AMR Awareness Week: Public health needs to be bottom line

Antimicrobial resistance (AMR) has been described as a silent pandemic. However, there is nothing silent about this escalating global crisis, which is now associated with nearly five million deaths a year, making it one of the world’s biggest killers. 

New antibiotic treatments are urgently needed. But to stay ahead of drug-resistant bacteria, they also need to be the right antibiotics, those that have the greatest public health impact. 

For that, a new antibiotic research and development (R&D) model is needed, one that ensures that the people most in need get access to these drugs, particularly in lower-income countries. 

With the traditional R&D model profit, those most vulnerable have been left behind. It also is now well-known that we have seen the antibiotic pipeline dry up in recent decades, with pharmaceutical companies steadily withdrawing from the market. 

But it is also why some clinically important antibiotics never got developed, because they wouldn’t be profitable enough, and it is why lower-income countries often struggle to get access to essential antibiotics, and one reason why they have the highest AMR burden. This is the public health failure at the heart of the AMR crisis.

In 2016, the organisation that I run, the Global Antibiotic Research & Development Partnership (GARDP), was created to address precisely this issue, by creating a novel public-private partnership model for antibiotic R&D that places public health needs as its central objective. 

Our primary focus is the development of new antibiotic treatments that target World Health Organization priority pathogens — those multidrug-resistant bacteria that pose the greatest threats to public health — and ensuring that people in need get access to them.

Three aspects of our model, in particular, make this possible. By having an integrated R&D and access approach, we are able to factor public health constraints into the drug development process. 

This means that we can make sure the end product is suitable for low-resource settings and that production costs remain low. We don’t just fund trials, we can also carry them out. 

This allows us to be involved in making critical decisions, establish trial sites in regions with high prevalence of disease and recruit participants most affected by the disease that would normally be missed out, such as women, adolescents and people living with HIV.

We are also unique in our use of licensing agreements with pharmaceutical companies and manufacturers. By carrying out clinical trials and supporting regulatory submissions, these agreements help to de-risk antibiotic drug development for donor governments supporting this work and pharmaceutical companies looking to commercialise the drug. 

In exchange, we acquire the rights to manufacture and distribute treatments notably in low- and middle-income countries, making it possible for people in countries or regions of high burden to get access. Our aim is to work with a manufacturer to produce a drug that can be deployed around the world at affordable prices. 

This is also partly made possible by the fact that our public-private partnership model involves working with all key stakeholders across the entire pipeline, including scientists, industry, manufacturers, regulators, donors and civil society, enabling us to make the best use of public money. Using this approach, GARDP is already making good progress towards developing five new antibiotic treatments by 2025. 

Just earlier this month we announced the positive results of a phase 3 trial for zoliflodacin, a first in a new class of antibiotics, and the first to treat gonorrhoea in decades. With 82 million gonorrhoea infections each year and rising, a drug such as this couldn’t come soon enough. Resistance is growing to the last effective antibiotic treatment, particularly in Asia but now also spreading globally, so this sexually transmitted infection is now in danger of becoming one of the first diseases to no longer be treatable.

If it weren’t for this public-private model, it is unlikely that zoliflodacin would have made it this far. If it gets approved, GARDP will be licensed to distribute it to two-thirds of the world’s countries, making it available to people in lower-income countries. 

Gonorrhoea is just one example. We are also working on treatments for other disease areas, such as neonatal sepsis, for which we are also seeing an alarming increase in cases that are resistant to all antibiotics. This is making it harder to treat and reversing progress on reducing neonatal mortality, particularly in lower-income countries. 

In addition to developing new treatments, we are also committed to improving access to essential antibiotics that have already been approved. One reason why countries often aren’t able to get access to existing antibiotics and why they may experience shortages, is that they may be more complex to develop and manufacture and offer lower revenues than many other drugs. And yet at the same time they often have challenging regulatory requirements and smaller markets. 

So, not only are fewer new antibiotics being developed, but we are also now seeing fewer existing antibiotics produced. On top of this, demand for antibiotics can often be volatile, and many countries face challenges in the management of national supplies. All this conspires to make stockouts of antibiotics much more common than for other drugs. 

Through our access programme and a new joint GARDP and WHO initiative, called SECURE, we are working with countries to overcome such challenges and improve access to essential antibiotics. Part of this, for example, involves working with national regulatory authorities to see how they can help centralise the monitoring, mitigation and response to antibiotic shortages and improve market intelligence. 

Further down the line, SECURE could also help to increase supply security by encouraging countries to pool procurement with other countries, which could help create more buoyant and competitive markets. 

What is common to every aspect of this new public-private partnership model and why it works, is that public health is key. Because when it comes to AMR, the bottom line is that, public health needs to be the bottom line.

Manica Balasegaram is the executive director of the Global Antibiotic Research & Development Partnership (GARDP). 

Views expressed are the author’s own and don’t necessarily reflect those of Down To Earth.

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