Paris, 20 February 2017

The experience with the R&D of new paediatric medicines raises doubts over whether real therapeutic needs are a fundamental objective for pharmaceutical companies. It is also crucial to adapt the pharmaceutical form and the packaging of paediatric drugs to make them suitable for paediatric use.

> Click here to download Prescrire's response (pdf, 95 Ko)

Summary of Prescrire's response

• Notwithstanding an increase in the number of paediatric drug developments due to the provision of considerable financial incentives and rewards, such a rise is not a guarantee for obtaining medicines that truly meet patient needs. The experience with R&D of new paediatric medicines raises doubts over whether real therapeutic needs are a fundamental objective for pharmaceutical companies. In addition, it is also crucial to adapt the pharmaceutical form and the packaging of paediatric drugs to make them suitable for paediatric use.
   
• Prescrire invites the European and national public authorities to invest more in independent public or academically-driven clinical research focused on real health needs, including paediatric medicines. Independent, publicly-funded trials aim to guide healthcare professionals in making the best therapeutic choices.
   
• The 10-year experience gained with the Paediatric Regulation has shown the limitations and/or abuses of a reward/incentive system aimed at stimulating private for-profit R&D in areas of major medical need. It clearly illustrates that the pharmaceutical industry "plays the system" strategically to obtain the highest possible financial and economic results. 

©Prescrire February 2017

> Click here to download Prescrire's response (pdf, 95 Ko)