Two years into its work, a voluntary, industry-led effort to reduce pollution from antibiotic manufacturing facilities is drawing mixed reviews from outside analysts. A new report from a pharmaceutical industry group says it is making substantial progress toward curbing leaks of antibiotic compounds into the environment. But critics say the report highlights the need for governments to enact binding rules.
Studies have found that many antibiotic manufacturing facilities release the compounds they are making into the environment, often via wastewater, contributing to the deadly problem of antimicrobial resistance (AMR). (Overuse and improper disposal of drugs also contribute to AMR.) In 2017, after global leaders committed to tackling AMR, more than 100 drug companies and industry associations formed a group—the AMR Industry Alliance—in part to police manufacturing discharges. Alliance members account for roughly one-third of the world’s antibiotic sales.
Since then, the alliance has developed an industry framework for improving antibiotic manufacturing and has set voluntary targets for safe levels of antibiotics in the environment—known as predicted no-effect concentrations (PNECs). In a progress report released last week, the alliance said nearly 15 of the 18 member companies that manufacture antibiotics have assessed their production sites; 82% reported meeting, wholly or in part, the framework standards, which include a commitment to end discharges of untreated wastewater. Just over half of all the products made at sites owned by the 18 companies will meet the PNEC targets in 3 years, and 88% of products will meet the targets in 7 years, the report says.
The voluntary PNEC targets are a good starting point, says Joakim Larsson, an environmental pharmacologist at the University of Gothenburg. But he criticizes the alliance for setting targets only for surface waters such as rivers and streams, rather than imposing the limits on manufacturing wastewater. He notes bacteria are already present in wastewater, which can carry high levels of antibiotics. That means the bacteria can start to develop resistance before the waste reaches surface waters, where dilution can reduce drug concentrations. “It’s much easier to achieve targets applied to surface water, but it doesn’t mean [those targets are] protective,” Larsson says.
Critics are unhappy that the alliance is not publicly releasing key data that would allow for public oversight. Companies are only estimating drug discharge concentrations from internal data on production yields and losses of ingredients, rather than directly measuring pollution levels in wastewater samples. “This is not a very sensitive method and the numbers can’t easily be independently checked,” Larsson says.
There is also a “lack of transparency” in production chains, Larsson says. For example, the locations where antibiotic drugs are made are not made public. “They are still hiding the production in the shadows,” he says.
Despite such concerns, the alliance is making a difference, says Alistair Boxall, an environmental scientist at the University of York who has worked on a large European project with industry to assess the environmental impacts of pharmaceuticals. The alliance is encouraging companies to revamp their processes, for example, so that they reuse treated wastewater rather than discharging it to municipal treatment facilities. More research is needed to ensure that the voluntary standards are protective of the environment, Boxall says. And companies should monitor mixtures of antibiotic compounds and exposure to soil, he says, because emissions could also contaminate land. “I would certainly support the data being made more open to the scientific community,” he adds.
Others say legally enforceable regulations are needed to ensure manufacturing emissions are properly tracked and reduced. Most government don’t regulate antibiotic levels in waste, a situation that Health Care Without Harm (HCWH), a group with offices around the world that advocates for environmentally responsible health care, says must change. “We need to go beyond industry self-regulation initiatives,” an HCWH spokesperson says. “There is an urgent need to establish a strong legislative framework to increase transparency and improve consistency throughout the supply chain.”