ACCRA, GHANA: April 23, 2020 - The testing of samples for the coronavirus in a veterinary lab in Accra, Ghana.

Does It Really Matter How the COVID-19 Pandemic Started?

By Barbara Pfeffer Billauer

Throughout the COVID-19 pandemic, much air time and social media space has been allocated to the lab leak vs. natural spillover dispute regarding the origins of SARS-CoV-2.

To summarize briefly, the question is whether the pandemic was caused by a leak from a biosafety level (BSL) four lab in Wuhan, China, or whether it arose naturally as a consequence of a virus jumping from a bat to an animal and then to humans.

Given that the “truth” will likely never be known, and certainly not provable, the question becomes: is it important to seriously consider the lab leak theory?

The answer, I suggest, is an unabashed yes — but not for the reason you might think. The question is important prospectively, not retrospectively. Debating the origins of the COVID-19 pandemic is a fool’s errand. Considering laboratory accidents writ large, however, is important, as they remain a potent threat to international biosecurity.

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Bill of Health - Globe and vaccine, covid vaccine

Biotech Companies Are Opening Manufacturing Sites in Africa: Will This Help Vaccine Equity?

By Sarah Gabriele

Two pharmaceutical giants of the pandemic, Moderna and BioNTech, are taking steps for increasing the manufacturing capacity for the COVID-19 vaccine in Africa. Last March, Moderna announced its plan to set up a manufacturing facility in Kenya to produce messenger RNA (mRNA) vaccines, including COVID-19 shots. Similarly, in 2021, BioNTech started planning its own manufacturing plant in Africa, which will be composed of modular shipping containers.

Measures to address global vaccine inequity could not come sooner. As of December 15, 2022, only 34% of the population in Africa has received at least one dose of the COVID-19 vaccine, with Moderna and BioNTech having provided fewer doses compared to Oxford-AstraZeneca and Johnson & Johnson. After failing to successfully deliver vaccines equitably during the first two years of the pandemic, Moderna and BioNTech appear now to be taking steps to shoulder greater responsibility for vaccine equity.

However, if companies are ethically required to address the availability of vaccines, these well-intended efforts might still fail to fulfill their moral obligations. Indeed, while the construction of these new sites might sound like great news for fostering the delivery of vaccines in low- and middle-income countries, we should be aware that these manufacturing sites, as well as the existence of manufacturing capacity, might not be enough to achieve desired outcomes.

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Medical armored personnel carrier. Medical cross on the armor of an armored vehicle against the background of the flag of Ukraine at exhibition ARMS AND SECURITY - 2021. Kiev. Ukraine - June 18, 2021.

Sutures for Ukraine: The Medical Case for City Diplomacy

By Vrushab Gowda, Leslie Appleton, and Jesse Ehrenfeld

The war in Ukraine has brought nothing less than an unmitigated humanitarian catastrophe. Health care infrastructure has been deliberately — and systematically — targeted by Russian forces since the very outset of the invasion. Hospitals have been bombed, internal displacement has uprooted providers from their communities, and rail lines have come under sustained bombardment from cruise missiles, hindering the resupply of frontline towns. All of this has exacerbated the demands on an already fragile health care system, which strains to keep up. The Ukrainian people urgently need practical solutions.

Enter city diplomacy. In parallel to official channels of federal aid, American cities can play a decisive role in supporting their Ukrainian counterparts under threat. An “Adopt-a-City” campaign could leverage preexisting ties within a sister cities context (like Los Angeles and Kiev, if approved), which can be bolstered and intensified. Where these relationships do not exist, they can be created. New York could “adopt” Odessa. Atlanta, Kharkiv. Houston, Dnipro.

City departments of health would take center stage throughout all of this. Unlike howitzers, ammunition, electrical grids, and water supplies, medical aid is readily portable across international lines and can be concentrated in urban settings. An “Adopt-a-City” platform would provide a unified vehicle for channeling it, permitting American cities to render material and infrastructural assistance alike.

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Single strand ribonucleic acid.

The Secret World of mRNA: HDT Bio Corp v. Emcure and Access to Next-Gen mRNA

By Aparajita Lath

The future of public health in an “RNA world” is on trial in a trade secrecy dispute worth $950 million currently being fought before the District Court of the Western District of Washington, Seattle between HDT Bio Corp. and Emcure Pharmaceuticals.

The trade secrets at issue concern an improvement over existing mRNA technology called “self-amplifying RNA” or “saRNA.” saRNA are effective at much smaller doses and lower costs. The saRNA technology is being used to develop vaccines for COVID, Zoster, Zika and Rabies.

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Person in protective yellow hazmat suit and mask holds pills in hands.

Book Review: ‘The Truth Pill: The Myth of Drug Regulation in India’

By Aparajita Lath

The Truth Pill, authored by Dinesh Thakur and Prashant Reddy, is a monumental work that convincingly shows that drug regulation is but a myth in India.

In their investigative style, the authors explain drug regulation in India through the lens of history, both Indian and global. The book’s combination of history and contemporary issues makes for an immersive and compelling read. It may, however, leave you feeling frightened, given the dysfunctional regulatory system in India and the impact this can have on patients around the world. However, the book not only highlights problems but also offers several well-thought-out and actionable paths to reform.

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Lima, Peru - March 8 2019: Group of Peruvian woman supporting the movement girls not mothers (niñas, no madres). A social campaign for abortion rights for underaged raped girls.

Grassroots Mobilization Needed to Defend Abortion Access

By Camila Gianella

On August 3, Kansas voters spurned the recent decision in Dobbs v. Jackson Women’s Health Organization by rejecting a proposed constitutional amendment that, in line with the ruling, aimed to ban abortion in the state.

What happened in Kansas shows the central role of social and political mobilization in securing abortion rights. In Kansas, Dobbs caused an unprecedented mobilization of women voters.

On the other hand, without such mobilization, access to abortion can suffer – even if the law protects sexual and reproductive health and rights (SRHR). In the case of Peru, my country, which is often cited as an example of the internationalization of SRHR norms through supranational litigation, internationally recognized legal victories have often fallen short of the high expectations they created. Despite the success of international bodies, abortion rights in Peru have not been expanded. Further, there are attempts at the legislative level to advance a total ban on abortion.

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Blue biohazard sign in front of columns of binary code.

The International Weaponization of Health Data

By Matthew Chun

International collaboration through the sharing of health data is crucial for advancing human health. But it also comes with risks — risks that countries around the world seem increasingly unwilling to take.

On the one hand, the international sharing of health-related data sets has paved the way for important advances such as mapping the human genome, tracking global health outcomes, and fighting the rise of multidrug-resistant superbugs. On the other hand, it can pose serious risks for a nation’s citizens, including re-identification, exploitation of genetic vulnerabilities by foreign parties, and unauthorized data usage. As countries aim to strike a difficult balance between furthering research and protecting national interests, recent trends indicate a shift toward tighter controls that could chill international collaborations.

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New Delhi, India-May 4 2018: Supreme court of India building in New Delhi, India.

The Supreme Court of India’s Landmark Abortion Ruling, Explained

By Aparajita Lath

The Supreme Court of India recently ruled that all women, whether married or not, have equal rights to access abortion up to 24 weeks of gestation, in compliance with the provisions of the Medical Termination of Pregnancy Act, 1971 (MTP Act).

Prior to this ruling, the MTP Act was understood to permit abortions up to 20 weeks (on the advice of one medical practitioner), and up to 24 weeks in certain specific cases, e.g., minors, pregnancies resulting from rape, women experiencing changes in marital status, women with certain mental / physical disabilities, fetal malformation, or pregnancies in emergency situations. The Supreme Court has now expanded the law to ensure access to abortion for all women, regardless of marital status, up to 24 weeks gestation.

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Washington, USA- January13, 2020: FDA Sign outside their headquarters in Washington. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.

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

By Ameet Sarpatwari, Liam Bendicksen, Alexander Egilman, 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 August. The selections feature topics ranging from a discussion of opportunities for improving the use of U.S. Food and Drug Administration (FDA) advisory committees, an analysis of the key patents covering drugs recently approved by the FDA, and an examination of high-risk cardiovascular devices approved by the FDA for use in children and adolescents. A full posting of abstracts/summaries of these articles may be found on our website.

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Tilpath Valley Biodiversity Park spreads over an area of 69.56 ha on the Southern Ridge that is contiguous with Aravalli ranges of Haryana, in south Delhi, New Delhi India.

Proposed Amendments Would Make Foreign Investment in India’s Biological Resources Easier

By Aparajita Lath

Indian lawmakers are currently debating proposed amendments that would make it easier for foreign investors to research and develop products from native biological resources, such as plants.

India is one of the 17 internationally recognized mega biodiversity countries, and hosts four of the 35 globally recognized biodiversity hotspots.

Since countries have sovereign rights over their biological resources, Indian companies enjoy easier access to and use of these biological resources for various commercial applications, including pharmaceuticals, cosmetics, and biotechnology. Foreign companies and Indian companies with any foreign participation in share capital or management are strictly regulated.

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