of commercial insurance claims from a proprietary database containing data on more than 200 million people to identify temporal trends in the provision of gender-affirming hormone therapy and surgeries and to quantify the costs of these services.

The complexity and inefficiency of the U.S. health care system complicates the distribution of life-saving medical technologies. When the public health is at stake, however, there are alternatives. The proposal for a national PrEP program published in this issue of the Journal applies some of the lessons of the national COVID vaccine campaign to HIV prevention. In doing so, it draws on other examples of public health approaches to the financing of medical technology, from vaccines for children to hepatitis C treatment.

Using an implementation science framework, we detail how a national system for covering both standard and telemedicine laboratory testing would support a national PrEP program. Implementation strategies that will facilitate success include minimizing provider burden through uncomplicated billing systems and minimizing patient burden through centralized, online access systems. We anticipate that providing telemedicine and in-person laboratory testing options will optimize PrEP care by making it less burdensome, leading to cost-effective healthcare and improved population health.

This Article aims to show how the food industry has instrumentalized the right to freedom of expression to oppose innovative laws in Chile aimed at creating healthier food environments.

This article argues that the decision by the Columbian high court to totally ban the advertising and promotion of tobacco products is sound and could indeed be applied to other types of harmful products.

The paper identifies common barriers and challenges to Pre-Exposure Prophylaxis (PrEP) uptake and offers considerations for state and local public health departments to address barriers and retool infrastructure to increase access to PrEP to new users. Authors identify synergistic opportunities with federal agencies and funders to advance PrEP-related HIV prevention efforts, that prioritize strategies and investments to provide PrEP to people who could benefit from the intervention but are unaware of PrEP or struggle to access it. Barriers discussed and examined include financing strategies to reduce financial burden of PrEP medication, expanding PrEP access and outreach beyond clinical settings, and increasing the network and reach of the provider community to serve people we oppress through policy choices and discourses of racial and socioeconomic inferiority.

The Supreme Court of Canada has established that commercial speech is protected under the Canadian Charter of Rights and Freedoms and that commercial speech exists along a continuum of utility and value, which is balanced against objectives such as public health. This article examines jurisprudence to determine when infringements on commercial speech are acceptable, analyzing considerations of evidence, rational connections between policies and outcomes, proportionality, and minimal impairment.

Marketing restrictions to promote public health invoke competing rights, including the right to free commercial speech which for-profit entities use to protect their freedom to market products without undue regulation. The right to free commercial speech in South Africa has been developed through case law since the adoption of the first democratic constitution in South Africa in 1996. This article examines the impact of this recent judgment and the lessons for policy makers to ensure effective regulation of marketing practices in South Africa.

Transgender and gender diverse (TGD), Black, and Latinx communities have long borne a disproportionate share of the U.S. HIV epidemic, yet these same key demographics are continually underrepresented in national PrEP prescriptions. Black, Latinx, and TGD individuals are also more likely to be uninsured, meaning that a proposed federal program to cover PrEP for people without insurance could provide significant benefit to potential PrEP users from these populations. However, coverage of PrEP costs alone will not end disparities in uptake. This commentary provides additional context and recommendations to maximize effectiveness of a national PrEP program for TGD, Black, and Latinx populations in the US.

Prior to the recent introduction of generic TDF/FTC in the U.S., access to pre-exposure prophylaxis (PrEP) for HIV was greatly limited due to the downstream effects of the high cost of the medication. This article argues that despite drug copay cards and patient assistance programs, the promise of drastically reduced HIV diagnoses has never been fully realized, and more policy reforms on drug pricing are needed to make ending the HIV epidemic a reality.

This special edition of JLME centers on a novel proposal for a national PrEP access program with the potential to break through a failed status quo.

In Brazil, the normative landscape around advertising is complex, not the least because of limitations inherent to dispute resolution mechanisms. Focusing on unhealthy food and beverages, this case study identifies some challenges and opportunities around advertising restrictions, including in relation to freedom of speech.

This chapter explores the tension between public health protection and the freedom of commercial expression from a Commonwealth Caribbean perspective, using Barbados and Jamaica as case studies. First, it assesses the scope of the right to freedom of expression. Second, it discusses the extent to which public health protection may be invoked to restrict the right. The authors conclude that Commonwealth Caribbean states can justifiably restrict commercial speech about tobacco products and unhealthy food and beverages.

The U.S. has the tools to end the HIV epidemic, but progress has stagnated. A major gap in U.S. efforts to address HIV is the under-utilization of medications that can virtually eliminate acquisition of the virus, known as pre-exposure prophylaxis (PrEP). This document proposes a financing and delivery system to unlock broad access to PrEP for those most vulnerable to HIV acquisition and bring an end to the HIV epidemic.

The First Amendment to the US Constitution protects commercial speech from government interference. Commercial speech has been defined by the US Supreme Court as speech that proposes a commercial transaction, such as marketing and labeling. Companies that produce products associated with public health harms, such as alcohol, tobacco, and food, thus have a constitutional right to market these products to consumers. This article will examine the evolution of US law related to the protection of commercial speech, often at the expense of public health. It will then identify outstanding questions related to the commercial speech doctrine and the few remaining avenues available in the United States to regulate commercial speech including the use of government speech and addressing deceptive and misleading commercial speech.