Antimicrobial resistance (AMR) is emerging as a significant health threat in low- and middle-income countries (LMICs), accounting for 4.3 million of the five million global AMR-related deaths each year.
Despite this burden, these countries remain heavily dependent on high-income countries (HICs), particularly in the West, for the discovery, development, and access to antibiotics.
Although many LMIC governments have adopted action plans to address AMR, progress has been hindered by the high costs associated with research and clinical trials.
Over the past 80–85 years, antibiotics have revolutionised medicine, transformed public health, and saved millions of lives.
However, we are now entering a post-antibiotic era, with a sharp decline in the number of new antibiotics developed each decade. With AMR projected to cause nearly 10 million deaths annually by 2050, the need for new antibiotics — particularly in LMICs — has become increasingly urgent.
Pharmaceutical companies face numerous challenges in making antibiotics accessible in LMICs — from initial registration to maintaining a sustainable market presence. In many of these countries, the registration process is resource-intensive and companies often decide to register products based on projected market demand.
Supply chains are fragmented and complex, involving multiple stakeholders, factories and warehouses. With limited resources, LMICs struggle to manage these complex supply chains, resulting in longer lead times, increased costs and compromised quality.
A lack of reliable data on the specific antibiotic needs of different countries further complicates decisions for companies regarding which medicines to introduce where.
Additionally, LMICs often contend with weak regulatory frameworks and the uncontrolled use of substandard or falsified antibiotics. This not only reduces access to quality-assured drugs but also accelerates the development of resistance. Prolonged timelines for conducting clinical trials and burdensome regulatory processes further delay the market authorisation of antibiotics.
Even sustaining an antibiotic in the market is financially challenging. In 2020, total annual sales of the entire branded antibiotic market in the United States were lower than the revenue from a single blockbuster drug. Unlike treatments for chronic conditions such as hypertension or diabetes, many novel antibiotics are reserved for use as a last resort and for shorter durations, making them economically unattractive.
Consequently, antibiotic innovation is increasingly led by start-ups and SMEs that face high financial risk and limited investment.
Despite the challenges — fragmented supply chains, varying regulatory requirements, and narrow profit margins — there are several strategies that can help improve access to antibiotics in LMICs.
One such approach is enabling local production through technology and knowledge transfer, allowing manufacturers in the target country to produce needed antibiotics. Encouraging voluntary licensing by major pharmaceutical firms can further empower local manufacturers to produce patented products at lower costs, thereby enhancing accessibility.
Several pharmaceutical companies have already taken such steps. For example, Sanofi, the French multinational pharmaceutical company, has transferred technology to a local producer in Nigeria to manufacture metronidazole — an off-patent antibiotic listed on the WHO’s Model List of Essential Medicines and widely used for both community- and hospital-acquired infections.
Similarly, Japanese pharmaceutical company Shionogi has partnered with the Global Antibiotic Research and Development Partnership (GARDP) and the Clinton Health Initiative to market cefiderocol, a novel antibiotic for multidrug-resistant (MDR) infections, in LMICs.
Pfizer’s "Accord for a Healthier World" initiative also seeks to provide all its current and future patent-protected medicines — including the ceftazidime-avibactam antibiotic/beta-lactamase inhibitor combination — on a not-for-profit basis in 45 LMICs.
With the looming threat of AMR poised to become a global health crisis, governments and industry must work collaboratively to ensure timely access to antibiotics. A globally funded access programme for both existing and novel antibiotics could help mitigate the rising death toll from drug-resistant and drug-susceptible infections.
Pharmaceutical companies must continue to invest in innovation, while governments play a crucial role in supporting infrastructure, skilled personnel, research and development, and clinical trials.
To effectively combat AMR, we need a combination of innovation, supportive government policies, streamlined regulations, and the willingness of large pharmaceutical companies to make antibiotics — both existing and new — widely accessible across LMICs.
The writer is President, Global Critical Care, Venus Remedies Ltd and CEO, Venus Medicine Research Centre.
Views expressed are author's own and don't necessarily reflect those of Down To Earth