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HEALTH CARE MARKET . EUROPE. presented by Veronika Novakova HC Team Europe Liaison & Commercial Specialist, Prague, Czech Republic AACC Washington, July 2008. WHAT IS EUROPE?. 27 EU members Candidate Countries: Croatia Turkey Macedonia Other countries: Switzerland Norway, etc.

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slide1

HEALTH CARE MARKET

EUROPE

presented byVeronikaNovakovaHC Team Europe Liaison & Commercial Specialist, Prague, Czech Republic

AACC Washington, July 2008

slide2

WHAT IS EUROPE?

  • 27 EU members
  • Candidate Countries:
  • Croatia
  • Turkey
  • Macedonia
  • Other countries: Switzerland
  • Norway, etc.
  • http://europa.eu
slide3

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
slide4

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.
slide5

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
slide6

MARKET STATISTICS I

EU Projected Medical Equipment Market in 2007-8 (in $, mln.)

slide7

MARKET STATISTICS II

EU Projected Medical Equipment Market in 2007-8 (in $, mln.)

Source: EpiscomBus Intelligence – 01 June 2005 (taken from Austrade PPP)

slide8

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
slide9
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

PHARMACEUTICALS

  • Europe 30% of world market x NA 47%
slide10

GENERICS

Source: EGA internalsurvey 2005

slide11

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/supplements/index_en.htm
  • Trends: CEE: self-medication (young generation), informed customers, spending power on rise, growth in supplements popularity, demand for consultation services
slide12

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
slide13

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
slide14

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)
slide15

OPPORTUNITIES

  • World’s 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
slide16

CONTACTS

Ms. VeronikaNovakova

Commercial Specialist

US Commercial Service, US Embassy

Trziste 15, 118 01 Praha 1, Czech Republic

Phone: +420 257 022 437, Fax: +420 257 022 810

E-mail: Veronika.Novakova@mail.doc.gov

www.buyusa.gov/czechrepublic

www.buyusa.gov/europe