Person hands keys into another person's outstretched hand.

We May Not ‘Own’ Our Bodies. Should We?

By Adithi Iyer

As the provision of human tissue leaves the research realm and becomes a bona fide consumer transaction, our legal responses to these developments will be most effective when we know what we want to protect, and how.

Perhaps the most famous discussion around tissue “donation” comes from the story of Henrietta Lacks and her family. Ms. Lacks is the namesake and unknowing donor of HeLa cells, and subject of the Rebecca Skloot bestseller, The Immortal Life of Henrietta Lacks. In a settlement obtained just this past summer with manufacturing giant ThermoFisher, the Lacks estate (Ms. Lacks herself died of an aggressive cervical cancer in 1951) obtained a confidential payment for the unconsented taking of her cells for research. The settled case was built on an unjust enrichment claim, and while this wasn’t decided on the merits, it raises the question of whether a provision of tissue is a transfer of value. If so, what are our ownership stakes in that value? Read More

Person filling syringe from vial.

Public Health Emergencies and Human Rights Principles: A Solidarity Approach

By Anne Kjersti Befring and Cecilia Marcela Bailliet

  1. Introduction

The COVID-19 pandemic posed a grave threat to humanity and revealed the need for a new approach to improve transnational cooperation within the global health system and new perspectives on solidarity addressing the cross-border spread of infection and distribution of vaccines.

The Principles and Guidelines on Human Rights and Public Health Emergencies (“the Principles”), developed by the Global Health Law Consortium and the International Commission of Jurists, set forth a human rights-based solidarity approach that can provide a basis for implementing the obligations of States and responsibilities of Non-State actors to achieve the goal of limiting the harmful effects of serious health crises.

Read More

Hundred dollar bills rolled up in a pill bottle

Ketamine is the New Viagra

By Vincent Joralemon

Spravato, the first FDA-approved psychedelic therapy, just outsold Viagra. Johnson & Johnson’s ketamine-based formulation generated $183 million in Q3, surpassing Pfizer’s erectile dysfunction (ED) drug, which earned $110 million over the same period. Remarkably, a therapeutic made from ketamine, once dismissed as a “club drug” or “horse tranquilizer,” now sells more than one of the most notable 21st-century pharmaceuticals. 

Yet, these two drugs have more in common than meets the eye, and the path Spravato has taken looks strangely similar to that of Viagra. By looking at the journey traversed by Viagra over the past twenty years, we can predict where Spravato (and other psychedelic therapies) are headed.

Read More

Group of Diverse Kids Playing in a Field Together.

Securing a Place for Children’s Rights in Public Health Emergencies

By Sheila Varadan, Ton Liefaard, and Jaap Doek

The Principles and Guidelines on Human Rights and Public Health Emergencies (Principles) make a significant contribution towards clarifying the scope of States’ legal obligations under international human rights law during public health emergencies. What is missing, however, is a specific and detailed discussion on the rights obligations and principles owed to children during public health emergencies. This leaves open the question of how States will guarantee respect for and protection of children’s rights in future public health emergencies, and what measures, if any, will be taken to ensure children are actively listened to and engaged with in the prevention of, preparedness for, and response to public health emergencies (PPRR).

Read More

scales on blue background.

Judging in the Pandemic – A Malawian Perspective

By Zione Ntaba

Malawi is not a stranger to public health crises in the last number of years, having faced a severe HIV epidemic and several cholera outbreaks continuing into 2023. Nevertheless, the onset of the COVID-19 pandemic caused a major panic in the country’s legal system and judiciary. COVID-19 brought to fruition a major ethical dilemma in ensuring the justice system’s continued functioning, while also protecting the lives of all those involved, and simultaneously ensuring the promotion and protection of human rights.

The constitutional mandate of ensuring access to justice in Malawi, a country which already struggles with effective and efficient justice delivery at the best of times, required urgent resolution, especially noting the potential of human rights violations arising from State responses to COVID-19 worldwide. Interestingly, in addition to the general need to safeguard the justice system as a whole, the pandemic itself brought before the courts issues relating to public health and human rights.

The prevailing principle in Malawi, as it is internationally, is for the judicial system to ensure that there exists an equal balance between the protection and promotion of human rights and the fair and just administration of justice. The courts in Malawi were called upon to rise above the political bureaucracy, to ensure judicial impartiality when dealing with pandemic-related issues. This was crucial in a context in which political responses to the pandemic sometimes remained unquestioned or unchallenged. However, unless these principles — of human rights and fair administration of justice — were properly upheld by the courts, sadly they may have remained in the world of the metaphysical.

It is with this context in mind that I turn to reflecting on the Principles and Guidelines on Human Rights and Public Health Emergencies (“Principles”).

Read More

An ordinary classroom in an African school.

Two Years On: The Reversal of Tanzania’s Education Policies for Adolescent Mothers

By Joelle Boxer

In November 2021, Tanzania’s Ministry of Education reversed a policy preventing adolescent mothers from attending public schools. Two years on, research shows the movement for #ArudiShuleni (“Back to School”) requires continued support.

Prior to the policy change, an estimated 6,55015,000 Tanzanian girls and adolescents were forced out of school each year due to pregnancy, while thousands more were subject to coercive pregnancy testing. The reversal has fundamental implications at the intersection of rights to sexual and reproductive health care and education.

This article will review the expulsion policy, efforts leading to its reversal, and the government’s recent re-entry guidelines, with a focus on the driving role of civil society.

Read More

President Joe Biden at desk in Oval Office.

What’s on the Horizon for Health and Biotech with the AI Executive Order

By Adithi Iyer

Last month, President Biden signed an Executive Order mobilizing an all-hands-on-deck approach to the cross-sector regulation of artificial intelligence (AI). One such sector (mentioned, from my search, 33 times) is health/care. This is perhaps unsurprising— the health sector touches almost every other aspect of American life, and of course continues to intersect heavily with technological developments. AI is particularly paradigm-shifting here: the technology already advances existing capabilities in analytics, diagnostics, and treatment development exponentially. This Executive Order is, therefore, as important a development for health care practitioners and researchers as it is for legal experts. Here are some intriguing takeaways:  Read More

Bill of Health - Gavel on mask during pandemic, class action lawsuits during pandemic

Old Dogs and New Tricks: A Case for the Principles and Guidelines on Human Rights & Public Health Emergencies

By Nerima Were and Allan Maleche

Taking into account our experiences as human rights lawyers working in Kenya during the COVID-19 pandemic, in this article we briefly analyze the Principles and Guidelines on Human Rights and Public Health Emergencies (the Principles) and make a case for their utility in guiding State measures to prepare for, prevent, and respond to future pandemics consistently with international human rights law and standards.

Read More

Suboxone.

Five Opportunities to Use the Law to Address Persistent OUD Treatment Gaps 

By Jon Larsen and Sterling Johnson

People who need opioid use (OUD) treatment in the United States are often not receiving it — at least two million people with OUD are experiencing a treatment gap that prevents or hampers their ability to receive life-saving care and support. This reality reflects structural, policy, and legal misalignments common to the entire U.S. health care system, but that are especially present for behavioral health needs like substance use, and are exacerbated by other challenges related to stigma, lack of employment, and fragmented or nonexistent care coordination.  

With support from the Foundation for Opioid Response Efforts (FORE), public health law experts from Indiana University McKinney School of Law and the Temple University Center for Public Health Law Research at the Beasley School of Law recently embarked on a systematic review of U.S. drug policy using a whole-of-government (W-G) approach to assess where these misalignments are occurring among different agencies at the same level of government (referred to as horizontal W-G), and across different levels of government (referred to as vertical W-G). It ultimately provides a tool to address these misalignments directly. 

Read More