Check out the latest news from the Petrie-Flom Center!

PFC_Banner_DrkBlueCheck out the March 20th edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.

Featured in this edition:

KIngKing v. Burwell and the Future of the Affordable Care Act

April 1, 2015

8:00 AM – 12:00 PM
Wasserstein Hall, Milstein East B
Harvard Law School
1585 Massachusetts Avenue
Cambridge, MA

A full agenda is available on our website. Register here!

This Term, in King v. Burwell, the Supreme Court will consider whether the Affordable Care Act permits the government to extend tax-credit subsidies to citizens of states that have chosen not to establish their own insurance exchange. If the Court rules that these subsidies are not permitted under the law, the fallout will be extensive and possibly devastating to state insurance markets, and countless local, state, and federal actors will have to decide how to move forward.  This event will bring together scholars and practitioners in the fields of law, public health, and economics to evaluate the oral argument in the case and consider how the Court is likely to rule before exploring the likely impacts of a decision against the government and finally beginning to build groundwork for politically-viable fixes at all levels of public and private involvement.

This event is supported by the Oswald DeN. Cammann Fund.

For more on news and events at Petrie-Flom, see the full newsletter.

THIS WEEK (3/18 – 3/20): Families Matter: Ethically, Legally, and Clinically

Families Matter: Ethically, Legally, and Clinically

child_pediatrician_slide_270_200_85_c1March 18 – 20, 2015

Harvard Medical School
Joseph B. Martin Conference Center
77 Avenue Louis Pasteur
Boston, MA 02115

A full agenda is available on our website.

We often talk, in bioethics, about individual autonomy.  Yet our most challenging ethical, legal and clinical controversies in health care often center around family roles and responsibilities: How should we handle parents’ refusals of medically recommended treatment or, conversely, parents’ requests to medicate or surgically alter their children?  What should be known, and by whom, about a child’s genome, especially when genetic information effects other family members?  What weight should be given to family interests in decisions about a child’s health care?  How should we think about 3-parent embryos? Gamete donors? Gestational mothers? What rights and responsibilities should fathers have with regard to decisions about abortion and adoption, for example, as well as health care decisions for their offspring?  Health care decisions might be messier, but maybe they would also be better if we gave more attention to family matters, and how families matter.

This multidisciplinary program has been developed to inform and deliberate with ethicists, health care providers, attorneys and the public about changes in conceptions of the family and medical technologies and practices that challenge moral conventions and contemporary law.  Faculty experts and participants will engage in thoughtful discussion regarding a broad range of ethical and legal issues that arise from new ways of creating and new ways of understanding families and providing health care for expectant parents, growing fetuses, infants, children, adolescents….and their families.

Co-sponsored with the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund.

Two forthcoming publications on (1) European Stem Cell Patenting, and (2) IP issues in Biobanking

I am happy to announce the following publications:

1) Minssen, Timo and Nordberg, A., The Evolution of the CJEU’s Case Law on Stem Cell Patents: Context, Outcome and Implications of Case C‑364/13 International Stem Cell Corporation (March 11, 2015). Available at SSRN: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2576807  (under review for journal publication)

Abstract:  

On 18th December 2014, the CJEU rendered its’ much-anticipated decision in C‑364/13 International Stem Cell Corporation v Comptroller General of Patents (ISCC). Qualifying its’ earlier ruling in Brüstle v. Greenpeace (Brüstle) with regard to non-fertilised human ova stimulated by parthenogenesis, the Court held that in order to constitute a ‘human embryo’ – and thus to be unpatentable under the EU Biotechnology Directive – the stimulated ovum must have the “inherent capacity to develop into a human being”. This would allow patents on innovative parthenotes which had not been genetically modified to achieve totipotent capabilities. Hence the judgment establishes a crucial limitation of the broad interpretation of “human embryos” in Brüstle, where the CJEU held that parthenotes are covered by the term “human embryo” since they are “capable of commencing the process of development of a human being”. The ISCC decision is to be welcomed since it provides an ethically justifiable leeway for patenting and offers reasonable support to the commercial viability of European cell therapy research. Yet, ISCC’s impact still depends on national implementations and only applies to certain hESC cells. Thus, further clarifications would be helpful concerning other non-totipotent hESCs.

Continue reading

Check out the latest news from the Petrie-Flom Center!

PFC_Banner_DrkBlueCheck out the March 6th edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.

Featured in this edition:

KIngKing v. Burwell and the Future of the Affordable Care Act

April 1, 2015

8:00 AM – 12:00 PM
Wasserstein Hall, Milstein East B
Harvard Law School
1585 Massachusetts Avenue
Cambridge, MA

A full agenda is available on our website. Register here!

This Term, in King v. Burwell, the Supreme Court will consider whether the Affordable Care Act permits the government to extend tax-credit subsidies to citizens of states that have chosen not to establish their own insurance exchange. If the Court rules that these subsidies are not permitted under the law, the fallout will be extensive and possibly devastating to state insurance markets, and countless local, state, and federal actors will have to decide how to move forward.  This event will bring together scholars and practitioners in the fields of law, public health, and economics to evaluate the oral argument in the case and consider how the Court is likely to rule before exploring the likely impacts of a decision against the government and finally beginning to build groundwork for politically-viable fixes at all levels of public and private involvement.

This event is supported by the Oswald DeN. Cammann Fund.

For more on news and events at Petrie-Flom, see the full newsletter.

FREE REGISTRATION! Families Matter: Ethically, Legally, and Clinically

Families Matter: Ethically, Legally, and Clinically

child_pediatrician_slide_270_200_85_c1March 18 – 20, 2015

Harvard Medical School
Joseph B. Martin Conference Center
77 Avenue Louis Pasteur
Boston, MA 02115

A full agenda is available on our website.

We often talk, in bioethics, about individual autonomy.  Yet our most challenging ethical, legal and clinical controversies in health care often center around family roles and responsibilities: How should we handle parents’ refusals of medically recommended treatment or, conversely, parents’ requests to medicate or surgically alter their children?  What should be known, and by whom, about a child’s genome, especially when genetic information effects other family members?  What weight should be given to family interests in decisions about a child’s health care?  How should we think about 3-parent embryos? Gamete donors? Gestational mothers? What rights and responsibilities should fathers have with regard to decisions about abortion and adoption, for example, as well as health care decisions for their offspring?  Health care decisions might be messier, but maybe they would also be better if we gave more attention to family matters, and how families matter.

This multidisciplinary program has been developed to inform and deliberate with ethicists, health care providers, attorneys and the public about changes in conceptions of the family and medical technologies and practices that challenge moral conventions and contemporary law.  Faculty experts and participants will engage in thoughtful discussion regarding a broad range of ethical and legal issues that arise from new ways of creating and new ways of understanding families and providing health care for expectant parents, growing fetuses, infants, children, adolescents….and their families.

Co-sponsored with the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund.

Check out the latest news from the Petrie-Flom Center!

PFC_Banner_DrkBlueCheck out the February 20th edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.

Featured in this edition:

child_pediatrician_slide_270_200_85_c1FREE REGISTRATION!
Families Matter: Ethically, Legally, and Clinically

March 18 – 20, 2015
Harvard Medical School
Boston, MA

We often talk, in bioethics, about individual autonomy.  Yet our most challenging ethical, legal and clinical controversies in health care often center around family roles and responsibilities: How should we handle parents’ refusals of medically recommended treatment or, conversely, parents’ requests to medicate or surgically alter their children?  What should be known, and by whom, about a child’s genome, especially when genetic information effects other family members?  What weight should be given to family interests in decisions about a child’s health care?  How should we think about 3-parent embryos? Gamete donors? Gestational mothers? What rights and responsibilities should fathers have with regard to decisions about abortion and adoption, for example, as well as health care decisions for their offspring?  Health care decisions might be messier, but maybe they would also be better if we gave more attention to family matters, and how families matter. Continue reading

Check out the latest news from the Petrie-Flom Center!

PFC_Banner_DrkBlueCheck out the February 6th edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.

Featured in this edition:

genderreassignment_slideGender (Re)assignment:Legal, Ethical, and Conceptual Issues

Tuesday, February 10, 2015, 12:00 PM

Pound Hall 102 1563 Massachusetts Avenue, Cambridge, MA [Map]

Trans and intersex individuals face a series of legal, medical, and social challenges. This panel explores these overlapping issues, including: healthcare coverage of treatments such as gender reassignment therapy, the legal recognition of trans identities, intersexuality, and asexuality.  Join us for a wide-ranging panel discussion. Panelists include: Noa Ben-AsherElizabeth F. EmensGerald L. NeumanMatthew J.B. Lawrenceand I. Glenn Cohen.

For more on news and events at Petrie-Flom, see the full newsletter.

Upcoming Event (2/12): A Dialogue on Agency, Responsibility, and the Brain with Stephen Morse

MorseA Dialogue on Agency, Responsibility, and the Brain with Stephen Morse

Thursday, February 12, 2015, 12:00 PM

Wasserstein Hall, 3019                       Harvard Law School                                       1585 Massachusetts Avenue                     Cambridge, MA 02138 [Map]

Join guest speaker Professor Stephen J. Morse, JD, PhD, former MacArthur Foundation Law & Neuroscience Project co-Chair and co-Director of the Center for Neuroscience and Society and CLBB Faculty members Judge Nancy A. Gertner and Professor Amanda C. Pustilnik for a conversation about how – or whether – new knowledge about the brain is changing legal concepts of agency and responsibility.

Stephen J. Morse is the Ferdinand Wakeman Hubbell Professor of Law; Professor of Psychology and Law in Psychiatry; and Associate Director, Center for Neuroscience & Society at the University of Pennsylvania. Morse works on problems of individual responsibility and agency. Morse was Co-Director of the MacArthur Foundation Law and Neuroscience Project. Morse is a Diplomate in Forensic Psychology of the American Board of Professional Psychology; a past president of Division 41 of the American Psychological Association; a recipient of the American Academy of Forensic Psychology’s Distinguished Contribution Award; a member of the MacArthur Foundation Research Network on Mental Health and Law; and a trustee of the Bazelon Center for Mental Health Law.

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

Part of the Project on Law and Applied Neuroscience.

Tomorrow (1/29): A “Natural” Experiment: Consumer Confusion and Food Claims, a lecture by Efthimios Parasidis

A “Natural” Experiment: Consumer Confusion and Food Claims, a lecture by Efthimios Parasidis

Thursday, January 29, 2015, 12: 00 PM

Wasserstein Hall, Milstein West B                               Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA [Map]

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

Efthimios Parasidis is Associate Professor at The Ohio State University Moritz College of Law and holds a joint appointment with the College of Public Health. He is an inaugural member of College of Medicine’s Center for Bioethics and Medical Humanities. His scholarship focuses on the regulation of medical products and human subjects research, the interplay between health law and intellectual property, and the application of health information technology to public health policy. He has published in leading law reviews and health policy journals, is co-authoring a casebook, and has a book under contract with Oxford University Press. The Greenwall Foundation awarded Professor Parasidis a Faculty Scholar in Bioethics fellowship for 2014-2017.

The lecture will be followed by an audience question and answer session moderated by Jacob Gersen, Professor of Law at Harvard Law School and Director of the Food Law Lab.

Cosponsored by the Food Law Lab and the Harvard Food Law and Policy Clinic at Harvard Law School.

Check out the latest news from the Petrie-Flom Center!

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Happy New Year! Check out the January 9th edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.

Featured in this edition:

Harvard Law School 2013-05-03 Petrie-Flom Center Food ConferenceOutbreak: Developing New Medical Products for Epidemics, A lecture by Peter Hutt                                Thursday, January 15, 2015, 12:30 PM                         Hauser Hall 102,                                     1575 Massachusetts Avenue, Cambridge, MA

 

The recent outbreak of Ebola has called attention to the substantial difficulties associated with developing and testing new products for time-sensitive epidemics. What are the legal, ethical, and economic barriers to getting essential treatments and preventative measures from the lab into the hands of patients – and how can they be overcome?

Please join the Petrie-Flom Center for a discussion of these issues by Peter Barton Hutt, Partner at Covington & Burling, LLP, and Lecturer on Law at HLS. Rachel Sachs, Petrie-Flom Center Academic Fellow, will respond.

For more on news and events at Petrie-Flom, see the full newsletter.

A Physician Fights Surgery

Physician and bioethicist Carla C. Keirns described the potentially dangerous impact of medicalization on her own childbirth in the Narrative Matters section of Health Affairs this month. A segment of that writing was reproduced in the Washington Post yesterday.

In each piece, Keirns outlines the challenges she faced in vaginally delivering her son in a hospital environment that seemed committed to performing a caesarian section. Particularly given Keirns’ expertise in and familiarity with health care, the lack of patient-centered care in the story is striking. Several staff suggested that surgery was a foregone conclusion while others appeared unprepared for her son’s long-awaited arrival.

Continue reading

A Right to Die? The M.D. Case Before the Argentine Supreme Court

by Martín Hevia

In 2015, the Argentine Supreme Court is to hear a case involving the right to die, death with dignity, and informed consent. Because of a car accident in the Province of Neuquén, M.D., the patient, has been in a permanent, irreversible, vegetative state for 18 years. His sisters and curators have requested the discontinuation of the vital supportive measures which maintained M.D alive in an artificial way.

This will not be the first time that the Supreme Court hears a case of death with dignity. In 2012, the Court heard the case of Albarracini Nieves, who was unconscious when admitted to a hospital in Buenos Aires. The physicians established that a blood transfusion was necessary. But, as Albarracini belonged to the cult “Jehovah’s Witnesses”, he had had made a statement before a public notary in 2008 where he expressed he would not accept any blood transfusions even if his life were in danger. His father requested a cautionary measure that would order the transfusion to be practiced. The first instance court admitted the solicited measure, considering that although Albarracini had expressed that he refused an eventual transfusion, he was not “in a condition to make decisions with full discernment.”The case then reached the Supreme Court, which argued that there were no reasons to doubt over the current validity of Albarracini’s expression of will and that there was no evidence that he would not have considered the significance of his decision.The Court argued that “…this Court has clearly established that Article 19 of the National Constitution grants the sphere of freedom, within which he can freely adopt fundamental decisions about himself without any State or third parties interference, as long as those decisions do not violate third parties’ rights.”The Court stated that“The possibility of accepting or refusing a specific treatment, or selecting an alternative form of treatment, is part of self-determination and personal autonomy; that patients have the right to choose options according to their own values or points of view, even when they may seem irrational or imprudent, and that free choice must be respected.”

The M.D. case is different in that it is difficult to prove the patient’s will – unlike in the Albarracini Nieves case – because there is not a patient’s written statement on whether it is appropriate for him to continue or not certain medical treatment to keep him alive. The Superior Court of Justice of the Province of Neuquén has decided on the case invoking the 2009 Patients´ Rights Act: according to this law, the sisters have standing to grant informed consent in the name of their brother.

The Supreme Court and Argentine lower courts have interpreted the National Constitution and concluded that it grants patients a wide range of autonomous choice as regards their autonomy, reflected in their right to refuse medical treatment.  On that basis, the Supreme Court will probably confirm the decision of the lower court.

Check out the latest news from the Petrie-Flom Center!

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Check out the December 19th edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.

Featured in this edition:

Harvard Law School 2013-05-03 Petrie-Flom Center Food ConferenceOutbreak: Developing New Medical Products for Epidemics, A lecture by Peter Hutt                                                                                                            Thursday, January 15, 2015, 12:30pm                           Hauser Hall 102,                                                   1575 Massachusetts Avenue, Cambridge, MA

The recent outbreak of Ebola has called attention to the substantial difficulties associated with developing and testing new products for time-sensitive epidemics. What are the legal, ethical, and economic barriers to getting essential treatments and preventative measures from the lab into the hands of patients – and how can they be overcome?

Please join the Petrie-Flom Center for a discussion of these issues by Peter Barton Hutt, Partner at Covington & Burling, LLP, and Lecturer on Law at HLS. Rachel Sachs, Petrie-Flom Center Academic Fellow, will respond.

For more on news and events at Petrie-Flom, see the full newsletter.

Check out the latest news from the Petrie-Flom Center!

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Check out the December 5th edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.

Check out the latest news from the Petrie-Flom Center!

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Check out the November 14th edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.

European Responses to the Ebola Crisis: Initiatives at the European Medicines Agency (EMA)

By Timo Minssen

The current Ebola outbreak already attracted much attention on “Bill of Health” resulting in some excellent blogs on a horrible topic.

While it is evident that the current health crisis requires both immediate responses and more sustainable changes in health care policy, research and regulation, medicines regulators are collaborating internationally to find innovative solutions enhancing evaluation of and access to potential new medicines to fight Ebola outbreaks. In a statement announced by the International Coalition of Medicines Regulatory Authorities (ICMRA) in September 2014, regulators around the world led by the FDA and the EMA have vowed to collaborate in supporting accelerated evaluation of experimental new drugs to treat Ebola virus infections and say they will encourage submission of regulatory dossiers. This clearly backs up the World Health Organization’s (WHO) decision to test experimental Ebola treatments in infected patients in the current outbreak region in West Africa and to speed up the development of vaccines.

In the following I would like to summarize and discuss some of the recent European responses to the current crisis starting with an overview on recent initiatives at the EMA.

Like its US counterpart, the EMA leads a close and consistent dialogue with public and private developers of Ebola products and spends much effort in reviewing available information on the various experimental Ebola treatments currently under development. These experimental drugs range from experimental antivirals or vaccines based on the adenovirus or stomatitis vaccine to experimental therapies based on mono- and polyclonal antibody technologies. One of these unapproved antibody combination drugs – MAPP Biologicals’  ZMapp – has already been used in some care workers affected by Ebola. Other experimental drugs that are currently reviewed by the EMA include Biocryst’s BCX 4430, Fab’entech’s Hyperimmune horse sera, Sarepta’s AVI-7537, Toyama Chemicals and MediVector’s Favipiravir and Tekmira’s TKM-Ebola.

Other companies such as Bavarian Nordic  and the Russian Mikrogen are close to follow.

In addition to monitoring experimental drugs and enhancing global collaboration, the European Medicines Agency has like the FDA initiated several activities in order to support and speed up the development of these drugs towards market approval.  Continue reading

Bioethics on the Ballot

In addition to the closely-watched senate and gubernatorial candidates, 146 ballot questions were up for vote yesterday in 42 states across the nation. Below is a review of the some of the most pressing bioethics issues on the docket and the latest information on what passed according to Politico’s Ballot TrackerContinue reading

Check out the latest news from the Petrie-Flom Center!

10-31_Newsletter_ScreenshotHappy Halloween! Check out the October 31st edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.

Check out the latest news from the Petrie-Flom Center!

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Check out the October 17th edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.

Check out the latest news from the Petrie-Flom Center!

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Check out the October 3rd edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.