Ensuring children have accelerated access to optimal drug formulations

Mission: The mission of GAP-f is to function as a global platform to enhance the coordination and accelerate the prioritization, investigation, development, introduction, and safe rollout of high-quality medicines in optimal formulations for children in need.

 Vision: The Global Accelerator for Paediatric Formulations, GAP-f, contributes towards achieving Universal Health Coverage by providing better medicines to children in need.

 At GAP-f, Children are at the top of our agenda. While there have been significant achievements in child health with six million fewer children under the age of five years dying in 2016 than in 1990, urgent action is needed to achieve the UN Sustainable Development Goals (SDG), particularly SDG 3, which aims to ensure healthy lives and promote wellbeing for all people at all ages and the related target to achieve Universal Health Coverage by 2030.

Following the resolution at the 69th World Health Assembly on promoting innovation and access to quality, safe, efficacious and affordable medicines for children, GAP-f was conceived to build on and formalize the model developed within the HIV community to provide a sustainable mechanism that ensures that safer, more effective, and more durable paediatric formulations are developed and made available to children against an accelerated timeline.

GAP‑f works across the life cycle of drug development to prioritize, evaluate, develop, and deliver optimal formulations for paediatric populations by:

• Prioritizing and Evaluating: develop a clear prioritized drug portfolio; ensure that efficient, and high‑quality clinical trials are completed; establish safety, dosing and efficacy (when needed) across all relevant weight bands for each product; and support all regulatory submission activities to facilitate pediatric drug product approvals.
• Developing: Establish and maintain business relationships and coordinate them across all parties; launch product development in line with GAP‑f criteria; deliver GAP‑f portfolio products faster.
• Delivering: ensure that products are introduced in an accelerated, quality and coordinated manner, that healthcare providers are familiar with new products, and that safety monitoring improves.

GAP-f structure

The GAP-f Network is anchored in WHO and hosted within the Research for Health Department in the Science Division.

GAP-f is coordinated by a small internal WHO Secretariat that liaises with all relevant focal points in various WHO departments to promote a concerted effort for all WHO work related to pediatric drug prioritization, research, development, and introduction. The GAP-f Secretariat works in close collaboration with GAP-f member organizations and the GAP-f Steering Group to implement the GAP-f business plan.

The Steering Group is responsible for the entirety of GAP-f’s paediatric prioritization, evaluation, drug development, and delivery and uptake strategy, leading GAP‑f’s advocacy work, and overall operations of GAP‑f. The GAP‑f Steering Group is composed of representatives from the following organizations:

• World Health Organization (WHO)
• Clinton Health Access Initiative (CHAI)
• Elizabeth Glaser Pediatric AIDS Foundation (EGPAF)
• Medicines Patent Pool (MPP)
• Paediatric European Network for treatment of AIDS (PENTA)

In addition, GAP-f has forged strategic partnerships with stakeholders across the public and private sectors who are involved in the pediatric drug development and delivery arena. Managed by members of the Steering Group, the GAP‑f Working Groups are tasked to implement the GAP‑f strategy and to ensure deliverables are met in a timely manner. Currently, these working groups consist of the following:

• Prioritization Working Group
• Clinical Research Working Group
• Product Development and Regulatory Affairs Working Group
• Access and Treatment Delivery Working Group

GAP-f progress updates

We are glad to share updates on our continued efforts to advance the development of GAP-f:

• March 2020
• September 2018
• May 2018
• February 2018