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The Gap in Global Guidelines on Human Milk Banking

As human milk banks have proliferated, it has raised other concerns – technical, religious and political – and local policymakers would benefit from an international framework that would help them set regulations.

Written by Andrew Green Published on Read time Approx. 5 minutes
A worker sorts containers with breast milk at a donor breast milk bank at the Scientific Center of Children’s Health in Russia. Sergei Bobylev\TASS via Getty Images

In 2016, the Nairobi-based Africa Population Health Research Center (APHRC) set out to determine just what Kenyans thought about human milk banking.

In situations where mothers are unable to breastfeed their child, the World Health Organization (WHO) recommends donated milk as the next-best option. That’s where human milk banks come in – they collect, screen, process and dispense human milk. As awareness has increased and demand has grown, the number of human milk banks around the world has risen – now to more than 600.

But there is no human milk bank in East Africa, and APHRC wanted to find out if the time was ripe to consider introducing the first.

In a study they ran across in the second half of 2016, researchers there learned several things, including that most people were unfamiliar with the concept of human milk banks and that, once they learned about them, they were broadly supportive of the initiative.

“What stood out is that people are very ready,” Elizabeth Kimani, who heads APHRC’s Maternal and Child Wellbeing Unit, told News Deeply. “They accept the whole idea of human milk banking.”

Now APHRC is guiding the launch of the first milk bank in East Africa – an experimental effort based in one hospital that is set to open in August in Kenya and run through the rest of the year.

“We’ve established that it’s acceptable,” Kimani said. “Now we want to see if people actually come to donate, and whether people will allow the children to be given the donated breast milk.”

The nutrition community has largely applauded the rise in acceptance of human milk banking. Breast milk offers better nutrition than formula to infants who cannot access their mother’s milk. But as the centers have proliferated, it has raised other concerns – technical, religious and political – that the people behind new human milk banks, like the APHRC staff, must wrestle with. And experts say the field would benefit from top-level guidance that could help address these myriad issues and better position human milk banking as part of a spectrum of services that boost breastfeeding.

Regulatory Gap

The WHO classifies breast milk among a group of medical products of human origin. These “biological materials that are derived wholly or in part from the human body and are intended for clinical application” also include blood, plasma, ova, sperm and other types of tissue. And most of those materials come with guidance around how they should be selected, screened and tested.

That is not the case with breast milk, which means regulation has fallen to the regional or national level – or in some cases meant no substantive regulation at all. This “lack of infrastructure, regulation and guidance,” according to research published by PATH, a Seattle-based nonprofit, has hindered “quality control, safety, scale-up and generation” of breastfeeding supporters in some settings.

“It’s kind of shocking,” Kiersten Israel-Ballard, the associate director of PATH’s maternal, newborn and child nutritional health program and one of the authors of the paper, told News Deeply. “It’s the only one [of the medical products of human origin] that doesn’t have standards or guidance associated with it. And it’s being given to the most vulnerable population.”

The growth of human milk banking has raised a number of issues – regulatory, bureaucratic, religious – that would benefit from international guidance, experts say. Though the outcomes would vary based on national contexts, global direction would at least help frame some of the issues, expedite their resolution and provide assurance to local communities who might be worried about the safety of the product.

“That’s a daunting task, if there are no WHO standards, to go about developing guidelines that are appropriate,” Israel-Ballard said. In some countries, the process can take a year or longer.

Among the questions countries must grapple with is how to categorize human milk. In some contexts it is considered a tissue. In others it is a food product. And in some communities it is categorized as a therapeutic good. Each classification brings with it a different regulatory framework and reflects a different set of local priorities.

In South Africa, for instance, officials were eager to discourage the sale of human milk and encourage donations, so they classified it as a tissue. Caretakers generally require a doctor’s prescription to access donor milk from one of the dozens of sites across the country. In Kenya, on the other hand, where regulations on human tissue are extremely “tight,” according to Kemisa, they pushed for human milk to be classified as a therapeutic food.

Then there are religious questions that have slowed the expansion of human milk banks in settings with large Muslim populations. The Islamic faith includes the concept of milk kinship, where the sharing of breast milk creates familial ties and, as a result, marriage prohibitions. Human milk banking, where breast milk is often pooled from a variety of donors, creates clear challenges for Muslim families, who worry that an infant might end up later married to a milk kin.

But researchers and Islamic scholars have proposed workarounds that would allow Muslim families to access donated milk. This includes limiting the number of donors whose milk is pooled and keeping careful records, so caretakers can easily identify who their children are sharing milk with.

The reality, experts said, is that many of the challenges around successful human milk banking have been resolved. It is now a question of gathering that knowledge and helping guide countries or communities toward models that would best meet their needs. And having a clear process might help spur greater political – and financial – commitments from governments.

“In some situations, it’s a political question,” Dr. Jean-Charles Picaud, an expert on human milk banking, told News Deeply. “It’s not a medical or technical question anymore.”

A Holistic Approach

In the absence of global guidance, PATH has been working with communities to discuss the myriad issues that go into setting up a human milk bank, through a phased approach for ensuring ownership, building technical capacity and developing locally appropriate systems to integrate human milk banking with breastfeeding promotion. They also organize opportunities for people who are thinking of starting a milk bank to visit already existing facilities to learn from others’ experiences. In Kenya, they facilitated a trip to a South African site for a team of policymakers and clinical leaders.

They are also doing something that might seem unexpected: Pushing those communities to really consider whether a human milk bank is needed and how it would be integrated into existing structures and sustained.

“We’re not trying to launch as many milk banks as possible around the world. Absolutely not,” Israel-Ballard said. “We want it to be part of a much more comprehensive program to support mothers.”

Which is another way that standardized guidance might be useful: by encouraging milk bank champions to think about how the service will be part of a continuum of care that encourages mothers to exclusively breastfeed and provides support to those who are having difficulty. And how, if it is needed, a milk bank might be built into the larger structure of support for breastfeeding women and infants.

“We want to use the enthusiasm about the milk bank to bring in the whole picture and making sure that all the systems are optimal,” said Kimberly Mansen, a program officer for maternal, newborn and child nutritional health at PATH. ”We’re catalyzing the energy that is there and saying this is part of a bigger picture to improve maternal lactation support systems and neonatal nutrition.”

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