Contents lists available at ScienceDirect Environmental Science and Policy journal homepage: www.elsevier.com/locate/envsci Activities related to human medicines in Romania: Legal environmental protection issues Alexandra Toma*, Ofelia Crişan Department of Pharmaceutical Legislation and Management, Faculty of Pharmacy, “Iuliu Haţieganu” University of Medicine and Pharmacy, 12 Ion Creangă Street, Cluj- Napoca, Romania ARTICLE INFO Keywords: Human medicines Pharmaceutical waste Environmental protection Legislative measures ABSTRACT Current environmental research focuses extensively on pharmaceutical waste, demonstrating the contamination caused by active pharmaceutical ingredients. Regulations and programs to evaluate, prevent, and reduce en- vironmental risks linked to human medicines are currently being developed in various countries. We assessed the Romanian legislation to identify the potential areas of development of environmental protection policies in the pharmaceutical field. Laws and regulations of interest were selected, and their relevant provisions were analysed using methods of legal interpretation, then corelated with their equivalent in more developed countries. Romanian legislation requires an evaluation of the environmental impact of human medicines, an assessment of non-clinical research and pharmaceutical manufacturing projects, appropriate management of pharmaceutical waste and its disposal on a contract basis, and the collection and disposal of expired or unused medicines by pharmacies. In practice, however, a coherent system for pharmaceutical waste management is lacking because of many legal loopholes in environmental protection. Romanian legislation does not include specific rules re- garding sound environmental practice for clinical research laboratories, pharmaceutical manufacturers, and wholesale distributors. The pharmaceutical industry has no legal responsibility to manage and dispose expired or unused medicines collected from the population. Equitable sharing of environmental responsibility by the pharmaceutical industry actors along with the involvement of public authorities should be established via leg- islation and regulation that reflect the requirements mandated by other more advanced countries. Additionally, continuous training programs should be provided for practitioners to reinforce their role in the rational use of medicines and professional campaigns should be created to raise public awareness about preventing environ- mental contamination. 1. Introduction Numerous authors have demonstrated their interest in the en- vironmental effects of medicines by conducting research in several countries and proposing the adoption of adequate measures to mitigate the aforementioned effects. These measures include improving en- vironmental and pharmaceutical legislation, implementing sustainable policies, and establishing dedicated partnerships between stakeholders to coordinate their efforts (Beek et al., 2016; Depledge, 2011; Klatte et al., 2017; Küster and Adler, 2014; Larsson, 2014; Straub, 2016; Toma and Crişan, 2017, 2019). Environmental contamination from active pharmaceutical ingredients is caused mainly by their excretion via urine and faeces following the administration of medicines to humans and animals. Incorrect disposal of expired or unused medicines also contributes to contamination risk (Bebianno and Gonzalez-Rey, 2015; Tit et al., 2016; Toma and Crişan, 2018). All medicine-related activities are accompanied by the risk of environmental contamination. The green pharmacy concept has been used to define the measures taken to manage these activities in a manner that reduces their environmental impact (Beek et al., 2016; Klatte et al., 2017; Straub, 2016; Toma and Crişan, 2018). Research and manufacturing facilities have shifted their focus and adopted green/sustainable chemistry processes such as three- dimensional printing or cyclodextrin encapsulation to develop phar- maceutical ingredients that generate fewer pollutants (Baron, 2012; Kummerer, 2007). The pharmaceutical industry has created non-profit organisations responsible for disposing unused and expired medicines in collaboration with wholesale distributors and pharmacies in coun- tries such as France, Hungary, and Spain (Cyclamed, 2018; Recyclomed, 2015; SIGRE et al., 2019). Pharmacies usually serve as information offices and collection points for communities, sometimes https://doi.org/10.1016/j.envsci.2020.01.002 Received 20 June 2019; Received in revised form 4 January 2020; Accepted 5 January 2020 ⁎ Corresponding author. E-mail address: alexandra85.toma@gmail.com (A. Toma). Environmental Science and Policy 106 (2020) 22–28 1462-9011/ © 2020 Elsevier Ltd. All rights reserved. T