I am happy to announce the publication of our new working paper on “Patenting Bioprinting Technologies in the US and Europe – The 5th element in the 3rd dimension.” The paper, which has been co-authored by Marc Mimler, starts out by describing the state of the art and by examining what sorts of bioprinting inventions are currently being patented. Based on our findings we then discuss what types of future innovations we can expect from the technological development and how far these would and/or should be protectable under European and US patent laws.
The paper is forthcoming in: RM Ballardini, M Norrgård & J Partanen (red), 3D printing, Intellectual Property and Innovation – Insights from Law and Technology. Wolters Kluwer, but the working paper is already available on SSRN. Continue reading →
New technologies in biology offer a brave new world of possibilities. Promising solutions to some of the most urgent challenges faced by humanity: climate change, environmental protection, growing population, renewable energy and improved health care. Scientific and technological progress has been remarkable. Simultaneously, emerging life science technologies raise outstanding ethical, legal and social questions.
In this research seminar, Prof. Esther Van Zimmeren from the University of Antwerp joins Prof. Timo Minssen, Postdoc Ana Nordberg and Ph.D. Student Jakob Wested from the Centre for Information and Innovation Law, debating bold new policies for intellectual property law and incentive to life science innovation.
15:00 – 15:10
Welcome Prof. Timo Minssen, CIIR, Faculty of Law, University of Copenhagen.
15:10 – 15:30
Waiting for the Rumble in the Jungle: – An overview of current CRISPR/CAs9 patent disputes, central legal issues and some thoughts on conditioning the innovation system. PhD Student Jakob Wested, CIIR, Faculty of Law, University of Copenhagen.
15:30 – 15:50
From FRAND to FAIR for Synthetic and Systems Biology? The Implications of Openness, IP Strategies, Standardization and the Huawei-case. Prof. Esther van Zimmeren, Faculty of Law, University of Antwerp.
15:50 – 16:10
Keeping up with the technologies: IP Law and Regulation in the age of gene editing. Postdoc Ana Nordberg, CIIR, Faculty of Law, University of Copenhagen.
In January of this year, Cell published a study modestly titled, Interspecies Chimerism with Mammalian Pluripotent Stem Cells. It reports success bioengineering a mostly-pig partly-human embryo. One day before, Nature published a report that scientists had grown (for lack of a better word) a functioning genetically-mouse pancreas within the body of a genetically-modified rat. The latest study raises the likelihood that before long, it will also be scientifically possible to grow human organs within bioengineered pigs.
The implications for transplantation are tremendous. But hold the applause for now. Imagine a chimera with a brain made up of human neurons which expressed human genes. Would organ procurement without consent be okay? That troubling possibility raises questions about whether manufacturing chimeras with human-like properties for organs is even appropriate in the first place. Here’s what University of Montreal bioethicist Vardit Ravitsky told the Washington Post:
“I think the point of these papers is sort of a proof of principle, showing that what researchers intend to achieve with human-non-human chimeras might be possible … The more you can show that it stands to produce something that will actually save lives … the more we can demonstrate that the benefit is real, tangible and probable — overall it shifts the scale of risk-benefit assessment, potentially in favor of pursuing research and away from those concerns that are more philosophical and conceptual.”
I respectfully disagree. Saving more lives, of course, is good. Basic science is also valuable – even more so if it might translate to the bedside. This line of research, though, is positioned to upend our entire system of transplantation, and so its implications go beyond organ supply. In this post I will argue that to assess this technology’s implications for organ procurement in particular, there is good reason to focus on harms, not benefits. Continue reading →
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.
This past week week I attended the International Neuroethics Society’s (INS) annual conference in San Diego, California. Neuroethics is multidisciplinary field that grapples with the implications of neuroscience for—and from—medicine, law, philosophy, and the social sciences. One of the many excellent panels brought together scholars from each of these four disciplines to discuss the diverse approaches to the field. The panel featured; Paul Appelbaum, a Professor of Psychiatry at Columbia University; Tom Buller, Chair of philosophy at Illinois State University; Jennifer Chandler, Professor of law at the University of Ottawa, and; Ilina Singh, Professor of Neuroscience & Society at the University of Oxford.
The panel started by considering the importance of the “competing identities” present in the field of neuroethics. As moderator Eric Racine explained, right from the start, even the term ‘neuroethics’ suggests a tension. Consider the variety of research methodologies employed in the field. For instance, a scholar trained in philosophy might approach neuroscience from a conceptual and purely analytical basis, and yet a social scientist might research the same question by collecting empirical interview data. The interplay between empirical and theoretical work was a theme that defined the discussion.
A psychiatrist by training, Dr. Applebaum spoke on the medical approach to the field. He argued that a focus on ethical issues in clinical psychiatry and neurology should be viewed as a part (but only a part) of neuroethics. Furthermore, medicine’s empirical approach to neuroethics is one (but not the only) way to advance thinking on neuroethical issues. Continue reading →
I just watched the movie Concussion (2015) as an assignment for one of my bioethics courses. The movie is about a physician, Dr. Bennet Omalu, as he unravels the association between playing in NFL and an acquired neurodegenerative disease, a condition he calls, “chronic traumatic encephalopathy” (CTE). At one point Dr. Omalu tries to convince a prominent researcher that, despite suffering head traumas similar to those of football players, animals like the woodpecker have the means of avoiding CTE;
“The woodpecker’s tongue comes out the back of the mouth through the nostril and goes around the top of its head. Basically, it’s one big safety belt for the brain.” (source)
The tongue shoots out through the nostril? As a medical student, I found this trivial aside absolutely fascinating. But when I tried to learn more I quickly realized–to my dismay–that most experts would balk at this characterization. Woodpeckers don’t develop CTE for a variety of reasons, including; (1) smaller mass means less force from deceleration; (2) no head rotation during each peck as to decrease angular forces, and; (3) their skulls have a physiologic protective cushion. I won’t delve further into the weeds about where exactly the movie’s assertions depart from reality, but to put it generously, this crucial argument totally misrepresents the science.
The problem with all of this is that it’s tempting to watch Concussion and feel better informed about the controversies surrounding professional football and CTE. To be honest, I was mesmerized watching familiar events brought to life on screen, and it all seemed credible as it used the actual names of people involved. Movie reviews by Rolling Stone even suggest that it should be mandatory for football fans, and The New York Times remarks on how it, “sells a complex issue.” Sure, everyone knows Concussion is “for entertainment purposes only,” but can’t stories that are true also be entertaining? However, the seemingly-trivial inaccuracy about woodpeckers was a potent reminder that this film is not a documentary. Concussion should be viewed as it is–a major Hollywood blockbuster starring Will Smith and Alec Baldwin.
A new Op-Ed by Bill of Health Contributor Dov Fox on CNN:
The upcoming Supreme Court term promises to be a sleeper. Still down a justice, the court isn’t slated to hear its usual blockbusters on the likes of abortion, affirmative-action or same-sex marriage. But its first day back in session does feature at least one intriguing controversy in the case of Peña Rodriguez v. Colorado.
At the heart of the case are two incompatible visions of what a jury is supposed to be. The first ideal emphasizes objective decision-making. It demands that jurors arrive at verdicts free of any influence beyond the testimony and evidence that’s presented in court. The second ideal stresses jurors’ subjectivity. It insists on a jury of peers that can speak as the voice of the community. How can jurors remain unbiased, however, while relying on the very experiences and perspectives that bias them? […]
As reported by Science, today the NIH announced plans to lift a preemptive year long moratorium on funding chimera research – that which mixes human and animal cells, often at the embryonic stage.
Here is a snippet from the Science article about the new proposed NIH process:
According to twonotices released today, NIH is proposing to replace the moratorium with a new agency review process for certain chimera experiments. One type involves adding human stem cells to nonhuman vertebrate embryos through the gastrulation stage, when an embryo develops three distinct layers of cells that then give rise to different tissues and organs. The other category is studies that introduce human cells into the brains of postgastrulation mammals (except rodent studies, which won’t need extra review).
These proposed studies will go to an internal NIH steering committee of scientists, ethicists, and animal welfare experts that will consider factors such as the type of human cells, where they may wind up in the animal, and how the cells might change the animal’s behavior or appearance. The committee’s conclusions will then help NIH’s institutes decide whether to fund projects that have passed scientific peer review.
The devil will, of course, be in the details. It will be interesting to see how much NIH takes a more categorical approach as opposed to more case-by-case rule making like in the Institutional Review Board or ESCRO setting. Continue reading →
Doctor Strafford delivered a masterful overview of the trajectory of scientific perspective and research about children and pain. Over the course of her career, the medical perspective has transformed from “children do not feel pain” to “children do not remember pain” to inquiry into “when and how children feel pain.” Strafford described the medical complexities of understanding the physical and subjective aspects of pain as well as the impossibility of confidently “pinpointing” the exact point in fetal development when a neonate experiences pain.
Professor Pustilnik gave an equally compelling review of law and legal language regarding abortion, particularly law that specifically references fetal pain as a reason for limiting abortion. This served to frame a conversation about pain and suffering in the law and the ways in which law reflects normative considerations and provides rhetoric (viewed respectively by partisans as “compelling” or “inflammatory”) to political discourse. In this case, discourse about fetal pain both attracts attention and is intended to facilitate empathy for the neonate. Continue reading →
At first glance it seems like unequivocal good news: Juvenile crime rates are at approximately the same levels as the early 1970’s and high school graduation rates have risen from 65 percent four years ago to 82 percent in 2013-2014. But, a closer look suggests a different picture under the surface of this aggregate national data.
Overall rates of juvenile crime have diminished considerably since the high-water mark in the late 1980’s and early 1990’s but “hot spots” of violent crime by juveniles and young adults—especially gun violence—persistently burn in neighborhoods of large cities like Detroit, Chicago, Oakland, Cleveland, and Baltimore as well as in smaller cities like Flint (MI), New Haven (CT), Rockford (IL), Odessa (TX), and Springfield (MA), and in many rural areas with intractable high poverty rates and which have seen gang infiltration in recent years. Continue reading →
It is fitting that I am writing this first blog of my time as Senior Fellow in Law and Applied Neuroscience as we transition through the change of seasons. It is a privilege to have the time afforded by this joint Fellowship between Harvard Law School (Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics) and Massachusetts General Hospital (Center for Law, Brain, and Behavior) to focus upon the intersections of behavioral science, developmental neuroscience, and juvenile justice. The autumnal change of seasons is a fitting metaphor for the slow but profound changes occurring in juvenile justice which have been spurred in large measure by emerging neuroscience increasingly describing the neurobiology of adolescence. This neuroscience provides the biological complement to what developmental psychologists have well described and what parents have long known: Children are different.
This emerging neuroscience has become a quiet but increasingly pervasive force in helping us understand why most delinquent youth desist with maturation—even adolescents who are chronically delinquent and violent. It helps us understand why punitive “tough on teen crime” approaches born of fears in the 1990’s of the rise of violent teen “super-predators” actually compromises public safety over time—especially when youth are tried as adults and incarcerated with adults. And, it helps us understand why mass detention and incarceration of youth—many of them for non-violent offenses—not only harms those youth but tends to increase their risks of continued misconduct and of later deep penetration into the adult criminal justice system. Continue reading →
Professional football has come under significant scrutiny in recent years, particularly because of concerns over player health and safety. While concussions are most often discussed, players also face a variety of other health risks, from joint and muscle problems to cardiac malfunction to issues with chronic pain. But health risks are just one part of story. So, too, are the potential short and long-term benefits these exceptional athletes may reap from the game.
Come learn more about the debate, and about The Football Players Health Study at Harvard University, which seeks to understand and improve the health and wellbeing of former NFL players. This study looks at the risks and benefits of playing football at the professional level over the life of the player, supports novel discoveries and new therapies, and seeks to improve the systems and organizational structures that may affect player health.
The neuroscience of adolescent brain development has had increasing impact on American jurisprudence. The U.S. Supreme Court relied on this neuroscience in Roper v. Simmons (2005) in barring execution for capital crimes committed as a juvenile and in Miller v. Alabama (2012) in holding that mandatory life without possibility of parole for juveniles is also unconstitutional. This panel will examine the implications of developmental neuroscience for law in specific domains including death penalty mitigation for young adults over age 18 such as the Tsarnaev case, a developmentally informed view of Miranda and Competence to Stand Trial for juveniles, trial of youth as adults, and conditions of confinement in juvenile and adult incarceration. The panel will also discuss the promises and perils for constitutional jurisprudence, legal and public policy reform, and trial practice of relying upon a complex body of science as it emerges.
What should the future look like for brain-based pain measurement in the law? This is the question tackled by our concluding three contributors: Diane Hoffmann, Henry (“Hank”) T. Greely, and Frank Pasquale. Professors Hoffmann and Greely are among the founders of the fields of health law and law & biosciences. Both discuss parallels to the development of DNA evidence in court and the need for similar standards, practices, and ethical frameworks in the brain imaging area. Professor Pasquale is an innovative younger scholar who brings great theoretical depth, as well as technological savvy, to these fields. Their perspectives on the use of brain imaging in legal settings, particularly for pain measurement, illuminate different facets of this issue.
This post describes their provocative contributions – which stake out different visions but also reinforce each other. The post also highlights the forthcoming conference-based book with Oxford University Press and introduces future directions for the use of the brain imaging of pain – in areas as diverse as the law of torture, the death penalty, drug policy, criminal law, and animal rights and suffering. Please read on!
The recent meeting at Harvard on neuroimaging, pain, and the law demonstrated powerfully that the offering of neuroimaging as evidence of pain, in court and in administrative hearings, is growing closer. The science for identifying a likely pattern of neuroimaging results strongly associated with the subjective sensation of pain keeps improving. Two companies (and here) recently were founded to provide electro-encephalography (EEG) evidence of the existence of pain. And at least one neuroscientist has been providing expert testimony that a particular neuroimaging signal detected using functional magnetic resonance imaging (fMRI) is useful evidence of the existence of pain, as discussed recently in Nature.
If nothing more is done, neuroimaging evidence of pain will be offered, accepted, rejected, relied upon, and discounted in the normal, chaotic course of the law’s evolution. A “good” result, permitting appropriate use of some valid neuroimaging evidence and rejecting inappropriate use of other such evidence, might come about. Or it might not.
We can do better than this existing non-system. And the time to start planning a better approach is now. (Read on for more on how)
By Frank Pasquale, Professor of Law, University of Maryland Carey School of Law
Many thanks to Amanda for the opportunity to post as a guest in this symposium. I was thinking more about neuroethics half a decade ago, and my scholarly agenda has, since then, focused mainly on algorithms, automation, and health IT. But there is an important common thread: The unintended consequences of technology. With that in mind, I want to discuss a context where the measurement of pain (algometry?) might be further algorithmatized or systematized, and if so, who will be helped, who will be harmed, and what individual and social phenomena we may miss as we focus on new and compelling pictures.
Some hope that better pain measurement will make legal disability or damages determinations more scientific. Identifying a brain-based correlate for pain that otherwise lacks a clearly medically-determinable cause might help deserving claimants win recognition for their suffering as disabling. But the history of “rationalizing” disability and welfare determinations is not encouraging. Such steps have often been used to exclude individuals from entitlements, on flimsy grounds of widespread shirking. In other words, a push toward measurement is more often a cover for putting a suspect class through additional hurdles than it is toward finding and helping those viewed as deserving.
Of Disability, Malingering, and Interpersonal Comparisons of Disutility (read on for more)
As someone who has been greatly concerned about and devoted much of my scholarship to legal obstacles to the treatment of pain, I applaud Professor Pustilnik for increasing attention to the role of neuroimaging in our efforts to understand our experience of pain and how the law does or does not adequately take into account such experience. Pustilnik has written eloquently about this issue in several published articles but her efforts to bring together scientists, medical experts, legal academics, and judges (see also here) deserves high praise as a method for illuminating what we know and do not know about pain and the brain and to what extent brain imaging can serve as a diagnostic tool or an external validator of pain experience.
In this post, I discuss how DNA testing serves as a precedent for how to develop responsible uses of new technologies in law, including, potentially, brain imaging for pain detection. The ethical, legal, and social implications (ELSI) of DNA research and testing were integral to developing national protocols and rules about DNA. Brain imaging of pain needs its own ELSI initiative, before zealous adoption outpaces both the technology and the thinking about the right guiding principles and limitations.
The idea of brain images serving as a “pain-o-meter” to prove or disprove pain in legal cases is clearly a premature use of this information and likely an over simplification of the mechanisms of pain expression. However, the potential for an objective diagnostic tool or indicator of the pain experience is something that lawyers representing clients in criminal, personal injury, workers comp or disability cases may find too attractive to resist and attempt to have admitted in the courtroom. This state of affairs brings to mind the ways in which lawyers have attempted to use genetic test results, initially obtained for medical purposes, in litigation. (Read on for more about ELSI in DNA and several national pain initiatives that could adopt the Human Genome Project and DNA ELSI model).
Earlier this month the Supreme Court of New South Wales ruled that an individual who experienced post-traumatic stress disorder (PTSD) as the result of an airplane crash could recover damages under the Montreal Convention. The case was important because many courts have previously ruled that PTSD, absent any other “bodily injury,” was not covered by the bodily injury provisions of the international agreement.
The case is illustrative of the way in which courts across the world continue to find a meaningful distinction between “physical” (or “bodily”) injury/pain and “mental” (or “emotional”) injury/pain. If you want an example closer to home, pull out your auto insurance policy and scan for the phrase “bodily injury.” Auto insurance cases sometimes include disagreement about whether mental injuries are considered bodily.
I’m on the record as saying this traditional physical/emotional distinction no longer holds up because substance dualism is no longer a viable theory. If neurons and glia cells are physical (and last I checked they were), then emotions and emotional pain must be physical too. But that doesn’t mean that the law has to treat all pain the same. Even if everything is physical, law may – for a variety of good reasons – choose to differentiate amongst them. For instance, do we want to understand assault (which is the infliction of “bodily injury”) to include the infliction of emotional pain? Maybe, but it’s not so cut and dry.