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Medicines Policy and equity in health How can generic drug producers contribute?

Medicines Policy and equity in health How can generic drug producers contribute?. Christian Wieser GENAS Slovak Generic Association. E U legislation.

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Medicines Policy and equity in health How can generic drug producers contribute?

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  1. Medicines Policy and equity in healthHow can generic drug producers contribute? Christian WieserGENASSlovak Generic Association

  2. EU legislation „Generic medicinal product shall mean a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies. The different salts, esters, ethers, isomers, mixtures of isomers, complexes of derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy....“ Directive 2001/83/EC of the European Parliament (Medicinal products for human use) as amended by 2002/98/EC, 2004/24/EC, 2004/27/EC, Page 20, Art.10/2b

  3. Innovative drugs and generics – complementary from customer’s perspective New innovative medicines Generics free up funds for innovative medicines Innovation offers • improved treatment options • new therapeutic opportunities and thereby leads to replacement of older/less effective medication Patent expiration High quality generics Generic obsolescence Source: Novartis (adapted)

  4. Strategic Customer Values Innovative Industry High Therapeutic Risk High Affordability High (Monopoly) Price Low TherapeuticRisk Low price New TherapeuticValue Generic Industry

  5. Global Generics market Pro-forma 2005 third party net sales1, in USD m Teva Sandoz Merck Gx ratiopharm Watson Actavis Stada Mylan Ranbaxy Barr Pliva Krka Cipla 7,511 5,751 2,232 1,989 1,632 1,562 1,270 1,249 1,159 1,088 976 689 624 Gx sales Non-Gx sales • 1 Including acquisition for full year 2005 • Source: Company annual reports, quarterly reports and press releases

  6. GENAS: Slovak Association of Generic producers

  7. The environment: A

  8. The environment: B

  9. The environment: C Increasing life expectancy – not least an outcome of modern, high effective drugs – results in severe challenges for healthcare systems. The generation 65+ represents 14% of the population, with a drug consumption of approx. 30-40% • EU populationwill decrease from 376mio (2000) to 364mio(2050) • Share of working population (15-64) will decrease by 20% • Generation 65+ will increasefrom 61 Mio to 103 Mio

  10. Leading causes of death, SR 2002 zdroj. MZ SR

  11. Top 10 molecules in terms of savings Zdroj údajov: IMS, v cenách výrobcov, *000 SK

  12. Impact of generic market entries SKK IMS

  13. Generic blockbusters: # of treatments and costs Source: IMS, Amlodipineat manufacturer prices

  14. Generic blockbusters: # of treatments and costs

  15. Slovakia: Five of the top 20 are generic companies Source: IMS Health

  16. Development of market shares (value) 31% 29% 30% 33% 32% IMS, >95% pharma market, Rx drugs only

  17. Status quo of Generics in Slovakia The 2003-2006 Healthcare reforms effected a disproportional pressure onGeneric manufacturers: • Extreme price erosion on „exchangeable“ molecules, whereas less contested (even less established,older) molecules occupied comfortable niches • Patient co-payments became main decisive factor • Today Generic drugs in Slovakia are among the cheapest in all Europe  impact on potential further price cuts very questionable

  18. Status quo of Generics in Slovakia The 2003-2006 Healthcare reforms effected a disproportional pressure onGeneric manufacturers: • Drug consumption in too many therapy groups below EU average  Generics as a powerful tool to treat significantly more patients for similar costs • Plans on generic substitution have to be considered counterproductiveconsidering required Gx marketing activities  without adequate promotion by Generic producers, prescribers will switch to patent-protected, moreexpensive drugs (incl. „me too“ molecules)

  19. Thank you very muchĎakujeme za pozornosť

  20. Christian WieserGeneral Manager Sandoz Slovakia Prezident asociácie Genas Ruzinovska 4282103 Bratislava Phone: +421.2.48200.600 Email: christian.wieser@sandoz.comWeb: www.sandoz.skwww.genas.sk

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