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      필수의약품에 대한 접근 보장과 국영제약사의 역할: 해외 사례가 한국에 주는 시사점 = The role of state-owned pharmaceutical companies & its implications for South Korea

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      https://www.riss.kr/link?id=A100425173

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      다국어 초록 (Multilingual Abstract) kakao i 다국어 번역

      Access to medicines is a central element of health rights, and state has responsibility to ensure it for people. But in reality, for-profit private pharmaceutical companies take lead in production and supply of medicines in many countries, and this makes allocation of medicines to be determined by demands, not by needs. Besides, worldwide reinforcement of patent rights due to the introduction of TRIPS regime in 1995 strengthens monopoly of pharmaceutical companies and hinders access to medicines. Countries including Thailand, India, Indonesia, and Brazil have been operating state-owned pharmaceutical companies to actively ensure access to medicines. The national essential medicines lists are officially announced and these companies have produced and supplied these medicines at low prices and have successfully achieved self-sufficiency. If necessary, essential medicines are produced and supplied by these companies with application of compulsory licensing. These companies are also engaged in importing inexpensive generics from other countries. In Korea, healthcare system and the infrastructures of pharmaceutical industry are not similar to these countries. However, Korea is vulnerable to the strengthened TRIPS and challenged by rising burden of healthcare expenditures, which might affect access to medicines. Although problems in access to medicines, especially resulting from production and supply problem, have been raised several times, there is insufficient policy to ensure stable supply of medicines. Recently, there have been debates on feasibility of establishment of state-owned pharmaceutical company and its specific plan in Korean setting. This study suggests salient policy implications on these issues by reviewing foreign experiences and situations of access to medicines in Korea.
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      Access to medicines is a central element of health rights, and state has responsibility to ensure it for people. But in reality, for-profit private pharmaceutical companies take lead in production and supply of medicines in many countries, and this ma...

      Access to medicines is a central element of health rights, and state has responsibility to ensure it for people. But in reality, for-profit private pharmaceutical companies take lead in production and supply of medicines in many countries, and this makes allocation of medicines to be determined by demands, not by needs. Besides, worldwide reinforcement of patent rights due to the introduction of TRIPS regime in 1995 strengthens monopoly of pharmaceutical companies and hinders access to medicines. Countries including Thailand, India, Indonesia, and Brazil have been operating state-owned pharmaceutical companies to actively ensure access to medicines. The national essential medicines lists are officially announced and these companies have produced and supplied these medicines at low prices and have successfully achieved self-sufficiency. If necessary, essential medicines are produced and supplied by these companies with application of compulsory licensing. These companies are also engaged in importing inexpensive generics from other countries. In Korea, healthcare system and the infrastructures of pharmaceutical industry are not similar to these countries. However, Korea is vulnerable to the strengthened TRIPS and challenged by rising burden of healthcare expenditures, which might affect access to medicines. Although problems in access to medicines, especially resulting from production and supply problem, have been raised several times, there is insufficient policy to ensure stable supply of medicines. Recently, there have been debates on feasibility of establishment of state-owned pharmaceutical company and its specific plan in Korean setting. This study suggests salient policy implications on these issues by reviewing foreign experiences and situations of access to medicines in Korea.

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      참고문헌 (Reference)

      1 권혜영, "희귀의약품 보험약가결정: 문제점과 시사점" 한국보건경제정책학회 16 (16): 17-37, 2010

      2 박실비아, "희귀난치성 질환자의 의약품 접근성 제고 방안" 한국보건사회연구원 2010

      3 현정석, "항바이러스제 넘치는데··· 독감백신은 품귀"

      4 변진옥, "특허신약의 가격통제 및 공급 정책으로서의 강제실시 : 한국에서의 가능성과 한계" 한국보건행정학회 20 (20): 64-86, 2010

      5 허정헌, "타미플루가 고무줄인가, 유효기간 또 늘린다고?"

      6 Angell, M., "제약회사들은 어떻게 우리주머니를 털었나" 청년의사 2007-, 2007

      7 Law, J., "제약회사는 어떻게 거대한 공룡이 되었는가" 궁리 2008

      8 한국희귀의약품센터, "자가치료목적 수입의약품내역"

      9 공정거래위원회, "인플루엔자 백신 입찰 담합 건"

      10 박실비아, "의약품의 안정적 공급체계 구축을 위한 필수의약품 관리방안" 한국보건사회연구원/식품의약품안전청 2009

      1 권혜영, "희귀의약품 보험약가결정: 문제점과 시사점" 한국보건경제정책학회 16 (16): 17-37, 2010

      2 박실비아, "희귀난치성 질환자의 의약품 접근성 제고 방안" 한국보건사회연구원 2010

      3 현정석, "항바이러스제 넘치는데··· 독감백신은 품귀"

      4 변진옥, "특허신약의 가격통제 및 공급 정책으로서의 강제실시 : 한국에서의 가능성과 한계" 한국보건행정학회 20 (20): 64-86, 2010

      5 허정헌, "타미플루가 고무줄인가, 유효기간 또 늘린다고?"

      6 Angell, M., "제약회사들은 어떻게 우리주머니를 털었나" 청년의사 2007-, 2007

      7 Law, J., "제약회사는 어떻게 거대한 공룡이 되었는가" 궁리 2008

      8 한국희귀의약품센터, "자가치료목적 수입의약품내역"

      9 공정거래위원회, "인플루엔자 백신 입찰 담합 건"

      10 박실비아, "의약품의 안정적 공급체계 구축을 위한 필수의약품 관리방안" 한국보건사회연구원/식품의약품안전청 2009

      11 이로리, "의약품 특허보호 관련 TRIPS-Plus협정의 법적 쟁점 및 시사점" 안암법학회 (38) : 419-446, 2012

      12 홍지, "의약품 접근권 달성을 위한 강제실시"

      13 양봉민, "의약품 생산 및 공급의 공공성 강화방안" 국민건강보험공단·서울대학교 산학협력단 2013

      14 "온타리오주 보건·장기요양부(Ontario Ministry of Health and Long-Term Care)"

      15 "약학정보원"

      16 보건복지부, "약제의 결정 및 조정 기준(시행 2013.12.31.)"

      17 리병도, "약들이 사라지고 있어요 - 이제는 국영제약사가 필요하다"

      18 최은택, "수익성 없어 못 만든다. 의약품 77건 공급 중단: 식약청 보고건수 총 167건…원료 수급 차질 어려움도"

      19 이상훈, "서울대병원 생산중단약 공급 요청에 제약계 ‘난색’"

      20 장철호, "부지 매입 둘러싸고 녹십자-화순군 갈등: 지난 2월부터 화순공장 가동...약속한 분양부지 매입 미뤄"

      21 황인태, "대학병원에 필수약이 없다, “이게 무슨소리?"

      22 김대진, "국공립병원 의약품 공급중단 현황 및 정보 전달체계 개선연구" 대한약학회 57 (57): 150-159, 2013

      23 박남오, "국감, 김현숙 “87억 들인 ‘결핵硏’, 녹십자 딴 제품만 생산”: 이학영 “‘NAT 장비교체사업’ 녹십자 특혜의혹 밝혀야”"

      24 WHO, "World Health Statistics 2011"

      25 Beall, R., "Trends in Compulsory Licensing of Pharmaceuticals Since the Doha Declaration: A Database Analysis" 9 (9): 1-9, 2012

      26 Bozeman, B., "The “Publicness Puzzle” in Organization Theory: A Test of Alternative Explanations of Differences between Public and Private Organizations" 4 (4): 197-224, 1994

      27 유엔 경제·사회·문화적 권리 위원회(UN Committee on Economic, Social and Cultural Rights), "The right to the highest attainable standard of health: 08/11/2000. E/C.12/2000/4.(General Comments)"

      28 Lu, Y., "The World Medicines Situation 2011: Medicine Expenditures"

      29 Pesch, U, "The Predicaments of Publicness: An Inquiry into the Conceptual Ambiguity of Public Administration" Eburon Publishers 2005

      30 Magalhães, J. L., "The Official pharmaceutical laboratories and their relevance to Brazil's public health" 5 (5): 2011

      31 Gustafsson, L. L., "The 'Wise List' - A Comprehensive Concept to Select, Communicate and Achieve Adherence to Recommendations of Essential Drugs in Ambulatory Care in Stockholm" 108 (108): 224-233, 2011

      32 Focus Reports, "Thailand: Pharma report"

      33 이로리, "TRIPS협정상 의약품 특허의 강제실시에 대한 최근 동향" 법무부 (90) : 118-141, 2009

      34 Ford, N., "Sustaining access to antiretroviral therapy in the less-developed world: lessons form Brazil and Thailand" 21 (21): S21-S29, 2007

      35 IMS consulting group, "Securing IP and Access to Medicine: Is Oncology the Next HIV? An IMS Consulting Group White Paper on compulsory licensing and other risks to intellectual property rights in oncology"

      36 Kalant, N., "Research output of the Canadian pharmaceutical industry: where has all the R&D gone?" 1 (1): 21-34, 2006

      37 인도네시아 국가AIDS위원회(National AIDS Commission), "Republic of Indonesia Country Report on the follow up to the Declaration of Commitment On HIV/AIDS(UNGASS): Reporting Period 2008-2009)"

      38 브라질 보건부, "Relação Nacional de Medicamentos Essenciais"

      39 Mossialos, E., "Regulating pharmaceuticals in Europe: striving for efficiency, equity and quality" Open University Press 1-37, 2004

      40 Bozeman, B., "Public-value failure: When efficient markets may not do" 62 (62): 145-161, 2002

      41 WHO, "Public-private roles in the pharmaceutical sector: Implications for equitable access and rational drug use" WHO 1997

      42 Widdus, R., "Public-private partnerships for health: their main targets, their diversity, and their future directions" 79 (79): 713-720, 2001

      43 WHO, "Public health: innovation and intellectual property rights" WHO 2006

      44 WHO, "Promoting Access to Medical Technologies and Innovation"

      45 Fiocruz, "Production and innovation"

      46 Huffschmid, J., "Privatisation against the European Social Model" Palgrave Macmillan 245-257, 2009

      47 Reinhardt., U.E., "Pharmaceutical innovation : incentives, competition, and cost-benefit analysis in international perspective" Cambridge University Press 25-53,

      48 Lichtenberg, F.R, "Pharmaceutical innovation : incentives, competition, and cost-benefit analysis in international perspective" Cambridge University Press 127-152,

      49 Roberts, M.J., "Pharmaceutical Reform: A Guide to Improving Performance and Equity" The World Bank 2011

      50 "OECD Health Data"

      51 태국 국가의약품위원회(National Drug Committee), "National List of Essential Medicines 2008"

      52 인도네시아 보건부, "National List of Essential Medicines 2008"

      53 WHO, "Medicines: essential medicines"

      54 Embrey, M., "Management Sciences for Health, MDS-3: Managing access to medicines and health technologies" Management Sciences for Health 1.1-1.19, 2012

      55 The Lancet Oncology, "Is India ready to lead the battle for fair access to medicines?" 14 (14): 437-, 2013

      56 Public Citizen, "Indonesia Licenses Patents for Seven HIV & Hepatitis B Medicines -Precedent-Setting Government Order has Extraordinary Lifesaving Potential"

      57 World Bank, "Indonesia Health Sector Review: Pharmaceuticals, Why reform is needed"

      58 Greene, W., "India’s pharmaceutical industry and implications for US generic drug market" U.S.International Trade Commission 2007

      59 인도 화학·비료부, "Indian Drugs & Pharmaceuticals Limited (IDPL)"

      60 Kimia Farma, "History"

      61 Hampton, T., "Experts look for ways to lessen impact of drug shortages and discontinuations" 298 (298): 727-728, 2007

      62 Cohen, J.C., "Expanding drug access in Brazil - Lessons for Latin America and Canada" 97 (97): 15-18, 2006

      63 Fox, E. R., "Drug Shortages: A Complex Health Care Crisis" 89 (89): 361-373, 2014

      64 Andrews, R., "Dimensions of Publicness and Organizational Performance: A Review of the Evidence" 21 : I301-I319, 2011

      65 Duffin, J., "Canadian drug shortage: recent history of a mystery" 184 (184): 1000-, 2012

      66 Matter, M., "Brazil's Pharmaceutical Industry: Opportunities for Swiss Suppliers" OSEC (Business Network Switzerland) 2010

      67 인도 의약품청, "Annual Report 2011-12"

      68 Bozeman, B, "All organizations are public: bridging public and private organizational theories" Jossey-Bass 1987

      69 Bigdeli, M., "Access to medicines from a health system perspective" 28 (28): 692-704, 2013

      70 IDPL, "About Us"

      71 Gehrett, B. K., "A prescription for drug shortages" 307 (307): 153-154, 2012

      72 Wanning, W., "A lifeline to treatment: the role of Indian generic manufacturers in supplying antiretroviral medicines to developing countries" 13 (13): 2010

      73 국민건강보험공단, "2012 건강보험통계연보"

      74 GPO, "2011 Annual Report"

      75 Kimia Farma, "2011 Annual Report"

      76 홍지은, "2010년 1월 15일~22일 인도 델리 방문 보고서: 의약품 접근권 운동의 제논의들"

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