It Is Emphatically the Province and Duty of State Courts to Say What Tort Law Is

Following the U.S. Supreme Court’s 2011 decision in PLIVA, Inc. v. Mensing, consumers of generic prescription drugs suffering from unwarnedof side effects largely remain without an avenue of legal recourse due to their inability to sue their own manufacturers. But in the pursuit for legal redress, some generic plaintiffs have pursued a narrow window of liability by bringing failure-to-warn claims, sounding in negligence, against the manufacturer responsible for producing the brand-name equivalent of the generic drug. Such claims rest on the rationale that the sui generis federal regulatory scheme governing the prescription drug industry furnishes an inextricable nexus between the brand-name manufacturer and generic-drug user such that it generates a negligence duty of care between them. The case law on this duty question remains fractured. Until late 2017, the majority of courts confronting the duty issue ruled for the brand-name defendant and held no duty as a matter of law. However, beginning in December of 2017, two landmark decisions by the California and Massachusetts supreme courts, in support of duty, have called for a reexamination of settled case law and, accordingly, given new hope to the generic-drug user’s pursuit of legal remedy. In light of these recent developments, this Note seeks to equip future courts confronting the duty question with a functional understanding of the considerations that lie on both sides of the duty inquiry. In addition, this Note proposes a remedial position that incorporates both the policy concerns cutting against duty and the doctrinal considerations undergirding it. At its core, this Note argues that doctrine demands a duty be recognized and, further, that courts have the core institutional competence to craft tort law in ways that will avert ruinous public policy consequences. In making this argument, this Note conveys a fighting message to courts: where tort doctrine says a duty of care exists, courts should endeavor to give effect to that duty

Reference Pricing of Pharmaceuticals for Medicare: Evidence from Germany, the Netherlands and New Zealand

This paper describes three prototypical systems of therapeutic reference pricing (RP) for pharmaceuticals -- Germany, the Netherlands, and New Zealand -- and examines their effects on the availability of new drugs, reimbursement levels, manufacturer prices and out-of-pocket surcharges to patients. RP for pharmaceuticals is not simply analogous to a defined contribution approach to subsidizing insurance coverage. Although a major purpose of RP is to stimulate competition, theory suggests that this is unlikely and this is confirmed by the empirical evidence. Other effects of RP differ across countries in predictable ways, reflecting each country's system design and other cost control policies. New Zealand's RP system has reduced reimbursement and limited the availability of new drugs, particularly more expensive drugs. Compared to these three countries, if RP were applied in the US, it would likely have a more negative effect on prices of on-patent products, due to the more competitive US generic market, and a more negative effect on R&D and on the future supply of new drugs, due to the much larger US share of global pharmaceutical sales.

Pharmaceuticals Delivery in Ireland. Getting a Bigger Bang for the Buck

Ireland

Human Capital Formation and Global Warming Mitigation: Evidence from an Integrated Assessment Model

Based on recent empirical evidence, this paper includes human capital and knowledge in an integrated assessment model and it assesses the interplay between innovation, human capital, climate change, and education policies. Results indicate that climate policy stimulates a dedicated form of energy-knowledge without reducing generic R&D investments. Since advancements in labour productivity have a negative impact on the environment because labour is assumed to be complement to energy, climate policy reduces education investments, on which human capital is built. However, a policy mix combining climate and education targets shows that education and climate goals can be coupled incurring in small additional economic penalties.climate policy, innovation, human capital

The impact of generic reference pricing interventions in the statin market

The objective of this study was to evaluate the intended and unintended impact on pharmaceutical use and sales of three public financing reforms applied to the prescription of statins: a Spanish generic reference pricing (RP) system for lovastatin and simvastatin, and two competing policies introduced by the Andalusian Public Health Service (APHS) for all statins, first a maximum consumer price (MCP) and then a so called quality prescribing incentive for general practitioners (MCP plus PI). This study is designed as an observational, retrospective, interrupted time series analysis with comparison series (APHS and the rest of Spain) of 46 monthly drug use and sales ratios from January 2001 to October 2004 for each active ingredient in the group of statins. RP has been effective at reducing the volume of sales growth of the off-patent statins, yet its overall impact on sales of all statins has been relatively modest. The quantity and volume of sales impact heavily depends on regulatory RP details such as when the system is introduced, how often it is updated, and how the reference price is calculated.Pharmaceutical sales, generic medicines, pharmaceutical reference pricing, statins

Spectrum Auction Design

Spectrum auctions are used by governments to assign and price licenses for wireless communications. The standard approach is the simultaneous ascending auction, in which many related lots are auctioned simultaneously in a sequence of rounds. I analyze the strengths and weaknesses of the approach with examples from US spectrum auctions. I then present a variation, the package clock auction, adopted by the UK, which addresses many of the problems of the simultaneous ascending auction while building on its strengths. The package clock auction is a simple dynamic auction in which bidders bid on packages of lots. Most importantly, the auction allows alternative technologies that require the spectrum to be organized in different ways to compete in a technology-neutral auction. In addition, the pricing rule and information policy are carefully tailored to mitigate gaming behavior. An activity rule based on revealed preference promotes price discovery throughout the clock stage of the auction. Truthful bidding is encouraged, which simplifies bidding and improves efficiency. Experimental tests and early auctions confirm the advantages of the approach.Auctions, spectrum auctions, market design, package auction, clock auction, combinatorial auction