Some comparative remarks on pharmaceutical product liability

The European Union, the United States Japan and Brazil have developed different product liability rules which, in spite of showing some trends towards harmonisation, still make it impossible for manufacturers of pharmaceuticals to implement globally acceptable product designs, manufacturing processes and labelling. In the products liability rules for pharmaceuticals there are still differences as regards the contract/tort approach, the use of alternative instruments of no-fault compensation schemes, the need to establish specific rules for some sort of pharmaceuticals and the understanding of some of the core elements of products liability such as the notions of product, defect, causation and defences. This paper deals with some of these questions from a comparative prospective trying thereby to establish a general framework for some of the problems that will be dealt with in more detail in the other papers included in this issue.