Month: September 2013

Video Now Available: “Gene Patenting, the Supreme Court’s Myriad Decision, and the Future of Biotechnology”

The Petrie-Flom Center Staff Leave a comment

In case you missed it live on Monday evening, video from the Petrie-Flom Center’s event “Gene Patenting, the Supreme Court’s Myriad Decision, and the Future of Biotechnology” (co-sponsored by the Broad Institute) is now available here.

09/27/13 UPDATE: Our intern Fatima Mirza also wrote up this summary:

At this event, a distinguished panel of law and biotechnology experts convened to discuss the landmark Supreme Court Myriad decision and its implications on the future of scientific innovation and development.

The discourse began with an introduction of the high-profile case that extended beyond simply the scientific, political, or legal spheres.

“A broad coalition of people came to file this case,” said Tania Simoncelli, former Science Advisor to the ACLU. “Everyone from clinical geneticists, genetic counselors, individual women who could not access testing, the American Medical Association, the American Association of Human Genetics, and the March of Dimes were involved.”

In order to provide context for the case, Glenn Cohen, Professor at Harvard Law School and Faculty Co-Director of the Petrie-Flom Center, offered a brief history of biotechnology and patent law.  He highlighted developments from as early as 1911 when adrenaline, a naturally occurring compound, could be patented and distributed commercially based on the principle of purification. Emphasizing paradigm shifts in a rapidly advancing society, Cohen further outlined the role of the Patent and Trademark Office. “At the heart of patent law is whether we will have a pro-innovation or anti-innovation effects,” said Cohen.

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Petrie-Flom Intern’s Weekly Round-Up: 9/20-9/27

The Petrie-Flom Center Staff Leave a comment

By Fatima Mirza

Introducing Guest Blogger Kuei-Jung Ni

The Petrie-Flom Center Staff Leave a comment

Kuei-Jung Ni will be a contributor at Bill of Health during his time as a Visiting Scholar at the Petrie-Flom Center in the 2013-2014 academic year. His current research explores the systems of governmental food safety regulation in the United States and Europe, with the goal of developing a suitable regulatory system for the Taiwanese government. Ni is visiting the Center with support from a Fulbright grant and the Top University Strategic Alliance (TUSA) of Taiwan.

Professor Ni holds an LL.M. from the University of California, Berkeley, School of Law, and a Ph.D. in Law from the University of Edinburgh School of Law. He is currently on leave from his role as Professor and Director at the Center for Technology Law, National Chiao Tung University, Taiwan.

The priorities in the benefit packages vs. the priorities of those who dole out the benefits

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In my last post I promised I would provide details about the new piece of statutory legislation that was recently enacted by the Colombian Congress on the right to health, but first I should talk a little more about the prior jurisprudence that set the stage for it–especially since there’s so much of it. Every year, hundreds of thousands of right-to-health cases go before judges in Colombia, and some estimate that up to one out of every five Colombians has used the judicial system to gain access to health services.

By far, most of these cases are won by the plaintiff. And they should be.

Nearly 90% of the cases that involve procedures, and over 30% of the cases for medications, involve benefits that are actually already covered by the public benefit package (plan obligatorio de salud, or POS). And most of these aren’t over particularly expensive, complicated, or scarce benefits in the POS. The most frequently litigated medications are omeprazole (Prilosec) and oxygen. The most frequently litigated procedures aren’t even the procedures themselves, but specific parts of the procedures that aren’t explicitly listed in the bundle of benefits covered by the POS. For example, the POS covers colostomies, but the insurance companies systematically deny the colostomy bags. “We’ll open the hole in your flank, but it’ll be on you to figure out what to do with the excrement that’ll start oozing out. . .”

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Twitter Round-Up

The Petrie-Flom Center Staff Leave a comment

By Sara Providence (PFC Intern)

As another way to keep you up to speed on what’s happening in the world of health policy, we’ll be compiling relevant tweets from our bloggers and posting them here on a bi-weekly basis.  Take a look:

Richard Epstein (@RichardAEpstein) tweeted a policy report from the Manhattan Institute concerning FDA regulation of stem-cell procedures. The report rebuts, among other arguments, the FDA’s position that stem-cell treatments are within its purview of preventing communicable diseases. (9/24)

Frank Pasquale (@FrankPasquale) tweeted an article about potentially limited choice of provider under the new health law. According to the authors, the Affordable Care Act keeps premiums low by restricting the number of doctors and hospitals available to patients. (9/24)

Arthur Caplan (@ArthurCaplan) tweeted about the “exploitation of women in poor, underdeveloped nations for surrogacy,” alongside his post of this article. The piece describes the growing phenomenon of wealthy Chinese families paying American women to be surrogate mothers. (9/23)

Michelle Meyer (@MichelleNMeyer) tweeted an article about Penn State’s decision not to sanction employees for non-compliance in a wellness plan. Employees were previously required to respond to a controversial survey administered by a health management company, or pay a fine. (9/18)

Arthur Caplan (@ArthurCaplan) tweeted a piece about continuing bias against gay blood donors. “Gay-rights advocates are fighting to amend the U.S. ban on blood donations by gay and bisexual men, which dates from the first years of the AIDS epidemic,” the author writes. (9/16)

HBR/NEJM online forum on health care innovation

W. Nicholson Price Leave a comment

By Nicholson Price

For those of you who haven’t seen it yet, there’s a great ongoing online forum over at the joint Harvard Business Review and New England Journal of Medicine Insight Center on Leading Health Care Innovation.  It’s online at HBR here, and will feature an ongoing series of posts about innovation in high-value health care through November 15.  Short articles from scholars in various fields will focus on three main areas: Big Ideas (foundational principles of high-value health care); Managing Innovations (organization and delivery); and From the Front Lines (stories of specific case solutions from practitioners).

They’re looking to host a lively forum, so comments seem both quite welcome and unusually thoughtful so far.

 

OHRP Revises Guidance on Remuneration for Human Research Subjects

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by Suzanne M. Rivera, Ph.D.

The Office of Human Research Protections (OHRP) has issued revised guidance about research subject compensation.  And, although it has not attracted a great deal of fanfare, it deserves attention because the new guidance offers greater flexibility to investigators and to the Institutional Review Boards (IRBs) charged with reviewing proposed human research studies.   Under its list of Frequently Asked Questions (FAQ) related to informed consent, there is a question (7) which reads, “When does compensating subjects undermine informed consent or parental permission?”  (https://www.hhs.gov/ohrp/policy/consentfaqsmar2011.pdf).

Aside from the fact that it’s still a very leading question (asking “when does it?” implies that, in fact, it does…), the new answer provided by OHRP clarifies that compensation in and of itself is not necessarily coercive or a source of undue influence.  It says that remuneration to subjects may include compensation for risks associated with their participation in research and that compensation may be an acceptable motive for some individuals agreeing to participate in research.

That is a real paradigm shift. Read More

Worth Reading This Week

Nicolas P. Terry Leave a comment

By Nicolas Terry