自由貿易協定下TRIPS-Plus與藥品相關之規定和藥品可近性永續關係之研究:兼論台灣與泰國對美貿易談判之啟示

The Study of Sustainable Accessibility to Medicines under TRIPS-Plus and Pharmaceutical-related Provisions in FTAs: Modality for FTA and TPP Negotiations of Taiwan and Thailand with the US

陳光合(Nattapong Suwan-in, Esq.)

指導教授 ： 謝銘洋教授

國立臺灣大學/法律學院/法律學研究所/博士(2015年)

https://doi.org/10.6342/NTU.2015.10679

摘要

摘要

平衡藥廠產業的利益與一般人民近用藥物之公共利益對於科技發展強勢的國家而言(如美國)一直是個爭議的話題。尤其是自從多方談判轉至雙方談判之層面，而美國現行採用此談判方式主張較嚴格、較高標準的專利保障—即最近出現在諸多自由貿易協定裡的TRIPS-Plus條款，此等問題更發展至相當嚴重之結果。

自TRIPS智慧財產權協定時代開始，貿易與智慧財產在某程度上逐漸產生關聯，尤以藥物專利最為顯著。有鑒於 i) TRIPS-Plus條款對一般人藥物近用產生不利之影響，且 ii) 美國企圖將其專利體系以雙邊條約方式植入世界各國，此二因素與公共崛起形成相當緊張之關係。回顧我諸多相關之研究，嵌入美國專利體系的TRIPS-Plus條款除帶來藥品高單價、低通用藥品及藥品無可近性之爭議外，根據一些一般被忽略甚至被要求要進一步去證明、查證等等過去發生的經驗之證據，顯示此規範還產生以下重要問題，即 i) TRIPS-Plus條款與美國專利法的相似性，ii) 會員國對於TRIPS第七條及第八條等具平衡功能之規範所能實際執行的層面，及 iii) 這些美式標準的規範及實際影響兩者間的關聯。

透過本篇論文的比較研究美國與越南、新加坡、澳洲、哥倫比亞及南韓簽訂之自由貿易協定，以美國專利法中的Hatch-Waxman法案為例，可清楚發現到，在各國不同背景下實施協訂的內容，其實是無法發生與1984年在美國一樣的運作情形；可見在不同背景、不同國家之市場結構下，是不可能有一體適用之學說產生。而且，事實上諸多條款最終都是犧牲掉人民藥物近用之權利，包括新增具爭議的「藥品訂價之相關規定」在內。研究發現，依據TRIPS-Plus的規定，與藥物近用相關之影響，事實上只出現在某些方面，如將這些已簽訂協定的樣本與其他因素作比較，藥物近用所佔的比率權重相對上是較低的，而這些，至今仍不受法律研究者重視。

在現今區域貿易合作再次受到全球矚目之時，為了台灣及泰國未來談判之預備，本篇論文之見解，乃針對兩國，不以與美國或在跨太平洋夥伴協定論壇為限，在未來自由貿易協定或區域貿易協定裡接觸到有關專利法及新增「藥品訂價之相關規定」時，可為國家之健保及永續發展等相關政策作準確的評估及判斷。從本篇論文被節錄進來的樣本裡可發現，美國所提出的貿易協定其實具有多種模式，我們可以依據國家開發之程度所能預見之衝擊來評估兩國與對美國未來談判之方向。而且，從條約的解釋工具來看—以維也納條約法公約為例，在WTO架構之下，本篇見解也較能減輕衝擊並適應各國獨特的市場環境。

關鍵字

自由貿易協定 ； TRIPS-Plus ； 藥品相關規定 ； 藥品可近性 ； 台灣自由貿易 ； 泰國自由貿易 ； 專利保護標準 ； TPP

並列摘要

ABSTRACT

The balance of innovation in pharmaceutical industry and public interest in accessing to medicines has long been a subject of standing controversy in developing countries and a technologically powerful state such as the US. Especially at this time when forum shifting is now used to introduce a stricter and higher standard of patent protection, known in the name of TRIPS-Plus that appears in many FTAs, the problem becomes very serious and severe in effect.

To the extent that trade is made related to intellectual property, particularly patent in the context of drugs, started since the TRIPS era, there has been being fears among public arisen now and then regarding the i) the negative effects of TRIPS-Plus provisions to people’s access to medicines and ii) the US’s attempt in introducing its patent system worldwide via bilateral trade agreement. Through my review of various researches available, following their arguments that the American template of patent law embedded in TRIPS-Plus would invariably bring higher prices of drugs, lower generic medicines, and worsen accessibility of people, there are yet important questions on i) the similarities of TRIPS-Plus provisions and the US’s patent law, ii) the balancing function of the law, in pursuit of TRIPS Articles 7 and 8, practically enforced in Member states, and iii) the correlation between the American standard of protection and actual impacts, basing on empirical evidences, generally be omitted and required to be further proved and studied.

Via my comparative study of the US-FTAs previously made with Vietnam, Singapore, Australia, Colombia, and South Korea, by analyzing the US’s patent law—Hatch-Waxman Act and its implementation in different countries and in diverse context, it is argued that the US’s patent law cannot likely function as it was meant back in 1984. No one-size-fit-all concept will always work subject to different background and different market structure of different states. There are in fact various factors, including the problematic pharmaceutical provisions newly added to the FTAs, that all contribute to the problem of accessibility to medicines of people. The research outcome shows that the TRIPS-Plus provisions are actually related to the accessibility in only some dimensions. Its weighting ratio on the negative effects produced is thus lower in the sample FTA countries comparing to other factors. These are barely mentioned in legal research.

In this time when regional trade collaboration again captures global attention, to prepare Taiwan and Thailand for the path of future trade negotiations, either unilaterally made with the US or even in the TPP forum, it is argued by view of this paper that it is significant for the two countries to estimate accurate impacts resulted from both the patent as well as the newly added pharmaceutical provisions in the FTA or RTA in advance as they are related to states’ healthcare policy and the countries’ sustainable development. Found in the research, there are trends that can be extracted from the previous samples that can likely anticipate their future impacts. Through the use of treaty interpretative tool such as the VCLT, it is expected that the impacts can also be mitigated to fit with the countries’ unique market environment, a modality in favor of pro-development approach that should be legitimately permitted under the framework of WTO.

並列關鍵字

TRIPS-Plus ； US-FTA ； accessibility to medicines ； impacts of TRIPS-Plus provision ； impacts of pharmaceutical provision ； patent protection in free trade agreement ； TPP ； patent standard ； TRIPS-Plus and drug price

參考文獻

REFERENCES

I. THAI

1. Dental Center (Chiang-Mai University), Table of Comparison of the SSS and UCS Benefit Schemes (2011), http://www.dent.cmu.ac.th/mis/dis/UserFiles/File/dental_center/comparegoldandsso.pdf, last visited Oct. 31, 2014.

2. Health Systems Research Institute, Report of the Research and Study for Development of Drug Price Policy in Thailand (2012), http://kb.hsri.or.th/dspace/bitstream/handle/11228/3682/hs1977.zip?sequence=2&isAllowed=y, last visited Oct. 14, 2014.

1. Food and Drug Administration, Procedures of Drug Selection for Enlisting on the National List of Essential Medicines B.E. 2554, http://drug.fda.moph.go.th:81/nlem.in.th/principles/medicine/procedure, last visited Oct. 18, 2014.