Environmental considerations in the European Union's pharmaceuticals legislation: Key instruments and their challenges in addressing global manufacturing supply chains

• Published date: 01 April 2023
• Author: Anita Kittery,Mirella Miettinen
• Date: 01 April 2023
• DOI: http://doi.org/10.1111/reel.12488

ORIGINAL ARTICLE

Environmental considerations in the European Union's

pharmaceuticals legislation: Key instruments and their

challenges in addressing global manufacturing supply chains

Anita Kittery | Mirella Miettinen

UEF Law School, the Center for Climate

Change, Energy and Environmental Law,

University of Eastern Finland, Joensuu, Finland

Correspondence

Mirella Miettinen, UEF Law School, University

of Eastern Finland, Joensuu, Finland.

Email: mirella.miettinen@uef.fi

Funding information

Strategic Research Council at the Academy of

Finland, Grant/Award Numbers: 320210,

320220, 346571

Abstract

This article analyses how two key instruments of European Union pharmaceuticals

legislation—good manufacturing practices and environmental risk assessment of

pharmaceuticals—address known risks posed by the release of pharmaceuticals in the

environment to human health and the environment and identifies the challenges that

they face in regulating global manufacturing supply chains. The analysis reveals that

these instruments fail to address the environmental challenges posed by pharmaceu-

ticals within global manufacturing supply chains. Based on these findings, we propose

to revise European pharmaceuticals legislation by expanding the scope and informa-

tion requirements of both human and veterinary environmental risk assessment and

increasing its weight in the risk–benefit analysis for human pharmaceuticals; by

including direct environmental requirements for certain prioritized pharmaceuticals;

and by integrating environmental considerations and related verification mechanisms

into good manufacturing practices.

1|INTRODUCTION

The global need for pharmaceuticals rises in step with the intensifica-

tion of urbanization and increased life expectancy. The global medi-

cine market is expected to grow at 3%–6% (CAGR)

1

through 2026,

reaching US $1.8 trillion in 2026, including spending on COVID-19

vaccines.

2

Pharmaceuticals contain active pharmaceutical ingredients

(APIs) that interact biologically at low concentrations with living sys-

tems when released in the environment. Pharmaceuticals in the envi-

ronment (PiE), which usually refers to APIs, their metabolites and

degradation products as substances of concern,

3

have been identified

in various environmental locations, including sewage and surface

water, groundwater, soil, air and non-human living organisms.

4

PiE

emanate from three main pathways: wastewaters discharged from

pharmaceutical manufacturing facilities, proper consumer or animal

use discharged from wastewater treatment plants and livestock farm-

ing, and improper disposal of unused or expired medicines by con-

sumers.

5

The United Nations Environment Programme (UNEP) has

highlighted environmental pollution caused by human and veterinary

pharmaceuticals as an emerging and global environmental problem.

6

1

Compound annual growth rate.

2

IQVIA Institute for Human Data Science, ‘The Global Use of Medicines 2022: Outlook to

2026’(IQVIA 2022) 2.

3

M Miettinen and SA Khan, ‘Pharmaceutical Pollution: A Weakly Regulated Global

Environmental Risk’(2022) 31 Review of European, Comparative and International

Environmental Law 75, 83. Miettinen and Khan have collected example definitions for PiE in

table 1 in their article.

4

M Ågerstrand et al., ‘Improving Environmental Risk Assessment of Human Pharmaceuticals’

(2015) 49 Environmental Science and Technology 5336, 5336.

5

K Kümmerer, ‘Pharmaceuticals in the Environment’(2010) 57 Annual Review of

Environment and Resources 57, 61. It should be noted that globally approximately 80% of all

wastewater is discharged without treatment; see United Nations World Water Assessment

Programme (WWAP), ‘The United Nations World Water Development Report 2017.

Wastewater: The Untapped Resource’(WWAP 2017) 2.

6

UNEP, ‘Global Chemicals Outlook II: From Legacies to Innovative Solutions: Implementing

the 2030 Agenda for Sustainable Development—Synthesis Report’(UNEP 2019) 33.

Received: 11 January 2022 Accepted: 9 December 2022

DOI: 10.1111/reel.12488

This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium,

provided the original work is properly cited.

© 2022 The Authors. Review of European, Comparative & International Environmental Law published by Wiley Periodicals LLC.

RECIEL. 2023;32:77–91. wileyonlinelibrary.com/journal/reel 77