The American Society for Law, Medicine & Ethics (ASLME) is pleased to announce the 4th annual bioIP Faculty Workshop on Friday April 26, 2019, at Boston University.
The Workshop offers a unique opportunity for three scholars in their first decade of teaching to present their work in progress for in-depth critique and commentary by respected senior scholars in the field.
Join us in wonderful Copenhagen at our CeBIL Kick-Off Conference: ”Innovation Gaps on Life Science Frontiers? From Antimicrobial Resistance & the Bad Bugs to New Uses, AI & the Black Box”. The Conference marks the start of the Novo Nordisk Foundation’s Collaborative Research Programme in Biomedical Innovation Law which is carried out within a unique network of international core partners, including internationally renowned experts at Harvard Law School’s Petrie Flom Center, Harvard Medical School/Brigham & Women’s Hospital, University of Cambridge, University of Michigan, and UCPH’s Department of Food and Resource Economics (IFRO).
Leading international experts, including i.a. our distinguished Bill of Health colleagues Glenn Cohen, Aaron Kesselheim; Nicholson Price, and Kevin Outterson, will discuss legal, economic, societal and scientific aspects of selected Life Science areas.
Time: Monday, 5 March 2018 09:00 – 18:00 (followed by a reception in the Gobelin Hall)
Venue: The Ceremonial Hall (Festsalen), University of Copenhagen, Main Building, Frue Plads 4, DK-1168 Copenhagen K
More information on speakers, agenda and registration is available here and here.
Extended background:
Biomedical innovation is experiencing changes of epic proportions. Rapid progress in many scientific areas, such as gene editing, pharmacogenomics, artificial intelligence and big data-driven precision medicine, has greatly advanced the promises and opportunities of the health and life sciences. Nevertheless, the total number of truly new and innovative drugs receiving market approval is unsatisfactory. At the same time, some of the more innovative therapies that actually could reach patients have become extremely expensive or ethically problematic. These new technological possibilities raise many complex scientific, legal and ethical issues affecting many stakeholders, such as medical practitioners, regulators, patients and the industry.
To support the in depth study of these developments, the Novo Nordisk Foundation has awarded a grant of DKK 35 million for a new Collaborative Research Programme in Biomedical Innovation Law (CeBIL). CeBIL’s overall aim is to help translate ground-breaking biomedical research into affordable and accessible therapies by scrutinizing the most significant legal challenges to biomedical innovation and public health from a holistic cross-disciplinary perspective. CeBIL is hosted by a new Centre for Advanced Studies at the University of Copenhagen’s Faculty of Law. The research is carried out within a unique network of international core partners, including internationally renowned experts at Harvard Law School, Harvard Medical School, University of Cambridge, University of Michigan, and UCPH’s Department of Food and Resource Economics (IFRO). Moreover, CeBIL will collaborate with a broad network of stakeholder organizations and international experts within law, economics, life science, medicine, sociology and pharmacy.
This Kick-Off Conference marks the start of CeBIL which opened its’ doors on January 1st, 2018. Reflecting the research projects that will be at the focus CeBIL’s research during the first 5 years, leading international experts will discuss legal, economic, societal and scientific aspects of selected life science areas and debate future challenges and opportunities.
Ironic that the leading argument against the President’s Executive Order 13768 on Sanctuary Cities is none other than the states’ rights / coercion arguments that convinced seven Justices to make the Medicaid expansion voluntary. Backstory on this element of National Federation of Independent Business (NFIB) v. Sebelius from 2012 here, with the abstract below:
Of the four discrete questions before the Court in National Federation of Independent Business v. Sebelius, the Medicaid expansion held the greatest potential for destabilization from both a statutory and a constitutional perspective. As authors of an amicus brief supporting the Medicaid expansion, and scholars with expertise in health law who have been cited by the Court, we show in this article why NFIB is likely to fulfill that promise.
For the first time in its history, the Court held federal legislation based upon the spending power to be unconstitutionally coercive. Chief Justice Roberts’ plurality (joined for future voting purposes by the joint dissent) decided that the Medicaid expansion created by the ACA was a “new” program to which Congress could not attach the penalty of losing all Medicaid funding for refusing to participate. NFIB signals the Roberts Court’s interest in continuing the Federalism Revolution. The Court relied on, seemingly modified, and strengthened at least two existing elements of the test for conditional spending articulated in South Dakota v. Dole. Clear notice and germaneness now appear to be folded into the newly fashioned yet undefined coercion doctrine, which relied on quantitative as well as qualitative analysis to determine that the Medicaid expansion was unconstitutionally coercive. The Court is now actively enforcing the Tenth Amendment to protect states from federal spending legislation. Read More
CALL FOR PARTICIPATION – ‘Research for Impact’ & the G20: How can global health innovation drive sustainable development?
Date: April 28th 2017
Location: Central Berlin
Time: 10:00-17:00
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. Read More
Nick Bagley and I have an op-ed in today’s New York Times calling for serious economic incentives for antibiotics, delinking revenues from sales volumes with a $4 billion prize system.
From the piece:
On Friday, the Centers for Disease Control and Prevention released a disturbing report about the death of an elderly woman in Washoe County, Nev. What killed her wasn’t heart disease, cancer or pneumonia. What killed her were bacteria that were resistant to every antibiotic doctors could throw at them.
This anonymous woman is only the latest casualty in a war against antibiotic-resistant bacteria — a war that we are losing. Although most bacteria die when they encounter an antibiotic, a few hardy bugs survive. Through repeated exposure, those tough bacteria proliferate, spreading resistance genes through the bacterial population. That’s the curse of antibiotics: The more they’re used, the worse they get, especially when they’re used carelessly. […]
Read more here.
Yesterday US HHS announced a new global partnership to fund pre-clinical antibiotic R&D, coordinated by the Boston University School of Law. The partnership is known as CARB-X, which is the abbreviation for the Combating Antibiotic-Resistant Bacteria (CARB) Biopharmaceutical Accelerator. CARB-X is the culmination of one key part of the US National Action Plan on antibiotic resistance. Background paper in Nature Reviews Drug Discovery.
Under the grant, BU Law will coordinate more than $350 million in new funds for R&D over the next five years, in partnership with BARDA, NIAID, the Wellcome Trust, the AMR Centre, MassBio, the California Life Sciences Institute and the Broad Institute at Harvard and MIT. Kevin Outterson is the PI and Executive Director of CARB-X.
While the bulk of the project funds pre-clinical R&D, we are also interested in the role of law, IP and other innovation incentives, using the unique dataset that CARB-X will generate.
If you will be in DC on Thursday, we have a great meeting about economic incentives for antibiotic innovation. Location is Capitol Hill. Register here.
Panelists include Rep. Peter Roskam (House Ways & Means), Sir Jim O’Neill, head of the UK AMR Review, Dr. Susan Coller Monarez, National Security Council and Christine Ardal, coordinator of WP2 (economic incentives) in DRIVE-AB. I will present the first look at the long-awaited Chatham House report.
@koutterson
Or so we claim in this month’s WHO Bulletin. Resistance is a global common pool problem requiring simultaneous action on three fronts: access to effective antibiotics (many more deaths from susceptible bacterial infections currently); conservation (protect and extend the most effective drug class in history through rational use and infection prevention); and innovation (new drugs, diagnostics, vaccines and agricultural practices). Providing any one alone is counterproductive over the long term: access alone will speed resistance; conservation alone denies access and undermines innovation incentives; innovation alone brings more drugs to the market, but without safeguards to prolong their usefulness and to ensure that low income populations have access to these life saving therapies.
See also this Chatham House Members’ Event last Wednesday on how resistance threatens global health security, with audio.
@koutterson
This new post by Kevin Outterson appears on the Health Affairs Blog, as part of part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015.
Dame Sally Davies, the Chief Medical Officer of England, warns that we are approaching an antibiotic apocalypse. A former chief economist at Goldman Sachs estimates that unless dramatic action is taken now, antimicrobial resistance could kill 50 million people a year and cause $100 trillion in cumulative economic damages.
In the US, dire warnings have issued from the Centers for Disease Control and Prevention (CDC), the President’s Council of Advisors on Science and Technology, and the President himself through an Executive Order on Combating Antibiotic-Resistant Bacteria in September 2014 (summary here). The President’s new budget asks for $1.2 billion to be spent on antibiotic resistance. […]
Read the full post here.
We’ve heard a lot about “death spirals” and how they could stand in the way of the Affordable Care Act’s goal of a functioning individual health insurance marketplace. Seth Chandler has an interesting blog devoted to the subject, “ACA Death Spiral.” And those who have been following King v. Burwell, the Supreme Court’s latest ACA case, have been predicting that a ruling against the government there would be disastrous because it would only exacerbate the “death spiral” threat to individual health insurance markets. (See a sum-up of such predictions here.)
But could death spirals save the ACA? According to a fascinating amicus brief filed in the King case by a number of interest groups and co-signed by several prominent law professors and Bill of Health contributors (I understand that Abigail Moncrieff is the driving force behind the brief, joined by Allison Hoffman, Sharona Hoffman, Russell Korobkin, Joan Krause, Stephen Marks, Kevin Outterson, and Theodore Ruger), the answer might be yes. The argument boils down to “death spirals to the rescue.” (Here is a copy: 14-114 bsac JALSA.)