Regulatory and logistical issues influencing access to antineoplastic and supportive care medications for children with cancer in developing countries


  • John T. Wiernikowski PharmD,

    Corresponding author
    1. Pediatric Hematology/Oncology, McMaster Children's Hospital, Hamilton, Ontario, Canada
    2. Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada
    • Correspondence to: John T. Wiernikowski, Pediatric Hematology/Oncology, 3F Clinic, McMaster Children's Hospital, 1200 Main Street West, Hamilton, ON, Canada L8N 3Z5.


    Search for more papers by this author
    • Clinical Pharmacist
    • Clinical Assistant Professor
  • Stuart MacLeod MD, PhD,

    1. Department of Pediatrics, University of British Columbia, Vancouver, British Columbia, Canada
    2. Child and Family Research Institute, Vancouver, British Columbia, Canada
    Search for more papers by this author
    • Professor
    • Senior Clinician Scientist
  • for The Working Group on Essential Medicines of the Pediatric Oncology in Developing Countries committee of SIOP

  • Working group members: Barr R, Casanova M, Denburg A, Frazier L, Grynszpancholc E, Kienesberger A, MacLeod S, McGoldrick D, Petrilli S, Rousseau R, Weerasuriya K, and Wiernikowski J.


Globally there are numerous impediments, both logistical, regulatory and more recently global drug shortages, hindering pediatric access to therapeutic drugs of all types. Efforts to reduce barriers are ongoing and are especially important in low and middle income countries and for children requiring treatment of conditions such as those encountered in pediatric oncology characterized by the risk of life threatening treatment failures. Progress has been made through the efforts of the World Health Organization and regulators in the US and Europe to encourage the development of therapeutic agents for use in pediatrics and measures taken have fostered the availability of stronger pediatric data to guide therapeutic decisions. Nonetheless, pharmaceuticals remain a global commodity, subject to regulation by the World Trade Organization and this has often had detrimental effects in low and middle income countries. This article emphasizes the need for closer international collaboration to address the barriers currently impeding access to antineoplastic and supportive care medicines for children. Pediatr Blood Cancer 2014; 61:1513–1517. © 2014 Wiley Periodicals, Inc.