Partnership for Growth: ItalyU.S. Collaboration in Favor of New Financing Options

1
HEALTH CARE MARKET
EUROPE
presented byVeronika Novakova HC Team Europe
Liaison Commercial Specialist, Prague, Czech
Republic AACC Washington, July 2008
2
WHAT IS EUROPE?

• 27 EU members
• Candidate Countries
• Croatia
• Turkey
• Macedonia
• Other countries Switzerland
• Norway, etc.
• http//europa.eu

3
MARKET SIZE

• Population EU27 495 mln. inhabitants (
  Candidate countries Norway, Switzerland,
  Ukraine, etc.) versus USA - 304 mln. inhabitants,
  Europe market is about twice the size
• Economic output (GDP) EU27 EUR10,957 bln.
  versus USA EUR10,012 bln.
• HC market Market no. 2 after US, Japan is
  third

• Europe EU Single Market x Regional Approach
  Western Europe, Central Europe, Eastern Europe,
  non-EU countries former Soviet Union countries

4
EU LEGISLATION

• EU does not have FDA the European Commission
  works in cooperation with member state health
  authorities
• CE Mark
• Medical devices regulated under three
  directives
• 1. The Medical Devices Directive (MDD) all
  general medical devices not covered by the other
  two directives.
• 2. Active Implantable Medical Devices (AIMD) -
  all active devices and related accessories
  intended to be permanently implanted in humans.
• 3. In Vitro Diagnostic Devices (IVDD) - all
  devices and kits used away from the patient to
  make diagnosis.

5
MEDICAL DEVICE

• Competitive market with a good potential for
  innovative and state of art technologies
• Top three markets 1. Germany - no. 3 in the
  world, 6.9 of the world market (12.9 bln.) 2.
  France (7.14 bln.) 3. UK high price market
  (4.9 bln.)
• Western Europe X Central Eastern Europe

6
MARKET STATISTICS I
EU Projected Medical Equipment Market in 2007-8
(in , mln.)
7
MARKET STATISTICS II
EU Projected Medical Equipment Market in 2007-8
(in , mln.)
Source EpiscomBus Intelligence 01 June 2005
(taken from Austrade PPP)
8
DENTAL EQUIPMENT

• The Federation of the European Dental Industry
  (FIDE) - www.fide-online.org regulatory
  issues
• Number of dentists problem in some CEE

• Estimated Market size 129.5 mln.
• Best prospects cosmetic dentistry, innovative
  products and equipment

9
PHARMACEUTICALS

• Europe 30 of world market x NA 47

• The 12 states in CEE are an overall market of
  EUR11.8 bln., less than 10 of the total
  pharmaceutical market of EU-15 (EUR162.2 bln.)
  CEE growth 6 x EU15 2-3
• Regulated market balancing expenditures and
  patient health treatment accessibility
• Reference pricing used in many European
  countries transparency issues (EU Transparency
  Directive)
• Increasing level of private expenditures
  especially in Eastern Europe OTC drugs,
  supermarket sales on rise

10
GENERICS
Source EGA internal survey 2005
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SUPPLEMENTS

• Highly competitive market rise in custom
  duties for supplements from US after EU entry
  for new members
• European Union Food Directive challenged at
  the EU court, went into effect in August 2005
  Annex of Directive 2002/46/EC and its 2006
  Amendment (2006/37/EC) list all vitamins
  minerals allowed on the EU market
  http//ec.europa.eu/food/food/labellingnutrition/s
  upplements/index_en.htm
• Trends CEE self-medication (young generation),
  informed customers, spending power on rise,
  growth in supplements popularity, demand for
  consultation services

12
IN VITRO DIAGNOSTICS

• IVD Expenditures out of THE (2006)
• EU 15 - 0.9 (i.e. 21.3 per capita), New EU
  states - of 1.5 (i.e. 6.2 per capita) X
• US -1.1 (i.e. 36.7 per capita)
• EDMA European organization for national
  associations of the in vitro diagnostics industry
  www.edma-ivd.be

13
HEALTH CARE IT

• Growth of the market expected at around 7 new
  EU countries offer good potential as their
  private sector expands
• Opportunities national e-Health initiatives -
  Germany's Health Smartcard, the English NHS's
  National Program for Information Technology
• The European Commission's e-Health initiative
  voices for single EU harmonized systems

14
MARKET CHALLENGES

• Product Registration all the products have to
  be registered to sell in Europe sometimes
  lengthy process
• Reimbursement challenging problem especially
  in pharmaceutical sector - calls for transparency
• Late payments especially in case of
  hospitals, in some cases delay in payment may be
  over 1 year (challenge for distributor)

15
OPPORTUNITIES

• Worlds second largest market
• Demand for innovative US technologies US
  products considered high quality backed by
  extensive research
• EU Tender database
• www.buyusa.gov/europeanunion/tender_search.html
• Financing
• US Trade and Development Agency (TDA) -
  www.ustda.gov
• US AID www.usaid.gov
• EU Funds - http//www.buyusa.gov/europeanunion/
  eu_funds.html

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CONTACTS

• Ms. Veronika Novakova
• Commercial Specialist
• US Commercial Service, US Embassy
• Trziste 15, 118 01 Praha 1, Czech Republic
• Phone [phone], Fax [phone]
• E-mail Veronika.Novakova_at_mail.doc.gov
• www.buyusa.gov/czechrepublic
• www.buyusa.gov/europe