GHC, in collaboration with AAP, EGPAF, and PATH, would like to address agenda item 16.4.
We share WHO Secretariat’s concerns about shortages of essential medicines for children. Children have distinct pharmacotherapy needs related to drug administration, medicine-related toxicity, and taste preferences, and require medicine formulas that are tailored to their ages, sizes, physiologic conditions, and treatment requirements. WHO has recently added the requirement to include pediatric data in the application if the medicine is relevant for children. We applaud this decision; however, it should require that all applications for inclusion of new medicines, changes, or deletions to the EML be evaluated for the EMLC as well.
Furthermore, we are concerned by the continued lack of optimal and acceptable pediatric formulations of anti-retrovirals, contributing to irregular treatment adherence and high treatment failure rates. Clinical studies on ARVs for children often occur long after drugs are approved for adults, denying children the benefits of the safest and most effective drugs for several years. Current formulations remain unpalatable, toxic, and difficult to swallow. We need urgent development of fixed-dose combinations and other pediatric ARV formulations that are simple to procure, prescribe, administer, and take.
Finally, we welcome the Secretariat’s report on addressing the global shortages of medicines. Many noncommunicable diseases (NCDs) in both adults and children cannot be diagnosed or managed without basic medical technologies, and often require lifelong services. We encourage coordinated efforts to include essential medicines and basic technologies for NCDs in activities addressing medical supply shortages and stock outs to ensure their consistent availability at all levels of care, and to bring Member States closer to achieving the WHO Global Action Plan target of 80% availability of essential medicines and technologies for NCDs by 2025. Thank you.