의약품 자료독점제도의 국가별 현황과 국내 제도의 발전방향

제목
의약품 자료독점제도의 국가별 현황과 국내 제도의 발전방향
Pharmaceutical Data Exclusivity - Comparative Study and Future Direction in Korea
저자

박실비아

키워드
pharmaceutical; data exclusivity; intellectual property rights
발행연도
2009-12-18
발행기관
한국약제학회
Series
약제학회지, vol. 39, no. 4, pp. 299 - 307
Journal Title
약제학회지
초록
ABSTRACT - Data exclusivity is one of the most important intellectual property rights of pharmaceutical. During data exclusivity pediod, third parties are prohibited from relying on the data which the original company has submitted to regulatory authority for drug application. I investigated data exclusivity sysrems for pharmaceuticals in the US, EU, Canada and Korea. New chemical entities were usually given the longest periods of data exclusivity compared to drugs with new indication or new formulation, although the protection periods varied by country. For new drugs to be entitled to a data exclusivity, strict conditions should be met. Data exclusivity has also been provided as an incentive to promote clinical investigation and drug development for pediatric population or orphan diseases. In Korea, data exclusivity was adopted in 1995 as an addictive provision to "drug re-examination" which is to investigate post-marketing safely information of new drugs. I was introduced with few discussion on the purpose of effects of data exclusivity on pharmaceutical industry and pharmaceutical market in this country. I found that Korea's data exclusivity system falls short of considerations on valuing innovation of pharmaceutical research. It is necessary to improve data exclusivity system in order to promote innovative pharmaceutical development and to balance intellectual property rights protection and access to drugs in this country.
ISSN
2093-5552
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