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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Bill of Health - Globe and vaccine, covid 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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close up of hands signing contract.

Using Contracts to Lessen Inequities in Access to Medicines in Pandemics and Epidemics

By Sapna Kumar and Ana Santos Rutschman

Research funding contracts can help to safeguard against profound inequities in global allocation and distribution of lifesaving diagnostics, drugs, and vaccines.

During large transnational public health crises, global demand soars for diagnostics, drugs, and vaccines. Although some of these products can be developed within compressed timelines, global production capacity remains limited. Against a backdrop of product scarcity, wealthier countries can out-bid their lower-income counterparts and capture most of the supply during the early stages of pandemics and epidemics. This leaves the vulnerable low-income populations waiting months, or even years, for their turn.

This predictable, inequitable pattern can be held off before the next pandemic. At the research and development (R&D) stage, government funders can bind producers to equity goals through targeted contractual provisions, as we explain in a recently-published Nature Biotechnology article. We summarize our proposals in the following sections. Read More

WASHINGTON MAY 21: Pro-choice activists rally to stop states’ abortion bans in front of the Supreme Court in Washington, DC on May 21, 2019.

Tennessee on My Mind: Reflections on the Reinstated Abortion ‘Reason Bans’

By Cathy Zhang

In February, the Sixth Circuit Court of Appeals issued a one-sentence order allowing Tennessee’s “reason ban” abortion restrictions to go into effect. The restrictions make it a felony for a provider (or any other person) to perform an abortion if the provider “knows” the patient is seeking an abortion on account of the fetus’s sex, race, or probable diagnosis of Down syndrome.

The court below had previously enjoined the Tennessee law, which also includes a pre-viability abortion ban. This order leaves the previability ban in place while lifting the injunction on the reason bans; the reason bans will remain in effect until the Supreme Court makes a further ruling on abortion in Dobbs. In her dissent, Circuit Judge Karen Nelson Moore charged that the court’s order “subvert[s] the normal judicial process” and reflects a growing tendency of federal courts “to delay the adjudication of laws that significantly impair constitutional rights.”

Numerous health organizations, racial justice groups, and disability advocates alike have warned against the harms that the reason bans will inflict on people of color and disabled persons. Statements from these groups, along with 19 states and the District of Columbia, a host of constitutional law scholars, and other amici make clear that the law’s purported concern for marginalized groups belies an effort to restrict abortion access at the expense of pregnant people’s health and constitutional rights.

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Physical therapist helps person in wheelchair.

Balancing Patient Rights and Costs in Medical Malpractice Claims

By John Tingle and Amanda Cattini

The issue of the high and increasing costs of clinical negligence (medical malpractice) in the National Health Service (NHS) in England has long been a contentious one. There are common themes in the debate. The economic arguments supporting reform explain that the NHS is spending a considerable amount of money out of its health budget on malpractice claims, which otherwise could be put into front line health care services.  While the economic arguments are important, others contend that the patient’s voice must be heard more widely in the reform debate. They emphasize that it is important to look deeper as to what compensation means to victims of clinical negligence, and caution against unnecessarily fettering patients’ reasonable pursuit of claims.

Two recently published reports provide several key perspectives on these issues.

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Traffic light.

The COVID-19 Pandemic, the Failure of the Binary PHEIC Declaration System, and the Need for Reform

This post was originally published on the Verfassungsblog as part of our joint symposium on international pandemic lawmaking.

By Ilja Richard Pavone

The COVID-19 pandemic has raised unprecedented challenges for the global health framework and its long-term consequences are not yet in full sight. The legal and institutional regime aimed at preventing and controlling the spread of infectious diseases, grounded on the International Health Regulations (IHR) was heavily criticized.

The alarm mechanism based on the declaration of Public Health Emergency of International Concern (PHEIC), in particular, has been severely tested. A PHEIC is an extraordinary event that constitutes a potential public health risk through the international spread of a disease outbreak. The WHO Director-General bases his decision to “ring the bell” upon the technical advice of an Emergency Committee (EC) carrying out “an assessment of the risk to human health, of the risk of international spread, and of the risk of interference with international traffic.”

A PHEIC, then, is declared only when an event is already sufficiently acute and has started to spread internationally. It is not an early warning, but a formal alert, and in the case of COVID-19 it was issued with extreme delay only on 30 January 2020, (one month after notification of early cases by the Chinese government), after Beijing had already adopted quarantine measures around the city of Wuhan, and draconian measures to curb the spread of the disease in the country had been announced.

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The Mexican-American border, with some construction still ongoing on the American side.

Pandemics without Borders? Reconsidering Territoriality in Pandemic Preparedness and Response Instruments

This post was originally published on the Verfassungsblog as part of our joint symposium on international pandemic lawmaking.

By Raphael Oidtmann

The COVID-19 pandemic has (yet again) disclosed that, in contemporary international law, the notion of borders resembles a distinct emanation of legal fiction, i.e., “something assumed in law to be fact irrespective of the truth or accuracy of that assumption.” This characterization of international borders holds particularly true with a view towards managing, containing, and countering the spread of highly contagious pathogens: especially in the context of responding to the global COVID-19 pandemic, it has hence become apparent that the traditional conception of borders as physical frontiers has been rendered somewhat moot. On the contrary, the pandemic experience has proven that a more flexible, fluid, and functional understanding of (international) borders might be warranted, also with a view towards (re-)conceptualizing international health law.

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Geneva, Switzerland - December 03, 2019: World Health Organization (WHO / OMS).

Towards Member-driven International Pandemic Lawmaking

This post was originally published on the Verfassungsblog as part of our joint symposium on international pandemic lawmaking.

By Ching-Fu Lin and Chuan-Feng Wu

The COVID-19 pandemic has blatantly exposed the flaws of the World Health Organization (WHO) and its International Health Regulations (IHR) in addressing cross-border communicable diseases. Commentators have examined the IHR’s decades of struggle in fulfilling its objectives to control cross-border pandemics such as COVID-19, pointing out problems over the level of obligation, precision of language, delegation of power, settlement of dispute, and lack of enforcement power, among others. What has been overlooked, however, is the crucial question of whether the institutional design of the IHR enables the WHO and its Member States to deliver good global pandemic governance.

We argue that the IHR is ill-designed: its rules and mechanisms are disproportionately tied to the Director General’s (DG) exercise of power, rendering insufficient member access to and participation in core decision-making and greater tendency of regulatory capture. For example, the IHR failed to facilitate the timely declaration of a Public Health Emergency of International Concern (PHEIC) due to the DG’s and the Emergency Committee’s misinterpretation and misapplication of rules allegedly driven by political considerations. On 23 January 2020, even when COVID-19 cases had already been found outside of China, thereby indicating the risk of cross-border transmission (IHR Article 12(4)(e)), the second meeting of the Emergency Committee decided to confine the definition of “international spread” to “having actual local spread of COVID-19 in a country beyond China,” instead of “having the potential for, or a risk of, cross-border transmission,” and refused to declare a PHEIC. The WHO is also criticized for abusing its bureaucratic influences to further the agendas of individual Member States like China, letting politics override science.

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Society or population, social diversity. Flat cartoon vector illustration.

The Right to Participation in Global Health Governance: Lessons Learned

This post was originally published on the Verfassungsblog as part of our joint symposium on international pandemic lawmaking.

By Sara (Meg) Davis, Mike Podmore, and Courtenay Howe

What should the role of those most affected by pandemics be in future pandemic governance and co-ordination mechanisms?

Drawing on human rights standards and principles, and on existing structures in the HIV, TB and malaria sectors, we argue that the human right to participation should extend to permanent seats and votes for civil society and affected communities on governance boards.* Our argument is informed by an analysis by STOPAIDS, Aidsfonds, CSSN and Frontline AIDS, by consultations led by STOPAIDS, and by the examples of the Global Fund to Fight AIDS, TB and Malaria (“the Global Fund”), Unitaid, and the Access to Covid Technologies-Accelerator (ACT-A).

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