복제약품의 국제무역 = International Trade of Generic Drugs

다국어 초록 (Multilingual Abstract)

In order to facilitate international trade of generic drugs, it is necessary to balance various interests, such as international trade liberalization pursued by the WTO, intellectual properties related to the (original) drugs and each member state`s public health policy. WTO 2001 Doha Ministerial Conference Declaration on the TRIPs Agreement and Public Health provides some of the standards for the balancing, like “flexibility” in the application of the TRIPs Agreement. As lots of disputes concerning generic drugs show, however, the 2001 Doha Declaration is not enough to tackle the balancing. At first, international community should make an effort to crack down counterfeit medicines, which bring risks and real injuries to human health. If a drug is made in a way of appropriation of the patent, trade mark, brand name, design or trade dress of another drug, the drug should be considered as counterfeit medicine. However, such cracking counterfeit medicines down should not result in unnecessary trade barrier on international trade of generic drugs. A generic drug authorized in a WTO member state should not be considered as a counterfeit medicine except for the case decided by DSB of WTO to be illegal. The better way for a clear distinction between a generic drug and a counterfeit medicine is harmonization of the each state standard for the patentability. Each state should expand its effort to harmonize standards for the patentability. It is expected that the DSB of WTO will provide some clear standards in the case of ‘European Union and a Member State - Seizure of Generic, Drugs in Transit.’ The relation between an original drug and a generic drug could be governed by the values, such as right for public health, right of access to medicine, and “flexibility” in the application of the TRIPs Agreement. When a developing country, which lacks of ability to produce sufficient medicine, imports cheap generic drugs including the drugs produced in a way of compulsory licensing, there should not be any kind of international trade barriers. For the states, parallel import of drugs including drugs supported by public health fund of a state, needs to be permitted For rapid releasing generic drugs onto a market, it is necessary to facilitate and simplify the procedure of authorization. To facilitate the procedure, Early Working with flexible interpretation of the TRIPs Agreement could be introduced.