Abstract

The issues relating to the licensing of a biopharmaceutical are described. In particular attention is focused on the mind of the regulator who has the responsibility of recommending licensure. There are two key factors which operate on the mind when confronted with such a task: psychology and ethics. The different factors which influence the psychological acceptability of a product for licensure are many and varied; they include perceived need, novelty, education, context and others. Also involved is the regulator’s view of the ethicality of such products and the organisms which make them, with particular reference to those which are genetically engineered. These ethical views are in turn derived by reference to basic systems of ethics which provide guidelines for behavior. It is important for the manufacturers of biopharmaceuticals to be aware of both the psychological and ethical aspects of the regulator’s mind when addressing such individuals with a view to obtaining a license to manufacture a particular biopharmaceutical.