Globe and vaccine.

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

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.

Read More

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 SarpatwariBeatrice Brown, Alexander Egilman, 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 June. The selections feature topics ranging from an analysis of the characteristics of clinical studies supporting supplemental indications approved between 2017 and 2019, to an evaluation of the effect of California’s prescription drug coupon ban on generic drug use, to a comparison of how various international regulatory bodies approach postmarket safety communication. A full posting of abstracts/summaries of these articles may be found on our website.

Read More

3d rendering of a robot working with virtual display.

Artificial Intelligence and Health Law: Updates from England

By John Tingle

Artificial intelligence (AI) is making an impact on health law in England.

The growing presence of AI in law has been chronicled by organizations such as the Law Society, which published a forward-thinking, horizon-scanning paper on artificial intelligence and the legal profession back in 2018.

The report identifies several key emerging strands of AI development and use, including Q&A chatbots, document analysis, document delivery, legal adviser support, case outcome prediction, and clinical negligence analysis. These applications of AI already show promise: one algorithm developed by researchers at University College London, the University of Sheffield, and the University of Pennsylvania was able to predict case outcomes with 79% accuracy.

Read More

international connections concept art.

The Prospects for an IP Waiver Under the TRIPS Agreement

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.

Read More

doctor holding clipboard.

The Latest on Never Events in the NHS in England

By John Tingle

Never Events” — medical errors that should never occur — are a major and recurring problem in health care in England.

When they do occur, they sap confidence and trust in the health care system, and can result in significant injury or death to the patient. They can result in expensive litigation. There is also a significant financial cost to the NHS, which is always short of financial resources. The patient, their relatives, and all those involved in the incident bear emotional costs, too.

In the National Health Service (NHS), Never Events are defined and listed. The list includes such incidents as a foreign body being left in a patient, wrong implant/prosthesis, and wrong site surgery, among others. Sadly, the incidence of Never Events in the NHS is still too high.

Never Events are also a major patient safety metric that helps regulators such as the Care Quality Commission (CQC) and the public judge the safety of a hospital or other health care facility.

Recent publications highlight that Never Events remain a critical and a stubbornly persistent problem for the NHS to address.

Read More

New Market, Esplanade, Kolkata, 05-23-2021: Due to lockdown, closed market and roadside hawker stalls at S. S. Hogg Market, which usually is heavily crowded as a popular shopping arena.

A Critical Analysis of the Eurocentric Response to COVID-19: Global Classism

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.

The first post in this series scrutinized the technification of the international response to COVID-19. The second post looked at how the international pandemic response reflects primarily Western ideas of health, which in turn exacerbates negative health outcomes in the Global South.

This third and final installment analyzes the classist approach to the pandemic response. The international response has paid insufficient attention to the existence of the informal economy and of the needs of those who must work to eat — both of which are found more commonly 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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More