Contracting to counter gene patents – a 21st Century solution to access and innovation

By Sarah Ali-Khan and E. Richard Gold

As Precision Medicine becomes a reality, molecular tests are an increasingly critical part of patient care. While patients and their physicians would like to maximize access, they have confronted a roadblock in the form of patents covering genes and methods of diagnosis. Many hoped that the landmark 2013 Supreme Court of the United States decision in Myriad v AMP spelled the end of these patents, but the number of gene patents has actually increased since that decision. This is because, while limiting the availability of patents over genomic DNA, the court decision was narrow, leaving substantial grey zones such as over cDNA or where the patent covers a sequence of DNA used in a particular way. Patent agents have been assiduous in exploiting these grey zones to file for and obtain patents over molecular tests. This development points to continued adverse consequences of gene patents not only in the US, but around the world. Our recently published GiM article Gene patents still alive and kicking: their impact on provision of genetic testing for Long QT syndrome in the Canadian public health-care system’, not only examines the impact of gene patents in one country, Canada, but shows how 21st Century contracting can provide a nuanced and pragmatic means to enabling both access and innovation around patented genetic tests.

In Nov 2014, in the first Canadian instance of a public interest ‘test case’ in intellectual property and public health, The Children’s Hospital of Eastern Ontario (CHEO) challenged five patents held by Transgenomic Inc. over a genetic test for Long QT Syndrome (LQTS), a potentially fatal cardiac disorder most commonly striking in children and youth. Widely reported, settled in March 2016, and named as one of the year’s cases having the most impact on intellectual property, the case produced the CHEO Public Health Access Agreement. The Agreement does not itself alter law– gene patents remain valid in Canada. Rather, it constitutes a contractual agreement between parties to the litigation, allowing for efficient, no-cost test implementation. The Agreement explicitly states that Transgenomic will freely grant a license to test the LQTS-associated genes to any entity providing services within Canada’s public healthcare system. That is, except for a marginal private market, all LQTS in Canada can now be provided free. Read More

Genomes on-line and the Health of Privacy

By Effy Vayena and Alessandro Blasimme

Technology Concept

In January 1999, Scott McNealy, CEO of Sun Microsystems (now part of Oracle Corporation), announced that we should no longer be concerned with privacy, since consumers ‘have zero privacy anyway’ and should just ‘get over it.’ His argument, that in the era of information technology we have become unable to protect precisely what such technology relies on and delivers (information) has met the full spectrum of imaginable reactions – from outrage to enthusiastic endorsement. Many different cures have been proposed to treat at least the symptoms of the disease caused by the loss of privacy. Yet there is little disagreement concerning the diagnosis itself: privacy does not enjoy an enviable state of health. Recent emphasis on big data and their inescapable presence have only made the prognosis dimmer for the once cherished ‘right to be let alone’ – as Samuel D. Warren and justice Louis D. Brandeis famously defined privacy back in 1890.

Such a deteriorating outlook should sound especially alarming in the fields of healthcare and medical research. In such domains, professional norms of medical confidentiality have long ensured sufficient levels of privacy protection, accountability, and trust. Yet we are told that this may no longer be the case: sensitive, personal, health-related information – just like any other type of information – now comes in electronic formats, which makes it much more reachable than before, and increasingly difficult to protect. Imagine the consequences this may have in the case of genomic data – arguably one of the most sensitive forms of personal information. Should such information fall into the wrong hands, we may face harsh consequences ranging from discrimination to stigmatization, loss of insurance, and worse. To enjoy the right to genomic privacy, one has to be able to exercise some meaningful amount of control over who gets access to her genetic data, be adequately shielded from harms of the sort just mentioned, and yet retain the possibility of deciphering what’s written in her DNA for a variety of purposes – including, but not limited to, health-related ones. All this is undoubtedly demanding. All the more so now that we know how even apparently innocent and socially desirable uses, like genomic research employing anonymized DNA, are not immune from the threat of malicious re-identification.

In light of such considerations, one might be led to think that health privacy protection is a lost cause. In fact, one may go even further and argue that, all things considered, we shouldn’t worry too much about the decline of privacy. Having our sensitive data in a state of highly restricted accessibility, so the argument goes, prevents us from extracting medically valuable insight from those data and hinders medical discovery from which we may all benefit. Read More

Self-reporting and participatory health platforms: Empowerment through sharing information about oneself online?

This post is part of Bill of Health’s ongoing blog symposium on Critical Studies of Citizen Science in Biomedical Research. Here, Dana Mahr examines claims of empowerment in participatory health platforms and the implications of this for participants and biomedical research more broadly. Background on the symposium is here. You can call up all of the symposium contributions already published by clicking here.

By Dana Mahr

A new social contract for health?

Since the beginning of the 21st Century, self-reported experiential knowledge of patients (alongside other data) has often been communicated and promoted as an untapped treasure for both medical research and patient empowerment (Goetz 2008). Although this portrayal lacks historical and sociological accuracy (the sharing of experience has always been part of medical practice; e.g. the process of anamnesis) it informs a prominent discourse on so-called “P4-medicine”: “prediction”, “prevention”, “participation” and “personalization” (Hood 2013). Within this coordinate system of concepts, practices of participatory self-reporting (via fitness tracking, information sharing in social health networks, etc.) are seen as steps towards a “New Social Contract for Medical Innovation” (Horne et al. 2015).

Advocates of this social contract claim that it “tackle[s] the rising tide of chronic diseases and transform[s] healthcare from a disease-oriented provision to a true health maintenance service” (Horne et al. 2015). The core element of this new social contract is the collection and use of large amounts of participatory generated data for the democratization of biomedical research. The growing variety of online participatory medicine platforms can be interpreted as part of this trend. Other relevant aspects, however, are market interests, bio-governmentality, and people’s curiosity for self-exploration, self-presentation, and the urge to compare oneself with others. This is most evident in direct-to-consumer (DTC) genetic testing. The slogan of the DTC company 23andMe is telling in this respect: “Welcome to you”. Read More

TODAY, 4/17 at 5 PM! Health Law Workshop with Judith Daar

April 17, 2017, 5-7 PM
Hauser Hall, Room 104

Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Download the Presentation: “A Clash at the Petri Dish: Transferring Embryos with Known Genetic Anomalies”

Judith Daar is Professor of Law at Whittier Law School with a joint appointment at the UCI School of Medicine. She focuses her teaching and scholarship at the intersection of law, medicine and ethics. Her interdisciplinary work in law and medicine focuses in the area of reproductive medicine, where she holds leadership positions including Chair of the American Society for Reproductive Medicine Ethics Committee. In 2005, Professor Daar became Chair of the Association of American Law School’s Section on Law, Medicine and Health Care, and in 2006 she was named to the Board of Directors of the American Society of Law, Medicine & Ethics. She was elected President of ASLME in 2009 and re-elected for a second term in 2010. In 2007, she was appointed to the Society for Assisted Reproductive Technologies, Committee on Informed Consent in ART, an interdisciplinary group of physicians and attorneys charged with drafting a model informed consent document for patients undergoing in vitro fertilization. From 2008 to 2012, Professor Daar served as Associate Dean for Academic Affairs. In 2012, she was elected to the American Law Institute.

Professor Daar is a member of the UCI Medical Center Medical Ethics Committee, where she serves on the Bioethics Consultation Team. She has also served as a member of the Harbor-UCLA Hospital Institutional Review Board, and the ABACoordinating Group on Bioethics. Professor Daar has lectured extensively in the field of reproductive medicine, including giving testimony to the California legislature and the National Academies of Science, Committee on Science, Technology, and Law on the issue of oversight and regulation of reproductive medicine. Her scholarship focuses in the area of assisted reproductive technologies where she has authored over one hundred articles, book chapters, editorials and white papers on topics including stem cell research, human cloning, frozen embryo disputes, the use of genetic technologies and the regulation of reproductive medicine. Her first book, Reproductive Technologies and the Law, was published in January 2006, with a second edition appearing in 2013. Her most recent book, The New Eugenics: Selective Breeding in an Era of Reproductive Technologies, will be published by Yale University Press.

DTC Genetic Risk Reports Back on Market

By Kayte Spector-Bagdady, JD, MBE & Michele Gornick, PhD, MA

On Thursday, April 6th, the FDA announced that it will allow the direct-to-consumer (DTC) genetic testing company 23andMe to market “Genetic Health Risk” (GHR) tests for 10 diseases or conditions including early-onset Alzheimer’s and Parkinson’s Diseases. This is in addition to 23andMe’s current offering of ancestry, wellness (e.g., lactose intolerance), trait (e.g., hair color), and autosomal recessive carrier screening (e.g., sickle cell anemia) test reports.

The decade since 23andMe entered the market has been a regulatory labyrinth of twists and turns. But what direction are we headed now?

The way we were

23andMe was a pioneer of the field, entering the DTC genetics market in 2007 with a product offering 13 health-related reports for $999. By December 2013, it was offering more than 250 reports; including carrier status, drug response, and over 100 GHRs. In response to a set of FDA Untitled Letters that went out in 2010, 23andMe filed for de novo 510(K) premarket clearance for some tests… but also concurrently marketed them in a national television and web campaign. Read More

Patenting Bioprinting Technologies in the US and Europe – The Fifth Element in the Third Dimension

By Timo Minssen

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. Read More

Will the Recent Workplace Wellness Bill Really Undermine Employee Health Privacy?

By Jessica L. Roberts

While the effort to repeal and replace the Affordable Care Act (ACA) has taken center stage, another health-related bill has been making its way through the House without nearly as much attention. On March 2, 2017, Representative Virginia Foxx (R-NC) introduced House Resolution (HR) 1313 on behalf of herself and Representative Tim Walberg (R-MI).   The bill would lift current legal restrictions on access to genetic and other health-related information. Specifically, HR 1313 targets provisions of the Americans with Disabilities Act (ADA) that prohibit employers from conducting unnecessary medical examinations and inquiries that do not relate to job performance; the Genetic Information Nondiscrimination Act’s (GINA) provisions proscribing employers from requesting, requiring or purchasing the genetic information of their employees; and GINA’s prohibition on group health insurance plans acquiring genetic information for underwriting purposes and prior to enrollment. The bill passed through the Committee on Education and the Workforce last Wednesday along strict party lines with 22 Republicans supporting the proposed legislation and 17 Democrats opposing it.

Despite the public outcry against the bill, HR 1313 may not be as far-reaching as it initially appears. First, while advocates of genetic privacy fear the worst, both the ADA and GINA contain exceptions for wellness programs that already allow employers to access at least some employee health data. Second, even if HR 1313 passes, employees would still enjoy the ADA’s and GINA’s antidiscrimination protections.   HR 1313 could well give employers additional access to genetic and other health-related information about their employees but it is not a license to then use that information to discriminate.

Read More

Bold New Policies for The Brave New Biologies: IPRs and Innovation in Synthetic Biology and Gene editing

Research Seminar at the University of Copenhagen debating intellectual property and innovation in synthetic biology, systems biology & gene editing.

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.

Programme

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.
16.10 – 17.00 Questions and panel debate

Time: 13 March 2017, 15:00 – 17:00

Venue: Meeting Room 7A-2-04 , Faculty of Law, Njalsgade 76, DK-2300 Copenhagen S

Registration:
The event is free to attend. Registration is mandatory. Please use this registration form no later than Monday, 13 March 2017, 11:00 at the latest.

Organizer: Copenhagen Biotech & Pharma Forum, at CIIR, Faculty of Law, University of Copenhagen

Genetic counselors, genetic interpreters, and conflicting interests

By Katie Stoll, Amanda Mackison, Megan Allyse, and Marsha Michie

The booming genetic testing industry has created many new job opportunities for genetic counselors. Within commercial laboratories, genetic counselors work in sales and marketing, variant interpretation, as “medical science liaisons” to clinicians, and providing direct patient care. Although the communication skills and genetics expertise of the genetic counselor prepare them well for these roles, they also raise concerns about conflicts of interest (COI).

Why are genetic counselors leaving clinics and hospitals for industry jobs? Alongside greater job flexibility and taking on new challenges, a big reason is better pay. Hospitals and clinics have difficulty competing with the higher salaries at commercial labs because of continuing challenges in insurance reimbursement. Apart from limited preventive care covered under the Affordable Care Act, genetic counseling is inconsistently covered by private payers. Medicaid reimbursement for genetic counseling is state-dependent, and Medicare does not recognize genetic counselors as reimbursable health care providers at all.

Genetic counselors’ primary objective has historically been to help patients navigate difficult medical genetic information and decisions, supporting their autonomy.  But as laboratory employees, they must also navigate their employer’s financial interests, including increasing the uptake of genetic testing. In this changing landscape, can the profession of genetic counseling maintain the bioethical principles of beneficence, informed consent, and respect for autonomy that have been its foundation and ethos? Read More

Bill of Health Blog Symposium: How Patients Are Creating the Future of Medicine

We are pleased to host this symposium featuring commentary from participants in the University of Minnesota’s Consortium on Law and Values in Health, Environment & the Life Sciences event, “How Patients Are Creating Medicine’s Future: From Citizen Science to Precision Medicine.”  Below, Susan M. Wolf tees up the issues.  All posts in the series will be available here.

How Patients Are Creating the Future of Medicine: Roundtable at the University of Minnesota

By Susan M. Wolf, JD (Chair, Consortium on Law and Values in Health, Environment & the Life Sciences; McKnight Presidential Professor of Law, Medicine & Public Policy; Faegre Baker Daniels Professor of Law; Professor of Medicine, University of Minnesota)

Citizen science, the use of mobile phones and other wearables in research, patient-created medical inventions, and the major role of participant-patients in the “All of Us” Precision Medicine Initiative are just a few of the indicators that a major shift in biomedical research and innovation is under way. Increasingly, patients, families, and the public are in the driver’s seat, setting research priorities and the terms on which their data and biospecimens can be used. Pioneers such as Sharon Terry at Genetic Alliance and Matthew Might at NGLY1.org have been forging a pathway to genuine partnership linking patients and researchers. But the legal and ethical questions remain daunting. How should this research be overseen? Should the same rules apply as in more conventional, academically driven research? What limits should apply to parental use of unvalidated treatments on children affected by severe, rare disease? And should online patient communities be able to set their own rules for research?

In December 2016, the University of Minnesota’s Consortium on Law and Values in Health, Environment & the Life Sciences convened four thinkers with diverse academic and professional backgrounds to analyze these trends. This event, “How Patients Are Creating Medicine’s Future: From Citizen Science to Precision Medicine” was part of the Consortium’s Deinard Memorial Lecture Series on Law & Medicine, co-sponsored by the University’s Center for Bioethics and Joint Degree Program in Law, Science & Technology, with support from the Deinard family and law firm of Stinson Leonard Street. To see a video of the event, visit http://z.umn.edu/patientledvideo.

The four speakers offered diverse and provocative perspectives, each of which is highlighted in this series.