Pharmaceutical waste emissions questioned in study

A study authored by researchers affiliated with the University of Eastern Finland has criticized the European Union for not adopting regulations that might mitigate emissions into the environment at pharmaceutical production facilities located outside the EU.

According to the researchers, the scope of existing good manufacturing practices (GMP) and environmental risk assessment (ERA) regulation is limited, and does not “prevent the release of pharmaceuticals into the environment along the manufacturing supply chain.”

“For example, ERA focuses exclusively on the risks associated with the use of the product and does not address the emissions associated with manufacturing in third countries,” says Senior Researcher Mirella Miettinen of the University of Eastern Finland, one the study’s co-authors.

“Moreover, in the EU, it is not possible to refuse the marketing authorization of human pharmaceuticals based on environmental reasons,” Miettinen says, adding, “For veterinary pharmaceuticals, this is possible, but extremely rare.”

Publishing their findings in the Review of European, Comparative & International Environmental Law, the researchers say challenges in assessing whether overseas facilities are abiding by disposal best practices include the “limited scope and weight of regulation, and lack of competence among inspectors.”

“A committee of experts appointed by the World Health Organization has encouraged the inclusion of environmental emissions in these inspections, but they’ve also noted that inspectors may lack adequate training to do so,” Miettinen says.

“Since environmental emissions from manufacturing are currently not taken into account in GMP inspections, the practical impact of the EU’s GMP regulation on the manufacturing of active substances of medicinal products – which carries the highest risk of environmental emissions – remains minor,” she adds.

The study thus concludes that, currently, subcontracted producers based in third countries “have little incentive to reduce their environmental emissions.”

Although a news release summarizing the study does not mention any countries by name, India is one of the world’s largest producers of exported pharmaceutical industry products.

A New Delhi-based organization called the India Brand Equity Foundation (IBEF) says Indian drug and pharmaceutical exports “stood at $24.6 billion” in the nation’s 2022 fiscal year. The IBEF cites “low cost of production” and Indian research and development capabilities as factors that have led to a “competitive exports” landscape.

“India is the largest provider of generic drugs globally and is known for its affordable vaccines and generic medications,” IBEF says. The group says India supplies more than 50 percent of global demand for various vaccines, 40 percent of generic drug demand in the United States and 25 percent “of all medicine in the United Kingdom.”