New research reveals that EU regulation is not currently considering the environmental emissions of pharmaceuticals in global manufacturing supply chains.
The EU regulation that covers good manufacturing practices and environmental risk assessment of pharmaceuticals, does not concentrate on the impact of environmental emissions resulting from the global pharmaceuticals manufacturing supply chains.
Researchers from the University of Eastern Finland analysed how good manufacturing practices (GMPs) and environmental risk assessment (ERA) address the environmental emissions in the pharmaceutical industry. The findings are published in the Review of European, Comparative & International Environmental Law.
Revising the pharmaceutical strategy for Europe
The Pharmaceutical Strategy for Europe, originally published by the European Commission in 2020, highlighted the need to revise the EU’s general pharmaceutical legislation (Directive 2001/83 and Regulation 726/2004) regarding environmental risk assessment. It also found that improvements were required for the supervision and transparency of global manufacturing supply chains. The European Commission’s aim to revise the EU’s pharmaceutical legislation is currently in preparation.
Through the researcher’s analysis, they found various challenges surrounding the environmental emissions of the pharmaceutical supply chain. This includes limited scope, the weight of regulation, and a lack of competence among the inspectors. The researchers noted that the scope of GMP and ERA regulation is limited; however, it 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,” Senior Researcher Mirella Miettinen, one the authors, of the University of Eastern Finland, commented.
“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 said, shedding light on the weight of ERA in current regulation.
Are EU Member States doing enough to reduce environmental emissions?
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. Despite this, environmental emissions and other considerations are 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,” Miettinen added.
Environmentally sustainable production is needed
Currently, subcontracted producers based in third countries have no incentive to reduce their environmental emissions. As a result, EU-based customers play an important role in incentivising methods to be hopefully implemented 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 said.
“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,” Miettinen concluded.