Extended Impact Assessment of a Draft EC Regulation on Medicinal Products for Paediatric Use

This impact assessment of the draft regulation on
paediatric medicines was conducted by RAND Europe for the European
Commission. 

The paper draws the conclusion that the EU’s new regulation
on medicinal products for paediatric use will cost money to
industry, government and consumer but will improve the health of
children and, on balance, the gains will outweigh the losses.

This document was put together by Wija J. Oortwijn,
Edwin Horlings, Silvia Anton, Mirjam van het Loo and James P.
Kahan, can be downloaded from the RAND website.