A male pharmacist is examining a drug from a pharmacy inventory.

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Alexander Egilman, Aviva Wang, andAaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.

Below are the citations for papers identified from the month of April. The selections feature topics ranging from a discussion of manufacturer’s restricted delivery of 340B drugs to contract pharmacies and ensuing litigation, to an analysis mapping the European patent landscape for medical uses of known products, to an evaluation of the clinical benefit of novel drugs approved in the U.S. from 2018-2019. A full posting of abstracts/summaries of these articles may be found on our website.

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Hand holding glass ball with inverted image of surroundings reflected in ball.

Flipping the Script: Adoption and Reproductive Justice

By Kimberly McKee

Adoption is a reproductive justice issue. Pretending otherwise ignores how adoption is used as a red herring in anti-abortion arguments. A recent invocation of this faulty logic occurred in Justice Amy Coney Barrett’s questions during the November 2021 oral arguments in Dobbs v. Jackson Women’s Health Organization. Coney Barrett’s statements implied that the option to relinquish infants vis-à-vis adoption rendered abortion availability unnecessary. This line of thinking is one with which I am familiar, as both a Korean international, transracial adoptee, and a critical adoption studies scholar. 

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gavel.

Adoptee Rights and Adoption Annulment

By Gregory Luce

Annulling or legally ending an adoption is not a new concept, but it has rarely applied to the benefit of adopted people. Instead, informal practices, as well as specific legal frameworks dating back more than 100 years, have long-supported a “right of return” policy for adoptive parents who no longer feel an adoption is beneficial or even desired.

Activists within today’s adoptee rights movement, however, are working to establish a right to end a person’s own adoption by building on what has long existed in the law for adoptive parents, but refocusing it on the specific demands for autonomy of adopted people, particularly those who do not view adoption to be in their best interests.

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Austin, TX, USA - Oct. 2, 2021: Two women participants at the Women's March rally at the Capitol protest SB 8, Texas' abortion law that effectively bans abortions after six weeks of pregnancy.

Organizing and Activism of Adopted and Displaced People

By Lina Vanegas

I am a transracial and transnational displaced person. I was separated from my country, language, and culture and taken to Michigan, which has no connection to me or my ancestors. I was taken there to create a family for strangers who had the privilege and resources to buy me. I had family in Colombia and I was far from being a true orphan. I was bought in Bogota, Colombia and sold to a white couple living in the Midwest in 1976. 

I use the word “displaced” intentionally, because the word “adopted” does not define my lived experience in an accurate way. The word “adopted” is language that was created by the child welfare-industrial complex, also known as the adoption industry. I do not subscribe to any of the constraints or barriers that they attempt to put onto my life with their language choices. Using the word “displaced” defines the intentional separation from my family by the child welfare-industrial complex. 

My lived experience has informed who I am and has inspired and motivated the work that I do online and in the world. It is very rare that adopted and displaced people’s lived experiences are seen, heard, validated, centered, and believed, so my mission is to do that online, on my podcast, Rescripting The Narrative, and in the work that I do as a social worker and with the organization Adoptees for Choice.

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CABA, Buenos Aires / Argentina; March 9, 2020: international women's day. Women shouting slogans in favor of the approval of the law of legal, safe and free abortion.

Lessons from Latin America as the U.S. Regresses on Reproductive Rights

By Alma Beltrán y Puga

As the Supreme Court of the United States moves closer to overturning Roe and Casey, looking south to Latin America highlights the egregiousness of these developments.

Recently, Mexico and Colombia have provided landmark decisions that recognize a woman’s freedom to choose over her body is a fundamental right. Both rulings use strong arguments to frame abortion as protected under a constitutional umbrella that enshrines the right to equality and non-discrimination, and to health and reproductive freedom, as fundamental liberties.

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KYIV, UKRAINE - Feb. 25, 2022: War of Russia against Ukraine. A residential building damaged by an enemy aircraft in the Ukrainian capital Kyiv.

Misplaced Skepticism on Accountability for War Crimes Against Health Care in Ukraine

By Leonard Rubenstein

Russian attacks on hospitals, ambulances, and health workers in Ukraine — including more than 180 attacks confirmed by the World Health Organization, and double that number reported by the Ministry of Health — have gained global attention. In one case, viral photos document the evacuation of pregnant women, including one on a stretcher who later died, from a maternity hospital in Mariupol destroyed by Russian shelling. It is likely that investigations will show that many of these acts are war crimes. Accountability for these crimes must be pursued.

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Sign at train station in Berlin that describes free support for pet owners coming from Ukraine.

Ethical Challenges Associated with the Protection of Pets in War

(Photo: Sign at the central train station in Berlin (Berlin Hauptbahnhof) that offers free support for pet owners coming from Ukraine. Courtesy of Kristin Sandvik.)

By Kristin Bergtora Sandvik

Introduction

The care for animals rapidly became a part of the humanitarian narrative of the attack on Ukraine.

There are countless accounts of the efforts of activists, shelters and zoo staff to keep animals alive, as well as underground operations to get them to safety. And, as Ukrainians flee for their lives, they are frequently accompanied by their pets.

EU initiatives and advocacy efforts by animal rights groups pushed receiving countries to modify entrance requirements, waive fees, provide veterinary services, and shorten or eliminate quarantine times. The EU announced a special derogation in Regulation 2013/576, allowing the import of Ukrainian refugee pets without meeting standard requirements. Many governments have welcomed Ukrainian pets with or without their owners, and without documentation, rabies vaccine, and/or microchip.

Humanitarian action is typically human centric; this broad societal acceptance of pets as legitimate refugee companions, and the attendant rapid regulatory accommodations, are unique developments. In this blog, I draw on perspectives from disaster studies, international humanitarian law (IHL), refugee studies, and animal studies to articulate a set of ethical dilemmas around classification and policymaking that arise when pets are recognized as a humanitarian protection problem.

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Vaccine.

The Proposed TRIPS Compromise Risks Setting Several Bad Precedents

By James Love

On March 15, 2022, STAT published text of a proposed compromise at the World Trade Organization (WTO) to temporarily relax global standards for intellectual property for COVID-19. The original proposal tabled by India and South Africa in 2020 as IP/C/W/669 would have waived 40 articles of the WTO Trade Related Agreement on Intellectual Property Rights, known as the TRIPS.

The proposed compromise would allow for “the use of patented subject matter required for the production and supply of COVID-19 vaccines without the consent of the right holder to the extent necessary to address the COVID-19 pandemic, in accordance with the provisions of Article 31 of the Agreement, as clarified and waived.” In short, the compromise only waives a single 20-word paragraph in one article: the one dealing with exports under a non-voluntary authorization.

In general, there are no legal benefits to the proposal. Countries can already export a non-predominant share of vaccine production under the TRIPS agreement, with mechanisms that are broader regarding both exports and imports, available regardless of the technology, and permanent.

This note focuses on the practical risks the proposed agreement presents as a precedent.

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GHRP affiliated researchers.

Introducing the Global Health and Rights Project’s New Affiliated Researchers

(Clockwise from top left: Alma Beltrán y Puga, Luciano Bottini Filho, Ana Lorena Ruano, María Natalia Echegoyemberry)

By Alicia Ely Yamin and Chloe Reichel

Leer en español.

In the years before the pandemic, and especially since the pandemic began, there have been increasing calls to decolonize global health. Setting aside what Ṣẹ̀yẹ Abímbọ́lá rightly characterizes as the slipperiness of both the terms “decolonizing” and “global health,” these calls speak to the need to reimagine governance structures, knowledge discourses, and legal frameworks — from intellectual property to international financial regulation.

Global health law itself, anchored in the International Health Regulations (2005), purports to present a universal perspective, but arguably rigidifies colonialist assumptions about the sources of disease, national security imperatives, priorities in monitoring “emergencies,” and governance at a distance. The diverse tapestry of international human rights scholarship related to health is often not reflected in analyses of the field from the economic North. In turn, that narrow vision of human rights has also increasingly faced critiques from TWAIL, Law & Political Economy, and other scholars, for blinkered analyses that fail to challenge the structural violence in our global institutional order — which the pandemic both laid bare and exacerbated.

In an attempt to enlarge discussion of these important topics and amplify diverse voices, the Petrie-Flom Center is welcoming four new affiliated researchers to the Global Health and Rights Project (GHRP).

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Globe and vaccine.

COVID ‘Compromise’ on International IP Underscores Need for New Approach

By Cynthia M. Ho

The leaked compromise regarding a “waiver” of international intellectual property (IP) obligations under the TRIPS Agreement for World Trade Organization (WTO) members has met harsh criticism as a shadow of the original proposal to waive international obligations regarding patent, trade secret, and copyright obligations relating to any COVID vaccine, treatment, diagnostic, or personal protective equipment (PPE).

The compromise excludes diagnostics, treatments, and PPE. It only narrowly modifies compulsory licenses of patents covering COVID vaccines. Moreover, it imposes additional restrictions on use of compulsory licenses. But still, multinational pharmaceutical manufacturers have protested even these modest changes from the status quo, arguing that there is no IP problem that needs to be fixed.

Clearly there is a problem. It has taken 18 months since the original Indian and South African proposal to get to this limited compromise, while gross vaccine inequity between wealthy and poor countries continues. In addition, the leaked compromise between four WTO members is still being debated — and even if agreement can be reached, it needs agreement of over 100 other WTO members. We need a new approach.

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