Campaigning group SumOfUs suggested expanding the scope of GMP assessments this week after publishing a report accusing several major drugmakers of sourcing drug ingredients from suppliers that pollute.
Study co-author Nusa Urbancic told us the organisation wants environmental criteria to be included in good manufacturing practices (GMP) guidelines and said industry initiatives like the Pharmaceutical Supply Chain Initiative (PSCI) do not go far enough.
“Companies signing up to these [PSCI] principles, which are entirely voluntary, must - among other things - have systems in place to ensure the safe handling, movement, storage, recycling, reuse, or management of waste, air emissions and wastewater discharges.”
Urbancic added that: “This is a good starting point, but obviously nothing will happen as long as the principles remain voluntary and as long as transparency is not enforced by regulators.”
She suggested all companies involved in drug production should “prioritise environmental management; in particular, the factories supplying intermediates or APIs must be required to prove that they are committed to clean production throughout the manufacturing process.”
When asked, the PSCI told us its focus is to promote “continuous improvement of labour, ethics, safety, health and environmental practices in the pharmaceutical and bio pharmaceutical supply chain.”
At present neither EU GMP nor US cGMP consider the environmental impacts of API production. Sweden’s Medicinal Products Agency (MPA) did suggest including some anti-pollution requirements in 2011, however, nothing came of the recommendation.
Antibiotic resistance
Much of SumOfUs’ report focuses on the production of antibiotic APIs in China where the organisation says that pollution from facilities contracted by Western drugmakers is increasing the spread of antibiotic resistance.
To combat this, the organisation suggests regulators force drugmakers to publicly disclose their supply chains according to Urbancic.
“The best way to verify this information is by making supply chains transparent, which is something that regulators in the EU and US should put in place.
“If we can trace back the origin of our coffee, why is it impossible to know, where our life-saving drugs were produced and whether the production of these drugs is not fuelling environmental and health problems on the other side of the world?”
She added that: “Antibiotics pollution should be taken very seriously because it can create resistant bacteria that can spread around the world and cause a global health disaster.”