ปัญหาการปนเปื้อนของยาในสิ่งแวดล้อม : ศึกษาเปรียบเทียบมาตรการทางกฎหมาย ในการประเมินความเสี่ยงด้านสิ่งแวดล้อมของยาแผนปัจจุบันสำหรับมนุษย์ ของประเทศสหรัฐอเมริกาและแคนาดา

Abstract

This article examines the problems of Pharmaceutical Contamination in the Environment emerging worldwide. For Thailand, research reports and academic articles show that active pharmaceutical ingredients of modern medicine for human use have been detected in the wastewater treatment systems and receiving water bodies, representing that the current technologies used in wastewater treatment plants may be inefficient to accomplish their complete removal. Moreover, the exposure to human drugs in the environment not only causes damage to environmental quality but also causes adverse effects on animals as well as living organisms in food chains and humans. Therefore, this article surveys the provisions concerning environmental risk assessment (ERA) of modern medicine for human use before marketing authorization in the United States (USA) and the Dominion of Canada (Canada) to find a recommendation for Thailand.

From the comparative study, the USA requires the ERA of human pharmaceuticals at the stage of registration, while Canada assesses the environmental risk of substances or the active pharmaceutical ingredients before the substance is manufactured or imported into the country. This article agrees with the USA’s approach because Thailand’s mechanism of supervising modern medicine for human use is more consistent with the legal measures of the USA. Consequently, Thailand should impose legal requirements for applicants filing for approval of modern pharmacopeias for human use to submit documents of environmental risk assessment (ERA). In addition to drug labeling, legal measures should be enacted for displaying environmental information together with methods for disposing of pharmaceutical wastes and current ministerial EIA notification should be amended by listing pharmaceutical plants manufacturing active pharmaceutical ingredients in Thailand.