미국과 한국의 제네릭 의약품 활성화와 의약품 동등성 확보 정책에 대한 논의과정 비교
Comparison of the Discussion Process on the Policy of Promoting Generic Usage and Assuring Therapeutic Equivalence in the US and Korea
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Objectives: This study aimed to analyze the process of policy discussion related to generics, in order to investigate the cause of the low reliability of generics in Korea. Methods: This study compared the process of two policy discussions related to generics in Korea with those in the United State. One was the introduction of generic usage promotion policy such as generic substitution, and the other was the therapeutic equivalence assurance policy such as management of bioequivalence tests. Literature review was performed based on each basic research corresponding to the US and Korean cases, and we additionally reviewed documents that describe the details of the discussion at the time. Results: Discussions in the US took place openly, mainly at parliamentary hearings, and developed in a progressive direction regarding how to assure drug equivalence. On the other hand, discussions in Korea began with a limited number of people at government-affiliated committee. Even though the policy was greatly revised by opposition from the National Assembly and interest groups, it became unreliable for them. Conclusion: The main difference in the process of policy discussions between the US and Korea was transparency, which contributed to civil society’s trust and compliance with government policies, and policy development. Accordingly, it seems necessary to make the discussion process transparent, when introducing policies related to the promotion of generic usage in the future.
Abstract
Objectives: This study aimed to analyze the process of policy discussion related to generics, in order to investigate the cause of the low reliability of generics in Korea. Methods: This study compared the process of two policy discussions related to generics in Korea with those in the United State. One was the introduction of generic usage promotion policy such as generic substitution, and the other was the therapeutic equivalence assurance policy such as management of bioequivalence tests. Literature review was performed based on each basic research corresponding to the US and Korean cases, and we additionally reviewed documents that describe the details of the discussion at the time. Results: Discussions in the US took place openly, mainly at parliamentary hearings, and developed in a progressive direction regarding how to assure drug equivalence. On the other hand, discussions in Korea began with a limited number of people at government-affiliated committee. Even though the policy was greatly revised by opposition from the National Assembly and interest groups, it became unreliable for them. Conclusion: The main difference in the process of policy discussions between the US and Korea was transparency, which contributed to civil society’s trust and compliance with government policies, and policy development. Accordingly, it seems necessary to make the discussion process transparent, when introducing policies related to the promotion of generic usage in the future.
참고문헌 (23)
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