Pediatric disclaimers and off-label use of medicines in children was observed and criticized by US pediatricians since safety and efficacy had to be proven in drugs. After several attempts with limited success, a new pediatric legislation was introduced in the USA in 1997 that appealed to voluntary contribution from pharmaceutical companies. Due to its success it was prolongued in 2002. A second, complimentary approach to give FDA authority to request mandatory pediatric research was introduced 1998, successfully challenged in court 2000, and then re-introduced as a new law in 2003. Both paths are linked and will sunset in September 2007. To a large degree initiated by the US precedence, a comparable debate in Europe started on national level in several countries, was addressed a first time on the level of the EU Health Commission in 2000, and led to a first draft legislation submitted to the EU parliament in September 2004. The EU approach combines voluntary and mandatory aspects. A powerful institution, the pediatric committee, will be responsible to negotiate pediatric investigation plans (PIPs) with the pharmaceutical companies, and to decide about waivers and deferrals. It can further be assumed that some reward will be granted for pediatric research although the details are still under consideration. Until now, the EU debate has focused on the magnitude of the financial rewards. No research planning exists that acknowledges the achievements of US-triggered pediatric research and identifies potential further research to be triggered by the EU legislation. This dialogue between pharmaceutical companies, academic research and the EU health authorities is beginning only now. It is also still open which research requests the future EMEA pediatric committee will express beyond commitments companies have agreed upon with the FDA. The EU debate has, however, certainly contributed to increase globally the awareness for the need for better medicines for children.

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