Abstract
The application of quality control and assurance procedures to the components of animal cell cultures has transformed what was an art to a viable industrial technology. This results in the successful large scale operation of such cultures. However it is clear that the cost of obtaining a license to produce materials from animal cells in culture severely impedes the movement of products into the market place. It is therefore necessary to examine in more detail the reasons for the reluctance of the regulatory authorities to issue product licences and in particular to appreciate the way ethical issues influence this process. This paper reviews these issues and indicates a way ahead.