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KMID : 0986720210290020183
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Korean Journal of Medicine and Law
2021 Volume.29 No. 2 p.183 ~ p.217
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A Comparative Law Study on the regulations pertaining to Human Medicines used in Animals : Korea, Denmark, USA, UK and Japan
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Park Ji-Young
Lee Dae-Sung
Park Hye-Kyung
Kwon Kyeng-Hee
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Abstract
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There is a risk of misuse and abuse of human medicines used in animals because Korean laws do not stipulate provisions related to human medicines used for animals and thus, which regulatory agency is responsible for this matter is unclear. In order to understand the cause of these problems, we felt the necessity of comparing Korean and foreign laws governing human medicines used in animals and tried to seek the implications. Denmark, the USA, the UK, and Japan were selected for this comparative study, and we reviewed the website of each country's laws and guidelines for veterinarians or guidelines published by governments. As a result, it is allowed in all countries except Korea that veterinarians can prescribe and dispense human medicines only when the animal suffers severe pain or when therapeutic effects cannot be expected by veterinary medicines. Pharmacists are also permitted in these countries to dispense human medicines for the use in animals by veterinarians’ prescription. Regarding the conditions of human medicine use in animals, Denmark and the UK stipulate that they can be used in stages only when there are no veterinary medicines for all animals. On the other hand, in the USA, human medicines can be used in animals other than food-producing animals even if medicines for these kind of animals exist. However, for the food-producing animals, it is not allowed in the USA to use human medicines in these animals when the veterinary medicines for the food-producing animals are available. In Japan, the use of human medicines in animals is permitted when no treatment effect can be expected by the approved veterinary medicines. But only the conditions of use for food-producing animals are stipulated. However, in Korea, there are no laws specifying the prescribing or dispensing authority allowed to prescribe human medicines to be used in animals, and the conditions under which human medicines can be used in animals. To prevent human safety problems pertaining to food safety derived from food-producing animals and antibiotic resistance issues in animals, conditions for the prescribing and dispensing human medicines in animals should be clearly stipulated, managed and supervised. This will ultimately achieve animal welfare and human health together.
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KEYWORD
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animal, human medicine, conditions of use, prescription, dispensing, law
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