Tag: health law policy

a crowd of people shuffling through a sidewalk

Reopening the Country During COVID-19: Legal and Policy Issues 

The Petrie-Flom Center Staff Leave a comment

By Mark A. Hall and David M. Studdert

Every public health crisis poses unique legal and ethical challenges, but none more so in modern times than the novel coronavirus pandemic. Urgent responses to the pandemic have halted movement and work and dramatically changed daily routines for most of our population in ways entirely unprecedented. As we wrote recently, this sweeping response challenges a host of civil liberties that state and federal statutes and constitutions protect. It should come as no surprise, then, that we are starting to hear widespread grumbling. There are even reports of some initial “protest” lawsuits. But even without overt legal challenges, public health officials are well attuned to the need to respect civil liberties in setting appropriate policies. And, if those officials are not well-attuned, politicians, who are concerned about widespread economic fallout, will forcefully remind them.

It follows that there is a pressing need for a set of principles to guide not just the imposing of COVID-type restrictions, but also relaxing or lifting them.

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an ambulance parked at the entrance of an emergency department

Patient Safety and Health Quality in the NHS (National Health Service) in England: A Zip Code Lottery?

John Tingle Leave a comment

By John Tingle

The independent regulator of health and social care in England, the Care Quality Commission (CQC) regularly produces detailed inspection reports on the health and care organisations that it regulates. These reports show that quality of care and patient safety are not consistent across England’s health and care facilities. Wide variations in quality and safety between core services in the same NHS hospital or in the same locality as well as regionally are sometimes revealed. It is clear from reading the reports that patient safety and health quality cannot be a measured as a constant across England.

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The Ostrich Syndrome and Patient Safety

John Tingle Leave a comment

By John Tingle

Sadly, the NHS (National Health Service) in England is littered with examples of cases where individuals and organisations have seemingly buried their heads in the sand when patient safety errors have occurred. Attitudes that can be seen in past reports range from,’ it’s not my responsibility’, to procrastination, or passing the buck, assuming that another organisation is dealing with the matter or just simply delaying a response or even ignoring the situation completely.

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gavel on top of a pile of bills and pills

A Local City Takes on Pharma

Phebe Hong Leave a comment

By Phebe Hong

A city northwest of Atlanta is taking on Big Pharma. On February 6th, the city of Marietta filed a lawsuit in federal court in Atlanta against Mallinckrodt, a global specialty pharmaceutical company. The class action complaint alleges that Mallinckrodt is “unjustly enriched” by its “exorbitant and unconscionable prices” for Acthar, a therapeutic adrenocorticotropic hormone (ACTH) approved in 1952 and indicated for various disease conditions, most notably infantile spasms and multiple sclerosis relapse. Marietta brings the class action suit on behalf of itself and “[a]ll third-party payors and their beneficiaries and people without insurance” that have paid for Acthar in the past four years.

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Photograph of a report on a table, the report is labeled, "NHS"

The NHS In England: Patient Safety News Roundup

John Tingle Leave a comment

By John Tingle

There is always a lot happening with patient safety in the NHS (National Health Service) in England. Sadly, all too often patient safety crises events occur. The NHS is also no sloth when it comes to the production of patient safety policies, reports, and publications. These generally provide excellent information and are very well researched and produced. Unfortunately, some of these can be seen to falter at the NHS local hospital implementation stage and some reports get parked or forgotten. This is evident from the failure of the NHS to develop an ingrained patient safety culture over the years. Some patient safety progress has been made, but not enough when the history of NHS policy making in the area is analysed.

Lessons going unlearnt from previous patient safety event crises is also an acute problem. Patient safety events seem to repeat themselves with the same attendant issues

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A family consisting of two adults and one child walk stairs with their backs to the camera.

Lessons from One Child Nation for Health Policy

Katherine Drabiak Leave a comment

By Katherine Drabiak

The acclaimed One Child Nation, streaming on Amazon Prime, provides a haunting look at the reasoning, implementation, and consequences behind China’s (now revised) One Child Policy. Director Nanfu Wang expertly weaves together interviews from population health officials, medical professionals, and family members to describe how government policy strictly enforced population control measures through propaganda, forced sterilization, abortion, steep fines, and infanticide.

At first blush, it seems convenient to contextualize these gross violations of human rights as a product of a vastly different system of law and government than the U.S., but this is an oversimplification. Like the U.S., China also has a Constitution that enshrines central principles, such as deriving authority by the power of the people, equality under the law, preservation of human rights, freedom of the human person, freedom of speech and press, and certain freedoms of family life.  Unlike the U.S., a co-existing provision grants broad power to the government to promote responsible family planning.  Among key differences, One Child Nation illustrates the danger of interpreting rights through a prism that elevates social goals, public order, and government defined community interests above individual rights.

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Graph with number of biosimilar approvals on the X axis and years from 1970 until 2018 on the Y axis. The line on the graph represents a generally upward trend.

The Rise of Biosimilars: Success of the BPCIA? (Part III)

Jonathan Darrow Leave a comment

By Jonathan Darrow

This is Part III in a series exploring the history, challenges, and opportunities in the regulation of biosimilars, or biologic medical products that are very similar to already approved biological medicines.  Part III considers a path forward in the regulation of biologics.  For Part I, click here.  For Part II click here.

A Path Forward

The small number of biosimilar approvals compared to generic drug approvals cannot establish the failure of the BPCIA due to differences in industry familiarity with each follow-on pathway, the number of reference products available for copying, patient population sizes, patent barriers, and drug costs. The later arrival of US laws and guidance documents—not inadequate legal design—is the most straightforward explanation of why the first US biosimilar approvals were delayed compared to those in Europe.

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Soft-focus photograph of wheelchairs lined up in a hospital hallway

Toward a Safer NHS in 2020

John Tingle Leave a comment

By John Tingle

As the New Year begins its important to reflect on the previous year’s National Health Service (NHS) patient safety milestones in England. We should ask also whether the NHS patient safety agenda will make major advances in 2020.

The year 2019 was another bumper year for NHS patient safety policy developments and crises. Some major patient safety publications were produced, and stories of NHS patient safety crisis continued to regularly hit the headlines. The NHS is no sloth when it comes to patient safety policy report writing and the number patient safety adverse incidents happening. Read More

Three hard hats for construction work lined up on a concrete wall

Enhancing Patient Safety Education and Training through Legal Study

John Tingle Leave a comment

By John Tingle

In the new NHS Patient Safety Strategy for England there is a discussion of patient safety education and training. While safety is now better understood there are significant numbers of people who still have a limited understanding of safety science.

A National Patient Safety Syllabus

A commitment is made to have a universal patient safety syllabus and training program for the whole of the NHS. Health Education England (HEE) will have a pivotal role: Read More

A mother holds her baby close to her chest and gazes at their face

Maternity Scandal Hits the NHS

John Tingle Leave a comment

By John Tingle

Unfortunately, it’s never too long before a major NHS patient safety crisis hits the newspaper headlines in the United Kingdom. The Shrewsbury and Telford Hospital Trust (SATH) maternity scandal has just become a major breaking U.K. patient safety news story.

Shaun Lintern reports in The Independent:

Hundreds of families whose babies died or were seriously injured at the Shrewsbury and Telford Hospital Trust do not even know their cases have been identified for investigation in the biggest maternity scandal to ever hit the NHS… Dozens of babies and three mothers died in the trust’s maternity wards, where a ‘toxic culture’ stretched back to 1979, according to an interim report leaked to The Independent this week.

Patient Safety Scandals

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