ITA Trade Facilitation Activities and Review of Key Medical Device Markets

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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_at_ita.doc.gov

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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 worlds population but
  consume only about 5 of medical devices globally

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Global Medical Device Market (USB)
Source Espicom Business Intelligence
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Global Medical Device Market U.S. Position

• U.S. medical technology companies lead the world
  in medical device production
• The U.S. is the worlds largest market for
  medical technologies (85 Billion)
• U.S. share of world medical device market has
  held at roughly 45-47 in recent years

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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
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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
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ITAs 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
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ITAs 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)

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International Trade Administration
Market Access Compliance
Commercial Service
Manufacturing Services
Import Administration
Regional/Country Offices
Global Network of Trade Specialists
IndustrySpecialists
Import Analysts
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U.S. and Foreign Commercial Service

• USGs 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.

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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)

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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

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MAS Office of Health and Consumer Goods

• Two Teams - Health Products and Technologies
  (HPTpharmaceuticals, 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

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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

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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

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Primary Issues

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

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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

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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

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Key Markets - CHINA

• One of the worlds 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

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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

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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

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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

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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

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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

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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

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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)

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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.

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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

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Contact OHCG atwww.ITA.DOC.GOV/TD/HEALTH
Vince_Suneja_at_mail.doc.gov Richard_Paddock_at_ita
.doc.govPhone 202-482-0122Phone
202-482-3360Fax [phone]
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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

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U.S. Commercial Service
The U.S. Commercial Service is a program of the
U.S. Department of Commerces International Trade
Administration.

• 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

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We can...

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Global Healthcare Team
Network of Trade Specialists Events and
programs Trade Leads Resource
Visit www.buyusa.gov/healthcare and
http//www.export.gov/industry/health/ to learn
more
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How to contact us

• Jennifer Loffredo
• Tel [phone]
• Fax [phone]
• Email Jennifer.Loffredo_at_mail.doc.gov

Http//www.buyusa.gov/healthcare
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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_at_mail.doc.gov

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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

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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

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Submit your complaint to The TCCs Trade
Complaint Hotline
www.trade.gov/tcc
Report a Trade Barrier
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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
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China Imported Medical Device Regulatory Regime

• Chinas 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.

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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.

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Use our Free Resources Available from the TCC
Web site www.trade.gov/tcc

• TCCs Trade Complaint Hotline
• Checklist of common trade problems
• Texts of over 270 trade agreements
• Exporter Guides concise explanations in
  laymens terms of key trade agreements
• Market Access News
• WTO Standards Notifications Notify U.S.
• Mailing List Subscribers receive weekly Whats
  New e-mail updates on trade news
• StopFakes.gov with IPR Information
• Compliance Attaches

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Contact the TCC atwww.trade.gov/tcc Email
tcc_at_mail.doc.govPhone 202-482-1191Fax
202-482-6097Fernando Sanchez202-482-2305fernan
do.sanchez_at_mail.doc.gov
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SwitzerlandBurdensome Diesel Filter Regulation

• A U.S. auto association expressed concern over a
  draft Swiss ordinance that would create
  burdensome emissions standards and require the
  use of special filters on all diesel cars.
• In response, the U.S. Government raised the issue
  at the WTO Technical Barriers to Trade Committee,
  questioning whether the draft ordinance was based
  on sound science and its consistency with
  international standards.
• Subsequently, Switzerland rejected the draft
  ordinance.

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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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Trade Compliance CenterMaking Americas Trade
Agreements Work For You!

• The TCC coordinates Commerces monitoring of and
  compliance with U.S. trade agreements and
  provides a gateway to a network of resources
  assisting exporters and investors in combating
  foreign trade barriers.