<p> </p><p> </p><div id="editor_note"> <p>由美國1988「綜合貿易及競爭力法（Omnibus Trade and Competitiveness Act）」規定，美國貿易代表署（USTR）製作的〈<a href="https://ustr.gov/sites/default/files/2016-NTE-Report-FINAL.pdf" target="_blank">THE 2016 NATIONAL TRADE ESTIMATE REPORT</a>〉p.403-p.410台灣篇</p></div><p>美國「2016 年外國貿易障礙評估報告（NTE）」，<a href="http://www.trade.gov.tw/App_Ashx/File.ashx?FilePath=../Files/PageFile/9…; target="_blank">中文譯文</a>為台灣駐美代表處經濟組翻譯。</p><p>有關我國內容之中譯文</p><p>駐美國代表處經濟組</p><p>2016 年 3 月 31 日</p><p>一、貿易概況</p><p>2015 年美國貨品出口至臺灣總額為 259 億美元，較上年減少2.8%；同年美國自臺灣進口總額為 407 億美元，較去年同期增加0.3%，對臺灣之貨品貿易赤字為 148 億美元，較上年增加 6.2%。2014 年（最新可得資料）美國服務出口至臺灣之金額為 128 億美元；自臺灣進口服務總額為 75 億美元。同年美國在臺灣直接投資（存量）為 171 億美元，較 2013 年增加 1.6%，主要投資業別為製造業、批發貿易及金融保險。</p><p>二、技術性貿易障礙及食品安全檢驗與動植物防疫檢疫措施</p><p>技術性貿易障礙（TBT）</p><p>食品 — 生物科技強制性標示規定</p><p>臺灣於 2015 年 5 月發布生物科技產品標示規定，涵蓋包裝食品、食品添加劑及散裝食品，規範使用生物科技生產的原料及該原料直接製造而成的高層次加工食品，例如使用基因轉殖玉米所製成的玉米糖漿，必須標示「基因轉殖食品」，但該玉米糖漿所製成飲料則毋需作此標示。標示含量的門檻為 3% （原有規定為 5%），餐廳及供應食物的營業場所均需遵守此規定。包裝食品及食品添加劑的標示規定自 2015 年 12 月 31 日開始實施，散裝食品則分成2015 年 7 月 1 日、10 月 1 日及 12 月 31 日共 3 階段實施。美國持續在 2015 年 10 月 1 日臺美「貿易暨投資架構協定（TIFA）」及1WTO 技術性貿易障礙委員會關切此規定缺乏科學基礎，且將影響貿易，對於執行規定亦不明確。</p><p>臺灣立法院於 2015 年 12 月通過「學校衛生法（School Health Act）」修正案，禁止學校餐點使用含有基因轉殖作物所製成的食材及加工食品。臺灣並未提出本項禁令之科學基礎，一旦生效，將顯著衝擊美國黃豆出口。</p><p>化妝品 — 標示與其他規定</p><p>臺灣「化妝品衛生管理條例」修正草案業於 2015 年 7 月送至行政院審議，在立法院通過此修正案後，臺灣食品藥物管理署將研擬、公告並接受公眾評論管理辦法，包括產品資訊檔案（productinformation files）、產品通知、優良製作準則（GMP）、產品索賠及廣告等。</p><p>利害關係人關切該修正案通過後，業者將增加許多負擔，包括需要在上市前廣泛提供可能含機密商業資訊（CBI）的文件，以及自目前上市前核准過渡至修正草案擬實施之上市後監督期間，這兩套系統對化妝品業者造成重複的守法成本。美國在 TIFA/TBT 工作小組、WTO/TBT 委員會及業者座談會中，均鼓勵臺灣將業界意見納入修法過程，並在立院通過該修正案後，相關實施管理辦法須提供合理評論期予 WTO 會員。</p><p>美方利害關係人另關切數項藥妝產品，包括牙膏、口腔清新劑及防曬乳等將受到負面影響。美國 2015 年出口化妝品、清潔及衛生等相關產品至臺灣的總值達到 1 億 6，400 萬美元。</p><p>化學物質</p><p>依據臺灣「勞工安全衛生法」，勞動部規定化學物質的進口商與2製造商均須向勞動部登記販售或生產中使用的全部化學物質。環保署提出的「毒性化學物質管理法」修正案在 2013 年 12 月 11日通過，要求在臺製造、進口或出口既有化學物質及新化學物質均須向環保署申報。臺灣於 2013 年 7 月 3 日通過「勞工安全衛生法」之修法，並更名為「職業安全衛生法」，該法已於 2014 年 7月 3 日生效。</p><p>臺灣於 2014 年 9 月 8 日通報世界貿易組織（WTO）其依據修正後TCSCA 所制訂的「新化學物質及既有化學物質登錄管理辦法」，該辦法納入環保署的既有化學物質（ECN）清單以及未在 ECN 內的新化學物質（NCN）清單，並於 2014 年 12 月 11 日生效。臺灣另於2014 年 10 月 28 日通報 WTO 其依據「職業安全衛生法」制訂的「新化學物質登記管理辦法」，該法納入所有未列在勞動部化學清單中的新化學物質，並於 2015 年 1 月 1 日生效。原先的 ECN及 NCN 均以自願性為原則，惟上述依據「毒性化學物質管理法」及「職業安全衛生法」制訂的辦法實施後，均成為強制性規定。利害關係人關切環保署與勞動部實施的清單，將造成重覆申報的負擔。環保署於 2015 年 8 月宣布，該署將作為兩單位之統一窗口受理案件，此舉為美國 25 億美元的化學品出口減少甚多的文件作業。臺灣是美國無機化學品的第 9 大出口市場，2015 年出口總值達到 8 億 9，700 萬美元。</p><p>美國將持續與臺方討論 CBI 保護及法規涵蓋範圍等問題。環保署於 2015 年 10 月公布釐清相關問題的「常見問答集（FAQ）」，確認申請人得自行認定 CBI 及自願提供相關證明文件。美國將持續與臺灣討論 CBI 保護年限，並尋求延長 CBI 保護的彈性作法。有機產品</p><p>3臺灣法規規定，倘經檢驗出有任何化學藥物殘留，則該產品即不得標示為有機產品。此規定並未將無法排除之非故意環境污染殘留納入考量，並已影響美國有機產品銷臺。有機產品亦面臨額外抽查及抽樣檢測。此外 2015 年 11 月臺灣農業委員會公布有機專法草案，將有機產品（含進口品）之生產、行銷、檢驗與標示納入管理。該項法案要求臺灣給予美國及其他貿易夥伴之有機同等性承認，倘未給予互惠待遇，即將取消原有之有機同等性承認。食品安全檢驗與動植物防疫檢疫措施</p><p>牛肉及牛肉產品</p><p>美國於 2003 年發現牛海綿狀腦病（BSE）後，臺灣禁止美國牛肉和牛肉產品進口。2006 年臺灣允許 30 個月齡以下之美國去骨牛肉進口。2009 年 10 月臺美簽訂「臺美牛肉議定書」，擴大供人食用之美國牛肉和牛肉產品全面輸銷臺灣。惟該議定書生效後，臺灣立法院於 2010 年 1 月「食品衛生管理法」修正案，實質禁止美國牛絞肉、內臟、風險物質等產品輸銷臺灣，違反臺灣在該議定書之義務。此外臺灣宣布額外之邊境措施，包括牛雜輸入許可證規定，並對若干較具敏感性之牛雜（如舌頭）採取更嚴格之檢驗措施，以阻止該等產品進口。臺灣於 2014 年 7 月允許唇、耳、背板筋、腹膈膜及橫膈膜進口，然而其他邊境措施仍阻礙該等產品貿易。美國將會持續促請臺灣基於科學基礎、世界動物衛生組織（OIE）之準則、美國之 BSE 風險可忽略等級及「臺美牛肉議定書」，全面開放美國牛肉和牛肉產品市場。</p><p>乙型受體素 （Beta-agonists）</p><p>2012 年 9 月臺灣就牛肉採行符合食品法典委員會（Codex）之萊克4多巴胺殘留容許量（MRL）標準，惟臺灣拖延實施其在 2007 年向WTO 提出之通知，擬就其他牛肉產品（如牛雜）及豬肉訂定萊克多巴胺 MRL 標準。臺灣表示受制於國內豬肉產業壓力及消費者關切，無法就含萊克多巴胺之豬肉訂定 MRL。除萊劑之外，臺灣亦未訂定其他乙型受體素之 MRL 標準，且未提出零檢出政策的科學評估報告。美國將持續敦促臺灣依據科學證據儘速制定萊克多巴胺及其他乙型受體素之 MRL 標準。</p><p>農業化學品殘留容許量 （MRL）</p><p>臺灣制定農藥 MRL 之程序緩慢，導致 MRL 申請案積案；臺灣對尚未制定 MRL 農藥之零檢出政策已對美國農產品出口造成限制。美國於 2014 年 5 月提供臺灣一份制定 MRL 優先清單，包括超過 250 種化合物。美方將持續與臺灣主管機關合作，以利早日訂定相關農藥之 MRL，俾排除農產品輸入障礙。</p><p>三、進口政策</p><p>關稅</p><p>臺灣於 2002 年 1 月起成為 WTO 會員，就小客車及 24 項農產品實施關稅配額（TRQs），之後陸續取消 8 項農產品關稅配額，尚餘16 項適用關稅配額產之品，包括稻米、花生、香蕉及鳳梨等。臺灣針對數項適用關稅配額之農產品，仍持續採行 WTO 農業協定第 5 條所允許之特別防衛措施（SSG），在進口數量超過 SSG 基準數量，或進口價格低於 SSG 基準價格時，臺灣即可課徵額外關稅。由於上述多項產品臺灣過去並未進口，SSG 之基準數量相對較低，目前臺灣對 15 項農產品適用 SSG，包括禽肉、特定內臟及牛奶等。</p><p>5美方利害關係人持續要求臺灣調降或撤銷若干產品關稅，包括重型機車、農產品及蘇打灰等。農、漁產品</p><p>臺灣在加入 WTO 前，曾禁止 42 項農漁產品進口。2007 年底臺灣撤銷柿子、鯖魚、鰮魚與鰺魚之關稅配額，如前所述，臺灣尚對16 項農產品實施關稅配額。</p><p>稻米</p><p>臺灣在 2002 年加入 WTO 時，承諾取消稻米進口限制，並依「特殊待遇」規定，每年開放 14 萬 4，720 公噸配額數量之稻米進口，臺灣每年 WTO 進口配額分為公部門 65% （94，068 公噸）與私部門35% （50，652 公噸）兩部分。公部門之進口配額又分為國家別配額及 招 標 採 購 形 式 （ 即 買 賣 同 時 決 標 （SBS） 及 一 般 採 購 （normaltenders）兩部分）。美國業者較為偏好 SBS 制度，因為在該制度下，係由民間進口業者負擔進口、倉儲及配銷之所有成本。</p><p>臺灣於 2003 年依國家配額（CSQ）制度執行公部門之進口配額，其中美國配額量為 6 萬 4，634 公噸。惟特定年間臺灣以美國供應商之報價高於其底價為由，未全部完成美國國家配額之採購。美國出口商就臺灣之底價制度表達關切，認為其未對外公布底價機制，自行裁量訂定價格低於美商之標金而導致流標。</p><p>例如 2014 年，臺灣僅順利採購美國國家配額之 4 萬 6，100 公噸美國米，其原因之一即為底價過低。2015 年臺灣全數履行美國國家稻米配額。美國將持續向臺灣強調稻米標售須反映市場價格，以及要求採取更透明化之底價制度。</p><p>蒸餾酒</p><p>6臺灣將料理酒分為兩類，其中一類含鹽，另一類為「料理用酒精產品」，其酒精含量為 20 度以下，並標示「料理專用」。在該分類制度下，米酒每公升課稅新臺幣 9 元，遠低於非料理用酒之每公升含每度酒精課徵新臺幣 2.5 元之稅額。</p><p>美國及其他貿易夥伴持續表達其強烈關切，認為主管機關應採取作為，俾確保國產米酒不會與類似之進口酒品競爭及替代，而且與國產酒品相較，進口酒品不應被課更高的稅額。</p><p>此外，蒸餾酒業持續在臺灣市場面臨法規不確定性、過多限制與標示要求等挑戰。</p><p>五、智慧財產權保護</p><p>權利人持續關切有關著作權、網路盜版、非法影印教科書等侵權議題，另對藥品創新保護、營業秘密保護、IPR 執法部分則表示肯定。我國 2015 年支付美方各式著作權作品之權利金為 1.09 億美元，2006 年至 2014 年間我方支付美方著作權產品權利金之年成長率僅 2.1%，遠低於同期間支付其他形式 IPR 權利金年之成長率（16.9%）。</p><p>網路侵權形式多元，包括以檔案分享及使用存有侵權內容物之媒體盒（media box）或桌上機（OTT hardware）之方式。2009 年立法院已通過著作權法修正案，要求 ISP 業者採取強有力之「通知與取下」行動，以遏止網路侵權，並免除 ISP 業者因用戶違法侵權而負連帶責任，臺灣尚未有效執行該法律；智慧局多次就強化取締網路侵權之方式與 ISP 業者及權利人召開多次會議，雙方已達成共識。臺灣教育部回應美方有關非法影印教科書議題之關切，2015 年教育部與權利人召開會議，以討論提升校園 IPR 保護之相關方案。使用媒體盒透過網路接收侵權內容仍為美方主要關切，7智慧局關切此類產品之販售，並與出口此類產品之貿易夥伴進行溝通，惟仍未能徹底解決本項議題。</p><p>臺美雙方透過 TIFA 會議討論有關營業秘密竊取相關議題，美方歡迎臺灣就此議題推動相關立法。臺灣立法院業於 2013 年 1 月通過「營業秘密法」修正案，大幅加重對盜取公司營業秘密之罰則；2014 年 1 月通過「通訊保障及監察法」修正案，強化執法單位對於營業秘密犯罪案件之調查能力；同年 5 月通過「智慧財產案件審理法」修正案，要求營業秘密案件之被告提出具體答辯；另立法院尚未審議有關 2015 年 4 月擴大營業秘密適用證人保護法之修正案。臺灣在營業秘密保護雖有前述正面發展，惟囿於原告對於案件證據取得日益困難，該等案件於臺灣法院有時亦難以成案。臺美雙方於 2015 年進行有關營業秘密保護、調查、起訴、裁定等相關議題交流，本（2016）年亦將持續辦理。</p><p>2014 年臺灣承諾推動藥品專利連結制度，以及研議將生物製劑涵蓋於資料專屬保護範疇之內，隨後於 2015 年及本年初提出藥事法相關修正草案及召開公聽會。另權利人持續關切保智大隊於 2014年 1 月改制後是否仍有足夠人力及資源。</p><p>六、服務業障礙</p><p>銀行服務</p><p>2013 年臺灣金管會表示將允許在臺外國銀行可同時擁有子行及分行執照，但要求同時擁有兩執照者，須避免其分行主要業務範圍與子行重覆，包括企業融資及對大企業之衍生服務。</p><p>臺灣於 2014 年 5 月 6 日實施「金融機構作業委託他人處理內部作業制度及程序辦法」，解除先前規定銀行須在臺設立獨立境內資8料中心（stand-alone onshore data centers）之要求。</p><p>證券服務</p><p>2012 年 12 月金管會表示將修改管理措施，針對符合其設立境內資料中心之外國信託基金提供優惠發照待遇。2014 年 11 月金管會宣布，為鼓勵外資對臺灣市場之長期投資，將境外基金國人投資比重，自 70%調降至 50%，在某些情況下可降至 40%。境外基金業者未符合「鼓勵境外基金深根計畫」之條件，包括在臺設立據點、投資我國投信基金額達 40 億元新臺幣，及聘雇一定人數之臺灣人才等，而無法受惠各項優惠措施者，亦適用此 50%之上限。迄 2015 年 12 月，2 項境外基金符合前述條件，7 項境外基金獲得1 年寬限期至 2016 年 9 月 30 日，金管會將每年審查這些基金之優惠資格。根據金管會統計，迄 2015 年 9 月，共 48 項境外基金不符合本計畫之條件。</p><p>電信</p><p>電信業（無線及有線）外資直接加間接持股比例上限為 60%，其中直接投資上限為 49%。對交通部擁有部分股權的中華電信則另訂規範，中華電信擁有臺灣 97%固網通訊市場，其外人直接加間接投資之總上限於 2007 年 12 月調升為 55%，其中包括 49%之直接投資上限。</p><p>付費電視服務</p><p>有線廣播電視法限制外人直接投資付費電視之持股上限為 20%，或直接加間接之投資股權上限為 60%，衛星電視之外資持股上限為 49%。</p><p>國家通訊傳播委員會（NCC）於 2012 年 7 月表示將針對採取數位訊9號服務之有線電視業者放寬經營區域限制。臺灣數位電視（DTV）普及率自 2013 年 9 月 38.9%，至 2015 年 6 月已提升至 85%，NCC之目標係於 2017 年達到 100%。專家指出，目前新臺幣 600 元之最高月費限制，有礙臺灣民眾接觸更多及高品質節目。NCC 已宣布將於 2017 年取消最高月費限制，並提供客制化選單付費制度。</p><p>七、投資障礙</p><p>臺灣禁止或限制外人投資部分行業，如農業生產、化學製造、巴士運輸及公用社會服務（包括:公共教育、健康、衛生、育幼、汙水處理與水服務）等。</p><p>電力傳輸配送、天然氣管路傳輸、高速鐵路之外資持股上限為49%；航空公司、航空站地勤、承攬、航空貨運站、空廚及航空貨運承攬業之外資持股上限仍為 49.99%，個別外資持股上限為25%。</p><p>在 2015 年 10 月 TIFA 會議中，美方關切臺灣投資審查程序之透明性及一致性。臺灣提案修正「外國人投資條例」以促進外來投資，修正內容包括取消投資額在 100 萬美元以下者之事前審核程序等。但立法院迄 2015 年會期結束為止，尚未通過前述修正。</p><p>八、其他障礙</p><p>藥品</p><p>美方利害關係人持續要求臺灣健保制度對於藥品（包括新藥）之定價及給付政策賦予更多之透明度及可預測性，2015 年 7 月，臺灣衛福部宣布將原試辦之藥品費用支出目標（drug expenditure target，DET）計畫展延 2 年（2015-2016），此項 2013 年展開之計畫係改良先前較不具預測性之藥價調查制度（price volume survey system），10然而美方仍有以下關切:DET 計畫對於給付專利藥品之待遇不一致、如何計算年度藥品費用支出目標，以及不清楚若超出支出目標時衛福部將採取哪些行動。</p><p>美方鼓勵臺灣增加定價及給付政策之透明度及可預測性，並持續提供各利害關係人表達意見之機會，以兼顧病人權益及支持創新。2015 年美國出口至臺灣藥品總值達 3 億 7 千 1 百萬美元。</p><p>醫療器材</p><p>臺灣係美國醫療器材出口之主要市場，2014 年總值達 2 億 6 千 4百萬美元。美方持續關切臺灣針對相關產品之上市許可及價格審查機制。醫療器材輸入製造廠品質系統文件（QSD）在臺灣須強制註冊，不論該醫療器材是否已在臺灣上市，且每 3 年需重複註冊，雖然食藥署已就醫療器材之審查提供快速申請程序，美國業者仍持續關切這些文件要求。</p><p>二代健保中納入自費及差額負擔（balance billing）機制允許部分病患選擇政府未完全給付之醫療器材，惟中央健保署目前給付範圍並不包括植入性器材。業者必須為該類器材與許多未納入給付之一般性器材先申請自費代號（self-pay code），惟此項選擇目前並不適用於許多其他非植入性器材中。無自費代號之器材均不得在臺灣販售，違反規定醫院將受到健保署處罰。為加快核發自費代號，健保署已自 2014 年 4 月起，針對緊急或需求量大之醫療器材，於接獲申請後 2 個月內核發暫時性自費代號。由於健保署須待審查過新醫療程序後才會核發新醫療器材之暫時性自費代號，業者建議針對新醫療程序亦核發暫時性自費代號，以讓病人更快使用新醫療器材。</p><p>112013 年 1 月引進差額負擔制度後，健保署有權設定病人差額負擔之上限，惟應確保相關機制之透明度及合理程序，且該機制恐無法有效辨別不同器材之成效。健保署已於 2014 年設立相關網站，供消費者比較不同醫院之器材費用，既可回應消費者顧慮，亦無須設定平均差額負擔上限，係一正面發展。美方利害關係人持續敦促健保署對於屬相同功能類別之產品取消差額負擔上限，及採取更為彈性之作法以允許醫院設定費率。12</p><p>TAIWAN TRADE SUMMARY</p><p>The U.S. goods trade deficit with Taiwan was $14.8 billion in 2015, a 6.2 percent increase ($868 million) over 2014. U.S. goods exports to Taiwan were $25.9 billion, down 2.8 percent ($741 million) from the previous year. Corresponding U.S. imports from Taiwan were $40.7 billion, up 0.3 percent. Taiwan was the United States' 14th largest goods export market in 2015.</p><p>U.S. exports of services to Taiwan were an estimated $12.8 billion in 2014 (latest data available), and U.S. imports were $7.5 billion. Sales of services in Taiwan by majority U.S.-owned affiliates were $7.2 billion in 2013 (latest data available), while sales of services in the United States by majority Taiwan-owned firms were $2.3 billion.</p><p>U.S. foreign direct investment (FDI) in Taiwan (stock) was $17.1 billion in 2014 (latest data available), a 1.6 percent increase from 2013. U.S. direct investment in Taiwan is led by manufacturing, wholesale trade, and finance/insurance.</p><p>TECHNICAL BARRIERS TO TRADE / SANITARY AND PHYTOSANITARY BARRIERS</p><p>Technical Barriers to Trade</p><p>Food – Mandatory Biotechnology Labeling</p><p>New biotechnology labeling regulations for prepackaged foods, food additives, and unpackaged foods were promulgated on May 2015. The regulations cover highly refined foods that are “directly” manufactured using biotechnology crops. For example, Taiwan has said corn syrup, made of biotechnology corn, must be labeled GE (genetically engineered), whereas a beverage made with corn syrup is exempt from GE labeling. The regulations impose a three percent labeling threshold (down from the previous five percent) for products containing biotechnology material. These regulations cover restaurants and catering establishments. The labeling requirements for prepackaged foods and food additives were implemented on December 31, 2015, and the requirements for unpackaged foods were implemented in three phases concluding on July 1, October 1, and December 31, 2015, respectively. The United States has continued to raise the lack of scientific basis for these labeling requirements, the potential impact on trade, and lack of clarity with respect to implementation at the October 1, 2015 Trade and Investment Framework Agreement (TIFA) Council meeting and WTO TBT Committee.</p><p>In December 2015, the Taiwanese legislature passed amendments to the School Health Act that would ban the use of biotechnology food ingredients and processed food with biotech ingredients in school meals. Taiwan has not provided any scientific basis for this ban. Once this policy takes effect, this ban could significantly impact U.S. soy exports.</p><p>Cosmetics – Labeling and Other Requirements</p><p>Draft amendments to Taiwan’s Cosmetic Hygiene Control Act were sent to the Executive Yuan, Taiwan’s cabinet, for review in July 2015. The Taiwan Food and Drug Administration (TFDA) is drafting guidelines that are anticipated to address requirements for product information files (PIF), product notification, good manufacturing practices, product claims, and advertisements, which would be issued for public comment after the Legislative Yuan approves the amendments.</p><p>Stakeholders have raised concerns that the amendments, if approved, would place an onerous burden on industry by requiring extensive pre-market documentation submissions, including documents that might contain confidential business information (CBI). Under the proposed amendments, during the transition from a pre-market approval to a post-market surveillance system, both systems would be in effect, creating a duplicative compliance burden for cosmetics businesses. The United States, through its TIFA TBT Working Group with Taiwan, WTO TBT Committee discussions, and seminars with U.S. businesses, has encouraged Taiwan to engage with industry on the draft amendment and provide a reasonable interval for WTO members to comment after the Legislative Yuan approves the draft.</p><p>U.S. stakeholders have expressed concerns that trade in medicated cosmetic products, including toothpaste, breath fresheners, and sunscreen, might be adversely affected under the amendments. U.S. exports of beauty products, makeup, hair, bath and shaving preparations, dental hygiene products, and related materials totaled $164 million in 2015.</p><p>Chemical Substances – ECN and NCN Programs</p><p>Under the Labor Safety and Health Law (LSHL), importers and producers of chemical substances must register all chemical substances they sell or utilize in production with the Ministry of Labor (MOL, known prior to February 2014 as the Council of Labor Affairs, or CLA).</p><p>Amendments to the Toxic Chemical Substances Control Act (TCSCA), drafted by the Environmental Protection Agency of Taiwan (EPAT), were passed on December 11, 2013. The amended TCSCA covers existing and new chemical substances that are manufactured in, exported from, or imported into Taiwan. The amended TCSCA mandates registering existing chemical substances with EPAT under an Existing Chemical Notification (ECN) program and new chemical substances under a New Chemical Notification (NCN) program. On July 3, 2013, Taiwan’s Legislative Yuan passed amendments to the LSHL and renamed it the Occupational Safety and Health Act (the OSH Act), which became effective on July 3, 2014.</p><p>On September 8, 2014, Taiwan notified the WTO of its draft “Regulation of New and Existing Chemical Substances Registration,” enacted pursuant to the amended TCSCA. This regulation covers existing chemical substances listed in EPAT’s ECN inventory, as well as new chemical substances not listed in the ECN inventory. This regulation became effective on December 11, 2014. On October 28, 2014, Taiwan notified the WTO of its draft “Regulation of New Chemical Substances Registration,” enacted pursuant to the OSH Act and covering any new chemical substances not listed in the existing MOL chemical inventory.</p><p>This regulation became effective on January 1, 2015. While previous ECN and NCN programs permitted implementation on a voluntary basis, separate ECN/NCN registrations under the TCSA and OSH Act implementing regulations both became mandatory from their entry into force. In response to stakeholder concerns that duplicative EPAT and OSHA listings create undue burdens, in August 2015 EPAT announced that it would serve as a consolidated single registration window. This step, taken in response to U.S. advocacy through the TIFA TBT Working Group, industry seminars, and other fora, has reduced regulatory complexity associated with $2.5 billion in U.S. chemical exports. Taiwan is the United States’ 9th largest market for inorganic chemicals, worth $438 million in 2015, and the 14th largest market for organic chemicals, worth $897 million in 2015. Sales of other chemical products reached an additional $547 million in 2014.</p><p>The United States has continued to raise questions regarding the protection of confidential business information and the scope of coverage of the revised regulations. EPAT released a set of frequently asked questions in October 2015 aimed at clarifying the implementing regulations, including procedures related to CBI protection, in which EPAT affirmed that applicants are allowed to self-certify CBI and that submission of supporting documents is voluntary. The United States will continue to raise concerns with Taiwan on the limited duration of CBI protection and seek greater flexibility in extending the CBI protection term.</p><p>Organics</p><p>Taiwan regulations do not allow product labeled as organic to test positive for any chemical residues. This zero residue policy, which does not take into account unintentional environmental contamination, has impeded U.S. organic exports to Taiwan. Organic products may be subject to additional and random testing or screening. In addition, in November 2015, Taiwan’s Council of Agriculture released draft legislation regarding the production, marketing, testing, and labeling of organic products, including imported products. The legislation further mandates that the organic equivalency that Taiwan grants the United States and other trading partners become reciprocal or be retracted.</p><p>Sanitary and Phytosanitary Barriers</p><p>Beef and Beef Products</p><p>Taiwan banned imports of U.S. beef and beef products following the detection of an animal with bovine spongiform encephalopathy (BSE) in the United States in 2003. In 2006, Taiwan began allowing imports of U.S. deboned beef derived from animals under 30 months of age. In October 2009, the United States and Taiwan reached an agreement on a protocol to expand market access to fully re-open to U.S. beef and beef products for human consumption. However, in January 2010, Taiwan’s Legislative Yuan adopted an amendment to the Food Sanitation Act that banned imports of U.S. ground beef, internal organs and eyes, brains, spinal cord, and skull meat for at least 10 years since the last confirmed BSE or variant Creutzfeldt- Jakob disease case, contrary to Taiwan’s obligations under the 2009 beef protocol. Taiwan announced additional border measures, including a special import licensing scheme for permitted offals, and imposed stricter inspection requirements for certain “sensitive” beef offals (e.g., tongue) that discourage trade for eligible items. In July 2014, Taiwan confirmed market eligibility for U.S. beef lips, ears, backstrap, skirt sinew, and tunic tissue, though barriers such as batch-by-batch inspections discourage trade. The United States will continue urging Taiwan to open its market fully to U.S. beef and beef products based on science, World Organization for Animal Health (OIE) guidelines, the United States’ negligible risk status, and the beef protocol.</p><p>Beta-agonists</p><p>In September 2012, Taiwan adopted and implemented a maximum residue limit (MRL) for ractopamine in beef muscle cuts consistent with the Codex Alimentarius Commission standard. Taiwan has not implemented an MRL for ractopamine in other beef products (e.g., offal) or pork, despite notifying the WTO in 2007 of its intent to do so. Taiwan authorities state that pressure from the local pork industry and consumer groups prevent their establishment of an MRL for pork. Apart from ractopamine, Taiwan has also not established MRLs for other beta-agonist compounds or provided science to support its policy. The United States will continue urging Taiwan to implement the remaining proposed MRLs for ractopamine without delay, and accept and approve new applications for MRLs for beta-agonists based upon science in a timely manner.</p><p>MRLs for Agrochemicals</p><p>Taiwan’s slow process for establishing MRLs for pesticides, low number of approved MRLs, and zero tolerance policy for pesticides without established MRLs have resulted in U.S. shipments stopped at ports of entry and other restrictions on U.S. agricultural exports to Taiwan. In May 2014, the United States provided Taiwan authorities with a prioritized list for MRLs for more than 250 chemicals. The United States will continue working with Taiwan authorities to establish MRLs for pesticides that do not currently have an approved MRL in Taiwan and find ways to further reduce the risk of rejected or delayed shipments in the future.</p><p>IMPORT POLICIES</p><p>Tariffs</p><p>When Taiwan became a WTO Member in January 2002, the authorities implemented tariff-rate quotas (TRQs) on small passenger automobiles and 24 agricultural products. Taiwan subsequently eliminated TRQs for eight of those agricultural products. TRQs remain on 16 agricultural products, including rice, peanuts, bananas, and pineapples.</p><p>Taiwan maintains special safeguards (SSGs) for a number of agricultural products covered by TRQs. SSGs, which are permitted under Article 5 of the WTO Agreement on Agriculture, allow Taiwan to impose additional duties when import quantities exceed SSG trigger volumes or import prices fall below SSG trigger prices. Because Taiwan previously did not import many of these products, its SSG trigger volumes are relatively low. Currently, Taiwan applies SSG provisions to 15 agricultural product categories, including poultry meat, certain types of offal, and milk.</p><p>U.S. stakeholders continue to request that Taiwan lower or eliminate tariffs on many goods, including large motorcycles, agricultural products, and soda ash.</p><p>Agriculture and Fish Products</p><p>Prior to joining the WTO, Taiwan banned or restricted imports of 42 agriculture and fish products. At the end of 2007, Taiwan phased out TRQs for persimmons, mackerel, carangid, and sardines. As noted above, 16 agricultural products still are subject to TRQs.</p><p>Rice</p><p>Upon accession to the WTO in 2002, Taiwan committed to lifting the ban on rice imports and opened an import quota of 144,720 metric tons (MT) on a brown rice basis under a “special treatment” regime. Taiwan’s annual WTO TRQ is divided into two portions: 35 percent or 50,652 MT for private sector imports, and 65 percent or 94,068 MT for public sector imports. The amount allocated to public sector imports is divided by both country of origin and tender type (i.e., the simultaneous buy-sell (SBS) scheme and normal tenders). The SBS scheme is attractive to U.S. exporters because private importers bear all costs of importing, storing, and distributing the rice.</p><p>In 2003, based on input from the United States and other WTO members, Taiwan implemented a public sector import quota based on a country-specific quota (CSQ) regime, with the U.S. quota of 64,634 MT accounting for the largest share. However, in certain years Taiwan has rejected bids for U.S. rice under its WTO CSQ, arguing that high U.S. prices had exceeded Taiwan's ceiling price. U.S. exporters have raised concerns that Taiwan’s ceiling price mechanism, which is not made public, arbitrarily sets prices lower than the levels bid by U.S. exporters, causing the tenders to fail.</p><p>For example, in 2014, out of the total CSQ allotted to the United States, only 46,100 MT were successfully awarded for U.S.-origin rice. One reason for this shortfall is that multiple tenders failed due to low ceiling prices. Taiwan did complete the 2015 CSQ for both normal and SBS tenders. The United States will continue to underscore to Taiwan that rice tenders should reflect the market price and to press for greater transparency in its ceiling price mechanism.</p><p>Distilled Spirits</p><p>Taiwan categorizes cooking wine into two subgroups, one group with a salt content requirement, and the other under “cooking alcoholic products” for products with alcohol content no greater than 20 percent and labeled “exclusively used for cooking.” Based on these specifications, mijiu rice wine under these categories is taxed at NT$9 ($0.30) per liter, a much lower tax rate than that applied to non-cooking alcoholic products, NT$2.5 ($0.08) per liter per degree (percentage) of alcohol content.</p><p>The United States and other trading partners continue to express their strong concerns to the Taiwan authorities that steps should be taken to ensure that the domestic mijiu rice wine is not marketed to compete with, or substitute for, like imported alcoholic beverages, and that imported alcoholic beverages should not be taxed at a higher rate than like domestically produced alcoholic beverages.</p><p>The distilled spirits industry also continues to face challenges in the Taiwan market stemming from unclear regulations, excessive restrictions, and burdensome labeling requirements.</p><p>INTELLECTUAL PROPERTY RIGHTS PROTECTION</p><p>Intellectual property rights holders face serious challenges in Taiwan’s overall protection and enforcement of intellectual property, including with respect to copyright, online piracy, and illegal textbook copying. In the areas of protecting and promoting pharmaceutical innovation, trade secrets protection and IPR enforcement, Taiwan authorities have taken important steps in recent years to address key concerns.</p><p>Taiwan payments to U.S. rights holders for the use of movies and television, books and sound recordings, and related copyrighted works were worth $109 million annually as of 2014; however, the compound annual growth rate in Taiwan payments of 2.1 percent for copyrighted materials from 2006-2014, lagged behind payments from Taiwan for other forms of intellectual property, which grew 16.9 percent annually over the same period.</p><p>Infringement of copyrighted material on the Internet takes various forms, including file sharing and the use of unregulated media box or over-the-top (OTT) hardware that may contain or facilitate the user’s access via the Internet to pirated content. Taiwan’s Copyright Act was amended in 2009 to require Internet service providers (ISPs) to undertake effective notice-and-takedown actions and introduce a graduated response system against online infringers as a condition of avoiding liability for infringing activities of users on their networks. While implementation of the notice-and-takedown system has been effective, Taiwan has yet to implement effectively the graduated response provisions under the Copyright Act amendments. Meetings convened by the Taiwan Intellectual Property Office (TIPO) between ISPs and rights-holders aimed at producing a consensus on specific measures to address repeat infringement have been successful. In response to U.S. efforts to seek redress of publishers’ concerns over continued textbook copying and new forms of infringement related to digital educational content, Taiwan’s Ministry of Education (MOE) in 2015 held meetings with rights holders to consider recommendations on improvements to on-campus IPR protection, including on MOE administered networks. However, these discussions have yet to translate into new policies.</p><p>Serious concerns remain with regard to media box devices that facilitate infringement via Internet links to pirated content. TIPO has increased outreach to law enforcement bodies on media box piracy in an attempt to mount an effective response to this new form of infringement, with a focus on retailers that overtly advertise media boxes as being sold for purposes of accessing infringing content. Taiwan has also taken steps to engage with governments which reportedly host exporters of the devices. However, these positive efforts have not fully addressed the problem, particularly with media box devices that may be shipped via couriers and that do not overtly advertise the hosting of infringing content.</p><p>Through the TIFA, the United States and Taiwan have engaged on effective responses to trade secrets misappropriation. The United States has welcomed the legislative steps that Taiwan has taken in recent years to improve protections against trade secrets misappropriation and theft of trade secrets from major foreign and Taiwan businesses. The Legislative Yuan amended Taiwan’s Trade Secrets Law in January 2013 to provide more deterrent, enhanced penalties for trade secrets misappropriation. Under January 2014 amendments to Taiwan’s Communications Protection and Surveillance Act, law enforcement bodies were also given additional enforcement tools to deal with trade secret theft. Additionally, May 2014 amendments to the Intellectual Property Case Adjudication Act oblige defendants in lawsuits concerning trade secrets to submit substantive defenses. April 2015 amendments to the Witness Protection Act that extended coverage to witnesses in trade secrets cases were pending review by the Legislative Yuan. Despite these positive steps, it remains difficult to pursue civil trade secret actions in Taiwan courts, in part due to continuing challenges in developing and securing access to evidence that is critical to plaintiffs. In 2015, the United States and Taiwan conducted exchanges on trade secrets protection, investigation, prosecution and adjudication, and will continue these exchanges in 2016.</p><p>In 2014, Taiwan authorities also took positive steps in the direction of enhancing patent and test data protections for innovative pharmaceutical products in certain respects by committing to establish a patent linkage system and study expanding the scope of regulatory data protection to cover a broader range of innovations in pharmaceuticals and biologics. In 2015 and early 2016, Taiwan authorities commenced drafting of and held a series of public hearings on amendments to the Pharmaceutical Affairs Act that would implement these commitments.</p><p>Taiwan’s Intellectual Property Rights Police completed a restructuring on January 1, 2014 into a Criminal Investigative Brigade (CIB), with the stated intent of improving operational capacity, as well as coordination and cooperation with other enforcement agencies. Rights holders raised concerns over reduced staffing and the small number of enforcement actions, which the United States raised with Taiwan in 2014 and 2015 TIFA engagements. The CIB has reported increased seizure values, and that after a significant dip in value in 2014, the volume and value of both trademark and copyright cases in 2015 exceeded the level in 2013.</p><p>SERVICES BARRIERS</p><p>Banking Services</p><p>In 2013, Taiwan’s banking regulatory body, the Financial Supervisory Commission (FSC) indicated that it would allow foreign banks in Taiwan to keep both their subsidiary and branch operations, but asked that foreign banks’ branches limit their primary business scope to areas that do not overlap with those of the subsidiaries, including corporate finance and derivatives services for large companies.</p><p>In May 2014, Taiwan authorities implemented the “Regulations Governing Internal Operating Systems and Procedures for the Outsourcing of Financial Institution Operation,” which lifted previous requirements that both local and foreign banks establish standalone onshore data centers.</p><p>Securities Services</p><p>In December 2012, the FSC announced that it would adopt a differential management approach and provide preferential licensing procedures for foreign trust fund companies that meet FSC’s localization standards. In November 2014, FSC announced new measures to promote long-term investment in the Taiwan market by lowering the ceiling for Taiwan investors’ share of an offshore fund from 70 percent to 50 percent, and down to 40 percent in some cases. The lower ceiling levels would apply if the offshore fund does not meet certain qualifications for the preferential management scheme, such as establishing a local presence, investing an average of NT$4 billion ($127.5 million) in onshore funds, and recruiting a certain number of Taiwan staff. As of December 2015, two offshore funds have met these criteria and seven others received a one-year grace period until September 30, 2016. FSC will review these funds’ preferential status annually. According to FSC statistics, as of September 2015, 48 offshore funds in Taiwan do not meet the criteria.</p><p>Telecommunications</p><p>The combined direct and indirect foreign ownership limit for wireless and wire line telecommunications firms is 60 percent, with a direct investment limit of 49 percent. Separate rules exist for Chunghwa Telecom (CHT), the legacy carrier still partially owned by the Ministry of Transportation and Communications. CHT controls 97 percent of the fixed line telecommunications market. For CHT, the cap on direct and indirect foreign investment was raised to 55 percent in December 2007, with a direct investment limit of 49 percent.</p><p>Pay Television Services</p><p>Taiwan’s Cable, Radio, and Television Act restricts foreign investment in cable television broadcasting services to a total equity share of 20 percent for direct investment, or 60 percent for combined direct and indirect investment. Foreign investment in satellite television broadcasting services is limited to 49 percent of the total shares issued.</p><p>The National Communications Commission (NCC) in July 2012 relaxed geographic restrictions on cable franchises for new and incumbent operators that agreed to use digital signals. The cable digital television (DTV) penetration rate rose from 38.9 percent in September 2013 to 85 percent in June 2015, while NCC’s target is to reach 100 percent in 2017. Industry experts point to continuing caps of NT$600 ($20) on monthly cable television fees as hampering public access to a broader range and higher quality of programming. The NCC has announced plans to implement “a la carte” DTV service by 2017, which would remove the cap on monthly fees and allow for differential payment by consumers.</p><p>INVESTMENT BARRIERS</p><p>Taiwan prohibits or restricts foreign investment in certain sectors, including agricultural production, chemical manufacturing, bus transportation, and public social services (including public education, health, child care, sewage, and water services).</p><p>Foreign ownership in power transmission and distribution, piped distribution of natural gas, and high speed railways is limited to 49 percent of the total shares issued. The foreign ownership ceiling on airline companies, airport ground handling companies, forwarders, air cargo terminals, and catering companies is 49.99 percent, with each individual foreign investor subject to an ownership limit of 25 percent.</p><p>In the October TIFA Council meeting, the United States raised the need for transparency and consistency in Taiwan’s investment review process. Taiwan authorities have proposed amendments to the Statute for Investment by Foreign Nationals that aim to bolster inbound investment, including by eliminating pre- investment approval requirements for investments under $1 million. However, the Legislative Yuan did not approve the amendments before the conclusion of its 2015 session.</p><p>OTHER BARRIERS</p><p>Pharmaceuticals</p><p>Stakeholders continue to underscore the need for greater transparency and predictability in Taiwan’s pricing and reimbursement policies for pharmaceuticals, including innovative pharmaceuticals, in Taiwan’s health care system. In July 2015, Taiwan’s Ministry of Health and Welfare announced that it would extend by an additional two years (2015-2016) the pilot drug expenditure target (DET) program. The 2013 introduction of the DET served as an improvement over the less predictable price volume survey system that preceded it. However, there remain concerns over the DET’s inconsistent treatment for reimbursing patented pharmaceutical products, the calculation of annual drug expenditure targets, and confusion over what actions will be taken if targets are exceeded.</p><p>The United States encourages Taiwan to increase transparency and predictability in its pricing and reimbursement policies, while continuing to provide meaningful opportunities for input by relevant stakeholders with a view towards improving patients' access while supporting innovation. U.S. exports of pharmaceutical products to Taiwan were valued at $371 million in 2015.</p><p>Medical Devices</p><p>Taiwan is a major market for U.S. medical device exports, valued at $264 million in 2014. Concerns persist over Taiwan’s product license approvals and pricing review mechanisms. Manufacturing facility (Quality Systems Documentation, QSD) registration is mandatory in Taiwan, regardless of whether a medical device is already on the market or new to Taiwan’s market; and re-registration is required every three years. While TFDA makes available an expedited application process for regulatory review of medical devices, U.S. industry has continued to express concern with the documentary requirements.</p><p>Self-pay and balance-billing are two mechanisms that have been introduced by Taiwan authorities to allow Taiwan patients to have the option of choosing medical devices that are not paid in-full by the authorities. At present, the National Health Insurance Administration (NHIA) does not provide reimbursement for implanted devices. Implants, in addition to a range of other commonly used devices not approved for reimbursement, must instead be issued a self-pay code, but this option is currently not available to a range of other non-implantable devices. Stakeholders report that hospitals that ask patients to self-pay for devices without a code are subject to administrative penalties by NHIA. To expedite code issuance, in April 2014, NHIA began assigning temporary self-payment codes for urgent or high-demand medical devices within two months of application. Temporary self-payment codes for new medical devices cannot be issued until NHIA completes review of new therapeutic procedures in which the device is used, and industry has suggested that issuance of temporary self-pay codes for new procedures are needed to accelerate patient access to new devices.</p><p>The balance billing mechanism, introduced in January 2013, allows partial patient self-pay for high-end devices or new technologies. NHIA has the authority to introduce price caps that apply ceilings on what patients pay on new balance billing items. Transparency and due process mechanisms are critical in this process and stakeholders expressed concern that the current balance billing system does not effectively distinguish among devices of differing effectiveness. In a positive development in 2014, NHIA established a website used to help consumers compare the cost of devices at different hospitals as a way to address a consumer concern without resorting to setting a balance billing cap. Stakeholders continue to urge NHIA to lift balance-billing caps on products with the same functional classifications, and to adopt a more flexible approach in allowing hospitals to set charges.<br> </p>
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