European Journal of Clinical Pharmacology

, Volume 68, Issue 1, pp 1–10 | Cite as

The status of paediatric medicines initiatives around the world—what has happened and what has not?

  • Kalle HoppuEmail author
  • Gabriel Anabwani
  • Facundo Garcia-Bournissen
  • Madlen Gazarian
  • Gregory L. Kearns
  • Hidefumi Nakamura
  • Robert G. Peterson
  • Shalini Sri Ranganathan
  • Saskia N. de Wildt
Review Article



This review was conducted to examine the current status of paediatric medicines initiatives across the globe.


The authors made a non-systematic descriptive review of current world situation.


Two regions, the United States (US) and the European Union (EU), and the World Health Organization (WHO) have introduced strong paediatric initiatives to improve children’s health through improving access to better paediatric medicines. The experience from the US initiative indicates that it is possible to stimulate development and study of paediatric medicines and provide important new information for improvement of paediatric therapy. The early results from the EU initiative are similarly encouraging. In Canada, Japan, Australia and other developed countries, specific paediatric medicines initiatives have been less extensive and weaker, with modest results. Disappointingly, current evidence suggests that results from clinical trials outside the US often do not benefit children in the country in which the trials were largely conducted. Pharmaceutical companies that have derived a financial benefit commensurate with the cost of doing the paediatric trials in one country do not seem to be making the results of these trials available to all countries if there is no financial incentive to the company. The WHO campaign ‘make medicines child size’ has produced substantive accomplishments in building improved foundations to improve mechanisms that will enhance children’s access to critical medicines in resource-limited settings. However, practically all of this work has been performed using an amalgamation of short-term funding from a variety of sources as opposed to a sustained, programmatic commitment.


Although much still needs to be done, it’s clear that with concerted efforts and appropriate resources, change is possible but slow. Retaining and fostering public and political interest in paediatric medicines is challenging, but pivotal for success.


Biomedical research Legislation Jurisprudence Child Drugs, investigational 



We thank Professor Gita Batmanabane, India, for providing information on the situation in India. Dr Kalle Hoppu and Dr Hidefumi Nakamura are members of the Global Research in Paediatrics (GRIP) consortium which has received research funding from the European Union 7th Framework Program.


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Copyright information

© Springer-Verlag 2011

Authors and Affiliations

  • Kalle Hoppu
    • 1
    Email author
  • Gabriel Anabwani
    • 2
  • Facundo Garcia-Bournissen
    • 3
  • Madlen Gazarian
    • 4
    • 5
  • Gregory L. Kearns
    • 6
    • 7
  • Hidefumi Nakamura
    • 8
  • Robert G. Peterson
    • 9
  • Shalini Sri Ranganathan
    • 10
  • Saskia N. de Wildt
    • 11
  1. 1.Hospital for Children and Adolescents and Dept. of Clinical PharmacologyUniversity of Helsinki and Poison Information Centre, Helsinki University Central HospitalHelsinkiFinland
  2. 2.Botswana-Baylor Children’s Clinical Centre of ExcellenceGaboroneBotswana
  3. 3.Buenos Aires Children’s Hospital “R Gutierrez”Buenos AiresArgentina
  4. 4.Paediatric Therapeutics Program, School of Women’s and Children’s HealthUniversity of New South Wales and Sydney Children’s Hospital, RandwickSydneyAustralia
  5. 5.School of Medical Sciences, Faculty of MedicineUniversity of New South WalesSydneyAustralia
  6. 6.Departments of Pediatrics and PharmacologyUniversity of MissouriKansas CityUSA
  7. 7.Division of Pediatric Pharmacology and Medical ToxicologyThe Children’s Mercy HospitalKansas CityUSA
  8. 8.Division for Clinical Trials, Clinical Research CenterNational Center for Child Health and DevelopmentTokyoJapan
  9. 9.Department of Pediatrics, Faculty of MedicineUniversity of British ColumbiaVancouverCanada
  10. 10.Department of Pharmacology, Faculty of MedicineUniversity of ColomboColomboSri Lanka
  11. 11.Intensive Care and Pediatric SurgeryErasmus MC, Sophia Children’s HospitalRotterdamThe Netherlands

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