Generic and therapeutic orphans

This commentary discusses the need to develop methods to ensure the availability of non-profitable, off-patent medicines to children and other populations. The history and some of the shortcomings of legislative attempts to provide drug therapy to children are briefly reviewed. Some examples of the inability of the current generics and non-generics pharmaceutical industry as well as the current development and drug production system to adequately respond to the needs of children and other ‘orphan’ populations are then discussed. Finally, some potential solutions are mentioned.