Separating sheep from goats- a European view on the patent eligibility of biomedical diagnostic methods

New publication on the patentability of biomedical diagnostics out:

Abstract: This brief comment complements Dan Burk’s excellent paper ( Dolly and Alice, J Law and the Biosciences (2015), 1–21, doi:10.1093/jlb/lsv042 ) by providing a very brief summary of the European approach regarding patents on medical diagnostic methods. This serves as the basis for a comparative discussion of the current US approach and its’ impact on biomedical innovation. We are concerned that unless the Supreme Court clarifies its two-part test and adopts a more holistic interpretation of the eligibility-test, global standards for medical diagnostic patents will diverge to the detriment of advanced therapies and ultimately patients worldwide. In case that the current US eligibility doctrine prevails without further Supreme Court clarification, we highlight the need for developing a more flexible, well-calibrated system for alternative and complementary forms of drug development incentives.

Citation: Separating sheep from goats: a European view on the patent eligibility of biomedical diagnostic methods Timo Minssen; Robert M. Schwartz Journal of Law and the Biosciences 2016; doi: 10.1093/jlb/lsw019

 

 

 

 

LGBT Backlash Legislation and the Politics of Biology

By Maayan Sudai

Of the many responses to the monumental victory of the gay marriage movement in Obergefell v. Hodges in 2015, one was a backlash of legislative proposals submitted by conservative groups. A popular target was the regulation of sex-segregated public spaces like bathrooms, schools, etc. – also called “bathroom bills” – in TexasFloridaKentucky, and other states. The anti-LGBT bills are meant to either block the extension of anti-discrimination protections that could accommodate free use of sex-segregated public spaces, or strictly ban Transgender people from entering public bathrooms that fit their self-identified gender.

In South Dakota, failed bill HB1008 would have made it illegal for schools to provide accommodations for Transgender students and would have required every public bathroom, shower, or locker room be “designated for and used only by students of the same biological sex.” The bill did not pass, as Governor Dennis Daugaard vetoed it last March, affirming the authority of local municipalities to determine their own standards. Nevertheless, a few weeks later a similar bill was passed in North Carolina. The new law, also known as HB2 or the “Charlotte Bill” (more formally: “Public Facilities Privacy and Security Act”) came as a response to a local non-discrimination ordinance issued by the Charlotte City Council which provided protections and accommodation to the LGBT community in public bathrooms. HB2 affectively repealed the Charlotte ordinance, and restricted the ability of other cities in the state to expand equality measures beyond the standard determined by HB2.[1] Rich Schragger said that HB2 is “thus an anti-LGBT law masked as an anti-discrimination provision.”

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Webcast: Dennis on Precision Medicine and Cancer Pathology

The Regulatory Science Series at University of Arizona

presents

Eslie Dennis, MD,
Vice President and Head Global Medical Affairs Ventana Medical Systems, Inc., a member of Roche Group

speaking on 

“Cancer, Pathology, and Precision Medicine:  Virchow Revisited Through Grogan’s Lens”

Available live at 3PM Eastern Apr 6 and archived at https://goo.gl/NGEBPt

From Chance to Choice to Court

[Cross-posted from the Huffington Post Blog]

By Dov Fox

It used to be that whether you got the child you wanted — or one you hadn’t planned on — was left to cosmic fate or the randomness of reproductive biology. Now, new powers of reproductive medicine and technology promise to deliver us from the vagaries of the natural lottery.

The likes of voluntary sterilization and embryo screening give people who can afford them greater measures of control over procreation. Except, that is, when reproductive professionals make mistakes that frustrate efforts to pursue or avoid pregnancy or parenthood.

When, for example — just a few recent cases — a pharmacist fills a woman’s birth control prescription with prenatal vitamins. Or when a fertility clinic implants embryos carrying the hereditary disease that a couple underwent in vitro fertilization (IVF) to screen out. Just this week comes another report of losing IVF embryos.

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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

Breaking News: NAM Releases Report on Mitochondrial Replacement Therapy (Part II My First Take)

By I. Glenn Cohen

My last post was a summary of the NAM’s Recommendations on Mitochondrial Replacement Therapy (MRT). Now here is my take on the report. But keep in mind the report was just released and all I could give it was a quick read, so these are really more like initial impressions: Continue reading

Breaking News: NAM Releases Report on Mitochondrial Replacement Therapy (Part I Summary)

By I. Glenn Cohen

As readers know I’ve written on mitochondrial replacement therapy and its attendant ethical and regulatory issues. Today the National Academy of Medicine (formerly known as the IOM) released a terrific report today with its recommendations. I’ll have a second post with my reactions but here is a summary from the report of their recommendations. The big headline is they have recommended FDA largely move towards allowing it to go forward under a regulatory pathway with restrictions, the most important of which is the transfer only of male embryos (to avoid germ-line issues).

In the NAM’s own words:

Recommendation 1: Initial clinical investigations of mitochondrial replacement techniques (MRT) should be considered by the U.S. Food and Drug Administration (FDA) only if and when the following conditions can be met: Continue reading

REGISTER NOW! (3/29) The Future of Health Law and Policy: The Petrie-Flom Center’s 10th Anniversary Conference Celebration

PFC 10th Logo-Horizontal-Otlns-FnlThe Future of Health Law and Policy: The Petrie-Flom Center’s 10th Anniversary Conference Celebration
March 29, 2016 8:00 AM – 5:00 PM
Wasserstein Hall, Milstein East ABC
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

The Petrie-Flom Center is celebrating its first decade and kicking off the next by looking at the future of health law and policy!

Please join us as we bring together Petrie-Flom and other prominent Harvard Law School alumni to discuss major trends, developments, and open questions in the fields of health law policy, biotechnology, and bioethics. We’ll hear about the founder’s vision for the Center and the Dean’s perspective on the Center’s influence within the Harvard Law School community and beyond. Center Leadership will discuss what we have accomplished in the first ten years, and more important, our plans for the future. Alan Weil JD ’89, Editor-in-Chief of Health Affairs, will deliver the keynote address.

Agenda

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Genomic data sharing: How much oversight is necessary?

By Mahsa Shabani

Introducing data sharing practices into the genomic research has brought a number of concerns in research ethics and governance to the fore. For instance, research participants and the general public raised concerns about potential privacy issues in personal genomic data protection, as well as the scope of the secondary uses. In order to address such concerns, Data Access Committees (DACs) were seen crucial in the governance of main genomic databases such as the database of Genotypes and Phenotypes (dbGaP) and the European Genome-phenome Archive (EGA). Surprisingly, the component of access review, the structure, and the functionality of such committees have been barely scrutinized to date.

In a recent study published in Genetics in Medicine, we solicited the opinion of 20 DAC members and experts on genomic data access. Specifically, the interviewees were asked about the goals of access review and their experiences with reviewing the ethical and scientific aspects of proposals. The respondents unanimously agreed that the complexity of the access review should correspond with the concerns associated with genomic data sharing. In this regard, privacy risks often seemed possible, yet were not viewed as an imminent threat. The respondents could only recall a few examples of re-identification of genomic data in the past, yet could not promise full privacy protection given the evolving nature of the field. Regardless of the scarcity of such incidents, the controlled-access model is generally considered necessary to maintain public trust. As a DAC member put it: “I think the future of science depends upon high levels of public trust and you can only have high levels of public trust if people feel the data sharing is being managed.” Continue reading

EEOC Tries to Harmonize ACA’s Promotion of Employer Wellness Programs with GINA’s Ban Against Employer Access to Genetic Information of Employees and Employees’ Family Members

[Cross-posted from the Genomics Law Report blog]

By

Gina-name-tagThe Equal Employment Opportunity Commission (EEOC) is responsible for enforcing Title II of the Genetic Information Nondiscrimination Act (GINA), which prohibits employers from requesting genetic information (defined broadly) from their prospective, current, or former employees. GINA contains only six limited exceptions to this prohibition, one of which is an exception for wellness programs in which the employee’s participation is voluntary.

On October 30, 2015 the EEOC issued a proposed ruleto amend GINA regulations in an attempt to harmonize them with the Affordable Care Act’s promotion of employer wellness programs to lower health care costs. The proposed rule tries to clarify that employers are permitted to offer incentives for an employee’s spouse to participate in a voluntary wellness program (but not the employee’s other dependents). The permissible incentives are capped at 30% of the total cost of the plan in which the employee and dependents are enrolled. The EEOC’s expressed intent is to treat GINA’s Title I (health insurance) and Title II (employment) provisions similarly. The proposed rule would allow employers to request current and former health status information from an employee’s spouse as part of their participation in the employer-sponsored wellness program. And there’s the rub: the current or former health status of an employee’s spouse is the employee’s own “genetic information” as the term is statutorily defined in GINA. The EEOC has prepared a Q&A page to explain the proposed rule, and the Congressional Research Service issued a report (R44311) on the topic on December 17, 2015. Continue reading

Some Commentary on How to Think About Secondary Research with Biospecimens

The public comment period on the NPRM to revise the Common Rule has just closed, and now we wait to see what happens (if anything), and when.  One of the most controversial proposals in the NPRM would require at least broad consent for secondary research with biospecimens (i.e., research on specimens originally collected for another purpose, either clinical care or a different study), regardless of whether those specimens retain identifiers.  This is a substantial change from the status quo, which does not require consent for such research with de-identified specimens.  How should we feel about this status quo, and the proposed change?  My own view is that it’s really not so bad: the risks to individual research participants are quite low, and the current approach facilitates critically important scientific advancement.  There is certainly room for improvement, e.g., to impose punishment on those who would act to re-identify de-identified specimens without permission, to inform the public that such research takes place, and to educate them about its value, perhaps allowing those who still feel very strongly that they prefer not to be included an opportunity to opt-out.  But what has been actually proposed has more problems than what it would replace, and in fact, wouldn’t solve some of those it seems to be a response to.

Rebecca Skloot feels otherwise.  She is the author of a book called The Immortal Life of Henrietta Lacks, which chronicles the origin of one particularly important cell line – HeLa  – derived from cells that had been excised from Ms. Lacks in the course of a 1951 surgery to treat her cancer, and later used for research without her knowledge or permission.  Ms. Lacks was poor, uneducated, and black, and her descendants have also faced more than their fair share of adversity.  Ms. Skloot paints a compelling story of exploitation, but in my opinion, it is much more effective as a narrative about the horrible and enduring legacy of racism in this country than as proof that researchers who conduct secondary research with biospecimens without consent (as permitted under the current regulations, remember) or even without profit-sharing have behaved badly. After all, if individual risks are low and social benefits high – both true – then what’s the problem?  And it is far from clear that specimen sources deserve compensation for no other reason than that their discarded material actually proves valuable to scientists.  Nonetheless, the book has been used as a rallying cry by people from all walks of life who believe that they should be allowed to control whether, and potentially how, their specimens are used for research. Indeed, The Immortal Life of Henrietta Lacks is probably the single most important development that pushed the proposed revisions to the Common Rule forward, for the first time since they were released in 1991.

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The Impact of Genetic Testing on Children: What do we know, what’s missing?

Wakefield_Pic
By: Claire E. Wakefield, Lucy V. Hanlon, Katherine M. Tucker, Andrea F. Patenaude, Christina Signorelli, Jordana K. McLoone and Richard J. Cohn

Genetics research often pushes the boundaries of science, and by the far-reaching nature of genetic information, pushes us out of our comfort zones to consider new psychosocial, ethical, and legal scenarios. Conducting genetic testing on children arguably pushes our boundaries most. Yet, there can be medical benefits for some children, who may then be offered tailored medical care to match their risks. Children can also be indirectly affected by genetic testing, when they learn genetic information about themselves because a family member has had a genetic test. Continue reading

NPRM Symposium: How Should We Think About Whether To Donate Our Leftover, Non-Identified Tissue to Research?

Proposed changes to the federal Common Rule would ask patients for the first time to decide whether to allow their non-identified, leftover tissue to be used for research or thrown away. For that choice to be meaningful, the public needs to be aware of the nature, risks, and benefits of biospecimens research, and of what the proposed changes will—and will not—do. In my latest Forbes essay, “No, Donating Your Leftover Tissue To Research Is Not Like Letting Someone Rifle Through Your Phone,” I consider the power of analogies and other reflections on Rebecca Skloot’s recent New York Times op-ed on the NPRM.

Bioethicist Art Caplan: Engineering the Better Baby

Bill of Health Contributor Arthur Caplan has a new article in Project Syndicate:

There should no longer be any doubt about whether humans will one day be genetically modified. A new tool – called CRISPR – is already being used to edit the genomes of insects and animals. Essentially a very sharp molecular knife, CRISPR allows scientists to carve out and insert genes precisely and inexpensively. It is only a matter of time before it will be used to engineer our descendants – eliminating many dangerous hereditary diseases in the process.

To be sure, this eventuality is being hotly debated. The main arguments against genetic modification of human embryos are that it would be unsafe and unfair, and that modification would quickly go beyond efforts to reduce the incidence of inherited maladies. But, ultimately, none of these reasons is likely to be persuasive enough to stop the technology from being widely used. […]

Read the full article here.

Should a patient have a right not to know genetic information about him or herself?

By Benjamin E. Berkman, JD, MPH

While promising to eventually revolutionize medicine, the capacity to cheaply and quickly generate an individual’s entire genome has not been without controversy.  Producing information on this scale seems to violate some of the accepted norms governing how to practice medicine, norms that evolved during the early years of genetic testing when a targeted paradigm dominated.  One of these widely accepted norms was that an individual had a right not to know (“RNTK”) genetic information about him or herself.  Prompted by evolving professional practice guidelines, the RNTK has become a highly controversial topic.  The medical community and bioethicists are actively engaged in a contentious debate about the extent to which individual choice should play a role (if at all) in determining which clinically significant findings are returned.

In a recent paper published in Genetics in Medicine, my coauthors and I provide some data that illuminates this and other issues. Our survey of 800 IRB members and staff about their views on incidental findings demonstrates how malleable views on the RNTK can be.  Respondents were first asked about the RNTK in the abstract: “Do research participants have a right not to know their own genetic information?  In other words, would it be acceptable for them to choose not to receive any GIFs?”  An overwhelming majority (96%) endorsed the right not-to-know.  But when asked about a case where a specific patient has chosen not to receive clinically beneficial incidental findings, only 35% indicated that the individual’s RNTK should definitely be respected, and 28% said that they would probably honor the request not to know.  Interestingly, the percentage of respondents who indicated that they do not support the RNTK increased from 2% at baseline to 26% when presented with the specific case.  The percentage of people who are unsure similarly jumps, from 1% to 11%.

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Hormonal Treatment to Trans Children – But what if?

A few weeks ago I ran across this BuzzFeed post, telling the story of Corey Mason, a 14 year old male to female Trans teenager who was filmed getting her first pack of estrogen hormones. Her mom Erica, who uploaded the video to Facebook and YouTube, spurred a social-media discussion on the topic of hormonal treatment for Trans children and youth.

Erica said the vast majority of reactions were very supportive. On the other hand, different views and opinions were put on the table as well, even from people who ally completely with Trans identity politics.  One of them, a Trans woman, said she fears from rushing (perhaps gay) teenagers into irreversible treatments, as most Trans kids “GROW OUT OF IT”. Aoife commentThis position was also taken by Alice Dreger, a Bioethicist and a historian writing on Intersex issues, in describing the uneasy choice between the two models available at the moment: On the one hand you have the ‘therapeutic model’ offering mental health support to the Trans person and/or family, to help ease up the tensions caused by gender identity dysphoria (GID). This model aims to relax the dysphoria and so avoids any medical irreversible interventions. On the other hand, you have the ‘accommodation model’ asserting there’s nothing wrong with the trans person and/or his/her family, and so offers medical interventions to accommodate it.[1]

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Monday, 10/19, HLS Health Law Workshop with Julian Savulescu

HLS Health Law Workshop: Julian Savulescu

October 19, 2015, 5:00 PM
Lewis International Law Center, Room 214A
1557 Massachusetts Ave, Cambridge MA 02138

Download the papers:
“The Ethics of Gene Editing”
“Mitochondrial Transfer Is Transplantation, Not Genetic Engineering”

Julian Savulescu is Uehiro Chair in Practical Ethics, Director of The Oxford Centre for Neuroethics, Director of the Oxford Uehiro Centre for Practical Ethics, and Director of The Institute for Science and Ethics, The Oxford Martin School. His areas of research include: the ethics of genetics, especially predictive genetic testing, pre implantation genetic diagnosis, prenatal testing, behavioural genetics, genetic enhancement, gene therapy; research ethics, especially ethics of embryo research, including embryonic stem cell research; new forms of reproduction, including cloning and assisted reproduction; medical ethics, including end of life decision-making, resource allocation, consent, confidentiality, decision-making involving incompetent people, and other areas; sports ethics; the analytic philosophical basis of practical ethics.  He is on the Advisory Board for the journal Neuroethics. Savulescu and Bostrom initiated the two year EU ENHANCE project, an interdisciplinary project devoted to studying the ethical implications of human enhancement and to providing detailed recommendations to European policy makers. Oxford led the cognitive enhancement theme. Savulescu is editor of two major collections on enhancement: one, co-edited with Bostrom, entitled Human Enhancement (OUP) and another draws on research from the ENHANCE project, entitled Enhancing Human Capacities (Wiley Blackwell, due for publication January 2011).

Before coming to Oxford in 2002 as Uehiro Chair in Practical Ethics, Professor Savulescu was Director of the Ethics Program at the Murdoch Children’s Research Unit, University of Melbourne, before which he studied for a Bachelor of Medicine and Surgery at Monash University, followed by a PhD under the supervision of Professor Peter Singer.

 

The Testosterone Rule

Dutee Chand is an Indian athlete that has been in the focus of a recent drama in elite sport. Chand, a gifted athlete and champion, was suspended from participating in competitions by the International Association of Athletics Federations (IAAF), after she was found to have high levels of testosterone. A biological condition called “hyperandrogenism” caused Chand to have three times more testosterone than an average woman athlete, similar to that of men. Chand was given the unappealing alternative of undergoing surgery and hormonal treatments meant to “normalize” her so she could race again, or turning to the Court of Arbitration for Sport (CAS), she chose the latter.

One would think that in a world in which men and women’s sports are so profoundly separated, distinguishing between male and female athletes would be a no-brainer.  Well, it’s not like that at all. Chand’s case can be traced along a history of similar episodes in which female athletes (like South African runner Caster Semanya and others) were suspected for not being “true females,” having to undergo medical scrutiny in order to conclude on the matter. This ambiguity is not special to athletes. It even has a name – “intersex,” an umbrella term describing a range of conditions in which the person’s sex cannot be conclusively determined. To read more on intersex variations click here.

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Bioethicist Art Caplan: No time to waste – the ethical challenges created by CRISPR

Bill of Health Contributor Art Caplan has a new article in EMBO Reports:

The term “CRISPR” has gained a lot of attention recently as a result of a debate among scientists about the possibility of genetically modifying the human germ line and the ethical implications of doing so. However, CRISPR is not just a method to edit the genomes of embryonic cells, as the public discussion might have implied; it is a powerful, efficient, and reliable tool for editing genes in any organism, and it has garnered significant attention and use among biologists for a variety of purposes. Thus, in addition to the discussion about human germ line editing, CRISPR raises or revives many other ethical issues, not all of which concern only humans, but also other species and the environment.

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Big Data, Genetics, and Re-Identification

by Zachary Shapiro

While all scientific research produces data, genomic analysis is somewhat unique in that it inherently produces vast quantities of data. Every human genome contains roughly 20,000-25,000 genes, so that even the most routine genomic sequencing or mapping will generate enormous amounts of data. Furthermore, next-generation sequencing techniques are being pioneered to allow researchers to quickly sequence genomes. These advances have resulted in both a dramatic reduction in the time needed to sequence a given genome, while also triggering a substantial reduction in cost. Along with novel methods of sequencing genomes, there have been improvements in storing and sharing genomic data, particularly using computer and internet based databases, giving rise to Big Data in the field of genetics.

While big data has proven useful for genomic research, there is a possibility that the aggregation of so much data could give rise to new ethical concerns. One concern is that promises of privacy made to individual participants might be undermined, if there exists a possibility of subject re-identification.

Re-identification of individual participants, from de-identified data contained in genetic databases, can occur when researchers apply unique algorithms that are able to cross-reference numerous data sets with the available genetic information. This can enable diligent researchers to re-identify specific individuals, even from data sets that are thought to be anonymized. Such re-identification represents a genuine threat to the privacy of the individual, as a researcher could learn about genetic risk factors for diseases, or other sensitive health and personal information, from combing through an individual’s genetic information.

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