The European Commission is reviewing the use of supplementary protection certificates (SPCs), a patent term extension motivated by the increasing length of market approvals for pharmaceuticals. The initiative is driven by EU Health Ministers thinking that changes in patent exclusivity rights...

Error-proofing in the production process of pharmaceuticals isn't just a matter of good business, it has life-and-death implications for consumers. To that end, the 2013 Drug Quality and Security Act in large part requires new mandates on tracking and tracing chain of custody in the supply...

This paper studies the effect of pharmaceutical regulation at the wholesale level, if markets are integrated by parallel trade, i.e. trade outside the manufacturerś authorized distribution channel. In particular, maximum wholesale margins, a restriction of pricing by the intermediary, and...

This paper analyzes a maximum price system and a reference price system in a vertical differentiation model with a brand-name drug and a generic. In particular, both instruments are compared with respect to their performance in reducing public expenditure, limiting financial exposure of...

While at least a dozen state legislatures are considering bills to allow the consumption of marijuana for medicinal purposes, the federal government has recently intensified its efforts to close medical marijuana dispensaries. Federal officials contend that the legalization of medical marijuana...

Inhaltsverzeichnis Vorwort 1. Einleitung 9 1.1 Forschungsstand und Fragestellung 9 1.2 Quellenlage ...

The US and the EU recently introduced regulation to curb the extent of risky off-label drug use. It offers manufacturers a prolongation of patent protection or exclusivity if they invest in pediatric clinical tests. This paper shows that a reinforcement of physician liability for off-label use...

The US and the EU recently introduced regulation to curb the extent of risky off-label drug use. It offers manufacturers a prolongation of patent protection or exclusivity if they invest in pediatric clinical tests. This paper shows that a reinforcement of physician liability for off-label use...

Trading health for wealth -- A primer on pharmaceutical IP -- Market failures and fallacies -- Local politics, strange bedfellows, and the challenges of human rights mobilization -- Patient advocacy and access to medicines litigation -- Writing globalization's rulebook