European legislation for veterinary medicines: Would a monograph system improve the environmental risk assessment?

• Published in: Integrated environmental assessment and management Vol. 17; no. 6; pp. 1274 - 1285
• Main Authors: de la Casa‐Resino, Irene, Haro Castuera, Amparo, Casimiro Elena, Ramiro, Rubio Montejano, Consuelo, Carapeto García, Ricardo
• Format: Journal Article
• Language: English
• Published: United States Blackwell Publishing Ltd 01.11.2021; John Wiley and Sons Inc
• Subjects: Directive 2001/82/EC; Environmental assessment; Environmental Impact Assessment; Environmental management; Environmental Policy & Regulation; Environmental protection; Environmental risk; Environmental risk assessment; Feasibility studies; Integrated environmental assessment; Legislation; Regulation; Regulation (EU) 2019/6; Risk assessment; Toxicology; Veterinary medicinal product; Environmental risk assessment; Veterinary medicinal product; Directive 2001/82/EC; Monograph; Regulation (EU) 2019/6
• ISSN: 1551-3777; 1551-3793
• DOI: 10.1002/ieam.4431

The environmental risk assessment (ERA) of veterinary medicinal products (VMPs) has been a regulatory requirement in the European Union (EU) since 1993. However, in the last few years, the potential impact of human and veterinary medicines on the environment has become a growing concern worldwide. Indeed, the legal requirements for VMPs in the EU are changing. Regulation (EU) 2019/6, which will be applied from January 28, 2022, aims to update the regulatory framework for VMPs and replaces Directive 2001/82/EC. This paper analyzes the ability of both legislations to ensure a high level of protection of the environment while authorizing VMPs. Consideration is also given to the impact on administrative burdens in both the legislations. We conclude that the Regulation improves the Directive by reducing to a certain extent the regulatory burdens for the applicants and authorities. However, the knowledge of the environmental risks of all authorized VMPs and the consistency of the assessments remain quite similar between both legislations. Nevertheless, the new Regulation proposes to examine the feasibility and applicability of an assessment system based on the critical review of properties of the active substances (“monographs”) or other potential alternatives. With this in mind, two proposals (a basic and an enhanced approach) for developing a monograph system are presented and their main advantages and disadvantages are explored. Integr Environ Assess Manag 2021;17:1274–1285. © 2021 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC) KEY POINTS The environmental risk assessment (ERA) of veterinary medicinal products (VMPs) performed according to the Directive 2001/82/EC does not allow the systematic review of the environmental risks of all the VMPs authorized and supposes a lack of harmonization among equal active substances. The forthcoming legislation (Regulation [EU] 2019/6) improves the Directive in terms of ERA. However, the issues related to the lack of information on the environmental risks of all the VMPs in the market and the issues related to consistency remain. Article 156 of the Regulation gives the opportunity to study the feasibility of an active substance‐based review system (the so‐called “monographs”) or other potential alternatives for the environmental risk assessment of VMPs. The development of a monograph system could be a good opportunity to solve the shortcomings detected in the ERA of VMPs of the current and forthcoming legislation.