Bridging the Antimicrobial Access Gap: Data, Accountability, and Solutions
The week of 22nd January sees the convening of WHO’s Executive Board (EB) in Geneva, where the key areas of the global health agenda are set out for WHO member states for the year ahead. Among other issues, MSF is presenting a position statement to the EB on the global challenge of antimicrobial resistance (AMR). In our blog post, first published in November 2023 during World Antibiotic Awareness Week, we shine a light on the critical issue of antimicrobial access ‘gaps’. This is a key concern that needs to be addressed as part of a holistic approach at the EB and leading up to the UN High-Level Meeting scheduled for September 2024, where it’s hoped that sustainable and equitable solutions to the AMR crisis will be agreed by UN member states together.
Dušan Jasovský, MSF Access Campaign AMR Pharmacist
Antimicrobial resistance (AMR) is recognized by the World Health Organization as a major public health threat. It caused 1.27 million directly attributable deaths in 2019 alone. The likelihood of dying from bacterial AMR is higher for individuals in low- and middle-income countries (LMICs) compared to those in wealthier countries. This gap widens dramatically in the case of young children: In 2019, 1 in 5 deaths caused by AMR occurred in children under the age of 5 — often from treatable infections — and nearly all child fatalities under the age of five due to AMR occur in LMICs.
As a medical humanitarian organisation operating in low-resource environments globally, we’re witnessing the concerning effects of AMR in our projects. From war-wounded people in Yemen to newborns in the Democratic Republic of Congo to malnourished children in Niger, our teams see the impact of AMR every day. Our response as an organisation involves a collaborative, cross-disciplinary strategy to both manage and prevent drug -resistance where we can. However, much effort is still needed, and addressing AMR on a worldwide scale demands extensive collaboration across multiple sectors, as well as a strong commitment of political will and resources.
The Imperative of Equitable Access in the Global Health Arena
The upcoming UN High-Level Meeting on Antimicrobial Resistance (HLM AMR) in September 2024 offers a critical opportunity for the international community to address this issue head-on. Given the state of the AMR crisis globally, the AMR HLM cannot be merely another forum for discussion. It must instead be a platform for commitment and accountability, where countries and global health actors take concrete steps on AMR.
Amongst the challenges most urgently in need of redress is the antibiotic access gap: patients in LMICs often face significant disparities in the availability of life-saving medicines compared to patients in higher-income countries. This dynamic is of course by no means limited to antibiotics: MSF has long witnessed restricted access to health products in resource-poor settings and advocated for more equitable global distribution of these life-saving goods. However, in the case of antibiotics, the lack of access is not only an issue of equity but a driver of AMR. That’s why universal availability of antimicrobials alongside stewardship measures is needed to decrease transmission of resistance, by limiting inappropriate use of other antimicrobials with higher resistance potential which happens when first-line treatments are inaccessible.
In addition to the dual challenges of access and excessive use of antibiotics, the lack of access to culture and antimicrobial susceptibility testing (AST) is a significant concern. This limitation hinders not only our wider understanding of the scale of the problem through providing a general surveillance of antimicrobial resistance, but it also critically impairs the quality of medical care for individual patients while undermining overall efforts in antibiotic stewardship in ensuring that antibiotic availability does not inadvertently accelerate the development of drug resistance through inappropriate use.
Defining the Scope of Global Antibiotic Inaccessibility Through Data
Even beyond its role in driving AMR, lack of access to antibiotics already constitutes a global health crisis. The 2016 Political Declaration of the high-level meeting of the General Assembly on AMR ‘note[d] with concern that …the current lack of access to health services and access to antimicrobial medicines in developing countries contributes to more deaths than antimicrobial resistance.’ Individuals in LMICs bear the brunt of infectious diseases and antimicrobial resistance worldwide, yet often struggle to obtain appropriate treatments. Research suggests that many may still die due to lack of access to effective antimicrobial treatment.
In some cases, people in LMICs lack access to medical tools because prices are too high, while in others, tools simply aren’t available locally or haven’t been adapted for use in lower-resource settings. Antimicrobials are also frequently subject to supply interruptions and scarcities, a challenge that affects countries at all income levels and other procurers (including MSF) and is exacerbated during global health crises like COVID. LMICs are most vulnerable to shortages, however, due to their more fragile supply chains — and while high-income countries are rapidly seeking ways to shore up supply chains and build domestic manufacturing capacity to ensure national health needs are met on an ongoing basis, in low-resource settings, in contrast, the issue is underreported and often completely unaddressed.
The 2016 Declaration urged Members States and other global health actors forward in ‘… promoting access to existing and new, quality, safe, efficacious and affordable antimicrobial medicines based, where available, on diagnostic tests; sustained research and development for new antimicrobial and alternative medicines; rapid diagnostic tests, vaccines and other important technologies.’ However there has been little progress since the 2016 HLM on redressing the access gap, and in many places where MSF works, problems with access to both novel and older antimicrobials persist.
Registration is one of the barriers to access in LMICS: only half of new antibiotics entering the market between 1999 and 2014 were registered in more than 10 countries, and for studied antibiotics introduced between 2012–2018 registrations have been filed in fewer than five countries per year. Even the registration of older off-patent products is limited, restricting availability in countries where the needs are often the greatest. One recent study found that only 14% of off- patent/generic products are filed for registration in 10 or more of the 102 LMICs it covered in the study.
There has been a notable shortage of the old but essential antibiotic amoxicillin, affecting 80% of the countries monitored by the WHO in the later part of 2022 and into 2023.
In many regions and conflict areas where MSF operates, such as Gaza, access to essential antibiotics, primarily through donations, has been a continuous challenge due to the blockade and embargoes, resulting in availability as low as 45% even before 2023.
Addressing Complex Barriers in Antibiotic Availability for LMICs
The reasons behind the access gaps and shortages are multifaceted and diverse, encompassing issues such supply disruptions; a highly consolidated market with a limited variety of quality-assured sources; a market environment that disincentivizes sustainable manufacturing of some basic existing antimicrobials; inaccurate forecasts of countries’ needs; lack of capacity for active stock management; weak procurement systems; and clinical knowledge gaps and biases. Historically, the metrics specific to AMR have focused on consumption and overuse. Therefore, to guide policymaking and bridge the access gap, there’s a pressing need for more comprehensive data collection on access to antimicrobials, through existing or new mechanisms.
As described above, when new antimicrobials promising to combat drug-resistant infections come to market, LMICs often experience considerable delays in obtaining them. Frequently, these countries are not considered viable markets for new antimicrobials due to their limited economic appeal. The expansion of access to these novel antimicrobials, especially those intended as last resort treatments for carbapenem-resistant bacterial infections, is notably difficult, resulting in an ongoing access gap where, as calculated, vast majority of patients in certain LMICs suffering from carbapenem-resistant infections have only a very limited access to effective treatment.
Access is further hampered by the prohibitive prices of new drugs, along with intellectual property protections, that can block the entry of more affordable generic versions into the market.
Additionally, the challenges associated with implementing antimicrobial stewardship in resource-poor settings can further hinder the availability of these crucial last-line treatments where they are most needed.
Pool procurement solutions spearheaded by SECURE, the Antibiotic Facility in accelerating access to last-line recently developed antibiotics in LMICs, such as cefiderocol, could offer a practical move forward. Additionally, the Global Drug Facility’s work in making tuberculosis treatments accessible and affordable, offer valuable insights. Such supranational platforms can guide future strategies to improve the availability of both non-patented and patented antimicrobials.
Leveraging Multilateral Agreements for Enhanced Global Access to Antimicrobials
Multilateral agreements such as the High-Level Meeting in 2024 on AMR present an opportunity to put in place explicit objectives and indicators to increase access to antimicrobials — both existing and yet-to-be developed. The high-income countries and broader global health community must in concert with LMICs improve sustainable access to existing medical tools by measuring the access gap, supporting countries’ forecast capabilities, making global supply chain systems more transparent and responsive, diversifying quality-assured manufacturing sources, and helping countries to band together and procure more affordable medical tools jointly, while providing funding to support this procurement. Similarly, the funders of biomedical R&D must also take steps to make sure that innovations resulting from that investment are accessible and affordable everywhere they’re needed.
The modalities of next year’s HLM AMR are yet to be determined, but it is certain that without a truly cooperative, global approach, no country will be insulated from the impacts of the antimicrobial access gap.
This blog contains elements of a broader analysis from the recently published MSF Issue Brief on addressing AMR withing global processes, including those on improving Pandemic Preparedness and Response.
For the full report: Addressing Antimicrobial Resistance Within Global Processes to Improve Pandemic Preparedness and Response