Last year I was asked to speak at a side event of the 72nd World Health Assembly, on the challenges faced by the Global Health community in bringing new health products to low-income countries in a sustainable, equitable way. Why aren’t life-saving commodities – old and new – not reaching the people who need them?

This is a hugely topical debate as the Universal Health Coverage agenda intensifies on the global stage, and as politically thorny issues of transparency in drug-pricing and access to medicine make the headlines. Here I give an overview of some of the issues I’ve seen in the field over the past few years which severely constrain access to, utilisation of and compliance with essential, lifesaving commodities in deprived communities, before diving deeper into a real example of where we’re tried to address these issues head-on.

Insights from the field: what do we see?

This is by no means a comprehensive account of every single bottleneck observed across our health programmes but gives a flavour of the challenges we face on a daily basis in trying to achieve better health outcomes for mothers and children.

· Broken supply chains. Why is it that bottles of Coca Cola can be found in the most remote villages of Kasai Oriental while cheap, heat-stable, lifesaving medicines are nowhere in sight? I always find it tragic when essential, affordable medicines end up getting stuck in cities or regional purchasing centres instead of making their way down to the clinics and health posts that need them. We’ve recently had to procure drugs internationally for a health project in the Democratic Republic of Congo, after an audit revealed that local procurement centres were storing commodities in such awful conditions that buying from them would have posed a real threat to patients’ health in the area.

· Near complete absence of certain drugs. Until Save the Children introduced Rotavirus Vaccine in the public health system of Lagos, Nigeria a couple of years ago, this lifesaving vaccine was only available in private clinics at a cost of over $100 a vial, out of reach for most Nigerians, let alone the poorest of them. Two-tier healthcare where essential drugs and vaccines are only available to the few who can afford is the norm across most low-income countries.

· Insufficient quantities of lifesaving commodities. Amoxicillin is the most effective antibiotic to treat bacterial pneumonia in children. It has been around for nearly half a century and is produced at low-cost by several generic manufacturers in the global South. Despite this, shortages are rife across Africa, to the point that millions of parents have probably never even seen a tablet of Amox-DT in their entire life.

· Lack of awareness of hugely effective therapies. Whilst we have seen a significant increase in the awareness and use of Oral Rehydration Solution (ORS) to treat children sick with diarrhoea, the combined therapy using both ORS and Zinc – a very effective micronutrient to reduce the severity of diarrhoeal episodes – isn’t getting much traction despite the hugely compelling evidence base that underpins it. After four years of intense community awareness raising and behaviour change activities in poor communities of Nigeria and India, adequate use of Zinc for diarrhoea treatment remains stuck at 20%.

· Inappropriate / unwieldy formulation of drugs. Another reason Zinc isn’t being used anywhere near as widely as it should is user-friendliness: treatment involves crushing a tablet every day for 14 days – a long regimen given most children get better after two to three days of ORS treatment, and not the easiest way to administer a medicine to an infant. Not enough R&D goes into reformulating existing drugs so that they are more user and child friendly, which could be a prime activity for a domestic low margins generic industry. A typical of example of supply not meeting demand and a research agenda not being driven by need.

· Low acceptability. The antivax movement, responsible for an upsurge in measles across much of Western Europe, no longer needs an introduction. In Pakistan, the polio eradication campaign faced an uphill battle after community leaders spread false rumours that the vaccination effort was a plot for mass sterilisation of Muslims. Less unreasonably, many mothers find it difficult and unnecessary to comply with a strictly exclusive breastfeeding regimen for their young infants, either because they can’t combine it with the need to work, or because of traditional practices involving giving water and solid foods at a very young age.

· Inexistence of health products in the market. Pneumonia is the largest infectious cause of child mortality globally. Yet, I am not aware of any serious R&D initiative to develop a low-cost Rapid Diagnostic Test (RDT) for detection of bacterial pneumonia, like the ones which have been so instrumental in reducing the global burden of malaria over the past decade. It beggars belief that something so obviously needed isn’t even on the map for health research priorities.

A case study: introducing chlorhexidine gel in Kenya

These are extraordinarily difficult issues to solve and require global, national and local partnerships on an entirely new level. Our project to introduce a gel formulation of chlorhexidine for umbilical cord care in one county of Kenya was an attempt to address a number of these issues in a concrete setting. The successes registered are very real, as are the challenges we’re now facing on our “journey to scale”.

The umbilical cord stump can be an entry point for lethal infections such as newborn sepsis, which is believed to cause up to one million neonatal deaths every year (WHO, 2017) mostly in Africa and South Asia. Chlorhexidine is a common antiseptic and was identified as a lifesaving commodity by the UN in 2012 which, if more widely accessed and properly used for umbilical cord care in low-income countries, could save hundreds of thousands of lives.

This prompted calls to develop thermostable formulations of chlorhexidine, to be used in high heat and humid areas of the Global South. A request from the Kenyan Ministry of Health prompted the pharmaceutical company GSK to reformulate the antiseptic solution used in its Corsodyl™ mouthwash into a gel and packaged it in single doses to be used by midwives, nurses but also mothers themselves, particularly when they give birth at home.

Save the Children supported the introduction of this new formulation of chlorhexidine in 21 health facilities of the Bungoma district, in Western Kenya, as part of a Managed Access Programme (MAP) in 2016. An acceptability study was carried out with healthcare providers and produced compelling results. The product was found to be easy-to-use. It was perceived as a genuine improvement on traditional methods (such as applying cow dung or lizard droppings). It seemed to accelerate the healing of the stump in many cases, and it noticeably reduced the number of cases of sepsis recorded in the facilities.

This, however, was only the inception of an arduous journey to make this lifesaving drug available to all Kenyan mothers. The reason? Political will is important but not enough.

A key step for the successful introduction of any new health product is to undertake a quantification of needs the whole population. This then enables pharmaceutical companies to forecast demand and manufacture enough supplies for that country. This exercise was not carried out in this instance: we were effectively taking a leap of faith, and national companies had no oversight of the country’s pharmaceutical needs in relation to chlorhexidine.

Even more importantly, the “political economy” of a health issue must be thoroughly understood: what is the real burden of disease? How does this issue rank in the priorities of healthcare providers and end users? What is the government’s willingness and capacity to pay for the procurement of this drug on a national scale and for many years to come? Is the national health system able to “absorb” this new product without putting undue pressure on an already stretched delivery platform? Will local manufacturers be willing and able to step in and produce cheaper versions of the drug to ensure affordability and sustainability? These questions are seldom fully answered before a new drug, vaccine or diagnostic tool is introduced in a low-income African country.

Change is hard, unpredictable, subject to many competing forces and incentives. The journey to making chlorhexidine available for every newborn child in Kenya is no exception. With an Essential Medicine List getting longer every year that goes by, choices are having to be made by cash-strapped ministries of health.

But arduous as it is, the journey continues, and the day will come when stories of babies dying needlessly of a completely preventable disease will be so rare that they’ll make the headlines.

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