illustration of abstract ecnomics

The Need for an Economic Bioethics

As the animations of markets increasingly shape the timbre and character of medicine, scholars studying ethical issues in health and medicine must be increasingly attentive to the role of market forces as they shape modern health care.

For those interested in the social, ethical, and conceptual dimensions of contemporary health and medicine, there has been a sustained focus on a key set of important challenges; how do we ensure adequate access to health for marginalized and global populations? What are the social and ethical implications of emergent technologies? How are issues of consent articulated in the everyday interactions of the clinic? What are our obligations to persons in terms of end-of-life care? These longstanding concerns regarding access, new technologies and the rights of patients comprise the major thrusts and foci of bioethics, health care ethics, and associated areas of inquiry.

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Will the EPO’s Enlarged Board of Appeal step into the CRISPR patent battle?

By  Jakob Wested, Timo Minssen & Esther van Zimmeren

Another version of this contribution has been published in Life Science Intellectual Property Review (LSIPR).

The Broad Institute is facing a formidable task in defending the revoked CRISPR patent claims in their pending appeal at the European Patent Office (EPO). Ultimately, some of the issues might still be referred to the Enlarged Board of Appeal. However, this might require a significant amount of legal and rhetorical agility.

“The Opposition Division’s interpretation of the EPC [European Patent Convention] is inconsistent with treaties designed to harmonize the international patent process, including that of the United States and Europe.”

This was the rather strong reaction of the Broad Institute after the EPO’s Opposition Division’s (OD) decision to revoke one of their CRISPR patents. It could, however, also be argued that the case presents a simple failure of the patent applicants to comply with the long-standing European practice to apply an “all applicants” approach when claiming priority under article 87 of the European Patent Convention.

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Massachusetts Wants To Drive Down Medicaid Drug Costs: Why Is The Administration So Nervous?

This new post by Nicholas Bagley and Rachel Sachs appears on the Health Affairs Blog. 

Although drug formularies are ubiquitous in Medicare and the private insurance market, they’re absent in Medicaid. By law, state Medicaid programs that offer prescription drug coverage (as they all do) must cover all drugs approved by the U.S. Food and Drug Administration, however expensive they are and however slim their clinical benefits may be.

Massachusetts would like to change all that. In a recent waiver proposal, Massachusetts asked the Centers for Medicare and Medicaid Services (CMS) to allow it to adopt a closed formulary in Medicaid. That would allow Massachusetts to exclude certain brand-name drugs from Medicaid, increasing its leverage in price negotiations beyond what it can achieve through existing utilization management techniques like prior authorization.

Among Medicaid advocates, the proposal is controversial. Some fear that state budgets would be balanced on the backs of Medicaid beneficiaries, who could be denied access to expensive therapies. But Massachusetts thinks there’s room to drive down drug spending without threatening access to needed medications. In any event, the state has to do something. Drug spending in Massachusetts has increased, on average, 13 percent annually since 2010, threatening to “crowd out important spending on health care and other critical programs.”

By all rights, CMS should welcome Massachusetts’s proposal. Closed drug formularies are tried-and-true, market-based approaches to fostering competition over drug prices, and the Trump administration’s Council on Economic Advisers recently released a report saying that “government policy should induce price competition” in Medicaid. If Secretary of Health and Human Services (HHS) Alex Azar means it when he says that “drug prices are too high,” letting Massachusetts try out a formulary makes a ton of sense. […]

 Read the Full post here!

Wishes at the end of life: comparing the right to try and right to die

By Oliver Kim

After an initial procedural hiccup, the House of Representatives passed a modified version of a federal “right to try” bill, legislation that would allow pharmaceutical companies to bypass the federally-prescribed clinical trial process to allow terminally ill patients to try experimental drugs. Similar legislation passed the Senate as part of a horse-trade in order to allow the swift passage of the FDA user fee reauthorization before that program expired. A majority of the states have passed right-to-try legislation, which is largely ineffective given federal preemption.

Much has been written about the ethical and legal questions surrounding the right to try as well as the political forces behind it. Proponents argue that the right to try is based on notions of mercy, compassion, and autonomy.

What has interested me about this debate is that often those same notions are used to justify the “right to die,” or aid in dying usually for terminally ill patients. I’ve written (and will be publishing a longer piece) and will be speaking about this question and if there are lessons that proponents of the right to die can learn from the political success of the right-to-try movement.

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Innovation Gaps on Life Science Frontiers

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.

 

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The Opioid Crisis Requires Evidence-Based Solutions, Part II: How the President’s Commission on Combating Drug Addiction Ignored Promising Medical Treatments

By Mason Marks

Last year more than 64,000 Americans died of drug overdose, which is “now the leading cause of death” in people under 50. Opioids kill an estimated 91 Americans each day and are responsible for most drug-related deaths in the US. This public health crisis requires solutions that are supported by science and reason instead of emotion and political ideology. In Part I of this three-part series, I discuss how the President’s Commission on Combating Drug Addiction and the Opioid Crisis misinterpreted scientific studies and used data to support unfounded conclusions. In this second part of the series, I explore how the Opioid Commission ignored medical interventions that are used successfully in the U.S. and abroad. In Part III, I will discuss non-medical interventions such as drug checking and safe injection sites. The Commission’s failure to consider these options is likely driven by emotions such as fear and disgust rather than a careful review of scientific evidence.

Medical marijuana is currently accepted in 29 U.S. states and the District of Columbia. It is also permitted in at least 10 countries. However, the Opioid Commission outright rejected calls to consider the use of medical marijuana as an alternative to opioids for managing pain. Prior to the Commission’s first meeting, it solicited input from industry and members of the public on how to address the opioid crisis. In response, it received over 8,000 public comments. According to VICE News, which obtained the documents by submitting a Freedom of Information Act (FOIA) request, most comments were submitted by individuals urging the Commission to “consider medical marijuana as a solution to the opioid epidemic.” A spokesman for the Office of National Drug Control Policy, a body of the Executive Branch that provides administrative support to the Opioid Commission, reports receiving “more than 7,800 public comments relating to marijuana.” Despite these comments, in its final report, the Commission dismissed the notion that marijuana should play a role in treating chronic pain and opioid addiction. Its report cited a recent study from the American Journal of Psychiatry, which concluded that marijuana use was associated with an increased risk of opioid abuse. However, this study relied on data that was collected over twelve years ago. One of its authors, Columbia Medical School Professor Mark Olfson, told CNN that if the data were collected today, they could yield different results.

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The Opioid Crisis Requires Evidence-Based Solutions, Part I: How the President’s Commission on Combating Drug Addiction Misinterpreted Scientific Studies

By Mason Marks

The opioid crisis kills at least 91 Americans each day and has far-reaching social and economic consequences for us all. As lawmakers explore solutions to the problem, they should ensure that new regulations are based on scientific evidence and reason rather than emotion or political ideology. Though emotions should motivate the creation of policies and legislation, solutions to the opioid epidemic should be grounded in empirical observation rather than feelings of anger, fear, or disgust. Legislators must be unafraid to explore bold solutions to the crisis, and some measured risks should be taken. In this three-part series on evidence-backed solutions to the opioid crisis, I discuss proposals under consideration by the Trump Administration including recent recommendations of the President’s Commission on Combating Drug Addiction and the Opioid Crisis. Though the Commission made some justifiable proposals, it misinterpreted the conclusions of scientific studies and failed to consider evidence-based solutions used in other countries. This first part of the series focuses on the misinterpretation of scientific data.

Last year more than 64,000 Americans died of drug overdose, which is “now the leading cause of death” in people under 50. Opioids are responsible for most of these deaths. By comparison, the National Safety Council estimates about 40,000 Americans died in auto crashes last year, and the Centers for Disease Control reports that 38,000 people were killed by firearms. Unlike deaths due to cars and firearms, which have remained relatively stable over the past few years, opioid deaths have spiked abruptly. Between 2002 and 2015, U.S. opioid-related deaths nearly tripled (from about 12,000 deaths in 2002 to over 33,000 in 2015). Last year, synthetic opioids such as fentanyl contributed to over 20,000 deaths and accounted for the sharpest increase in opioid fatalities (See blue line in Fig. 1 below). Read More

Innovation and the Firm: Vertical Integration in Patent-Intensive Industries – Seminar 9/8 at the University of Copenhagen

Looking forward to hear Professor Peter Lee’s (UC Davis) talk on “Innovation and the Firm: Vertical Integration in Patent-Intensive Industries” at the University of Copenhagen on Friday, Friday, September 8th 2017 from 10:00 – 12:00. If you are interested to join, please register here.

Abstract of Professor Lee’s talk:

Recent scholarship has highlighted the prevalence of vertical disintegration in high-technology industries, whereby distinct, specialized entities along a value chain transfer intellectual assets between them. Patents play an important role in vertical disintegration, for they lower the cost of technology transactions between upstream suppliers and downstream users.

This presentation, however, draws on empirical accounts to explore the peculiar persistence of vertical integration in patent-intensive fields. In biopharmaceuticals, agricultural biotechnology, and information technology, firms are increasingly acquiring technology providers rather than simply licensing their patents. This dynamic is even evident to a certain extent in university-industry technology transfer, where universities and commercializing firms frequently engage in institutional meshing to transfer patented technologies. Read More

Biobanks as Konwledge Institutions – Seminar 11/3 at the University of Copenhagen

Biobanks as Knowledge Institutions

“Global Genes –Local Concerns” Seminar with Prof. Michael Madison (University of Pittsburgh, U.S.)

Join us at the University of Copenhagen on November 3rd, 2017 to discuss the legal implications of “Biobanks as Knowledge Institutions” with Professor Michael Madison. 

Abstract

The presentation characterizes the material and immaterial attributes of biobanks as knowledge resources, and it characterizes the broader questions that they pose as resource governance questions rather than as questions solely of law or of public policy. Biobanks are knowledge institutions. Professor Madison argues that despite the varied and diverse nature of biobanks today (indeed, precisely because of their diversity), their social and scientific importance dictates the need for a robust program of research of a comparative nature to identify shared features that contribute to their success (where they succeed) and features that likely contribute to problems or even failure. Both their importance and the associated governance challenges have only grown larger and more complex as biobanks meet the era of data science. In that regard Professor Madison points to emerging scholarly literature that focuses on governance challenges of material and data in biobank contexts, which builds on a knowledge commons governance framework. He concludes by suggesting directions for future work. Read More

Copenhagen Conference: Legal Perspectives on Synthetic Biology and Gene Editing

Join us at the Centre for Information and Innovation Law (CIIR) Faculty of Law, University of Copenhagen on 20 November, 2017 to discuss Legal Perspectives on Synthetic Biology and Gene Editing.

CALL FOR PAPERS

Emerging technologies in Synthetic Biology and Gene Editing offer incredible opportunities and promising solutions to some of the most urgent challenges faced by humanity, such as climate change, environmental protection, growing population, renewable energy and improved health care. But the emerging applications also raise exceptional ethical, legal and social questions.

This conference marks the final phase of the participation of the Copenhagen Biotech and Pharma Forum (CBPF) Research Group at the Centre for Information and Innovation Law (CIIR) in the cross-faculty research project BioSYNergy. In accordance with the goals of this large cross-faculty project on Synthetic Biology, the event explores legal perspectives on synthetic biology, systems biology and gene editing. Dealing with the legal responses to ethical and scientific challenges raised by emerging life science technology. Read More