Drug Pollution from Manufacturing and Antimicrobial Resistance: How Does the European Union Manage the Potential Environmental and Health Risks of Importing Pharmaceutical Active Ingredients From Third Countries? The European Drug Import Safety under Scrutiny

TY - ABST

T1 - Drug Pollution from Manufacturing and Antimicrobial Resistance: How Does the European Union Manage the Potential Environmental and Health Risks of Importing Pharmaceutical Active Ingredients From Third Countries?

T2 - 2018 IUCN Academy of Environmental Law Colloquium

AU - le Gal, Elodie Jeanine Odette

N1 - Conference code: 16

PY - 2018

Y1 - 2018

N2 - To improve people’s livelihoods and protect human and animal health, new pharmaceutical products are being developed throughout the world by private companies of various sizes, universities and public research organisations. Recent technological innovations in virus vaccines, gene editing techniques and nanotechnologies show a promising future for managing human and animal health risks. However, the history of commercialized technological discoveries within and outside the pharmaceutical sector shows that the road to successful commercialization can also be fraught with social, economic and environmental failures. Over the past three decades, the scientific literature has been increasingly reporting case studies on environmental pollution from drug manufacturing, human excretions and improper disposal of unused or expired drug residues in different parts of the world. Active ingredients, which are responsible for the biological activity of drugs, have been identified as the main vector of pharmaceutical pollution. Associated with the environmental risk of pharmaceutical pollution in soils and waterways is the predicted risk of antimicrobial resistance (AMR) expected to increase and to dramatically accelerate the spread and distribution of infectious human and animal health diseases worldwide. The potential public health, economic, social and environmental significance of antimicrobial resistance correlated with drug pollution is providing the rationale for new pharmaceutical law reform proposals in the European Union to green the pharmaceutical sector.By offshoring pharmaceutical manufacturing to produce active ingredients in emerging countries, this paper argues that not only do industrialised countries export drug pollution overseas, but that they also could contribute to spreading the risk of drug pollution and anti-micro-bacterial resistance within their own borders by buying and importing drugs manufactured in third countries, such as India and China. With a focus on drug pollution from manufacturing, the goal of this paper is to explore the European drug import safety regime. It intends to better understand how the European Union manages the potential environmental and public health risks of importing pharmaceutical active ingredients into the European Union.This paper is structured as follows: The introductory part provides a background of the present study. The second part outlines key aspects of the European legal framework that governs medicinal products for human and veterinary use. The third part specifically focusses on some of the key legal and institutional arrangements that structure the European import surveillance drug. The concluding section summarises the key findings of the present study, discusses research implications and provides further practical research directions.

AB - To improve people’s livelihoods and protect human and animal health, new pharmaceutical products are being developed throughout the world by private companies of various sizes, universities and public research organisations. Recent technological innovations in virus vaccines, gene editing techniques and nanotechnologies show a promising future for managing human and animal health risks. However, the history of commercialized technological discoveries within and outside the pharmaceutical sector shows that the road to successful commercialization can also be fraught with social, economic and environmental failures. Over the past three decades, the scientific literature has been increasingly reporting case studies on environmental pollution from drug manufacturing, human excretions and improper disposal of unused or expired drug residues in different parts of the world. Active ingredients, which are responsible for the biological activity of drugs, have been identified as the main vector of pharmaceutical pollution. Associated with the environmental risk of pharmaceutical pollution in soils and waterways is the predicted risk of antimicrobial resistance (AMR) expected to increase and to dramatically accelerate the spread and distribution of infectious human and animal health diseases worldwide. The potential public health, economic, social and environmental significance of antimicrobial resistance correlated with drug pollution is providing the rationale for new pharmaceutical law reform proposals in the European Union to green the pharmaceutical sector.By offshoring pharmaceutical manufacturing to produce active ingredients in emerging countries, this paper argues that not only do industrialised countries export drug pollution overseas, but that they also could contribute to spreading the risk of drug pollution and anti-micro-bacterial resistance within their own borders by buying and importing drugs manufactured in third countries, such as India and China. With a focus on drug pollution from manufacturing, the goal of this paper is to explore the European drug import safety regime. It intends to better understand how the European Union manages the potential environmental and public health risks of importing pharmaceutical active ingredients into the European Union.This paper is structured as follows: The introductory part provides a background of the present study. The second part outlines key aspects of the European legal framework that governs medicinal products for human and veterinary use. The third part specifically focusses on some of the key legal and institutional arrangements that structure the European import surveillance drug. The concluding section summarises the key findings of the present study, discusses research implications and provides further practical research directions.

KW - Risk - Risk management

KW - Pharmaceutical pollution

M3 - Conference abstract for conference

Y2 - 4 July 2018 through 6 July 2018

ER -