Drugmakers face strict new rules on wastewater pollution

Drug manufacturers are facing new scrutiny on how they dispose of waste water. 

A new set of rules aims to prevent pollution from their factories and subsequently reduce the risk of antibiotic resistance.

The rules were published this week by the World Health Organization in its first-ever "guidance on antibiotic pollution from manufacturing."

The new guidance on wastewater and solid waste management for antibiotic manufacturing sheds light on this important but neglected challenge ahead of the United Nations General Assembly High-Level Meeting on antimicrobial resistance on September 26.

"The emergence and spread of AMR caused by antibiotic pollution could undermine the effectiveness of antibiotics globally, including the medicines produced at the manufacturing sites responsible for the pollution," WHO said.

Despite high antibiotic pollution levels being widely documented, the issue is largely unregulated and quality assurance criteria typically do not address environmental emissions.

In addition, once distributed, there is a lack of information provided to consumers on how to dispose of antibiotics when they are not used, for example, when they expire or when a course is finished but there is still antibiotic left over.

“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 Dr Yukiko Nakatani, WHO assistant director general for AMR.

AMR occurs when bacteria, viruses, fungi and parasites no longer respond to medicines, making people sicker and increasing the risk of spread of infections that are difficult to treat, illness and deaths. AMR is driven largely by the misuse and overuse of antimicrobials, yet, at the same time, many people around the world do not have access to essential antimicrobial medicines.

Some studies in Kenya indicate a high prevalence of antibiotic resistance. In 2019, there were 8,500 deaths attributable to AMR and 37,300 deaths associated with AMR, according to a study by the Institute for Health Metrics and Evaluation.

Globally, there is a lack of accessible information on the environmental damage caused by manufacturing of medicines.

“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,” said Dr Maria Neira, a director at WHO.

“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.” 

However, data shows that more than 1.27 million people around the world die each year due to antimicrobial resistance with one in five of those deaths in children under five.

International bodies – WHO executive board, the G7 health ministers and UNEP – have called for guidance.

“The role of the environment in the development, transmission and spread of antimicrobial resistance needs careful consideration since evidence is mounting. There is a widespread agreement that action on the environment must become more prominent as a solution," said Jacqueline Alvarez, chief of branch for the industry and economy division at Unep.

"This includes pollution prevention and control from municipal systems, manufacturing sites, healthcare facilities and agri-food systems.”

The guidance was developed in close collaboration with a diverse group of international experts representing academia, regulators, inspectors, international organizations such as Gigiri-based UNEP, and other sectors.

The draft also underwent public consultation, receiving valuable input from industry and other stakeholders. Industry has also taken up this challenge, though a voluntary industry-led initiative which can be updated in some areas to align with the new guidance. 

The guidance provides human health-based targets to reduce the risk of emergence and spread of AMR, as well as targets to address risks for aquatic life caused by all antibiotics intended for human, animal or plant use.

It covers all steps from the manufacturing of active pharmaceutical ingredients (APIs) and formulation into finished products, including primary packaging.