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The World Health Organization (WHO) released its first ever global guidance on antibiotic pollution stemming from manufacturing processes on September 3, 2024. Titled Guidance on wastewater and solid waste management for manufacturing of antibiotics, the comprehensive document offers a scientific framework for regulators, industry players and other stakeholders to implement effective controls against antibiotic pollution.
“The guidance provides an independent and impartial scientific basis for regulators, procurers, inspectors and industry themselves to include robust antibiotic pollution control in their standards,” Maria Neira, director for department of environment, climate change and health, WHO, stated in a press release.
Developed in close collaboration with a diverse group of international experts, the guidance addresses a wide range of stakeholders, aiming to foster a collective effort to mitigate the environmental impact of antibiotic manufacturing.
The report takes a comprehensive approach, adopting a common conceptual framework that outlines three core elements, while also identifying the parties responsible for implementing each one.
The key elements are:
Defining targets for resistance selection and ecological effects, based on exposure and risk assessments.
Establishing risk management processes to achieve these targets using recognised risk management tools, such as the principles of hazard analysis and critical control points, alongside internal audits and public communications.
Conducting independent audits to verify that targets are being met.
The report also mentioned two guiding principles: A precautionary approach for target setting and the concept of progressive improvement towards meeting these targets.
The elements outlined in the document bear many similarities to the Antimicrobial Resistance (AMR) Industry Alliance standard, but in certain areas, it goes beyond the requirement. For example, it incorporates a two-level approach (‘good’ and ‘stringent’) and specifies limits on the use of mass balance calculations.
Following the guidance’s release, WHO hosted a webinar to discuss the document and its implications with global experts.
For the first time we now have a guidance by an intergovernmental agency that lays down a common frame of reference backed by WHO with reference to public health. This document not only contains scientific knowledge but also gives civil societies like Centre for Science and Environment (CSE) the option to ask right questions from the stakeholders
Amit Khurana, programme director, CSE
Khurana, who was a panelist at the webinar, played a key role as an expert reviewer in the development of the report.
The document emphasised public transparency and underscored the importance of safeguarding the supply and affordability of antibiotics, particularly for vulnerable populations.
“Critically, the strong focus on transparency will equip buyers, investors and the general public to make decisions that account for manufacturers’ efforts to control antibiotic pollution,” added Neira.
While the guidance did not include a detailed financial and economic analysis of implementation, it encouraged stakeholders to conduct such analyses to assess its applicability within their specific contexts.
AMR occurs when bacteria, viruses, fungi and parasites no longer respond to medicines, leading to more severe illnesses and an increased risk of infections that are difficult to treat, potentially causing greater illness and death. Antibiotic discharge from manufacturing is recognised as a significant driver of the growing AMR crisis.
Although residual levels of antibiotics have been detected in waterbodies downstream from manufacturing sites, antibiotic pollution from manufacturing remains largely unregulated.
“Pharmaceutical waste from antibiotic manufacturing can facilitate the emergence of new drug-resistant bacteria, which can spread globally and threaten our health. Controlling pollution from antibiotic production contributes to keeping these life-saving medicines effective for everyone,” said Yukiko Nakatani, WHO assistant director-general for AMR ad interim, in the press release.
Researchers at CSE previously published a report on this issue and have since conducted multiple consultations with stakeholders to address antibiotic pollution from manufacturing in India.
