“ generic medicines in the taiwanese and german legal systems” 03 june 2011 in taipei, taiwan
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“ Generic Medicines in the Taiwanese and German Legal Systems” 03 June 2011 in Taipei, Taiwan. Role of Generics in the German Health Care System Financial Impacts and Implementation Measures. Silke Baumann Federal Ministry of Health (Germany). Introduction The German Health Care System. - PowerPoint PPT PresentationTRANSCRIPT
“Generic Medicines in the Taiwanese and German Legal Systems”
03 June 2011 in Taipei, Taiwan
Role of Generics in the German Health Care SystemFinancial Impacts and Implementation Measures
Silke Baumann
Federal Ministry of Health
(Germany)
Introduction
The German Health Care System
Otto von Bismarck (1815-1898)
1883: 1st act on Statutory Health Insurance (SHI)
•pay-as-you-go principle
•proportional contributions from insurees and their employers
•self-governmental structures to operate the sickness funds and decide about benefit coverage beyond the legally defined scope
Germany‘s Health Care System Today
others (3,0 Mio.)
private (8,5 Mio.)
SHI (70,4 Mio.)
approx. 150
Funds
source: Federal Ministry of Health/KV45
SHI Spendings 2009: 170 Billion Euro
dental prostheses 2%
dental treatment5%
pharmaceutical products
18%
medical devices3%
remedies3%
in-patient treatment32%
sickness allowance4%
transport2%
prevention and reha1%
domestic nursing2%
administration 5%
out-patient treatment (doctors)
17%
Share of Drugs in Total SHI-Spendings
source: Federal Ministry of Health/KJ 1
12,92% 13,21% 13,65% 13,42% 13,90%14,67% 15,05%
16,09% 16,40% 16,69%15,56%
17,63% 17,53%18,07% 18,18% 17,98%
1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009
SHI-spendings on drugs 1994 – 2009
in b
illio
n Eu
ro
source: Federal Ministry of Health/KJ 1
15,1716,38
17,46 16,8117,72
19,2120,12
22,3323,45
24,22
21,81
25,36 25,8727,76
29,2330,70
1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009
Drug Supply in the Statutory
Health Insurance
Access to Drugs
out-patient care:
reimbursement by SHI
in-patient care:
drugs covered by hospitals (DRGs)
market authorisation
(proof of quality, safety and efficacy)
cost-containing instruments by law
no further legal restrictions
market authorisation reimbursement by SHI
(price set by producer)
Drug supply in the out-patient sector
exclusion by law•life style drugs•OTC
G-BA guidelines•exclusion or restriction•reimbursement amounts therapy advice•...
co-payment•10 %, min 5 €, max. 10 €•release is possible•individual limits
limitations of reimbursement => cost containment
Cost Containment and the Role of Genenics
in Germany
Share of Generics 2009 (prescriptions)
Non Generics30%
Generics70%
source: AVR/WIdO
Share of Generics (prescriptions)
0,00%
10,00%
20,00%
30,00%
40,00%
50,00%
60,00%
70,00%
80,00%
90,00%
100,00%
1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009
of total market of market with generic potential
Average Price per DDD
Total Market0,55 € Generics
0,44 €
Non Generics0,61 €
Average Price per DDD in 1991
Total Market0,84 €
Generics0,41 €
Non Generics1,95 €
Average Price per DDD in 2009
Cost Containment Measures
Fixed Reimbursement Amounts2 steps:
1. Clustering of pharmaceutical substances by the Federal Joint Committee same active ingredient (ATC 5) therapeutic equivalence (ATC 4)
2. Establishing reimbursement amountsby Federal Association of Sickness FundsPrice-Level: maximum price at lowest third of price range
Effects of Reimbursement Amounts
most companies lower their prices to the reimbursement amount (or even lower)
if not: losing of market share
SHI spendings: stable for drugs subject to reimbursement amounts
Market Share: with/without Reimbursement Amounts 2009
source: Insight Health
Prescriptions 2009
28%
72%
without reimbursement amounts with reimbursement amounts
Spendings 2009
61%
39%
without reimbursement amounts with reimbursement amounts
Individual Rebates/Tendering Sickness funds are allowed to tender for rebates on
drugs Producers can contract with sickness funds
rebates vs. higher sales quantity share of generics (presciption volume): 96 % (source:
ProGenerika) savings in 2010:
approx. 1 Bill. Euro
Substitution of Drugs
prescribtion by INN or by brand name (original or generic)
INN
brand name
pharmacy hands out one of the 3 cheapest products
pharmacy hands out the prescribed product or one of the 3 cheapest ones
rebate contract NO rebate contract
pharmacy hands out a rebated product
PHARMACY
Release from Co-Payment
Patients‘ co-payment: 10 % of the price min. 5 Euro max. 10 Euro
Release from co-payment for drugs with price at least 30 % lower than fixed reimbursement amount
Price-index January 2005 – May 2007
Cost-containment Instruments
fixed reimbursement amounts „aut-idem“ (substitution) individual rebates/tendering release of co-payment prescription controlling no access to physician-related priscibing data for industry no manipulated software for pysicians no free drugs for pharmacies ...
Priceindex/DDD 1991 - 2009
50
100
150
200
250
300
350
1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009
Total Market Generics Non Genericssource: AVR/WIdO
Prescribed DDD 1991 - 2009
-
5,0
10,0
15,0
20,0
25,0
30,0
35,0
40,0
1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009
Mio
. DDD
Total Market Generics Non Genericssource: AVR/WIdO
Total Spendings 1991 - 2009
-
5,0
10,0
15,0
20,0
25,0
30,0
1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009
Bill.
Eur
o
Total Market Generics Non Genericssource: AVR/WIdO
