“基本药物”的历史——权利与利益之争
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摘要
1975年,世界卫生组织(World Health Organization, WHO)首次提出了"基本药物"的概念,旨在解决各国普遍存在的药物成本过高和跨国药企在发展中国家药物倾销等问题。本文在行动者网络理论的视域下,将基本药物的概念和实践置于发达国家、发展中国家、药企、不同国际组织和非政府组织等不同行动者所构成的网络情境中,全面回顾世界卫生组织基本药物的历史,梳理在不同阶段塑造基本药物理念和实施的语境、不同行动者及其作用,从而检视其关涉伦理、权利、利益甚至国际关系与政治的复杂性,为理解基本药物制度的形成和当下依然存在的争论提供更为清晰的路线图。
In order to resolve the common problem of over high expenditure on drugs and pharmaceutical dumping particularly prevailing in the less developed countries, the concept of "Essential Medicines" was officially raised by the World Health Organization(WHO) in 1975. Using the perspective of Actor-NetworkTheory, we attempt to comprehensively trace the history of WHO Essential Medicines, and to analyze the role of various actors in shaping the conceptualization of Essential Medicines in three different stages; and to dig up all the context determinants which determined or influenced its definition, selection criteria and procedure as well as implementation, through which we may probe into the complexity of Essential Medicines involving ethics, rights, interests and even international relations and politics, so as to provide a more transparent historical approach to understanding the construction of Essential Medicines policy and the persistent controversies around it.
In order to resolve the common problem of over high expenditure on drugs and pharmaceutical dumping particularly prevailing in the less developed countries, the concept of "Essential Medicines" was officially raised by the World Health Organization(WHO) in 1975. Using the perspective of Actor-NetworkTheory, we attempt to comprehensively trace the history of WHO Essential Medicines, and to analyze the role of various actors in shaping the conceptualization of Essential Medicines in three different stages; and to dig up all the context determinants which determined or influenced its definition, selection criteria and procedure as well as implementation, through which we may probe into the complexity of Essential Medicines involving ethics, rights, interests and even international relations and politics, so as to provide a more transparent historical approach to understanding the construction of Essential Medicines policy and the persistent controversies around it.
引文
[1]Liang,R.'25 Years of the WHO Essential Medicines Lists:Progress and Challenges'[J].The Lancet,2003,9370:1723-1729.
[2]Howard,N.J.'Changes in the World Health Organization Essential Drug List'[J].The Lancet,1991,8769:743-745.
[3]Quick,J.D.'Twenty-five Years of Essential Medicines'[J].Bulletin of the World Health Organization,2002,80(11):913-914.
[4]'The Royal Tropical Institute,The London School of Hygiene and Tropical Medicine.An evaluation of WHO’s Action Programme on Essential Drugs(Vol 1-2)'[R].Submitted to the Management Advisory Committee,The Action Program on Essential Drugs.
[5]Greene,J.A.'Making Medicines Essential:the Emergent Centrality of Pharmaceuti-cals in Global Health'[J].BioSocieties,2011,6(1):10-33.
[6]Zacher,M.W.,Keefe,T.J.The Politics of Global Health Governance:United by Conta-gion[M].New York:Palgrave Macmillan,2008,107-109.
[7]Cruickshank,P.J.'The Teleology of Care:Reinventing International Health,1969-1989'[D].Harvard University,Department of the History of Medicine,Ph.D.Dissertation,2011.
[8]WHA28.11.'Director General Report'[R],Geneva:The World Health Organization,1975.
[9]WHA28.66.'Prophylactic and Therapeutic Substances'[R].Geneva:The World Health Organization,1975.
[10]WHO/UNICEF.Declaration of Alma-Ata[EB/OL].www.who.int/hpr/NPH/docs/declaration_almaata.pdf.2017-10-15.
[11]World Pharmaceutical News[J].Scrip,1977,258:7.
[12]Ford,N.'The Enduring Crisis in Neglected Diseases'[A],Clare,J.,Illingworth,P.,Schuklenk,U.(Eds)The Power of Pills:Social,Ethical,and Legal Issues in Drug Development,Marketing&Pricing[C],Ann Arbor,MI:Pluto Press,2006,110.
[13]World Pharmaceutical News[J].Script,1977,259:23.
[14]Godlee,F.'WHO in Retreat:Is It Losing Its Influence?'[J].British Medical Journal,1994,309(6967):1491-1495.
[15]WHO.WHA 21.41.'Pharmaceutical advertising'[R].Geneva:World Health Organization,Seventeenth Plenary Meeting,1968.
[16]WHO.'The Rational Use of Drugs'[R].Report of the Conference of Experts,Held in Nairobi,Kenya,Geneva:World Health Organization,1987.
[17]齐谋甲.中国医药年鉴[M].中国医药科技出版社,1991,310
[18]Cueto,M.'The Origins of Primary Health Care and Selective Primary Health Care'[J].American Journal of Public Health,2004,94(11):1864-1874.
[19]Litsios,S.'The Long and Difficult Road to Alma-Ata:APersonal Reflection'[J].International Journal of Health Services,2002,32(4):709-732.
[20]Garner,P.'The Bamako Initiative'[J].British Medical Journal,1989,298(6694):277-278.
[21]Brown,T.'The World Health Organization and the Transition From‘International’to‘Global’Health'[J].American Journal of Public Health,2006,96(1):62-72,
[22]Buse,K.'World Health:The World Bank and Global Cooperation in Health:The Case of Bangladesh'[J].The Lancet,1998,9103:665-669
[23]Werner,D.'Elusive Promise,Whatever Happened to‘Health for All?’'[EB/OL].http://www.newint.org/issue331/elusive.htm.2017-10-15.
[24]Godlee,F.'WHO in Europe:Does It Have a Role?'[J].British Medical Journal,1994,309(6969):1636
[25]Holloway,K.A.'WHO Essential Medicines Policies and Use in Developing and Transitional Countries:An Analysis of Reported Policy Implementation and Medicines Use Surveys'[J].PLos Medicine,2014,11(9):e1001724
[26]苏静静、张大庆.基本药物在中国:从国际理念到国家制度[J].自然辩证法通讯,2017,39(5):63-71.
[27]Farmer,P.Pathologies of Power:Health,Human Rights and the New War on the Poor[M].Berkeley-Los Angeles-London:University of California Press,2004.
[28]Trouiller,P.'Drug Development for Neglected Diseases:a Deficient Market and a Public Health Policy Failure'[J].The Lancet,2002,359:2188-2194.
[29]WHO Regional Office for South-East Asia.'Access to Medicines and Vaccines:Im-plications of Intellectual Property Protection and Trade Agreements'[R].Meeting of Health Ministers of Countries of SEAR.Colombo,Sri Lanka,2005.
[30]Sykes,A.O.'TRIPS,Pharmaceuticals,Developing Countries and the Doha'Solu-tion''[J].Chicago Journal of International Law,2002,3(1):47.
[31]WHO,'WHA 49.14.Revised Drug Strategy'[R].World Health Organization,1996.
[32]Regan,T.The Case for Animal Rights[M].Berkeley and Los Angeles,California:University of California Press,2004,116-117.
[33]Chan,M.'Return to Alma-Ata'[J].The Lancet,2009,9642:865-866
[34]Veronika,J.W.'Essential Medicines for Universal Health Coverage'[R].Commissioned by Lancet,2016,[35]Latour,B.Reassembling the Social:An Introduction to Actor-Network-Theory[M].Oxford:Oxford University Press,2005.
(1)因Drug有毒品之意,后在2000年更名为essential medicines。
(1)在推行基本药物之前,WHO负责的仅是药物的标准等技术问题,并未涉及相关药物政策的制定。当时该司只有一个分管药品事务的药物处(Pharmaceutical unit),药物处在50年代主要负责药典的编写和药品通用名的标准化,60年代后主要关注药品安全和疗效以及质量控制。
(2)WHO的总部设在日内瓦,分六个地区委员会和地区办事处,分别为西太平洋区、非洲区、欧洲区、美洲区、东南亚区、东地中海区。
[2]Howard,N.J.'Changes in the World Health Organization Essential Drug List'[J].The Lancet,1991,8769:743-745.
[3]Quick,J.D.'Twenty-five Years of Essential Medicines'[J].Bulletin of the World Health Organization,2002,80(11):913-914.
[4]'The Royal Tropical Institute,The London School of Hygiene and Tropical Medicine.An evaluation of WHO’s Action Programme on Essential Drugs(Vol 1-2)'[R].Submitted to the Management Advisory Committee,The Action Program on Essential Drugs.
[5]Greene,J.A.'Making Medicines Essential:the Emergent Centrality of Pharmaceuti-cals in Global Health'[J].BioSocieties,2011,6(1):10-33.
[6]Zacher,M.W.,Keefe,T.J.The Politics of Global Health Governance:United by Conta-gion[M].New York:Palgrave Macmillan,2008,107-109.
[7]Cruickshank,P.J.'The Teleology of Care:Reinventing International Health,1969-1989'[D].Harvard University,Department of the History of Medicine,Ph.D.Dissertation,2011.
[8]WHA28.11.'Director General Report'[R],Geneva:The World Health Organization,1975.
[9]WHA28.66.'Prophylactic and Therapeutic Substances'[R].Geneva:The World Health Organization,1975.
[10]WHO/UNICEF.Declaration of Alma-Ata[EB/OL].www.who.int/hpr/NPH/docs/declaration_almaata.pdf.2017-10-15.
[11]World Pharmaceutical News[J].Scrip,1977,258:7.
[12]Ford,N.'The Enduring Crisis in Neglected Diseases'[A],Clare,J.,Illingworth,P.,Schuklenk,U.(Eds)The Power of Pills:Social,Ethical,and Legal Issues in Drug Development,Marketing&Pricing[C],Ann Arbor,MI:Pluto Press,2006,110.
[13]World Pharmaceutical News[J].Script,1977,259:23.
[14]Godlee,F.'WHO in Retreat:Is It Losing Its Influence?'[J].British Medical Journal,1994,309(6967):1491-1495.
[15]WHO.WHA 21.41.'Pharmaceutical advertising'[R].Geneva:World Health Organization,Seventeenth Plenary Meeting,1968.
[16]WHO.'The Rational Use of Drugs'[R].Report of the Conference of Experts,Held in Nairobi,Kenya,Geneva:World Health Organization,1987.
[17]齐谋甲.中国医药年鉴[M].中国医药科技出版社,1991,310
[18]Cueto,M.'The Origins of Primary Health Care and Selective Primary Health Care'[J].American Journal of Public Health,2004,94(11):1864-1874.
[19]Litsios,S.'The Long and Difficult Road to Alma-Ata:APersonal Reflection'[J].International Journal of Health Services,2002,32(4):709-732.
[20]Garner,P.'The Bamako Initiative'[J].British Medical Journal,1989,298(6694):277-278.
[21]Brown,T.'The World Health Organization and the Transition From‘International’to‘Global’Health'[J].American Journal of Public Health,2006,96(1):62-72,
[22]Buse,K.'World Health:The World Bank and Global Cooperation in Health:The Case of Bangladesh'[J].The Lancet,1998,9103:665-669
[23]Werner,D.'Elusive Promise,Whatever Happened to‘Health for All?’'[EB/OL].http://www.newint.org/issue331/elusive.htm.2017-10-15.
[24]Godlee,F.'WHO in Europe:Does It Have a Role?'[J].British Medical Journal,1994,309(6969):1636
[25]Holloway,K.A.'WHO Essential Medicines Policies and Use in Developing and Transitional Countries:An Analysis of Reported Policy Implementation and Medicines Use Surveys'[J].PLos Medicine,2014,11(9):e1001724
[26]苏静静、张大庆.基本药物在中国:从国际理念到国家制度[J].自然辩证法通讯,2017,39(5):63-71.
[27]Farmer,P.Pathologies of Power:Health,Human Rights and the New War on the Poor[M].Berkeley-Los Angeles-London:University of California Press,2004.
[28]Trouiller,P.'Drug Development for Neglected Diseases:a Deficient Market and a Public Health Policy Failure'[J].The Lancet,2002,359:2188-2194.
[29]WHO Regional Office for South-East Asia.'Access to Medicines and Vaccines:Im-plications of Intellectual Property Protection and Trade Agreements'[R].Meeting of Health Ministers of Countries of SEAR.Colombo,Sri Lanka,2005.
[30]Sykes,A.O.'TRIPS,Pharmaceuticals,Developing Countries and the Doha'Solu-tion''[J].Chicago Journal of International Law,2002,3(1):47.
[31]WHO,'WHA 49.14.Revised Drug Strategy'[R].World Health Organization,1996.
[32]Regan,T.The Case for Animal Rights[M].Berkeley and Los Angeles,California:University of California Press,2004,116-117.
[33]Chan,M.'Return to Alma-Ata'[J].The Lancet,2009,9642:865-866
[34]Veronika,J.W.'Essential Medicines for Universal Health Coverage'[R].Commissioned by Lancet,2016,[35]Latour,B.Reassembling the Social:An Introduction to Actor-Network-Theory[M].Oxford:Oxford University Press,2005.
(1)因Drug有毒品之意,后在2000年更名为essential medicines。
(1)在推行基本药物之前,WHO负责的仅是药物的标准等技术问题,并未涉及相关药物政策的制定。当时该司只有一个分管药品事务的药物处(Pharmaceutical unit),药物处在50年代主要负责药典的编写和药品通用名的标准化,60年代后主要关注药品安全和疗效以及质量控制。
(2)WHO的总部设在日内瓦,分六个地区委员会和地区办事处,分别为西太平洋区、非洲区、欧洲区、美洲区、东南亚区、东地中海区。