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ITA Trade Facilitation Activities and Review of Key Medical Device Markets

ITA Trade Facilitation Activities and Review of Key Medical Device Markets. MDMA Webinar December 16, 2008 Vince Suneja and Richard Paddock Office of Health and Consumer Goods (OHCG) U.S. Department of Commerce 202-482-3360 Richard Paddock@ita.doc.gov.

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ITA Trade Facilitation Activities and Review of Key Medical Device Markets

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  1. ITA Trade Facilitation Activities and Review of Key Medical Device Markets MDMA Webinar December 16, 2008 Vince Suneja and Richard Paddock Office of Health and Consumer Goods (OHCG) U.S. Department of Commerce 202-482-3360 Richard Paddock@ita.doc.gov

  2. Global Medical Device Market Growth Potential • The global medical device market is projected to exceed $250 Billion by 2012 • U.S., UK, Japan, Germany, France, and Italy 15% of population, 75% of medical device use • China, India, Indonesia, Brazil and Pakistan have about half of the world’s population but consume only about 5% of medical devices globally

  3. Global Medical Device Market ($USB) Source: Espicom Business Intelligence

  4. Global Medical Device Market— U.S. Position • U.S. medical technology companies lead the world in medical device production • The U.S. is the world’s largest market for medical technologies ($85 Billion) • U.S. share of world medical device market has held at roughly 45-47% in recent years

  5. U.S. Medical Device Exports (2007) Latin America 11.3% All Others 11.8% Canada 8.9% Total U.S. Medical Device Exports: $31.9 Billion Japan 11.6% Asia, Except Japan 10.0% European Union 46.4% Source: U.S. International Trade Commission

  6. Global Market Share by Country 1 10-15 9 2 8 7 3 6 4 5 5 6 4 7 1 8 9 3 10 11 12 13 2 14 15

  7. ITA’s Mission To create prosperity by strengthening the competitiveness of U.S. industry, promoting trade and investment, and ensuring fair trade and compliance with trade laws and agreements ITA is designed to help all companies, but particularly small and medium-sized ones

  8. ITA’s Structure • U.S. and Foreign Commercial Service (FCS) • Trade Promotion/Export Expansion • Market Access and Compliance (MAC) • Trade Compliance/Barriers/” Country Experts” • Manufacturing and Services (MAS) • Competitiveness/Industry Outreach/” Sector Experts” • Import Administration (IA) • Enforcing Trade Laws (AD/CVD)

  9. International Trade Administration Commercial Service Market Access & Compliance Manufacturing & Services Import Administration Global Network of Trade Specialists Regional/Country Offices IndustrySpecialists Import Analysts

  10. U.S. and Foreign Commercial Service • USG’s primary trade promotion agency • Over 2,000 trade professionals worldwide based at 160 offices in 82 countries representing 96% of world exports • Trade specialists in more than 100 USEACs across the U.S. and USDOC HQ in Washington D.C.

  11. Market Access and Compliance (MAC) • Trade specialists covering countries worldwide • Understand broad trends in country/region • Often lead when industry needs advocacy or has country-specific market access issues • Offices for activities relating to multilateral agreements (EU, NAFTA, APEC)

  12. Manufacturing and Services (MAS) • Promotes competitiveness of U.S. industry, both domestically and internationally • Analyzes economic trends and important policy developments in specific industries • MAS includes OHCG for pharmaceuticals, biotechnology and medical devices • Data and descriptive analysis

  13. MAS Office of Health and Consumer Goods • Two Teams - Health Products and Technologies (HPT—pharmaceuticals, medical devices, and biotechnology) and Consumer Goods • HPT covers markets globally but focuses mainly on key markets [e.g. China, India, EU, Brazil, etc.] • HPT take a lead role on broader issues affecting multiple markets

  14. Office of Health and Consumer GoodsHealth Products and Technologies Team • Work closely with industry to identify and resolve trade issues • Work with other USG agencies [e.g. State, USTR, USFDA] to support agreements, voice concerns • Work within various forums to address impediments to trade • Support development of fair , transparent regulations in key markets

  15. Office of Health and Consumer GoodsHealth Products and Technologies Team • Organizes and conducts medical device regulatory training programs • Organizes and lead trade policy missions • Conducts research and report on issues impacting industry competitiveness • Provides information to industry on foreign markets

  16. Primary Issues • Regulatory and Reimbursement • Counterfeit medical products • Intellectual property issues • Procurement issues • Health Information Technologies • Product Specific issues (IVDs, Blood Plasma) • Domestic competitiveness

  17. Issues - Regulatory • Encourage transparency, fairness and harmonization with international best practices • Address Product Registration and Classification Issues • Ensure medical devices are not treated as pharmaceuticals • Encourage quality systems over type testing • Work toward acceptance of test data • Remove unnecessarily burdensome requirements on importers

  18. Issues - Reimbursement • Promote transparency and fairness • Discourage discrimination against U.S. imports • Discourage use of foreign reference pricing • Ensure consideration of advanced technologies • Content with issues arising from cost containment measures\HTAs

  19. Key Markets - CHINA • One of the world’s fastest growing market for medical devices (11-18%*) • Forum - JCCT Pharmaceutical and Medical Device Subgroup/Medical Device Task Force • Market presents various challenges for foreign suppliers: regulatory redundancies, transparency/centralized tendering, type testing, acceptance of test data, blood products ban, pricing • *Various sources

  20. Key Markets - INDIA • One of top twenty markets and rapidly growing driven by private sector investment • Forum – U.S. India High Technology Cooperation Group (HTCG) Biotech/Life Sciences Working Group • Issues: Uncertainties associated with evolving regulatory regime; product registration; labeling and testing; pricing

  21. Key Markets – WESTERN EUROPE • Long-standing, well established medical device trade relationship with the U.S. • Represents about 47 percent of U.S. exports • Past re-classification of devices • Planned changes in Medical Device Directives • Reimbursement • Additional regulations (e.g. REACH) • Cooperation on Third Country Market Access

  22. Key Markets - GERMANY • $12.4* billion medical products market ranked behind only U.S. and Japan, second behind U.S. in medical device imports • Dynamic healthcare sector with pros and cons • Reimbursement issues and significant downward pressure on prices *Source: Espicom Business Intel

  23. Key Markets – LATIN AMERICA • Regulatory and market conditions vary greatly by country • Most countries do not have full fledged regulatory systems – require USFDA approval AND approval from the country of origin (manufacturer) • Largest markets are Brazil ($2.9 B), Mexico (2.4B), Columbia ($457 M) and Chile ($368 M)* • * Source: Espicom Business Intel

  24. Key Markets - BRAZIL • Imports a high proportion of advanced med tech products • Efforts underway to engage Regulatory authority ANVISA in information exchange program • Forum – Commercial Dialogue • Examining possible nationalized system of price controls

  25. Key Markets – SOUTH KOREA • Imports about two thirds of total market • Challenging market access issues, but GOK is engaged • Forum - bilateral discussions associated with FTA • Pricing issues: “90% Rule”, transparency in reimbursement rates, planned use of functional category system, lack of transparency, valuation of innovative products

  26. Key Markets - Other • Japan - covered by MAC due to MOSS Talks • Australia - OHCG engaged in past re-registration and reimbursement issues • Association of Southeast Asian Nations (Asean) – good markets, 5-7 percent growth, regulations under development using GHTF documents, some regulatory and pricing issues • Taiwan – Fourth largest Asian market, moderate growth, extensive product regulatory requirements make it difficult to navigate • Mexico – ranked 17th globally ($2.4 B)

  27. Cooperation with APEC • OHCG has organized and conducted a series of APEC-funded seminars on medical device regulatory harmonization based on GHTF guidance documents • OHCG will coordinate two 2009 APEC-funded Medical Device Regulatory Harmonization visits for officials from APEC economies to Australia, Canada and U.S.

  28. Online - WWW.TRADE.GOV • Find a local office • Find statistics and analysis • Trade events and missions • Export counseling services • Find information on Advisory Committees • Report a trade barrier • File a trade complaint • Find a policy initiative

  29. Contact OHCG at:www.ITA.DOC.GOV/TD/HEALTHVince_Suneja@mail.doc.gov * Richard_Paddock@ita.doc.govPhone: 202-482-0122*Phone: 202-482-3360Fax: 202-482-0975

  30. U.S. Commercial Service Global Healthcare Team from the US Commercial Service MDMA Webinar December 16, 2008 Jennifer Loffredo Global Healthcare Team Leader U.S. Commercial Service U.S. Department of Commerce

  31. U.S. Commercial Service Our mission: To promote the export of goods & services from the United States, particularly by small- and medium-sized businesses To represent U.S. business interests internationally To help U.S. businesses find qualified international partners The U.S. Commercial Service is a program of the U.S. Department of Commerce’s International Trade Administration.

  32. Trade specialists in 108 U.S. cities and more than 150 posts in 80 countries worldwide... Our Network & What it can do for you We can... • Locate international buyers, distributors & agents • Provide expert help at every stage of the export process • Help you to enter new markets faster and more profitably

  33. Products & Services Market Research Gold Key Matching Service Trade Counseling & Advocacy International Partner Search Commercial News USA Catalog Exhibitions Trade Missions

  34. Global Healthcare Team Network of Trade Specialists Events and programs Trade Leads Resource Visitwww.buyusa.gov/healthcareand http://www.export.gov/industry/health/to learn more

  35. How to contact us Jennifer Loffredo Tel: 248-975-9600 Fax: 248-975-9606 Email: Jennifer.Loffredo@mail.doc.gov Http://www.buyusa.gov/healthcare

  36. Trade Agreements Monitoring and Compliance MDMA Webinar December 16, 2008 Fernando Sanchez Trade Compliance Center U.S. Department of Commerce 202-482-2305 Fernando.sanchez@mail.doc.gov

  37. What is the Commerce Department Trade Agreements Compliance Program? • A top priority for the Commerce Department • A one-stop program for coordination of USG efforts to remove foreign trade barriers. • Comprised of 3 Key Elements: • Pro-Active Monitoring • Compliance Action and Case Work • Outreach to U.S. Suppliers • Coordinated with USTR, Department of State and other agencies

  38. Trade Agreements Monitoring We Can Assist You in Overcoming Barriers Related To: • Excessive tariff and customs barriers • Discriminatory rules of origin, certificates of origin, or import licensing requirements • Burdensome standards, testing, labeling, or certification requirements • Lack of Intellectual Property Rights protection • Non-transparent government procurement procedures

  39. www.trade.gov/tcc Submit your complaint to The TCC’s Trade Complaint Hotline: Report a Trade Barrier

  40. Team escalates the issue by bringing the full weight of the U.S Government to resolve the issue Implementation of Action Plan Team uses leverage of relevant trade agreements: • Bilateral discussions • Multilateral/ WTO fora • FTA negotiations • Additional Diplomatic Tools: • Meetings with foreign officials • Phone calls and letters • Non-papers • Demarches • Visits by Washington officials As a last resort: Team may recommend referral to USTR for WTO Dispute Settlement Body when appropriate

  41. China – Imported Medical Device Regulatory Regime • China’s AQSIQ regulatory agency issues new draft regulation imposing new redundant and burdensome inspection regime for imported medical devices. • DOC partners with USTR and European Commission and engages China using correspondence, bilateral meetings, WTO TBT Trade Committee, and U.S. –China Joint Commission on Commerce and Trade. • After repeated consultations with AQSIQ and Ministry of Commerce, AQSIQ agrees to suspend the measure.

  42. Japan – Medical Device Reviewers • U.S. medical technology industry association concerned that Japan is slow to approve medical device applications for the Japan market. • This “device lag” is partly due to low staffing levels at Japans’ ‘PMDA which reviews product applications. • Delays raise costs for U.S. device manufacturers forcing production lines of obsolete devices to remain active. • DOC urges Japan under U.S.-Japan Regulatory Reform Initiative and MOSS Agreement to increase PMDA staffing and expedite product approvals. • DOC and industry associations efforts result in increase in the number of PMDA reviewers.

  43. Use our Free Resources Available from the TCC Web site: www.trade.gov/tcc • TCC’s Trade Complaint “Hotline” • Checklist of common trade problems • Texts of over 270 trade agreements • Exporter Guides: concise explanations in laymen’s terms of key trade agreements • Market Access News • WTO Standards Notifications — “Notify U.S.“ • Mailing List: Subscribers receive weekly “What’s New” e-mail updates on trade news • StopFakes.gov with IPR Information • Compliance Attaches

  44. Contact the TCC at:www.trade.gov/tccEmail: tcc@mail.doc.govPhone: 202-482-1191Fax: 202-482-6097Fernando Sanchez202-482-2305fernando.sanchez@mail.doc.gov

  45. Outline • The Trade Compliance Center and the Commerce Trade Agreements Compliance Program • Identifying Foreign Trade Problems • How We Take Action • Resources Available

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