管制与竞争美国药品市场中政府的作用

管制与竞争：美国药品市场中政府的作用蔡江南(JohnCai)博士,美国麻省卫生福利部医药卫生国际研讨会2003年10月31日－11月1日,上海2美国的药品市场美国药品市场是一个具有多种竞争利益组成的复杂混合体。既不存在一个特定的药品市场，对于每种特定药品也不存在一个单一的价格。药品市场中有着众多的顾客、多种流通渠道、多种处方药报销系统、多种购买方式、多种定价方法、多种市场营销技巧和多种价格控制工具。RobinJ.StronginSource:“PharmaceuticalMarketplaceDynamics”,NationalHealthPolicyForum,IssueBriefNo.755,Washington,D.C.2000.3I.背景信息美国制药工业概述卫生与药品支出药品的用量与价格对顾客的影响制药业的财务状况4美国的制药业2002年美国药品研究与制造商协会(PhRMA)的全球销售额为1970亿,其中美国的销售额为1450亿(占74％)。2000年美国处方量接近30亿。2000年销售前20名的公司占了美国处方药市场份额的81.6%美国食品药品管理局(FDA)自1985年到2000年批准了422种新药,平均每年28种。过去20年来全球上市的152种药中近一半是在美国研发的。PhRMA:PharmaceuticalResearchandManufacturersofAmerica.51997年世界药品销售LatinAmerica7.7%SoutheastAsia&China7.3%Japan15.9%Europe29.0%US34.5%MiddleEast1.9%Canada1.6%Africa1.2%Australia0.9%Source:PharmaceuticalIndustryProfile1999,PhRMA,Washington,D.C.,1999.62001年美国国家卫生支出RetailPrescriptionDrug10%Administration6%NursingHome7%Physician22%Hospital32%Other23%Source:CentersforMedicare&MedicaidServices(CMS),Washington,D.C.Otherspendingincludesdental,otherprofessionalservices,homehealthcare,durablemedicalproducts,OTCmedicinesandsundries,publichealth,researchandconstruction.PrescriptionDrugExpendituresTotal:$141billionPerCapita:$497NHEshare:10%NationalHealthExpenditures(NHE)Total:$1,425billionPerCapita:$5,035GDPshare:14.1%71997-2000年间部分OECD国家人均药品支出$252$253$313$375$385$459$473$556$0$100$200$300$400$500$600Australia(1998)UK(1997)Japan(1999)Germany(2000)Canada(2000)Italy(2000)France(2000)US(2000)PercapitainU.S.$Source:OCEDHealthData2002,OrganizationforEconomicCooperationandDevelopment,Paris,2002.81990-2001年间美国部分卫生支出的年变化百分比0%4%8%12%16%20%AnnualChange%RetailPrescriptionDrugs14.7%11.4%7.3%8.4%6.6%11.2%10.5%12.8%15.2%19.7%16.4%15.7%PhysicianServices11.2%11.0%8.4%8.5%4.6%4.8%4.0%5.0%6.6%5.2%6.9%8.6%HospitalCare10.1%10.1%8.2%8.0%3.9%3.4%3.4%3.5%2.9%4.1%5.8%8.3%199019911992199319941995199619971998199920002001Source:CentersforMedicare&MedicaidServices(CMS),Washington,D.C.Billion$19902001IncreaseDrug$40$141249%Physician$158$31499%Hospital$254$45178%DrugPhysicianHospital91997-2000年间美国处方药支出增长的影响因素Price24%Utilization48%DrugType28%价格：现有药品的出厂价格升高用量：处方量变化药物品种：从处方药总支出的增长中扣除价格和用量变化后的剩余部分。Source:PrescriptionDrugTrends–AChartbookUpdate,KaiserFamilyFoundation,November2001.101992-2000年间美国的处方量1,8732,0202,0882,2162,3162,4232,5882,8232,9807.37.88.08.48.79.09.610.410.805001,0001,5002,0002,5003,0003,5004,000199219931994199519961997199819992000NumberofPrescriptions,Millions024681012PrescriptionsPerCapitaTotalDispensedPrescriptionsPrescriptionsPerCapitaSource:PrescriptionDrugTrends–AChartbookUpdate,KaiserFamilyFoundation,November2001.111991-2000年现有药品出厂价增长与所有零售处方药价格的增长7.2%5.5%3.0%1.7%1.9%1.6%2.5%3.2%4.2%3.9%8.2%10.3%5.1%5.8%9.5%8.7%7.6%10.4%7.9%2.5%0%2%4%6%8%10%12%1991199219931994199519961997199819992000AnnualChange%ManufacturerPriceIncreaseforExistingDrugsAllRetailPrescriptionPriceIncreaseSource:PrescriptionDrugTrends–AChartbookUpdate,KaiserFamilyFoundation,November2001.ExistingDrugsAllDrugs121990-2000年间美国处方药平均零售价格$10$11$12$13$14$15$16$17$17$18$19$27$30$35$37$40$45$50$54$61$65$22$24$26$27$29$30$33$36$38$42$46$34$0$10$20$30$40$50$60$7019901991199219931994199519961997199819992000$PerPrescriptionSource:PrescriptionDrugTrends–AChartbookUpdate,KaiserFamilyFoundation,November2001.BrandNameDrugsGenericDrugsAllPrescriptions131990-2000年美国处方药支付来源56%56%54%49%45%42%39%37%35%27%27%31%35%38%40%42%43%17%18%19%20%20%20%21%21%22%59%34%26%25%44%22%16%0%10%20%30%40%50%60%70%80%90%100%19901991199219931994199519961997199819992000Source:PrescriptionDrugTrends–AChartbookUpdate,KaiserFamilyFoundation,November2001.Out-Of-PocketPrivateInsurancePublicInsurance141980-2000年美国部分卫生支出中病人所占份额5.2%4.4%3.1%3.1%3.2%3.2%30.2%19.3%12.0%11.7%11.6%69.4%59.1%42.7%34.9%33.4%32.0%11.9%0%10%20%30%40%50%60%70%80%198019901995199819992000%PaidOut-of-PocketSource:CentersforMedicare&MedicaidServices(CMS),Washington,D.C.PrescriptionDrugPhysicianServicesHospital151999年消费者年药品支出及其在家庭总支出中的份额$370$97$162$254$368$497$706$0$100$200$300$400$500$600$700$800All2525-3435-4445-5455-6465+AgeGroupAnnualConsumerSpendingonDrugs$Source:PrescriptionDrugTrends–AChartbookUpdate,KaiserFamilyFoundation,November2001..1.0%0.4%0.4%0.6%0.8%1.3%2.7%65岁以下人口：23％没有药品保险65岁以上人口:·占总人口的13％;·药品用量超过1/3·占药品总支出的42％·38％没有药品保险161990-2001年美国主要药商研发费用及国家卫生研究所(NIH)预算$8.4$9.7$11.5$12.7$13.4$15.2$16.9$19.0$21.0$22.7$26.0$29.8$7.1$7.7$10.3$10.9$11.3$11.9$12.7$13.6$15.7$17.8$20.3$8.4$0$5$10$15$20$25$30$35199019911992199319941995199619971998199920002001Billion$Source:PharmaceuticalIndustryProfile2003,PhRMA;U.S.NationalInstitutesofHealth(NIH),Washington,D.C.,2003.1999年NIH占美国卫生研发支出的28％产业研发NIH预算171991-2001年制药业盈利在财富500家企业中的排名3.2%2.4%2.9%4.6%4.8%5.0%4.9%4.4%5.0%4.5%3.3%5.5%6.5%13.5%13.3%13.9%13.6%13.2%15.8%14.1%13.5%12.8%11.5%12.5%16.1%14.4%17.1%16.1%18.5%18.6%18.6%18.5%6.4%0%2%4%6%8%10%12%14%16%18%20%19911992199319941995199619971998199920002001AnnualReturnonRevenues%Fortune500MedianIndustryRanked#2DrugIndustrySource:ProfitingfromPain:WherePrescriptionDrugDollarsGo,FamiliesUSA,Washington,D.C,June2002.从1994年起商