This article offers a proposal for the regulation of stem cell products by the Food and Drug Administration (“FDA”) that corresponds to a specialized product liability scheme. It shows how product liability and administrative law can be successfully integrated to create a comprehensive legal...

The aim of this report is to foster a better understanding of past trends in, and drivers of, productivity growth in the countries of the European Union (EU) and of the interplay between productivity and monetary policy. To this end, a group of experts from 15 national central banks and the...

The decision of whether to release transgenic crops in the EU is one subject to flexibility, uncertainty, and irreversibility. We analyse the case of herbicide tolerant sugar beet and reassess whether the 1998 de facto moratorium of the EU on transgenic crops for sugar beet was correct from a...

This paper studies the diffusion of biopharmaceuticals across European countries, focusing on anti-TNF drugs, which are used to treat autoimmune diseases (e.g., rheumatism, psoriasis). We use detailed sales information on the three brands Remicade, Enbrel and Humira for nine European countries...

We analyze the impact of national pharmaceutical regulation on the launch delay of new chemical entities approved by the EMEA's centralized procedure. We find that direct price control regimes have a significantly negative impact on the launch timing. These results cannot be found when...

The article deals with the issue of health care, focusing on expenditure allocated to it. The first part of the article reviews some selected European Union countries, analyzing their expenditure on their health care sectors. The second part brings an analysis of expenditure on health care in...

This paper studies interaction of pharmaceutical regulation and parallel trade in a North-South framework. An innovative Örm located in the North can sell its drug only in the North or in both countries. Governments may limit reimbursement for the drug. Reimbursement limits reduce the Örmís...

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...

Patient mobility is a key issue in the EU who recently passed a new law on patients' right to EU-wide provider choice. In this paper we use a Hotelling model with two regions that differ in technology to study the impact of patient mobility on health care quality, health care financing and...

Prescription drug expenditures make up less than 10 percent of total personal health care expenditures in the United States, but over the last decade the amount that Americans spend on prescription drugs has grown much faster than any other component of personal health care. For example, between...