Two Years On From A “Landmark” Abortion Decision in Kenya

Joelle Boxer Leave a comment

Two years ago, the Kenyan High Court in Malindi decided PAK and Salim Mohammed v. Attorney General et al., affirming that the constitutional right to abortion is “fundamental.”

Approximately 2,600 people lose their lives to unsafe abortion in Kenya each year, with an additional 21,000 people requiring hospitalization. While the Kenyan Constitution, adopted in 2010, allows for abortion when the pregnant person’s life or health is at risk under Article 26(4), the Kenyan Penal Code still criminalizes it—a legal grey area creating “ambiguity, confusion, and stigma.

This article will describe the PAK decision and analyze it in line with trends in transnational abortion law.

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Salus Populi: Training the Judiciary in the Social Drivers of Health

The Petrie-Flom Center Staff Leave a comment

By Elaine Marshall, Isabel Geisler, L. Virginia Martinez, Krystal Abbott, and Katherine Hazen

Social drivers of health (SDOH), sometimes known as the social determinants of health, are factors in the social environment that shape individual and population health, including poverty, racism, housing, education, and employment. When judges decide cases that impact these social factors, their rulings can have important health implications. While cases impacting the SDOH can be landmark Supreme Court cases, such as the ruling on the CDC’s eviction moratorium during the COVID-19 pandemic, judges also make decisions on a daily basis that can affect the SDOH and thereby health. Take, for example, a child welfare case out of New York, In re Brittany T, 852 N.Y.S.2d 475 (N.Y. App. Div. 2008), where the issue before the judge was whether a family willfully and without just cause violated orders meant to support their child’s health through diet and exercise. The order required the family to use all resources available to ensure the well-being of the child, enroll the child at their own cost in a local gym and attend it at least 2-3 times a week, and actively and honestly participate in a nutrition program.

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Cell Therapies and their Legal Discontents

Adithi Iyer Leave a comment

In February, the news broke that the Food and Drug Administration (FDA) had approved a “first of its kind” new cancer therapy. Iovance’s AMTAGVITM, the subject of the approval, is a personalized immunotherapy for advanced melanoma. To be treated, adult patients who are ineligible for surgery or have metastatic disease provide their tumor cells to their medical team. Tumor-attacking T-cells are isolated from the sample, grown and multiplied in-lab, and re-infused into the patients for a turbo-charged immune response that, according to clinical trial data, have shown promise in shrinking patients’ tumors. This drug joins a list of others that work something like this: Patients provide cell samples, which are then isolated and modified or expanded in-lab, and then eventually infused back into their bodies. This general patient experience, though, indicates a different model from what we have seen before. These “living drugs” use your own cells, but better, to fight these daunting battles.

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Protecting Health Privacy is a Royal Pain

Bobby Stroup Leave a comment

Heightened Scrutiny of Your Royal Highness

On Sunday, March 10, tabloids were in quite a frenzy when the British royal family published a photoshopped picture of Catherine, princess of Wales. The hubbub was extra hubbubbly, because this was the first official photo after the princess had abdominal surgery this past January. The order of events caused some people to speculate the edits indicated there was something to hide about the princess’s health status.

Shortly after the public reaction, the princess issued an apology for the edits. Sadly, less than two weeks later, the rumors were confirmed to be true: Princess Catherine did have a health problem. She had been diagnosed with cancer and had commenced preventative chemotherapy. As part of this announcement, Princess Catherine bravely encouraged the public, “For everyone facing this disease in whatever form, please do not lose faith or hope. You are not alone.” Read More

EU and US Regulatory Challenges Facing AI Health Care Innovator Firms

The Petrie-Flom Center Staff Leave a comment

 

 

 

By Suzan Slijpen, Mauritz Kop & I. Glenn Cohen

 

 

 

1. Introduction: A Fragmented AI in Healthcare Regulatory Landscape

In the past few years, we have witnessed a surge in artificial intelligence-related research and diagnostics in the medical field. It is possible that in some fields of medicine in the future AI tools used in diagnostics will generally perform far better than a human clinician. Prime examples of this can be found in radiology, particularly in the detection -and even the prediction- of malignant tumors.

Although the actual development of a clinically usable, deployable deep-learning algorithm is a challenge in and of itself, we have moved from an early period where there was not enough guidance as to ethical and other issues to an era where many guidelines have proliferated. While one might ordinarily say “let a thousand flowers bloom,” the fact that they partially overlap, sometimes diverge, and are often written at different levels of generality make it difficult for well-meaning companies to keep up. This is specifically the case for innovative firms who aim to bring their product into the European market.

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Insurance Coverage for Psychedelic Therapy

Vincent Joralemon Leave a comment

By Vincent Joralemon

As therapies using drugs like MDMA, psilocybin, and LSD advance through the FDA research and approval pipeline, patients should be prepared for steep price tags attached to these procedures. For example, experts estimate MDMA-assisted therapy for PTSD will cost upwards of $12,000 per patient.

These high costs highlight the need for comprehensive insurance coverage because many of those experiencing symptoms of conditions like PTSD also frequently lack the resources to pay for such treatments. Looking at how the current system works, including presently available psychedelic therapies, can help to inform coverage policies moving forward.

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Silver Spring, MD, USA - June 25, 2022: The U.S. Department of Health and Human Services (HHS), U.S. Public Health Service (USPHS) and FDA logos are seen at the FDA headquarters, the White Oak Campus.

The FDA Backdoor to MDMA Rescheduling

Vincent Joralemon Leave a comment

By Vincent Joralemon

MDMA (also known as the club drug “molly” or “ecstasy”) is a Schedule I controlled substance — the most restrictive drug class with the most severe criminal consequences linked to it. But, perhaps not for long.

A recent effort to get MDMA approved by the U.S. Food and Drug Administration (FDA) for post-traumatic stress disorder (PTSD) means the drug may be rescheduled, which will lead to substantially decreased regulations attached to it. This provides a compelling model for efforts to decriminalize and destigmatize other substances moving forward.

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figurine with a void shape of a child and family of parents with a child. Surrogacy concept.

Regulating International Commercial Surrogacy

Hannah Rahim Leave a comment

By Hannah Rahim

In January 2024, Pope Francis called for a universal ban on surrogacy as a threat to global peace and human dignity, claiming that the practice is a “grave violation” of the mother and child’s dignity and based on the “exploitation of situations of the mother’s material needs.” Surrogacy raises complex ethical and legal issues, particularly in cases of international surrogacy, where people seek surrogacy services from another country. There is currently no regulation of international surrogacy. Creating such regulation is important to allow appropriate access to surrogacy services while mitigating its harmful consequences.

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Stethoscope on Ghana flag.

Dr. Eunice Brookman-Amissah: A Pioneer in Safe Abortion Law Reform

Joelle Boxer Leave a comment

By Joelle Boxer

Late last year, Dr. Eunice Brookman-Amissah won the Right Livelihood Award, also known as the “Alternative Nobel Prize,” for her pioneering efforts to improve safe abortion access in sub-Saharan Africa.

According to Dr. Brookman-Amissah, of the 36,000 deaths that occur globally due to unsafe abortion, almost 24,000 are in sub-Saharan Africa. “That was a totally unacceptable state of affairs,” she said, “given the fact that nobody, absolutely no woman has to die from a totally treatable and manageable cause.” Her advocacy work is credited with contributing to a 40% reduction in deaths from unsafe abortion in the region since 2000.

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