Loneliness as epidemic

By Wendy S. Salkin

Just a few weeks ago, The New York Times ran an article confirming that, indeed, we are facing an epidemic of loneliness. There is “mounting evidence” that links loneliness to illness, as well as “functional and cognitive decline.” What’s more, loneliness turns out to be a better predictor of early death than obesity.

Neuroscientist John Cacioppo, who has spent much of his career working on loneliness, defines “loneliness” as “perceived social isolation.” Similarly, Masi, et al. (following Russell, et al. 1980) define “loneliness” as “the discrepancy between a person’s desired and actual social relationships.” As Masi, et al., point out, there is a distinction to be made between loneliness, on the one hand, and social isolation, on the other, although the two phenomena may indeed often go together. Whereas social isolation “reflects an objective measure of social interactions and relationships,” loneliness “reflects perceived social isolation or outcast.” Following Peplau & Perlman 1982 and Wheeler, et al. 1983, they go on to point out that “loneliness is more closely associated with the quality than the number of relationships.” (It’s important and timely to note that the 2016 Nobel Laureate in Literature, Bob Dylan, brought out one application of this conceptual distinction in his song, “Marchin’ to the City,” when he sang: “Loneliness got a mind of its own / The more people around the more you feel alone.”)

The health risks posed by loneliness are several and can be severe. Loneliness can contribute to increased risk of coronary heart disease, cardiovascular disease, and stroke. In a 2016 systematic review and meta-analysis in Heart, Valtorta, et al., reported that “poor social relationships were associated with a 29% increase in risk of incident CHD [coronary heart disease] and a 32% increase in risk of stroke.” And in a March 2015 meta-analysis in Perspectives on Psychological Science, Holt-Lunstad, et al., reported that a substantial body of evidence supports the following two claims:

  1. Loneliness puts one at greater risk for premature mortality. In particular, “the increased likelihood of death was 26% for reported loneliness, 29% for social isolation, and 32% for living alone.”
  2. The heightened risk for mortality due to “a lack of social relationships” (whether reported loneliness, social isolation, or living alone) is greater than the risk due to obesity.

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Organs and Overdoses: The Numbers (Part I)

By Brad Segal

The surging opioid epidemic is a threat to the nation’s public health. This year the CDC reported that mortality from drug overdose reached an all-time high, with the annual death toll more than doubling since 2000. Yet in the backdrop of this epidemic, the country also faces ongoing shortages of a different sort–too few organs for transplantation. Every day, approximately 22 people die while waiting for an organ to become available. To some it is not a surprise–or at least not inconceivable–that the fastest-growing source of organ donors is being fueled by the national spike in drug overdoses. This first post will help delineate the scope and scale of the situation. My follow-up will discuss the ethical considerations and ramifications for public policy.

To start: the numbers. The Organ Procurement and Transplantation Network (OPTN) makes domestic transplant data publicly available online, which currently extends from 1994 to September 30th, 2016. Two decades ago, 29 organ donors died from a drug overdose.* In just the first nine months of this year, that number has climbed to 888 donors. Even with a quarter of the calendar year left to be counted, 2016 has already surpassed previous record set in 2015 (Figure 1).


Figure 1

One might question whether this trend is an illusion–perhaps a rise in the incidence of donors who had overdosed reflects an increasing number of transplants. But the data suggest the opposite. Also plotted in Figure 1, the percentage of total organ donors who died from overdose (maroon diamonds, right-sided Y axis) has not remained constant–instead, the percentage has steadily increased. Two decades ago, overdose caused the deaths of 0.6% of all organ donors; this year, it is the cause of death among 12.0% of organ donors nationwide. The rising percentage means that not only are more victims of drug overdose donating organs, but that the pool of organ donors is increasingly composed of such individuals. Continue reading

CMS Prohibits Arbitration Clauses in Long-Term Care Facility Contracts

By Wendy S. Salkin

On Wednesday, the Centers for Medicare and Medicaid (CMS)—an agency within the Department of Health and Human Services (HHS)—released a final rule that “will revise the requirements that Long-Term Care facilities [LTCs] must meet to participate in the Medicare and Medicaid programs” (1). (Almost all LTCs receive funds from Medicare or Medicaid.) This is the first time that these requirements have been “comprehensively reviewed and updated since 1991” (6)—that is, in the past 25 years. One of the most striking changes to the regulation is found in §483.65, where CMS “require[es] that facilities must not enter into an agreement for binding arbitration with a resident or their representative until after a dispute arises between the parties” (12) which means that CMS is “prohibiting the use of pre-dispute binding arbitration agreements” (12). Among the reasons provided by CMS for this change is a recognition of the notable power differential between LTCs and their residents:

There is a significant differential in bargaining power between LTC facility residents and LTC facilities. LTC agreements are often made when the would-be resident is physically and possibly mentally impaired, and is encountering such a facility for the first time. In many cases, geographic and financial restrictions severely limit the choices available to a LTC resident and his/her family. LTC facilities are also, in many cases, the resident’s residence. These facilities not only provide skilled nursing care, but also everything else a resident needs. Many of these residents may reside there for a prolonged period of time, some for the rest of their lives. Because of the wide array of services provided and the length of time the resident and his/her family may have interactions with the LTC facility, disputes over medical treatment, personal safety, treatment of residents, and quality of services provided are likely to occur. Given the unique circumstances of LTC facilities, we have concluded that it is unconscionable for LTC facilities to demand, as a condition of admission, that residents or their representatives sign a pre-dispute agreement for binding arbitration that covers any type of disputes between the parties for the duration of the resident’s entire stay, which could be for many years. (402-403)

As The New York Times reported, when the rule was first proposed in July 2015, it was “aimed at improving disclosure.” But, this final version of the rule “went a step further than the draft, cutting off funding to facilities that require arbitration clauses as a condition of admission.”

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Whole Woman’s Health – Some preliminary thoughts on benefits, purposes, and fetal status

The Supreme Court’s decision in Whole Woman’s Health is sure to be dissected in the coming days, weeks, and months.  In the meantime, I wanted to quickly reengage the discussion about the status of the “purpose prong” of Casey and what, if anything, Whole Woman’s Health tells us about it.  While Justice Breyer’s analysis in the majority opinion does not seem to be couched expressly in terms of Casey’s purpose prong, the majority’s willingness to assess the applicable laws’ benefits may ultimately be purpose dressed in different clothing.  If there is not sufficient evidence of a law’s benefit, there could be a problem.

As a quick refresher, recall that Casey prohibits laws that have either the purpose or effect of placing a substantial obstacle in the path of a woman seeking an abortion of a nonviable fetus.  While most folks can readily associate Casey’s “undue burden” test in terms of abortion restrictions that have the effect of placing obstacles, Priscilla Smith and Caitlin Borgmann, have written about courts seemingly ignoring Casey’s other mandate that laws should not have the purpose of even trying to place such obstacles (regardless of whether they succeed in creating that effect).  This avoidance of the purpose prong coupled with great deference to the asserted justifications of the legislature (without the kind of benefits inquiry seen in Whole Woman’s Health) has historically led to many TRAP (targeted regulation of abortion provider) laws being upheld.

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Stem cell patenting on the other side of the pond

We are pleased to announce a new publication in the International Review of Intellectual Property and Competition Law (IIC). Our paper analyzes new case law in European stem cell patenting and compares these developments with the US situation and International treaties. Further information and an abstract is available below:

Authors: Ana Nordberg & Timo Minssen, University of Copenhagen, Centre for Information and Innovation Law (CIIR)

Title: A “Ray of Hope” for European Stem Cell Patents or “Out of the Smog into the Fog”? An Analysis of Recent European Case Law and How it Compares to the US
Journal: IIC – International Review of Intellectual Property and Competition Law, 47(2), 138-177
DOI: 10.1007/s40319-016-0449-x

ABSTRACT:  Continue reading

Surrogacy Contracts Directly Enforcible in Pennsylvania

Surrogacy is legal in many states.  Some, like California, directly enforce gestational carrier contracts.  Others, like Texas, Illinois, and Virginia, enforce only those contracts that are entered into by a married couple who need a surrogate for medical reasons which a judge approves before embryo transfer occurs.  A Pennsylvania court has now shown why gestational surrogacy contract should be directly enforced in the absence of legislation.  Its well-reasoned opinion suggests that more states may be open to this approach to surrogacy.

The Pennsylvania case, In re Baby S., arose out of a gestational surrogacy agreement involving embryos created with donor eggs and husband sperm. The written agreement was indisputably clear that that the intended parents would be the legal rearing parents, their names would appear on the birth certificate, and the carrier would have no rearing rights or duties.  Unlike previous cases questioning the validity of a surrogacy contract, the challenge here came not from the carrier who now wished to assert rearing rights (see In re Baby M and Calvert v. Johnson) but from the wife (the intended rearing mother).  She had praised the carrier’s willingness to help her have a child, which she repeated both at the embryo transfer and at a 20 week ultrasound at 20 weeks of pregnancy, which both intended parents attended.  A month later she informed the parties that “irreconcilable marital difficulties” would make it difficult for her to co-parent the child with the intended father.  She also refused to complete the paperwork for her name to appear on the birth certificate as the mother.

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DCIS Study Amplifies Questions and Demand for Answers

By Dalia Deak

This week, a JAMA Oncology article made a splash when it intensified discussion around what ductal carcinoma in situ (DCIS) should be considered – cancer, precursor, or risk factor – and whether current treatment approaches have been effective. The New York Times, The Guardian, and others have picked up the story, and readers have reacted extensively, only amplifying a demand for answers to questions raised.

Often called Stage 0 breast cancer, DCIS is considered to be abnormal cells that are confined inside the milk ducts and, as such, are not considered invasive. Because of the increased risk associated with DCIS, many women who are found to have DCIS (a growing number considering the frequency of and improvements in mammography) undergo lumpectomies or mastectomies often accompanied by radiation therapy. Continue reading

Fetal Personhood and the Constitution

By John A. Robertson

The Rubio-Huckabee claim that actual and legal personhood start at conception has drawn trenchant responses from Art Caplan on the medical uncertainty of such a claim and David Orentlicher, drawing on Judith Thomson’s famous article, that even if a fetus is a person, woman would not necessarily have a duty to keep it in her body.

Their debate claim that the fetus is already a legal person under the constitution also deserves a response, for it has no basis in positive law.  In Roe v. Wade all nine justices agreed that the use of “person” in the Constitution always assumed a born person, and therefore that the 14th Amendment’s mention of person did not confer constitutional rights until after a live birth.  In the years since Roe, when the make-up of the court has changed, no justice has ever disagreed with that conclusion, including those who would overturn Roe and Casey. Continue reading

Pain-o-meters: How – and Why – Should We Develop Them?

By Karen Davis

The prevalence of chronic pain is staggering.  The Institute of Medicine reported in 2011 that 100 million Americans suffer from chronic pain – more than those with heart disease, cancer and diabetes combined.  The report also highlights that the annual costs for medical care, lost wages and productivity is more than $600B.  These enormous personal and societal costs of chronic pain has driven an effort to “prove” if and how much pain an individual is suffering from for health care providers, insurance companies and legal actors.  This is challenging because pain is a personal and subjective experience.  Ideally, self report would be sufficient to establish the “ground truth” of the pain experience.

However, some are not able to provide self reports accurately, and the potential financial gain associated with claims of pain has tarnished the perceived authenticity of subjective reports.  This has led some to develop brain imaging-based tests of pain – a so-called “painometer.”  Yet, current technologies are simply not able to determine whether or not someone has chronic pain.  Here, I consider specifically how we could develop a brain-imaging based painometer – and whether we would want to do so.  As we ask: “Can we do it?,” we should always ask, “Is this the right thing to do?”

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Pain on the Brain: A Week of Guest Posts on Pain Neuroimaging & Law

By Amanda C. Pustilnik

This week, the Petrie-Flom Center of Harvard Law School and the Center for Law, Brain & Behavior (CLBB) at Massachusetts General Hospital are hosting a series of posts on how brain imaging can help the law address issues of physical and emotional pain. Our contributors are world leaders in their fields, who participated on June 30, 2015, in the CLBB/Petrie-Flom conference Visible Solutions: How Brain Imaging Can Help Law Reenvision Pain.  They addressed questions including:

  • Can brain imaging can be a “painometer” to prove pain in legal cases?
  • Can neuroimaging help law do better at understanding what pain is?
  • How do emotion and pain relate to each other?
  • Does brain imaging showing emotional pain prompt us to reconsider law’s mind/body divide?

Professor Irene Tracey, D.Phil., a pioneer in pain neuroimaging and director of the Oxford Centre for Functional Magnetic Resonance Imaging of the Brain, opened the conference with a keynote explaining what happens when the brain is in pain.

Professor Hank T. Greely, Edelman Johnson Professor of Law and Director of the Program in Neuroscience and Society at Stanford Law School, provided a keynote explaining the many implications of brain imaging for the law.

This conference was the culmination of CLBB’s year of work on pain neuroimaging and law. As the first CLBB-Petrie-Flom Center Senior Fellow on Law & Applied Neuroscience, I focused on pain because it is one of the largest social, economic, and legal problems that can be addressed through new insights into the brain. Pain imaging can be a test case for how neuroscience can contribute positively to law and culture.  (Full conference video proceedings are available here.)  Please read on below! Continue reading

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

pfc-web-logoCheck out the May 28th 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:


glassesofwine_slidePetrie-Flom / Center for Bioethics Reception at ASLME 38th Annual Health Law Professors Conference

June 4, 2015 7:30 – 9:30 PM
Hilton St. Louis at the Ballpark
1 South Broadway, St. Louis, MO

Come learn more about the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Center for Bioethics at Harvard Medical School at this jointly-hosted dessert reception at the 2015 annual ASLME Health Law Professors Conference.

We hope to see you there!

For more information, please contact Brooke Tempesta at Brooke_Tempesta@hms.harvard.edu.

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

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

Check out the May 15th 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:

brain_pain_slide_270_174_85REGISTER NOW!
Visible Solutions: How Neuroimaging Helps Law Re-envision Pain

June 30, 2015, 8:00 AM – 5:00 PM
Wasserstein Hall, Milstein West A
Harvard Law School,
1585 Massachusetts Ave.,
Cambridge, MA [Map]

Can brain imaging be a “pain-o-meter” that tells courts when a person is in pain?  Can fMRI help us discern whether intractable chronic pain is “all in your head” or all in the brain – or will it require us to reconsider that distinction? Leading neuroscientists, legal scholars, and bioethicists will debate standards and limits on how the law can use brain science to get smarter about a subject that touches everyone.


The full agenda will be announced in the coming weeks. Check back here for news!


This event is free and open to the public, but seating is limited and registration is required. Register now!

This event is part of the Project on Law and Applied Neuroscience, a collaboration between the Center for Law, Brain & Behavior at Massachusetts General Hospital and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Cosponsored by the Center for Bioethics at Harvard Medical School, and with support from the Oswald DeN. Cammann Fund. 

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

Cassandra C. Goes Home – Connecticut Misses an Opportunity

By Jonathan F. Will

On Monday Cassandra C. was sent home from the hospital.  Her cancer is in remission after responding well to treatments.  Many will recall that those treatments were forced on Cassandra against her wishes and those of her mother.   Back in January, the Connecticut Supreme Court issued a two-page order agreeing with state officials that Cassandra, at seventeen years three months, should be compelled to undergo chemotherapy to treat her Hodgkin’s Lymphoma.

The success of this medical treatment may be viewed by some to vindicate the comments of those like bioethicist Art Caplan and Fox News legal analyst Peter Johnson, Jr., who agreed with the decision.  Indeed, Mr. Johnson, after giving a personal anecdote of his own history with Hodgkin’s Disease, declared this decision to be right on the law, right on the ethics, and right on humanity.

Mr. Johnson gave the impression that a minor should never be permitted to make such a medical decision, while Dr. Caplan at least implied that his conclusion might be different if the refusal was based on religious beliefs.  Then you have a commentator in The Economist who came to the exact opposite conclusion.  He expressed concerns about Cassandra’s liberty and the rights of her mother to make decisions on her behalf.

I’m not so easily convinced by their arguments.

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

Check out the April 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.

Featured in this edition:

PFC Logo-RGB-Round-Otlns-NewApply Now!
2015-2016 Petrie-Flom Student Fellowships

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics is an interdisciplinary research program at Harvard Law School dedicated to the scholarly research of important issues at the intersection of law and health policy, including issues of health care financing and market regulation, biotechnology and intellectual property, biomedical research, and bioethics. The Student Fellowship Program is designed to support student research in these areas. More information on our current fellows and their work, is available on this website.

Eligibility: The student fellowship program is open to all Harvard graduate students who will be enrolled at the University during the fellowship year and who are committed to undertaking a significant research project and fulfilling other program requirements.  Although the fellowship is open to all graduate students, including those in one-year programs, we encourage those who are in multi-year programs at Harvard to wait until after their first year to apply.
Resources: The Center will award each fellow a $1,500 stipend, paid at the end of the academic year once all fellowship requirements (including submission of an acceptable paper) are completed. Additionally, fellows may be eligible to request additional funding to cover reasonable costs associated with their research projects (e.g., copying, publications, conference fees, travel).
Application: Applications will be accepted on a rolling basis until 9AM, Friday, August 7, 2015. Notifications of awards will be made by August 21, 2015.

View the full requirements and application instructions on the call for applications.

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

The Brocher Summer Academy 2015: Ethical, Legal and Social Issues in assisted Reproductive Technologies.

The Brocher Summer Academy 2015 will address a much controversial topic: Ethical, Legal and Social Issues in assisted Reproductive Technologies.

The Brocher Summer Academy on Ethical, Legal and Social Issues (ELSI) in Assisted Reproductive Technologies (ART) brings together distinguished professors from different disciplines and countries and highly promising researchers willing to acquire a strong background on a ELSI in ART. It gives the participants a rare opportunity to meet personally and exchange ideas with many established international professors in an intimate and collegiate atmosphere.  The sessions take place at the Brocher Centre in Geneva, Switzerland in an amazing and peaceful environment on the shore of the Lake of Geneva.

Deadline for applications: 30 April 2015

Further information is available at:  Posted in Events, Reproductive Technology, Timo Minssen | Tagged , ,

Symposia at the Brocher Foundation in Switzerland

Dear colleagues,
Do not miss this splendid opportunity to get support for organizing symposia at on of the most beautiful spots in Europe:


The Brocher Foundation is inviting junior and senior researchers to submit proposals for a 1.5 day multidisciplinary symposium project on the Ethical, Legal and Social Implications of new medical developments.

The Brocher Foundation will host and support the costs of the event between February and April or between July and October 2016.

The fully equipped Brocher Center Conference room – situated in Hermance, 15 kilometers from Geneva downtown, can welcome up to 60 participants in its exceptional location on the shores of Lake Geneva.

Excepted the travel reimbursements which will be directly arranged by the organizers, the Brocher Foundation will be responsible for all the logistics, according to its standard.

The call will end on the 17 May 2015 at midnight GMT.

Further information is available at:  Posted in Environment, Events, Timo Minssen | Tagged ,

Workshops at the Brocher Foundation

Dear colleagues,
Do not miss this splendid opportunity to conduct and discuss biomedical and legal research at on of the most beautiful spots in Europe:
The Brocher Foundation is inviting junior and senior researchers to submit proposals for a 2 to 3 day multidisciplinary workshop project on the Ethical, Legal and Social Implications of new medical developments.

The Brocher Foundation will host and support the cost of the event between 2 May and 30 June 2016 or between 2 November to 16 December 2016, or between 9 January and 27 January 2017 at the Brocher Center.

Excepted the travel reimbursements which will be directly arranged by the organizers, the Brocher Foundation will be responsible for all the logistics, according to its standard.

The call will end on the 17 May 2015 at midnight GMT.

Further information is available at:  Posted in Timo Minssen | Tagged ,

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)


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.

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