Vaccines.

COVID-19, Patents, and Trade Secrets

By David Gindler & Jasper L. Tran

Has the worldwide distribution of COVID-19 vaccines been impacted by patent rights? David Gindler, head of IP at Milbank LA, and Jasper L. Tran, senior associate at Milbank LA, argue that the story is much more complicated — making vaccines involves much more than waiving patents, they explain.

The following article, which is adapted from the authors’ conversation with Vanderbilt Law Review podcast editor Jacob Goodman on Hot Topics in Intellectual Property Law, provides an overview of the complicated intellectual property landscape associated with COVID-19 vaccines and therapeutics.

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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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Brooklyn, New York, United States - JUNE 13 2021: Protest in Brooklyn, NY for trans youth rights.

Misleading, Coercive Language in Bills Barring Trans Youth Access to Gender Affirming Care

By Arisa R. Marshall

On Friday, a federal judge temporarily enjoined part of a new Alabama law that would make it a felony for physicians to provide gender-affirming care to trans youth. The law had been in effect for less than a week.

This is only the most recent development relating to a raft of anti-trans legislation sweeping the country. More than twenty bills that would impose life-changing healthcare restrictions on transgender children have been introduced in statehouses nationwide over the past two years, threatening the wellbeing of transgender youth and communities. Most of these bills aim to entirely ban gender-affirming medical care for minors, including surgeries, prescription puberty blockers, and hormone replacement therapies.

These laws are detrimental to the mental, physical, and social health of children. They are dismissive of the experiences of transgender children and teenagers, misleading, and manipulative.

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Pill pack.

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 March. The selections feature topics ranging from a discussion of patient assistance programs and the Anti-Kickback Statute, to an analysis of the effects of state opioid prescribing laws on the use of opioids and other pain treatments, to an evaluation of the association between regulatory drug safety advisories and changes in drug use. A full posting of abstracts/summaries of these articles may be found on our website.

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Woman experiencing headache lying in bed in darkened room.

Small Doses of Psychedelics for Cluster Headaches

By Bob Wold

One understudied condition for which small doses of psychedelic substances such as psilocybin may be beneficial is cluster headache.

As founder and executive director of the advocacy group Clusterbusters, I have seen firsthand, as a patient and an activist, that, despite its modest name, cluster is far from “just” a headache. It is a chronic pain condition that lasts “on” and “off” for months or years, often with no hint as to its origin. Estimates suggest that one in 1,000 people – which equates to over 332,000 Americans – suffer from cluster headache.

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pieces of paper with chemical structures, micro dosing concept.

Findings from the Microdose.me Study: A Large Scale Observational Study of Psychedelic Microdosing

By Joseph Rootman

Public uptake of psychedelic microdosing has outpaced research on the practice, which has left gaps in our understanding. In order to help fill some of these gaps in the scientific literature, our clinical psychology research team at the University of British Columbia has launched the Microdose.me study along with a team of international researchers and partners. This symposium contribution provides an overview of our findings to date, and offers suggestions for future microdosing research.

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Human heart with blood vessels. 3d illustration

Safety First: Potential Heart Health Risks of Microdosing

By Kelan Thomas

Given the current evidence for psychedelic “microdosing,” the risks may outweigh the benefits for many people.

This is because there is compelling theoretical evidence to suggest prolonged and repeated microdosing may cause valvular heart disease (VHD), and only weak survey evidence that it provides the benefits microdosers typically seek, such as enhanced cognition, or relief from depression and anxiety.

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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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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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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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