New global guidelines aim to curb antibiotic pollution from production

The World Health Organization (WHO) published its first guidelines on antibiotic pollution from production. New guidelines on wastewater and solid waste management for antibiotic production shed light on this important but neglected challenge ahead of the United Nations General Assembly (UNGA) high-level meeting on antimicrobial resistance (AMR) on 26 September 2024.

The emergence and spread of AMR caused by antibiotic pollution could undermine the effectiveness of antibiotics globally, including drugs produced in production sites responsible for the pollution.

Despite numerous documents on high levels of antibiotic pollution, the issue is largely unregulated, and quality assurance criteria usually do not address environmental emissions. In addition, once distributed, there is a lack of information for consumers on how to dispose of antibiotics when they are not in use, for example, when they have expired or when the course has ended but antibiotics are still available.

“Pharmaceutical waste from the production of antibiotics can facilitate the emergence of new drug-resistant bacteria, which can spread globally and threaten our health. Controlling pollution caused by antibiotic production contributes to maintaining the effectiveness of these life-saving medicines for everyone,” said Dr Yukiko Nakatani, WHO's Assistant Director-General for AMR ad interim.

In the world, there is a lack of available information about the environmental damage caused by the production of medicines. “The guidelines provide an independent and unbiased scientific basis for regulators, contracting authorities, inspectors and the industry itself to incorporate robust antibiotic pollution control into their standards,” said Dr Maria Neira, Director of the Department of Environment, Climate Change and Health, WHO. “Critically, a strong focus on transparency will empower buyers, investors and the general public to make decisions that take into account manufacturers' efforts to control antibiotic pollution.”

A number of international bodies have called for these guidelines, including WHO Executive Boardthe Ministers of Health G7 and UNEP. “The role of the environment in the development, transmission and spread of antimicrobial resistance should be carefully considered as the evidence is mounting. There is widespread agreement that environmental action must become more prominent as a solution. This includes preventing and controlling pollution from municipal systems, manufacturing sites, health facilities and agri-food systems,” said Jacqueline Alvarez, Head of the Industry and Economy Division at the United Nations Environment Program (UNEP).

The guidelines were developed in close collaboration with a diverse group of international experts representing academia, regulators, inspectors, international organizations such as UNEP and other sectors. The draft also underwent a public hearing, with valuable input from industry and other stakeholders. Industry has also accepted this challenge, although it is a voluntary industry-led initiative that may be updated in some areas to comply with new guidelines.

The guidelines provide human health-based targets to reduce the risk of the emergence and spread of AMR, as well as targets to address the risks to aquatic life posed by all antibiotics intended for use in humans, animals or plants. It covers all steps from active pharmaceutical ingredient (API) production and formulation to finished products, including primary packaging.

AMR occurs when bacteria, viruses, fungi and parasites no longer respond to drugs, making people sicker and increasing the risk of spreading hard-to-treat infections, disease and death. AMR is mainly caused by the misuse and overuse of antimicrobials, but at the same time, many people around the world do not have access to basic antimicrobials.