Very few industries are as profoundly influenced by regulation as the pharmaceutical industry. All aspects of the life-cycle of new drugs are regulated, from patent application, to marketing approval, commercial exploitation, patent expiration and competition with generics. The nature of demand...

This paper explores the European Union (EU) regulatory regime for Traditional Chinese Médicine and its legal, cultural, economic , and international trade implications. The controversial Directive on Traditional Herbal Medicinal Products (THMPD) amended the European Community Code for medicinal...

Debate about the adequacy of civil liability and compensation arrangements for nuclear reactor accidents increased markedly after the 1986 Chernobyl accident. The subsequent development of international nuclear liability and compensation conventions has sought to address the principal...

Pharmaceutical Companies are highly globalized. This widening of drug markets leads to an erosion of the national government's legislative powers. With trials and marketing of compounds and pharmaceuticals carried out in different countries, ensuring safety and effectiveness of drugs becomes...

This are the concluding remarks to an edited volume on climate change liability. The introduction sketches the reasons for writing a book on climate change liability as well as the problem definition, methodology and structure of the book. The concluding remarks show that from the contributions...

The present paper focuses on the emerging human rights-based climate change litigation legal movement and proposes an ECHR law-based litigation route that can be used, along with European and national constitutional law arguments, in national courts of states that participate in the ECHR system,...

In contrast to the whirlwind pace and the efficiency with which the science and commercialization of modern biotechnology have developed in the past few decades, the creation of an adequate and comprehensive regulatory regime for agricultural biotechnology has proven to be a lengthy and arduous...

The climate change problem forces the government to implement a policy protecting its society and economy against the possible damage that might be caused by changing weather conditions. At the same time, it can be questioned to what extent citizens are able to (and should) take responsibility...

Hydraulic fracturing has been the subject of much debate recently, both in the United States and increasingly in Europe. Advances in hydraulic fracturing technology have led to a shale gas boom in the United States, significantly lowering natural gas prices, and causing some foreign businesses...