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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POPLAR affiliated reseachers

Introducing Affiliated Researchers for the Project on Psychedelics Law and Regulation

(Clockwise from top left: Kwasi Adusei, Ismail Lourido Ali, Jonathan Perez-Reyzin, Dustin Marlan.)

We are excited to welcome our inaugural group of affiliated researchers for the Project on Psychedelics Law and Regulation (POPLAR). Through regular contributions to Bill of Health, as well as workshops and other projects, POPLAR affiliated researchers will share their expertise and perspectives on developments in psychedelics law and policy. We look forward to learning from and sharing their insights with our audiences. Keep an eye out for their bylines!

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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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Melbourne, Australia - 1st November 2021: A person wearing full PPE holds a vial of sotrovimab medicine covid-19 virus treatment. It is under an emergency use authorization to treat covid in Australia.

Litigation Challenges Prioritization of Race or Ethnicity in Allocating COVID-19 Therapies

By James Lytle

Recent guidance from the U.S. Food & Drug Administration (FDA) encouraged several states to adopt policies that prioritized race or ethnicity in the allocation of monoclonal antibody treatments and oral antivirals for the treatment of SARS-CoV-2.

The guidance proved to be highly controversial, prompting two states, Utah and Minnesota, to withdraw their guidance, and leading a third state, New York, to become the subject of two federal lawsuits that challenge the guidance’s legality: one (Jacobson v. Bassett) brought by a white, non-Hispanic Cornell Law Professor, William Jacobson, in the Northern District of New York (“Jacobson”) and a second (Roberts v. Bassett) initiated by Jonathan Roberts and Charles Vavruska, two white, non-Hispanic residents of New York City in the Eastern District (“Roberts”).

Public health and policy experts have published commentaries on the challenging issues underlying New York’s COVID treatment guidelines and others have offered more detailed guidance, including on this blog, on what criteria should be used in allocating scarce COVID treatments. What follows is focused on the litigation pending in New York and its potential impact on the broader issues at the intersection of the pandemic response and racial equity.

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LONDON, UNITED KINGDOM- 1 APRIL 2015: A newspaper rack holding several international newspapers, such as The International New York Times, USA Today, Irish Times, Londra Sera and Corriere Della Sera.

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

By Ameet SarpatwariBeatrice Brown, Aviva Wang, and Aaron 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 February. The selections feature topics ranging from an analysis of how the Bayh-Dole Act can be updated to promote innovation and affordable access to drugs developed using federal funds, to an examination of the upcoming reauthorization of the Prescription Drug User Fee Act and its implications for FDA regulation and policies, to a systematic review and meta-analysis of preapproval clinical testing of biosimilars used in the treatment of cancer. A full posting of abstracts/summaries of these articles may be found on our website.

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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

Healthcare concept of professional psychologist doctor consult in psychotherapy session or counsel diagnosis health.

A Precautionary Approach to Touch in Psychedelic-Assisted Therapy

By Neşe Devenot, Emma Tumilty, Meaghan Buisson, Sarah McNamee, David Nickles, and Lily Kay Ross

Amid accelerating interest in the use of psychedelics in medicine, a spate of recent exposés have detailed the proliferation of abuse in psychedelic therapy, underscoring the urgent need for ethical guidance in psychedelic-assisted therapies (P-AT), and particularly relating to touch and consent.

Acknowledging the need for such guidance, McLane et al. outline one set of approaches to touch in a recent Journal of Medical Ethics blog. However, we find their piece at odds with the available information in the fields of P-AT and psychotherapy. We explain three major concerns: consent and autonomy, risk mitigation, and evidence and reasoning. In our view, these concerns merit a precautionary approach to touch in P-AT, given the current state of research on touch-based interventions.

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Large pile of amber prescription pill bottles

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

By Ameet Sarpatwari, Alexander Egilman, Beatrice Brown, and Aaron 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 January. The selections feature topics ranging from a discussion of why state laws restricting mifepristone access may be subject to federal preemption, to an analysis of patents impacting the availability of biosimilars, to an evaluation of the hypothetical out-of-pocket costs of guideline-recommended medications for the treatment of older adults with multiple chronic diseases. A full posting of abstracts/summaries of these articles may be found on our website.

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Cigarettes.

Tobacco Issues Awaiting Robert Califf at the FDA

By Cathy Zhang

Yesterday, the Senate confirmed Dr. Robert Califf for his second, non-consecutive term as Commissioner of the U.S. Food and Drug Administration (FDA), bringing a drawn out and contentious process to a close. Califf will be the second-ever FDA Commissioner to serve non-consecutive terms, and the first to have been confirmed by the Senate on two separate occasions.

Prior to his first term as Commissioner during the Obama administration, Califf, a cardiologist, served as the FDA’s Deputy Commissioner for Medical Products and Tobacco.

In addition to fielding scrutiny over mifepristone access, reviewing opioid regulations, and handling COVID-19 vaccine and treatment approvals in the midst of a pandemic, Califf will be overseeing the FDA at a time when public health advocates are anticipating agency action on several tobacco issues.

Two major developments expected in this area include a menthol ban and greater regulation of e-cigarettes.

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Child with bandaid on arm.

Reflections on Procedural Barriers to Pediatric COVID Vaccine Access

By Fatima Khan

When news broke last week that Pfizer-BioNTech was submitting for Emergency Use Authorization (EUA) a two-dose COVID vaccine regimen for children under 5 to the U.S. Food and Drug Administration (FDA), many parents felt a glimmer of hope after a long time.

Up until a few days before, the public was expecting approval to possibly drag into summer. While the regimen would likely require a third dose, it became a possibility that children could start getting some level of protection as early as March. Finally children were acknowledged during a time when their needs have often been neglected or even ignored.

The shift in the FDA’s decision process is a critical moment to reflect on how we got here, and what we should strive for to ensure children aren’t repeatedly left behind amidst our new COVID reality.

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