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A Global Implementation Framework

By Maternal, Newborn, Child Health & Nutrition

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Framework cover

Donating breast milk is an ancient practice for infants in need. Throughout history, women have breastfed infants who were not their own. Greek and Roman mythology, the Bible, the Torah, and Islamic scripture describe wet nurses who nourished infants who would become prominent figures, such as the Prophet Muhammad. Provision of donor milk continues today as an effective strategy to support and normalize breastfeeding and human milk while also educating communities on the disadvantages of formula feeding and saving newborns’ lives when their mother’s own milk is unavailable. Despite the irrefutable evidence in support of the provision of donor milk, the majority of vulnerable infants around the world in need of this lifesaving intervention do not have equitable access to it, primarily due to lack of awareness, supportive policy, and resources.

More than 60 countries, however, have developed human milk bank systems with robust quality control systems to offer safe donor milk, foster community support for breastfeeding, and meet local needs. This global human milk banking community possesses the vast knowledge, experience, and evidence to inform the creation and expansion of human milk bank programs and the integration of these programs into existing maternal and infant health care systems. PATH, an international health organization that drives transformative innovation to save the lives of women and children, sought to develop a resource framework to simplify access to this global knowledge base. Increasing our understanding of existing human milk bank processes and lactation support resources is an essential step to ensuring equitable access to human milk and increasing public awareness and informing policy to support breastfeeding and the use of donor human milk if needed. Drawing on the experiences of milk banks and lactation support programs from around the world, PATH has developed this document as a resource framework that ministries of health, policymakers, implementers, and existing and emerging human milk banks can use to identify the critical components required for an effective human milk bank program and gain access to the knowledge and resources needed to strengthen and integrate human milk banking systems into existing maternal and newborn care systems.

This framework outlines the core requirements and quality principles that should be universal for all human milk banks. We present a compilation of critical factors and current practices, based on solid evidence, which implementers and policymakers can use as a guide when developing context-specific guidelines for each facility, region, or country. This framework is not intended to provide specific recommendations since universal human milk banking guidelines are neither feasible nor appropriate due to the diversity of resources, risks, and cultures. Rather, our goal is that this framework serves as a powerful resource, facilitating communication with the global human milk and breastfeeding community, and empowering policymakers, health departments, health care facilities, and health workers with the tools and information they need to develop and support locally appropriate human milk banks as one strategy to protect, promote, and support breastfeeding. Ultimately, our goal is to ensure that all vulnerable infants around the world have equitable access to lifesaving human milk, through breastfeeding or donor human milk if needed.

Updated in 2018, the revised version of this Framework has the added strength of weaving together the human milk banking resources developed by PATH as part of the Strengthening Human Milk Banking: A Resource Toolkit for Establishing and Integrating Human Milk Bank Programs. In addition to helping programs identify the critical components required for an effective and individualized human milk bank program, the added contribution of this Framework provides access to tools, standards, and knowledge needed to establish a new human milk bank and evaluate, monitor, and improve those already existing. This updated Framework 2.0 also contains additional sections and content on sustainable systems, evidence generation and dissemination, safety systems, the breadth and range of practices and policies, ethical issues, and the impact and importance of human milk regulation and policy support for the equitable access of human milk for all infants.