30 April 2025
The peer-reviewed article “Accelerating access to paediatric medicines: lessons learned from the Global Accelerator for Paediatric Formulations, a WHO-hosted network”, published in The Lancet Child & Adolescent Health, reflects on the experience and lessons from GAP-f’s phase 2 strategy between 2022 and 2024, and how these can inform the work moving forward into GAP-f’s phase 3 strategy for 2025-2030.
Despite progress in reducing neonatal and child mortality, access to age-appropriate medicines remains inequitable, particularly in low-income and middle-income countries. The Global Accelerator for Paediatric Formulations (GAP-f), a WHO-hosted network established in 2020, addresses these gaps by uniting 33 partners to promote innovation and access to child-friendly formulations. Phase 2 (2022–24) of GAP-f’s work focused on therapeutic areas where innovation and access efforts often did not have stakeholder alignment and coordination of designing and implementing innovative clinical trial methodology, engaging with regulators to address systemic barriers, identifying novel technologies for safe and effective delivery, and collaborating across stakeholders for product roll out. Learnings from GAP-f work include the need to adapt prioritisation processes to diverse therapeutic areas and focus on high-impact areas based on unmet needs. Platform trials emerged as a promising tool to accelerate evidence generation but require guidance from regulators, collaboration among pharmaceutical companies, and operational challenges and funding constraints to be overcome. Incentivising paediatric formulation development remains crucial for small volume paediatric markets, and efforts are also needed to more proactively enhance, accelerate, and effectively match innovations to deliver medicines to children more efficiently. Even when products are successfully developed, political will and community engagement are essential to creating demand, supporting roll out, and ensuring equitable access and appropriate use in children. Dedicated funding and targeted programmes are crucial to drive systemic and sustainable change. GAP-f implementation lessons discussed in this Personal View will inform the future of this needed initiative, accelerating progress towards improved medicines for children.
Figure 1. Global Accelerator for Paediatric Formulations formalises collaborations across sectors to ensure accelerated development and uptake of the most needed drugs and formulations for children
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The Medicines Patent Pool (MPP) is a United Nations-backed public health organisation working to increase access to and facilitate the development of life-saving medicines for low- and middle-income countries. Through its innovative business model, MPP partners with civil society, governments, international organisations, industry, patient groups, and other stakeholders to prioritise and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations.
To date, MPP has signed agreements with 22 patent holders for 13 HIV antiretrovirals, one HIV technology platform, three hepatitis C direct-acting antivirals, a tuberculosis treatment, a cancer treatment, four long-acting technologies, a post-partum haemorrhage medicine, three oral antiviral treatments for COVID-19 and 16 COVID-19 technologies.
MPP was founded by Unitaid, which continues to be MPP’s main funder. MPP’s work on access to essential medicines is also funded by the Swiss Agency for Development and Cooperation (SDC), Government of Canada, the World Intellectual Property Organization (WIPO) and the Government of Flanders. MPP’s activities in COVID-19 are undertaken with the financial support of the Japanese Government, the French Ministry for Europe and Foreign Affairs, the German Agency for International Cooperation, and SDC.