The World Health Organization (WHO) has issued its first guidance on managing antibiotic pollution from manufacturing, highlighting a critical but often overlooked issue. The release of these guidelines on wastewater and solid waste management comes ahead of the United Nations General Assembly (UNGA) High-Level Meeting on Antimicrobial Resistance (AMR) scheduled for September 26, 2024.
Antibiotic pollution is a significant contributor to the rise and spread of AMR, which threatens the global effectiveness of antibiotics, including those produced by the very manufacturing sites causing the pollution. Despite documented high levels of antibiotic pollution, the issue remains largely unregulated, with environmental emissions rarely addressed in quality assurance criteria. Additionally, there is little information provided to consumers on proper disposal methods for unused or expired antibiotics.
“Pharmaceutical waste from antibiotic manufacturing can lead to the emergence of new drug-resistant bacteria, which can spread globally and endanger public health. Controlling pollution from antibiotic production is essential to maintaining the effectiveness of these life-saving medicines,” said Dr. Yukiko Nakatani, WHO Assistant Director-General for AMR ad interim.
Globally, there is a notable lack of accessible information regarding the environmental impact of medicine manufacturing. “This guidance offers an independent and impartial scientific foundation for regulators, procurers, inspectors, and the industry to integrate robust antibiotic pollution controls into their standards,” stated Dr. Maria Neira, Director of the Department of Environment, Climate Change, and Health at WHO. “The emphasis on transparency is crucial, empowering buyers, investors, and the public to make informed decisions based on manufacturers’ efforts to control antibiotic pollution.
“Several international bodies, including the WHO Executive Board, the G7 health ministers, and the United Nations Environment Programme (UNEP), have called for this guidance. “The role of the environment in the development, transmission, and spread of antimicrobial resistance requires careful consideration as evidence continues to grow. There is widespread consensus that environmental action must become a key part of the solution, including pollution prevention and control across municipal systems, manufacturing sites, healthcare facilities, and agri-food systems,” said Jacqueline Alvarez, Chief of Branch for the Industry and Economy Division at UNEP.
The guidance was developed through close collaboration with a diverse group of international experts, including representatives from academia, regulatory bodies, inspectors, and international organizations such as UNEP. It also underwent public consultation, receiving valuable feedback from industry and other stakeholders. Industry players have already started to address this challenge through a voluntary initiative, which may be updated to align with the new guidelines.
The guidelines set human health-based targets to reduce the risk of AMR emergence and spread, as well as targets to mitigate risks to aquatic life posed by antibiotics used in human, animal, or plant applications. They cover all stages of production, from the manufacturing of active pharmaceutical ingredients (APIs) to the formulation of finished products and primary packaging.
AMR occurs when bacteria, viruses, fungi, and parasites evolve to resist the effects of medications, leading to more severe illness, increased spread of infections, and higher mortality rates.
AMR is primarily driven by the misuse and overuse of antimicrobials, yet, paradoxically, many people worldwide still lack access to essential antimicrobial medicines.
