Department of Law

The Risk Assessment of Pharmaceuticals in the Environment: EU and US Regulatory Approach

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The potential exposure to organisms and humans of pharmaceutical waste presents society with a wicked problem. The health benefits of pharmaceuticals are obvious, but the public awakening to the risks posed by pharmaceutical residues in the environment is in its early stages. Regulators in the US and the EU require an environmental risk assessment of a medicinal product before it can enter the market. This article compares the US and EU approach to assessing these risks, with the purpose of providing a different perspective on how to approach this delicate balancing act of risk and benefit and to reveal the different values underpinning the risk assessment.
Original languageEnglish
JournalEuropean Journal of Risk Regulation
Pages (from-to)527-547
Number of pages21
Publication statusPublished - 1 Jun 2018

    Research areas

  • Pharmaceuticals, Environmental impacts, risk assessment

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