EU regulation lacks consideration of pharmaceutical industry emissions

The study has described the current regulation of pharmaceutical companies as being unable to prevent the release of chemicals into the environment throughout the manufacturing supply chain.

The University of Eastern Finland 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.

The findings, published in the journal Review of European, Comparative & International Environmental Law, identified several challenges including the limited scope and weight of regulation, and a lack of competence among inspectors

“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,” said Mirella Miettinen, one of the authors and a senior researcher. 

“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.” 

Under the current regulation, 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 Organisation has encouraged the inclusion of environmental emissions in these inspections, but they’ve also noted that inspectors may lack adequate training to do so,” said Miettinen.

“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.”

In addition, subcontracted producers based in third countries have little incentive to reduce their environmental emissions. Given this situation, the researchers stressed the important role that EU-based customers play 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 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.

The effects of global warming continue to be felt around the world. Earlier this week, the UK saw record annual temperatures in 2022 that averaged over 10°C across the year, the Met Office said.

In 2022, the European Commission published the Pharmaceutical Strategy for Europe, which highlighted 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. 

The University of Eastern Finland’s study was carried out as part of the Sustainable Drug Discovery and Development with End-of-Life Yield project funded by the Strategic Research Council at the Academy of Finland.