To Push Antibiotic Makers to Be More Green, a New System Will Certify Manufacturing Practices

This article first appeared in STAT.

In response to concerns about pollution caused by antibiotic production, an industry group is launching a new system to certify that manufacturers meet environmental goals.

The idea is to create a far-reaching standard for measuring discharge from antibiotic production facilities, since standards currently vary across the globe. Pharmaceutical companies that obtain a certificate can then use the document to satisfy customers — such as government agencies — that are increasingly incorporating environmental metrics in purchase agreements.

“Waste should be minimized and strictly controlled every time production is run, so we want to create a robust environmental management system,” said Steve Brooks, an advisor to the AMR Industry Alliance, a collection of about 100 companies that pushed the certification effort as part of its focus on issues surrounding antimicrobial resistance. “The goal here is to provide an independent lens.”

Each certificate, which will be valid for three years, will be backed up by independent, third-party verification that waste streams containing active pharmaceutical ingredients and finished drug products are controlled during manufacturing. The oversight includes annual surveillance to verify ongoing maintenance and adherence.

Although voluntary, a certificate is designed to appeal to companies that want to assure customers they meet environmental standards. In some countries, nearly one-third of criteria used in supply agreements refer to environmental goals, according to Courtney Soulsby, global director for health care at BSI, which develops programs for improving business practices and worked with the AMR Alliance.

“There is quite a lot of pollution around these products,” said Eirik Sverrisson, who chairs the procurement group at the Nordic Pharmaceutical Forum, a collaboration between purchasing organization from five countries — Norway, Sweden, Denmark, Iceland, and Finland — that will implement the new certification system.

“Some of the antibiotics are very old, their prices have gone down, and they are made in factories that are not top-notch. These are not the most glorified production sites. And you see emissions in drinking water in the environments, such as the ground water, surrounding some of those factories. We want to send a signal.”

The effort arrives amid rising concern over climate change and increasing scrutiny of the pharmaceutical industry’s impact. Globally, large public biotech and pharmaceutical companies are responsible for more than 200 million metric tons of carbon dioxide and equivalent emissions, according to My Green Lab, a nonprofit focused on sustainability in science.

A study published last year in the Proceedings of the National Academy of Sciences found that one-quarter of 1,052 samples taken from sites along 258 rivers and other bodies of water in dozens of countries had concentrations of at least one active pharmaceutical ingredient that was considered unsafe for aquatic organisms.

Yet there is a dearth of information about the extent to which pharmaceuticals effect the environment.

Data on environmental impacts of active pharmaceutical ingredients is not available to the public or authorities in the European Union, assessments of environmental risks cover only a minority of pharmaceuticals, and no specific emission limits in place for releasing active pharmaceutical ingredients from manufacturing plants, according to a report by the European Environmental Bureau.

And only 30% of development-stage, publicly traded biotech companies referenced environmental, social, and governance issues in their regulatory filings and other disclosures, according to a survey released a year ago. At the time, nearly four of every five investors reported they believe ESG disclosures will become significantly or moderately more important.

All this helps explain why a growing number of investors and government procurement officials are searching for ways to push the pharmaceutical industry at large to alter its practices.

Toward that end, the new certification system will take a carrot-and-stick approach, according to Sverrisson. To win a contract, a company may encounter criteria that is based not only on price and supply capabilities, but also environmental goals. A company that scores poorly on that metric may lose the contract, even if its price is lower than competitors, he explained.

“This will test the willingness to pay for a better product,” he told us. “If one product costs $100 and the other costs $130, but that product scores higher on all the environmental questions, it will win over the $100 product. That’s the whole point. We know there are costs involved to change industry’s view, so you have to be willing to pay to get the superior product.”

For one manufacturer, the investment will be worth it if contracts can be won. Centrient, which produces active pharmaceutical ingredients for antibiotics as well as antibiotics of its own, estimated that it will pay $15,000 to $20,000 for each product to win certification. And this does not include the cost for ongoing testing of water samples.

More customers — pharmaceutical companies that make antibiotics — are asking questions about meeting environmental standards, according to Alba Tiley, global sustainability and public affairs director at Centrient. But while the costs can add up in a business where margins are thin, a certificate may provide an edge over competitors that, for now, are not thinking the same way.

“There is not a lot of consistency and we were not always recognized by the buyers, who did not always consider ESG topics, when doing procurement,” she said. “It’s important to get a level playing field through a common manufacturing standard. This is a chance for companies to show they are doing the right thing and be rewarded for doing the right thing.”