Delivered by Laetitia Bigger, Director, Vaccines Policy
IFPMA welcomes WHO’s efforts in developing a framework to mitigate or avert shortages and resulting stockouts. Together with our partners, we are united by a common purpose to save lives, improve health, and ensure long-term prosperity. We are committed to provide a reliable supply of medicines and vaccines to safeguard the progress we have made together.
Moving forward means focusing on the practicalities of the definition and framework to enable better identification of common causes of shortages and to support solutions we can implement together. Special attention should be given to identify the trigger points within the supply chain for measurement of agreed indicators.
While supply is one factor, shortages can be influenced by a range of complex issues, such as unpredictable country demand, complex regulatory requirements or lot release procedures, and lack of timely communication.
We call for timely dialogue between manufacturers and public health authorities to address challenges before shortages occur, to anticipate the evolution of national health programs, to understand the manufacturing cycle, and to ensure more accurate demand forecasting.
We should work together to reduce and harmonize regulatory approval times for post-approval changes and in-country testing for lot release, and reduce the number of national product and packaging requirements. This will help to streamline product manufacturing and optimize existing capacity. When supply is stretched, we should work together to apply interim allocation and supply strategies that can maximize availability to prevent or treat priority conditions or groups.
IFPMA supports WHO’s inclusive and open process to develop the definition and framework for mitigating and avoiding shortages. We also believe that a platform for an open and constructive dialogue which enables health authorities, Member States, regulatory authorities, scientific experts, and manufacturers to collectively develop solutions is essential to reach sustainable and flexible supply of quality medicines and vaccines that meet patient needs.