Paper on “Legal aspects of biobanking as key issues for personalized medicine & translational exploitation”

By Timo Minssen

I am pleased to announce that my co-author Professor Jens Schovsbo from the University of Copenhagen and I completed a paper addressing “Legal aspects of biobanking as key issues for personalized medicine & translational exploitation”.

This perspective article, which has been written upon request by the medical journal “Personalized Medicine”, deals with the legal aspects of biobanking and points towards the concerns, interest, and choices that should be considered when establishing and operating a biobank. It focuses on public biobanks in a university setting and the specific challenges posed by PM with a special focus on publicly funded biobanks, commercialization issues and the involvement of industry.

To this end we start out by briefly discussing differing definitions of the term biobank and highlighting the particular significance of biobanks for the development of PM and translational innovation. The next part describes the inherently complex, dynamic and heterogeneous environment in which legal challenges to biobanking and the regulation of biomedicine must be considered. Based on our finding we then sketch out more specific legal problems that might occur throughout the various chronological stages of biobanking regarding consent obligations and intellectual property rights (IPR). After this we use an on-going interdisciplinary research project based at the University of Copenhagen (UCPH) to illustrate how the legal and ethical challenges might be dealt with analytically and in a practical way that reflects the concerns and interest of stakeholders in biobanking and results in a transparent, legally and ethically robust system. In our closing remarks we make recommendations on how to improve the legal framework for biobanking and in particular for the challenges posed by PM.

We conclude that any decisions as to the design of the regulatory environment should follow a process that takes account of the values, hopes and concerns of all stakeholders involved. In particular, we stress the importance of a careful planning of consent obligations combining traditional legal methods with an adequate institutional set up. In order to enhance the translational exploitation of biobanks, we further emphasize the pressing need to carefully consider a great variety of strategies and policy choices relating to intellectual property rights (IPRs).

We will publish the paper on SSRN as soon as we receive the approval by “Personalized Medicine”. I’ll keep you posted.

UPDATE: The full paper is now available here.

Genetically Modified Crops

The USDA’s Animal and Plant Health Inspection Service (APHIS) has released a Draft Environmental Impact Statement associated with its deregulation of a new generation of genetically modified herbicide-resistant crops.   While many in the agricultural industry hail this as a much-needed step in the development of new weed-control technologies, critics worry that it will accelerate an “herbicide treadmill” at the cost of more sustainable management strategies.

As a bit of background, the development of the first generation of genetically modified (GM) herbicide-resistant crops revolutionized agricultural weed management in the mid 1990s.  Prior to this development, weed management required significant skill and knowledge.  Farmers had to not only carefully manage the timing of various herbicide applications, but also integrate other nonchemical control practices.  Herbicide-resistant crops, by contrast, were effective and easy to use.

During the initial phase of development, a variety of GM options came to market, but Monsanto’s “RoundupReady” varieties (which are resistant to a broad-spectrum herbicide known as “glyphosate”) quickly became dominant.   By 2008, 63% of corn fields and 92% of soybean fields in the US were being planted with RoundupReady seeds.  The outcome of this single-track approach to weed management has been a dramatic increase in the number of weed species that are resistant to the herbicide glyphosate.

In response to the evolution of these “super weeds,” Congress has held hearings to assess whether additional government oversight is needed to address the problem.  The response of the seed and agrichemical industries, by contrast, has been to develop new GM seeds that are resistant to other broad-spectrum herbicides for which weeds have not yet developed resistance.  Read More

Introducing Guest Blogger Timo Minssen

Timo Minssen is Associate Professor of IP & Innovation Law at the University of Copenhagen (UCPH), Centre for Information & Innovation Law (CIIR), Denmark. Before joining UCPH, Timo graduated from law school in Göttingen (Germany) in 2001 and was trained in the German court system from 2002-2003. He also passed the Swedish “juris licentiate” (LL.Lic.) and “juris doctor” exams (LL.D.) and holds two IP- and Biotech- related masters degrees from the Universities of Uppsala and Lund (Sweden). In addition he worked for a Life Science company and for various law firms in Sweden and Germany.

From 2007-2009 Timo was a stipendiary at the Max Planck Institute for Intellectual Property and Competition Law in Munich. He was also responsible for a course in comparative patent law at the Chicago-Kent College of Law (USA) and worked for the European Patent Office. At Lund University he was engaged as a teacher at the Faculty of Law and in interdisciplinary epigenetics research at the Pufendorf Institute for Advanced Studies. At UCPH he is co-leading CIIR’s Copenhagen Biotech & Pharma Forum and teaches international classes for both students and pharma professionals in EU-, Competition-, and Pharmaceutical Law and IPR. Timo is a frequent speaker on a variety of topics and has published extensively in comparative US and European patent law, EU- and Competition Law. In 2013-14, he will be a Visiting Scholar at the Petrie-Flom Center, and later at the University of Oxford.

See a full listing of Minssen’s research here.

Art Caplan: ‘Life support’ is wrong for brain-dead pregnant woman

Art Caplan has a new piece at NBC News online weighing in on the case of Marlise Munoz, the pregnant Texas woman who was declared brain dead by doctors several weeks ago and yet is being kept on “‘life support’ technology” against her family’s wishes. Based on their reading of a Texas law that bans the withdrawal of such machines in cases where the patient is pregnant — regardless of advance directives or the family’s wishes — the hospital claims it has no choice. Caplan argues:

The hospital, however, is very confused. If Marlise is dead, then the Texas law does not apply. Even the legislature of Texas cannot compel continued use of medical interventions on a dead body. “Life support” technology need not be continued if the patient is dead. Erick Munoz made that case in his lawsuit against John Peter Smith Hospital.

“In fact, Marlise cannot possibly be a ‘pregnant patient’ — Marlise is dead,” the suit says. “To further conduct surgical procedures on a deceased body is nothing short of outrageous.”

But even if Marlise were alive — assuming she has either a terminal or irreversible condition — the hospital has the choice to do the right thing ethically, follow the wishes of her husband and family and stop intervening.

Read the full article.

 

Petrie-Flom Center Seeks Harvard Law School Student Interns for Winter/Spring 2014

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is seeking student interns to start immediately for the upcoming winter and spring terms beginning in January 2014.   We may consider extension through Summer 2014 if there is mutual interest.

Harvard Law School students with an interest in the Center’s work are eligible to apply. More information about the Center is available here. We particularly welcome applications from students with a background in health policy, philosophy, bioethics, health law, medicine, business economics, and the sciences.

To view the full call for applications, please visit our website.

Open Questions in Health Law?

By Christopher Robertson

As I prepare to teach the health law survey course here at HLS in the spring, I am putting together some exercises for students to work on “open questions” in the field. For example, I am thinking about tasking a group of students to explore ways that insurers could or already do structure their contracts with patients and providers to prevent pharmaceutical companies from using coupons to undermine cost-sharing burdens. (Medicare simply does so with the anti-kickback statute.) I have another question about whether the inventor of a new medical device could use crowd-sourcing (e.g,. kickstarter) to raise funds for product development, without running afoul of the FDA proscriptions on unapproved marketing. I would love to get your ideas about open questions in other areas, including bioethics, medical malpractice, public health law, scope of practice, etc. Please post them in the comments or contact me. I’m happy to reciprocate.

Daniel Kahneman & Cass Sunstein at Harvard Business School, 2/3

If you’re interested in the Petrie-Flom Center’s upcoming annual conference, “Behavioral Economics, Law, and Health Policy,” you may want to check out this event at Harvard Business School:

On February 3rd, at 5:00 PM in Spangler Auditorium at Harvard Business School, Daniel Kahneman, Nobel Prize-winning author of Thinking, Fast and Slow, will be speaking with Cass Sunstein, Robert Walmsley University Professor. This event is co-sponsored by the Behavioral Insights Group at the Center for Public Leadership at the Harvard Kennedy School, and the Negotiations, Organizations, and Markets Unit at Harvard Business School.

RSVP required https://www.surveymonkey.com/s/7VXDZ3M ; for any questions, contact Abigail Dalton (abigail-_dalton@hks.harvard.edu,  617-496-4391).

How Drug Samples Are Being Used to Fight the Good Fight

By Deborah Cho

I would highly recommend reading the Stanford Social Innovation Review’s recent article An Rx for Surplus Meds featuring the Dispensary of Hope, a brilliant model of providing prescription medications to those who need but can’t afford them.

In a nutshell, the Dispensary of Hope, a not-for-profit enterprise, collects unused medication samples from participating physicians and pharmacies across the country and redistributes those medications to safety-net health centers.  Those health centers can then prescribe these much-needed medications to patients who are unable to obtain them otherwise.  Since many of those medications would likely sit on shelves until they had to be discarded if they were not donated, this is beneficial to both the physician practices that no longer have to worry about proper drug sample disposal and also to safety-net health centers and their patients.

More specifically, participating physician practices and pharmacies simply fill with medications the boxes that are shipped to them by the organization and then ship the box back to the organization’s headquarters.  The organization’s staff and volunteers there do all the legwork necessary to properly inventory the drugs so that they can be distributed.  This way, time and effort required on the parts of these physician and pharmacy groups is minimal (not to say that their contribution is minimal – the Stanford article states that $14 million of sample donations were expected for 2013).  The organization thus provides a missing link, acting as an intermediary between the donors and the recipients to keep the supply constant and regular.

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