The World Health Organization launched a new market-shaping strategy on September 15, 2026, alongside its first-ever prequalification pathway for twelve childhood cancer medicines, seeking to tackle profound global survival inequalities where children in low- and middle-income nations face survival rates below thirty percent.
Addressing a Stark Global Survival Gap
Childhood cancer survival remains profoundly unequal across the globe. More than eighty percent of children diagnosed in high-income countries survive their illness, while fewer than thirty percent do so in many low- and middle-income nations. This persistent gap is driven largely by inconsistent access to quality-assured essential treatments and a lack of age-appropriate formulations.
An estimated 400,000 children develop cancer each year worldwide. Since the launch of the Global Initiative for Childhood Cancer in 2018, nearly 500,000 children across 90 countries have benefited from strengthened care systems. Yet availability remains fragile. A baseline evaluation across 12 countries, conducted before the establishment of the Global Platform for Access to Childhood Cancer Medicines, found that only about forty-five percent of essential childhood cancer medicines were actually available across the 51 hospitals visited. Nearly half of those products had been out of stock for at least one month during the preceding year.
“Access to childhood cancer medicines depends not only on what medicines exist, but on whether markets are able to deliver them reliably, affordably, and at quality.”
Mr Santiago Millan, Technical Lead for the Global Platform for Access to Childhood Cancer Medicines at WHO’s Department of Noncommunicable Diseases and Mental Health
A New Prequalification Pathway for Twelve Essential Medicines
To combat supply disruptions and formulation shortages, the World Health Organization opened its first-ever prequalification pathway for childhood cancer treatments. The initial Expression of Interest invites manufacturers to submit eligible products for evaluation, dividing the targeted medicines into two distinct operational groups.
The first group comprises six medicines prioritized for the development of age-appropriate paediatric formulations: cyclophosphamide, etoposide, mercaptopurine, methotrexate, procarbazine, and temozolomide. These were identified during a Paediatric Drug Optimization exercise convened in January 2024. WHO has outlined specific target product profiles, such as dispersible tablets and orodispersible minitablets, designed to give clinicians greater dosing flexibility in resource-limited settings.
The second group focuses on six established essential medicines where persistent supply and access gaps threaten treatment continuity: pegaspargase, asparaginase, hydrocortisone, dactinomycin, vincristine, and cytarabine. Once manufacturers submit required documentation, WHO evaluates product data on quality, safety, and efficacy, inspects manufacturing sites for compliance with good manufacturing practices, and can order random sampling and laboratory testing.
Market Shaping Strategy and Regional Implementation
The newly unveiled strategy, titled Closing the childhood cancer survival gap through sustainable access to medicines: market shaping strategy 2026-2030, addresses structural market failures. These include a fragile, concentrated supplier base and fragmented, underfunded demand that drives up costs and causes severe supply bottlenecks.
Photo: Unicef
The strategy was developed through the Global Platform for Access to Childhood Cancer Medicines, jointly established by the World Health Organization and St. Jude Children’s Research Hospital in collaboration with the United Nations Children’s Fund and the Pan American Health Organization Strategic Fund.
“No child should be denied a chance of survival because the medicines they need are unavailable, unaffordable, or out of reach.”
The Global Platform for Access to Childhood Cancer Medicines
Dr Carlos Rodriguez-Galindo, executive vice president of St. Jude and director of St. Jude Global
Countries are already engaging with these frameworks. Zambia has taken an early leadership role within the Global Platform.
“Zambia is proud of our progress in childhood cancer, including our early leadership in the Global Platform for Access to Childhood Cancer Medicines,” said Dr Kennedy Lishimpi, Permanent Secretary for Technical Services, Ministry of Health, Zambia. “Yet persistent market challenges continue to affect access for children, and it is critical that we continue to work together to enhance the reliability and affordability of childhood cancer medicines.”
Dr Kennedy Lishimpi, Permanent Secretary for Technical Services, Ministry of Health, Zambia
Next Steps and Future Oversight
Global Platform partners are actively putting the framework into motion. The World Health Organization published its first expression of interest inviting manufacturers to submit childhood cancer medicines for prequalification in August 2026. This move is designed to accelerate national product registrations and diversify the pool of quality-assured suppliers.
Photo: Oncodaily
The initiative also builds on pilot procedures previously developed for biotherapeutic products, which included rituximab, trastuzumab, and human insulin. Moving forward, the Global Platform is working directly with twelve governments to stabilize procurement markets, with additional countries scheduled to join the effort as the 2026-2030 strategy rolls out.
New strategy to build a healthier market for childhood cancer medicines
