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 environmental 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 regarding 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 legislation 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 environmental contamination.
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