The EU’s regulation around good manufacturing practices and the environmental risk assessment of pharmaceuticals has been criticised by researchers.
The team from the University of Eastern Finland said the rules do not adequately consider the environmental emissions of pharmaceuticals in global manufacturing supply chains.
Published by the European Commission in 2020, the Pharmaceutical Strategy for Europe highlights the need to revise the EU’s general pharmaceutical legislation with regard to environmental risk assessment, and to improve the supervision and transparency of global manufacturing supply chains. The European Commission’s initiative to revise the EU’s pharmaceutical legislation is currently in preparation.
Publishing their findings the researchers analysed how good manufacturing practices (GMPs) and environmental risk assessment (ERA) address critical stages of the manufacturing supply chain with regard to environmental emissions, and what kind of challenges these instruments face in regulating the global manufacturing supply chain.
According to the researchers, the scope of GMP and ERA regulation is “limited”, and they do 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,” senior researcher Mirella Miettinen, one the authors, of the University of Eastern Finland, explained. “Moreover, in the EU, it is not possible to refuse the marketing authorisation of human pharmaceuticals based on environmental reasons. For veterinary pharmaceuticals, this is possible, but extremely rare,” Miettinen says, shedding light on the weight of ERA in current regulation.
The analysis added the EU Member States are responsible for ensuring that the manufacturing sites of medicinal products, their active substances, or intermediate products in third countries comply with GMPs, if they are to be imported into a Member State. So far, however, environmental considerations have been largely ignored in inspections.
“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 said. “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,”
Currently, subcontracted producers based in third countries have little incentive to reduce their environmental emissions said the research. This being the situation, EU-based customers play an important role in incentivising measures hoped to be taken by third countries.
“The inclusion of environmental considerations and related verification requirements in the EU’s GMPs would be a way to encourage authorities in third countries to support the achievement of a minimum level of environmentally sustainable pharmaceutical production,” Miettinen concluded. “As our recommendation, we’ve also suggested that the weight of ERA in the marketing authorisation process should be strengthened, and environmental emissions outside the EU should be included in the assessment.”.