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.
|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
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.
By John Tingle
In the introduction to a new report on the state of acute hospitals in the NHS in England, the Chief Inspector of Hospitals, Professor Sir Mike Richards of the Care Quality Commission (CQC) controversially states:
“The NHS stands on a burning platform — the model of acute care that worked well when the NHS was established is no longer capable of delivering the care that today’s population needs. The need for change is clear, but finding the resources and energy to deliver change while simultaneously providing safe patient care can seem near impossible.” (p.4)
This statement raises the fundamental question of whether the current model of the NHS is,’ fit for purpose’? The NHS since its formation has always had both a good and bad press. Since its inception it always been short of resources. Changing times bring with them new demands which can make established health care delivery structures obsolete and no longer capable of delivering optimal performance. One important NHS developing health care trend is the need to keep pace with a growing elderly population with more complex health needs along with other trends. Continue reading
Given the Trump Administration’s stance on immigration, it probably shouldn’t be surprising that the new health law it is touting, the American Health Care Act (AHCA), will likely have a devastating effect on immigrant and their families. Although not surprising, it should nevertheless be troubling.
Even under the ACA, noncitizen immigrants are far less likely than citizens to have health insurance. In part, this is because immigrants are poorer than the native-born population and are less likely to receive insurance through their workplace. It is also because, contrary to the contentions of its critics, the ACA does not provide any coverage to undocumented immigrants. Indeed, the Obama Administration refused to treat young immigrants who received work permits under the Deferred Action for Childhood Arrival (DACA) program as lawfully in the country and thus eligible to purchase insurance on the exchanges. In addition, the ACA kept in place the 1996 Personal Responsibility and Work Opportunity Reconciliation Act‘s (PRWORA’s) tight restrictions on immigrants’ eligibility to Medicaid and CHIP. As a result, by 2015, 7 million of the 33 million Americans without insurance were noncitizen immigrants.
Yet although the ACA leaves many immigrants uninsured, it does provide relief to some lawful immigrants. First, it permits lawfully present immigrants who are ineligible for Medicaid to purchase insurance on the exchanges, even if their incomes are below the threshold required for citizens to participate on the exchanges. Second, because immigrants have lower wages than native born citizens, those who are not barred from Medicaid or CHIP due to PROWRA are more likely than native-born citizens to benefit from the ACA’s Medicaid expansion. More generally, because of their lower wages, immigrants benefit disproportionately from the ACA’s progressivity. Continue reading
Medicare Advantage was introduced as a mechanism for capturing some of the oft-extolled efficiencies of the private health insurance market. Instead of paying providers for services directly, as in traditional Medicare, the government pays Medicare Advantage insurers a predetermined, risk-adjusted amount of money per patient to cover all medical expenses for the year. The risk adjustment ensures that companies insuring Medicare Advantage patients with chronic diseases — who will likely need more intensive, expensive care — receive additional funds to help cover those costs. For each qualifying condition a patient has, the Medicare Advantage plan receives on average an additional $3000 annually.
While the risk adjustment of Medicare Advantage payments was well intentioned and economically rational, it appears to have opened up an avenue for significant abuse on the part of Medicare Advantage insurers. The Department of Justice recently joined a lawsuit against UnitedHealth, a large provider of Medicare Advantage plans, for allegedly defrauding the government out of hundreds of millions, if not billions, of dollars. The complaint alleges that UnitedHealth “upcoded” its risk-adjustment claims by submitting for conditions patients did not actually have and refusing to correct false claims when it discovered or should have discovered them. In essence, the company allegedly realized it could extract more money out of the government by making the patients it covers appear sicker than they actually are, and took full advantage of that.
Believe it or not, the Patient Protection and Affordable Care Act (Obamacare, or here, ACA) has intellectual property provisions. In addition to establishing mandates, subsidies and insurance exchanges, the ACA also created a new pathway for the approval of biosimilar drugs, which are akin to generic drugs. That pathway appears in a corner of the ACA that has its own title: the Biologics Price Competition and Innovation Act (BPCIA). The BPCIA is rich with intellectual property (IP) provisions that are now the subject of litigation in the Supreme Court.
Background: Generic Drugs And Biosimilars
Many of us take generic drugs for granted, but we have them only because the Hatch-Waxman Act (1984) provided an abbreviated pathway by which FDA could approve them. Under this pathway, a generic drug could be approved based on the safety and efficacy of the branded drug, plus a showing by the generic that it was essentially identical to the branded drug. This pathway also included provisions by which generic drug manufacturers could challenge the validity of patents protecting the branded drug. […]
Read the full post here.
To limit liability and increase predictability, scholars and policymakers have long focused on capping damages awards. In particular, they have been worried that there are many runaway jury awards for non-economic damages (i.e., pain and suffering). Because these are not based on tallies of medical bills or lost wages, these are the least predictable component of the jury’s award. Still, statutory caps on damages effectively nullify the jury’s determination (and the trial judge’s oversight) of how much to compensate a plaintiff for pain and suffering. The laws substitute an arbitrary maximum instead (which, in many states, has not adjusted with decades of inflation).
There is now a cottage industry of scholarship that tries to understand the effects of these state caps on payouts, the supply of physicians, liability insurance, economic damages awards, and the aggregate cost of medical care (which may decrease or increase). (See a synthesis of the literature.)
In new work with John Cambpell and Bernard Chao, I study a different way to cabin jury awards for non-economic damages. Rather than capping runaway awards ex post, some states have tried to prevent them in the first place, by manipulating what a jury hears in closing arguments. Continue reading
Join us for the 2017 Policy Surveillance Summer Institute. Learn more and register today! Space is limited and registration closes on May 1.
Friday, March 10, 10:30am – 2:30pm
Harvard Law School, Wasserstein Hall, Milstein East BC, 1585 Massachusetts Ave.
Join leading health care executives, experts, policymakers, and other thought leaders as they embark upon a project to develop a guiding framework for providing improved care for people with serious illness. You are invited to observe the inaugural working session where distinguished panelists will discuss innovations in program design and pathways for delivering high quality care to an aging population with chronic illnesses, especially those with declining function and complex care needs.
Check out the full agenda and list of roundtable participants on the website!
Attendees are welcome to participate in Q&A sessions, and lunch will be provided. Please RSVP for lunch here.
This project is funded by the Gordon & Betty Moore Foundation, and this convening is part of the Project on Advanced Care and Health Policy, a collaboration between the Coalition to Transform Advanced Care (C-TAC) and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.
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? Continue reading
This event is free and open to the public, but seating is limited and registration is required. Register here.
Join us for a film screening and panel discussion on challenges that arise from tragic acts of community violence. The event will begin with a screening of Newtown, a documentary examining the impact of the mass shooting at the Sandy Hook Elementary School in December 2012. The screening will be followed by a panel of experts in health law policy, the neurobiology of trauma, and community approaches to violence in a discussion of public health, gun violence, and responses to community trauma. Discussion will highlight the issue of “healing the helpers”—the first responders, medical staff, clergy, mental health providers, and others who respond to the needs of victims, families, and communities in the wake of community violence.
- Martha Minow, Morgan and Helen Chu Dean and Professor of Law, Harvard Law School
- Michelle Bosquet Enlow, Assistant Professor of Psychology, Harvard Medical School and Associate in Psychology, Boston Children’s Hospital
- Rufus J. Faulk, Program Director, Gang Mediation Initiative, Boston TenPoint Coalition
- Wendy Parmet, Matthews Distinguished University Professor of Law, Director of the Center for Health Policy and Law, and Associate Dean for Interdisciplinary Education and Research Support, Northeastern University School of Law; Professor of Public Policy and Urban Affairs, Northeastern University School of Public Policy and Urban Affairs
- Moderator: Ahmed Ragab, Richard T. Watson Associate Professor of Science and Religion and Director, Science, Religion, and Culture Program, Harvard Divinity School
This event is free and open to the public, but seating is limited and registration is required. Register here.
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 William James College and the Science, Religion, and Culture Program at Harvard Divinity School.
CALL FOR PARTICIPATION – ‘Research for Impact’ & the G20: How can global health innovation drive sustainable development?
Date: April 28th 2017
Location: Central Berlin
The G20 has underlined its commitment to contribute to the implementation of the 2030 Agenda, adopted by the United Nations in September 2015, as leaders look to cohere the related dialogues and processes into mutually beneficial and complementary projects. The 2016 G20 Action Plan on the 2030 Agenda focuses on “sectors and themes…where the G20 has comparative advantage and can add value as a global forum for economic cooperation”. Germany assumed the G20 Presidency on December 1, 2016 and has prioritized global health as an area where the G20 can make a substantial contribution to achieving the objectives of Agenda 2030.
The co-hosts invite individuals and organizations interested to participate in roundtable discussions on global health innovation in the G20 to respond to this call. Delegates are invited to participate and discuss with co-hosts, stakeholders, politicians, think tanks, NGO’s and representatives from G20 and G77 countries. Continue reading
American political, social, and religious history has made abortion a deeply partisan issue. This despite the reality that many women (as well as trans and gender non-conforming individuals) from diverse racial, cultural, class, and religious backgrounds regularly access abortion-related services. The outcome of the 2016 elections has set into motion an expected but nonetheless deeply damaging anti-abortion agenda that is slowly taking form in the Trump administration’s early days — aided by the Republican majority House and Senate. These early moves signal that the new administration aims to roll back gains made toward reproductive justice in 2016.
The attack on abortion rights and, in turn, reproductive justice, by this administration is no surprise. The GOP Platform released during the elections makes many references to defunding or restricting abortion services. The document specifically attacks key victories for reproductive health including the 2016 Whole Woman’s Health v. Hellerstedt Supreme Court decision overturning key provisions of the 2013 Texas House Bill 2. The law required that doctors who provide abortion services must obtain admitting privileges at local hospitals no farther than 30 miles away from the clinic, and abortion providers comply with guidelines to become Ambulatory Surgical Centers. The Supreme Court found the regulations to be unconstitutional because they result in substantial obstacles in the path of women seeking pre-viability abortions — contrary to the claim made by the Texas Department of State Health Services that the laws make abortions safer. […]
Read the full post here.
Enacting universal healthcare was a 65 year project, which cost two Presidents control of Congress and jeopardized their chance for reelection. From the time the Affordable Care Act was enacted in 2010 to the end of President Obama’s second term, its repeal was the number one priority of the Republicans in Washington, and it was deeply unpopular across the nation. Now that the Republicans have control of all branches of government, the repeal agenda is complicated by the new support for the law by voters and some Republican governors. This lecture will discuss the complicated politics surrounding the Affordable Care Act and the policy options for the future.
Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.
Below are the abstracts/summaries for papers identified from the month of February. The selections feature topics ranging from the effect of reminder devices on medication adherence, to the relationship between industry sponsorship and research outcomes, to the contribution of industry funded post-marketing studies to drug safety. A full posting of abstracts/summaries of these articles may be found on our website.
- Choudhry NK, Krumme AA, Ercole PM, Girdish C, Tong AY, Khan NF, Brennan TA, Matlin OS, Shrank WH, Franklin JM. Effect of Reminder Devices on Medication Adherence: The REMIND Randomized Clinical Trial. JAMA Intern Med. 2017 Feb 27. [Epub ahead of print]
- Gagne JJ, Polinski JM, Jiang W, Dutcher SK, Xie J, Lii J, Fulchino LA, Kesselheim AS. Outcomes Associated with Generic Drugs Approved Using Product-Specific Determinations of Therapeutic Equivalence. Drugs. 2017 Feb 8. [Epub ahead of print]
- Larochelle M, Downing NS, Ross JS, David FS. Assessing the potential clinical impact of reciprocal drug approval legislation on access to novel therapeutics in the USA: a cohort study. BMJ Open. 2017;7(2):e014582.
- Lundh A, Lexchin J, Mintzes B, Schroll JB, Bero L. Industry sponsorship and research outcome. Cochrane Database Syst Rev. 2017 Feb 16;2:MR000033. [Epub ahead of print]
- Luo J, Kesselheim AS, Greene J, Lipska KJ. Strategies to improve the affordability of insulin in the USA. Lancet Diabetes Endocrinol. 2017;5(3):158-159.
- Sherman RE, Davies KM, Robb MA, Hunter NL, Califf RM. Accelerating development of scientific evidence for medical products within the existing US regulatory framework. Nat Rev Drug Discov. 2017 Feb 24. [Epub ahead of print]
- Spelsberg A, Prugger C, Doshi P, Ostrowski K, Witte T, Hüsgen D, Keil U. Working Group on Health and Working Group on Freedom of Information, Transparency International Deutschland eV. Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies. BMJ. 2017;356:j337.
- Wong J, Motulsky A, Abrahamowicz M, Eguale T, Buckeridge DL, Tamblyn R. Off-label indications for antidepressants in primary care: descriptive study of prescriptions from an indication based electronic prescribing system. BMJ. 2017;356:j603.
Editor’s Note: This is an update of the post “Second Amendment Rights and Mental Illness,” originally published on September 1, 2015.
By Mariam Ahmed, JD/MSPP
In September 2015, we offered a glimpse of the current landscape of laws addressing mental health and gun violence. Many of the laws addressed public safety concerns that arose from active shooters with mental illnesses. At both the state and federal levels, government officials continue to debate the relationship between gun violence and mental health issues. Questions of safety and stigma continue to be asked, and are leading to changes in the laws. Here’s where we stand now:
In July 2015, Congress introduced the Safer Communities Act of 2015, but after being passed around four different committees, it was never released to the House floor for a vote. If the bill had passed, it would have further clarified who is restricted from possessing a gun based on their mental health and treatment.
After the bill died in committee, agencies such as the Department of Health and Human Services (HHS) and the Social Security Administration (SSA) have passed regulations to further define reporting and restriction requirements for people with mental illnesses. On January 4, 2016, HHS finalized a rule that modified the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The modification allows HIPAA-covered entities to release personal information to the National Instant Criminal Background Check System (NICS) if the person has a “mental health prohibitor” on their record that limits ability to possess, transport, receive, or ship a firearm under federal law. The rule went into effect on February 5, 2016. Continue reading
This new post by Gregory Curfman appears on the Health Affairs Blog in a series stemming from the Fifth Annual Health Law Year in P/Review event held at Harvard Law School on Monday, January 23, 2017.
With health care spending approaching 20 percent of Gross Domestic Product (GDP), controlling health care costs is a top priority not only for the federal government, but also the individual states. To develop successful strategies for cost control, states need comprehensive data on utilization of and spending on health care services. Medicare data are valuable but not representative of the entire national population or of the prices that private payers pay. In private insurance, prices are not under administrative control as they are in Medicare, and they vary widely in different geographic regions.
All-payer claims databases (APCDs) were developed, first in Maryland in 1995, to provide comprehensive state-level data on health-care utilization and spending, and there are now 16 APCDs nationwide. As the name implies, APCDs collect data from all payers, and the spending data reflect the actual negotiated prices of services. Thus, APCDs are a valuable source of information for state health policymakers and health services researchers. For example, in Massachusetts, the Health Policy Commission uses the state’s APCD to set state-wide health care spending targets, which have been important in achieving state cost control. […]
Read the full post here!
“What makes drug development long and expensive is the need to prove, beyond statistical doubt, that your damn drug works”
Michael Gilman, Biotech Entrepreneur
2017 is going to be terrific. Tremendous, even. Things are going to change, big league.
The new President has promised fantastic reforms to the drug industry. He’s going to get the big players in the pharmaceutical industry around a table and negotiate huge price reductions. Of course, he’s not going to touch their bottom line. If anything, he’s going to improve it. Innovation is being choked by over-regulation and he’s going remove burdensome FDA hurdles. But he has Executive Orders to give and walls to build, so he’s drafting in the very best people to help. We’re still waiting for those people to be officially named. Meanwhile, the media have had a month and a half of fun and speculation. The volume and variety of names being thrown around make it feel like a food fight at a Chinese buffet. One of those names is Peter Thiel.
By Brad Segal
Manuel—not his real name—was admitted to the hospital with decompensated heart failure. As a child he had scarlet fever which, left untreated, had caused the valves of his heart to calcify and stiffen. Over time, pumping against increased resistance, his heart’s contractions began to weaken until finally, they lost all synchrony and the normal function of his heart spiraled out of control. At this stage, his fate was tied to whether or not he would receive a new heart in time.
He was in his 30’s and had no other illnesses. From a medical perspective, Manuel was the ideal candidate for a cardiac transplant. But a decade ago Manuel crossed the United States border in pursuit of a better life. As an undocumented immigrant, he was ineligible for the insurance coverage necessary to pay for a heart transplant. After being thoroughly evaluated by the hospital’s transplant center, given his modest financial resources and inability to obtain new insurance coverage, Manuel was not placed on the waiting list for a new heart.
The average heart transplant costs about a million dollars to perform. Subsequent follow-up care adds another $30,000 annually. Health insurance will usually cover most, if not all, of these costs. But uninsured patients are kept off transplant lists on the grounds that the inability to pay for care allegedly jeopardizes an organ’s long-term success. Continue reading
March 6, 2017, 5-7 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA
Download the presentation:
Note from the Presenter:
I am circulating the introductory chapter from my first ethnography, Reproducing Race: An Ethnography of Pregnancy as a Site of Racialization, and a book proposal for my as yet untitled second ethnography.
My first book grew out of eighteen months of ethnographic fieldwork research that I conducted in the obstetrics clinic of a public hospital in New York City. I found myself in the clinic because I was interested in studying race as a process: I wanted to explore how ideas about race are made material on the bodies of poor women during the event of pregnancy. Moreover, I was curious about the role of the law in this process of race-making.
What I did not realize back when I was writing Reproducing Race was that the book would be a prelude to my second ethnography—a book about which I am now beginning to think. This ethnography will extend the analysis began in Reproducing Race to affluent women of color. Reproducing Race revealed that poor, pregnant women of color are treated in ways that are significantly different from the ways in which wealthier pregnant women are treated. But, how much of that different treatment is an effect of race? How much of it is an effect of class? By training its focus on women of color with class privilege, my second ethnography will try to figure it all out. Thus, the central preoccupation that motivates the study is the complex relationship between race and class. How does class privilege alter the experience of race? How does one’s status as a racial minority alter the experience of class privilege?
The second ethnography is very much in its earlier stages. So, any and all feedback on this project is welcome.