# Presentation: 731378

## 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

## 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

## Global Medical Device Market  ($USB)

- Source:  Espicom Business Intelligence

## 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

## U.S. Medical Device Exports (2007)

**European Union**
**46.4%**

**Japan **
**11.6%**

**Canada **
**8.9%**

**Latin America **
**11.3%**

**All Others **
**11.8%**

**Total U.S. Medical ****Device Exports:**
**$31.9 Billion**

*Source:  U.S. International Trade Commission*

**Asia, Except Japan   10.0%**

## Global Market Share by Country

** ****1**

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**5**

**6**

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**8**

**9**

**10-15**

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##  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

## 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)

## International Trade Administration 

**Market Access**
**& Compliance**

**Commercial**
** ****Service**

**Manufacturing**
**& Services**

**Import**
**Administration**

- Regional/Country
- Offices

- Global Network of
- Trade Specialists

- IndustrySpecialists

- Import
- Analysts

## 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.

## 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)

## 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

## 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

## Office of Health and Consumer GoodsHealth 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

## Office of Health and Consumer GoodsHealth 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

## Primary Issues

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

## 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

## 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

## 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

## 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

## 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

## 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

## 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

## 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

## 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

## 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)

## 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.

## 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

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

## 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. Department of Commerce

## 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.*

## 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

## Products & Services

- Market Research
- Gold Key Matching Service
- Trade Counseling & Advocacy
- International Partner Search
-  Commercial News USA
-  Catalog Exhibitions
- Trade Missions

## Global Healthcare Team

- Network of Trade Specialists
- Events and programs
- Trade Leads
- Resource

- Visit _[www.buyusa.gov/healthcare](http://www.buyusa.gov/healthcare)_ and _[http://www.export.gov/industry/health/](http://www.export.gov/industry/health/)_ to learn more

## 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

##  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

**Notes:**
Good afternoon, my name is Fernando Sanchez, and I am an International Trade Specialist at the Trade Compliance Center/TCC in the U.S. Department of Commerce.  
I want to thank MDMA for inviting me to talk  to you today.
I’m delighted to have the opportunity to speak to you about how to work with my office to help your company identify and overcome Foreign Trade Barriers.

## 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**

**Notes:**
The Commerce Trade Agreements Compliance Program works to ensure that foreign countries’ trade agreement obligations to the United States are closely monitored, that compliance violations are addressed promptly, and that U.S. exporters are aware of the rights created by these trade agreements.  

We use a Commerce Department wide Program rather than a single office to ensure broad responsiveness to requests for help, and to ensure responses draw upon on all parts of the Commerce Department.  It also allows for coordination with key US Government agencies.

The Program entails Pro-Active Monitoring of Trade Agreements to identify problems.
It uses a team based case work system to address problems, which I will explain further later.

A key part of the Program is to conduct outreach to let US firms know about their rights under trade agreements.

## 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

**Notes:**
Your company may potentially encounter many types of foreign trade barriers.  Foreign trade barriers can be broadly defined as “government laws, regulations, policies, or practices that either protect products from foreign competition or artificially simulate exports of particular domestic products.”  Foreign trade barriers may affect US exports of goods and services, foreign direct investment by US persons, and protection of intellectual property rights.  We have addressed many of these global trading issues and challenges.
How do you identify if your company is encountering a foreign trade barrier that should be brought to our attention for help?  Here are sample questions to consider when your company is facing an export problem. Even if you are unsure if you’re facing a foreign trade barrier, contact us and we can work with you.  
Some Common Market Access Issues we can help with include:
Customs problems, such as the misclassification or misvaluation of a product that may result in a higher import duty. 
Common import licensing problems include complicated, non-transparent import licensing procedures that are being used to impede or restrict your access to a foreign market.
Regarding standards, or technical trade problems, your company might be experiencing vague, unique and/or burdensome product, testing or certification requirements keeping your goods out of a foreign market.  
Lack of Intellectual Property Rights protection occurs when a country does not enforce IPR protection on counterfeit or pirated goods. 
AND Non-transparent Government Procurement rules, such as when a foreign government does not abide by open and competitive requirements for its governments’ purchases or may be favoring a particular supplier.
There are no dollar requirements or thresholds for the issues we help companies with.  We find that smaller cases can be as important as large ones because our goal is to make the market clear of barriers for present and future trade.

## Submit your complaint to The TCC’s Trade Complaint Hotline:

_**www.trade.gov/tcc**_

**Report a Trade Barrier**

**Notes:**
For your company to start to receive assistance from the TCC, you can easily Report a Barrier on the TCC’s Trade Complaint Hotline, www.trade.gov/tcc

The online hotline was designed to allow you to inform us of a problem you may be facing.  By filling out this short online form, you will obtain access to US Government resources easily and free of charge.  The hotline allows you to e-mail your complaint directly to the TCC from our website.  The TCC help desk reviews complaints daily and assembles all relevant government resources for handling the request.  We place a high priority on responding as soon as possible.

Also on this page there is a a link for our “checklist of common trade problems” which goes into great detail on the types of trade barriers companies encounter.

## Team escalates the issue by bringing the full weight of the U.S Government to resolve the issue

**Additional Diplomatic Tools:**
-   Meetings with foreign officials
**   **Phone calls and letters
-    Non-papers
-    Demarches
-    Visits by Washington officials

**Team uses leverage of relevant trade agreements:**
-   Bilateral discussions
-    Multilateral/ WTO fora
-    FTA negotiations

**Implementation of Action Plan**

**As a last resort:  Team may recommend referral to USTR for WTO Dispute Settlement Body when appropriate**

**Team escalates the issue by bringing the full weight of the U.S Government to resolve the issue**

**Notes:**
The team implements the action plan to resolve, that is, reduce or eliminate a foreign trade barrier.
If necessary: the team monitors the foreign government action or implementation of solution to verify that success was achieved.

## 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.

## 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.

## 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

**Notes:**
In addition to our site’s centerpiece – the on-line trade complaint hotline that I mentioned earlier, where you can identify and report your export problems – the site also contains the full texts of over 270 international trade and related agreements that  can be read or downloaded, as well as Exporter Guides with brief explanations of selected agreements in plain-language summaries.

The site also has a link to WTO standards notifications via the Notify U.S. Web site, to learn about WTO Standards Notifications and get up-to-date news on changes in foreign standards.

The site also has international government procurement notices.  In addition, please consider subscribing to our free weekly e-mail update service called “What’s New” that contains the latest information on U.S. and foreign government practices, trade agreements, and other trade-related developments affecting access to foreign markets by U.S. companies.

The TCC site also links to www.stopfakes.gov – which provides information on how you can learn to protect or obtain IPR in the US or overseas, or to file a complaint.  You can also call 1-866-999-HALT to speak to a trade specialist, file a complaint, or request assistance with IPR problems.

## Contact the TCC at:www.trade.gov/tcc Email:  tcc@mail.doc.govPhone: 202-482-1191Fax: 202-482-6097Fernando Sanchez202-482-2305fernando.sanchez@mail.doc.gov

**Notes:**
Thank you very much for your attention today. 

## Switzerland:Burdensome 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.

**Notes:**
Switzerland – Burdensome Diesel Filter Regulation 
A U.S. automotive industry association expressed concern over a draft Swiss ordinance, which would effectively create unique and burdensome emissions standards in Switzerland requiring the use of special filters on all diesel passenger cars.  The U.S. Government raised the issue with the Swiss Government at the WTO Technical Barriers to Trade Committee, questioning whether the new methodology prescribed by the standard was based on sound science and its consistency with international standards.  Subsequently, Switzerland rejected the draft ordinance. 

## Outline

- The Trade Compliance Center and the Commerce Trade Agreements Compliance Program
- Identifying Foreign Trade Problems
- How We Take Action
- Resources Available

**Notes:**
The TCC’s mission is to assist U.S. exporters who are facing foreign trade barriers or unfair foreign trade practices.

I plan to describe the program the TCC coordinates, the Commerce Trade Agreements Compliance Program, and explain what this Program can do for companies who are experiencing market access problems as the result of a country not living up to its international trade obligations.

I’ll also talk about how to identify common trade problems, and the process we use to help companies that have encountered a foreign trade barrier, and about more information and resources.

And I’ll also provide a real life example of a foreign trade problem a U.S. company encountered and how we helped resolve the issue.

## Trade Compliance CenterMaking America’s Trade Agreements Work For You!

- The TCC coordinates Commerce’s 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.

**Notes:**
The Trade Compliance Center is the U.S. Government's focal point for monitoring foreign compliance with trade agreements, and to see that U.S. firms and workers get the maximum benefits from these agreements.

The TCC was set up in 1996 to ensure a systematic approach to monitoring foreign trade agreements obligations, and to ensure that compliance problems are addressed promptly.  

This office is responsible for coordinating the Commerce Trade Agreements Compliance Program.  This program is designed to work with companies of all sizes. We are specifically targeting our services to small and medium-size firms. We know you don’t have a lot of time to study trade agreements or figure out how to help your company deal with foreign government obstacles or trade barriers.  So we will find the right team of Commerce Department and other US government experts to assist you with your particular need or problem.  

Our goal is to help you identify and overcome foreign trade barriers by developing a strategy together with you and setting up attainable goals for success.