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17 A Collective View of Human Milk Banking

Published onJul 01, 2018
17 A Collective View of Human Milk Banking

17 A Collective View of Human Milk Banking

João Aprigio Guerra de Almeida, Prof; Ben Hartmann, PhD; Kiersten Israel-Ballard, DrPH; Guido E. Moro, Prof, MD/PhD

Expected Key Learning Outcomes

  • Definition of a human milk bank

  • The importance of human milk banks

  • Important considerations when setting up a milk bank

  • Cost implications

  • Guidelines and standards to support the set up and running of a milk bank

17.1 Introduction

Human milk banks are becoming more popular as the importance of human milk, especially for vulnerable infants, is increasingly highlighted. However, there is no defined way to set up or run a milk bank, no standard global guidelines, and many cultural and regional elements come into play. This chapter provides opinions from key professionals who are highly respected in the field of milk banking:

  • Professor João Aprigio Guerra de Almeida, Fernandes Figueira National Institute for Women Children and Adolescent Health, Brazil

  • Dr Ben Hartmann, King Edward Memorial Hospital for Women Neonatology Clinical Care Unit, PREM Milk Bank, Australia

  • Dr Kiersten Israel-Ballard, PATH, USA

  • Professor Guido Moro, Italian Association of Donated Human Milk Banks (AIBLUD), Italy

Some sections of this chapter provide a collective opinion while most are direct interview responses (interviewer: Janet Prince, Lactation Consultant at the Family Larsson Rosenquist Foundation).

17.2 Interviewer: What is Human Milk Banking?

17.2.1 Defining Human Milk Banking

Kiersten Israel-Ballard: There is no official definition for human milk banking, but, in my view, human milk banking can be defined in a number of ways. The historical definition is that it is a facility only, a room in a hospital where milk is processed and treated. There is a safe system for screening and recruiting donors, for storing, pasteurising, screening, and re-storing the milk, and for facilitating its distribution to the wards.

Human milk banking can also be seen as an opportunity, and not just a processing centre. The physical space for processing provides the opportunity to create a safe place for women to come for support, providing a support centre for mother and child. This is how we see a human milk bank – a place where mothers can go to get help on anything related to breast feeding; support can be accessed whether they want to be a donor or not. Having some kind of link to kangaroo mother care is important. This package is called The Mother-Baby Friendly Initiative plus (MBFI). When we talk about a milk-banking programme, we refer to the MBFI plus programme – the plus being the milk bank. The milk bank is there, but it’s part of a much bigger, holistic approach to newborn care.

Guido Moro: Human milk banking is a service with the purpose of selecting, collecting, screening, storing, and distributing donated human milk. It is to be utilised, particularly for premature infants but also for sick infants, when there are specific requests from doctors in the health system.

Ben Hartmann: Human milk banking is difficult to define as practice varies internationally. However, a very simple definition that covers almost every situation is “a service that stores human milk to use when required.” This may sound very simplistic, but it also allows us to think about the questions that can be raised by such a definition. Firstly, “What is the definition of an appropriate donor and what duty of care does the milk bank have to their donor?” Secondly, regarding the last part of the sentence, “for use when required”, “What is the definition of an appropriate recipient (so for what reason do we provide donor milk) and what is the duty of care the milk bank has to the recipient?”. I am not entirely sure that milk banking clearly defines this, but certainly it is something that we need to consider.

João Aprigio: According to the Brazilian Ministry of Health and the Ministries of Health of the 23 countries that make up the Global Network of Human Milk Banks (Angola, Argentina, Bolivia, Belize, Cape Verde, Colombia, Costa Rica, Cuba, Guatemala, Ecuador, El Salvador, Spain, Honduras, Panama, Peru, Mexico, Mozambique, Nicaragua, Paraguay, Portugal, Dominican Republic, Uruguay, and Venezuela), the official definition of Human Milk Banks is: specialised service responsible for actions to promote, protect and support breastfeeding and to carry out activities of collection of the nursing mother’s lactic production, its processing, quality control, and distribution.

17.2.2 History and Future

Interviewer: How did milk banks develop?

Kiersten Israel-Ballard: When you understand that wet nurses are described in the Koran, the Bible, and other religious books, you realise that the concept of sharing milk to support infants’ needs has been around since the beginning of civilisation. A more formalised approach through human milk banks has been in place for over a 100 years, as a clinical approach for safely providing human milk to infants in need.

Guido Moro: Wet nurses are the first example of human milk banks. When a mother was not able to give her milk to her baby, there were women who were breastfeeding a baby and who had a lot of excess milk. The mother who did not have milk took her baby to this “nurse”, and the nurse was able to give milk to her baby and to the other woman’s baby. These wet nurses were very well paid in the 17th and 18th century and, at this time, it was the highest paid work for women. They earned a lot of money by giving their milk to other women’s babies. However, also in the 18th century, wet nurses became less popular after they began to strike for higher wages; when money became involved, things deteriorated. At the beginning of the 20th century, in Europe, wet nurses were not so popular and were substituted by regular human milk banks. The first milk bank was opened in 1909 in Vienna, the second opened one year later in 1910 in Boston, and from then onwards there was a rapid increase in the number of human milk banks, particularly in Europe. They became less popular with the HIV crisis, but are now starting to increase in popularity all around the world, as people more and more realise how vital human milk is to these vulnerable infants.

Ben Hartmann: As we understand, the very first milk banks were established in Europe. Milk banks arose out of two things coming together, research and clinical experience demonstrated that human milk was essential for hospitalised infants and technology became available to collect, store, and process human milk.

If we look to more contemporary milk banking, and certainly in Australia ten years back when we started a milk bank here in Perth, we were working in a country that hadn’t had milk banks for over 25 years. We were therefore in the position of being able to ask ourselves about what sort of service we wanted to deliver, and define a solution to a very specific problem that we intended to address by re-establishing milk banking.

João Aprigio: Human milk banks have been one of the most import strategic elements in public policy favouring breastfeeding in the last two decades in Brazil. Nevertheless, social perceptions and construct concerning human milk banks have witnessed ups and downs in their history. Since the first such service was implemented in Brazil, social actors and groups have ascribed meaning to human milk banks that have characterised them as both support structures for the exceptional situations involved in commercially-induced weaning and units at the service of direct breastfeeding, depending on the specific moment in history.

The first human milk bank in Brazil was founded in October 1943 under what was then the National Institute for Child Care, now the Fernandes Figueira Institute (IFF), belonging to the Oswaldo Cruz Foundation (Fiocruz). Its main objective was to collect and distribute human milk to meet what were considered special cases, like prematurity, nutritional disorders, and allergies to heterologous proteins. Taking this same approach, five more human milk banks had been created in Brazil by the early 1980s. The trend was constant from 1943 to 1979, with an average of one new human milk bank per decade. But over the course of the 80s, particularly beginning in 1985, human milk banks expanded tremendously in Brazil, with 47 new units. An additional 56 human milk banks were opened in the 1990s, giving a total of 104 milk banks in operation in the country according to an estimate presented at the 1st Brazilian Congress of Human Milk Banks, held in the national capital of Brasília in July 1998.

The history of human milk banks in Brazil can be divided into two phases. The first began in 1943, with the creation of the human milk bank at the Fernandes Figueira Institute, and lasted until 1985, when there was a break with the original paradigm and a new model was established, still operating today.

The main prospect for human milk banks is to spawn a new approach to breastfeeding issues. Three levels of investment can be proposed: to build channels to facilitate access by health care professionals to new knowledge on human milk, seeking to interconnect its unique biological properties to the ecological perspective of human development; to define ways to foster the development of scientifically-based expertise, capable of counteracting the scientific vanguard informed by formula milk marketing; and to replace dogmatic and ideological breastfeeding discourse with scientifically-based positions informed by various fields of knowledge.

Training health personnel must be a priority for human milk banks in the new millennium, since they will be the key to consolidating centres of excellence in breastfeeding, focusing not only on service activities but also reflecting the dynamics in the scope of human milk banks that shape breastfeeding as a nature-culture hybrid.

Interviewer: What is the situation today?

Kiersten Israel-Ballard: The current human milk bank system globally is disjointed and inadequate to fully meet the needs of infants around the world. It is shocking that this is an evidence-based approach, a World Health Organization (WHO) recommendation, and that there are entire regions of the world that are without a milk bank. East Africa, and indeed most of Africa, are without a milk bank, India has very few to meet the massive need in that region. These most needy places have no provision for supporting their most vulnerable infants. Brazil has a highly effective, nationalised network for human milk banking, but even under this optimal model there are still infants without access to a human milk bank.

Interviewer: Why are there so few?

Kiersten Israel-Ballard: In the 1980s, HIV was discovered in breast milk and trust in human milk banks was compromised due to fear of transmission. As a result, many human milk bank systems were impacted.

However, fear of HIV transmission is not the only reason for lack of effective scale-up of human milk banks. In the absence of global standards on safety and quality control, developing appropriate guidelines and operating procedures can be challenging. Additionally, alignment of global and regional newborn and nutrition policies is needed to prioritise use of human milk for neonates – through promoting mothers own milk or donor human milk when needed. Also, strengthening of systems is needed to ensure effective integration of human milk banks as a mechanism for protecting, promoting and supporting breastfeeding. And finally, innovation is critically needed to improve the quality and safety of donor human milk processing – novel technology approaches could reduce cost and increase global access.

Guido Moro: Today the number of human milk banks has increased a lot; we almost have more than 500 human milk banks distributed worldwide, but mainly in Europe, USA, and Brazil. Brazil has the most, with more than 200 human milk banks.

Looking at Europe, France has 36 human milk banks and was the first country to develop a law to regulate human milk banks. Italy follows with 33 milk banks, which in 2014 also became regulated by national law. The number of human milk banks is increasing all over Europe, including Russia that opened its first human milk bank in 2015. In the 70s and 80s, there was a large number of milk banks in Russia, but these were closed due to the problem of HIV. After many discussions, the government gave permission to trial a milk bank in a large hospital in Moscow. With such positive results in terms of increasing breastfeeding rates and decreasing cases of necrotising enterocolitis (NEC) and sepsis, I am hopeful that there will be agreement to open more milk banks throughout Russia. Poland and other countries in eastern Europe are also starting to open milk banks, which can only be positive.

Ben Hartmann: I think it is a really interesting time for milk banking. We find ourselves in a time where there is a huge range of activities that operate under the banner of human milk banking. We certainly find in Australia that in general there is some uncertainty of what constitutes a milk bank and what service it provides. We also find that there are many other sorts of activities: human milk sharing, human milk buying, and human milk selling. All these sorts of activities are bundled together under the banner of human milk banking. I think this is creating an identity problem for milk banks that is, at the moment, somewhat unresolved. This, I think, could potentially impact the credibility of the clinical service of human milk banking.

Interviewer: How do you see the future?

Kiersten Israel-Ballard: We see increased focus globally on essential newborn care that goes beyond survival and special attention on thriving. As a result, policies such as the Early Newborn Action Plan includes breastfeeding as an essential intervention for optimizing health of vulnerable neonates. This is an exciting time because human milk banking has an opportunity to leverage this increased momentum on nurturing care for the newborn. It is critical though that human milk banking be implemented as a part of this package for early and essential newborn care, not as a separate intervention only focused on provision of donor human milk. There appears to be an ever-increasing awareness around the importance of donor human milk in general. You hear Ministries of Health wanting to prioritise milk banking in their countries and this was not heard two or three years ago. That’s progress. On a country level basis, certainly we see more demand, and that’s what is needed – demand for United Nations International Children’s Fund (UNICEF), WHO, and the major organisations and funders to build milk banking into their list of priorities.

There also needs to be better communication and links between programmes, especially in this modern world where technology can enable this. We have some conferences, but they are more localised and small. In this field, people don’t have the funding to travel to these conferences. One solution would be a global network, where policies, best practice standards, research, case studies, and education can be shared. There are some very useful resources available, but not nearly enough. There is no easy platform and, in today’s world of technology and communication, that shouldn’t be the case. There should be a global society, a group of passionate people with a common aim to collaborate, provide transparency, and support to each other without feeling threatened.

Guido Moro: I think that the future is very interesting and positive. The number of human milk banks is increasing all over Europe; I refer to Europe because I know the situation there much better than in other countries. The number of milk banks will increase and therefore the number of babies who receive donor human milk will also increase, which can only be good. Two years ago, we did a survey in Italy and were able to establish that with the amount of milk that we are collecting now, we are able to cover the needs of one third of all the very low birth weight (VLBW) infants (birth weight < 1,500 g) born in our country. What we now need to establish is whether we should increase the number of milk banks or increase the volume of work of the existing ones. Sometimes it is better to increase the work load, because opening a new bank is very costly.

Through the Associazione Italiana Banche del Latte Umano Donato (AIBLUD), which was established in 2005, it is becoming possible to provide human milk to infants all over Italy. Of course, the first choice for feeding VLBW infants is human milk from the mother, but if mother’s milk is not available or it is not enough, the second option is to have human milk from a bank. So the future in Europe is one where formula or artificial milk are not even considered. The future is to provide only two options – mothers milk or milk from a human milk bank – and this can happen by really looking at the countries’ need: new milk banks or increasing workload in existing ones.

Ben Hartmann: There is a great future for human milk banking. I think that there is a need for human milk banks to demonstrate that they are a safe service. I think we have already done this quite well, but also we need to demonstrate that we are also effective, ethical, and sustainable, and that we understand very clearly who requires this service and when. I am not entirely sure that this is clearly defined, but that’s certainly something we need to consider. It is also important to acknowledge that each jurisdiction that practices milk banking may have different issues to address and one universal practice of milk banking may not be achievable.

17.3 Why Human Milk Banks?

Interviewer: What is the benefit of having a human milk bank, and how can they save lives, money and improve health outcomes?

Kiersten Israel-Ballard: We know that breastfeeding saves lives and improves general health; anything ranging from allergies to cancer prevention, from obesity to IQ. Making the link between milk banks and that they can benefit those infants who can’t access their own mother’s milk is important, particularly when these infants are extremely vulnerable, when they are preterm, low birth weight, orphaned or abandoned. Provision of human milk is the optimal first food, it should be viewed as an essential medicine and protected as a basic child right. When mother’s own milk is not possible, the WHO clearly recommends donor human milk as superior to infant formula. Ultimately we need to do all we can to help mothers breastfeed. Are there systems in place for supporting mothers when their babies are in the NICU? Too often babies receive formula – or even donor human milk – when they should have received mothers own milk. The proper role of a human milk bank is to provide safe donor human milk; when implemented properly donor human milk should displace formula use, not mothers’ own milk.

When human milk banks exist as part of a comprehensive breastfeeding promotion program, then the actual indicator of success is increased breastfeeding rates in the facility and in the community. The overall perception of the value of human milk increases and all of the babies in the community should benefit. This in turn results in improved health outcomes and reduced burden on the health system. Implemented correctly, this is a life-saving and cost-saving intervention.

Guido Moro: It is internationally recognised that human milk is the best nutrient for infants, not only term infants but also preterm infants. We know that many mothers who deliver preterm infants don’t have the possibility to give their milk, because they do not have milk or do not have enough milk. In this case, it has been shown that human milk, donated from another mother and given to the bank, processed by the bank, and administered to premature infants is the best option after own mother’s milk. The main purpose of human milk banks is to deliver human milk to premature infants and to sick infants.

Interviewer: How does a human milk bank save lives?

Guido Moro: There have been many papers published in the last few years showing that human milk is protecting premature infants from several diseases, particularly NEC; for example, the rate of NEC in premature infants receiving formula is 7%. This percentage is from the Vermont Oxford Network, which takes into consideration data from neonatal intensive care units (NICU) all over the world. However, the rate of NEC in infants receiving human milk, either mother’s milk or donor human milk, is between 1% and 2%. This is a big reduction in the rate of NEC. It has also been demonstrated that donor human milk protects against both early and late sepsis, bronchopulmonary dysplasia, and retinopathy of prematurity. These are short term advantages, but there are also long-term advantages as prevention of metabolic diseases. It is clear that if you are able to prevent such type of diseases, you are able to save money.

Saving lives is the priority, because the mortality rate of infants with NEC is approximately 30%. Secondary to this, there are also monetary savings. Based on data reported in literature and in Italy, I calculated that for each infant with a birth weight below 1,500 g receiving human milk instead of formula, there is a saving of more than 8,000 US Dollars. The number of all very low birth weight infants in a country can also be calculated. In Italy, we have approximately 8,250 very low birth weight infants every year. If 8,000 US dollars are saved for each newborn infant, the total saving is 67 million US dollars, equivalent to 52 million Euros, each year. This is very impressive. These are numbers that can be used to persuade politicians and hospital managers to support breastfeeding and the use of human milk in every premature infant, particularly in VLBW infants. These are therefore extremely important calculations.

Interviewer: How important are human milk banks?

Ben Hartmann: I have a problem with the word “important” with reference to human milk banks. From a biologist’s view, it’s a simple physiological fact that we evolved to milk feed our young, and it’s important that everything is done to ensure that the mother can successfully feed her own baby. Where this is not possible, there might be situations where feeding donor milk provides some advantages, over other milk alternatives. However, it’s clear that donor milk is also an alternative to the biological normal model of feeding for humans. I think that a donor human milk bank certainly has a place, but it is a very defined place, and this has to be made very clear.

Things have really changed since we first started our milk bank here in Perth. At first, we were focused on producing as much donor milk as we possibly could. My feeling, certainly about milk banking, has become more nuanced; that the primary function should be to focus on maximising mum’s success. In our situation, in neonatal intensive care in Australia, I think that once we have done everything we can to support a mother, then donor milk banking is a solution, but only in very specific instances. These are identifiable by the existing clinical literature, and future research may no doubt show more potential uses of donor milk. It is a fine line that milk banks have to walk, and it’s a challenge, but it’s something they have to be really very conscious and aware of.

Now that we have had milk banking for ten years, registrars and senior registrars have trained in situations where it is quite easy to get donor milk. Therefore, we always have to make sure that we maintain that emphasis on supporting mums first and then using donor milk as an option if that isn’t working.

Interviewer: How can human milk banks help vulnerable infants?

Kiersten Israel-Ballard: The data is there, about the impact of human milk on NEC and sepsis, and the whole outcome is significantly different if infants are fed formula. The need ranges anywhere from needing that milk for 24 hours, to mothers recovering while her breast milk is coming, or to the longer term if the baby has been abandoned or the mother is very sick or has died. There is a significant gap here and why it is not addressed by most infant and child nutrition programmes, I don’t know.

Perhaps we will get some idea why from the following example. We were in South Africa and asked “How many babies? How do we justify a milk bank when we are not talking about all babies?” In the NICU, which is our primary target, we put these questions to the neonatologist. For a couple of days during her rounds, she asked the other nurses and doctors “How would a milk bank help these infants? Of all the babies in the ward, how many would potentially be impacted if there is a milk bank?”, regardless of whether they needed milk for a short while or a longer period.

The neonatologist found that 40% of the babies in her unit ward could have used donor milk, whether it was for the short or long term. That was an unbelievable task. Historically, we usually see 15% as the quoted proportion at any given time in a NICU, indicating that about 15% of babies need donor human milk, whether it be for 24 hours or two months. So, any number from 15% to 40% of infants need donor human milk, depending on your location and the scenario in your facilities. We also have to keep in mind that South Africa has a very high HIV prevalence, so those babies might have been very special cases. However, the numbers are there, and there is a real demand for donor milk. Looking at the health outcome, let’s say 15% of those babies don’t receive donor milk, they are fed formula, and they have complications as a result. They stay in the unit ward for an additional two weeks, perhaps they die. In this situation, there is not only the health outcome, the lives lost that can’t be quantified, but there is a cost. The policy maker will ask how much does a milk bank cost and where is the cost benefit, but by reducing the stay in a unit ward, the facility saves some money.

Guido Moro: If you are able to reduce the number of infants with NEC, you are able to increase the number of infants who survive. I did some calculations relating to the number of deaths that you can save and the economic advantages. For example, based on the data in Italy, we have 7% of NEC in premature infants receiving formula, between 1% and 2% of NEC in infants receiving human milk, and the mortality rate for NEC is 30%. For every 1,000 premature infants, we have 21 deaths from NEC in infants who receive formula and between 3 and 6 deaths in infants receiving human milk. This means that we can save between 15 and 18 newborn-infant lives by using human milk. That is a very impressive saving of lives, and with this there are also economic advantages.

Ben Hartmann: I can only speak in the context of an Australian NICU (obviously there are many different contexts where milk banks operate internationally). We have approached the questions of what is the benefit and what’s the requirement of donor milk by acknowledging the available clinical literature that suggests that NEC can be reduced by providing pasteurised donor milk to very low birth weight babies as an alternative to infant formula feeding.

That was principally what we were trying to deliver when we provided the milk banking service to the King Edward Memorial Hospital. With ten years of milk banking experience at this hospital, we can compare the incidences of NEC in our unit with those from the rest of the country. In Australia we still don’t have many milk banks operating, so there is a big difference between the care here in Western Australia compared to the rest of the country. We have a national data collection on babies born at less than 28 weeks. The incidence of NEC in Australia pre milk banking, so pre 2005, in the entire country including in the community, was between 8% and 11% in babies born at less than 28 weeks. Since we started milk banking in 2005, we have seen the incidences of NEC decrease. The latest national data is from 2012. At the King Edward Memorial Hospital, the incidence of NEC sits between 2% to 5% in a 28-week population. The rest of the country still remains at the 2005 level, between 8% and 11%. While not a randomised controlled trial, certainly the biggest different between the care in Western Australia and the rest of the country is access to donor human milk, and there does seem to be a marked difference between the incidence of NEC in our hospital and in the rest of the country.

Taking the 2012 data across the whole country, if the rest of the country was operating at the levels of King Edward Memorial Hospital PREM Milk Bank, there would have been about 40 fewer diagnoses of NEC in 2012. Based on the outcomes after a diagnosis of NEC in Australia, we would have seen 16 fewer deaths, 16 fewer surgically-managed NEC cases, and 8 fewer medically-managed NEC cases had there been access to donor milk across the whole country and the same outcomes as at the King Edward Memorial Hospital. Then, add the cost of care to that. So if there was equitable access to donor milk across the country, we would have expected a saving of about 3.5 million Australian Dollars due to donor milk banking or access to donor milk, plus the potential prevention of 16 deaths.

This only puts a value on the immediate cost of care of babies in the NICU. There are a lot of other potential implications. Poor neuro-developmental outcomes are associated with a diagnosis of NEC, so there is potentially quite a high long-term cost saving of having donor human milk in a NICU. This saving is not really captured by this sort of comparison, but even very conservative estimates suggest that there is a huge benefit in terms of clinical outcomes, costs, and broader public health outcomes of having access to donor human milk banking in Australia.

Interviewer: Those are pretty impressive figures. It is also quite startling when you hear those figures and think about all those infants who could have been saved.

Ben Hartmann: Yes, it is and there will be a different equation in every country. In Australia, we have very high breastfeeding rates in all NICU, and quite low incidences of NEC even in our high-risk babies across the whole country, in areas with and without a milk bank. The equations are different if we look at the cost benefit of human milk banking. In Australia, we have to run a very focused service and provide it to the most at-risk patients, because of the very low incidence of NEC and the small population; still very significant, but only a small number of patients where we can see the benefits. The costs of running a service versus the potential benefits is a relatively fine line, so this dictates that we have to be quite specific to that high-risk preterm population. In other countries, where there might be a higher incidence of NEC, there may be a bit more flexibility on who might be a beneficiary of donor human milk. These are questions that every milk bank needs to define.

Returning to the definition that I mentioned, and the question of identifying when donor milk is required, this is unique to every project and to every jurisdiction. These decisions, about the actual outcome that you are trying to deliver, have to be made in the planning stages of a milk bank.

It is likely there is always going to be a need for milk banking, particularly within neonatal intensive care. At the moment, it appears that where early and aggressive enteral nutrition is practiced, most physiologically normal mothers will not be able to produce the milk volumes that the doctor might prescribe for their baby, and certainly there will be a need of donor human milk in those situations. We have to make sure that we minimise the use of donor milk in our unit. That is certainly our goal now – to support mothers to reach their full potential for milk production and therefore use as little of the donor milk as we possibly can.

João Aprigio: Human milk banks can reduce the length of hospitalisation of newborns in NICU; reduce the cost of care, improve quality of life, lower the rates of hospital infections, and eliminate enterocolitis, both septic and microbial. In some countries, the results are even more striking. For example, in Asuncion, Paraguay, 6 or 8 months after introducing milk banking, baby formula was not being used anymore. In the first year of having a milk bank in operation, Cape Verde reduced the death of newborns in the NICU by 55%. Positive results for the practice of breastfeeding among mothers of premature babies and in the post-discharge period also increased significantly.

17.4 The Selling of Breastmilk

17.4.1 Expert Collective Views

Interviewer: What are the issues surrounding the selling of breast milk?

Private and public institutions view milk banks differently; the former consider the economic aspects of donor milk and expect a return on their investment, while the latter consider the health implications. The selling of breast milk negatively impacts the credibility of the clinical service of milk banking.

In the past, in some countries, donors were paid for their milk according to quantity, which led to its dilution with water or with cow’s milk. In Italy, legislation stipulates that milk donation must be free of charge and that no money should be involved in the donation of human milk in any breastfeeding activity

In Italy, there are no private milk banks, but there is an association between some private and public institutions. As such, the private institutions finance the opening of human milk banks and the public institutions provide the staff. The joint venture works because donors are not paid and, while they cover the costs, the private institutions gain from the publicity of their activity. There are two examples of such an association; one in Bologna and the other in Vicenza. Both are funded by the private dairy companies, Granarolo and the Centrale di latte di Torino, respectively. The public institutions gain as they now have human milk banks in these cities, and the private companies benefit from increased returns on their dairy produce. The balance is critical, but can be done if approached judiciously.

The practice of selling milk on the Internet is a big problem in the US, but not yet in Europe. However, as with everything emanating from the US, it is only a matter of time before it becomes a concern in Europe. Because of this, the European Milk Bank Association published an opinion statement against human milk sharing on their website, which was written jointly with the Human Milk Banking Association of North America (HMBANA). Associations in Italy and France share this same statement.

Advising against milk sharing is unlikely to influence the amount of milk available to mothers. Mothers need to be convinced that this is not the correct strategy to get human milk for their baby, and that donor milk from a milk bank is by far the safer option. Importantly, to reduce Internet milk sharing, mothers also need to be persuaded to breastfeed their babies. Increasing the rate of breastfeeding increases the rate of milk donation, enabling those infants who need donor milk to benefit. Without such action, a mother will sell her milk rather than donate it to a milk bank, with all the dangers that are connected to this practice.

In Australia, the general community frequently asks about how to access donor milk from milk banks and the safety of informal milk sharing. This presents a challenge for milk banking, because it needs to be separated from the many different activities (including milk sharing) that are grouped under that banner. A clear definition of exactly what is meant by a human milk bank is necessary, but is difficult to master. However, this raises two very different issues. The first is a public health concern, where donor human milk banks are seeking to address a particular public health problem such as reducing NEC in a NICU. The second is in developing countries, where there are no safe alternatives to mother’s breastfeeding and human milk feeding.

It is clear that the difference between milk banking, milk sharing and milk selling needs to be defined, that these practices are not grouped together, and that human milk donors are not paid for their milk.

17.5 Legal Aspect: Guidelines, Standards, Regulations, and Governing Bodies

Interviewer: What is in place to support human milk banks from guideline, regulatory and standardising point of view?

Kiersten Israel-Ballard: Guidelines present a challenge – there are guidelines, and the National institute for Health and Care Excellence (NICE) guidelines are probably the most robust. They are also accessible, available online, and some are interactive, but they are designed for the UK. There are different guidelines around the world, such as those from HMBANA, the Italian Association, Australia, and Norway, but generally they are not very accessible for new policy makers. In 2012, professionals from around the world assembled at a global technical advisory group meeting. This was at a time when we were still learning about milk banking and when, naïvely, we thought that we could help create global guidance and make it accessible, such as on the WHO website. Quickly, we learned that this is not so easy – every country and every setting has different risks, different needs, and different resources. Overarching guidelines just won’t work, they need to be adapted. Instead, what can be done is to provide the tools to help countries to adapt guidelines and establish quality control principals. The quality principles that guide the processes selected for each setting originate from Ben Hartmann. We have an online framework guideline document and we hope people find it useful, although it needs more work in terms of getting clear guidance and resources in an accessible way.

Interviewer: Is there a governing body for this framework guideline?

Kiersten Israel-Ballard: Not globally, but regionally, and even then they are not everywhere and are very disassociated. For example, in South Africa, there is a human milk banking association that is not a government-based organisation, but it provides technical assistance to the government. Brazil is an incredible model globally with a nationalized network and a robust communication and mentorship platform.

In the absence of global guidance on human milk banking, a mechanism for sharing best practices and collaboration is needed. PATH has been working to establish a systematic approach for building ownership and sustainability through learning exchanges to foster collaboration and connections. An increase in regional associations who could serve a robust mentorship role would be useful. Ideally, there would also be a global body to work with technical and policy leaders to establish standards and policies.

Guido Moro: In Europe, there are two countries with legislation. The first country to regulate the activity of human milk banks by law was France where legislation was passed between ten and 15 years ago. A year ago, Italy passed a law to regulate the activity of human milk banks. Regulation is the way forward or things will be done differently. There must be a regulation to be followed for all human milk banks: the rules and what should be checked and performed have to be specified. There has to be some type of control over the activity of human milk banks or it will be a disaster. Italy provides such an example; here, there are a few human milk banks collecting 15–20 litres of milk per year while others collect more than 2,000 litres per year. Imagine the cost of a small bank working for 20 litres in one year: it’s a nonsense! You should have the possibility to constrain low production banks to increase their activity or to close

Interviewer: Who (i.e., which governing body) controls this?

Guido Moro: This is the next step after getting the legislation. The ministry has sent a form to all milk banks in Italy to collect information about the activity of the banks. Now we are checking the data to create a picture of the situation in our country. After that, our association (AIBLUD) will send some members of the Board to the milk banks, control their activity, see if they are performing according to the legislation, and, if necessary, give suggestions on what to change and how to change it. The most important aspect is that we do not want to go to a milk bank to inform people that they are not performing well and consequently they have to close. We must have a positive impact: tell them that they are working well, but can work even better, and give suggestions on how they can improve the quality of their service. It is extremely important to involve other milk banks in this activity.

Interviewer: In Italy, do you know all the human milk banks that are there?

Guido Moro: Yes.

Interviewer: How could this be done in other countries where there are milk banks that may not be registered or that the government or the health ministries are unaware of; how would you deal with these sort of situations?

Guido Moro: I think that there is the need of a local association. The local association should have a knowledge of all the banks and give support to people who want to open a new human milk bank. This centralises the control. The association can act as an interface between the milk bank and the Ministry of Health or local politicians. Otherwise, for people responsible for a single bank it will be very difficult to get attention to their requests. An association is more powerful: on the milk banks behalf, it can interconnect with the Ministry of Health or the local politicians. This is my advice.

Interviewer: You have national guidelines in Italy, are there any international guidelines? Where can people go to develop their own national guidelines?

Guido Moro: Many countries in Europe have their own guidelines: Italy, France, UK, Germany, and Switzerland have guidelines, and several are published in English. These are similar and different at the same time. The main aspects are similar, with only small differences, such as, for example, the number of bacteria taken into consideration before pasteurisation. The most important things are common to all human milk banks in Europe. If you want to open a human milk bank, at least for the baseline requirements, you have to follow some of the guidelines published in Europe. Otherwise, go to PATH. PATH has published a booklet, which is available from their website, comparing similarities and differences between all existing guidelines around the world. Look at these tables, starting with the aspects that are similar and common to all the human milk banks. PATH did a good job; so, if you want to know how to set up a human milk bank, this is the simplest and least expensive way to work.

Ben Hartmann: A lot of people certainly have published guidelines, as there are national guidelines for milk banking, but how useful these are in other projects or jurisdictions is questionable. There is no real governing body ensuring safe practice in milk banking. There are all sorts of guidance but no real accreditation or validation available for milk banks; this is something that could potentially give milk banking a lot more credibility. There are groups working towards this, but I think it is clear that there isn’t one universal approach to this in milk banking at this stage. In Australia, we certainly didn’t see the Australian Government or State Government having the appetite to create regulatory certainty for milk banking, which is still a very open question in this country.

We have a separate regulator for food and for therapeutic goods, and this has been really problematic for milk banks, which fit the definitions of both. Over the last ten years, there has been constant argument as to whether human milk is a food or therapeutic. I don’t necessarily say that this is a problem, it is just semantics. I think it’s more important for milk banks to choose the best regulatory outcome in any particular jurisdiction. In Australia, we have always been very clear to suggest it is our view that the suitable regulator for human milk banking is the Therapeutic Goods Administration, as we think this provides the better regulatory structure to ensure safety. For the milk banks themselves, that might mean that they have more onerous regulatory requirements and it may make milk banking slightly more expensive. But, from the perspective of the safety for the recipient of the donor milk, which is really the only perspective we should have here, the Therapeutic Goods Administration is much better outcome, given the significance and type of clinical risks that require management. We certainly make more than just nutritional claims about our products and the benefits of donor human milk banking in the NICU, and as such as the Therapeutic Goods Administration seems a more sensible option.

As the Government have not put any legislation in place to regulate human milk banking, it is something that we need to facilitate as it has been a barrier to the development of human milk banks in Australia. Since the interview, we have seen commercial milk banks move into the Australian market. These are unregulated at present and are a concern.

Interviewer: Do you think that it will be possible to develop international guidelines?

Ben Hartmann: Absolutely, but I think we have to be really clever about the way it is done, because there is no single recipe for a human milk bank. There is no single practice that is appropriate for all situations, because outcomes and goals of a milk banking service differ in almost every jurisdiction. However, the way that we approach milk banking should be consistent. I think that we can almost universally agree that human milk banks should be run in a way that is safe and effective, so that they do no harm and deliver what they say they will deliver. These outcomes should be defined by each project and be measurable.

I also think we agree that milk banks should be ethical and sustainable clinical services. They should support some broader public health benefits and they should be sustainable. Milk banks need a business model that allows them some certainty of continuing into the future. If international guidelines were built around that sort of assessment, around how you design a milk bank to achieve specific goals, both clinically responsible and socially responsible, they could adapt to differences in specific practices internationally. This accepts that there will be some variation in practice from jurisdiction to jurisdiction, where a milk bank is providing donor milk to a different patient and where there are different costs driving the service. It is entirely valid to assess this differently in different jurisdictions. I certainly think it’s possible, but we should focus on how milk banks are designed, developed, run, and managed rather than on the particular steps or workflows involved in donor human milk banking, which may well differ from jurisdiction to jurisdiction.

Interviewer: You have mentioned classification, that breast milk is classified as different things – sometimes food, other times tissue, and is sometimes unclassified. Why is this?

Ben Hartmann: Globally, there has to be flexibility. Maybe, there is the need for third party accreditation for milk banks to be able to demonstrate and justify their own practices to suit their own situation. I don’t know that there is a desire to develop a single “method” for the operation of milk banking internationally – but I can’t see this being successful. Where I have worked with other projects in different jurisdictions, I see that it is very common for people to look at the practice in another country and try to use it in their situation; quite often this works but in many circumstances it does not. It can also be that there are underlying assumptions that are defining practice that don’t hold somewhere else. Take donor screening as an example; here we are looking to manage the risks of particular blood-borne viruses and these may vary from country to country. We have to be able to tailor our practice to a particular situation. I certainly don’t think there is a single rule for milk banking or a single way to approach milk banking that is safe when the focus is on effective outcomes.

We really have to think about how we design these projects. Is there a way to design a milk bank for a particular situation? This is something that is becoming more of an issue. We don’t yet have a good toolkit to design the right solution for the problem.

João Aprigio: In Brazil, several issues hampered legislation and guidelines. Firstly, there was no benchmark against which to evaluate. In collaboration with the hospital’s Department of Psychology, we developed a form of care that focused mainly on the mothers. It offered support so that she could focus on and reconnect with her baby, help her to understand that she was not responsible for not being able to breastfeed directly, and express her milk. However, our human milk banks were also designed to collect milk from other mothers, process it safely, and perform quality control to provide milk to premature babies who temporarily could not receive their mothers’ milk.

Secondly, donor milk protocols had to be developed. Since Fiocruz provides research and technological development for the Brazilian Ministry of Health, we turned problems into research projects to find technological solutions. For example, due to the high cost of packaging, we investigated the packaging of milk in special bottle glasses, analysing the chemical, physiochemical, and microbiological characteristics, which became our “gold standard”.

Thirdly, at great expense, equipment had to be imported from the US, Germany, or France to pasteurise human milk. Thus, we adapted a technique using an ultra-thermostatic water bath produced in Brazil for about $1,000.

Fourthly, quality control. The European model is very safe, doesn't pose a risk to the child, and, considering human milk to be a human fluid, it is fully clinically tested to ensure product quality. However, we preferred to work with the references of food technology. On the understanding that milk is a functional food and that its composition has numerous variations, we created processing protocols and quality controls (chemical, physicochemical, nutritional, and microbiological) to ensure the quality of all milk in favour of the child. Bacterial analysis to determine the presence and identify the species of bacteria evaluates the risk of that product. This model means that samples that are suitable for consumption may be rejected, but milk that is not suitable for consumption is never accepted.

Based on these solutions, we developed our quality control system, protocols, and legislation. The accumulated knowledge from academically validated research formed a guideline, which was disseminated among other hospitals all over Brazil. Regional centres of excellence for human milk banks were set up to ensure they reached all the different regions.

In 1987, the Ministry of Health began funding the implementation of these centres, and the WHO and the Pan American Health Organization (PAHO) created protocols and legislation. In 1988, WHO accredited the Brazilian protocol as being safe from HIV in human milk and the guideline became a regional reference model. By the end of the 1990s there were 150 units operating in Brazil. In 2000, the WHO committee made an assessment of the initiatives undertaken around the world in the “Health for all in the year 2000” – health for women, children, and the elderly. The effort for establishing the Brazilian network of human milk banks was regarded as one of the projects that contributed most to the reduction of worldwide child mortality in the 90s. The work of the Brazilian human milk banks earned international visibility, and the international cooperation in human milk banks began.

By 2005, Brazil was ready to start international cooperation. Common principles were established to build a human milk network in Latin America. This resulted in a document known as the Letter of Brasilia, where countries would commit to building a human milk bank network. Thirteen Ministries of Health from different countries signed the letter, which was also signed by UNICEF, PAHO, IBFAN (International Baby Food Action Network) and WABA (World Alliance for Breastfeeding Action). The Brazilian government decided to bring the human milk bank to the international agenda and the milk bank became part of the foreign-Brazilian Portfolio initiative. The cooperation projects started to be established and we began to work with other countries in the same manner as we had been working with the Brazilian states.

In September 2015, 20 countries met in Brasilia in order to evaluate the results achieved in the period 2010–2015, according to the commitment made by the signatories of the Letter of Brasilia in 2010. The result of the meeting highlighted the contribution of human milk banks for the health system of countries to achieve the Millenium Development Goals 4 and 6 as well as the construction of a common strategy to meet the demands of the Agenda 2030 for Sustainable Development.

Finally, it is worth mentioning that the main result of the event was the creation of the “Global Network of Human Milk Banks” formalised in the Letter of Brasilia 2015, with the signatures of representatives of Ministries of Health of the 20 countries, World/Pan American Health Organization Health (Opas/OMS), UNICEF, Ibero-American General Secretariat (Segib), and the Brazilian Cooperation Agency (ABC).

17.6 Opening a Milk Bank

17.6.1 Expert Collective Views

Interviewer: What are the main challenges when considering opening a human milk bank?

Perhaps the greatest challenge worldwide is that milk banks are set up without a foundation of breastfeeding support and promotion. As a result, milk banks struggle to achieve sufficient donors and thus don’t have the supply to meet the demand. The model to be implemented is a “slow down” model; to establish a milk bank quickly would mean doing so without the necessary support.

In Brazil, the entire thinking around the value of human milk was changed by putting breastfeeding support and promotion first. Taking this more holistic approach, by first ensuring that the necessary foundation of breastfeeding support and promotion is in place, may mean waiting several months before a milk bank is opened, but this is the culture that makes it work and it requires government backing.

Another challenge is the acceptance of milk banks in certain areas where milk sharing (which is what most people see it as) is taboo. In the Kwa Zulu Natal province of South Africa, the department of health sees milk banks as a priority. They have been ahead of the game globally, having had to deal with HIV and complex feeding issues for years. However, like in Brazil, their vision is not just a milk bank, but to change the face of what breastfeeding means. Using social media and a community drama group that presents to the kangaroo mother unit and the community, breastfeeding is promoted as a priority but also mothers learn about donor milk and milk banking.

Milk safety cannot be overlooked and there has to be efficient quality control.

Costs are one of the greatest disadvantages of opening a milk bank. Particularly significant at a time of general economic crisis, it is not an easy task to convince people to spend money on a new milk bank. To demonstrate its worth, it is imperative that the advantages gained in terms of health outcomes and cost effectiveness are presented to offset the high costs of opening a milk bank.

The procedure for opening a milk bank is far from clear. The first steps are to determine that milk banking is the solution to the particular problem and then to design the appropriate milk bank for that problem. However, experts at PREM Milk Bank are frequently asked for advice about safety and efficiency once the decision to establish a milk bank has been made and the bank is functioning. In these cases, the vital first steps in the process have been missed. For each project, we first need to ask: What is the problem that we are trying to address in this situation, is milk banking actually the solution to that problem and, then, what design of milk bank will solve that particular problem? This is a common oversight. All too often it is assumed that a milk bank is a pasteuriser, a freezer, pieces of equipment, and screening for donors, without thought as to what is trying to be achieved by this process.

Interviewer: Is it always relevant to open a milk bank or should it be on a needs assessment basis?

An assessment of the need for a milk bank is appropriate worldwide. In most cases, there is a need for a milk bank, but this need has to be defined. Defining the problem and solution first was the approach taken in Perth, which was a business planning process. In the developed world, the focus is on the high-risk preterm baby and reducing the risk of NEC; in other situations, safe alternatives to mothers’ own milk may not be available or there may be a broader public health benefit for breastfeeding support. By defining the need there is greater understanding of the potential recipient, who might vary from project to project, and this tailors the risk environment and the required outcomes. The responsibilities of the service provider should be defined as an evaluation of whether the milk bank is operating safely, operating ethically, effective, delivering the desirable outcome with a sustainable business model. These are common responsibilities across all milk banking services.

A milk bank is not simply a facility requiring equipment such as a pasteuriser and freezer. Assessing needs in terms of resources and equipment specific to the setting is the minor consideration, which should follow the more important overall system assessment. To be effective, the entire system has to be carefully designed and assessed, including breastfeeding promotion and milk bank integration into care of the newborn and breastfeeding. Ideally, that requires establishing a foundation, calling stakeholder meetings, and a government supporting the neonatologists, microbiologists, lactation support staff, dietitians, and infection control to produce guidelines specific to the setting. Local advisory groups are required long before the milk bank is set up, and with breastfeeding promotion in place, the milk bank will have donors. A communication strategy is needed to assess the perceptions surrounding human milk and milk banking and to make people aware of the advantages. In Brazil, the marketing is highly successful, with the community inundated with milk banking messaging.

Only then can the actual facility slowly begin to be set up. Documenting change once the milk bank is in place is also important, particularly if it is the first one in a region and likely to expand. Getting baseline data and documenting changes in breastfeeding practices, in the neonatal unit, and in outcomes are the challenges because most facilities do not have funding for this.

However, as more groups go through the process of setting up milk banks, it is becoming increasingly obvious that a good framework for designing a milk bank is lacking. Tools or workshops are needed to define a structure for a process for opening milk banks. This would enable the right milk banks to be set up and assessment that the process that’s been developed is appropriate for the particular situation. Moreover, provision of data collection and evaluation tools to assess what can be done in a facility and to analyse the data would be very useful.

Interviewer: Are there key processes and procedures that need to be considered?

The safety of human donor milk is paramount. An important part of the assessment process is to have the milk bank take responsibility for safety, that being to clinically risk assess their donor and recipient populations and the entire procedure including donor human milk collection, storage and processing. This safety assessment is an absolute requirement because every process differs, and thought is going into developing tools to help milk banks conduct those risk assessments. Much of this is already known. For a group looking to set up a milk bank, PREM Milk Bank among others can make a risk assessment in the context of the particular project, depending on who is going to receive the product. However, this process would be made a lot easier by providing a template for the design of milk banks, although it then has to be tailored to the specific project.

The pasteurisation method currently used in all human milk banks is thermal pasteurisation, which heat-treats the milk at 62.5 °C for 30 minutes. At this temperature, all viruses in the milk are inactivated and all bacteria are destroyed. At the end of the process, the milk is microbiologically safe for the infant. However, heat treating the milk is not without some disadvantages because some components of the milk are inactivated or destroyed at high temperatures, such as some immunological and nutritional components. New technologies to improve the quality of human milk produced in a milk bank are therefore under evaluation. One such procedure is high temperature, short time pasteurisation (HTST), which treats the milk at 72 °C between 5 and 15 seconds. HTST has been shown to provide better quality milk in terms of immunological and nutritional components compared with other pasteurisation methods.

Screening of human milk is very important when selecting donors for human milk banks. Mothers wishing to become a donor have to complete a form regarding their medical history, diet, and lifestyle. They then have a clinical examination and must present negative blood tests for Hepatitis B, Hepatitis C, and HIV. While pasteurisation destroys these viruses, this is a necessary precaution to minimise the risk of infected milk contaminating milk at the bank. With regard to bacteria, guidelines permit up to a certain number of microbes; above that and the milk has to be discarded. Most guidelines stipulate to do a bacteriological check at the first donation, before and after pasteurisation, and at regular intervals thereafter.

There are two different scenarios with regard to the pooling of human milk. Some banks pool the milk from one donor only, while others mix the milk from two to a maximum of six donors. The advantages of having one donor only is that you know the exact donor and the milk characteristics. The milk from more than one donor will have different characteristics, but the protein and nutritional content of the milk is more balanced than when taken from a single individual. The process of microbiological screening of donors is the same for either strategy.

Interviewer: Where does funding for milk banks come from?

Kiersten Israel-Ballard: This is a real challenge. I think it is critical to ascertain a level of government commitment. If we talk about a milk bank in a facility like a hospital, it probably has to rely on public facility and funding. Hospital staffing are key; you are going to make sure that systems are in place. If it is a private hospital, then you will ensure that the facility wants a milk bank and will help support the staffing. Staffing is a basic operational constraint. In a public facility, often staff share their duties.

In the short term, groups are turning to international organisations for funding to set up a milk bank, such as the Rotary club. There could also be private donations from corporate or private sectors, and the donors could be recognised. This could be appropriate for the initial set up while putting things in place, but the ongoing upgrading costs have to be assumed to be borne by the facility, private or public. Funding has to be put in place before policy makers can understand the potential impact; it is then an easy decision for them to place it under other budgetary items because it’s not that expensive.

Guido Moro: We calculated how much it cost to produce one litre of human milk in our human milk bank at Macedonio Melloni Hospital in Milan. The figure is very similar to that calculated for the human milk bank at Meyer Hospital in Florence, the first human milk bank to be set up in Italy in 1971. This cost is between 80 and 100 Euros per litre. By taking the number of litres of human milk processed in the bank and the volume of human milk utilised for feeding premature infants, you can calculate the total cost of running a milk bank. That includes the equipment, the staff, and the materials used in the human milk bank.

Interviewer: These are the sorts of figures to throw at health ministers or people implementing the change. They will be extremely impressed, there is no question.

Guido Moro: These are the calculations I made for our country to show to politicians. After the survey, we also had data showing that two-thirds of premature infants born in Italy were not receiving human milk. We took these figures to the ministry management and told them that they could save both lives and money by supporting us to achieve this result. The Ministry of Health management agreed and, henceforth, our association and the ministry staff started to work together. Within six months the collaboration had set up a new milk bank.

Interviewer: The idea would be to then use the information to empower governments to make changes?

Guido Moro: Yes, in every country, you can collect data and calculate the figures for local situations.

Interviewer: What sort of resources and equipment would be needed to set up a milk bank?

Guido Moro: When you talk about outcomes, you have to think about the cost. This will be the first question that is asked when you go to the manager of a hospital asking to open a human milk bank because of its advantages. However long it takes to explain the advantages, the first question will always be the cost of the bank. You have to evaluate the cost of what is necessary to open the milk bank – the pasteuriser, the freezer, the refrigerator, and the staff – and it will cost approximately 50,000 Euros. But, you must then calculate that while paying this cost, you are saving both lives and money. There will be fewer infants with NEC, with reduction of the cost of therapies and surgery for NEC, fewer antibiotics needed because of the lower number of sepsis, and shorter stays in the NICU for infants. One of the main positive advantages from a human milk bank is that money is saved immediately from the time the baby is admitted to the NICU, and because the rate of NEC and infections will be lower. When talking about the expenses of setting up a milk bank, you have to estimate 50,000 Euros at the beginning to buy equipment and for the staff involved in the activity, but you must consider the advantages deriving from utilisation of donor human milk in feeding VLBW infants.

Ben Hartmann: The first question I am always asked is about costs, and I always respond by saying that I can only tell them what our milk bank costs. We have to think about milk banks as businesses to be able to design them as efficiently and effectively as we possibly can. We should be providing milk banks with better tools to make those cost decisions, because I don’t think that a third party can answer those questions. I find it very difficult when contacted by someone in a country that I know very little about, who wants to set up a milk bank and asks how much it will cost. In our hospital, we know our patient population. We know how many deliveries there are by gestation period (i.e., how many babies are born at 23 weeks, 24 weeks, etc.) so we know how much milk is needed at these times. However, birth rates and times will vary from country to country. We have a good understanding of how our milk banking service is used by a recipient, according to our inclusion criteria for receiving human donor milk, but this will not necessarily apply in other jurisdictions.

Fundamentally, equipment has a dollar value, but we have found that fund raising for equipment doesn’t seem to be challenging. The human resources to run milk bank are always going to be the most difficult to acquire, and this is something that I have seen in milk banking around the world. It is often the case that milk banks are developed by people who are very well meaning and care about having a milk bank, and these people often spend a lot of their own time delivering the milk banking service. I have been very lucky to have the opportunity to focus my energy on running a milk bank in Australia.

Coming back to your question about the costs, I think we need to design a milk bank to understand what a milk bank will cost, and to understand what we are trying to deliver. Then we can consider the cost appropriate for the benefit that we are trying to demonstrate. There is a business argument for a milk bank in most cases.

Interviewer: Maybe like a cost assessment, you first have to look at the investment needed and the outcome you are going to achieve. We don’t know that though, and so it is a long-term investment – the return is not so fast!

Ben Hartmann: Yes, it depends on the business model for the milk bank. In Australia, we are a public hospital and government funded. I think that our milk bank has a responsibility to use taxpayer money effectively, and to provide a service that benefits clinical outcomes of patients. We therefore feed a very specific group of patients where we have clear evidence of benefit. But we also should be providing a benefit to the community and reducing the cost of health care in Australia. Our service can demonstrate both those goals. We developed our inclusion criteria to focus on patients with a high risk of NEC. However, if we allow wider access to donor milk and provide it more generally, we would lose the cost benefit of the service, because we wouldn’t be able to show benefits to patients outside of those criteria. This is difficult for a milk bank to even contemplate, because idealistically, we would like to provide access wherever a mother’s milk is not available. This is simply not feasible or practical, so we have to link the service to the most appropriate patient.

Interviewer: From this last question I realise that opening a milk bank is not an easy, quick fix as first thought. It requires careful consideration, needs assessment and overall a good supportive network for mothers to ensure its sustainability. This all necessitates buy-in from hospital management, community and governments.

Interviewer: There are milk banks set up around the world. What do you think of this?

Kiersten Israel-Ballard: I think it is fantastic as long as people understand what they are doing. Many groups do not have any concept of what it takes to set up a milk bank! It is good that milk banks are being set up so long as those doing so understand that the level of effort to ensure that it is sustainable and monitored, quality control is in place, and that it is integrated with the system, is not a minimal thing. There is often underestimation and disconnect between the set up being easy and fast, and doing it the right way. A critical first step is to assess the actual needs of the facility. Is a milk bank what is most needed? Or first should there be improvements to strengthen the support systems for breastfeeding? Establishing a human milk bank may be a highly visible and exciting event, however establishing the solid foundation upon which it will operate requires effort and planning. Often it is the integration that is most challenging, not the actual operationalisation of the milk bank. It’s good that milk banks are being set up, but we are also afraid of things going too quickly; it may only take one negative outcome to impact milk banks negatively on a global scale. There is excitement and fear at the same time.

Guido Moro: The European Milk Banking Association (EMBA) is trying to create a network among human milk banks in Europe. The majority of human milk banks are connected to this association. If you want to start a human milk bank in a European country, there are several possibilities. The first option is to get in touch with an expert in your country. If you are a policy maker or head of a hospital, you can get in touch with local experts, and find a solution for when to start, how to start, and where to start. The second option is to go to a local association, such as the one we have in Italy. The association gets in touch with the Ministry of Health, and a co-operation is started. The third possibility, if you have neither an expert nor an association, is to get in touch with the European Milk Bank Association for support. We are able to provide support because we know most of the experts in the field working in Europe. So, one of these three strategies should be followed.

Ben Hartmann: We should always be the ones asking milk banks whether milk banking is the solution for the particular problem: Is it effective, and how are they able to demonstrate and measure the outcomes that they intend to deliver? Milk banks should not only be able to answer these questions, but should be the ones asking themselves these questions.

My observation is that if we aren’t prepared to ask those questions, then the credibility of milk banking can suffer. For example, in Australia, if we can’t demonstrate the particular outcomes that are intended or we can’t articulate the outcomes that we intend to deliver, it is very difficult to then go to the government and say that this service should be funded. This is a challenge, but there certainly is also a lot more guidance and support milk banks could offer each other to achieve those goals. There is an enormous amount of value from having milk banking more closely aligned internationally, and from sharing information, support, and resources. There is a lot of information associated with human milk banking that is unvalued. By working together rather than working separately, milk banking can potentially be a lot more.

Interviewer: What are your key challenges then?

Ben Hartmann: I think a significant challenge is to recognise that two different milk banking services can operate in different jurisdictions and be different in how they are constructed, because they are entirely appropriate for the particular situation they are designed for. That’s a challenge, because there isn’t just one single set of rules for how you run a milk bank, and we need to be a bit smarter in how we go about designing and assessing them.

17.7 Low-Middle Income Countries

17.7.1 Expert Collective Views

Interviewer: What are some General Considerations when Looking at Milk Banking in Low-Middle Income Countries?

Milk Banks are being set up all over the world. In developed countries, milk banks are regulated from the beginning; every initiative has to follow the regulations created specifically for the opening a milk bank. In contrast, those in some low-middle income (LMIC) countries may not be regulated and lack the necessary infrastructure. At the start, every attempt to increase the possibility of providing human milk to a needy infant is seen as a positive initiative. Thereafter, activity of the milk bank has to be regulated to ensure the safety of the recipients.

However, of primary importance is to educate mothers on the advantages of breastfeeding, and put all significant efforts into increasing the breastfeeding rate. Human milk banks and donation of milk are secondary. While generally, orphan infants will need milk, the importance of milk banks should also be tailored to the country such as in areas with very high rates of HIV.

Interviewer: Is it possible to start a milk bank on a minimum budget?

All milk banks must be designed to serve their specific purpose. It is certainly possible to define the problem, decide whether milk banking is the solution and, if it is the solution, consider what type of milk bank is required and how it would operate.

Low-cost milk banking can be as appropriate as a high-cost milk bank, and the approach to both is the same. The focus is on safe, ethical, effective, and sustainable services. Milk banks’ actual services might differ, but these fundamental goals of what milk bank services should try to achieve are consistent wherever they are operating.

A key to milk banking is simplicity. PATH has considered how to simplify the process. Firstly, it can be low cost for small skilled milk banks as well as large facilities with huge budgets. In South Africa, PATH, together with the Human Milk Banking Association of South Africa, developed the FoneAstra, a low-cost, smart phone-based monitoring device that has been adapted to guide the operator through the pasteurisation process and record and transmit pasteurisation temperatures. While a traditional pasteuriser takes about two hours to complete its cycle and to prepare bottles, this system takes 17 minutes including the cooling. A small facility does not always need large numbers.

Secondly, PATH is looking towards rapid diagnostics instead of sending samples to microbiology laboratories, which are expensive. Laboratory costs present one of the largest challenges. However, if you had a rapid diagnostic test where the milk bank technician did the test directly at the milk bank then this would save money.

Thirdly, savings can be made by scheduling correctly and sharing staff, which are the greatest cost. In Brazil, there are different models, but there is always a lactation support person who is part of your key milk bank staff, and a technician. One small milk bank has a staff of two, with both working half days.

In addition to the human milk bank itself, other facilities can be installed when considering setting up a milk bank. A project in Mozambique has installed a library on woman’s, child’s, and adolescent’s health for educational purposes, and a laboratory of health telecommunications to enable a process to be followed in real time. The library is an extension of the institute library at the Maputo Central Hospital, Mozambique; joining the library system at the Maputo Central Hospital comes with an automatic entry to the library in Rio de Janeiro, with access to its books and journals. A team of trained librarians has full autonomy. Because of these facilities, the cost of the Mozambique project was higher than the cost of the usual projects undertaken. Additional funds were provided by Define and the Brazilian Cooperation Agency. Together these bodies made the project financially viable, keeping the commitment already established with Mozambique and without intervening with the principles underlying the technical cooperation.

Importantly, the collective performance of the network is monitored among the countries. International benchmarks for global health are adopted, and in 2010 the network was operated as a food and nutrition safety strategy, taking the goals of the millennium as a reference.

17.8 Key Considerations

Interviewer: Finally – What are some key considerations when setting up a milk bank?

Kiersten Israel-Ballard:

  • Establishing a human milk bank is an opportunity to change the culture; to enhance breastfeeding promotion and the thinking around the value of human milk in your facility

  • A milk bank must have a sound foundation, with the support of infrastructure around breastfeeding promotion.

  • It should be developed using an integrated approach, with an established network and links to kangaroo mother care, dietitians, and breastfeeding promotion, rather than by using a vertical model of a milk bank that processes milk.

  • It is critical that milk banks develop guidance specific to their area and facility, by talking to technical experts and thinking through the risks and resources specific to the facility. This leads to sustainability; by doing things right to begin with, then there is a high chance your operating procedures will be right for your resources – you won’t run out of things or place unnecessary orders.

  • The way forward is to come together as a community, by better linking, by transparency, and by providing an interactive platform for sharing resources, materials, and information. We need to give more support to our global community by providing these things as they try to establish their own networks and milk banks. We have to think innovatively around how this can be done.

  • Engage with policy makers. Even the smallest milk bank has the job of advocating milk banks in its region for the global community, and part of that is documenting and quantifying any differences. For example, it would be useful to have more data about the different models that work and don’t work in certain situations. There is more information around this than about outcomes, and perhaps what it needs is a call to action for a bank programme to collect and publish this data so that people can learn.

Guido Moro:

  • Breastfeeding is the gold standard for all infants, both term and preterm. If the mother has no milk for her infant, particularly when the infant is premature or sick, human milk from a bank has to be used. The government has to invest money in milk banks and in opening new ones, so that these banks can provide an alternative to breastfeeding.

  • Availability of donor human milk is mandatory when mother’s milk is not present. That means no incentive and no publicity for formula or other substitutes of human milk. This should be an extremely important local initiative, for single hospitals where there are doctors that are not involved or interested in human milk activity. Such doctors inform mothers that if they don’t have milk, then there are many formulas that are good enough, and that many infants grow up with formula and so they should not worry. Pediatricians, scientists, administrators, and policy makers all over the world should fight against this way of thinking.

  • The activity of human milk banks must be supervised, because otherwise the results could be extremely negative. I refer to the example previously described where, in Italy, there are human milk banks collecting only 20 litres of human milk per year and others collecting 2,000 litres. Banks with small volumes of milk collected have to increase their milk volume or have to be closed.

  • It must be kept in mind that there is a cost in giving human milk: it costs a lot, but you can save far more money by giving human milk than by giving formula in terms of health and quality of life later in life.

  • Associations are important for all countries considering establishment of new human milk banks. This is because they can check the activity of the existing banks and suggest where and how to set up new ones, and can more easily gain direct access to administrators, policy makers, and governmental bodies which take the final decision.

Ben Hartmann:

  • The term human milk bank is used to describe quite a wide range of practices and it is often that these practices are designed to achieve quite a range of outcomes. Milk banking means different things to different people.

  • A human milk banking service should be designed to be safe, effective, ethical, and sustainable.

  • Milk banking services should clearly define the service that they are trying to deliver and their intended benefit. The primary goal should be to maximise a mother’s own breastfeeding success.

  • A challenge for milk banks is a range of practices that potentially have a detrimental impact on the credibility of human milk banking as a clinical service. This happens with some of the less evidence-based uses of donor milk, or informal milk sharing, which get associated with human milk banks.

  • One potential solution to unifying milk banking where practices differ across jurisdictions might be to design and assess milk banks rather than the end practices. This solution would be one that can recognise the unique aspects of every jurisdiction that might result in differences in practice. These differences must be demonstrated to be appropriate for a particular purpose. By focussing on how a milk bank is designed and developed and what it is trying to achieve we can move away from focusing so much on practice differences.

17.9 Conclusions

A mother who is breastfeeding her own infant is biologically normal; anything else is suboptimal. Human milk from a donor milk bank is the next best option for mothers who cannot breastfeed or who cannot supply sufficient milk for her infant, and for preterm and sick infants where necessary. Only when these options are exhausted should other milk alternatives be considered.

The goal is to run milk banks to support the biological norm of a mother breastfeeding her baby. These should be the smallest possible so that the focus is on the mother breastfeeding naturally. There should be support for mothers to succeed in feeding her own infant, using donor milk from milk banks only where it is indicated and where it is necessary.

Key Points

  • Human milk banks provide a safe, secure service for the collection, screening, storing and distribution of donated human milk. Donated human milk should always be seen as bridging a gap until mother’s own milk can be used

  • Practice demonstrates that the benefit of human milk for sick and vulnerable infants is disproportionately high

  • Prior to setting up a milk bank it is paramount to evaluate the requirements to ensure it is adapted to the local necessities and at the same time being sustainable. Furthermore, an integrated approach with the provision of lactation support, will greatly enhance its long-term value to the community

  • The initial outlay to set up a milk bank as well as its running costs should be contrasted against the immediate return on investment in reducing NICU costs for therapies and surgery for illnesses prevented by administering human milk

  • The integration of the many different national guidelines into unified global standards and tools will greatly facilitate the set-up of integrated, safe, effective, ethical and sustainable milk banks

Professor João Aprigio Guerra de Almeida is the founder and coordinator of the Brazilian Network of Human Milk Banks, and coordinator of the Centre for Technology and Information on Human Milk Banks and Breastfeeding, ICICT/ FIOCRUZ. He is also a consultant for the Health Ministry of Brazil and consults with International Health Ministries to implement successful milk banking and projects worldwide. He established a successful network of over 290 milk banks around the world following his initiative of integrating breastfeeding support and milk banking.

Ben Hartmann, PhD is Manager of the PREM Milk Bank, Department of Health (Western Australia). After his PhD at the University of Western Australia in 2001, and qualifying in Small Business Management, he ran his own business. Since 2005, he has worked at the King Edward Memorial Hospital, establishing, then managing the PREM Milk Bank, the first donor human milk bank in Australia, with the aim to establish best evidence-based practices in human milk banking in Australia to support the wider re-establishment of this service. The service’s underlying principle is that donor human milk banking must support mothers feeding their own baby; its milk-banking goal is to not be required.

Kiersten Israel-Ballard, DrPH is an Associate Director with PATH’s Maternal Newborn, Child Health and Nutrition program. She has a DrPH degree from the University of California, Berkeley, School of Public Health, and over 15 years of international experience in assessing and supporting methods for optimal infant and young-child feeding. In her current role, she leads the human milk bank initiative at PATH. This has included establishing global teams to work with local governments to ensure sustainable implementation of human milk banking, and developing innovative technologies for resource-limited settings. She has also led programmes to support implementation of nutrition schemes for local governments and focuses on innovative approaches to improve infant health.

Professor Guido E. Moro, MD/PhD is Professor of Neonatology at the Postgraduate School of Paediatrics, University of Milan, Italy. His main field of research is infant nutrition, and he has published more than 250 scientific papers and presents at international meetings. He is the President of the Italian Association of Human Milk Banks (AIBLUD) and was the first President of the European Milk Banking Association (EM- BA). In 2005 he received the “Gold Medal” from the City of Milan due to his scientific and social activities.

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