On World Children’s Day, the Global Accelerator for Paediatric Formulations Network (GAP-f) is drawing attention to the need for improved access to essential medicines for children. Children, especially those in low-resource settings, represent a vulnerable and often overlooked population in global health. Despite their critical needs, access to age-appropriate medicines for children remains limited due to gaps in research, enabling policies and timely investments
This year, the 77th World Health Assembly (WHA) passed a resolution aimed at accelerating progress in reducing maternal, newborn and child mortality to achieve Sustainable Development Goals 3.1 and 3.2. Within this resolution, two specific calls were made for renewed efforts and appropriate financing to drive the development and availability of better medicines for children and GAP-f was recognized as a key collaboration platform to support this essential work.
GAP-f is a WHO hosted network created to respond to the paediatric medicines gap. GAP-f works by spurring collaboration across stakeholders to identify gaps, set priorities for needs and accelerate product investigation, development and delivery to improve and save the lives of children. GAP-f network partners are working together to remove barriers to developing and delivering appropriate, quality, affordable and accessible medicines for children globally.
To celebrate World Children’s Day, GAP-f is announcing the launch of its Progress Report, which covers the second strategic phase of the network (2022–2024). It highlights the impact of collaborative initiatives and demonstrates how resources are effectively leveraged to improve health outcomes for children. By showcasing achievements, pinpointing areas for continued focus and sharing insights gained, the report serves as a vital tool for sustaining trust and engagement with stakeholders, guiding the planning and focus of GAP-f’s next strategic phase.
To further mark this occasion, GAP-f is proud to amplify additional technical products co-developed with a range of WHO technical departments that we hope will contribute to advance the paediatric medicines ecosystem across a number of diseases globally.
Meeting report on Accelerating optimal approval of priority formulations for antibiotic use in children
On 24 March 2023, WHO launched the first-ever list of priority paediatric formulations for antibiotics, addressing critical gaps in age-appropriate treatments for infants and children. This list, developed through WHO’s Paediatric Drug Optimization (PADO) process, identifies antibiotics in urgent need of development to treat infections from high-priority pathogens. Leveraging GAP-f and partners like the Global Antibiotic Research & Development Partnership (GARDP) and PENTA, WHO AMR division co-led a technical consultation that concluded in March 2024. This consultation reviewed regulatory frameworks and streamlined clinical research, aiming to accelerate regulatory approvals and ensure equitable access to effective treatments. The outcomes of this meeting are captured in this report, underscoring the collaborative efforts needed to advance essential paediatric formulations, minimize delays and support globally aligned, evidence-based care for serious infections in children.
Paediatric research and development landscape for neglected tropical diseases technical brief
In general, due to limited financial incentives, few new drugs are being developed for neglected tropical diseases (NTDs). Several NTDs disproportionately affect children as opposed to adults. However, like most diseases affecting the general population, the paediatric burden is compounded by failure to include children in clinical trials and/or lack of age-appropriate dose regimens and formulations. Research conducted in 2022 showed that, overall, less than half of all WHO-recommended medicines for NTDs are approved for children, highlighting the urgent need to increase research activity for NTDs in children, giving priority to diseases that represent a significant burden and lack adequate treatment options.
This technical brief, co-led by GAP-f, WHO’s NTDs department and the Emerging technologies and Research prioritization and support unit in the Science Division’s Research for Health Department (RFH), is a synopsis of data from the WHO Global Observatory on Health Research and Development (GOHRD) and other appropriate sources. It provides succinct information for a broad group of stakeholders on the current research and development situation in terms of treatments for NTDs in children and existing gaps, with a view to addressing these gaps and supporting the research agenda.
Launch of Paediatric Drug Optimization report for childhood cancer
In January 2024, a Paediatric Drug Optimization Exercise (PADO) was co-led by GAP-f and WHO’s childhood cancer team. Six Global Initiative for Childhood Cancer (GICC) cancers were prioritized for the first PADO exercise based on the disease burden in children and an access call has been issued for dabrafenib and trametinib, which are both approved for the treatment of low-grade glioma and other types of solid tumours.
A second round of prioritization is anticipated to occur in 2025 where pipeline products in phase 2 will also be considered alongside intravenous medicines in phase 3, with the goal of shaping future drug optimization in childhood cancer therapies. In December 2024, the WHO is due to convene a technical consultation to define the target product profile that will set clear recommendations for manufacturers and product development partnerships for medicines to be prioritized and developed.