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HEALTH CARE MARKET

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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HEALTH CARE MARKET

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  1. HEALTH CARE MARKET EUROPE presented byVeronikaNovakovaHC 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. 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%

  10. GENERICS Source: EGA internalsurvey 2005

  11. 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

  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 • 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

  16. 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

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