WHO Issues New Global Guidance To Curb Antibiotic Pollution From Manufacturing

The World Health Organisation (WHO) has released its inaugural guidelines on managing antibiotic pollution from manufacturing processes. This guidance, focusing on wastewater and solid waste management, highlights a critical yet often overlooked issue. The announcement comes ahead of the United Nations General Assembly (UNGA) High-Level Meeting on antimicrobial resistance (AMR) scheduled for 26th September 2024.

Antibiotic pollution can lead to the emergence and spread of AMR, potentially rendering antibiotics ineffective globally. This includes medicines produced at the very sites causing the pollution. Despite widespread documentation of high antibiotic pollution levels, regulation remains minimal, and quality assurance standards typically ignore environmental emissions.

Dr Yukiko Nakatani, WHO Assistant Director-General for AMR ad interim, stated, "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."

The guidance was crafted with input from a diverse group of international experts from academia, regulatory bodies, inspectors, and organisations such as UNEP. Public consultation also played a role in refining the draft, incorporating valuable feedback from industry stakeholders.

Dr Maria Neira, Director of the Department of Environment, Climate Change and Health at WHO, noted that "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." She added that transparency is crucial for enabling buyers, investors, and the public to make informed decisions regarding manufacturers’ efforts to control antibiotic pollution.

Human Health-Based Targets

The new guidelines set human health-based targets aimed at reducing the risk of AMR emergence and spread. They also address risks to aquatic life posed by all antibiotics intended for human, animal or plant use. The scope covers every stage from manufacturing active pharmaceutical ingredients (APIs) to formulating finished products and primary packaging.

AMR occurs when bacteria, viruses, fungi, and parasites no longer respond to treatments. This makes infections harder to treat and increases illness severity and mortality rates. Misuse and overuse of antimicrobials are major drivers of AMR. Yet paradoxically, many people worldwide lack access to essential antimicrobial medicines.

Lack of Consumer Information

There is a significant gap in consumer information regarding the disposal of unused antibiotics. Consumers often lack guidance on how to dispose of expired or leftover antibiotics properly. This gap contributes further to environmental contamination.

The guidance aims to fill this void by providing clear instructions on managing pharmaceutical waste effectively. It encourages industries to adopt practices that minimise environmental impact while maintaining drug efficacy.

Industry Initiatives

The industry has begun addressing this challenge through voluntary initiatives that align with the new WHO guidelines. These initiatives can be updated as needed to ensure compliance with evolving standards.

This proactive approach by manufacturers demonstrates a commitment to reducing antibiotic pollution's global impact. It also underscores the importance of collaborative efforts between regulators and industry players in tackling AMR.

This comprehensive approach ensures that all stakeholders are equipped with the knowledge needed to mitigate antibiotic pollution effectively. By adhering to these guidelines, manufacturers can help preserve the effectiveness of vital medicines for future generations.

With inputs from WAM