Statement delivered at 74th World Health Assembly.
DNDi and Medicines for Malaria Venture (MMV) welcome progress in the implementation of the Global Strategy for Women’s, Children’s and Adolescents’ Health. However, the need for research and development of health tools to address the needs of children and women, who are disproportionately affected by infectious disease but whose specific medical needs are often neglected, has not been sufficiently highlighted.
Children are among the most neglected in drug development and paediatric formulations of drugs are often not developed. The needs of children with HIV illustrate this neglect where the development of optimal paediatric formulations still lags 20 years behind that of adults and whilst significant progress has been made in antimalarial development, more options are needed. Supporting research including paediatric trials and accelerating processes for developing, registering, and making available paediatric drug formulations is imperative.
We welcome the establishment of the Global Accelerator for Paediatric Formulations Network (GAP-f), of which DNDi and MMV are members, as an important step to promote innovation of and access to quality, safe, efficacious, and affordable medicines for children.
There is a knowledge gap in understanding the impact of medicines in females, especially for pregnant and lactating women, and women of childbearing age, who are often excluded from clinical trials due to concerns about effects on the foetus, resulting in delays in the availability of medicines. DNDi developed a proposal for a safe, ethical framework for the recruitment of women susceptible to and becoming pregnant in clinical trials and MMV have the Malaria in Mothers and Babies (MiMBa) strategy to guide their work. These and other proposals to ensure responsible strategies in gender-responsive drug development should be integrated into the strategy.
DNDi and MMV urge Member States to ensure that innovation of −and access to− medicines for children and women is integrated into the strategy, including a requirement to report on progress.