無藥可用的困境──我國非經濟動物用藥之法令管制探討

A Study on Regulation of Veterinary Pharmaceuticals

動物用藥管制旨在保障國民健康、增進動物福祉、維護畜牧業市場秩序，透過動物藥證制度確保藥品有效性與安全性。然而，我國動物用藥市場小，研發、申請、管理成本高昂，導致許多必要藥品缺乏，獸醫常使用無動物藥證藥品，此一情況在寵物醫療中尤為常見。目前我國已有暫行替代方案，並於2024年2月26日發布訂定「人用藥品用於犬貓及非經濟動物之使用管理辦法」確立了動保藥品的設計，但制度仍然不完備。本文中盤點了我國非經濟動物用藥現況，通過質性訪談深入認知獸醫臨床上的困難與藥師對動物用藥之看法，並比較美國、歐盟與澳洲法制度。最後本文建議政府採納藥證分級制度，原則上應達成動物用藥與人用藥分流的目標，並在例外情形下開放獸醫使用人用藥。同時建議主管機關建立動物雲端藥歷以完備化我國動物用藥管制法制，確實實現保障國民健康、增進動物權益以及維護畜牧業市場秩序之法益。

Animal medication regulation aims to safeguard public health, enhance animal welfare, and maintain order in the livestock market by ensuring the effectiveness and safety of medications through an animal drug licensing system. However, Taiwan’s animal medication market is small, resulting in high costs for research, development, application, and management, leading to a shortage of essential medications. Veterinarians often resort to using drugs that are unlicensed for animals, particularly in pet healthcare.
Although the Council of Agriculture has proposed temporary alternative plans, the regulation of veterinary drugs in Taiwan remains chaotic due to the complexity of drug control and the opposing stances of veterinarians and pharmacists.
This article conducts a legal study and draws on the legislative experiences of the United States, the European Union, and Australia to understand how other countries handle the discrepancy between the regulatory costs and economic benefits of animal drug licenses. These countries implement stratified control based on whether the animal is considered economic and the size of the animal population. They also appropriately allow the off-label use of drugs. This approach aims to protect public health and promote animal rights under controllable risks. Special control measures for antibiotics and biological drugs are also taken into account in these countries.
In conclusion, I suggest that the government refer to the experiences of foreign jurisdictions regarding drug licensing and stratified regulatory controls, and improve incentive mechanisms for medications used on non-economic animals. These efforts would help increase the number of licensed veterinary drugs and, in principle, achieve the separation of animal and human medications. In exceptional cases, the norms for off-label use in the United States, the European Union, and Australia can be referred to, allowing veterinarians to use non-animal drugs for animal treatment. To prevent significant environmental and social impacts, antibiotics and biological drugs should also be specially managed. Authorities should also consider establishing an Animal Pharma Cloud System to improve the legislation for animal medication control in Taiwan and truly realize the protection of public health, the promotion of animal rights, and the maintenance of the livestock market order.