A cancer medicine can be clinically effective, included on essential medicines lists and used for decades, and still fail to reach the child who needs it.
That is the problem the World Health Organization (WHO) is highlighting with six established childhood cancer medicines: pegaspargase, asparaginase, hydrocortisone, dactinomycin, vincristine and cytarabine.
Unlike the six medicines WHO has prioritized for the development of better child-friendly formulations, these products were selected for another reason: persistent supply, access, or formulation-related gaps that can threaten the continuity and safety of childhood cancer treatment.
Their inclusion in WHO’s first childhood cancer prequalification invitation exposes a broader problem in global oncology: sometimes the challenge is not discovering a new treatment, but keeping an established one reliably available.
Essential Medicines Can Still Be Difficult to Access
The six medicines were identified following horizon scanning and consultations with government agencies, healthcare professionals, partners, and technical experts through the Global Platform for Access to Childhood Cancer Medicines.
WHO’s prequalification invitation specifies the products and formulations it is seeking:
- Pegaspargase – 750 units/mL solution for injection or infusion in a 5-mL vial
- Asparaginase – 10,000 units powder for solution for injection
- Hydrocortisone sodium succinate – 100 mg powder for injection, preservative-free
- Dactinomycin – 500 mcg powder for injection
- Vincristine – 1 mg/mL solution for injection in single-dose vials
- Cytarabine – 100 mg/mL solution for injection, preservative-free, in several vial sizes
These are established medicines rather than new therapeutic concepts.
Their presence on the list therefore raises a different question: why can essential childhood cancer medicines remain difficult to procure reliably even when clinicians already know how and when to use them?
A Supply Problem That Can Become a Treatment Problem
Cancer treatment depends on timing.
Many paediatric oncology protocols involve combinations of medicines delivered according to defined schedules over weeks, months or even years. A missing medicine cannot always be treated like an ordinary stock problem.
When a key medicine is unavailable, clinicians may face treatment delays, substitutions or changes to established protocols. At the health-system level, repeated shortages can make it harder for hospitals to plan treatment and for families to complete care consistently.
WHO describes the six products as medicines affected by gaps that can compromise the continuity and safety of childhood cancer care.
And the wider data show that this is not an isolated problem. Before implementation of the Global Platform, a baseline assessment across 51 hospitals in 12 countries found that only around 45% of essential childhood cancer medicines were available at the hospitals evaluated.
Nearly half of the medicines assessed had also been out of stock for at least one month during the previous year, despite appearing on procurement lists or in hospital records.
The gap, in other words, is not simply between a medicine being approved and unapproved. It can exist between a medicine appearing on a national list and actually being available at the hospital when a child needs it.
Why Are Established Cancer Medicines Vulnerable?
WHO’s new 2026–2030 market-shaping strategy for childhood cancer medicines points to structural problems behind these shortages.
One is a fragile and concentrated supplier base for many essential childhood cancer medicines. Another is fragmented and underfunded demand, which makes the market difficult for both manufacturers and purchasers to predict.
Childhood cancer represents a relatively small market compared with many adult diseases. Demand for individual medicines can be scattered across countries and hospitals, while some older oncology products may offer limited commercial incentives for manufacturers.
At the same time, countries may procure relatively small quantities independently, reducing purchasing power and making demand less predictable.WHO identifies additional barriers including lengthy regulatory processes and affordability challenges.
The result can be a paradox: the medicine is medically essential, but the market supporting its production and distribution remains fragile.
WHO Unveils 2026–2030 Strategy to Close the Childhood Cancer Medicines Gap
Why These Six Medicines?
The selection of pegaspargase, asparaginase, hydrocortisone, dactinomycin, vincristine and cytarabine followed a structured prioritization process led by the Global Platform.
WHO says they were among the medicines with the greatest supply challenges identified through horizon scanning and consultations with key stakeholders.
Their inclusion alongside the six medicines requiring new child-friendly formulations also shows that childhood cancer medicine access has more than one dimension.
For some drugs, the formulation itself needs to change. For others, the immediate need is ensuring that a suitable, quality-assured product can be purchased and supplied reliably in the first place. WHO has therefore placed both groups within the same prequalification initiative.
What WHO Prequalification Could Change
WHO is now inviting manufacturers of the six established products to submit them for evaluation through the WHO Prequalification Programme.
Assessment includes review of product quality, safety and efficacy data; evaluation of manufacturing practices; inspections where appropriate; and potentially random sampling and testing. Products that satisfy WHO requirements can be included on the WHO List of Prequalified Medicines and considered acceptable for procurement by United Nations organizations and other purchasers.
Increasing the number of prequalified suppliers could help broaden the pool of quality-assured products available to procurement programs.
But WHO’s broader strategy makes clear that prequalification alone will not solve the problem. The organization is also pursuing measures including pooled procurement, consolidated demand forecasts, a broader quality-assured supplier base, regulatory reliance and stronger financing mechanisms.
Together, these measures aim to make the market sufficiently predictable for manufacturers while giving countries more reliable access to medicines.
From Having a Medicine to Being Able to Deliver It
WHO estimates that approximately 400,000 children and adolescents develop cancer each year, with close to 90% living in low- and middle-income countries.
Survival exceeds 80% in many high-income countries but remains below 30% in many lower-income settings. Limited access to quality-assured medicines is one of the factors contributing to that divide.
The six medicines highlighted by WHO illustrate why the problem cannot be measured only by whether a cancer drug exists. For a child undergoing treatment, a medicine on an essential medicines list has little value if the hospital cannot obtain it.
And for childhood cancers where treatment protocols already exist, reliable supply may be one of the most immediate opportunities to translate decades of oncology knowledge into better survival.
As Santiago Millan, Technical Lead for the Global Platform for Access to Childhood Cancer Medicines at WHO, said:
“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.”
WHO’s decision to prioritize these six established medicines sends a clear message: in childhood cancer, developing effective treatments is only part of the challenge. The medicines also have to be there when the child needs them.
Read further on OncoDaily: WHO Opens First-Ever Prequalification Pathway for 12 Childhood Cancer Medicines
