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NFIB v. Sebelius and the Right to Health Care: Government\u27s Obligation to Provide for the Health, Safety, and Welfare of Its Citizens
Get PDFOne of the most important roles government plays in contemporary society is protecting people from unsafe products and environmental conditions. Although the Supreme Court has rejected calls to read the Constitution of the United States to include positive rights, this article’s central claim is that the Supreme Court’s rejection of the Medicaid expansion in the Patient Protection and Affordable Care Act makes sense only if the Constitution is understood as requiring government to provide for the health, safety and welfare of its citizens. It’s not that Chief Justice Roberts intended this implication, but if states did not feel obligated to provide, in this instance, health care, they would not have felt coerced, as the Court’s opinion concluded they were, into accepting the Medicaid expansion. Congress violates this understanding when it enacts irrational exceptions to health, safety and welfare programs, such as the 1975 Proxmire Amendment which limits the FDA’s authority to regulate vitamins and supplements. Even if courts do not strike down irrational exceptions to health, safety and welfare laws, their inconsistency with government’s basic obligation to its citizens should make legislators and regulators hesitate before enacting or promulgating them
Business Model Options for Antibiotics: Learning from Other Industries
Get PDFAs resistance to antibiotics continues to grow, there is a well-recognized misalignment between the clinical need for new antibiotics and the incentives for their development. The returns from investment in antibiotics research and development (R&D) are perceived as too small. Partly as a result, the number of large multinational companies researching antibiotics has fallen drastically in the past 20 years and few high-quality antibiotics have been developed.
In looking at the antimicrobial resistance (AMR) situation, we were aware that other industries have faced conceptually similar challenges and that they might offer helpful lessons and possible solutions that could be adapted to the problems of antimicrobial R&D. Our focus was particularly on learning about models in which the incentive for R&D is delinked from the volume of sales.
A Big Innovation Centre and Chatham House workshop brought together on 1 September 2014 six companies that are members of the Big Innovation Centre: BAE Systems (defence), Allianz (insurance), Barclays Bank (finance), EDF Energy (energy), Dun & Bradstreet (corporate information) and Knowledge Unlatched (academic publishing). These companies presented business and incentivization models they had implemented or devised that could be explored further for their applicability to antibiotics R&D. It was made clear to them that any models shared might be adapted so that they a) provide the pharmaceutical industry with an incentive to invest in antibiotics R&D, b) offer insight to health services about how to fund and to maintain the availability of appropriate antibiotics and c) ensure that both new and existing antibiotics are used appropriately and wisely.
Learning from other industries has been a very fruitful exercise. They have offered a different perspective on how to tackle the AMR issue and have provided relevant analogies to consider.
This research report offers a number of innovative models and ideas that address many of the critical questions facing policy-makers in the EU and the US as they seek solutions. It also contributes to key new initiatives globally and in Europe and the US specifically, including the World Health Organization’s Global Strategy on AMR, the Innovative Medicines Initiative DRIVE-AB project in the EU, the UK’s Review on Antimicrobial Resistance and, in the US, the President’s Advisory Council and the National Strategy for Combating Antibiotic-Resistant Bacteria.
This report highlights important lessons about how these other industries have adapted to diverse challenges in their environment. Based on this work and on our own review over the past few months, we see a clear need for a ‘bucket’ of various funding mechanisms that can exist in parallel. There should be separate funding mechanisms in place during the R&D phase of developing an antibiotic and a different mechanism to fund the maintenance, delivery and distribution of the antibiotic after regulatory approval.
The report articulates three essential messages:
(1) Global collaboration is required on a scale not seen before in relation to antimicrobial resistance. Many independent initiatives are under way nationally and regionally, but they need to be brought together in a concerted worldwide effort to engage on a global scale. The report is designed to help bridge these various efforts and move towards consensus on global action. We propose four initiatives:
a. Creating a global antibiotics public-private partnership (GAPPP). A GAPPP should involve private companies, academic institutions and public bodies. It must be a sustainable, independent and self-funding operation with a focus on the research and early development of antibiotics in response to identified global public health needs.
b. Creating a global antibiotics fund (GAF), which would be set up to be an over-arching umbrella fund (potentially consolidating all the pre-existing small funds that exist globally). It could exist alongside or in collaboration with major existing funding sources, such as BARDA and IMI, that have very pre- defined targets for funding. A GAF would provide monetary support to a GAPPP in order to enable its R&D effort. A GAF would work with existing funders for better awareness of the work each is supporting and for collaboration in funding priorities, options and courses of action. Ultimately, proposals for a GAPPP and a GAF are a possible way forward to pool skills, resources and funding so as to ensure a sustainable long-term solution.
c. Exploring the Gavi (the Vaccine Alliance)-type model and determining whether or not an independent global body should serve as the global procurement and distribution entity for antibiotics.
d. Becoming better stewards of antibiotics, as they are valuable drugs. Otherwise, boosting the production of new antibiotics will be futile. Antibiotics must be used appropriately everywhere around the globe. A worldwide effort to conserve them and to ensure appropriate access and use requires international coordination and the participation of every country. Some form of an international treaty or framework agreement is called for.
(2) There is a need to explore ‘service-availability’/’option-to-use’ types of agreements/contracts between developers/manufacturers and health care systems as a means to support the ‘delinkage’ concept. As in the defence sector, products are developed but kept on the shelf, maintained and ready when needed, including all the services to deliver them effectively and efficiently. Long-term contracts with customers ensure that the services they require are available when needed. Innovators of new antibiotics should not be rewarded with the traditional ‘price x volume’ model but should focus more on delivering the product, resources and services when needed. Governments would pay an annual ‘service-availability’ fee/premium delinked from the volume of sales. Lessons from the insurance industry indicate how these annual ‘premiums’ could be calculated.
(3) There is a need to engage customers (in the broadest sense) and ensure that the right incentives, both financial and non-financial, are aligned from the bench to the bedside. We should not focus on incentives just for the pharmaceutical companies; we must include prescribers, health systems, patients and all other stakeholders
The Suez Crisis of 1956 and Its Aftermath: A Comparative Study of Constitutions, Use of Force, Diplomacy and International Relations
Get PDFThis article compares and juxtaposes constitutional war powers (deployed by the belligerents) and diplomacy (deployed by the US) as means of pursuing foreign policy during the 1956 Suez crisis.
In the fall of 1956 the United Kingdom, France and Israel launched a war against Egypt. It soon became clear that this was a coordinated effort. The war started a few days before the US presidential elections but the parties did not share their plans with President Eisenhower. The Hungarian rebellion and the Soviet invasion of Hungary occurred at the same time. Within weeks, the United States, in cooperation with the United Nations forced the belligerents to withdraw. France and Great Britain lost their dominant status in the Middle East. Israel gained navigation access to the Straits of Tiran as well as a demilitarized Sinai Peninsula, including the Gaza strip. None of the belligerents achieved their war aims.
This article situates the constitutional dimension of war powers in a dense description of the decision to go to war. It shows that while each country had a different constitutional process regulating the decision to go to war, a small circle in the executive branch was responsible for the fateful decision in each of the countries. The constitutional process was honored formally but substantively only minimal parliamentary or even cabinet deliberations took place. The article also offers summaries of the constitutional changes taking place in each of these countries in the aftermath of the war. The final part of the article reviews US constitutional presidential powers deployed to coerce the three belligerents to end the war and withdraw from Egyptian territory. In an effort to restore the status quo ante, the President of the United States used diplomatic means. His actions ended the age of colonialism in the Middle East and introduced the United States (and the Soviet Union) into Middle Eastern politics
Lord Mustill and the Channel Tunnel Case
Get PDFOver two decades ago, in the now legendary Channel Tunnel Case, the British House of Lords (as it then was) was asked to provide judicial support for the efficient completion of a monumental construction project. The decision in that matter, penned by the late Lord Mustill, illustrates the delicate interplay between the dynamics of otherwise applicable law and the bespoke arbitration framework chosen by sophisticated parties to govern their dispute
Did Commissioner Gallagher Violate SEC Rules?
No full textRecently SEC Commissioner Daniel M. Gallagher issued a paper, titled Did Harvard Violate Federal Securities Law? (described on the Forum here and in a WSJ article here). The paper, co-authored with Professor Joseph Grundfest, expressed the Commissioner’s opinions regarding shareholder proposals and the Harvard Law School clinic that assisted public pension funds filing those proposals in the previous three years. The Commissioner did not mince his words. In his opinion, Harvard University and its clinic violated the securities laws by assisting proponents that failed to include references to academic studies contrary to the views of those proponents. The Commissioner was clearly presenting a threat to the University and its clinic. However, his statements also raise a number of questions about his own behavior.
To begin with, the Commissioner should have recognized that, as Professor Macey has shown in a series of posts (available on the Forum here, here, and here), his accusations are without merit and the proposals were entirely consistent with current SEC rules, policies and practices. Furthermore, in making his accusations, the Commissioner deviated from standard SEC procedures and practices
Marbury Moments
Get PDFEvery court has its Marbury moment. To support this argument, this Article reviews seminal cases from three types of courts: U.S. federal, regional, and international. This Article concludes that Marbury moments provide novel insights about both Marbury v. Madison itself and the nature of domestic and international courts
Don\u27t Kill the Password. Change the Password
No full textTO ACCESS TO most accounts online and on computer systems, users authenticate their identity by logging in with a password. People are asked to do the Herculean task of coming up with unique long and complex passwords for each account, committing them all to memory, and then changing them frequently. The task is nearly impossible, and when most people fail, they’re the ones who are blamed. But people are not to blame. The problem is with passwords. Passwords are a terrible way to protect the security of data, and they are at the center of far too many data breaches.
It’s time for a change. Passwords alone can’t hack it. There is widespread consensus among data security experts that using only passwords is poor security, and there are readily available alternatives. Yet the lone password has been used for authentication for so long and so widely that it is difficult to change the status quo, even if many wished to. It’s time for the Federal Trade Commission (FTC) to step in and give the lowly password some backup in high risk contexts by requiring a second factor for authentication
SE(c)(3): A Catalyst for Social Enterprise Crowdfunding
Get PDFThe emerging consensus among scholars rejects the notion of tax breaks for social enterprises, concluding that such prizes will attract strategic claimants, ultimately doing more harm than good The SE(c)(3) regime proposed by this Article offers entrepreneurs and investors committed to combining financial returns and social good with a means of broadcasting that shared resolve. Combining a measured tax benefit for mission-driven activities with a heightened burden on shareholder financial gains, the revenue-neutral SE(c)(3) regime would provide investors and funding platforms with a low-cost means of screening out greenwashed ventures
Incorporating Legal Claims
Get PDFRecent years have seen an explosion of interest in commercial litigation funding. Whereas the judicial, legislative, and scholarly treatment of litigation finance has regarded litigation finance first and foremost as a form of champerty and sought to regulate it through rules of legal professional responsibility (hereinafter, the legal ethics paradigm ), this Article suggests that the problems created by litigation finance are all facets of the classic problems created by the separation of ownership and control that have been a focus of business law since the advent of the corporate form. Therefore, an incorporation paradigm, offered here, is more appropriate. Incorporating legal claims means conceiving of the claim as an asset with an existence wholly separate from the plaintiff This can be done by issuing securities tied to litigation proceed rights. Such securities can be issued with or without the use of various business entities. The incorporation paradigm also opens up the possibility of applying practices of corporate governance to litigation governance.
Indeed, in certain previously overlooked real-world deals, creative lawyers used securities tied to litigation proceed rights as well as corporate governance mechanisms. This Article analyzes and then expands upon such instances of financial-legal innovation, suggesting how various business entities can be used to deal with the core challenges presented by the separation of owner ship of and control over legal claims: specifically, the problems of (1) extreme agency problems; (2) extreme information asymmetries; (3) extreme uncertainty; and (4) commodification.
In addition, this Article discusses how incorporation of legal claims can reduce various costs that litigation imposes in other transactions, such as mergers and acquisition
New DTCA Guidance — Enough to Empower Consumers?
Get PDFAs one of only two countries that permit direct-to-consumer advertising (DTCA) of pharmaceuticals, the United States tasks the Food and Drug Administration (FDA) with regulating that advertising to ensure that it doesn\u27t mislead consumers. When a drug maker publishes or broadcasts a claim that its drug has benefits in a particular disease, the FDA requires it to include information on the product\u27s risks as well. Since it\u27s not feasible for companies to include all the important information about their products in a television ad, the FDA requires them to refer viewers to more complete information, such as that in a printed magazine ad. Companies have tended to comply with this requirement by supplementing colorful, persuasive ads with one or two pages of dry text providing the required disclosures, often simply using language that the FDA has approved for other purposes, such as package inserts for prescribers. But research shows that most patients who attempt to read these disclosures find them difficult to understand, and many don\u27t even try to make sense of them. Now, the FDA is in the process of adjusting its DTCA rules, aiming to provide greater assurance that patients receive due warning of the most significant risks — but its tweaks probably don\u27t go far enough to really empower consumers to make smart decisions about the drugs they put into their bodies