Therapeutic orphans: European perspective.

There are several factors to be considered when facing the problem of therapeutic orphans. First, there is the scientific one. We are all convinced that there is much need for more data concerning the use of drugs in children, infants, and neonates. Second, there is a regulatory factor involving political and technical institutions. Finally, we have to consider the economic interest of the pharmaceutics industry in investing money in research that would hardly generate sufficient return.