Tag: covid vaccine

Patient receives Covid-19 vaccine.

What’s the Law on Vaccine Exemptions? A Religious Liberty Expert Explains

The Petrie-Flom Center Staff Leave a comment

This article is republished from The Conversation under a Creative Commons license. Read the original article.

By Douglas Laycock, University of Virginia

For Americans wary of COVID-19 vaccine mandates, like the sweeping requirements President Joe Biden announced Sept. 9, 2021, it seems there are plenty of leaders offering ways to get exemptions – especially religious ones.

No major organized religious group has officially discouraged the vaccine, and many, like the Catholic Church, have explicitly encouraged them. Yet pastors from New York to California have offered letters to help their parishioners – or sometimes anyone who asks – avoid the shots.

These developments point to deep confusion over how to win a religious exemption. So what are they, and is the government even required to offer the exemptions in the first place?

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doctor holding clipboard.

Preventing Misuse of COVID-19 Vaccine Medical Exemptions

Ross D. Silverman 10 Comments

By Ross D. Silverman and Gabriel T. Bosslet

As COVID-19 vaccination mandates become increasingly common, we can expect exemption requests (and misuse) to become increasingly widespread, too.

Most entities requiring vaccination mandates or proof of vaccination upon entry may offer limited grounds upon which an individual may request an exemption, usually based upon religious beliefs or medical reasons. Recent history with childhood immunization programs shows less rigorously-structured and -enforced vaccination exemption policies are vulnerable to increased usage, relative to narrower or more stringently-monitored programs. That history also shows there is a possibility some health care licensees may be willing to support individuals seeking to circumvent COVID-19-related requirements through offering questionable medical exemptions.

Entities imposing COVID-19 vaccination mandates, and state health care licensure boards, can take several simple but significant steps to counter misuse of medical exemptions and better protect communities from COVID-19. These safeguards also can decrease the temptation for licensed health professionals to recklessly undermine critical, lawful, evidence-driven public health efforts.

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Access-to-Medicines Activists Demand Health Justice During COVID-19 Pandemic

The Petrie-Flom Center Staff Leave a comment

By Brook K. Baker 

It was apparent from the outset of the COVID-19 pandemic that a business-as-usual approach — perpetuating the biopharmaceutical industry’s intellectual property-based monopolies and allowing artificial supply scarcity and nationalistic hoarding by rich countries — would result in systemic failure and gross inequity.

The world had seen it all before, from the Big Pharma blockade of affordable antiretrovirals to treat HIV/AIDS, to the hoarding of vaccines by the global north during the H1N1 bird flu outbreak in 2009 and its stockpiling of Tamiflu.

Activists in the access-to-medicines movement quickly mobilized to combat the threat of vaccine/therapeutic apartheid.

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Person filling syringe from vial.

Religious Exemptions to Vaccines and the Anti-Vax Movement

Dorit Reiss 13 Comments

By Dorit Rubinstein Reiss

Two major problems with granting religious exemptions to vaccine mandates are that they are very hard to police, and that they are routinely gamed.

Religious freedom is a core value in the United States. This makes policing religious exemptions to vaccination hard – and rightly so. The government policing people’s religion raises a number of thorny issues.

The problem is that the same people who eagerly promote anti-vaccine misinformation are just as eager to misuse religion to avoid vaccinating, and have no hesitation or compunction about coaching others to do the same. And without policing, it is easy for those misled by anti-vaccine misinformation to use the religious exemption.

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The Prospects for an IP Waiver Under the TRIPS Agreement

Timo Minssen Leave a comment

By Duncan Matthews and Timo Minssen

The informal meeting of the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) Council today, July 6, 2021, focuses international attention once more on prospects for a waiver of the TRIPS Agreement in response to the COVID-19 pandemic.

Regardless of whether an actual TRIPS waiver ultimately comes to pass, the real significance of these efforts lies in the increased focus they have placed on the role of IP and trade secrets in improving access and affordability, and scaling-up of manufacturing and supply of vaccines and other health-related technologies. These conversations have introduced the possibility of a rethinking of the relationship between IP, innovation, conservation, and access.

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

Ameet Sarpatwari Leave a comment

By Ameet Sarpatwari, 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 May. The selections feature topics ranging from an analysis of the impact of generic drug spikes on Medicaid spending, to an evaluation of where drugs are tested for FDA approval and subsequent time to marketing approval in these countries, to an assessment of how net prices of diabetes drugs are affected by brand competition. A full posting of abstracts/summaries of these articles may be found on our website.

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Photo of person with gloved hand holding flask at lab bench.

US Support for a WTO Waiver of COVID-19 Intellectual Property – What Does it Mean?

Jorge Contreras Leave a comment

By Jorge L. Contreras

On May 5, 2021, U.S. Trade Representative Katherine Tai announced that the U.S. would support a “waiver of IP protections on COVID-19 vaccines to help end the pandemic” currently being discussed at the World Trade Organization (WTO). This announcement, representing a reversal of longstanding U.S. policy toward intellectual property, came as a welcome surprise to much of the world, but elicited strong negative responses from the pharmaceutical industry as stock prices of leading vaccine producers sank.

In the short time since the announcement was made, there has been a fair amount of speculation, hyperbole, and misinformation on the topic. In this post, I offer an explanation of what just happened, and my guess as to what its likely effects will be, bearing in mind that the situation is fast-moving and somewhat unpredictable.

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Syringe being filled from a vial. Vaccine concept illustration.

The COVID-19 Vaccine Patent Waiver: The Wrong Tool for the Right Goal

The Petrie-Flom Center Staff Leave a comment

By Ana Santos Rutschman and Julia Barnes-Weise

As the toll of COVID-19 continues to increase in many countries in the Global South, there has been a renewed push to address the problem of vaccine scarcity through a waiver of patent rights. Calls for waivers have been recurring throughout the pandemic, from formal proposals introduced in 2020 by some of the larger developing economies (India and South Africa), to op-eds in mainstream media, and editorials in scientific publications, such as Nature. This push gained momentum in early May 2021, just before the meeting of the World Trade Organization’s General Council.

Waiver proposals have attracted the support of prominent names in public health. Dr. Tedros Adhanom Ghebreyesus, the Director-General of the World Health Organization, endorsed patent waivers as a tool to address the current vaccine scarcity problem in an article titled Waive Covid Vaccine Patents to Put World on “War Footing.” Others — including, most recently, Dr. Anthony Fauci — have been critical of waiver proposals.

In this piece, we explain the mechanics of patent waivers and argue that waivers alone are the wrong policy tool in the context of the COVID-19 pandemic. We agree with supporters of the waivers in their ultimate goal — that of scaling up the manufacturing of COVID-19 vaccines, and then distributing them according to more equitable models than the ones adopted thus far. However, we doubt that the particular types of goods at stake here can be easily replicated and produced in substantially larger quantities simply through a waiver of intellectual property rights.

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Vaccine hopes collide with vaccine denial

The Petrie-Flom Center Staff Leave a comment

By Bailey Kennedy, J.D.

Americans have been able to feel a little more hopeful recently as vaccines begin to roll out across the country. But in some jurisdictions, officials have been surprised by how many people have refused to be vaccinated. As of the beginning of February 2021, about 24% of adults indicated that they would probably or definitely not allow themselves to be vaccinated. While we might hope that these numbers will go down as public health officials and others conduct outreach efforts in communities where vaccine refusal is particularly high, there will probably always be some percentage of people who will refuse to be vaccinated.

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