3rd National Conference on medicines policy, Bratislava December 2006 Medicines Policy and equity in health How can generic drug producers contribute? Christian Wieser GENAS Slovak Generic Association Christian Wieser GENAS Slovak Generic Association

3rd National Conference on medicines policy, Bratislava December 2006 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

3rd National Conference on medicines policy, Bratislava December 2006 Generic obsolescence New innovative medicines Innovative drugs and generics – complementary from customer’s perspective High quality generics Patent expiration 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 Source: Novartis (adapted)

3rd National Conference on medicines policy, Bratislava December 2006 Strategic Customer Values High (Monopoly) Price Low Therapeutic Risk High Affordability Low price High Therapeutic Risk New Therapeutic Value Generic Industry Innovative Industry

3rd National Conference on medicines policy, Bratislava December 2006 Global Generics market Pro-forma 2005 third party net sales 1, in USD m 1 Including acquisition for full year Including acquisition for full year 2005 Source: Company annual reports, quarterly reports and press releasesSource: Company annual reports, quarterly reports and press releases 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, Gx sales Non-Gx sales

3rd National Conference on medicines policy, Bratislava December 2006 GENAS: Slovak Association of Generic producers

3rd National Conference on medicines policy, Bratislava December 2006 The environment: A

3rd National Conference on medicines policy, Bratislava December 2006 The environment: B

3rd National Conference on medicines policy, Bratislava December 2006 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 % 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 % EU population will decrease from 376mio (2000) to 364mio (2050) EU population will decrease from 376mio (2000) to 364mio (2050) Share of working population (15-64) will decrease by 20% Share of working population (15-64) will decrease by 20% Generation 65+ will increase from 61 Mio to 103 Mio Generation 65+ will increase from 61 Mio to 103 Mio

3rd National Conference on medicines policy, Bratislava December 2006 Leading causes of death, SR 2002 zdroj. MZ SR

3rd National Conference on medicines policy, Bratislava December 2006 Top 10 molecules in terms of savings Zdroj údajov: IMS, v cenách výrobcov, *000 SK

3rd National Conference on medicines policy, Bratislava December 2006 Impact of generic market entries SKK IMS

3rd National Conference on medicines policy, Bratislava December 2006 Generic blockbusters: # of treatments and costs Generic blockbusters: # of treatments and costs Source: IMS, Amlodipine at manufacturer prices

3rd National Conference on medicines policy, Bratislava December 2006 Generic blockbusters: # of treatments and costs

3rd National Conference on medicines policy, Bratislava December 2006 Slovakia: Five of the top 20 are generic companies Source: IMS Health

3rd National Conference on medicines policy, Bratislava December 2006 Development of market shares (value) IMS, > 95% pharma market, Rx drugs only 31%29%30%33%32%

3rd National Conference on medicines policy, Bratislava December 2006 Status quo of Generics in Slovakia The Healthcare reforms effected a disproportional pressure on Generic manufacturers: Extreme price erosion on „exchangeable“ molecules, whereas less contested (even less established,older) molecules occupied comfortable nichesExtreme price erosion on „exchangeable“ molecules, whereas less contested (even less established,older) molecules occupied comfortable niches Patient co-payments became main decisive factorPatient co-payments became main decisive factor Today Generic drugs in Slovakia are among the cheapest in all EuropeToday Generic drugs in Slovakia are among the cheapest in all Europe  impact on potential further price cuts very questionable  impact on potential further price cuts very questionable

3rd National Conference on medicines policy, Bratislava December 2006 Status quo of Generics in Slovakia The Healthcare reforms effected a disproportional pressure on Generic manufacturers: Drug consumption in too many therapy groups below EU average  Generics as a powerful tool to treat significantly more patients for similar costsDrug 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 counterproductive considering required Gx marketing activities  without adequate promotion by Generic producers, prescribers will switch to patent-protected, more expensive drugs (incl. „me too“ molecules)Plans on generic substitution have to be considered counterproductive considering required Gx marketing activities  without adequate promotion by Generic producers, prescribers will switch to patent-protected, more expensive drugs (incl. „me too“ molecules)

3rd National Conference on medicines policy, Bratislava December 2006 Ďakujeme za pozornosť Thank you very much Ďakujeme za pozornosť

3rd National Conference on medicines policy, Bratislava December 2006 Christian Wieser General Manager Sandoz Slovakia Prezident asociácie Genas Ruzinovska Bratislava Phone: Web: