This is the first of three episodes of “Innovation and Protection: The Future of Medical Device Regulation,” a podcast miniseries created to replace the 2020 Petrie-Flom Center Annual Conference in light of the COVID-19 pandemic.
Category: Public Health
Patent Fakes: How Fraudulent Inventions Threaten Public Health, Innovation, and the Economy
By Jorge L. Contreras, JD
The U.S. patent system gives inventors a 20-year exclusive right to their inventions to incentivize the creation of new technologies.
But what if you have a great idea for a new technology, but never actually create it, test it, or determine that it works? Is that patentable? Conversely, should the U.S. Patent and Trademark Office (PTO) grant patents covering imaginary, fraudulent and otherwise non-existent inventions? Probably not, but it happens with alarming frequency, and it is causing serious problems.
A New Litigation Crisis on the Horizon: Negligent Delays for Non-COVID-19 Patients
By John Tingle
As the dust begins to settle around the COVID-19 pandemic, a clearer picture is beginning to emerge of possible litigation trends against the United Kingdom’s NHS (National Health Service) for actions taken during the crisis.
Many NHS services have been reduced or suspended during the crisis. Negligent delays in treatment are a common cause of action in clinical negligence and medical malpractice cases. Legal claims could be made by patients who argue that they have suffered, and continue to suffer, because of lack of access to care and treatment due to COVID-19 NHS emergency restrictions. These claims raise tort, public law and human rights concerns, and some law firms have already been approached by patients asking for advice in this area.
6 Questions for Alicia Ely Yamin on Partners In Health, Social Justice, and Human Rights
By Jonathan Chernoguz
Among many other accomplishments, Alicia Ely Yamin (Petrie-Flom Center Senior Fellow), will now serve as the Senior Advisor on Human Rights at Partners In Health (PIH).
Partners In Health is a global health and social justice organization committed to improving the health of the poor and marginalized as a matter of justice. PIH works with ministries of health to build local and national clinical capacity and works closely with impoverished communities to delivery high quality healthcare, address the root causes of disease, train providers, advance research, and advocate for global health policy change.
Yamin is a world-recognized pioneer and thought-leader in the field of health and human rights. She has a long track record of working on the ground as well as at policy levels, including in collaboration with PIH sister organizations from Peru to Malawi. Yamin will work across a multi-disciplinary team within PIH and the broader Global Health Delivery Partnership, to advance an advocacy and policy agenda for transformative structural change in global health architecture and its intersections. To learn more about her new role, we asked Yamin a few questions about the position, how it relates to Petrie-Flom, and the goals she aims to accomplish.
To Address COVID-19 Disparities, 340B Hospitals Need More Flexibility
By Sravya Chary
Many racial minorities and low-income individuals rely on 340B hospitals and associated child sites for access to discounted drugs and charity care.
In 1992, Congress enacted the 340B program as an avenue of access to prescription medication for “the nation’s most vulnerable patient populations.” Hospital savings incurred from purchasing 340B drugs at a steep discount are invested in charity care programs to enhance patient services and access to care.
The 340B program is an essential component of the COVID-19 response. Increased flexibility for 340B covered entities is necessary to address disparities faced by marginalized communities.
How Traditional Health Records Bolster Structural Racism
By Adrian Gropper, MD
As the U.S. reckons with centuries of structural racism, an important step toward making health care more equitable will require transferring control of health records to patients and patient groups.
The Black Lives Matter movement calls upon us to review racism in all aspects of social policy, from law enforcement to health. Statistics show that Black Americans are at higher risk of dying from COVID-19. The reasons for these disparities are not entirely clear. Every obstacle to data collection makes it that much harder to find a rational solution, thereby increasing the death toll.
Announcing The Journal of Philosophy of Disability
The Journal of Philosophy of Disability (JPD) is a new journal devoted to the philosophical study of disability.
Disability is central to human life. As the slogan from disability studies goes: “disability is everywhere, once you know how to look for it.” After a steady stream of scholarship from the 1990s onward, work in the field of philosophy of disability has expanded exponentially. Despite this explosion, there has never been a peer-reviewed journal devoted to scholarship in the field of philosophy of disability. Until now.
COVID-19 Clinical Negligence and Patient Safety Update
By John Tingle
Health care law is evolving particularly rapidly during the COVID-19 pandemic.
For example, as the COVID-19 pandemic continues, families in England who have lost loved ones to the virus are considering filing clinical negligence claims. And there have even been calls in some quarters to bring global lawsuits against China for breaches of international health regulations over its handling of COVID 19.
How Do We Arrive at Fair Pricing for COVID-19 Therapies?
By Padmashree Gehl Sampath
As the search for COVID-19 treatments and vaccines continues, questions of pricing and access are beginning to emerge.
How can pharmaceutical companies determine fair prices for these therapies? And how can they ensure that all those who need these treatments are able to access them? These are valid concerns in the current global pharmaceutical landscape, where in recent years, soaring drug prices have been an issue for almost all governments.
COVID-19 Underscores Racial Disparity in Advance Directives
Cross-posted from The Hastings Center Bioethics Forum, where it originally appeared on May 26, 2020.
By Stephen P. Wood
During a recent shift, I was the primary provider for a man in his 70s who was brought in by ambulance with respiratory failure. He had been sick for two days with a fever and a cough, weak and short of breath. The chest x-ray performed at his bedside revealed the diffuse, fluffy markings that are familiar signs of pneumonitis from COVID-19.
After giving him oxygen to improve his breathing, treating his fever, and running tests that are standard for COVID-19 patients, I clicked the admission button to cue him up for a bed. My patient and I then discussed goals of care and had a frank discussion about advance directives. He did not have an advance directive, but he knew he did not want to be resuscitated. He did not want to be put on a ventilator, go on dialysis, or receive artificial nutrition. He was quite clear and did not hesitate about these decisions. We signed the advance directive and filed it away in his chart.
