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“ 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 System Financial Impacts and Implementation Measures. Silke Baumann Federal Ministry of Health (Germany). Introduction The German Health Care System.

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“ Generic Medicines in the Taiwanese and German Legal Systems” 03 June 2011 in Taipei, Taiwan

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  1. “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)

  2. Introduction The German Health Care System

  3. 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 Otto von Bismarck (1815-1898)

  4. Germany‘s Health Care System Today

  5. source: Federal Ministry of Health/KV45

  6. Share of Drugs in Total SHI-Spendings source: Federal Ministry of Health/KJ 1

  7. SHI-spendings on drugs 1994 – 2009 in billion Euro source: Federal Ministry of Health/KJ 1

  8. Drug Supply in the Statutory Health Insurance

  9. Access to Drugs market authorisation (proof of quality, safety and efficacy) out-patient care: reimbursement by SHI in-patient care: drugs covered by hospitals (DRGs) cost-containing instruments by law no further legal restrictions

  10. 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 Drug supply in the out-patient sector reimbursement by SHI (price set by producer) market authorisation limitations of reimbursement => cost containment

  11. Cost Containment and the Role of Genenics in Germany

  12. Share of Generics 2009 (prescriptions)

  13. source: AVR/WIdO

  14. Average Price per DDD

  15. Cost Containment Measures

  16. Fixed Reimbursement Amounts 2 steps: • Clustering of pharmaceutical substances by the Federal Joint Committee • same active ingredient (ATC 5) • therapeutic equivalence (ATC 4) • Establishing reimbursement amountsby Federal Association of Sickness Funds Price-Level: maximum price at lowest third of price range

  17. 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

  18. Market Share: with/without Reimbursement Amounts 2009 source: Insight Health

  19. 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

  20. Substitution of Drugs prescribtion by INN or by brand name (original or generic) NO rebate contract rebate contract PHARMACY INN pharmacy hands out one of the 3 cheapest products pharmacy hands out a rebated product brand name pharmacy hands out the prescribed product or one of the 3 cheapest ones

  21. 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

  22. Price-index January 2005 – May 2007

  23. 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 • ...

  24. source: AVR/WIdO

  25. source: AVR/WIdO

  26. source: AVR/WIdO

  27. Silke Baumann Federal Ministry of Health Germany silke.baumann@bmg.bund.de Thank you for your attention!

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