No One Is Sovereign Over Genetic Sequences

Most of the time the sanctity of national sovereignty is invoked in international law, it’s covering for something bad. The debates about the interpretation of the Nagoya Protocol, a 2010 supplement to the Convention on Biological Diversity, are no exception.

A number of states party to the Protocol, a cryptic document designed to ensure the “fair and equitable sharing of benefits arising from the utilization of genetic resources,” enshrines a principle of state sovereignty over the genetic sequences of all life—including those of pathogens—within state territory.

This interpretation is not obvious on the face of the treaty. But neither is it foreclosed. The resolution of this question has profound implications for global public health: if the states that espouse this position are right, global genetic research will be impeded, possibly dramatically, and epidemics will be harder to fight. Read More

Petrie-Flom Center Welcomes Fellow-In-Residence Jacob Sherkow

Along with our partners at the Edmond J. Safra Center for Ethics at Harvard University, the Petrie-Flom Center is thrilled to announce our new jointly hosted Fellow-in-Residence, Jacob Sherkow!

Sherkow is a Professor of Law at the Innovation Center for Law and Technology at New York Law School, where he teaches a variety of courses related to intellectual property and the life sciences. His research focuses on how scientific developments, especially in the biosciences, affect patent law, regulation, and bioethics.

He is the author of over 40 articles on these topics in both scientific journals and traditional law reviews, including ScienceNature, the Yale Law Journal, and the Stanford Law Review, for which he has won multiple prizes. In 2018, he was appointed to the National Academy of Medicine as an Emerging Leader in Health and Medicine. Sherkow  is a graduate of the University of Michigan Law School as well as Columbia and McGill Universities.

You can learn more about Jake Sherkow on the Petrie-Flom website, follow him on Twitter, and catch up on his latest scholarship on SSRN.

 

 

FDA and Prescription Drugs: A Free, Online Course from HarvardX

Available March 26, 2019, a new course “FDA and Prescription Drugs: Current Controversies in Context” will be offered at no cost via the HarvardX online platform (part of the non-profit EdX consortium).  It is designed around a 6-week, self-paced schedule, and features expert guest speakers including former FDA commissioner Margaret Hamburg.

Video lectures, delivered by Harvard faculty from the Program on Regulation, Therapeutics, and Law (PORTAL), cover FDA history, expedited drug development, Right-to-Try, industry user fees, cancer treatments, Orphan drugs, dietary supplements, high prices, post-market surveillance, advertising, and much more. Starts March 26. Any interested person can preview the course trailer and enroll here (open to everyone).  #HarvardXFDA

An Urgent Need to Improve Mental Health Care in the National Health Service

Mental Health Care in the National Health Service in England has always existed in the shadow of physical care in terms of funding and NHS-government health policy priorities.

Many in the past have termed it the “Cinderella” part of the NHS. This neglect has been chronicled in numerous reports over the years pointing to many problems which include chronic under funding, poor patient safety, abuses of patient rights, poor complaint handling, unnecessary restrictive care regimes, poor patient, health carer communication, and poor patient satisfaction. Read More

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Aaron Kesselheim and Jonathan Darrow on “The Week in Health Law” Podcast

I am joined by Aaron Kesselheim and Jonathan Darrow, faculty members at Harvard Medical School and members of the Program On Regulation, Therapeutics, And Law (PORTAL) group directed by Dr. Kesselheim.

The conversation began with a discussion about drug price narratives, including whether drug prices are still increasing? We also critically discussed at least some of Vox’s 8 ideas for bringing down drug prices, and some better ones! The conversation then shifted to some issues, including pricing and expectations, with gene therapy drugs. We spent a short time on the resignation of Food and Drug Administration Commissioner Scott Gottlieb before ending our discussion with some information about PORTAL’s innovative online course, “The FDA and Prescription Drugs: Current Controversies in Context.”

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Medicaid Buy-In and Section 1332 State Innovation Waivers

As a new Medicare-for-all bill was introduced in the House recently, a number of state-level legislative projects are generating parallel excitement about Medicaid buy-in plans.

In his recent Bill of Health post, Rahul Nayak explained how Medicaid Buy-In would allow states to introduce a public option to their insurance marketplaces. Rahul points to some major questions about how buy-in plans might be implemented. Some of these questions relate to how these plans will operate within the federal statutory system that governs health care marketplaces and Medicaid. In a December Ohio State Law Journal article, for example, Professor Lindsay Wiley explored how Medicaid buy-in plans could be enacted within the waiver systems that shape state implementation of marketplaces and the availability of premium tax credits. Most recently, Emma Sandoe, in an interview for this blog, discussed the ways states are innovating in this space.

Specifically, states seeking to implement buy-in plans will navigate questions about how to leverage the Section 1332 waiver provision of the ACA. Section 1332 of the ACA allows states to apply for waivers of certain marketplace requirements. Through these waivers, states are empowered to provide insurance options that don’t meet all QHP standards and may receive premium tax credits to directly fund insurance products. How states choose to approach this waiver system will dictate what type of funds are available to subsidize coverage, the design of buy-in offerings, and the level of coverage buy-in plans will offer.

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The Problem With Doctors Communicating via Robot is Attitudes About Technology, Not Poorly Communicating Doctors

By Evan Selinger and Arthur Caplan

Perhaps you’ve seen the debate? A physician used video chat technology to inform a hospitalized Ernest Quintana and his family that he would be dying sooner than they expected. After he passed away, they objected to how the news was delivered. Over at Slate, Joel Zivot an anesthesiologist and ICU physician, responded to the uproar with an essay titled, “In Defense of Telling Patients They’re Dying Via Robot.” Read More