How can Gx producers contribute

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How can generic drugs contribute?

Christian WieserGENASSlovak Generic
Association
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EU legislation

• Generic medicinal product shall mean
  a medicinal product which has the same
  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.....

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
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Innovative drugs and generics complementary
from customers 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)
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Generic drugs v/s Originator drugs
Generic and originator drugs have to be seen in a
synergetic way. The main difference between a
generic and orginator product is significant
lower price due to the expired patent. NO
difference in safety, efficacy.
Public transport?
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The environment A
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The environment B
Below-average consumption of drugs per capita in
European comparison
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Status quo of Generics in Slovakia

• The 2003-2006 Healthcare reforms effected a
  disproportional pressure onGeneric
  manufacturers
• Extraordinary price erosion on generic molecules,
  whereas patent protected drugs did not face any
  price cuts
• Patient co-payments have become main decisive
  factor ? patient must be awarded for their
  cost contributions. As from 2007 tendential
  dilution of existingmodel
• Today Generic drugs in Slovakia are among the
  cheapest in all Europe- much in opposite to
  patent protected drugs
• ? financial impact on potential further Gx
  price cuts very questionable

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Status quo of Generics in Slovakia

• GENAS advocates for an increased usage of
  Generics in order to save within limited budgets
  to afford real innovative drugs. In Slovakia
  still too much money is spent for so called
  me-too drugs (analogue drugs) Up to 4 billion
  SKK (160m USD) could be freed up here without
  significant impact on the quality of treatment
• Slovak Healthcare has to catch up with European
  standards in drug consumption per capita, drug
  budget per capita is still limited in EU
  comparison
• The alarmingly low statistical life expectancy in
  Slovakia as a clear indicator here
• even compared to the Czech Republic.

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Risperidon tbl. price for 1 DDD
DDD Defined Daily Dose
1st generic
2nd generic
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Market for neuroleptics/antipsychotics
Enormous financial reserves for highly needed
high-tech treatments in oncology etc.
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Patent protected Risperidonvs patent free
Risperidon
Risperidon consta price for 1 DDD 440
SKKRisperidon Generic 19,7 SKK
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Main reasons for rapidly increasing drug costs in
the Slovak healthcare

• Prices of patent protected products on EUaverage
• Analogue (me-too) products
• Oncology diabetology etc. growth v

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Main reasons for rapidly increasing drug costs in
the Slovak healthcare

• SK Low per-capita budget for drugs

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Main reasons for rapidly increasing drug costs in
the Slovak healthcare
Prices for Generic drugs already on lowest level
in Europe any more potential for savings?

Cheapest generic inAustria
Cheapest generic inSlovakia
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Main reasons for rapidly increasing drug costs in
the Slovak healthcare

• Prices of patent protected products
• ... on average European level!

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Generic blockbusters of treatments and costs
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Patent linkage Slovak vs. the EU legislation

• Act 140/1998 relating to medicinal products and
  medical devices laying down the registration
  procedures
• There is not any legal basis for refusal of
  pending generic applications submitted in
  accordance with Directive 2004/27/EC and with
  reference to the original medicinal product which
  is under patent protection
• Safety, efficacy and quality of medicinal product
  should be allowed to be evaluated

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Registration procedure

• The submission and subsequent evaluation of an
  application for a marketing authorisation as well
  as the granting of an authorisation are to be
  considered as administrative acts and
  consequently falling outside the scope of patent
  protection
• (Council Working Party on Pharmaceuticals, 23 Apr
  2003)
• The Act 140/1998 not in line with the EU
  legislation in terms of conditions for refusal of
  applications for registration

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GENAS Slovak Association of Generic producers
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Thank you very muchDakujeme za pozornost
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• Christian Wieser
• Prezident asociácie Genas
• Ruzinovska 4282103 Bratislava
• Phone [phone]
• Email christian.wieser_at_sandoz.comWeb
  www.sandoz.sk www.genas.sk