Licensing of medicines

Abstract

The Medicines Act was a response to some of the major cases of drug toxicity that occurred in the late 1950s and early 1960s. Two of these resulted in significant morbidity and mortality for the developing fetus and the newborn infant: phocomelia caused by thalidomide1 2 and the grey baby syndrome caused by chloramphenicol.3 It is ironic that, despite drug toxicity occurring in this age group, neonates, infants, and children receive medicines that have not been through the licensing system. Many of the medicines given to children in hospitals either do not have a product license for use in children and hence are used off label (outside the terms of the product licence) or are simply not licensed at all for use in their current formulation.4 Recent studies suggest that up to 40% of children in hospital receive “unlicensed” medicines5 and this is of concern to children, their parents, health professionals, the regulatory authorities, and, more recently, politicians.6