Month: January 2017

Looking Forward: The Next Generation of Biosimilars

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Looking Forward: The Next Generation of Bio
similars

February 7, 2017 12:00 PM

Description

Many of today’s important medications are biological products made from living organisms, manufactured through biotechnology, derived from natural sources, or produced synthetically. Biosimilars are a type of biological product approved by FDA on the basis of being highly similar to an already approved biological reference product, like a generic drug.

This panel of experts will discuss the current state of biosimilars in the healthcare ecosystem and what comes next from a technical and legal perspective. Topics include how the next generation of biosimilars can improve patient access to standard-of-care therapies, the concept of “biobetters,” economic and intellectual property considerations, and policy approaches to support existing and future biosimilars.

Panelists

This event is free and open to the public. Lunch will be provided.

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

What is the Meaning of Trump’s Day 1 Executive Order on the ACA?

The Petrie-Flom Center Staff 2 Comments

Guest Post by Erin C. Fuse Brown

On the day of his inauguration, President Trump signed an executive order instructing the executive branch agencies to exercise their discretion and authority to  “waive, defer, grant exemptions from, or delay the implementation of” fees, taxes, or penalties under the Affordable Care Act (ACA).

The order does not specify which “fiscal burdens” it targets, but the individual mandate, the employer mandate, and the various industry and payroll taxes imposed by the law immediately jump to mind. These are all written into the law, and the President cannot unilaterally set them aside. The executive order says it is following the law, including the Administrative Procedure Act, which is good because it means the President is not instructing anyone to flout the law. Even existing ACA rules cannot be undone overnight and can only be changed or repealed through a lengthy notice-and-comment rulemaking process.

There is such a thing as “enforcement discretion,” which some suggest means that the individual mandate won’t be enforced anymore. I’m not so sure. If the President instructed the IRS to stop collecting taxes from billionaires under its enforcement discretion, that wouldn’t be legal. Read More

Digital Health @ Harvard Brown Bag Lunch Series: Free Independent Health Records, featuring Adrian Gropper, MD

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January 26, 2017 12:00 PM
Berkman Klein Center for Internet and Society
23 Everett St., 2nd floor, Harvard Law School, Cambridge, MA
Register for this event

The Digital Health @ Harvard brown bag lunch series features speakers from Harvard as well as collaborators and colleagues from other institutions who research the intersection between health and digital technology. The series is cosponsored by the Berkman Klein Center for Internet & Society at Harvard University and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. The goal of the series is to discuss ongoing research in this research area, share new developments, identify opportunities for collaboration, and explore the digital health ecosystem more generally.

These lunches are free and open to the public, but RSVPs are required. RSVP now!

This Month

Dr. Adrian Gropper is working to put patients in charge of their health records, arguably the most valuable and most personal kinds of connected information about a person. They encompass elements of anonymous, pseudonymous, and verified identity and they interact with both regulated institutions and licensed professionals. Gropper’s research centers on self-sovereign technology for management of personal information both in control of the individual and as hosted or curated by others. The HIE of One project is a free software reference implementation and currently the only standards-based patient-centered record. The work implements a self-sovereign UMA Authorization Server and is adding blockchain identity as self-sovereign technology to enable licensed practitioners to authenticate and, for example, write a compliant prescription directly into the patient’s self-sovereign health record. Read More

Housing Equity Week in Review

Temple University Center for Public Health Law Research Leave a comment

Here’s the latest in housing equity and law for the week of January 16-22, 2017:

Did we miss anything? Let us know.

Visiting Health Law Position at Indiana University Robert H. McKinney School of Law

Nicolas P. Terry Leave a comment

The Indiana University Robert H. McKinney School of Law invites applications for a visiting assistant professor position for 2017-18. The position would primarily involve teaching courses in the Health Law curricula and participation in the scholarly and student-centered activities organized by the law school’s Hall Center for Law and Health.

Applicants should indicate what Health Law courses they could offer and any additional courses they would be interested in teaching.

Please submit a letter of interest, a cv, and a list of three references to: Vice Dean Antony Page, Indiana University Robert H. McKinney School of Law at page@iu.edu  and Professor Nicolas Terry, terry@iupui.edu. The closing date for applications is Friday, February 24, 2017.

We are committed to achieving excellence through intellectual diversity and strongly encourage applications from persons of color, women, persons with disabilities, the LGBT community, veterans, and members of other groups that are under-represented on university faculties. The law school is an Equal Opportunity/Affirmative Action Institution and offers domestic partner benefits.

Can the Right to Stop Eating and Drinking be Exercised via a Surrogate Acting Pursuant to an Advance Instruction?

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by Norman L. Cantor

The right of a grievously stricken, competent patient to hasten death by ceasing eating and drinking is increasingly recognized. In the typical scenario, a person afflicted with a serious degenerative disease reaches a point where the immediate or prospective ordeal has become personally intolerable.  The stricken person decides to shorten the ordeal by stopping eating and drinking, precipitating death by dehydration within 14 days.  The dying process is not too arduous so long as there is a modicum of palliative care available – emotional support, lip and mouth care, and provision of a sedative if patient agitation or disorientation ensues.

A further question is whether a person can dictate a similar fatal course for his or her post-competence self by advance instruction to an agent.  The instruction would be that — once a pre-defined point of dementia has been reached — either no food or drink should be offered to the incompetent patient or no manual assistance should be provided where the patient is not self-feeding.  This post-competence SED tactic appeals to persons who view the prospective demented status as intolerably demeaning and wish to hasten their demise upon reaching that state. The legal claim would be that if a competent patient has a right to SED, the right ought to subsist post-competence when exercised by clear advance instruction.  According to this claim, just as an advance instruction to reject a respirator would be upheld as an exercise of prospective autonomy, so an instruction for cessation of nutrition should be respected.

     A person who undertakes responsibility for a demented person normally has a fiduciary duty to promote the well-being, comfort, and dignity of the ward.  A guardian who forgoes available care measures such as shelter, warmth, hygiene, and food is chargeable with unlawful neglect.  Provision of food and assistance in eating are normally part of that fiduciary obligation.  A legal exemption might apply, though, if the guardian – in discontinuing hand feeding pursuant to an advance instruction — is simply respecting the right of the ward to exercise prospective autonomy. The question becomes: Is the acknowledged right to SED exercisable by means of an advance instruction?  Read More

Does an Arbitration Clause in a Nursing Home Agreement Preclude Tort Actions Relating to the Resident’s Wrongful Death?

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By Alex Stein

Arbitration clauses in nursing home agreements are pretty much standard. Whether such a clause precludes tort actions complaining about the resident’s wrongful death is consequently an important issue.  The Pennsylvania Supreme Court has recently addressed this issue in Taylor v. Extendicare Health Facilities, Inc., 147 A.3d 490 (Pa. 2016). In that case, the resident’s family members sued the nursing home in their individual capacity as derivative victims of the alleged tort (the wrongful death action) and as representatives of the resident’s estate (the survival action). In the wrongful death action, the plaintiffs sought compensation for the emotional harm they sustained from losing their loved one prematurely and possibly for their economic losses as the resident’s dependents (the Court’s decision provides no details on that). The survival suit, on the other hand, focused on the resident’s entitlement to be compensated for pain and suffering and other harms she sustained from the alleged negligence. This entitlement belonged to the resident’s estate rather than her successors as individuals.

The agreement between the resident and the nursing home contained a standard compulsory arbitration provision that covered any resident’s suit against the nursing home. This provision consequently extended to the survival action, but not to the wrongful death suit filed by the nonparties to the agreement. However, under Pennsylvania Rule of Civil Procedure 213(e), wrongful death and survival actions cannot be bifurcated and must be tried together. Based on that rule, the trial court decided that the two actions must be consolidated, and because one of the actions fell outside the scope of the arbitration provision, both actions should go to trial.

The Pennsylvania Supreme Court overturned this decision for failure to account for the Federal Arbitration Act (FAA), as interpreted (inter alia) in Southland Corp. v. Keating, 465 U.S. 1, 3 (1984); Moses H. Cone Mem’l Hosp. v. Mercury Constr. Corp., 460 U.S. 1, 20 (1983); Dean Witter Reynolds, Inc. v. Byrd, 470 U.S. 213, 218 (1985); AT & T Mobility LLC v. Concepcion, 563 U.S. 333, 346 (2011); and KPMG LLP v. Cocchi, 132 S.Ct. 23, 26 (2011).  Read More

MONDAY (1/23)! PFC’s 5th Annual Health Law Year in P/Review

The Petrie-Flom Center Staff 1 Comment

p-review-logoHealth Law Year in P/Review
Featured Panel: The End of ObamaCare? Health Care Reform Under A New Administration
January 23, 2017 
Wasserstein Hall, Milstein West AB
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA
Register for this event

The Fifth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2016 and what to watch out for in 2017. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law. Read More

Sam Halabi on ‘The Week in Health Law’ Podcast

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By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

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We welcome University of Missouri-Columbia law professor Sam Halabi, who brings a wealth of academic and practical experience to the podcast. He is interested in corporate governance and regulation at both national and international levels. He has edited (with Lawrence O. Gostin and Jeffrey S. Crowley) Global Management of Infectious Disease after Ebola (Oxford University Press, 2017) and his book, Intellectual Property and the New International Economic Order: Knowledge, Exploitation, and Resistance is scheduled for publication by Cambridge University Press in 2018.

We discussed Sam’s article Selling Hospice (among others). Listeners may also be interested in a WaPo series on hospice care. The lightning round focused on past guest Allison Hoffman’s recent post on the seismic shift in the health policy landscape, the 21st Century Cures Act, new SAMHSA rules, and an OCR resolution agreement.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

The ACA’s Real Effect: Moving the Goalposts

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By Christopher Robertson

“I believe and I look forward to working with you to make certain that every single American has access to the highest-quality care and coverage that is possible. … [W]e believe it’s appropriate to put in place a system that gives every person the financial feasibility to be able to purchase the coverage that they want for themselves and for their family.”

That quote is not from Barack Obama.  It’s from Trump HHS nominee Tom Price, and it shows just how successfully the ACA has shifted the American political landscape towards universal coverage. As I argued earlier this month in STAT, with Glenn Cohen and Holly Fernandez Lynch, the debate is now about how to get universal health insurance coverage, rather than whether to do so.

Republicans will of course favor market-oriented approaches, and they will find difficulty conceiving a plan that is farther to the right than the ACA itself while actually achieving the goals that Price promises.  But for now, even if the ACA is soon repealed, it has succeeded in moving the goalposts for health policy.