공급거부를 원인으로 하는 희귀의약품에 대한 강제실시권의 종합적 판단
A review of application of exclusive rights and compulsory licensing of orphan drug
0
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
Rare disease refers to disease which frequency of occurrence is low and is very difficult to be cured. This paper raises a question if pharmaceutical company that developed an innovative drug and possesses a patent right for the drug discontinues supplying it, life of a patient who has rare disease may be threatened. FUZEON, AIDS medicine which was approved by FDA in 2003 was not developed by Roche, a distributor of FUZEON. FUZEON was discovered by Duke university and developed by a biotechnology company. Roche acquired the ownership of FUZEON by purchasing it. Roche had the exclusive right to sell FUZEON which led a charge for FUZEON to rise to 20 thousand dollars that amounts to three times higher than previous charge for FUZEON. Domestic essential drugs for treating a patient who has rare disease are required to undergo determination of the charge for a medicine by National Health Insurance Service. Market failure phenomena that ownership of medicine and fundamental human rights of patients conflict in that pharmaceutical company may discontinue a supply of the medicine if pharmaceutical company does not agree a charge for medicine presented during negotiation. This paper aims to solve a problem of legitimacy by verifying validity and basis of compulsory licensing and to deal with human right of health from viewpoint of positivism. And Research is to examine whether the case goes against flexibility of TRIPS and compulsory licensing in that compulsory licensing regarding orphan drug that depends on importation gets to medical policy.
Abstract
Rare disease refers to disease which frequency of occurrence is low and is very difficult to be cured. This paper raises a question if pharmaceutical company that developed an innovative drug and possesses a patent right for the drug discontinues supplying it, life of a patient who has rare disease may be threatened. FUZEON, AIDS medicine which was approved by FDA in 2003 was not developed by Roche, a distributor of FUZEON. FUZEON was discovered by Duke university and developed by a biotechnology company. Roche acquired the ownership of FUZEON by purchasing it. Roche had the exclusive right to sell FUZEON which led a charge for FUZEON to rise to 20 thousand dollars that amounts to three times higher than previous charge for FUZEON. Domestic essential drugs for treating a patient who has rare disease are required to undergo determination of the charge for a medicine by National Health Insurance Service. Market failure phenomena that ownership of medicine and fundamental human rights of patients conflict in that pharmaceutical company may discontinue a supply of the medicine if pharmaceutical company does not agree a charge for medicine presented during negotiation. This paper aims to solve a problem of legitimacy by verifying validity and basis of compulsory licensing and to deal with human right of health from viewpoint of positivism. And Research is to examine whether the case goes against flexibility of TRIPS and compulsory licensing in that compulsory licensing regarding orphan drug that depends on importation gets to medical policy.
참고문헌 (16)
- 민창식, "의약품 특허의 강제실시청구에 관한 심사기준 고찰 - 인간기능이론을 중심으로 -", 서울대학교 법학, 53(2), pp.419~468 (2012), 법학연구소[DOI]
- 박성민, "약가 제도의 역사와 약가 인하 소송들", FDC법제연구, 7(1・2) (2012), 한국에프디시법제학회
- 신영수, "독점규제법의 목적에 관한 재고", 법학논고, (37), pp.367~400 (2011), 법학연구원
- 신영수, "규제개혁과 공정거래법; 범위와 방향, 대안에 관하여", 기업법연구, 28(2), pp.127~154 (2014), 한국기업법학회
- 윤성욱, "의약품 허가-특허 연계제도에 도입에 따른 시사점: KORUS FTA를 중심으로", 홍익법학, 12(1), pp.535~557 (2011), 법학연구소
- 을 중심으로 -, "법학논고", 2015, 163~195, pp.법학연구원
- 최상필, "역지급합의와 특허권의 확장", 재산법연구, 30(4), pp.317~334 (2014), 한국재산법학회
- Christoph Stephan, "Impact of raltegravir on HIV-1 RNA and DNA forms following initiation of antiretroviral therapy in treatment-naive patients", Journal of Antimicrobial Chemotherapy (2014), Oxford University Press
- Drug Discovery and Development:Understanding the R&D Process, "Pharmaceutical Research and Manufacturers of America", PhRMA, ~
- Thamer M, "A cross-national comparison of orphan drug policies: implications for the U.S. Orphan Drug Act", J Health Polit Policy Law (1998)
- Todd Gammie, "Access to Orphan Drugs: A Comprehensive Review of Legislations, Regulations and Policies in 35 Countries", PLoS ONE, 10(10), pp.e0140002~ (2015)
- "Learning from Novartis: The recent case concerning Novartis's patent for Glivec shone a spotlight on India's patent system. Deepa Kachroo Tiku and Taapsi Johri Singh explore the questions it raised", Managing Intellectual Property, (232), EUROMONEY PUBLICATIONS PLC
- Villa S, "Orphan drug legislation: lessons for neglected tropical diseases", International Journal of Health planning and management, 2009(24) (2009)
- "미국식약청"[URL]
- "유럽의약품청"[URL]
- "세계보건기구"[URL]