“ generic medicines in the taiwanese and german legal systems” 03 june 2011 in taipei, taiwan

“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

Silke BaumannFederal Ministry of Health

Germany

silke.baumann@bmg.bund.de

Thank you for your attention!