Verifying Antibiotics Supply Chain Standards
This article was originally published in POLITICO Pro Morning Health Care.
From today, manufacturers of antibiotics and their raw ingredients can apply for a new certificate that proves the company is meeting certain standards to limit the run-off of antibiotics into the environment. British Standards Institute (BSI) has teamed up with the AMR Industry Alliance to formulate a thorough assessment of manufacturing processes, including testing water in local rivers. And if companies meet the requirements, they will receive a certificate.
The process comes ahead of any regulatory requirements to limit antibiotics effluent to certain thresholds — despite repeated calls from lawmakers and other stakeholders to do so. For Steve Brooks, chair of the manufacturing working group at the AMR Industry Alliance, the new certificate “could be a game changer for the antibiotic supply chain. We really hope so,” he told Helen in an interview.
The aim: A pilot of the certificate scheme was tested on some of alliance’s drug companies, including generic antibiotics manufacturers in India and China, the powerhouses of global antibiotics production. The hope is that it won’t only persuade companies manufacturing antibiotics for human health to clean up their facilities and apply for certification, but also companies producing for animal health, which produce antibiotics in much larger volumes.
Suppliers who want assurance that the medicines they’re buying are responsibly made will no longer have to ask loads of questions and wade through reams of paperwork, Brooks said. The certificate will make it much easier to ensure responsible supply chains, he said.
What’s a safe level? That’s the big question. The alliance has been working for several years to establish what constitutes safe levels of antibiotics in manufacturing wastewater. And it has adopted predicted no‐effect concentrations (PNECs) — levels below which adverse effects are not expected to occur — to serve as targets for risk assessments. The samples are taken from the local rivers and waterways after the wastewater has been through a treatment plant. Others, however, think it should be tested upstream before it gets treated.
“We remain open, and we are fundamentally … driven by science,” Brooks said. “But, for now, we feel we can make significant progress in significantly reducing concentrations of antibiotics getting into the environment by doing what we’re doing, whilst the science continues to evolve.”
To date, no regulator has established a safe threshold. But if they did, BSI and the AMR Industry Alliance would both be open to adapting their models. Alternatively, this model could be adopted by regulators: “Often, standards are used as a conduit to inform future development of regulation,” pointed out Courtney Soulsby, global director of health care, at BSI. “Third party assessment mechanisms or certification ultimately can also inform how a government regulatory body would formulate their inspection or assessment process to oversee the regulation once formed.”