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Regulatory and logistical issues influencing access to antineoplastic and supportive care medications for children
John T Wiernikowski1, Stuart MacLeod,
1Pediatric Hematology/Oncology, McMaster Children's Hospital, Hamilton, Ontario, Canada; Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.
Insights
Global drug shortages and regulations impede children's access to essential medicines, particularly in low-income nations. Enhanced international collaboration is crucial to overcome these barriers for pediatric cancer treatments.
Area of Science:
- Pediatric pharmacology
- Global health policy
- Drug accessibility
Background:
- Numerous logistical, regulatory, and drug shortage issues globally hinder pediatric access to essential medicines.
- These barriers disproportionately affect low and middle-income countries and children with life-threatening conditions like cancer.
- While progress has been made through international organizations and regulatory bodies, challenges persist.
Purpose of the Study:
- To highlight the significant impediments to pediatric access to therapeutic drugs worldwide.
- To emphasize the critical need for international collaboration in addressing these access barriers.
- To focus on the specific challenges in providing antineoplastic and supportive care medicines for children.
Main Methods:
- Review of global pharmaceutical access challenges.
- Analysis of regulatory and logistical barriers.
- Examination of the impact of international trade regulations on drug availability.
Main Results:
- Identified significant global barriers including logistical, regulatory, and drug shortages affecting pediatric drug access.
- Noted detrimental effects of World Trade Organization regulations on drug availability in low and middle-income countries.
- Highlighted progress made by organizations like the World Health Organization in fostering pediatric drug development and data.
Conclusions:
- Closer international collaboration is essential to overcome existing barriers.
- Addressing these impediments is vital for improving access to antineoplastic and supportive care medicines for children globally.
- Continued efforts are needed to ensure equitable access to pediatric therapeutics worldwide.
Abstract:
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.
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