a pill in place of a model globe

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

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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globe.

A Critical Analysis of the Eurocentric Response to COVID-19: Western Ideas of Health

By Hayley Evans

The international response to COVID-19 has paid insufficient attention to the realities in the Global South, making the response Eurocentric in several ways.

This series of blog posts looks at three aspects of the COVID-19 response that underscore this Eurocentrism. The first post in this series scrutinized the technification of the international response to COVID-19. This second post looks at how the international pandemic response reflects primarily Western ideas of health, which in turn exacerbates negative health outcomes in the Global South.

This series draws on primary research conducted remotely with diverse actors on the ground in Colombia, Nigeria, and the United Kingdom, as well as secondary research gathered through periodicals, webinars, an online course in contact tracing, and membership in the Ecological Rights Working Group of the Global Pandemic Network. I have written about previous findings from this work here.

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Bolivar Square with Cathedral and Colombian Palace of Justice - Bogota, Colombia.

The Stakes of the Pending Colombian Constitutional Court Abortion Decision

By Alicia Ely Yamin

Amid the massive social protests wracking Colombia, the Colombian Constitutional Court is currently considering whether to decriminalize abortion beyond the narrow exceptions already recognized in law.

The petition was brought before the court by the Causa Justa (“Just Cause”) movement, a group of activists and organizations who argue that the country’s broad criminalization of abortion through Article 122 of the Penal Code poses an unconstitutional violation of women’s rights.

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doctor holding clipboard.

Learning from Clinical Negligence Claims: The New NHS Patient Safety Syllabus

By John Tingle

As part of its patient safety strategy, the National Health Service (NHS) in England has created the first system-wide patient safety syllabus, training, and education framework.

Education and training are fundamental prerequisites for creating a patient safety culture in any health care system. This new patient safety syllabus is both innovative and reflective, combining systems and human factors thinking.

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Washington, DC, USA - Closeup view of December, 23, 2020: COVID-19 Vaccination Record Card by CDC on blurred documents background.

Key Considerations for the Ethical Design of COVID-19 Vaccine Passports

By Chloe Reichel

States, employers, retailers, and other industries are now grappling with how to update mask policies in light of recent CDC guidance, which suggests vaccinated individuals may remove their face coverings indoors. 

But without a system in place to discern who has been vaccinated, the guidance poses a major risk: unvaccinated individuals, who can still contract and spread the virus, may also opt to go maskless. 

COVID-19 digital health passes, often called vaccine passports, may prove useful as a tool to relax mask policies. Vaccine passports can help to verify whether individuals may safely enter a space without a face covering.

Their ethical implementation, however, is contingent upon a number of factors: first and foremost, equitable access to vaccines. Other considerations include minimizing distrust, accessibility, risks of discrimination, and privacy protections.

For policy makers considering the implementation of COVID-19 vaccine credentialing programs, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Edmond J. Safra Center for Ethics at Harvard University have developed a road map highlighting key considerations for their ethical design.

This post provides a summary of key considerations and responsive policy recommendations presented in the paper to guide more equitable implementation of vaccine passports and to minimize distrust.

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Cartoon of contact tracing for COVID-19.

A Critical Analysis of the Eurocentric Response to COVID-19: Data Colonialism

By Hayley Evans

The international response to COVID-19 has paid insufficient attention to realities in the Global South, making the response Eurocentric in several ways.

This series of blog posts looks at three aspects of the COVID-19 response that underscore this Eurocentrism. The first post in this series will scrutinize the digital aspect of the international response to COVID-19. In creating and promoting technological solutions that are impractical and ineffective in the Global South, this digital focus has afforded asymmetric protection to those located in the Global North.

This series draws on primary research conducted remotely with diverse actors on the ground in Colombia, Nigeria, and the United Kingdom, as well as secondary research gathered through periodicals, webinars, an online course in contact tracing, and membership in the Ecological Rights Working Group of the Global Pandemic Network. I have written about previous findings from this work here.

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Close-up Of Stethoscope On Us Currency And American Flag.

Fixing Prices: Immigration and Physician Competition

By Jill Horwitz and Austin Nichols

The Biden administration is off to a roaring start. It is expanding and maintaining coverage during the pandemic by shoring up subsidies, paying premiums for laid-off workers, and otherwise working to reverse the growth in the uninsured (and underinsured) population caused by the last administration. Now it’s time to tackle another, cost.

Not only are health expenditures a large and growing share of GDP, crowding out other spending, costs have been increasingly shifted to patients in the form of premiums and ever-growing deductibles, which together have grown much faster than wages over the past decade. Moreover, out-of-pocket spending often hits all at once; about a third of high-spending patients incur half of their annual out-of-pocket spending in a single day. Increasingly, even people with insurance cannot afford to use it, so high cost is undercutting access even for the insured

We can tackle the primary drivers of cost, prices, by dismantling market power. The most salient case is cartel prices charged by physicians, and the natural solution is expanding the supply of physicians. Congress has taken some steps in this direction by expanding Medicare graduate medical education (GME) by 1,000 positions last December. The administration can unilaterally increase supply by via immigration. As others have suggested, increasing immigration of physicians who would accept somewhat lower compensation than current market rates would put “downward pressure on” physician pay.

These steps are important because expenditures for physician and clinical services are key drivers of spending and spending growth. In 2019 they accounted for $772.1 billion or 20% of total health care expenditures, representing a growth rate of 4.6% over 2018. Overuse drives some of these cost increases, but prices are the main story.

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Grafton, Illinois, USA, June 1, 2019 -Car submerged under flood water in small river town, Grafton, Illinois, as Mississippi River floods roads, businesses and houses. vehicle under water, men in boat

Bail Out Humans

By Christina S. Ho

This past year has sensitized us politically to government’s affirmative obligations, especially the duty to backstop health catastrophes in order to dampen the risks that ordinary people must bear. 

Our government bails out large risks in so many other arenas. Yet we too often fail to backstop the most human risk of all — our vulnerability to suffering and death. 

Throngs of scholars have described our deep tradition of government-sponsored risk mitigation to nurture favored private activities and expectations, and relieve those favored actors from catastrophes beyond what they could be expected to plan for. I have characterized this distinctive political role figuratively as one of “government as reinsurer.”

The federal government provides standard reinsurance for private crop insurers, virtually full risk-assumption for private flood insurance, guarantees for employer pension benefits, robust backstops for bank liquidity risks, FHA mortgage insurance and a federal secondary market to absorb the risks of housing finance.

In these arenas and more, statistically correlated or high-magnitude catastrophic losses are shed onto the state in order to smooth out and shore up the underlying private risk market. We have yet to commit similarly in the health care domain. 

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Key Takeaways from Petrie-Flom Center Discussion on Vaccine Passports

As mask mandates fall to the wayside, COVID-19 digital health passes, often called vaccine passports, hold promise as a tool to verify whether individuals may enter a space without a face covering.

Vaccine passports, however, also pose a number of ethical and legal challenges. Panelists discussed these concerns during an April 28 webinar hosted by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics titled, “Vaccine Passports: A Path to the New Normal?”

This article highlights key points made during the conversation.

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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, Neeraj Patel, 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 April. The selections feature topics ranging from the pre-market development times for innovative vaccines, to an assessment of FDA postmarketing requirements and commitments from 2009 to 2018, to an analysis of implementation challenges and potential effects of U.S. adoption of international reference pricing for prescription drugs. A full posting of abstracts/summaries of these articles may be found on our website.

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