James Anderson
Chair, AMR Industry Alliance
Much of the global coordination on combatting AMR has rightly been focused on incentives, appropriate use, stewardship, diagnostics and other tools. But we must also consider the environmental dimension of antimicrobial resistance.
With over 100 members, the AMR Industry Alliance is the largest life-sciences coalition providing sustainable solutions to curb AMR, including awareness raising and adoption of responsible manufacturing practices. That is why we developed the first-ever Antibiotic Manufacturing Standard to minimise environmental emissions from antibiotic manufacturing plants.
AMR and the environment
Many factors contribute to antimicrobial resistance, such as poor infection control, misdiagnosis, misuse and overuse of antibiotics. However, it is accepted that, in sufficient concentration, the presence of antibiotics in the environment may increase selection pressure on bacteria to develop resistance.
While the major source of antibiotics in the environment results from human and animal use of medicine and subsequent excretion, other sources may include emissions from the manufacturing of antibiotics. Depending on a facility’s emission treatment program, antibiotic production processes involve a risk that antimicrobials can leave manufacturing plants through wastewater and enter the environment.
While pharmaceutical manufacturing is heavily regulated around the world, regulations typically do not address the environmental impact such concentrations of antibiotic waste can have.
Only together can we fight the spread of AMR and ensure the viability of our lifesaving medicines.
A new standard
Given the interconnected nature of human, animal and environmental health, the AMR Industry Alliance has developed a proactive approach to minimizing the release of antibiotics from manufacturing operations. The first thing was to work with leading scientists to define the minimum concentration targets for a range of antibiotics below which they are unlikely to drive resistance. These targets are extremely low — often in the order of a couple of pills in a swimming pool full of water.
Earlier this year, in partnership with British Standards Institution (BSI), the alliance created an Antibiotic Manufacturing Standard, which will be followed by a forthcoming certification scheme, that establishes and formalises a set of requirements and independent assessment for manufacturers in the global antibiotic supply chain. This standard and certification program aims to validate that the discharge from an antibiotic’s production is at such a level that the substance will not have an adverse effect on its environment. This independent certification will give confidence and provide further transparency in responsible manufacturing of antibiotics to purchasers, financial investors and other policymakers.
Forward together
Together with industry stakeholders and the assistance of BSI, we have developed a solution for the next chapter of responsible antibiotic manufacturing. Only together can we fight the spread of AMR and ensure the viability of our lifesaving medicines.
