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이진이·이주향·김지혜
건강보험정책연구원
연구보고서 2013-04
동일성분의약품들에대한
약가제도평가및약품비관리방안
연구보고서 2013-04
이진이
이주향
김지혜
머 리 말
인구의 고령화로 인한 의약품의 수요증가, 고가의 신약들의 시장진
입 등으로 우리나라는 물론 다수의 OECD 국가에서 공공재원 약제
비의 지출이 상당한 비 을 차지하고 있다.
부분의 국가에서는 특허가 만료된 의약품 시장에서 다양한 제네릭
의약품 사용 장려정책을 통해 약품비를 조 하는 정책을 수행해 오고 있
다. 그러나 우리나라는 건강보험 지출에서 약품비가 차지하는 비 이 높
고, 동일성분내 비용효과 인 의약품을 사용장려하는 정책이 활성화되
어 있지 못하다. 이에 본 보고서에서는 특허가 만료된 의약품에 한 약
가 리, 상 으로 비용효과 인 의약품의 사용장려 방안 등을 고찰하
여, 국내실정에 합한 약품비 감방안을 마련하고자 한다.
이번 연구결과가 건강보험 재정 건 화는 물론이고 국민모두에게 건
강한 의약품 사용을 장려할 수 있는 정책도입을 한 기 자료로 활용되
길 바라며, 이 연구의 시작부터 보고서 발간에 이르기까지 최선을 다해
연구진과 소 한 자문을 아끼지 않았던 많은 분들께 감사의 뜻을
하고자 한다. 한 이번 연구의 내용은 연구진들의 개인 인 의견이며
공단의 공식 인 견해가 아님을 밝 둔다.
2013년 11월
국민건강보험공단 이사장 김 종
건강보험정책연구원 원 장 박 병 태
목 차
·····························································································15
1 ··················································································27
1 ···························································27
2 ····································································29
3 ···················································································31
2 ··························································35
1 ···············································35
1. ···········································································35
2. ·····································································36
3. ·····································································42
2 ································47
1. ··················································································47
2. ··················································································53
3. ··············································59
3 ·························62
1. : ··························································································62
2. ········································································································64
3. ( ) ··························································································67
4. ·······················································································70
5. ······························································74
3 ···············································79
1 ····················································79
1. ········································································································79
2. ····································································································85
3. ·····························································································95
4. ································································································98
5. ······································································································102
6. ·······························································································108
7. ·····························································································125
8. ······································································································138
9. ······································································································143
10. ····································································································153
2 ······················································166
4 ·············171
1 ···············································································171
1. ·····························································································171
2. ·························································································171
2 ···········································175
1. ··············································································175
2. ·····························································································176
3. ······································································································181
3 ··················································182
1. ·····························································································183
2. ·····························································································183
4 ·························187
1. ··············································································187
2. ······································································································188
3. ···································································195
4. ··································································201
5 ······················································202
5 ···········································································207
1 ································207
1. ·····················································207
2. : / ··············210
2 ·························211
1. ············································211
2. ············································212
3. ··································································213
4. ·························································215
3 ······················································································217
····················································································221
·····························································································245
표 목 차
< Ⅱ-1> ······················································ 38
< Ⅱ-2> ··································· 40
< Ⅱ-3> ( : , , %) ························· 57
< Ⅱ-4> ( : ) ·························· 57
< Ⅱ-5> :
( : %) ··········································································· 69
< Ⅱ-6> (43 ) ( : ) ································ 73
< Ⅱ-7> : “ ” ······························································ 74
< Ⅱ-8> ························································ 75
< Ⅲ-1> ························································· 80
< Ⅲ-2> , ············ 80
< Ⅲ-3> ········································································ 81
< Ⅲ-4> ······················································ 86
< Ⅲ-5> , ·········· 87
< Ⅲ-6> ‘old' drugs · 88
< Ⅲ-7> ································ 90
< Ⅲ-8> ······································································· 95
< Ⅲ-9> (generic switching) ( ) ········································· 106
< Ⅲ-10> (Pharmaceutical Schemes),
(Eligibility)(a) ··············································· 108
< Ⅲ-11> (the Patent-Holder's Price for Off-Patent
Pharmaceuticals with Generic Competition) (a), IPHA ,
2006-2015 ····················································································· 117
< Ⅲ-12> (the Generic Price for Off-Patent Pharmaceuticals with
Generic Competition) (a), APMI , 2006-2015 ·········· 120
< Ⅲ-13> , Health(Pricing and Supply of Medical
Goods) Act 2013 , IPHA/APMI , 2012-2015(a) ············· 122
< III-14> 2011 (timelimes) ············· 126
< III-15> (2011 ) ··································· 128
< III-16> (2011 ) ······················································ 130
< III-17> (2011 ) ·········································· 130
< III-18> ····································· 132
< III-19> (2012 ) ··· 135
< III-20> ················································ 140
< Ⅲ-21> ( : NT$) ···································· 144
< Ⅲ-22> , (1995-2003) ················· 145
< Ⅲ-23> ················································ 159
< Ⅲ-24> ····················································· 160
< Ⅲ-25> ················································ 161
< Ⅲ-26> (2013) 164
< Ⅳ-1> (2007.1∼2013.1) ························· 173
< Ⅳ-2> ( ) ··············· 178
< Ⅳ-3> ·························· 179
< Ⅳ-4> ····················································· 180
< Ⅳ-5> ·············································· 181
< Ⅳ-6> ··························································· 184
< Ⅳ-7> 2011 ····················································· 185
< Ⅳ-8> ························································ 188
< Ⅳ-9> ························································ 189
< Ⅳ-10> ······································ 191
< Ⅳ-11> (2011 4 ) ···························· 193
< Ⅳ-12> (2012 4 ) ···························· 194
< Ⅳ-13> ······························································· 197
< Ⅳ-14> (2012 4 ) ························· 199
그 림 목 차
[ Ⅱ-1] ······································································ 37
[ Ⅱ-2] ····························································· 42
[ Ⅱ-3] · ······················································· 45
[ Ⅱ-4] ···························· 46
[ Ⅱ-5] (2011 ) ·············································· 60
[ Ⅲ-1] ( : ) ····························· 84
[ Ⅲ-2] ······························································· 92
[ Ⅲ-3] 2000~2005 ······································· 94
[ Ⅲ-4] ········································· 96
[ Ⅲ-5] (the Patent-Holder's Price for Off-Patent
Pharmaceuticals with Generic Competition(a)) , IPHA ,
2006-2015 ····················································································· 119
[ Ⅲ-6]
― ·················· 124
[ III-7] ( ) ································· 133
[ III-8] (mature market) ( ) ·· 134
[ III-9] (volume) 80% (
, 2009 %) ····················································· 137
[ III-10] ·············································· 138
[ Ⅲ-11] ·········································· 148
[ Ⅲ-12] ( ) ( ) ····· 156
[ Ⅲ-13] ················································ 157
[ Ⅲ-14] ············································ 157
[ Ⅲ-15] ( ) ······················································ 162
[ Ⅲ-16] ( ) 165
[ Ⅲ-17] ················································· 165
[ Ⅳ-1] (2006.4∼2013.4) ··· 172
[ Ⅳ-2] (2007.1∼2013.1) ··············································· 174
[ Ⅳ-3] 1 - 101405ATR acetaminophen encapsulated 650mg ······················· 186
[ Ⅳ-4] 2 - 161501ACH fluoxetine HCl 10mg ········································· 186
[ Ⅳ-5] 3 - 222402ATB ramipril 5mg ··················································· 187
요 약
1. 서론
□
○
○ ,
− , (
)
,
○ 2012
−
□
○
□
○
○
○
− , (
, ),
( )
○
− 2011 10 , 2012 1 , 2013 1
○ (2011 4
, 2012 4 )
− (1) , (2)
− ,
−
○
−
□
○ : ,
○
,
, ,
○ ,
2. 주요 련정책 황
□
○
○ , 2012
(
53.55%)
□
○ ( )
( ) ,
,
○ ( )
, ,
,
,
− ( - . )
, ,
30%
− - , ,
○ ( ) ‘ ( )’ ,
,
,
3. 외국의 련정책 운 황
□
○ ,
, ,
○
−
○
− ,
, ,
,
○ , , ,
,
−
○
,
○
Health Act 2013 ,
□
○
,
,
□
○
,
,
−
−
( . 1
(per diem drug fee):
)
□
○ ,
, 2008 5
− , ,
,
2008 17.6%
2012 25.8%
− 2012
− ( ) ,
,
4. 동일성분내 체가능 의약품 분석
□
○
○ ,
11.8% (2013 1 )
− , ,
6.3%
○ ,
,
30
□
○ 2012 (
)
− 90%
27.9% , 1 64.2%
□
○
2011 4 28.7%, 2012 4 36.9%
○ ( )
2011 4 44.4%, 2012 4 31.8%
− ,
12.7% 11.7%
○ ( )
2011 4 5.1%, 2012 4 2.8%
− 1.5% 1.0%
○
,
□
○ ,
5. 정책 제언
□
○ ( )
− ,
,
− , , ,
○ : / ( )
−
□
○ ( . )
−
,
,
○
−
− ,
, 53.55%
( . )
○
−
○
− , ,
제1장 서 론
제1 연구의 배경 필요성
(’12 27.11%),
. OECD Health Data(2012) 2010
20.3% OECD 15.0% 1.35
.
,
. (
10-15 ) .
( )
,
,
.
(intellectual property) .
․
(composition) (pharmaceutical form),
(bio-availability) ,
, .
.
.
.
,
.
.
,
.
.
, (
)
,
.
2011 12 30 ‘
’ ,
,
2012
.
70% , 12 ,
53.55%
, 2012 4
( ). 2012
,
.
,
,
,
.
.
제2 연구목 내용
.
.
, ,
.
,
.
,
, ( ,
), (
) .
, .
,
(2011 10 , 2012 1 , 2013 1 ).
, (2011 4
, 2012 4 ).
- ,
– .
, .
.
,
, ,
.
제3 연구방법
2 ,
.
, ,
.
,
. ,
, , .
, , ,
,
.
제2장 주요 련정책 황
제1 국내 제네릭 의약품 리 황
1.
( . ) ‘
’ , , , ·
, ·
( )
.
, , , , , ,
.
, .
. Brixner (2013)
, 50%
, 50% , WHO
, 65% (
) ,
(bioequivalence) .
.
■ ‘ (Generic Drug)' ( : R. Alfonso,
Univ. Washington, USA)
• WHO : …" (innovator product)
.
, (exclusive rights)
."
• FDA : " (dosage), (safety), (strength), (how
it is taken), (quality), (performance), (intended use)
."
• EMA: (reference medicinal product) (active
substances)
(pharmaceutical form) , (bioavailability)
(bioequivalence) .
2.
( II-1) .
[그림 Ⅱ-1] 의약품의 허가 차
: . (2013). . .
‘ ’
, , , ,
, .
‘ ( )’
( )
( )
( ) (
) , , ,
.
.
(2009. 1.~2013. 9.)
․
.
․
.
․
?
․
․
․ (Audit trail)
․
.
․
.
․
․ ,
100%
․ 20%
<표 Ⅱ-1> 제네릭 의약품에 한 불신과 진실
2011 11 25
( ) 1 ,
( , 2013).
. ( II-1 )
.
․
.
․
.
․
.
․
․
․ 2015
CTD
․‘14
( )
․
.
․
.
․
․
․ 3
․
․
: . (2013). . .
,
.
‘ ’
(‘11. 6), (‘11. 12), ‘
, !’ (‘13.4.30) .
,
,
·
- Audit Trail (’13. 12.)
- (’13. 12.)
- (’13. 12.)
․ (’13. 12.)
․ (’13. 12.)
-BE ,
․ (’13. 12.)
․ 3
․
-
-
-
<표 Ⅱ-2> 제네릭 의약품 품질 련 진행 인 제도 개선사항
.
( (‘11. 5.
26.), (‘12. 5. 16.), (’13. 9. 25.))
.
,
2013 12 ( II-2). ,
,
, ,
( ,
2013). ,
.
.
Kesselheim 2008
,
(narrow therapeutic index )
(propafenone, warfarin) (Kesselheim et al., 2008).
2010
,
(Kesselheim et al., 2010).
(atrovastatin)
(Boh et al., 2011).
Bakk (2013)
, 2000 -2012 , 121
(outcome comparisons) (review) ,
66%
, 64%
.
( , ),
(Drugs with a narrow therapeutic index (NTI)),
indications (or certain indications) ( . , ),
(Certain modified-release preparations)
( 1 ). ‘ ’
,
.
[그림 Ⅱ-2] 의약품 특성별 가격결정체계
3.
Brixner(2013) ,
, ,
( II-2).
: Brixner, D. (2013). The Value Implications of Generic Substitution Policies for Health Care Systems and Individual Patients. 10th annual meeting HTAi SEOUL 2013
. , 2005 ‘
’ ,
85% (Godman, 2012).
40% ,
(Godman, 2012).
55% , 18 7% (Godman,
2012).
1977
,
1999
.
,
,
2010 10 ‘ (
)’
. 1
,
, 2014 1 .
2000 7 ( , )
,
(Negative list)
90%
, 11 80%
. 2002 8
‘ ’ ( )
. 2006 5 「 」
68% , 80%
.
, ( ) ‘
’ (‘11.8.12) ,
2012
.
, 70%
,
59.5%( 85%: 70%*0.85)
. 1 ,
90% , 53.55% (59.5%*0.9)
- ( II-3).
- 2011. 12. 30. 「
」 , 2012. 1. 1. 「
」 , 2012 .
, 4 1 (
), 47.1% 6,506
1).
68%
2) ( , 2012). 2012
‘ ’
R&D , (
) 1
(68%) .
( )
’ ‘
, (
II-4).
< 이 > < 개선 >
[그림 Ⅱ-3] 제네릭 약가제도 개선 ·후 비교
: (2011.8)
[그림 Ⅱ-4] 제네릭 등 약가산정 상 의약품의 가격 산정 차도
주:1. 약제 여목록상의 투여경로, 성분, 함량 제형이 동일한 제품인 경우
2. 개발목표제품 상한 액의 90~110%로 산정(2011. 12. 30. 에는 80~90%로 산정)
3. 약제 여목록상의 투여경로, 성분 제형의 약제는 등재되어 있으나 함량만
다른 경우
4. 복합제란 2종 이상의 주성분을 함유하는 의약품을 의미하며 약제 여목록상 복
합제를 구성하는 개별 단일제와 동일제제가 있는 경우 개별 단일제 최고
가의 53.55%(2011. 12. 30 에는 68%)를 합산한 액으로 산정
5. ① 신청제품이 비교제품의 함량보다 많을 경우: {[(높은 함량/낮은 함량
-1)×0.5]+1}×근 한 함량의 상한 액의 53.55%(2011. 12. 30. 에는 68%)
② 신청제품이 비교제품의 함량보다 을 경우: {[(높은 함량/낮은 함량
-1)×0.5]+1}÷근 한 함량의 상한 액의 53.55%(2011. 12. 30. 에는 68%)
6. 기등재된 자사(동일업체)제품과 동일가로 산정
: , (2012.10)
제2 제네릭 의약품 사용권장과 련된 정책
1.
.
,
(International Nonproprietary name: INN)
(WHO) ,
,
(Guidelines on the Use of
INNs for Pharmaceutical Substances, 1997). INN
< 2> .
, , ,
.
( . , ).
. ,
, ,
(alternative proprietary names),
(Branded Generics) .
18 ( )
12 ( ) (
) ( ) ,
,
. 1
(’07. 9 – ’08. 6)
, 32% ( ,
2009).
.
.
1.
.
2.
.
3. (chemical class)
. ,
beta-blockers -ol , ACE-inhibitors -pril .
4.
.
. , .
5. ,
.
.
.
1) 품질(Quality)
, .
(Chemical equivalence:
), (Biological (bio-) equivalence:
(active drug) ), ( )
(Therapeutic (clinical) equivalence: )
.
.
(adjuvant ingredients) .
(a wide therapeutic index) ( . penicillins,
inhaled bronchodilators)
. (a narrow therapeutic index) , /
.
2) 방출 변형 제제(Modified-release formulations)
(standard-release formulations) (composition)
. .
The Medicines Control Agency(MCA)
. , the British National
Formulary(BNF) nifedipine diltiazem
,
.
3) 제조 책임(Product Liability)
, ( ) .
.
4) 환자의 수용성(Patient Acceptability)
, , ,
.
.
.
:
1)
2012 8 7 , (Prescription by
international non-proprietary name (INN)) “
(spending review)”
.
.
,
(the Italian Ministry of Health (MoH))
.
.
, .
(
) , .
,
.
2)
Farmindustria
,
INN “ (unsustainable)”
, “ ”
.
Italian Federation of General Practitioners(FIMMG)
, INN Italian
National Health Service
,
.
3)
,
.
,
( )
. (pro-branded culture)
.
(Godman, 2012)
2002 .
,
2.
.
. 2002 10 1 (reimbursed
drugs) , 5 22%
, 50% (Swedish
Pharmaceutical Benefits Board, 2008) 2005 70
SEK(7 5000 ) (Engström et al., 2006).
.
,
. , AUD$1.50
(Ping et al, 2010). , ,
(Ping et al, 2010). 35%
, (public prices)
(profit margin) ,
(Simoens
De Coster, 2006; Allenet Barry, 2003).
. branded generic
originator .
, .
,
(county) .
2002 , 2005 40%
, high-volume drugs
4~13% . TLV(reimbursement agency)
2
, Apoteket AB(national pharmacy chain)
( TLV
). TLV 2002 2005 70
(>6.97 billion SEK) . (tendering
process) 2011 80
.
TLV 2002 2005 70
. 1
. .
2009 ,
(ATC level 5), , package 1 extra .
,
, ,
, (washout period)
, 70% (crossed prescription
, 80%). .
. : 3)
‘ ’ ‘ ( )
, , ( 27 (
) 14 )’ .
, .
2012
. ,
27
, 2013
2012 20 ( 1.76% ) ,
.
. , ,
30% . “
”
.
2001. 7. 1. .
■
• ( )
-
-
, .
•
-
( 65720-1002 , 2001. 7. 2.)
- :
,
, 2012
, 2012 1
.
.
(A) (B) (B/A)
2010 456,311 295 0.063% 273,341 117,146
2011 476,346 402 0.085& 344,077 210,659
2012 489,154 406 0.083% 296,982 181,813
2013 6 246,633 220 0.089% 136,322 83,456
<표 Ⅱ-3> 동일성분 가약 체조제 실시 황 (단 : 천건, 천원, %)
2010 2011 2012 2013 6
(A) 21,096 21,079 20,958 20,968
(B) 13,581 12,531 11,182 10,535
(B/A) 64.4% 59.4% 53.4% 50.2%
<표 Ⅱ-4> 동일성분 가약 체조제 미실시 약국 황 (단 : 기 )
주1) 건강보험 약국 체조제 심사 결정분( 산매체, EDI)
주2) 체조제 건수: 약국 체조제 건 가약 인센티 지 이 발생한 건수만을 포함
주3) 체조제 감액 : (원처방약가 – 체조제약가 – 인센티 지 액) * 70%
※건강보험심사평가원 제출자료. 최동익 의원실 재구성
※건강보험심사평가원 제출자료. 최동익 의원실 재구성
.
1) 낮은 인센티 비율
30%
.
,
( , ‘13. 5 ) ,
(‘13. 11 )
. , ‘
’ 104 2 ,
.
.
2) 체조제 내역통보의 번거로움
,
,
, ,
.
3) “ 체조제 불가” 의 기 미비
.
, “ ”
,
,
, .
4) 병의원-약국 간 의존 계
,
.
-
4). ,
1
.
5) 생동성 인정 제네릭 의약품의 품질에 한 선입견
2006 ,
,
,
.
,
(
).
3.
( )
‘ ’ ,
.
, , ‘
( )’ , ,
,
,
,
. ,
,
.
.
( (the reference
group)) ( (the reference price))
. , .
,
.
(active substance), (pharmacological class),
(therapeutic class) ,
([ –5]).
[그림 Ⅱ-5] 유럽 국가별 참조그룹 결정 방법(2011년)
: European Generic Medicines Association. (2011). Market Review. Brussels, Belgium: European Generic Medicines Association.
( .
) .
. , , ,
(indication)
, (prescription
shift) .
, (prescription
shift) .
( . , ,
, , , , , , )
( . , , ,
) .
,
( . )
.
,
( . , ).
제3 제네릭 의약품 사용을 둘러싼 이해 계자들
1. :
,
,
.
, ,
.
(Theodorou et al,
2009).
,
.
,
, ‘ ’ 25.7%,
50.3%,
, ,
83% ( , 2013).
40%
36% ‘
(therapeutic failures are a serious problem with generic
products)’ (Barrett, 2005).
( ) , Vanderbilt University Medical Center (VUMC)
:
,
70
(Raffaele, 2008).
.
( . ) ,
.
– .
– .
,
. (formulary decision
support) (e-prescribing system)
(Fischer et
al, 2008).
.
Vanderbilt University Medical Center (VUMC)
, 32.1%
54.2%
(Stenner et al, 2010).
(변경 ): Pravachol( 랜드명)
(변경 후): Pravachol( 랜드명) 입력해도, Pravastatin(성분명)이 뜸
( ) ,
( ) ,
,
2.
,
.
5).
. ,
. ,
.
.
, 88.5%
‘ ’ (Ping et al, 2010).
2012
.
.
, ,
.
,
(Godman, 2012).
,
,
.
( ) (Dual monitor)
,
2013 2 , 3
(ㅅ ) 2013 3 31
, 27 , 4 87.1%
. 4 31 28 ,
3 90.3% .
1/3
*
-
,
KGMP
3. ( )
.
,
(
, 2006).
.
(medication adherence)
(Shrank et al, 2006). ,
(outcomes) (American
Medical Association, 2007).
(out-of-pocket costs) (adherence)
(Pham et al, 2007).
40% (Medco,
2005).
(Waber et al, 2008).
.
, ,
( , 2009).
Medicare
(Federman et al, 2006).
,
(Chen, A. Y., & Wu, S., 2008).
.
.
,
.
(2013. 8 ) ‘ ’
‘ ’ 1
19
1,000 ,
,
, 82.1%(
38.6% + 43.5%) , 6.0%
( 1.6% + 4.3%)
. , 30 ,
,
.
<표 Ⅱ-5> 응답자 특성표: 처방 받은 약과 성분과 효과가 같은 약 본
인부담 약에 한 의견 (단 : %)
: . (2013). .
.
, ,
‘ ’ .
.
4.
.
2003 4 ,
(Pharma Industry Finland, 2002; Timonen et al,
2006), ,
(Pharma Industry Finland, 2002).
, ,
package( : , , ) , R&D
(Pharma Industry
Finland, 2002; Vehkasaari, 2002; Lampila, 2003).
,
(Timonen et al, 2009).
,
.
(Honkanen, 2006; Andersin, 2007).
.
.
2012 ‘ ’
(‘11.12.30) .
(
- , 53.55%) .
. ,
ㆍ
,
.
R&D , (
) 1
(68%)
.
2015 15%
.
, 2012
,
.
.
(2013) , 2012 2013 1
, ,
, .
, ,
,
. ,
- . -
.
,
, ,
,
,
.
, 2014-15
.
2011 1 2012 1 2013 1
2,022,209 1,971,145 2,473,673
121,095 148,528 154,603
6.0% 7.5% 6.2%
<표 Ⅱ-6> 연도별 연구개발비 비 (43개 제약사) (단 : 백만원)
2010 2013 1
( II-6).
.
: (2013), , 8 2
-
, -
(
2012.12.7.).
.
,
.
.
,
( / ) ( / )
(
%)
100mg 4 21,281 2,553,720 127,686 100%
100mg
( )4 14,897 1,787,504 89,380 70%
4 14,471 1,736,530 86,826 68%
4 12,662 1,519,463 75,973 59.5%
CJ 100mg 4 4,916 589,920 29,495 23%
400mg 1 14,141 424,230 21,212 17%
<표 Ⅱ-7> 사례: “ 리벡”제네릭 의약품
( . – , )
.
,
.
: . (2013). . .
5.
, ,
.
/
,
- (
)
-
,
,
-
-
-
-
-
-
<표 Ⅱ-8> 이해 계자들의 견해 응 략
제3장 외국의 련정책 운 황
제1 국가별 제네릭 의약품 정책
1.
.
2010 14.8% 2000
13~15% ( , , 2012).
2010 1 640 US
, OECD 5 . 1997 ~2005 OECD
, OECD
3.7% ,
( , 2012).
.
.
. , ,
, 2002
15% 15
.
(demand-side regulation)(supply-side regulation)
Generic
reference
pricing
Therapeutic
reference
pricing
× ○ ○ ○ ○○
(lregressive)○(linear)
<표 Ⅲ-1> 독일의 약제비 통제를 한 규제
: Brekke, K. R. et al., 2010
reference
drug
reference
drug,
( )/
○ × ○
<표 Ⅲ-2> 독일의 의사, 약사 환자 상으로 한 가의약품 사용 증
진 방안
: KCE, 2010
.
.
, .
,
, . 2005
27,908 1,975 ( 7%, 4%)
.
level 1,2 3 . 1989
level 1 , 2006 level 2 3
, level 2 . 1989
, 2004
.
ATC
levelATC cluster
level
15 J05AB01
aciclovir
/
*
aciclovir
level
2
․4 C09CA ARB
candersartan, eprosartan,
irbesartan, olmesartan,
telmisartan, valsartan
level
33 N06A SSRI
fluoxetin, fluvoxamin,
paroxetin
<표 Ⅲ-3> 독일의 참조군 분류
* 제형 상이시 성분 동일해도 그루핑 되지 않음
.
2006 7 434
, 28,000 ,
.
,
,
.
(disincentive) . ,
,
.
.
. (Aut idem Rule)
2002 8 ,
. , 15% 15
.
.
7.6% .
(Busse et al., 2005). 2007 4
. “ ” , .
, .
,
. 2005
74.2% ,
57.3% ,
OECD
(Schwabe, 2007; ., 2012).
.
1) 약제비 감효과
2004 25
.
.
.
,
,
.
(
, 2012).
[그림 Ⅲ-1] 참조가격을 통한 보험재정 감액 비교 (단 : 억 유로)
: (2004)
1989
, 1993
. 1991 125
122 . 1994 1997
, .
5% , 1993 1994
.
1993 (Health Care Structure Act)
3 - . , ,
- 1 ,
18.8% . 1992 26
12
. 5 ,
5 . 60%
, 11.2%
,
(Busse and Howerth, 1999; ., 2012).
2.
.
2009 16.2% 2006
16% ( , 2012). 2010 15.8%
OECD 16.6% . 2010 1
626 US ,
OECD 8 ( , 2012).
.
1969 ~2010
,
,
30% . ,
(demand-side regulation)(supply-side regulation)
Generic
reference
pricing
Therapeuti
c reference
pricing*
○ × × ○ ○ ○(linear) ○(linear)
<표 Ⅲ-4> 벨기에의 약제비 통제를 한 규제
, .
2010 4 30%
30% .
.
.
,
, ,
.
*성분명 처방일 때는 약사의 체조제 가능
: KCE, 2010
reference
drugreference
drug,
( )× × ○
,
(
)
<표 Ⅲ-5> 벨기에의 의사, 약사 환자 상으로 한 가의약품 사용
증진 방안
: Brekke, K. R. et al., 2010
1) 참조가격제
2001 5 22 . 2001
5 (ATC-5), ,
, 2005 7 (ATC-5)
, 2006 1
esters, isomers .
case-by-case , esomeprazole
. 2009 5 “ ”
(availability) . ,
3 .
(reference price level)
30%(2005 7 ) ,
2001 16% . 2010 4
2 32.80%, 4 35.15%
(1 4 ). 2 2009 4
.
(reimbursement basis)
‘old' drugs 30%
2
-4%
4
-3.5%
12 15
: 15%40.50% 42.88% 44.88%
15 : 17% 41.90% 44.2% 46.2%
<표 Ⅲ-6> 벨기에의 참조가격제 ‘old' drugs 약가 인하로 인한 상환기 가
총 인하율
: Law of 23 23 December 2009
,
30% .
(supplement)
.
, .
,
3% UK 80%
.
2) 가의약품 최소비율 처방의무(low cost quota)(2006.4.1~)
(Speciality)(Quotas of low
cost prescriptions)
(Gynaecology-obstetric) 9 %
(Pneumology) 12%
(Rheumatology) 14%
(Paediatric) 14%
(Orthopaedic) 14%
(Neurosurgery) 15%
(Neurology) 15%
(Ophthalmology) 15%
(ORL) 15%
(Neuropsychiatry) 17%
(Physical medicine and rehabilitation) 17%
(Anaesthesiology-reanimation) 18%
(Plastic surgery) 19%
(Urology) 19%
(Dermatology-venereology) 21%
(Psychiatry) 21%
(Surgery) 22%
(Internal medicine) 24%
(General medicine) 27%
(Cardiology) 29%
(Gastroenterology) 30%
<표 Ⅲ-7> 벨기에의 문과목에 따른 가의약품 최소처방비율
. 2006 4 1 ( )
“ (cheap pharmaceuticals)”
. . ,
(GP) 27%, 30%, 29%, 15%,
14%, 9% .
(Radiotherapy-oncology) 30%
(Stomatology) 30%
(Dentistry) 30%
(Others specialities) 18%
,
. ,
.
, (accreditation)
,
. “ ”
(applied pharmacy retail price: PRP)
.
(generic substitution) ,
(International Nonproprietary Name: INN)
, “ ”
.
.
“ ”
.
․ ( .
)
․
․ (International Nonproprietary
Name: INN)
“ ”
. INAMI (Commission
for Good Prescription Evaluation)
,
(Quality accreditation system) .
,
. " “
,
(Vogler, S. et al., 2010; ., 2012).
3) 최 가 의약품(least costly) 처방 시작 의무 (2009년~)
6 ‘ ’
.
, 2009-2010 82.8%
. 10 8
( )
. INAMI ,
cost per DDD (
, , 2012).
2012
.
.
5% ,
.
, INAMI (
, 2012).
[그림 Ⅲ-2] 벨기에 최 가 체약 시
4) “Memento-Pharma"
,
(the Belgian Centre for Pharmacotherapeutic
Information, CBIP) .
, memento-pharma ,
, . ,
, , ,
.
.
1) 참조가격제 가의약품 처방의무 도입 효과
DDD 2000 ( ,
( , reference supplement
)) 1.1% 2001 6.6%
(4.2% , 2.4%). 2006
2004 17.2% 2006 37.1%
. 2008 40.3% 24.0%,
16.3%,
11.8% .
.
category B( 75%, 25%)
2003 3 16.2% 2006 4 37.7% . category
A( 100%) 26.5% ,
5%
.
2008
2,610 22.1% 4.5%
(
,
(reference supplement) ) .
2) 제네릭 의약품 사용
2000 2.48% 1.69% ,
2005 10.56% 9.09% 5 .
. 2009
15% .
( ) . ,
. INAMI Pharmanet
, (DDD ) 2000 1.05%
2005 16.7% .
30% .
[그림 Ⅲ-3] 벨기에의 외래 처방 제네릭 유율 2000~2005
VAT = + + + VAT(10%)
<표 Ⅲ-8> 오스트리아 약가 구조
3.
.
2010 12% 2000
12~13% ( , , 2012).
.
1) 의약품 가격 구조
, ( , OTC
) ,
. 9.5%,
9.0% , 29.6%,
20% ( ., 2010).
2) 제네릭 의약품 가격 결정
2004
. reimbursement
list EKO(Erstattungskodex, Reimbursement Code) Green Box
. (first follower, 1st F) 48%
, (2nd F)
[그림 Ⅲ-4] 오스트리아의 제네릭 의약품 가격 결정 단계
15% ,
(3rd F) 10%
. 3
30% ,
3 , ,
( ., 2010).
: HVB 2007
.
1) 제네릭 의약품 정보 제공
.
, “Helfen auch Sie sparen”
,
. (HVB)
(OEGV) .
2) 처방 가이드라인
(FASI)
Economic Guideline for Prescribing
Pharmaceuticals and medical Products , EKO Green
box(EKO 3 )
.
3) 의사처방 인센티
.
,
. ― ,
50% ― ,
,
.
,
, ( ,
, 2012; ., 2010).
.
.
2009 32.2%,
20.6% .
,
.
,
.
.
,
( , 2013).
4.
.
OECD .
2005 445 ( (purchasing
power parity conversion rate) ) , 1995 2005
3.7%(in real term) . 2005
21.9% .
.
. ,
, ,
.
1) 의사에 한 인센티
2002
(INN) ,
.
.
,
.
,
, . ‘
’ , INFARMED .
INFARMED
.
, (Pinto and
Teixeira, 2002).
,
.
(Simoens & De
Coster, 2006).
,
. , (rationale)
.
2) 약사에 한 인센티
2002 .
.
,
.
,
. /
, .
. (margins
amount) 2005 9 18.25% (a flat rate)
.
( (in absolute terms))
.
,
. ,
(discounts)
(Kanavos & Taylor, 2007).
.
3) 환자에 한 인센티
.
(INFARMED, 2006).
(endorsement)
,
(Figueiras et al, 2008).
,
.
.
.
. (reimbursement)
(2005 10 ), ,
(INN) ,
.
.
2004
NHS
, 15% 85% (Simoens 2009).
(by value)( .
) 2000 0.13% 2007 17.85%
, (by volume) 2007 11.67% .
5.
.
(UK)
. (England) ( ) 2008 ,
(by volume) 83% , 65%
, (by value) 25%
(Kullmann, 2010).
.
.
.
.
1) 제네릭 체 정책
(UK) ( ) .
,
. (England) NHS ( )
the Medicines Act 1968 the NHS Act 2006 . the
Medicines Act 1968 ,
.
. , ,
.
the NHS Act The NHS (Pharmaceutical Services) Regulations 2005
the NHS (Local Pharmaceutical Services etc.) Regulations 2006
,
,
.
The 2009 PPRS NHS
(affected parties) .
.
(a full public consultation)
.
. :
•
. proposals ,
NHS frontline delivery ,
.
• -
. (formal) (schemes)
(potential gain)
.
• ,
.
2013 2009 PPRS .
,
,
.
2) 성분명 처방 정책
, ․ ,
. the General Medical Council Good practice
guidance . “
(appropriateness), (effect), (cost) .”
, . (
( ) 2008 82.6%)
(Prescribing advisers) (GPs) (face
to face reviews) , (repeat prescribing etc
activity) .
, (GPs) ․
. (Local primary
care organisations) (incentive schemes)
, . ,
(performance
management arrangements) .
3) 처방 련 개
(Moon et al, 2011)
.
(high spend drug classes) (Scrutiny)
NICE ( pending generic)
(>£100m/year)
. NICE new therapies
.
(National generic first prescribing policy)
NHS
( ) .
(Generic anticipation policy)
.
• (Therapeutic substitution)
) (angiotensin receptor blockers) losartan
• (Reduced prescribing of combined formulations)
) simvastatin–ezetimibe angiotensin+diuretic
• (Active enantiomer to racemic
mixture substitution)
) esomeprazole omeprazole ; escitalopram citalopram
• (Rationalisation of unnecessary modified
release preparations)
) (sustained release formulations) ( .
standard release metformin)
• (Generic substitution)
) Plavix non-proprietary clopidogrel
<표 Ⅲ-9> 제네릭 환(generic switching)의 유형( 국)
(National therapeutic switching programmes)
(switching) ,
( III-9).
: MOON, J., FLETT, A. S., GODMAN, B. B., GROSSO, A. M., & WIERZBICKI, A. S. (2011). Getting better value from the NHS drugs budget. BMJ, 342(7787), 30-32.
4) 재정 , 규제 개
simvastatin,
losartan ( , GP,
) ‘0’
(prescription charge) .
,
, “me too” .
.
,
. (cost containment),
(enhanced patient acess to treatment),
(promotion of innovation and enhanced security of supply)
. NHS ,
,
, ,
– .
- .
, NHS
, , NHS .
.: NICE( ),
(local budget holders), , , (Department
of Health) , (“generic
first”) .
Statin (payback
time) .
scheme/payment
(General
Medical
Services (GMS))
(general practitioner (GP)) ,
(dependants)
(General Medical Services) .
(appliances)
. ,
, GMS Health
Service Executive(HSE) .
.
GMS Primary Care Reimbursement Service
, . 2010 10 1 ,
<표 Ⅲ-10> 아일랜드의 네 가지 주요 의약 제도(Pharmaceutical
Schemes), 무료 는 보조받는 의약품에 한 자격(Eligibility)(a)
statin, ACE inhibitor, proton pump
inhibitor , ,
.
6.
.
OECD
. , 2000 27
20 2005 31 9 , 2010 25 3
.
100 , 2000 46, 2005 58, 2010
70 . .
(Registered Medical Practitioner), ,
(Registered Nurse Prescriber), Contractor
/
€1.50(2013 1 ) ,
€19.50(2013 1 ) (limit) .
(prescription charge) HSE PCRS
(recoup) .
2011 12 31 (Claimant) (b): 1,507,152(
32.8%)
: €1,196 million
Drugs Payment
(DP)
GMS
(a monthly threshold)
Drugs Payment Scheme (
€144―2013 1 ).
2011 12 31 (Claimant) (c): 429,102 ( 9.3%)
(Total Cost of Prescriptions)(net)(d): €142 million
Long Term
Illness
Scheme (LTI)(e)
HSE , (long-term illnesses)
, LTI
(without charge) .
2011 12 31 (Claimant) (f): 59,274 ( 1.3%)
(Total Cost of Prescriptions): €118 million
High Tech
Drugs
(HTD)
High Tech Drugs initiate
, ,
. Health Service Executive , patient
care fee .
(the cost of the medicines) patient care fee Primary Care
Reimbursement Service .
: €368 million(a) 모든 값은 2011년과 련이 있다.
(b) 자격자(eligible persons) 수: 1,694,063 (인구의 36.9%)
(c) 자격자(eligible persons) 수: 1,518,241 (인구의 33.1%)
(d) 환자의 net co-payment
(e) 성 백 병(Acute Leukaemia), 정신(발달)장애(Mental Handicap), 뇌성마비(Cerebral
Palsy), 정신질환(Mental Illness (16세 미만)), 낭포성 섬유증(Cystic Fibrosis), 다발성 경화
증(Multiple Sclerosis), 요붕증(Diabetes Insipidus), 근이 양증(Muscular Dystrophies), 진성
당뇨병(Diabetes Mellitus), 킨슨병(Parkinsonism), 간질(Epilepsy), 페닐 톤뇨증
(Phenylketonuria), 우병(Haemophilia), 이분척추(Spina Bifida), 뇌수종(Hydrocephalus), 탈
리도마이드 사용으로 인한 질환들(Conditions arising from the use of Thalidomide)
(f) 자격자(eligible persons) 수: 142,585 (인구의 3.1%)
: Health Service Executive(HSE)(2013); personal communication, 20135 23
2000
. (Ex-factory prices)
. (Wholesale mark-ups) ,
(retail or pharmacy mark-ups) .
.
. , ,
.
.
.
( . ( )(single source in-patent))
EU .
.
(discount) .
(pharmaceutical representative bodies)
(discount) ,
.
(wholesale mark-up) 2008 3 17.66% , stages
―2009 7 , 2011 6 ― 8% (Gorecki et al, 2012).
DP LTI (pharmacy mark-ups) ,
(dispensing fee) , 2009 7
50% 20% . ,
(
) , . , 2013
Health (Pricing and Supply of Medical Goods) Act 2013
(reference pricing) (generic substitution)
.
.
GMS
2010 2012 50% .
EU ,
, (generic
penetration)
.
.
.: ;
‘
(dispense as written)’ ;
; . , 2010
2012
. GMS scheme
2010 2012 50%
.
1) Health (Pricing and Supply of Medical Goods) Act 2013
Health (Pricing and Supply of Medical Goods) Act 2013
. .
, (Irish
Medicines Board: IMB) .
.
,
. IMB statins, PPIs,
ACE inhibitors, angiotensin II receptor blockers 20
.
①
Health Act 2013 24(3) (section 24(3)) HSE
:
a) (the relevant listed items)
,
b) (the value for money),
c)
(the equivalent relevant prices)( ),
d) ,
e) ,
f) ․
(
(section) ) .
IPHA, APMI
(f) .
.
24 ,
, . ,
6 .
( ) , .:
• (high volume)
(tendering system)
• 2012–2015 /IPHA ,
•
(
)
•
, (claw backs)
.
②
Health Act 2013
. Health Act 2013
.
.
,
;
, (
) . ATC 5 level
. (ATC 4 level) Health Act 2013
.
Health Act 2013
(surrounding documentation)( . the RIA)
, Health Act
2013
. Health Act 2013
.
HSE
. , .
. , Health Act 2013 ,
, ,
(kickbacks), .
(cash-paying patient)
, , level
(price disclosure) .
IMB 20
(post) .
.
Health Act 2013
.
6).
.
pharmaceutical representative bodies
trade associations .
9 , 2
( )
.
.
(pharmacoeconomic assessment) .
(multiple source off-patent
pharmaceuticals) (agreement) .:
/IPHA(Irish Pharmaceutical Healthcare Association),
/APMI(Association of Pharmaceutical Manufacturers of Ireland).
,
,
. , 9 (basket)
(external reference price)
(benchmark) .
.
1) The State/IPHA Agreements
IPHA , ,
,
. (< Ⅲ-11>)
, .
(Agreement
Duration)
(State Signatories)
(Pricing Principles)
2006 9 1 -2010
8 31 (HSE)
First stage: /IPHA 6 ,
(pre-entry price) 20% .
Second stage: First stage 22 ,
15% . (b)
35%.
2010 2 1 -2012
3 1 (HSE)
2006 -2010 /IPHA 2010 2 1
,
40% . (b)
61%(c).
2006 -2010 /IPHA 2010 2 1
first stage ,
40% , second stage (b)
9% .
61%(d).
2010 2 1
, 2006 -2010 /IPHA
.
2012 6 18 -2012
10 31 (DoH)
2012 6 18 2006 ~2010 /IPHA
first stage
, 10% . (b) 30%.
2012 11 1 -2015
10 31 (DoH and
HSE)
40% ,
2012 11(b)
60% ; 12
10% . (b)
50%.
<표 Ⅲ-11> 아일랜드의 특허 만료 의약품의 가격(the Patent-Holder's
Price for Off-Patent Pharmaceuticals with Generic Competition) 결정(a), 국
가와 IPHA의 가격 정, 2006-2015
2012 11 1
. first stage, 30% ; second stage,
12 20% . (b) 50%.
(a) 이 표는 특허가 만료되고 the Irish Medicines Board 는 the European Commission에
의해 승인된 동일한 제형의 의약품이 있으며, 국가 제도(State schemes), State-funded
hospitals, 국가기 (State agencies) 하에서 처방이 가능한 의약품에 해 설명하는 것
이다. 이 기 들을 만족하는 의약품은 제네릭 경쟁을 하고 있는 것을 의미한다.
(b) 특허 보유자의 가격은 신약 가격 결정 규칙에 따라 결정된다.
(c) 2006-2010 국가/IPHA 정 하에서 가격인하는 35% 다. 만일 특허 보유자의 제네릭
진입 이 가격이 100이라면 그 가격은 65로 인하된다. 65의 40%는 26이므로 이 가격
은 이제 39 는 특허 보유자의 제네릭 진입 이 가격에 비해 61% 인하한 것이 된다.
(d) 2006-2010 국가/IPHA 정 하에서 first stage 가격 인하는 20% 다. 만일 제네릭 진입
특허 보유자 가격이 100이었다면, 가격은 80으로 인하된다. 80의 40%는 32이므로
가격은 48로 떨어진다. second stage 가격인하는 제네릭 진입 특허 보유자 가격의
9% 인하이며, 따라서 가격은 39가 되며, 제네릭 진입 특허 보유자 가격에 비하면
61% 인하가 된 것이 된다.
: HSE(Health Service Executive)
, 2006-2010 /IPHA 2012-2015
/IPHA
arrangements [ Ⅲ-5] .
stages . ,
, (35% , 50%) .
.
[그림 Ⅲ-5] 아일랜드의 특허 만료 의약품의 가격(the Patent-Holder's Price
for Off-Patent Pharmaceuticals with Generic Competition(a)) 결정, 국가와
IPHA의 가격 정, 2006-2015
(a) 2006-2010 국가/IPHA 정 하에서 first stage 가격 인하는 제네릭이 처음 시장에 나
타나고 6개월 후에 일어나며, second stage는 22개월 후에 일어난다. 2012-2015 국가
/IPHA 정 하에서 first stage 가격 인하는 제네릭이 처음 시장에 나타났을 때 이루어지
며, second stage는 12개월 후에 일어난다.
2) The State/APMI Agreements
/APMI /IPHA . IPHA
, AMPI .
( ,
) .
/APMI < Ⅲ-12>
.
(Agreement
Duration)
(State Signatories)
(Pricing Principles)
2006 9 10 -2010
9 9
(HSE)
2006-2010 /APMI
.
2006-2010 /IPHA
. ,
.
2010 10 1 –2012
3 1 (b)
(HSE)
2010 10 1 : APMI existing
2% ; APMI
(2010 2 1 )
5.6%
2012 11 1 -2015
(DoH and HSE)
2012 11 1
50% .(c)
Health(Pricing and Supply of Medical Goods) Act 2013
, (interchangeable
pharmaceutical groups)
60%(c).
Health(Pricing and Supply of Medical Goods) Act 2013
, (interchangeable
<표 Ⅲ-12> 아일랜드의 제네릭 약가(the Generic Price for Off-Patent
Pharmaceuticals with Generic Competition) 결정(a), 국가와 APMI의 가격
정, 2006-2015
(relative
to) . 2006-2010 /APMI
35% . 2012-2015
/APMI 50%~60% .
pharmaceutical groups)
52.5%(c)
.
50%
. ,
60%(c)
.
,
50% ,
52.5% .(c)
(a) 이 표는 특허가 만료되고 the Irish Medicines Board 는 the European Commission에
의해 승인된 동일한 제형의 의약품이 있으며, 국가 제도(State schemes),
State-funded hospitals, 국가기 (State agencies) 하에서 처방이 가능한 의약품에
해 설명하는 것이다. 이 기 들을 만족하는 의약품은 제네릭 경쟁을 하고 있는 것을
의미한다.
(b) 2010년 12월에 국가는 IPHA와 2011년 1월부터 약가를 인하하는 정을 맺었다. APMI
는 동등한 가격 인하를 시작했지만, 2011년 8월까지는 아니었다.(그래서 2011년 한
기간의 제네릭 약가는 동등한 의약품의 특허 보유자를 상회했다.) 그러나, 만일 특허
보유자 가격 인하와 동등해야 하는 APMI 멤버의 가격인하가 40%를 넘고, APMI 멤
버의 의약품을 생존 불가능(non-viable)하도록 한다면, 제네릭 약가를 동등한 의약품
에 한 특허 보유자 가격을 상회하도록 하는 심사 메커니즘(a review mechanism)이
시작된다. 이것은 외 인 경우에만 허용된다.
(c) 특허 보유자의 가격은 신약 가격 결정 규칙에 따라 결정된다.
: HSE(Health Service Executive) DoH(Department of Health)
. 2006-2010
APMI/IPHA
. 2010 2012 ,
APMI/IPHA ,
Existing5%
.
20%
.
New
29% (b);
5%
.
20%
.
(a) 이 표는 참조 가격이 결정되는 지 은 다루지 않는다.
(b) 이것은 처음에 제네릭 약가가 50%에서 결정되고, 특허 보유자 가격은 제네릭 진입
이 가격의 70%로 결정되는 것을 반 한다. 그래서 제네릭 의약품은 20/70=28.57%
더 낮다.
<표 Ⅲ-13> 아일랜드의 특허보유자와 제네릭 공장도 가격, Health(Pricing
and Supply of Medical Goods) Act 2013의 시행, 국가와 IPHA/APMI 간 정
들, 2012-2015(a)
. 2006
2012
.
2012-2015 APMI/IPHA
Health(Pricing and Supply of
Medical Goods) Act 2013
. <
Ⅲ-13> .
.
20% .
(5%) , ( 29%, 5%).
2013 ,
,
.
, 5% .
[그림 Ⅲ-6] 아일랜드의 제네릭 제조사들과 상호 체 가능한 의약품 그룹
내 특허 만료 후 다수 제조자가 존재하는 의약품의 가격 결정―그림
설명 시
*정상수익률- 제네릭 제조사들에 의한 할인 보고(widespread reports of discounting)를 기반
으로 제네릭 원가를 가정한다.
7.
.
(non-essential
features) ( . active enantiomer )
,
‘Evergreening’
, (dubious secondary patents)
.
Evergreening (tactics) ‘ ’ . ,
, ,
3 .
,
.
, ,
.
The Pharmaceutical Sector Inquiry 2000 2008
(patent settlement agreements)
. 50%
.
,
,
.
,
( . ) .
(Pricing) (Reimbursement)
(≤90 ) (＞90 ) (≤90 ) (＞90 )
,
, ,
,
, ,
,
,
, ,
, ,
,
, ,
,
, ,
,
,
, ,
, ,
: European Generic Medicines Association. (2011). Market Review. Brussels, Belgium: European Generic Medicines Association.
<표 III-14> 2011년 제네릭 의약품의 가격책정과 상환율 결정 기한
(timelimes)
(the day of application) 90
90
. 2011
.
.
․ /
.
: ( ), (
), ( ),
( ),
co-payments ( ),
( ),
( ), ,
( ) : .
( , , , )
( . ).
(comparable) .
․ ,
. WHO
.
(price linkage),
.
. , 2008
60% .
,
60% 42% .
. ( . )
(competitive bidding process)
. ,
,
,
. ,
.
, , ,
, , ,
, ,
, , , ,
: European Generic Medicines Association. (2011). Market Review. Brussels, Belgium: European Generic Medicines Association.
<표 III-15> 제네릭 의약품에 한 수요 심 정책들(2011년)
, .
, ,
.
.
,
/ ‘ ’ .
,
, , (key policy driver)
. ,
, ,
.
, 2011
(key policy driver) .
( . 3
) . ,
.
1) 의사 상 정책
: (pharmaceutical prescription
budgets) (prescription quota),
(instruments), .
,
.
,
, .
(measures)
. 2011 70%
(instruments) . 11
, 7 , 7
(independent body) , 7
. , ,
.
( ), matrix
models, peer-review meetings, quality circles
.
( )
.
.
(Is compulsory) , , ,
(Is encouraged) , , ,
<표 III-16> 유럽 국가별 성분명 처방(2011년)
: European Generic Medicines Association. (2011). Market Review. Brussels, Belgium: European Generic Medicines Association.
2) 약사 상 정책
.
,
( ) .
, .
(Is compulsory) , , , , ,
(Is encouraged), , , , , ,
, ,
: European Generic Medicines Association. (2011). Market Review. Brussels, Belgium: European Generic Medicines Association.
<표 III-17> 유럽 국가별 약사 제네릭 체조제(2011년)
. , ,
,
.: a)
, b) .
,
/
.
(beliefs)
.
, , .
3) 환자 상 정책
: , ,
.
,
co-payment , .
.
co-payment
. 2006 10%
co-payment
.
. ,
.
,
,
.
(Target) (Materials)
Generic medicines, find the
differencesTV, point-of-sale material 2001
Generic medicines, people
deserve itpoint-of-sale material 2002-03
Generics, equal quality
different price
TV, , , point-of-sale
material2004
Quality, safety and
efficacy. Generics. You
can trust.
TV, , outdoors and
point-of-sale material2007-08
Don't you think that being
ill already costs enough
/, point-of-sale material 2009
You save, we all save TV, 2010: Gomes M. (2012). Medicines policy: surviving the crisis. European Commission
technical seminar in the framework of technical assistance to Greece Moving toward a responsible consumption of healthcare products'. 2012. Athens, Greece. 27-3-2012.
<표 III-18> 포르투갈의 제네릭 의약품에 한 정보 캠페인
/ ,
.
,
.
.
1) 제네릭 시장 유
[ III-7] (
units ) 2006 2012 .
( . , , , ,
, , , ) 2006 40%
, 2012 50% .
[그림 III-7] 유럽 국가별 제네릭 의약품 시장 유(수량 기 )
주: 네덜란드는 2006년 데이터 신 2007년 데이터 사용
: IMS Health. (2013). MIDAS. London, IMS Health.
( ) 2006 2012
([ III–8]).
.
.
[그림 III-8] 유럽 국가 이미 포화된 제네릭 의약품 시장(mature
market)의 시장 유( 액 기 )
주: 네덜란드는 2006년 데이터 신 2007년 데이터 사용
: IMS Health. (2013). MIDAS. London, IMS Health.
, 2006 2012
(
, , , ) ;
( , , , , )
. (the former) ,
, 2006
,
(< III-19>).
.
:
1. + + + + - +/- - - -
2. /+/- + + + + - + - -
3. - + + + - - - - -
4. + + +/- + - - + - -
5. + + + + +/- +/- +/- - -
6. + - + + - + - + -
7. + + + + - +/- - + -
<표 III-19> 유럽 국가별 제네릭 의약품 시장을 발 시키기 한 주요 권
고사항 시행(2012 이후)
2) 제네릭 체조제로 인한 잠재 감 비용
7 ( , , , , EL, ,
) (2012 2016 )
(net budget impact) (net budget
impact) (European Commission, 2012).
190 .: 300 ,
110 . 7
spending 20% .
(in volume and value) (2010
) 80%
( ) ,
33%, 430 .([ Ⅲ-9])7)
(in volume)
.
40%
. ,
. EGA
300 (EGA, 2009). Simoens(2006, 2011a, 2011b)
48% ,
, 160
. EGA (2011) 9 2010 260
.
[그림 III-9] 제네릭 시장 유(volume)를 80%까지 증가시켰을 때의 잠재
감분(백만 유로, 2009년 공공 약제비 지출의 %)
주: 오른쪽 그래 에서 유럽연합의 지출은 10으로 나눴다. 키 로스: 공공부분만.
: IMS (2010), EGA (2011), Commission services (DG ECFIN).
[그림 III-10] 미국의 제네릭 경쟁과 평균 상 가격
8.
.
,
. [ III-10]
(=
/ )
.
.
(new drug approval: NDA)
ANDA(Abbreviated new drug approval) .
Orange Book
(Approved Drug Products
with Therapeutic Equivalence Evaluations) . Orange
Book 1980 FDA
(innovator company)
“ ”
indications .
FDA , ,
FDA ,
FDA
.
.
‘step therapy’( ,
) ,
health plan pharmacy benefits manager
(prior
authorization) (Shrank et al., 2010).
"positive formulary" ,
"negative formulary" ,
Orange Book positive negative
, ,
(Shrank et al., 2010).
. , ‘ ’ , ‘
’ .
(states) (territories)
Orange BookOrange Book : 32
Orange Book : 20
/
(Madatory/Permis
sive substitution)
: 12
: 40
(State drug formulary)
positive: 15
negative: 5
/: 40
: 12
: 33
: 17
: 8
NTI* NTI : 5
*NTI: narrow therapeutic index.
: National Association of Boards of Pharmacy. (2006). Survey of Pharmacy Laws, XIX: Drug product selection laws.State regulations on generic substitution(2007), Pharmacist's Letter, 22:220901, 2006. Retrieved April 15, 2008, from http://www.pharmacistsletter.com/ (S(grtd3055rt3i2cb0c14kjh23))/pl/ArticleDD.aspx?nidchk=1&cs=FACULTY&s=PL&pt=2&dd=220901#STATE Christensen, T. P., Kirking, D. M., Ascione, F. J., Welage, L. S., & Gaither, C. A. (2001). Drug product selection: legal issues. Journal of the American Pharmaceutical Association (Washington, DC: 1996), 41(6), 868.
<표 III-20> 미국 제네릭 체 련 법의 존재 유무
, .
< III-20> .
. ,
, ,
.
.
. (Board of Pharmacy)
Orange Book .
Kentucky (Board of Pharmacy) Narrow
Therapeutic Index (NTI) .
(Board of Pharmacy) NTI
. (Board of Pharmacy)
.: “1) NTI :
lithium; 2) Premarin Synthroid; 3) ‘Critical drugs':
anticoagulants, anticonvulsants, anti-asthmatics( time-release products),
insulin, (cardiac glycosides).” “ A
(A-rated products) ,
(unrated products)
.”
(NTI)
, FDA 1997 NTI
. 1995 FDA
NTI . 1990 , FDA
the Acting Commissioner
FDA NTI Orange Book
.
.
1) Zocor 사례(Shrank et al., 2010)
Shrank (2010) (states)
Zocor
simvastatin( )
Medicaid .
, 6 ,
simvastatin 48.7% .
statin 30% .
6 ,
simvastatin 98.1% ,
simvastatin 33% . Zocor
simvastatin
. Zocor
5 24.8% .
,
25% .
Medicaid
3 1
.
2) Generic-only Drug Benefits의 효과(Tseng et al., 2006)
Tseng (2006)
(Generic-only Drug Benefits)
Medicare managed care
plan .
611 (63% ) ,
(brand name coverage)
. ,
.
nonsedating antihistamines proton pump inhibitors
"nonessential" .
9.
.
.
2002 30 USD 2008 42 USD , 40%
(Department of Health, Executive Yuan, 2007; Liou, W. S. et al.,
2013). 2008 4,970 NTD( 19 ) ,
1,250 NTD( 4.8 ) 5.5%
. OECD
29% ,
25% (
, , 2012; , 2012).
'98 '99 '00 '01 '02 '03 '04 '05 '06 '07 '08
2,909 3,166 3,260 3,417 3,709 3,839 4,388 4,524 2,564 4,738 4,971
722 804 829 847 905 945 1,094 1,121 1,141 1,170 1,250
(%) 24.8 25.4 25.4 24.8 24.4 24.6 24.9 24.8 44.5 24.7 25.1
<표 Ⅲ-21> 만의 진료비 비 약품비 비 (단 : 억 NT$)
.
(Bureau of National Health Insurance(BNHI)) NHI
. co-payment,
(existing products) (inter-brand comparison),
(market price and volume survey),
, (grouping)(
), (global budget
payment system), 1 (flat daily payment rate)
(Lee, T. L. et al., 2008).
(Demand-side)
Negative and positive list (formulary) 1995. 3~
Drug co-payment 1999. 8~
(Supply-side)
Price-setting/freeze: payment price 1996. 11~
Limit payment rate for clinics 1995. 3~
(flat rate per day) –optional
(Price adjustment)
List price1996, 1997, 2000,
2001, 2003
Flat payment rate 2002. 1~
(Global budget)
(Clinics) 2001. 7~
(Hospitals) 2002. 7~
Management and utilization control
Regional financial responsibility 1999. 5~2001. 2
Utilization review/profiling 1995. 3~
(Practice guideline) 1995. 6~
(Auditing) 1995. 3~
<표 Ⅲ-22> 만의 약제비 감을 한 수요, 공 심 략 (1995-2003)
: Lee, T. L. et al., 2006.
. : (grouping)
, the National Insurance Drug List
(Lee et al., 2008). BNHI
(BNHI,
2008). , content, volume,
.
.
, 2001 BNHI
(grouping) . , content, volume,
.
. : ① R&D
(branded drugs), ②
(BA/BE (generics)), ③
BA/BE (common (generics))(BNHI,
2011).
① BNHI 10 (A10)( ,
, , , , , , , , )
. BA/BE
10 (median prices)
. 10 85%
.
② BA/BE 80%
. PBS BA/BE
.
③ 80% ,
BA/BE .
, . BNHI
.
,
( 8)) (Price Volume
Surveys) ( ,
, 2012). BNHI
,
(BNHI, 2008).
BNHI
1999 2001 , 2002
20%
, 2003 2 1
. ( )
.
, ,
(Grouping)
. ,
[그림 Ⅲ-11] 만의 특허만료의약품의 약가 조정 기
NHI
, NHI .
.
.
(Chen et al., 2008) ,
2001 ,
.
50% Anatomical Therapeutic
Classification (ATC) .
, 2001 (grouping)
(daily expense)
( 14.8%, 5.8%, 5.8% ). ,
(volume) . ,
.
(knock-on effects)
.
.
.
.
(the Department of Health (DOH))
. ,
Good Manufacturing Practice guide of the Pharmaceutical Inspection
Convention and Pharmaceutical Inspection Cooperation Scheme
(PIC/S GMP) ,
, .
BNHI ,
,
. 2010 90%
(Liu, Y. M., and Cheng, J. S., 2012).
( ). 1
(
., 2010).
.
1) 방해요인
,
(hospital formularies) .
, (on-site pharmacies)
. (refill prescriptions for chronic
disorders (RPCD)) .
.
, .
(on-site pharmacies)
, (gateway pharmacy(G-pharmacies))
(Lee, Y. C. et al., 2007).
RPCDs
.
.
.
.
1997 ,
.
(G-pharmacies) .
, medical centers,
metropolitan hospitals, community hospitals
(on-site pharmacists)
(committee board) , - -
. (on-site
pharmacists) (gateway pharmacies) (Lee, Y.
C. et al., 2007).
. NHI ,
(co-payment)
200NTD .
, (reimbursement prices)
(acquisition prices) (profit margins) ,
.
(Liu, Y. M., and Cheng, J. S.,
2012), , (lagged number of
generic competitors),
. Morton, F. M. S.(1999)
.
(countervailing power) .
(rent-seeking) .
(double-checking function) ,
.
2) 지지요인; Payment system
Liu, Y. M. et al.(2009) /
. , ‘
(financial incentives)’ .
(Global budget)
(fee-for-services system)
.
. ,
.
.
.
( )
.
(1 (per diem drug fee))
. 22 TWD 22 TWD ,
. 22
TWD ( ,
2011; , 2012).
10.
.
. , ,
.
( ) 70%
.
. , 20
90% ,
( ) 4~6% .( 6% .)
(Biosimilar) 70%
, 10%
77% (
, , 2012).
. : 5 Action Plan(MHLW, 2012)
(Ministry of Health, Labour and Welfare, MHLW)
,
2007 10 “
(the Action Program for Promotion of the
Safe Use of Generic Drugs)” .
.: [1]
(stable supply of the drugs), [2] (assurance of
the quality of the drug), [3]
(appropriate provision of information by generic manufacturers), [4]
(creation of the
appropriate environment for promotion of the use of these drugs), [5]
(matters related to the health
insurance system).
[그림 Ⅲ-12] 일본의 후발의약품(제네릭 의약품) 안심사용 진 조치
로그램(개요)
. 2012 “ 30% ”
.
, ,
the National Institute of Health Sciences “Generic
Medicines Quality Information/Investigation Committee”
, .
(Japan Generic
Medicine Association, JGA) IT
.
[그림 Ⅲ-13] 일본의 제네릭 의약품 품질보증 사례
[그림 Ⅲ-14] 일본의 제네릭 의약품 정보 공 시스템
. : 2012
,
,
,
.
2012 4 1)
, 2)
, 3)
, 4) (generic name) , 5)
.
1) 보험 약국의 조제 기본료의 후발 의약품 조제 체제 가산 검토
( ) 20% , 25% 30% ,
.
( ) ,
.
22% , 30% 35%
.
【 】
( )
3 (
)
.:
1. 20 % 6
2. 25 % 13
3. 30 % 17
【 】
( )
3 (
)
.:
1. 22 % 5 ( )
2. 30 % 15 ( )
3. 35 % 19 ( )
<표 Ⅲ-23> 일본의 조제료 가산에 한 개정 내용
※1 후발 의약품의 조제 수량의 비율을 계산할 때, enteral nuitrient solutions 특수 우유
제제, 한방 제제 crud herbal drugs은 후발 의약품의 조제 수량의 비율을 산출할 때
분모에서 제외하기로 한다.
※2 (생략)
2) 약제 정보 제공 기술을 활용한 제네릭 의약품에 한 정보 제공
(notification)
,
.
"
" " "
.
“ (Drug Information
Provision Sheets)” (
, ) .
【 】 ( )
30
【 】
20%
.
【 】
( )
1 35 ( )
2 28 ( )
【 】
1
30%
.
2
20%
.
<표 Ⅲ-24> 일본의 진료 보수 평가 개정 내용
3) 의료기 의 제네릭 의약품 극 사용 평가
,
.
4) 일반명 처방의 추진
" " .
,
.
【 】
1. 7 (
, 2
)
40
2 68
【 】
1. 7 (
, 2
)
40
2. 68
( )
2
.
<표 Ⅲ-25> 일본의 일반명 처방에 한 개정 내용
5) 처방 양식 변경
2008 "
" ,
. 2012
.
.
[그림 Ⅲ-15] 일본의 새로운 처방 양식(안)
.
2012 1 · "
“9)
.
· ,
(prioritization)· .
.
,
.
.
2011 9 22.8%
, 2013 3
24.8%, 25.6% ,
26.3% .
, ,
, "
(2013)" (MHLW, 2013).
“ 2018 3 60% ”
. ( , 2013).
①
②
③
④
⑤
⑥
<표 Ⅲ-26> 일본의 후발 의약품의 추가 사용 진을 한 로드맵(2013) 주요 추
진 내용
.
2011 ,
· 631 ( )
, 2011 56 1,339
78.3%, 21.7% .
2,638 , 91.5%,
8.5% .
( ) 64.6% ,
23.3%
. 880 ,
456 .
2012 4 2013 3
,
.
[그림 Ⅲ-16] 후발품으로 체 가능한 선발품을
가장 렴한 후발품으로 바꿀 시 감 효과(일본)
[그림 Ⅲ-17] 일본의 제네릭 의약품 시장 유율
* 2009년도부터 조사방법이 변화했기 때문에, 2008년도 이 과 2009년도 이후의 수치는 단
순히 비교할 수 없다.; 수량: 출하수량, 액: 약가기 .
: ( IMS )
제2 외국제도 종합 시사
,
, ,
.
.
.
.
, , ,
,
.
,
.
.
,
.
.
Health Act 2013 ,
.
.
.
, ,
.
,
,
, .
.
.
1 (per diem drug fee)
.
. 1980
.
, ,
, ,
.
,
, 2008 5
.
, ,
,
2008 17.6% 2012 25.8%
. 2012
,
( . ), ( )
, .
.
.
제4장 동일성분내 체가능 품목 가격 사용 황
제1 기 황
1.
.
, , , , ,
, , , ( / ), ,
.
‘ / / ’ ,
‘ / / ’
.
, ( )
.
2.
2006 4 2013 4
,
. 2013 1
5,401 2013 4 6,145 ,
2009 9 361 2013 4 972 2.7 (
Ⅳ-1 ).
[그림 Ⅳ-1] 체조제 인센티 지 상 의약품의 품목 성분 개수
추이(2006.4∼2013.4)
2007 2013
, 2007
14 2013 6 1 1
2007 15 2013 13 .
, .
200~299 ,
100~199 .
( Ⅳ-1 ).
2007.1 2008.2 2009.1 2010.1 2011.3 2012.1 2013.1
3,462 3,775 3,777 4,106 4,255 4,813 5,401
246 275 328 652 685 692 926
14 14 12 6 6 7 6
(1 1 )15 16 14 13 12 13 13
(A) 3,370 3,676 3,685 3,970 4,112 4,726 5,299
(C) 92 99 92 136 143 87 102
* 100~199 926 1,017 986 1,157 1,235 1,329 1,541
200~299 1,581 1,691 1,637 1,716 1,748 2,054 2,265
300~399 359 401 475 533 588 673 757
400~499 4 3 17 24 30 29 55
600~699 592 663 662 676 654 728 779
800~899 - - - - - - 4
3,395 3,716 3,724 4,018 4,167 4,746 5,334
67 59 53 88 88 67 67
<표 Ⅳ-1> 체조제 인센티 지 의약품목 황 (2007.1∼2013.1)
( : )
* 100~199: 신경계 감각기 용 의약품, 200~299: 개개의 기 계용 의약품, 300~399: 상성의
약품, 400~499: 조직세포의 기능용 의약품, 600~699: 항병원생물성 의약품, 800~899: 마약
(2007.1~2013.1) , 2007 2009
2~5 , 2010
1
( Ⅳ-2 ).
[그림 Ⅳ-2] 연도별 성분내 품목수(2007.1∼2013.1)
제2 우리나라 제네릭 의약품의 특성
1.
2013 1 926 ,
4,629 ,
.
Health and Social Care Board
( 1 < 1> < 3>)
.
.
, – (branded
generic) – . 1
.
WHOCC(WHO Collaborating Centre for Drug
Statistics Methodology) ATC/DDD Index 2013 ( :
'olmesartan medoxomil' , ‘ ’
). ‘… ’, ‘… ’, ‘… ’, ‘… ’
, ‘ …’
( : ‘ ’ , ‘ ’
).
926
, , (2013 8 )
.
.
FDA electronic orange
book (Approved Drug
Products with Therapeutic Equivalence Evaluations)
/ / .
2.
< 3> . 926 51 (5.5%), 4,629
143 (3.1%) UK Health and Social Care Board
. 926 33 ,
4,629 61
( 2 1 10 )
.
2013 1
< Ⅳ-2> < Ⅳ-3> . 4,629
11.8%
. 14.8%,
48.6% , 11.4%,
6.5%, ․ ․
6.3%(4,629 292 ) .
,
600~699 25.2%
. , ,
.
(%)(%) (%) (%)
4,629(100.0) 545 11.8 684 14.8 2,249 48.6
4,548(98.3) 544 12.0 682 15.0 2,221 48.8
81(1.7) 1 1.2 2 2.5 28 34.6
*
100~199 1,311(28.3) 96 7.3 134 10.2 668 51.0
200~299 1,960(42.3) 229 11.7 297 15.2 932 47.6
300~399 613(13.2) 38 6.2 57 9.3 335 54.6
400~499 27(0.6) 1 3.7 1 3.7 11 40.7
600~699 718(15.5) 181 25.2 195 27.2 303 42.2
800~899 - - - - - - -
4,582(99.0) 537 11.7 676 14.8 2,232 48.7
47(1.0) 8 17.0 8 17.0 17 36.2
2~5 561(12.1) 49 8.7 74 13.2 352 62.7
6~10 660(14.3) 60 9.1 81 12.3 429 65.0
11~30 1,318(28.5) 144 10.9 182 13.8 755 57.3
31 2,090(45.2) 292 14.0 347 16.6 713 34.1
350(7.6) 5 1.4 49 14.0 256 73.1
4,279(92.4) 540 12.6 635 14.8 1993 46.6
405(8.7) 20 4.9 57 14.1 276 68.1
4,224(91.3) 525 12.4 627 14.8 1,973 46.7
<표 Ⅳ-2> 가약 체조제 인센티 지 상 품목의 제품명 분석(계속)
* 100~199: 신경계 감각기 용 의약품, 200~299: 개개의 기 계용 의약품, 300~399: 상성의
약품, 400~499: 조직세포의 기능용 의약품, 600~699: 항병원생물성 의약품, 800~899: 마약
(%)
(%) (%) (%)
4,629(100.0) 530 11.4 300 6.5 292 6.3
4,548(98.3) 529 11.6 300 6.6 292 6.4
81(1.7) 1 1.2 0 0.0 0 0.0
*
100~199 1,311(28.3) 95 7.2 49 3.7 48 3.7
200~299 1,960(42.3) 223 11.4 132 6.7 127 6.5
300~399 613(13.2) 37 6.0 26 4.2 26 4.2
400~499 27(0.6) 1 3.7 1 3.7 1 3.7
600~699 718(15.5) 174 24.2 92 12.8 90 12.5
800~899 - - - - - - -
4,582(99.0) 523 11.4 296 6.5 289 6.3
47(1.0) 7 14.9 4 8.5 3 6.4
2~5 561(12.1) 46 8.2 39 7.0 36 6.4
6~10 660(14.3) 60 9.1 44 6.7 44 6.7
11~30 1,318(28.5) 144 10.9 92 7.0 92 7.0
31 2,090(45.2) 280 13.4 125 6.0 120 5.7
350(7.6) 4 1.1 4 1.1 3 0.9
4,279(92.4) 526 12.3 296 6.9 289 6.8
405(8.7) 19 4.7 13 3.2 12 3.0
4,224(91.3) 511 12.1 287 6.8 280 6.6
<표 Ⅳ-3> 가약 체조제 인센티 지 상 품목의 제품명 분석
* 100~199: 신경계 감각기 용 의약품, 200~299: 개개의 기 계용 의약품, 300~399: 상성의
약품, 400~499: 조직세포의 기능용 의약품, 600~699: 항병원생물성 의약품, 800~899: 마약
, 1
53.6% 13.7% .
/ /
, 30 .
30 5% . 1
,
( Ⅳ-4, Ⅳ-5
).
0 0 (0.0) 463 (50.0)
1 496 (53.6) 127 (13.7)
2~5 210 (22.7) 124 (13.4)
6~10 91 (9.8) 111 (12.0)
11~20 57 (6.2) 90 (9.7)
21~30 25 (2.7) 11 (1.2)
31~40 22 (2.4) 0 (0.0)
41~50 10 (1.1) 0 (0.0)
51~60 6 (0.6) 0 (0.0)
61~70 4 (0.4) 0 (0.0)
71~80 2 (0.2) 0 (0.0)
81~90 2 (0.2) 0 (0.0)
91~100 1 (0.1) 0 (0.0)
926 (100.0) 926 (100.0)
<표 Ⅳ-4> 한국과 미국의 성분내 품목수 비교
( : (%))
**
(SD) (SD)
926 5.83(11.34) 463 6.35(5.76)
(A) 887 5.97(11.56) 450 6.39(5.82)
(C) 39 2.62(2.57) 13 4.92(3.01)
894 5.96(11.52) 460 6.34(5.78)
31 2.16(2.48) 2 8.00(5.66)
* 100~199 323 4.77(8.66) 178 8.04(5.70)
200~299 353 6.42(12.02) 153 5.82(5.55)
300~399 103 7.35(14.91) 48 6.04(7.17)
400~499 32 1.72(2.14) 25 3.32(4.60)
600~699 111 7.02(13.39) 55 4.40(4.03)
800~899 4 1.00(0.00) 4 1.00(0.00)
<표 Ⅳ-5> 한국과 미국의 성분내 품목수 평균 비교
* 100~199: 신경계 감각기 용 의약품, 200~299: 개개의 기 계용 의약품, 300~399: 상성의
약품, 400~499: 조직세포의 기능용 의약품, 600~699: 항병원생물성 의약품, 800~899: 마약
** 100~199: 성분내 1품목 이상 존재하는 경우에 해서만 평균값 계산시 사용
3.
11.8% , , ,
4,629 292 .
.
/ /
,
30 . / /
.
.
,
.
,
.
제3 제네릭 약가제도 변화 평가
- ,
, 2012 1
, 61% (4,629 2,825
) 2012 4 1 .
,
.
.
1.
2011.10, 2012.1, 2013.1 3
.
.
[ = ( / ) *100]
3 (2011.10. 2012.1, 2013.1)
, 2011 100
2012 2013
. 2011
.
[2011 = (
/2011 ) *100]
2.
2011.10
80 ~90 33.7% , 2012.1
90 ~100 32.9%, 2013.1 90 ~100 64.2%
.
( Ⅳ-6 )
2011.10 2012.1 2013.1
0~10 0 (0.0) 0 (0.0) 0 (0.0)
10 ~20 14 (0.3) 10 (0.2) 2 (0.0)
20 ~30 44 (1.0) 38 (0.8) 13 (0.3)
30 ~40 91 (2.1) 82 (1.8) 39 (0.8)
40 ~50 183 (4.2) 158 (3.5) 83 (1.7)
50 ~60 226 (5.2) 292 (6.5) 159 (3.2)
60 ~70 399 (9.2) 352 (7.8) 286 (5.8)
70 ~80 704 (16.3) 624 (13.9) 257 (5.2)
80 ~90 1,457 (33.7) 1,460 (32.5) 917 (18.7)
90 ~100 1,204 (27.9) 1,479 (32.9) 3,143 (64.2)
4,322 (100.0) 4,495 (100.0) 4,899 (100.0)
<표 Ⅳ-6> 성분내 최고가 비 상 가격
( : , %)
2011 100 2012 2013
, 2011
100 2012 98.12, 2013 85.01
( Ⅳ-7 ).
2011. 10 2012. 1 2013. 1
(SD) (SD) (SD)
655 100.00(0.00) 98.12(4.46) 85.01(20.85)
(A) 627 100.00(0.00) 98.10(4.52) 85.24(21.14)
(C) 28 100.00(0.00) 98.55(2.70) 79.71(11.56)
625 100.00(0.00) 98.17(4.50) 84.83(21.13)
29 100.00(0.00) 96.99(3.38) 89.01(13.40)
* 100~199 256 100.00(0.00) 97.79(4.48) 85.99(24.36)
200~299 251 100.00(0.00) 98.65(4.60) 85.84(18.61)
300~399 56 100.00(0.00) 98.10(3.42) 80.30(17.71)
400~499 7 100.00(0.00) 99.00(2.65) 90.43(11.89)
600~699 85 100.00(0.00) 97.48(4.57) 82.23(17.48)
800~899 - - - -
<표 Ⅳ-7> 2011년 기 연도별 상 최고가
* 100~199: 신경계 감각기 용 의약품, 200~299: 개개의 기 계용 의약품, 300~399: 상성의
약품, 400~499: 조직세포의 기능용 의약품, 600~699: 항병원생물성 의약품, 800~899: 마약
, 1 ,
, ,
. 2 7
2011 100
2013 60 ,
. 3
, 10 , 8
, 2
( Ⅳ-3, Ⅳ-4, Ⅳ-5 ). 2011
2013 (
), .
[그림 Ⅳ-3] 사례 1 - 101405ATR acetaminophen encapsulated 650mg
[그림 Ⅳ-4] 사례 2 - 161501ACH fluoxetine HCl 10mg
[그림 Ⅳ-5] 사례 3 - 222402ATB ramipril 5mg
제4 동일성분내 의약품 사용량 청구액 분석
1.
, 2011 10 , 2012
10 3 – , 2011 4/4
2012 4/4 -
,
.
2.
2011 4 4,631
2012 4 5,296 . 2011 2012
98% , 200~299 42%
.
30 , 2011 69.8%, 2012
67.1% .
2011 97.4%, 2012 95.8% ( Ⅳ-8 ).
ATC < 4> .
2011 4 2012 4
4,631 (100.0) 5,296 (100.0)
(A) 4,541 (98.1) 5,207 (98.3)
(C) 90 (1.9) 89 (1.7)
4,561 (98.5) 5,229 (98.7)
70 (1.5) 67 (1.3)
* 100~199 1,297 (28.0) 1,498 (28.3)
200~299 1,982 (42.8) 2,227 (42.1)
300~399 604 (13.0) 753 (14.2)
400~499 30 (0.6) 53 (1.0)
600~699 718 (15.5) 770 (14.5)
800~899 - - 4 (0.1)
(10 ) 384 (8.3) 626 (11.8)
(10~29) 1,015 (21.9) 1,118 (21.1)
(30 ) 3,232 (69.8) 3,552 (67.1)
122 (2.6) 224 (4.2)
4,509 (97.4) 5,072 (95.8)
<표 Ⅳ-8> 분석 상 의약품의 품목수 황
( : (%))
* 100~199: 신경계 감각기 용 의약품, 200~299: 개개의 기 계용 의약품, 300~399: 상성의
약품, 400~499: 조직세포의 기능용 의약품, 600~699: 항병원생물성 의약품, 800~899: 마약
2011 4 2012 4
, 2011 665 2012 904 239
. 1 2011
44.7% 2012 53.3% . ( Ⅳ-9
)
2011 4 2012 4
665 (100.0) 904 (100.0)
(A) 637 (95.8) 874 (96.7)
(C) 28 (4.2) 30 (3.3)
635 (95.5) 873 (96.6)
30 (4.5) 31 (3.4)
* 100~199 259 (38.9) 313 (34.6)
200~299 255 (38.3) 348 (38.5)
300~399 58 (8.7) 99 (11.0)
400~499 7 (1.1) 29 (3.2)
600~699 86 (12.9) 111 (12.3)
800~899 - - 4 (0.4)
1 297 (44.7) 482 (53.3)
2~5 177 (26.6) 207 (22.9)
6~10 78 (11.7) 90 (10.0)
11~30 75 (11.3) 82 (9.1)
31 38 (5.7) 43 (4.8)
<표 Ⅳ-9> 분석 상 의약품의 성분수 황
( : (%))
* 100~199: 신경계 감각기 용 의약품, 200~299: 개개의 기 계용 의약품, 300~399: 상성의
약품, 400~499: 조직세포의 기능용 의약품, 600~699: 항병원생물성 의약품, 800~899: 마약
, 2011 4
10) 13,099 , 3
3,688 . 2012 4 13,315
, 3 1,579
.
2011
35.4% 4,631 ,
64.6% 8,468 . 1
2 33.1% 2
, 2.3% 1 .
, 1 1,332
33.6% . 28.7%
2 , 4.9%
1 .
22,355 66.4% .
2012
40.3% 5,296 ,
59.7% 7,839 . 1
2 36.7% 2
, 3.7% 1 .
, 15,826
50.1% 2011
.
36.9% 2 ,
13.2% 1 2011 1
.
15,754 (49.9%) 2011
( Ⅳ-10 ).
2011 4 2012 4
1) 13,099 (100.0) 33,688 (100.0) 13,135 (100.0) 31,579 (100.0)
(1 )
4,631 (35.4) 11,332 (33.6) 5,296 (40.3) 15,826 (50.1)
24,334 (33.1) 9,670 (28.7) 4,814 (36.7) 11,662 (36.9)
1297 (2.3) 1,663 (4.9) 482 (3.7) 4,164 (13.2)
8,468 (64.6) 22,355 (66.4) 7,839 (59.7) 15,754 (49.9)
<표 Ⅳ-10> 분석 상 의약품의 품목수 청구 액 황
( : , (%))
1) 해당기간 보험 여 청구실 이 있는 의약품 약품코드가 오류 입력 된 품목은 심평원
약가화일(2010.6.1.~2013.10.24. 용 약가화일)의 약가코드를 기 으로 제외시킴
2011 4
, 35 , 1 2
30 .
90% ,
.
,
( Ⅳ-11 ).
2012 4
, 48 , 1 2
38 2011
.
90% ,
. ,
,
( Ⅳ-12 ).
2011 2012 , 2011 2012
,
.
2011 4
1 2
4,631 4,334
665 368
145,738,313 130,671,172
( ) 1,133,225,430 (100.0) 966,958,316 (100.0)
․
1,037,453,889 (91.5) 885,460,662 (91.6)
95,771,540 (8.5) 81,497,653 (8.4)
174,692,005 (15.4) 130,361,780 (13.5)
182,947,416 (16.1) 143,519,054 (14.8)
95,240,188 (8.4) 83,421,654 (8.6)
7,962,550 (0.7) 7,149,725 (0.7)
634,513,072 (56.0) 568,177,677 (58.8) 1) 37,870,199 (3.3) 34,328,427 (3.6)
<표 Ⅳ-11> 분석 상 의약품의 사용량 청구 액(2011년 4분기)
( : , , ,(%))
1) ‘기타’는 치과병원, 치과의원, 보건소, 보건지소, 보건진료소, 보건의료원, 약국, 한방병원,
한의원 등을 포함
2012 4
1 2
5,296 4,814
904 482
176,909,114 151,460,112
( ) 1,582,551,522 (100.0) 1,166,191,372 (100.0)
․
1,427,604,080 (90.2) 1,060,586,149 (90.9)
154,947,443 (9.8) 105,605,223 (9.1)
364,110,708 (23.0) 212,173,597 (18.2)
318,787,054 (20.1) 214,232,918 (18.4)
125,556,038 (7.9) 100,018,804 (8.6)
11,216,056 (0.7) 9,756,818 (0.8)
719,807,641 (45.5) 593,466,054 (50.9) 1) 43,074,026 (2.7) 36,543,181 (3.1)
<표 Ⅳ-12> 분석 상 의약품의 사용량 청구 액(2012년 4분기)
( : , , (%))
1) ‘기타’는 치과병원, 치과의원, 보건소, 보건지소, 보건진료소, 보건의료원, 약국, 한방병원,
한의원 등을 포함
3.
.
2011 4 2012 4
2
.
“ ”
[ *
] .
.
“ ”
11),
[ – ]
.
2011 4 3 3,688 ,
9,670
28.7% . 2012 4
3 1,579 2011 4
, 1 1,662
36.9% .
,
2011 4,294 2012 3,705
. (
/ *100) 2011 44.4% 2012
31.8% . 2011 4 2012 4
( /
*100) 2011 12.7% 2012 11.7% .
2011 490
2012 324 .
( /
*100) 2011 5.1%, 2012 2.8% .
(
/ *100) 2011 1.5%, 2012 1.0% (
Ⅳ-13 ).
2011 4 2012 41) (A) 3,368,751,627 3,157,902,395
2)(B)
966,958,316 1,166,191,372
(B/A*100)28.7% 36.9%
< >3) 537,534,558 795,655,481
(C) 429,423,758 370,535,892
(C/B*100)44.4% 31.8%
(C/A*100)12.7% 11.7%
< >
(D)4) 49,022,466 32,395,228
(D/B*100)
5.1% 2.8%
(D/A*100)
1.5% 1.0%
<표 Ⅳ-13> 가 체시 약품비 감
( : , %)
1) 해당기간 보험 여 청구실 이 있는 의약품 약품코드가 오류입력된 품목은 심평원 약
가화일(2010.6.1.~2013.10.24. 용 약가화일)의 약가코드를 기 으로 제외시킴
2) 가약 체조제 인센티 상 품목 동일성분내 2개 품목 이상 존재하는 경우만 산정
3) 가약 체조제 인센티 상 품목 동일성분내 2개 품목 이상 존재할 경우, 해당성
분의 모든 사용량이 최 가 제품으로 사용될 경우를 가정했을 때의 약품비. 즉, (해당성
분의 총 사용량 * 최 가 품목의 보험상한가)를 성분별로 합산
4) 가약 체조제 인센티 상 품목 동일성분내 2개 품목 이상 존재할 경우, 동일 성
분내 가 평균가 이상 품목의 사용량에 (품목별 보험상한가-가 평균가)를 곱한 값
2012 4
,
. ,
14.7%, 11.9%,
10.3%, 7.9% .
.
. ,
. ( Ⅳ-14 )
5)
1)
(A)
851,
220,
673
684,
182,
758
266,
150,
456
21,8
03,2
41
1,27
0,55
8,71
0 63
,986
,558
2)(B
)21
2,17
3,59
7 21
4,23
2,91
8 10
0,01
8,80
4 9,
756,
818
593,
466,
054
36,5
43,1
81
(B/A
*100
)24
.9%
31.3
%37
.6%
44.7
%46
.7%
57.1
%
<>
3)14
5,01
9,46
3 14
4,01
6,50
1 68
,225
,838
6,
070,
558
407,
092,
022
25,2
31,0
99
(C)
67,1
54,1
34
70,2
16,4
17
31,7
92,9
66
3,68
6,26
0 18
6,37
4,03
2 11
,312
,083
(C/B
*100
)31
.7%
32.8
%31
.8%
37.8
%31
.4%
31.0
%
(C/A
*100
)7.
9%10
.3%
11.9
%16
.9%
14.7
%17
.7%
<>
<표 Ⅳ
-14> 요
양기
종별
가
체시 약
품비
감 (2012년 4분기)
(:
, %
)
5)
4) (D
)7,
919,
876
6,96
2,44
3 2,
654,
667
353,
258
13,7
08,1
06
796,
877
(D/B
*100
)
3.7%
3.2%
2.7%
3.6%
2.3%
2.2%
(D/A
*100
)
0.9%
1.0%
1.0%
1.6%
1.1%
1.2%
1) 해
당기간 보
험여 청
구실
이 있
는 의
약품
약품코드가 오
류입력 된
품목은 심
평원 약
가화일(2010.6.1.~2013.10.24.
용 약
가화일)의
약가코드를 기
으로
제외시킴
2)
가약
체조제 인
센티
상 품
목
동일성분내 2개 품
목 이
상 존
재하는 경
우만 산
정
3)
가약
체조제 인
센티
상 품
목
동일성분내 2개 품
목 이
상 존
재할 경
우, 해당성분의 모
든 사
용량이 최
가 제
품으로 사
용될 경
우를 가
정했을 때
의 약
품비. 즉, (해
당성분의 총
사용량 * 최
가 품
목의 보
험상한가)를
성분별로 합
산
4)
가약
체조제 인
센티
상 품
목
동일성분내 2개 품
목 이
상 존
재할 경
우, 동일 성
분내 가
평균가 이
상 품
목의 사
용량에 (품목별 보
험상한가-가
평균
가)를
곱한 값
5) ‘기타’는
치과병원, 치과의원, 보건소, 보건지소, 보건진료소, 보건의료원, 약국, 한방병원, 한의원 등
을 포
함
4.
-
, (2011. 4/4 ) (2012. 4/4
)
.
,
,
, 134 , 541 .
, ,
< 5> .
,
,
.
제5 분석결과 종합 시사
,
.
.
1
,
.
,
, 30
. ,
.
,
.
.
,
. ,
.
,
, 1
, .
.
제5장 정책제언
제1 제네릭 의약품 련 정책의 보완 방안
1.
,
.
, 12)
. ,
.
.
.
,
.
,
(WHO, 1997).
(1)
. ,
,
.
(2)
.
,
.
(3)
. ,
. -
- .
(4) ,
,
.
( . )
.
(5) ( )
,
,
.
.
(1)
-
- .
.
,
.
(2)
( )
.
, .
(3)
(
)
.
,
.
.
(4)
( 10-15 )
,
, , .
.
- , -
.
2. : /
‘ ( )’
( ).
.
.
,
,
.
,
.
제2 특허만료 의약품에 한 약품비 감 방안
1.
, ,
. ,
(Aalto-Setälä, 2008).
.
, .
.
. 1 1
,
.
,
.
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British Medical Journal, 311(7016), 1347.
Witt, D. M., Tillman, D. J., Evans, C. M., Plotkin, T. V., & Sadler, M.
A. (2003). Evaluation of the Clinical and Economic Impact of a
Brand Name—to‐Generic Warfarin Sodium Conversion Program.
Pharmacotherapy: The Journal of Human Pharmacology and Drug
Therapy, 23(3), 360-368.
www.lakemedelsverket.se. Consulted 13-12-2007.
www.lareb.nl bijwerkingendatabank, methylfenidaat en omeprazol.
Geraadpleegd op 19 mei 2006.
§505 [21 USC 355] of the Federal Food, Drug, and Cosmetic Act of
1938 (as amended). Retrieved April 11, 2008, from
http://www.fda.gov/opacom/laws/fdcact/fdcact5a.htm#sec505
2007 Iowa Code Chapter 155A, Iowa Pharmacy Practice Act. Retrieved
April 15, 2008, from http://www.state.ia.us/ibpe/pdf/IC155A.pdf
201 KAR 2:116, Drug products with therapeutic problems. Retrieved
April 15, 2008, from
http://www.lrc.state.ky.us/kar/201/002/116.htm
/
(Drugs with a
narrow therapeutic index)
Aminophylline
/ ․
.
.
( . )
.
Lithium
Theophylline
indications
(or certain
indications)
( . , )
Carbamazepine
Levetiracetam
Lamotrigine
Phenytoin
Sodium valproate
Topiramate
Midazolam
Ciclosporin
Tacrolimus
Mycophenolate
(Certain
modified-release
preparations)
Diltiazem BNF
(m/r)
.
Mesalazine
Nifedipine
Methylphenidate
(Controlled Drugs
including patches (Schedule
2 and 3))
Buprenorphine SR, XL (SR and XL
preparations)
. BNF
(review)
.
Fentanyl(transdermal)
Morphine
Oxycodone
(Certain
inhaler devices)
CFC Free
Beclometasone(+/-Formot
( . accuhaler,
turbohaler)
<표 1> 국 Health and Social Care Board1)에서 지정한 제네릭 이름 처
방에 부 합한 의약품(Items Unsuitable for Generic Prescribing)2)
[부록 1] 성분명 처방시 유의할 품목 국가별 기
/
erol) . CFC
Qvar Fostair(
)
.
Dry powder devices
(Multi-ingredient
products)
Stalevo®
practical
.
‘co-' ( .
co-amoxiclav, co-codamol,
co-amilofruse)
(combination products)
.
Hormone replacement
therapy
Oral contraceptives
Multi-ingredient GI
preps. . Peptac®,
pancreatin, rehydration
salts, laxatives .
Multi-ingredient ENT
preparations
Creams, Bath oils,
antiseptics, liquids or
gels
Bowel cleansing
solutions
indications
(Specific
brands for specific
indications)
Duloxetine
Buprenorphine
(Miscellaneous)
Antipsychotic depot
injections
.
(administration incidents)
.
Stoma care products &
appliances
Wound products
Insulin
Nutritional products
Vaccines
NRT
/
Calcium salts –
Natecal D3®, Adcal®
Pre-filled injectables –
. Adrenaline,
somatropin,
apomorphine,
erythropoietin .1) Health and Social Care Board는 북아일랜드(Northern Ireland)의 보건의료 서비스와 사회
서비스를 발 시키기는 것을 목 으로 하는 기 이다.
2) 이 목록은 the Medicines Management Advisors가 제네릭 처방에 권장하지 않는 의약품/
제제에 한 시를 보여 다. 그러나 이 목록은 오직 지침만을 한 것이며, practice
policy에 따라 다른 범주를 추가할 수 있다. 추가 정보는 BNF(the British National
Formulary)를 참고하거나 Medicines Management Advisor에게 문의하면 얻을 수 있다.
HSC의 비용 효과 인 선택이 되는 랜드 사용에 한 HSCB 지침을 참고할 것.
: HSC(Health and Social Care Board). (2013). Items Unsuitable for Generic Prescribing. Retrieved July 29, 2013, from http://www.hscboard.hscni.net/.../Prescribing%20Guidance/035%20Items_Unsuitable_for_Generic_Prescribing-April_2013.pdf
1)
,
NTI
Ciclosporin, lithium,
CFC-free beclometasone metered dose inhalers
(Qvar® and Clenil Modulite®), carbamazepine
Prolonged release preparations of carbamazepine,
theophylline, diltiazem, aminophylline, mesalazine,
nifedipine, morphine and oxycodone
Phenytoin
formulation Adrenaline pre-filled syringes,
transdermal formulations of fentanyl, buprenorphine
Combination topical preparations,
<표 2> 국 British National Formulary(BNF)에서 제시한 랜드 명으로 처
방 하는 것이 더 안 하고, 더 효과 이거나 투약과오(medication error)
험을 이는 약들
1)
hormone replacement therapy, oral contraceptives,
pancreatin supplements,
antacids preparations containing simeticone
Tacrolimus
( :
self-injection)Dry powder inhaler devices, insulin,
apomorphine, estradiol transdermal patches,
somatropin injection cartridges, alprostadil injection,
interferons
indications(licensed
indications)
Cyproterone (Androcur® or Cyprostat®),
silfenafil (Viagra®or Revatio®),
duloxetine (Cymbalta® or Yentreve®),
bisoprolol (Cardicor®orEmcor®),
buprenorphine (Temgesic® or Subutex®)
Biosimilars, vaccine products
1) Joint Formulary Committee. (2010). British National Formulary No 59, London: British
Medical Association, Royal Pharmaceutical Society of Great Britain.; UK Medicines
Information. (2009). Which medicines are not suitable for generic prescribing in primary
care?, Q&A 247.1, Liverpool: North West Medicines Information Centre.
: Duerden, M. G., & Hughes, D. A. (2010). Generic and therapeutic substitutions in the UK: are they a good thing?. British journal of clinical pharmacology, 70(3), 335-341.
1
2
3
4
5
6
7
8
(Aprindine)
(Carbamazepine)
(Clindamycin)
(Clonazepam)
(Clonidine)
(Cyclosporine)
(Digitoxin)
(Digoxin)
<표 3> 우리나라 식품의약품안 처에서 지정한 치료 역이 좁은 성분
(제2조 제1항 제10호 련)
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
(Disopyramide)
(Ethinyl Estradiol)
(Ethosuximide)
< >
(Guanethidine)
(Isoetharine)
< >
(Isoproterenol)
(Lithium)
(Metaproterenol)
(Methotrexate)
(Minoxidil)
(Phenobarbital)
(Phenytoin)
(Prazosin)
(Primidone)
(Procainamide)
(Quinidine)
(Sulfonylurea compounds1))
(Tacrolimus)
(Theophylline compounds2))
(Valproic acid)
(Warfarin)
(Zonisamide) 1) 리벤클라미드(Glibenclamide), 리클라짓(Gliclazide)
2) 아미노필린(Aminophylline), 옥스트리필린(Oxtriphylline=콜린테오필린, Choline
theophylline), 디 로필린(Diprophylline=디필린, Dyphylline), 록시필린(Proxyphylline),
테오필린(Theophylline)
: . (2013). .
antiarrhythmics classes I and III (adenosine, amiodarone, disopyramide, phenytoin,
flecainide, ibutilide, quinidine, lidocaine (parenteral only), procainamide,
<표 4> 네덜란드 KNMP(de Koninklijke Nederlandse Maatschappij ter
bevordering der Pharmacie)에서 제시한 치료역이 좁은 성분들1)
propafenone and sotalol)
traditional anti-epileptic drugs (phenobarbital and other barbiturates, carbamazepine,
ethosuximide, phenytoin, oxcarbazepine, sulthiame, trimethadion, valproic acid)
cyclosporine2), (graft rejection) ;
indication renal toxicity
indications .
tacrolimus3)
colchicine
coumarin derivatives (acenocoumarol and phenprocoumon)
digoxin
ergotamine
lithium salts
antineoplastic agents (busulfan, capecitabine, chlorambucil, cyclophosphamide,
cytarabine, doxorubicin, estramustine, etoposide, fludarabine, hydroxyurea, imatinib,
lomustine, melphalan, mercaptopurine, methotrexate, mitotane, procarbazine,tegafur/
uracil, temozolomide and thioguanine)
theophylline
thyroid preparations (levothyroxine, liothyronine)
(non-linear kinetics) : phenytoin1) 의약품들은 G-Standard에서 경고표시(GPK level에서)와 함께 제공된다.
2) Van Hest, R. M., & Van Gelder, T. (2004). Formuleringen ciclosporine niet zonder
meer uitwisselbaar. Pharm Weekbl, 139(49), 1643-7.; Pollard, S., Nashan, B.,
Johnston, A., Hoyer, P., Belitsky, P., Keown, P., & Helderman, H. (2003). A
pharmacokinetic and clinical review of the potential clinical impact of using different
formulations of cyclosporin A. Clinical therapeutics, 25(6), 1654-1669.; Proposal to
waive in vivo bioequivalence requirements for WHO model list of essential medicines
immediate release, solid oral forms. WHO Working document QAS/04.109
3) Besluit Spaanse ministerie voor Gezondheid en Consumentenzaken, gepubliceerd in
Boletin Oficial del Estado 25 november 2008 nr 284, besluit 18994.
: KNMP(de Koninklijke Nederlandse Maatschappij ter bevordering der Pharmacie). (2012). Guideline for generic substitution. the Royal Dutch Pharmacists Association.
[부록 2] WHO의 INN에 한 안내
( , )(International Nonproprietary Names
(INN)) (pharmaceutical substances)
(active pharmaceutical ingredients) ( ) . INN
(public property) .
(a nonproprietary name) .
INN 1950 World Health Assembly (
WHA3.11) , 1953 INN
. INN 7000
, 120-150 INN .
, INN
. INN
, ,
.
INN ,
. INN
, WHO
, " (nonproprietary)"
.
INN
“ (stem)”
. ,
(pharmacological
activity) .
INN .
( ) INN
INN . INN
INN . INN
,
.
INN
(Nonproprietary names) , , ,
, , ( : )
. INN , the European
Community .
British Approved Names (BAN), Dénominations Communes
Françaises (DCF), Japanese Adopted Names (JAN) and United States
Accepted Names (USAN) INN .
,
.
,
.
INN
, .
series
.
INN
INN the WHO Expert Advisory Panel on the International
Pharmacopoeia and Pharmaceutical Preparations
the World Health Organization . INN
.:
- / ; - INN(proposed
INN) comments (published for comments); -
, INN(recommended INN) ,
.
INN , (
) .
INN ,
(mixtures of substances) INN
. (herbal substances)( )
INN . alkaloids( : morphine, codeine)
(trivial chemical names)( :acetic acid)
.
INN . (salts),
(esters) INN
. INN modified INN (INNM)
.; mepyramine maleate (a salt of mepyramine with
maleic acid) INNM . INNM radical part
, INN radical
. ( , methanesulfonate mesilate )
INN , .
INN 4 INN
(an interested person)
. WHO
, .
, WHO INN .
INN . WHO (the WHO
Secretariat) INN
. INN
, INN .
INN
comments .
, INN(recommended INN) .
INN(proposed INN) WHO Drug
Information , 4 / comments
. ,
INN .
, INN INN
. INN .
INN .
INN , , , ,
.
.
. .
.
INN INN WHO Drug
Information . 1997 , INN
, INN 37
(graphic formulae) .
INN WHO Executive Board
.
Radicals
1975 (Nonproprietary Names for
Pharmaceutical Substances) , (salts)
(esters) INN , (salts) (esters)
INN (combination products of
substances) .
INN (normal chemical
practice) INN .
radicals
(composition) .
,
"Names for Radicals and Groups" .
(salts) (esters)
. "radical and group name" INN ,
International Nonproprietary Name (Modified) INNM
.
Modified INN (INNM)
(the base, acid, alcohol) INN
. formulation purposes,
(bioavailability), (absorption rate)
. 1975 INN
.
. INN oxacillin ibufenac oxacillin
sodium ibufenac sodium . oxacillin sodium
ibufenac sodium modified INN (INNM) .
INN .
“modified INN” base acid . ,
levothyroxine sodium INN levothyroxine INNM .
INN
WHO INN INN (note
verbale) ( 191 ), ,
. WHO
INN (trade name) INN
.
INN .
WHO Expert Committee on the use of Essential Drugs the Fifth
Report(1991 11 ) . :
“INN (licensed trade-marks)
. ,
INN .
promotion
INNs .
INN , INN
. INN
, INNs
.
.”
1991 10 (Ottawa)
International Conference of Drug Regulatory Authorities (ICDRA)
. WHO Expert Committee on the use of Essential Drugs
, (Nonproprietary
names for pharmaceutical substances) WHA46.19 1993
the Forty-sixth World Health Assembly ,
.:
-“...INN ( )
;-... multisource products
promote INN
;-...INN
INN ( )
”
INN
.
, ( : interferon
-feron, interleukin -leukin)
. INN
. INN
.
WHA46.19 INN
.
UK, HSC
1)
KFDA,
NTI2)
123102ATB carbamazepine 200mg 2 ○ ○
123102ATR carbamazepine 200mg 5 ○ ○
123104ATR carbamazepine 300mg 2 ○ ○
234201ACH tacrolimus 0.5mg 3 ○ ○
234203ACH tacrolimus 1mg 4 ○ ○
234205ACR tacrolimus 0.5mg 1 ○ ○
234206ACR tacrolimus 1mg 1 ○ ○
234207ACR tacrolimus 5mg 1 ○ ○
237001ACH theophylline 100mg 1 ○ ○
237001ACR theophylline 100mg 1 ○ ○
237002ACR theophylline 130mg 1 ○ ○
237003ACR theophylline 200mg 2 ○ ○
237003ATR theophylline 200mg 1 ○ ○
237005ATR theophylline 400mg 1 ○ ○
145703ACR diltiazem HCl 180mg 2 ○
145707ACR diltiazem HCl 90mg 1 ○
181001ATB lamotrigine 100mg 9 ○
181002ATB lamotrigine 25mg 5 ○
181003ATB lamotrigin 50mg 5 ○
181004ATB lamotrigin 5mg 1 ○
190803ATR mesalazine 500mg 1 ○
190808ATR mesalazine 400mg 1 ○
193201ACR methylphenidate HCl 10mg 1 ○
193205ACR methylphenidate HCl 20mg 1 ○
<표 5> 성분명 처방시 유의해야 할 품목
[부록 3] 가약 체조제 인센티 상 품목
성분명 처방시 유의해야 할 품목
UK, HSC
1)
KFDA,
NTI2)
193207ACR methylphenidate HCl 30mg 1 ○
197801ACH mycophenolate mofetil 250mg 7 ○
201401ACS nifedipine 10mg 1 ○
201405ATR nifedipine 33mg 3 ○
201407ACS nifedipine 5mg 1 ○
201408ATR nifedipine 66mg 1 ○
201409ATR nifedipine 40mg 1 ○
229701ATR sodium valproate 150mg 1 ○
229703ATB sodium valproate 200mg 1 ○
229705ACR sodium valproate 300mg 1 ○
229705ATB sodium valproate 300mg 3 ○
229705ATR sodium valproate 300mg 1 ○
229706ATR sodium valproate 500mg 1 ○
229707ATR sodium valproate 600mg 1 ○
229708ASY sodium valproate 60mg 1 ○
241801ATB topiramate 100mg 12 ○
241803ATB topiramate 25mg 11 ○
241804ATB topiramate 50mg 1 ○
488501ATB levetiracetam 500mg 12 ○
488502ATB levetiracetam 250mg 12 ○
488503ATB levetiracetam 1000mg 11 ○
495501ACH duloxetine 30mg 1 ○
495502ACH duloxetine 60mg 1 ○
359002ATR oxycodone HCl 10mg 1 ○
359003ATR oxycodone HCl 20mg 1 ○
359001ATR oxycodone HCl 40mg 1 ○
359007ATR oxycodone HCl 80mg 1 ○
135402ACH clindamycin HCl 300mg 1 ○
136401ATB clonazepam 0.5mg 1 ○
139201ACS cyclosporine 100mg 1 ○
139204ACS cyclosporine 25mg 1 ○
165402ATB glibenclamide 5mg 1 ○
165602ATB gliclazide 80mg 14 ○
165603ATR gliclazide 30mg 2 ○
194701ACS microemulsion cyclosporine 100mg 2 ○
UK, HSC
1)
KFDA,
NTI2)
194702ACS microemulsion cyclosporine 25mg 2 ○
217801ATB primidone 250mg 1 ○
249103ATB warfarin sodium 2mg 1 ○
249105ATB warfarin sodium 5mg 1 ○
250601ATB zonisamide 100mg 1 ○
421100ATB glibenclamide 2.5mg / metformin HCl 400mg 1 ○
144001ATB diethylamine ethyl theophylline 100mg 1 ○
192101ATB methotrexate 2.5mg 1 ○
443400ATB glibenclamide 2.5mg / metformin HCl 500mg 1 ○
443500ATB glibenclamide 5mg / metformin HCl 500mg 1 ○
165604ATR gliclazide 60mg 1 ○1) 국 Health and Social Care Board에서 지정한 제네릭 처방에 부 합한 의약품
2) 우리나라 식품의약품안 처에서 지정한 치료 역이 좁은 성분
: HSC(Health and Social Care Board). (2013). Items Unsuitable for Generic Prescribing. Retrieved July 29, 2013, from http://www.hscboard.hscni.net/.../Prescribing%20Guidance/035%20Items_Unsuitable_for_Generic_Prescribing-April_2013.pdf; . (2013). .
WHO ATC ATC
2011 2012
·
(01)
(01A)ANTIHYPERTENSIVES C02 17 3 22 7
(01B) DIURETICS C03 17 3 19 5
(01C) BETA BLOCKING AGENTS C07 130 9 122 11
(01D)CALCIUM CHANEL BLOCKERS C08 167 36 194 49
-
(01E)
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM C09 444 37 533 61
(02)
(02A)CARDIAC THERAPY C01 11 10 15 14
(02B)PERIPHERAL VASODILATORS C04 13 6 16 6
(03)
(03A)
DRUG FOR FUNCTIONAL GASTROINTESTINALDISORDERS A03 293 16 302 16
(03B)ANTIEMETIC AND ANTINAUSEANTS A04 8 4 9 5
(03C)BILE AND LIVER THERAPY A05 19 3 23 6
(03D) DIGESTIVES, INCL, ENZYMES A09 - - - -
(04)
(04A) ANTACIDS A02A - - - -
-
(04B)
DRUGS FOR PEPTIC ULCERAND GASTRO-OESOPHAGEALREFLUX
DISEASE (GORD)A02B 286 24 317 35
(04C)OTHER DRUGS FOR ACIDRELATED
DISORDERS A02X - - 1 1
(05)
(05A) LAXATIVES A06 1 1 3 3
,
/
(05B)
ANTIDIARRHEALS, INTESTINALANTIINFLAMMATORY/
ANTIINFECTIVE AGENTSA07 8 8 9 9
(05C)
VASOPROTECTIVES C05 1 1 2 2
(06) (06A)
ANABOLIC AGENTS FORSYSTEMIC USE-ANABOLICSTEROIDS A14 - - - -
<표 6> 연도별, ATC 코드별 품목 성분수
[부록 4] 연도별, ATC 코드별 품목 성분수
WHO ATC ATC
2011 2012
(06B) RALOXIFENG03XC01 2 1 3 1
(06C)
ANTIPARATHYROID AGENTS H05B - - 2 2
(06D)
DRUGS AFFECTING BONESTRUCTURE
ANDMINERALIZATION
M05BA 120 5 144 8
(07)(07A)
DRUGS USED IN DIABETES A10 312 27 392 40
(07B) PANCREATIC HORMONES H04A - - - -
(08)
(08A)
DRUGS FOR OBSTRUCTIVEAIRWAY DISEASES R03 115 26 139 30
(08B)COUGH AND COLDPREPARATIONS R05 49 10 48 10
(08C)
OTHER RESPIRATORYSYSTEM PRODUCTS R07 - - - -
(09) (09A)
ANTIHISTAMINES FORSYSTEMIC USE R06 77 14 81 18
(10)
(10A)
ANTIINFLAMMATORY ANDANTIPRAGMATIC PRODUCTS M01 334 47 359 49
(10B)
TOPICAL PRODUCTS FORJOINT AND MUSCULAR PAIN M02 - - - -
(10C)
OTHER DRUGS FORDISORDERS OF THEMASSCULT-SKELETALSYSTEM M09 - - - -
(10D)
TRAMYARD, TRAMYARDCOMBINATIONS
N02AX02N02AX52
19 6 61 7
(10E)ANTIHISTAMINEPREPARATIONS N02C 2 1 5 4
(10F)
OTHER ANALGESICS ANDANTIPYRETIC N02B 15 7 15 7
(11)
(11A) MUSCLE RELAXANTS M03 84 14 92 14
(11B) ANTIFROST PREPARATIONS M04 2 1 3 2
(12) (12A)ANALGESICS-OPIOID
N02A(N02AX02,N02AX5
2 )
- - 4 4
(13) (13A) ANTITHROMBOTIC AGENTS B01 106 15 129 22
(14)
,
(14A)
BLOOD SUBSTITUTES ANDPERFUSION SOLUTIONS B05 - - - -
(15) (15A) ANTIHEMORRHAGICS
B02, H01B
A - - - -
WHO ATC ATC
2011 2012
(16)(16A) ANTIEDEMIC PREPARATIONS B03 - - - -
·
(17)
NOOTROPIC
S(17A)
PSYCHOSTIMULANTS,AGENTS USED FOR ADHDAND
NOOTROPICSN06B 62 12 75 17
(17B) ANTIDEMENTIA DRUGS N06D 81 8 91 13
(17C)OTHER NERVOUS SYSTEMDRUGS N07 17 5 21 6
(18)(18A) ANTIEPILEPTICS N03 124 31 148 37
(19)(19A) ANTIPSYCHOTIC N05A 120 31 133 36
(20)(20A) ANTIDEPRESSANTS N06A 108 25 120 34
,
(21)
,
,
(21A)
ANXIOLYTICHYPNOTICS ANDSEDATIVES
N05BN05C 37 10 44 15
(22)(22A) ANESTHETICS, GENERAL N01A - - - -
(22B) ANESTHETICS, LOCAL N01B - - - -
(23) (23A)ANTIPARKINSON DRUGS N04 36 12 49 14
(24)
(
)(24A)
IMMUNOSUPPRESSIONAGENTS L04 42 13 42 15
(25)(25A)
IMMUNE SERA ANDIMMUNOGLOBLINS,VACCINES J06J07 - - - -
(26)(26A) IMMUNOSTIMULANTS L03 - - 1 1
(27)
TNF
(27A)
L04
ANTIRHEUMATOIDARTHRITIS DRUG
L04 - - - -
(29)
(29A)ANTIBACTERIAL FORSYSTEMIC
USE J01 473 57 516 66
(29B) ANTIMYCOTIC FORSYSTEMIC USE J02 102 5 105 7
(29C)ANTIMYCOBACTERIALS J04 10 8 10 8
(30) (30A)ANTIVIRAL FOR SYSTEMICUSE J05 165 12 172 27
(31)
(31A) ANTIPROTOZOALS P01 2 2 6 5
(31B) ANTHELMINTIC P02 - - - -
ECTOPARASITICIDES, INCL,SCARCITIES,
P03 - - - -
WHO ATC ATC
2011 2012
(31C) INSECTICIDESAND REPELLENTS
(32) (32A)
CORTICOSTEROIDS FORSYSTEMIC USE H02 15 5 18 5
(33)
(33A)
ANTERIOR PITUITARY LOBEHORMONES ANDANALOGUES H01A - - - -
(33B)HYPOTHALAMIC HORMONES H01C - - - -
(34)(34A)
THYROID THERAPY H03 2 2 2 2
-
(35)(35A)
ANTINEOPLASTIC AGENTS,THERAPEUTICRADIOPHAR
MACEUTICALS
L01V10 4 3 25 24
-
(36)(36A) ENDOCRINE THERAPY
G03HA01L0
226 4 28 5
(37)
(37A)ANDROGENS G03B - - - -
(37B)UROLOGICAL G04 154 17 172 26
(37C)
POSTERIOR PITUITARY LOBEHORMONES(VASOPRESSINAN
D ANALOGUES)
H01BA(
)
2 2 2 2
(38)
(38A)
GYNECOLOGICALANTIREACTIVE ANDANTISEPTICS G01 - - - -
(nafa
relin )(38B)
OTHER GYNECOLOGICAL,OTHER SEX GERMANIES
ANDMODULATORS OF THEGENITAL SYSTEM
G02, G03X(G03XC01
)H0
1CA02
1 1 1 1
(38C) OXYTOCIN H01BB - - - -
(38D)
ESTROGENS PROGESTOGENPROGESTOGEN
ANDESTROGENS IN COMBINATIONANTIANDROGENS
ANDESTROGENS
G03CG03D
G03FG03HB
1 1 3 2
(39) (39A)
GONADOTROPINS AND OTHEROVULATION STIMULANTS G03G - - - -
(40)
(40A)EMOLLIENT AND PROTECTIVE D02 - - - -
(40B) ANTIPOLITICS D05 - - 1 1
(40C)
CORTICOSTEROIDS,DERMATOLOGISTPREPARATIONS D07 19 5 13 5
(41)
(41A)
ANTIFUNGAL FORDERMATOLOGIST USE D01 31 2 31 2
(41B)
ANTIPARASITIC, INCL,ANTIHISTAMINE,ANESTHETIC
S, ETCD04 - - - -
ANTIBIOTICS ANDCHEMOTHERAPEUTIC
D06 - - - -
WHO ATC ATC
2011 2012
(41C)FORDERMATOLOGIST USE
( )
(42)
(42A)
PREPARATIONS FORTREATMENT OF WOUNDS ANDULCERS D03 - - - -
(42B)ANTISEPTICS ANDDISINFECTANTS D08 - - - -
(42
C)ANTICASTE PREPARATIONS D10 1 1 1 1
(42D)
OTHER DE3RMATOLOGICALPREPARATION
SD11 - - - -
(43)(眼)
(43A)OPHTHALMOLOGIC S01 41 12 43 13
(44)
(鼻)
(44A)NASAL PREPARATIONS R01 12 2 13 2
(咽喉) (4
4B)THROAT PREPARATIONS R02 - - - -
(耳)
(44C)
ETHOLOGICAL,OPHTHALMOLOGIC ANDONTOLOGICAL
PREPARATIONSS02S03 2 1 2 1
(
45)
(45
A)STOMATOLOGICALPREPARATIONS A01 1 1 1 1
(46
)
(46A)
ALL OTHER THERAPEUTICPRODUCTS V03 2 2 13 13
(46B) DIAGNOSTIC AGENTS V04 - - - -
(46C)GENERAL NUTRIENTS V06 - - 1 1
(46D)
ALL OTHERNON-THERAPEUTIC PRODUCTS V07 - - - -
X (46E) CONTRAST MEDIA V08 - - - -
(47)
(47A) VITAMINS A11 - - 1 1
(47B) MINERAL SUPPLEMENTS A12 - - - -
(47C)
OTHER ALIMENTARY TRACTAND METABOLISM PRODUCTS A16 19 3 21 4
(48)
(
48A)LIPID MODIFYING AGENTS C10 262 32 290 37
( ) 1)
(%)2)
2011 2012 2011 2012 2011 2012
1 ( ( ): 2011 13,299,811,730, 2012 10,877,527,091)
1 1,016 681 100 100 94.9 95.0
2 864 681 85 100 2.5 2.5
3 863 681 85 100 2.5 2.5
2 ( ( ): 2011 12,665,656,872, 2012 14,964,671,892)
1 3,984 3,984 100 100 72.4 72.5
2 3,203 3,203 80 80 26.8 26.3
3 2,868 2,868 72 72 0.4 1.1
4 2,722 2,722 68 68 0.4 0.2
3 ( ( ): 2011 8,548,872,636, 2012 8,470,915,779)
1 832 832 100 100 54.3 52.9
2 668 668 80 80 1.3 1.2
3 668 668 80 80 7.3 8.0
4 668 668 80 80 2.9 3.5
5 667 667 80 80 3.1 3.7
6 666 666 80 80 4.8 5.3
7 666 666 80 80 8.0 6.3
8 666 666 80 80 1.2 1.4
9 653 653 78 78 4.7 4.6
10 652 652 78 78 3.1 2.7
11 601 601 72 72 0.6 0.4
12 536 536 64 64 0.4 0.4
13 486 486 58 58 0.0 0.0
14 486 486 58 58 1.6 1.9
15 437 437 53 53 0.7 1.4
16 298 298 36 36 3.8 3.4
17 298 298 36 36 2.3 2.9
4 ( ( ): 2011 7,721,033,721, 2012 7,720,965,537)
1 77 77 100 100 73.4 73.7
1 61 61 79 79 23.9 23.8
2 33 33 43 43 2.6 2.4
<표 7> 성분 연도별 보험상한가, 상 가격, 성분내 사용비 비교
[부록 5] 성분 연도별 보험상한가, 상 가
격, 성분내 사용비 비교
( )1)
(%)2)
2011 2012 2011 2012 2011 2012
5 ( ( ): 2011 7,092,692,299, 2012 4,360,968,201)
1 639 410 100 100 90.8 94.4
1 548 369 86 90 5.5 1.2
2 455 369 71 90 3.6 4.3
6 ( ( ): 2011 6,460,893,162, 2012 4,610,461,433)
1 325 218 100 100 23.4 22.2
2 298 193 92 89 12.3 12.4
3 262 176 81 81 1.4 1.0
4 262 176 81 81 4.7 7.9
5 262 176 81 81 1.5 1.7
6 262 176 81 81 0.8 1.1
7 262 176 81 81 3.6 4.5
8 261 176 80 81 4.0 3.9
9 261 176 80 81 2.1 0.0
10 261 176 80 81 5.3 3.6
11 259 176 80 81 5.2 6.2
12 259 176 80 81 5.2 5.4
13 258 176 79 81 1.8 1.9
14 253 176 78 81 3.1 3.4
15 249 176 77 81 2.8 3.2
16 237 176 73 81 4.8 4.6
17 234 176 72 81 7.4 6.6
18 149 149 46 68 0.6 1.1
19 132 132 41 61 2.3 2.5
20 87 87 27 40 2.2 1.7
21 86 86 26 39 5.3 5.3
7 ( ( ): 2011 6,035,754,959, 2012 5,695,513,926)
1 64 60 100 100 33.9 32.5
1 63 59 98 98 10.8 9.2
2 57 53 89 88 11.5 11.5
3 54 51 84 85 6.0 5.8
4 52 51 81 85 10.1 10.7
5 52 51 81 85 7.7 7.5
6 51 51 80 85 0.4 0.7
7 50 50 78 83 19.6 22.1
8 ( ( ): 2011 5,402,929,386, 2012 5,080,292,002)
1 480 398 100 100 56.8 55.5
2 418 367 87 92 30.4 28.4
3 370 367 77 92 3.9 3.6
4 370 367 77 92 1.6 2.2
5 370 367 77 92 1.1 1.6
6 370 367 77 92 1.1 3.9
7 367 367 76 92 2.5 2.6
8 366 366 76 92 2.4 2.2
9 189 189 39 47 0.2 0.0
9 ( ( ): 2011 4,665,761,956, 2012 4,445,925,821)
( )1)
(%)2)
2011 2012 2011 2012 2011 2012
1 1,481 1,253 100 100 47.8 46.5
1 1,155 1,060 78 85 52.2 53.5
10 ( ( ): 2011 4,469,831,334, 2012 2,868,918,387)
1 548 352 100 100 71.9 70.7
1 471 316 86 90 11.3 11.9
2 471 316 86 90 7.1 7.3
3 470 316 86 90 5.0 4.1
4 422 316 77 90 4.7 6.0
11 ( ( ): 2011 4,260,186,289, 2012 3,857,339,432)
1 316 203 100 100 2.4 4.0
1 271 183 86 90 13.5 12.6
2 225 183 71 90 7.2 4.7
3 215 183 68 90 9.2 9.7
4 183 167 58 82 20.7 23.2
5 140 140 44 69 3.9 7.0
6 140 140 44 69 4.3 0.0
7 138 138 44 68 4.9 4.4
8 122 122 39 60 18.5 17.9
9 112 112 35 55 5.9 5.7
10 106 106 34 52 8.8 10.1
11 48 48 15 24 0.8 0.6
12 ( ( ): 2011 3,644,969,232, 2012 3,155,006,767)
1 527 444 100 100 24.9 23.7
2 522 444 99 100 28.4 28.5
3 521 444 99 100 18.3 18.8
4 515 444 98 100 28.3 29.1
13 ( ( ): 2011 3,562,960,824, 2012 3,706,976,947)
1 4,869 4,442 100 100 26.1 24.1
1 3,846 3,846 79 87 73.9 75.9
14 ( ( ): 2011 3,514,892,639, 2012 2,815,938,982)
1 1,018 680 100 100 5.6 6.8
2 809 547 79 80 15.3 13.5
3 809 547 79 80 20.8 17.1
4 806 547 79 80 32.3 31.0
5 800 547 79 80 5.5 5.0
6 786 547 77 80 10.7 12.7
7 466 466 46 69 2.3 2.3
8 441 441 43 65 1.3 1.8
9 419 419 41 62 0.0 0.0
10 419 419 41 62 2.5 4.1
11 419 419 41 62 3.8 5.7
15 ( ( ): 2011 3,450,535,829, 2012 3,208,147,851)
1 141 104 100 100 23.6 23.2
1 116 86 82 83 4.7 4.9
2 93 86 66 83 19.8 19.4
3 88 86 62 83 3.9 4.5
( )1)
(%)2)
2011 2012 2011 2012 2011 2012
4 80 80 57 77 3.0 2.5
5 78 78 55 75 4.0 4.0
6 77 77 55 74 35.2 35.5
7 75 75 53 72 4.9 5.1
8 53 53 38 51 0.9 1.0
16 ( ( ): 2011 2,989,602,886, 2012 2,482,711,321)
1 3,916 2,621 100 100 55.7 50.6
1 3,524 2,621 90 100 0.2 4.0
2 3,328 2,621 85 100 0.6 0.0
3 3,328 2,621 85 100 0.1 0.0
4 3,328 2,621 85 100 1.6 0.3
2 3,328 1,992 85 76 0.1 0.1
5 3,328 1,992 85 76 2.0 3.4
6 2,995 2,621 76 100 0.9 0.3
7 2,695 1,300 69 50 12.3 15.5
8 2,303 2,303 59 88 21.8 16.5
9 2,303 2,303 59 88 1.7 2.0
10 1,968 1,968 50 75 0.1 0.2
11 1,592 1,592 41 61 1.7 2.6
12 1,432 1,432 37 55 1.2 4.4
17 ( ( ): 2011 2,858,156,622, 2012 2,243,916,814)
1 340 244 100 100 74.9 76.8
1 293 222 86 91 4.0 3.6
2 293 222 86 91 6.9 5.8
3 293 222 86 91 2.6 2.3
4 293 222 86 91 2.9 3.2
5 293 222 86 91 1.4 1.3
6 292 222 86 91 3.0 2.7
7 290 222 85 91 2.5 2.1
8 271 222 80 91 1.7 2.2
18 ( ( ): 2011 2,800,113,898, 2012 2,257,693,699)
1 1,359 908 100 100 27.2 26.9
2 1,092 731 80 81 0.4 0.2
3 1,052 731 77 81 2.1 2.0
4 980 731 72 81 5.6 5.8
5 967 731 71 81 22.7 24.0
6 880 731 65 81 14.0 14.2
7 679 679 50 75 28.0 26.9
19 ( ( ): 2011 2,583,720,611, 2012 2,299,055,742)
1 844 567 100 100 4.1 3.2
1 843 566 100 100 22.7 16.1
2 683 457 81 81 10.1 9.5
3 682 457 81 81 7.9 6.1
4 681 457 81 81 0.8 0.9
5 668 457 79 81 46.3 57.4
6 483 457 57 81 8.1 6.7
( )1)
(%)2)
2011 2012 2011 2012 2011 2012
20 ( ( ): 2011 2,370,515,778, 2012 2,560,387,325)
1 2,606 2,382 100 100 66.1 66.3
2 2,095 2,095 80 88 33.6 33.7
3 1,780 1,780 68 75 0.2 0.0
21 ( ( ): 2011 2,327,384,566, 2012 2,558,622,188)
1 141 119 100 100 6.1 6.8
1 112 112 79 94 5.6 5.7
2 112 112 79 94 88.2 87.5
22 ( ( ): 2011 2,316,106,674, 2012 1,820,560,338)
1 1,006 672 100 100 32.7 31.7
1 915 587 91 87 15.4 13.7
2 805 541 80 81 38.5 37.6
3 778 541 77 81 13.4 16.9
23 ( ( ): 2011 2,297,075,927, 2012 2,004,822,522)
1 282 189 100 100 1.7 1.3
2 282 189 100 100 3.7 4.5
3 282 189 100 100 5.8 5.5
4 282 189 100 100 3.3 3.7
5 282 189 100 100 2.4 2.3
6 272 189 96 100 6.3 6.6
7 252 189 89 100 4.6 4.6
8 245 189 87 100 1.9 1.4
9 230 189 82 100 6.6 6.6
10 227 189 80 100 3.4 4.2
11 197 189 70 100 5.0 5.0
12 175 175 62 93 0.4 5.7
13 163 163 58 86 0.3 0.6
14 139 139 49 74 4.1 3.2
15 65 65 23 34 1.9 1.7
16 64 64 23 34 14.2 13.1
17 62 62 22 33 3.8 6.1
18 61 61 22 32 11.5 7.5
19 59 59 21 31 3.9 2.2
20 58 58 21 31 4.0 4.1
21 56 56 20 30 6.5 5.3
22 54 54 19 29 1.9 1.9
23 46 46 16 24 1.1 0.0
24 30 30 11 16 1.8 2.9
24 ( ( ): 2011 2,222,328,903, 2012 1,616,494,405)
1 152 101 100 100 53.4 57.1
2 92 81 61 80 46.6 42.9
25 ( ( ): 2011 1,984,018,309, 2012 1,502,918,372)
1 232 149 100 100 10.1 12.4
2 209 133 90 89 2.5 2.9
3 200 133 86 89 59.6 59.2
4 199 133 86 89 8.6 8.5
( )1)
(%)2)
2011 2012 2011 2012 2011 2012
5 199 133 86 89 19.2 17.0
26 ( ( ): 2011 1,899,055,014, 2012 1,519,912,098)
1 800 538 100 100 80.0 76.3
1 682 538 85 100 12.8 12.9
2 682 538 85 100 0.9 0.9
3 682 538 85 100 1.1 1.7
4 682 538 85 100 5.0 5.8
5 454 454 57 84 0.3 2.5
27 ( ( ): 2011 1,635,813,555, 2012 1,046,354,383)
1 158 104 100 100 81.7 81.6
2 69 69 44 66 16.2 16.4
3 39 39 25 38 2.1 2.0
28 ( ( ): 2011 1,589,165,339, 2012 1,100,894,771)
1 1,000 712 100 100 2.6 2.8
2 997 712 100 100 22.8 21.8
3 988 712 99 100 3.0 2.1
4 986 712 99 100 8.1 5.6
5 984 712 98 100 2.7 4.3
6 969 712 97 100 12.0 17.8
7 933 712 93 100 5.9 8.3
8 892 712 89 100 22.2 19.3
9 888 712 89 100 8.2 5.7
10 860 688 86 97 11.2 10.4
11 853 712 85 100 0.0 0.4
12 838 712 84 100 1.4 1.5
29 ( ( ): 2011 1,474,864,419, 2012 1,280,474,367)
1 884 683 100 100 85.7 86.6
2 707 568 80 83 5.0 8.2
3 707 568 80 83 9.4 5.3
30 ( ( ): 2011 1,436,617,977, 2012 1,393,886,914)
1 197 197 100 100 44.6 43.2
1 152 152 77 77 33.6 33.8
2 131 131 66 66 5.4 5.6
3 131 131 66 66 15.7 16.6
4 112 112 57 57 0.7 0.7
31 ( ( ): 2011 1,396,906,142, 2012 1,078,507,988)
1 297 193 100 100 76.2 81.1
2 247 173 83 90 23.8 18.9
32 ( ( ): 2011 1,366,671,002, 2012 1,140,660,865)
1 419 376 100 100 42.8 42.2
2 418 375 100 100 14.9 13.0
3 359 359 86 95 42.3 44.8
33 ( ( ): 2011 1,359,268,978, 2012 1,279,815,076)
1 441 410 100 100 84.7 88.4
2 353 353 80 86 15.3 11.6
34 ( ( ): 2011 1,322,290,542, 2012 1,376,528,933)
( )1)
(%)2)
2011 2012 2011 2012 2011 2012
1 1,879 1,879 100 100 95.7 95.7
2 1,020 1,020 54 54 4.3 4.3
35 ( ( ): 2011 1,268,650,617, 2012 1,092,888,234)
1 130 107 100 100 90.5 89.8
2 101 101 78 94 9.5 10.2
36 ( ( ): 2011 1,239,852,011, 2012 1,017,358,107)
1 475 389 100 100 28.2 27.0
2 460 376 97 97 71.8 73.0
37 ( ( ): 2011 1,187,594,773, 2012 987,952,878)
1 273 239 100 100 27.9 22.2
2 256 223 94 93 5.8 7.0
3 254 221 93 92 10.7 13.0
4 253 220 93 92 6.0 8.2
5 238 210 87 88 9.6 10.8
6 225 210 82 88 8.0 9.0
7 204 204 75 85 5.1 4.7
8 199 199 73 83 8.0 7.1
9 199 199 73 83 1.6 1.6
10 195 195 71 82 5.2 4.8
11 191 191 70 80 7.3 6.9
12 187 187 68 78 4.7 4.9
38 ( ( ): 2011 1,130,761,233, 2012 1,105,753,696)
1 465 356 100 100 8.3 11.9
2 463 356 100 100 18.0 17.2
3 461 356 99 100 29.8 23.1
4 419 356 90 100 5.9 6.7
5 373 356 80 100 23.3 25.8
6 339 339 73 95 14.7 15.2
39 ( ( ): 2011 1,044,757,844, 2012 953,214,698)
1 750 734 100 100 37.4 35.9
2 604 604 81 82 59.4 60.8
3 601 601 80 82 3.2 3.3
40 ( ( ): 2011 1,032,544,007, 2012 556,939,707)
1 606 564 100 100 83.1 80.6
2 143 143 24 25 16.9 19.4
41 ( ( ): 2011 1,012,400,357, 2012 693,776,342)
1 265 170 100 100 21.0 21.3
1 262 168 99 99 24.1 23.3
2 228 153 86 90 37.8 36.3
3 228 153 86 90 5.0 5.6
4 225 153 85 90 8.8 9.3
5 205 153 77 90 3.3 4.1
42 ( ( ): 2011 1,009,396,619, 2012 622,078,364)
1 493 317 100 100 81.7 83.1
2 424 285 86 90 2.1 1.8
3 424 285 86 90 9.1 8.1
( )1)
(%)2)
2011 2012 2011 2012 2011 2012
4 383 285 78 90 2.7 2.4
5 379 285 77 90 4.4 4.6
43 ( ( ): 2011 980,730,940, 2012 843,315,987)
1 863 578 100 100 28.7 26.0
1 360 360 42 62 0.9 0.3
2 330 330 38 57 2.5 2.7
3 330 330 38 57 35.4 36.0
4 328 328 38 57 22.1 22.2
5 226 226 26 39 10.5 12.7
44 ( ( ): 2011 971,056,029, 2012 870,476,114)
1 1,425 951 100 100 19.5 16.6
1 857 766 60 81 29.4 26.4
2 687 687 48 72 51.1 57.0
45 ( ( ): 2011 901,129,012, 2012 759,194,021)
1 127 104 100 100 81.2 82.4
2 117 97 92 93 18.8 17.6
46 ( ( ): 2011 872,615,837, 2012 460,176,892)
1 844 541 100 100 78.0 74.9
2 775 487 92 90 8.3 10.8
3 463 463 55 86 3.7 4.5
4 456 456 54 84 0.5 0.1
5 432 432 51 80 4.0 4.2
6 405 405 48 75 5.5 5.5
47 ( ( ): 2011 798,521,245, 2012 775,630,863)
1 23 23 100 100 62.3 61.9
1 23 23 100 100 37.7 38.1
48 ( ( ): 2011 791,398,029, 2012 548,145,185)
1 115 85 100 100 18.1 22.3
2 109 79 95 93 19.5 24.4
3 106 77 92 91 4.1 5.8
4 105 76 91 89 34.5 36.1
5 92 70 80 82 23.7 11.3
49 ( ( ): 2011 789,164,431, 2012 371,364,416)
1 269 180 100 100 45.0 46.2
2 219 145 81 81 0.5 0.1
3 216 145 80 81 6.4 8.4
4 212 145 79 81 13.0 10.1
5 212 145 79 81 6.5 6.9
6 191 145 71 81 14.0 12.9
7 182 145 68 81 14.5 15.3
50 ( ( ): 2011 694,589,957, 2012 611,637,511)
1 224 186 100 100 47.7 48.2
1 184 158 82 85 52.3 51.8
2 16 16 100 100 77.4 77.6
3 15 15 94 94 22.3 22.3
4 13 13 81 81 0.3 0.1
( )1)
(%)2)
2011 2012 2011 2012 2011 2012
51 ( ( ): 2011 692,511,650, 2012 652,726,847)
1 118 118 100 100 100.0 100.0
1 81 81 69 69 0.0 0.0
52 ( ( ): 2011 680,582,068, 2012 723,619,849)
1 188 188 100 100 73.1 73.2
1 145 145 77 77 26.9 26.8
53 ( ( ): 2011 667,511,303, 2012 674,845,790)
1 1,263 1,263 100 100 65.0 61.8
2 1,073 1,073 85 85 15.0 15.2
1 1,055 1,055 84 84 20.1 23.1
54 ( ( ): 2011 646,745,501, 2012 688,340,236)
1 766 671 100 100 90.9 89.8
2 652 652 85 97 9.1 10.2
55 ( ( ): 2011 613,014,570, 2012 463,000,172)
1 611 522 100 100 49.7 56.3
2 558 522 91 100 50.3 43.7
56 ( ( ): 2011 592,832,641, 2012 623,710,344)
1 1,478 1,478 100 100 43.1 44.6
2 876 876 59 59 10.7 9.0
3 703 703 48 48 14.4 13.5
4 496 496 34 34 31.9 32.9
57 ( ( ): 2011 590,258,861, 2012 496,375,694)
1 1,779 1,548 100 100 58.0 53.8
2 1,770 1,540 99 99 42.0 46.2
58 ( ( ): 2011 579,959,759, 2012 875,064,723)
1 34 49 100 100 96.1 97.0
2 27 27 79 55 3.9 3.0
59 ( ( ): 2011 576,509,113, 2012 429,377,525)
1 168 114 100 100 70.8 80.1
2 129 92 77 81 16.7 8.4
3 112 92 67 81 12.5 11.5
60 ( ( ): 2011 563,840,723, 2012 574,227,437)
1 62 58 100 100 70.4 78.6
2 61 57 98 98 8.9 9.3
3 59 55 95 95 11.1 11.3
4 38 38 61 66 0.7 0.2
5 37 37 60 64 8.9 0.7
61 ( ( ): 2011 547,703,017, 2012 461,424,199)
1 347 282 100 100 49.9 49.5
2 237 236 68 84 50.1 50.5
62 ( : 2011 538,834,828, 2012 511,334,111)
1 31 29 100 100 28.0 30.7
2 30 29 97 100 72.0 69.3
63 ( ( ): 2011 532,453,952, 2012 577,347,196)
1 1,382 1,222 100 100 37.7 41.4
2 1,145 1,043 83 85 19.6 24.7
( )1)
(%)2)
2011 2012 2011 2012 2011 2012
3 968 968 70 79 42.7 34.0
64 ( : 2011 525,728,350, 2012 407,941,746)
1 397 343 100 100 18.8 21.8
2 397 343 100 100 44.2 49.5
3 397 343 100 100 19.5 17.6
4 397 343 100 100 8.6 2.5
5 397 343 100 100 0.0 0.0
6 321 321 81 94 8.9 8.6
65 ( ( ): 2011 495,492,735, 2012 490,377,369)
1 1,039 998 100 100 59.3 56.1
2 715 715 69 72 11.7 10.7
1 705 705 68 71 29.0 33.2
66 ( ( ): 2011 430,233,740, 2012 410,972,807)
1 122 122 100 100 32.9 34.2
2 99 99 81 81 9.0 10.6
3 98 98 80 80 41.4 38.4
4 86 86 70 70 16.7 16.8
67 ( ( ): 2011 429,907,650, 2012 285,279,381)
1 524 350 100 100 99.7 99.9
2 357 282 68 81 0.3 0.1
68 ( ( ): 2011 424,745,356, 2012 302,769,232)
1 521 335 100 100 100.0 100.0
2 218 218 42 65 0.0 0.0
69 ( ( ): 2011 414,427,055, 2012 307,733,816)
1 176 118 100 100 71.1 69.3
1 175 117 99 99 28.9 30.7
2 63 63 100 100 1.6 0.8
3 55 55 87 87 8.2 10.9
4 48 48 76 76 16.0 16.3
5 47 47 75 75 12.8 12.0
6 45 45 71 71 54.3 56.6
7 45 45 71 71 3.8 0.5
8 44 44 70 70 3.4 3.0
70 ( ( ): 2011 382,681,797, 2012 198,794,418)
1 205 137 100 100 0.0 0.0
2 179 112 87 82 24.2 1.2
3 175 110 85 80 20.4 26.4
4 156 110 76 80 7.1 9.6
5 154 110 75 80 7.3 8.6
6 150 110 73 80 27.2 38.5
7 136 110 66 80 13.6 15.6
8 102 102 50 74 0.1 0.0
71 ( ( ): 2011 370,384,128, 2012 299,689,470)
1 513 488 100 100 92.2 93.5
2 414 414 81 85 7.8 6.5
72 ( ( ): 2011 368,186,238, 2012 340,321,069)
( )1)
(%)2)
2011 2012 2011 2012 2011 2012
1 28 28 100 100 88.9 98.0
2 28 28 100 100 11.1 2.0
73 ( ( ): 2011 366,316,842, 2012 336,881,544)
1 503 503 100 100 21.6 21.0
2 425 425 84 84 34.2 37.6
3 420 420 83 83 18.0 15.9
4 404 404 80 80 26.3 25.6
74 ( ( ): 2011 356,601,224, 2012 262,355,393)
1 396 254 100 100 20.2 20.8
1 341 229 86 90 36.6 36.3
2 341 229 86 90 3.1 3.6
3 341 229 86 90 10.6 9.5
4 337 229 85 90 8.4 9.5
5 307 229 78 90 21.0 20.3
75 ( ( ): 2011 349,514,630, 2012 266,083,057)
1 150 113 100 100 26.2 25.2
2 150 113 100 100 41.2 35.6
3 150 113 100 100 18.1 20.3
4 150 113 100 100 14.4 19.0
76 ( ( ): 2011 346,714,277, 2012 445,575,644)
1 992 916 100 100 62.7 50.8
1 843 843 85 92 37.3 49.2
77 ( ( ): 2011 341,981,071, 2012 299,024,373)
1 1,644 1,644 100 100 27.1 23.4
2 1,611 1,611 98 98 1.7 2.2
3 1,397 1,397 85 85 19.1 17.1
4 1,397 1,397 85 85 9.7 4.5
5 1,396 1,396 85 85 12.9 19.4
6 1,387 1,387 84 84 29.5 33.4
78 ( ( ): 2011 311,906,288, 2012 281,778,313)
1 37 37 100 100 16.2 17.5
2 33 33 89 89 41.6 41.0
3 30 30 81 81 42.2 41.5
79 ( ( ): 2011 309,446,238, 2012 311,968,429)
1 249 249 100 100 55.2 53.3
2 188 188 76 76 44.8 46.7
80 ( ( ): 2011 301,016,801, 2012 232,678,370)
1 1,359 912 100 100 46.7 51.0
1 1,094 736 81 81 8.8 9.3
2 1,094 736 81 81 8.7 7.2
3 1,092 736 80 81 10.3 9.3
4 835 736 61 81 25.5 23.2
81 ( ( ): 2011 294,562,404, 2012 244,709,581)
1 170 141 100 100 61.5 63.0
2 146 130 86 92 38.5 37.0
82 ( ( ): 2011 293,923,766, 2012 186,870,642)
( )1)
(%)2)
2011 2012 2011 2012 2011 2012
1 379 356 100 100 15.6 0.1
1 307 307 81 86 84.4 99.9
83 ( ( ): 2011 268,926,269, 2012 158,027,708)
1 274 179 100 100 45.5 48.5
2 245 155 89 87 3.5 4.3
3 202 155 74 87 51.0 47.2
84 ( ( ): 2011 266,020,799, 2012 264,658,010)
1 177 177 100 100 42.8 41.4
1 109 109 62 62 57.2 58.6
85 ( ( ): 2011 254,253,519, 2012 178,144,068)
1 170 114 100 100 71.7 76.5
2 112 91 66 80 9.0 8.1
3 95 91 56 80 19.3 15.3
86 ( ( ): 2011 251,688,100, 2012 249,357,201)
1 99 99 100 100 53.6 54.1
2 95 95 96 96 20.9 21.3
3 87 87 88 88 25.5 24.7
87 ( ( ): 2011 236,162,628, 2012 213,284,238)
1 8,656 7,349 100 100 14.4 17.6
1 7,926 6,791 92 92 33.2 25.3
2 7,446 6,791 86 92 46.5 49.1
3 7,446 6,791 86 92 5.9 8.0
88 ( ( ): 2011 226,793,263, 2012 210,006,245)
1 688 572 100 100 14.9 15.3
2 595 572 86 100 18.2 20.2
3 595 572 86 100 17.6 20.8
4 595 572 86 100 20.5 18.2
5 595 572 86 100 21.9 19.2
6 481 481 70 84 6.9 6.2
89 ( ( ): 2011 222,193,636, 2012 229,263,270)
1 604 402 100 100 0.5 0.5
2 295 295 49 73 34.4 34.5
3 292 292 48 73 3.6 3.4
4 266 266 44 66 50.2 54.1
5 213 213 35 53 4.0 1.8
6 192 192 32 48 6.2 4.5
7 172 172 28 43 1.3 1.3
90 ( ( ): 2011 221,628,948, 2012 135,149,945)
1 212 142 100 100 22.0 23.3
2 212 142 100 100 0.1 0.0
3 212 142 100 100 15.7 9.0
4 211 142 100 100 27.4 31.1
5 162 142 76 100 23.8 36.2
6 145 142 68 100 11.0 0.3
91 ( ( ): 2011 218,632,071, 2012 152,480,643)
1 283 206 100 100 100.0 100.0
( )1)
(%)2)
2011 2012 2011 2012 2011 2012
2 219 188 77 91 0.0 0.0
92 ( ( ): 2011 214,816,051, 2012 157,787,450)
1 176 113 100 100 37.1 40.0
1 175 112 99 99 36.0 35.0
2 151 101 86 89 10.2 11.9
3 151 101 86 89 7.5 7.3
4 115 101 65 89 9.2 5.9
93 ( ( ): 2011 212,206,863, 2012 219,240,860)
1 116 116 100 100 77.3 76.1
2 92 92 79 79 22.7 23.9
94 ( ( ): 2011 210,012,500, 2012 197,557,479)
1 603 561 100 100 79.3 80.9
2 593 551 98 98 20.7 19.1
95 ( ( ): 2011 206,488,837, 2012 108,479,946)
1 1,111 712 100 100 76.5 74.3
2 995 673 90 95 7.5 0.1
3 726 673 65 95 16.0 25.6
96 ( ( ): 2011 190,551,840, 2012 123,889,694)
1 227 155 100 100 38.6 36.4
2 202 155 89 100 61.4 63.6
97 ( ( ): 2011 183,771,210, 2012 172,262,413)
1 117 116 100 100 68.3 69.7
2 116 116 99 100 31.7 30.3
98 ( ( ): 2011 174,806,584, 2012 172,641,749)
1 30 30 100 100 98.9 99.5
2 30 30 100 100 1.1 0.5
99 ( ( ): 2011 166,497,599, 2012 123,635,710)
1 296 244 100 100 59.7 57.7
2 265 244 90 100 40.3 42.3
100 ( ( ): 2011 159,647,863, 2012 131,675,057)
1 204 162 100 100 71.5 74.0
2 204 162 100 100 28.5 26.0
101 ( ( ): 2011 154,729,115, 2012 83,422,861)
1 351 226 100 100 8.9 9.8
2 347 222 99 98 91.1 90.2
102 ( : 2011 138,697,112, 2012 85,988,700)
1 804 583 100 100 42.8 39.8
2 802 583 100 100 57.2 60.2
103 ( ( ): 2011 135,093,972, 2012 145,510,017)
1 600 399 100 100 6.9 6.3
1 220 220 37 55 26.9 26.0
2 220 220 37 55 66.2 67.6
104 ( ( ): 2011 117,498,002, 2012 69,181,634)
1 237 161 100 100 17.0 14.4
2 236 161 100 100 83.0 85.6
105 ( ( ): 2011 113,208,642, 2012 109,553,075)
( )1)
(%)2)
2011 2012 2011 2012 2011 2012
1 15 15 100 100 100.0 100.0
2 9 9 60 60 0.0 0.0
106 ( ( ): 2011 96,648,449, 2012 186,612,368)
1 574 574 100 100 0.9 0.3
2 574 574 100 100 10.5 11.5
3 574 574 100 100 50.6 21.7
4 500 500 87 87 37.3 66.5
107 ( ( ): 2011 96,587,161, 2012 68,741,656)
1 158 135 100 100 41.3 48.7
2 147 135 93 100 58.7 51.3
108 ( ( ): 2011 93,695,740, 2012 90,105,489)
1 380 304 100 100 49.0 45.8
2 359 304 94 100 51.0 54.2
109 ( ( ): 2011 83,768,216, 2012 95,605,119)
1 250 188 100 100 2.9 1.3
2 250 188 100 100 97.1 98.7
110 ( ( ): 2011 72,680,362, 2012 79,001,602)
1 3,334 3,334 100 100 32.9 32.5
2 2,766 2,766 83 83 67.1 67.5
111 ( ( ): 2011 68,808,205, 2012 55,973,869)
1 135 113 100 100 38.4 38.8
1 122 100 90 88 61.6 61.2
112 ( ( ): 2011 67,745,318, 2012 67,999,722)
1 39 39 100 100 90.4 86.1
2 30 30 77 77 9.6 13.9
113 ( ( ): 2011 67,712,336, 2012 51,373,253)
1 322 263 100 100 4.3 3.7
2 316 257 98 98 95.7 96.3
114 ( ( ): 2011 66,227,361, 2012 3,890,145)
1 461 397 100 100 99.4 96.4
1 315 315 68 79 0.6 3.6
115 ( ( ): 2011 62,871,904, 2012 44,372,729)
1 258 184 100 100 99.0 99.9
2 194 183 75 99 1.0 0.1
116 ( ( ): 2011 61,636,059, 2012 61,789,116)
1 84 84 100 100 47.5 49.1
2 76 76 90 90 52.5 50.9
117 ( : 2011 58,844,235, 2012 15,398,095)
1 191 178 100 100 51.9 0.7
2 152 152 80 85 48.1 99.3
118 ( ( ): 2011 57,002,706, 2012 82,054,168)
1 1,950 1,950 100 100 27.0 28.7
2 1,950 1,950 100 100 42.3 1.5
3 1,950 1,950 100 100 30.6 69.8
119 ( ( ): 2011 54,533,410, 2012 29,765,463)
1 1,081 724 100 100 91.7 97.9
( )1)
(%)2)
2011 2012 2011 2012 2011 2012
2 919 724 85 100 5.4 1.6
3 918 724 85 100 2.9 0.5
120 ( ( ): 2011 50,972,560, 2012 48,324,614)
1 131 115 100 100 67.5 66.6
2 112 105 85 91 32.5 33.4
121 ( ( ): 2011 41,742,724, 2012 47,040,532)
1 171 147 100 100 84.5 96.1
2 133 133 78 90 14.4 3.3
3 108 108 63 73 1.0 0.6
122 ( ( ): 2011 32,647,497, 2012 19,857,564)
1 210 157 100 100 66.7 67.9
2 201 149 96 95 6.8 0.5
3 199 147 95 94 26.5 31.6
123 ( ( ): 2011 29,626,711, 2012 30,043,291)
1 64 64 100 100 47.8 47.2
2 64 64 100 100 52.2 52.8
124 ( ( ): 2011 27,769,956, 2012 757,727)
1 280 233 100 100 99.6 97.2
1 235 215 84 92 0.4 2.8
125 ( ( ): 2011 25,578,482, 2012 21,096,370)
1 112 85 100 100 53.0 65.7
2 78 70 70 82 47.0 34.3
126 ( ( ): 2011 23,628,366, 2012 1,359,969)
1 46 43 100 100 83.4 79.8
2 46 37 100 86 16.6 20.2
127 ( ( ): 2011 23,168,818, 2012 28,298,395)
1 218 194 100 100 22.5 37.8
2 194 171 89 88 77.5 62.2
128 ( ( ): 2011 20,662,670, 2012 20,029,152)
1 12 12 100 100 18.9 27.5
2 10 10 83 83 81.1 72.5
129 ( ( ): 2011 15,629,955, 2012 19,293,321)
1 4,370 3,677 100 100 59.5 37.2
1 4,370 3,677 100 100 40.5 62.8
130 ( ( ): 2011 13,385,734, 2012 16,406,310)
1 2,437 2,437 100 100 26.5 16.1
2 2,437 2,437 100 100 54.4 10.1
3 2,437 2,437 100 100 19.1 73.8
131 ( ( ): 2011 1,894,991, 2012 554,489)
1 660 442 100 100 70.6 63.5
2 553 442 84 100 29.4 36.5
132 ( ( ): 2011 27,788, 2012 8,160)
1 306 267 100 100 47.2 8.3
1 223 223 73 84 52.8 91.7
1) 상 가격=성분내 최고가 비 상 가격=품목별 가격/성분별 최고가*100
2) 성분내 사용비 =성분내 상 사용량=폼목별 총 사용량/성분별 총 사용량*100(%)
2013-04
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