EU regulation pertaining to good manufacturing practices and environmental risk assessment of pharmaceuticals does not adequately consider the environmental emissions of pharmaceuticals in global manufacturing supply chains, a recent study from the University of Eastern Finland concludes.
Published by the European Commission in 2020, the Pharmaceutical Strategy for Europe highlights the need to revise the EU’s general pharmaceutical legislation (Directive 2001/83 and Regulation 726/2004) 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 in Review of European, Comparative & International Environmental Law, 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. The study was carried out as part of the Sustainable Drug Discovery and Development with End-of-Life Yield (SUDDEN) project funded by the Strategic Research Council at the Academy of Finland.
Challenges include limited scope and weight of regulation, and lack of competence among inspectors
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, points out.
“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 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 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,” Miettinen adds.
EU’s pharmaceuticals legislation should secure a minimum level of environmentally sustainable production
Currently, subcontracted producers based in third countries have little incentive to reduce their environmental emissions. 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 says.
“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 concludes.
For further information, please contact:
Senior Researcher Mirella Miettinen, University of Eastern Finland Law School, tel. +358 50 4720510
Research article:
Anita Kittery – Mirella Miettinen, Environmental considerations in the European Union's pharmaceuticals legislation: Key instruments and their challenges in addressing global manufacturing supply chains. RECIEL 2022;1–15. https://doi.org/10.1111/reel.12488.
